Speaker Biographies

Stephanie Abbott, PharmD, Clinical Research Program Director, Western Washington Medical Group

Dr. Abbott has been a clinical investigator for over 18 years, building clinical research centers in both a regional medical center and an outpatient investigator network. She continues to see patients in her daily practice and is dedicated to the continual improvement of the delivery of clinical trials.

Demissie Alemayehu, PhD, Head, Vice President, Biostatistics, Pfizer

Demissie Alemayehu, Ph.D., is currently Head of Statistical Research and Data Science Center (SRDC) in the Global Biometrics and Data Management organization at Pfizer Inc. He has over 25 years of leadership experience in the pharmaceutical industry, and has held positions of increasing responsibility within Pfizer since 1995. Over the years, he has been involved in extensive regulatory submissions and life-cycle management in major therapeutic areas. Demissie has been influential externally, with decades of research and teaching experience at major institutions, including Western Michigan and Columbia universities. He has held important offices at key professional societies, and has served on editorial boards of major journals. He is an elected Fellow of the American Statistical Association, and holds a Ph.D. degree in Statistics from the University of California at Berkeley. He has published extensively on pertinent statistical topics in refereed journals, and his current areas of focus include precision medicine, Big Data analytics, and health technology assessment.

Elizabeth Allardice, Family Advisory Board, Concussion Legacy Foundation

Elizabeth is a Family Advisory Board member, Concussion Legacy Foundation, former Board Chair, Duke Anesthesiology Dream Campaign, patient advocate, caregiver survivor of Chronic Traumatic Encephalopathy, and active REALTOR/industry leader in the Triangle Area of North Carolina.

Stephen Amato, Director, Pfizer Global Product Development

Dr. Stephen Amato is a Director within Pfizer Clinical Innovation and is currently working to augment the clinical trial process by leveraging mobile technologies to make clinical trial participation more engaging, informative and less burdensome. Prior to joining the mClinical team, Dr. Amato managed the BlueSky project, a collaboration between Pfizer and IBM tasked with using biosensors to develop a remote monitoring platform intended to quantify the physical and physiological signs of people with Parkinson’s disease. Dr. Amato received his Ph.D. in Biology from Boston University and held a postdoctoral fellowship performing novel drug target identification and validation at Pfizer.

Paul Andrews, Planning and Resource Management Head, Business Excellence, UCB Biosciences

Paul Andrews has twenty years of project, program, and portfolio management experience in the biotech, pharma, and CRO sectors of clinical research & development, across multiple therapeutic areas and geographies. He is currently the Global Head of Enterprise Project and Portfolio Management coordination and its global support team for R&D: including cross-functional strategic planning, resourcing and expenditure management for Clinical, Nonclinical, Regulatory Affairs, Drug Safety, Medical Affairs and Market Access. He coordinates the PM Centre of Expertise (R&D PMO) for product project management implementing training and new innovations and efficiencies to accelerate R&D and deliver therapies to patients faster.

Debora Araujo, Founder & CEO, ClinBiz

Débora S. Araujo has over a decade of experience in the pharmaceutical industry working and consulting for Fortune 500 companies. During her time in this industry her special focus has been on the business aspects of clinical trials including: clinical contracting and financial management, clinical outsourcing and CRO/vendor management, global clinical trial budgeting and forecasting, clinical financial analytics and metrics/KPIs, site budget development and negotiations, Fair Market Value (FMV) and global investigator site payments. She has also utilized her expertise and knowledge to drive practical change in this industry via thought leadership material, conference presentations and consulting engagements. Débora’s passion for driving practical change in the industry led her to launch ClinBiz (www.clinbiz.com), an online platform with a dedicated YouTube channel, podcast, blog and much more where clinical research professionals can stay connected and updated on the latest topics, trends and technologies related to the business aspects of clinical trials. Débora has also recently published a book on clinical trial agreement negotiations named ‘The Four Villains of Clinical Trial Agreement Delays and How To Defeat Them’ which quickly became an Amazon’s #1 New Release in the pharmaceutical and biotechnology category.

Mary Arnould, Director, Clinical Science Operations and RBM Lead, Astellas

Mary is Director, Clinical Science Operations and RBM Lead at Astellas. Her pharmaceutical career spanning over 25 years has included site monitoring, site monitoring management, development of technology and process solutions for site monitoring execution and leading RBM implementation efforts. She has been involved in RBM implementation at two pharma companies focusing on process refinement, technology deployment, and change management. Mary is also responsible for other clinical operations support. Mary holds both a BS and MS in Nursing.

Scott Askin, Digital Solutions Director, Digital Development, Novartis

Scott Askin, a Digital Solutions Director with Novartis, leads the company’s digital agenda in the areas of eSource (electronic Source) and electronic Informed Consent (eICF/eConsent), in addition to consulting on other key digital programs within Novartis. Scott has been leading digital projects for over 5 years and is working with strategic partners to drive the adoption of novel technologies across the company and industry. Scott brings with him over 18 years of industry experience and is currently based in Basel Switzerland.

Jiri Aubrecht, PhD, Scientific Director, Translational Biomarker Research, Takeda

Dr. Aubrecht has PharmD in clinical pharmacy and PhD in pharmacology from Charles University in Prague, Czech Republic and completed postdoctoral fellowship in molecular toxicology at the Harvard School of Public Health in Boston, MA. He has experience in academia, biotech and pharmaceutical industry. Currently, he is working as Scientific Director in Translational Biomarker Research at Takeda in Cambridge, MA and has appointment as adjunct professor at Georgetown University Medical School in Washington, DC. Dr Aubrecht authored over 65 peer-review publications in leading biomedical journals, six book chapters and two patents. His research interests are development and application of clinical and translational biomarker strategies with emphasis on qualification of novel biomarkers as Drug Development Tools. Dr Aubrecht serves as a co-director of Predictive Safety Consortium at the Critical Path Institute, is a member of the Society of Toxicology where he was a president of Clinical and Translational Toxicology Specialty Section. Dr. Aubrecht served as chair of the Technical Committee on Application of Genomics to Mechanism-Based Risk Assessment at the ILSI Health and Environmental Science Institute and was a member of the scientific advisory board of the EU project CarcinoGenomics.

Munther Baara, Senior Director, Development Business Technology, Pfizer

Munther has over 20 years of experience in the pharmaceutical industry. He is currently Sr. Director of Development Business technology at Pfizer, a worldwide pharmaceutical company. Munther is currently the head of Clinical Paradigm within the WRD-BT Development at Pfizer, Munther is spearheading initiatives driving innovation in development operations to align with the paradigm shift in the clinical trials execution model and emerging technologies. Munther Led the Clinical Aggregation Layer (CAL) implementation of a high-profile, large-scale clinical private cloud of clinical and operational data. In addition, he has extensive experience in application and system strategies, best practices, and standards that work for clinical and enterprise architecture, information management, workflow/process automation and integration of both home-grown and commercial applications across mixed platforms.

Mohan Bangalore, PhD, Global Head, BioAssets, Discovery Supply, GSK

Dr. Mohan Bangalore has about 20 years of industry experience in both drug discovery and clinical development. He started his career as a bench scientist in Biomarker group at GlaxoSmithKline (GSK) and then moved on to various roles of increasing responsibilities including Clinical Pharmacology, Outsourcing & Vendor Management, Clinical Operations, Alliances & Program Management, and Continuous Improvement in both Pharmaceutical (GSK, Wyeth/Pfizer, BMS) and CRO (PAREXEL) industries. Currently, Dr.Bangalore is the Global Head of Biological Asset management group in Discovery Supply department at GSK. Prior to this, Mohan led country (India) level clinical R&D operations for PAREXEL. Mohan holds a PhD in Molecular Biology and a MBA degree.

Abi Bangerter, DEdPsy, Clinical Research Manager, Janssen Research & Development

Abi Bangerter DEdPsy, joined the team at Janssen Research and Development in 2013 to assist in the development of Janssen Autism Knowledge Engine (JAKE®), a set of tools and technologies for measuring changes in ASD symptoms and behavior following intervention. She is an experienced clinician, working for 15 years as an Educational Psychologist, providing consultation, assessment and intervention advice to schools and families for individuals with a range of complex learning and behavior needs. From 2011-2013 she held the position of Senior Educational Psychologist with a responsibility for Research and Evidence Based Practice, across Buckinghamshire Local Authority, UK.

Dorothee Bartels, PhD, MScEpi, Chief Digital Science Officer BI X GmbH, Boehringer Ingelheim

Dorothee B. Bartels is Chief Digital Science Officer BI X, BI X is the digital lab of Boehringer Ingelheim. Prior to this role she was Corporate Head of Global Epidemiology at Boehringer Ingelheim for ten years. She holds a Professorship of Epidemiology and Public Health at Hannover Medical School and is Adjunct Professor at McGill University, where she lectures in the course of Advanced Pharmacoepidemiology. She also lectures in the Advanced Pharmacoepidemiology course at Harvard School of Public Health. Her research is focused on secondary data use and data linkages, on innovative approaches (e.g. digital epidemiology) and new strategies for faster drug developments and approvals.

Lynne Becker, Senior Data Analyst, Enterprise Intelligence & Data Solutions (EIDS) Program Management Office (PMO), Deputy Assistant Director Information Operations, Defense Health Agency (DHA)

I am a biostatistician with an emphasis in epidemiology with over 20+ years of experience in drug metabolism, orthopedics, diabetes, obesity, devices, oncology, ophthalmology, dermatology, animal research, gastrointestinal disorders, biologics, and behavioral research. I have corporate, academic, and government experience with a proficiency in telehealth applications and methodologies. I have an in-depth understanding of clinical trial management from both sponsor and site perspectives having managed multiple and diverse portfolio projects in dynamic environments both nationally & internationally. I possess a “Can Do” philosophy complemented by a “What If” mind. Currently, as a Senior Data Scientist for CACI, I identify and solve functional, applied, conceptual technical and design predictive analytical solutions for the healthcare enterprise for the DHA.

Sarah Bednarski, Associate Director, Strategic Monitoring, Sunovion

Sarah is currently leading the implementation of risk-based monitoring within Sunovion Pharmaceuticals. Sarah received her B.A. in Neuroscience from Johns Hopkins University and her M.S. in Statistics from The University of Georgia. She has held various roles in clinical operations, working in early stages of RBM at both large and small companies. Her educational foundation in science and mathematics drives her passion to collaborate between operations and data science to strategize on optimal ways to conduct a trial.

Michael Benecky, PhD, Senior Director, Global Regulatory Affairs, Precision & Digital Medicine, GSK

Mike received his B.A. in Biochemistry from the University of Wisconsin-Milwaukee and his Ph.D in Biophysical Chemistry from Princeton University. Mike continued his academic research career as a Post-Doctoral Fellow at Northwestern University and as an Assistant Professor at the University of Wisconsin Medical School-Milwaukee Clinical Campus. Mike then entered the in vitro diagnostic industry where he held product development positions of increasing professional responsibility. Mike gained expertise in the preparation of FDA IDE and PMA medical device submissions for lasers used for vision correction surgery at Bio-Reg Associates. At QIAGEN (formerly Digene), Mike led the Regulatory /Clinical Affairs Group that prepared numerous FDA PMA submissions for the first FDA approved HPV DNA test for cervical cancer screening. Mike Benecky joined GSK in October 2011 as Senior Director, Global Regulatory Affairs in Precision and Digital Medicine located in Research Triangle Park, North Carolina. In the area of Digital Medicine, Mike currently assists GSK Teams in regulatory strategy during use of digital health technology in both clinical trial and commercial settings. Recent projects include the commercial launch of the MyAsthma mobile medical app in the EU and inclusion of digital sensors and mobile apps within GSK clinical development programs.

Peter Bergethon, Vice President, Quantitative Medicine & Clinical Technologies, Biogen

Peter R. Bergethon, M.D. is Vice President and Head of Quantitative Medicine and Clinical Technologies (QMCT) at Biogen. He leads the identification of technologies and methodologies that transform drug development. QMCT creates value by leading the transition of clinical practice in Biogen’s core and emerging growth areas from a qualitative to a quantitative discipline, and connecting the Clinical with the Research enterprise, to advance therapeutics and personalized medicine. Peter came to Biogen in 2017 from Pfizer Worldwide Research and Development where he was Vice President and Head of the Pfizer Innovation Research Lab within the Early Clinical Development group. At Pfizer, Peter led both the Quantitative Medicine group and the Innovation Research Labs where he pioneered mobile and digital clinical assessment technology, human neurophenotyping, and multi-modal data analytics to accelerate clinical development in neuroscience, immunology, rare diseases, and cardiometabolic disease. He is an accomplished clinical neurologist and neuroscientist who, prior to joining Pfizer, was a Professor at Boston University and Tufts University in the Departments of Biochemistry, Neurology, Neurobiology & Anatomy, and Biomedical Engineering.

Karina Bienfait, PhD, Principal Scientist & Head, Global Genomics Policy, Process & Compliance, Merck

Karina Bienfait, PhD is a Principal Scientist in Translational Medicine at Merck Research Laboratories, and the head of Global Genomics Policy, Process and Compliance (GPPC). As head of GPPC, Dr. Bienfait works closely with Merck’s global subsidiaries to evaluate global laws and regulations pertaining to genomics and biobanking; and to develop strategies to address countries recalcitrant to genomic research. In this capacity, she works closely with global health authorities and ethical boards to negotiate approvals for genomic research in the context of Merck’s clinical trials. Dr. Bienfait also oversees the development of Merck policies, processes, and consent related to genomic research, and is responsible for ensuring compliant use of biospecimens. Dr. Bienfait completed an internship in Clinical Psychology at Nassau University Medical Center and a postdoctoral fellowship in Clinical Psychopharmacology in the Department of Psychiatry at Rutgers’ Robert Wood Johnson Medical School. She holds a PhD in Clinical Psychology from St. John's University and a B.A. in Psychology and French from New York University.

Dianna Blessington, MLT (ASCP), BS, MEd, Research Expert, Translational Sciences, Laboratory & Biospecimen Operations, Incyte Research Institute

Scientist with 30 years of laboratory experience in the Pharmaceutical and Clinical space. 15 years of my early career was spent as a researcher working in discovery in the areas of Immunology and Inflammatory diseases for DuPont Pharmaceuticals. I moved onto a Project management role for a few years outside of science and the laboratory. I returned to the lab and spent the next 6 years of my career working in a clinical laboratory and a hematology/oncology setting before joining Incyte Corporation 4 years ago. My current role within the Incyte Research Institute is Laboratory and Biospecimen Operations Manager for Translational Sciences.

Ron Bourque, Associate Director, RDI, Clinical Biologics, MedImmune/AstraZeneca

Ron is RDI Associate Director for Clinical Business Management and Analytics with MedImmune (Biologics business unit of AZ). Ron successfully migrated the eClinical Trial Management System over to a shared platform with AstraZeneca in support of the entire biologics trial delivery across clinical functions. He has provided leadership roles in various eClinical projects and has promoted the practical use of integration of eClinical ecosystems, environment and analytics that has enabled more real time based decisions in clinical research and trial delivery. Ron has over 30 years of experience from across clinical and clinical research, project management, system management to information analytics in healthcare and biopharmaceutical industries. Ron started as a monitor and data analyst, and then moved quickly into clinical research focusing on the use of data collection tools and their practical use in the day-to-day business in the fields of healthcare, clinical research and clinical trials.

Chuck Bradley, Vice President, Clinical Development, FibroGen, Inc.

Charles Bradley is VP Clinical Development and Head of Clinical Operations at FibroGen Inc. located in San Francisco, CA. Dr. Bradley is an experienced clinical research professional with an in-depth background in all phases of drug development. He is a seasoned senior manager with knowledge of resource allocation, portfolio management, budgetary processes, outsourcing strategies, and regulatory requirements associated with drug development. He has expertise in driving clinical programs forward in entrepreneurial environments, smaller biotech companies, and large traditional pharmaceutical companies. Chuck received his Ph.D. in bioanalytical chemistry from the University of Delaware, received post-doctoral training in Clinical Pharmacology at Uniformed Services University, and is Board Certified in Applied Pharmacology.

 

Loni Branon, Senior Director, Sitetrove Citeline, Informa - Pharma Intelligence

Loni Branon is Senior Director of Citeline’s Sitetrove, the pharma industry’s most comprehensive clinical investigator and trial site intelligence solution. Loni oversees data content and analyst support services for Sitetrove and works closely with clients on solving their site feasibility challenges by developing strategies to optimize country level decisions and identifying the best, most experienced clinical investigators and trial sites for their clinical programs. Loni is also part of Citeline’s Strategic Partnerships team helping clients integrate and analyze multiple data sources into a solution that works best for their work flow.

 

Carolyn Brehm, Associate Director, BMS Study Connect Business Lead , Bristol-Myers Squibb

Carolyn Brehm is the Business Lead for BMS Study Connect within Global Clinical Operations at Bristol-Myers Squibb and is responsible for the overall leadership of an industry-leading clinical trial engagement platform. Aligned with the focus to put patients first, Carolyn leads the development of a connected digital experience where patients and their care team can engage with BMS before, during and after a clinical trial. She achieves this by collaborating with key stakeholders, driving the execution of enhancements and maintenance, and developing application business processes. Key responsibilities include analytics, change management and vendor management. Before joining BMS in 2010, Carolyn started a Knowledge Management career in 2002 where she played an instrumental role in the implementation of enterprise communications, collaboration and information strategies, including expertise locator and communities of practice. Carolyn is a passionate knowledge management professional who is proficient at designing and managing collaboration and content solutions, recognized for developing and fostering business partnerships, and acknowledged for combining analytical and problem solving expertise to deliver business solutions.

Bonnie Brescia, Founding Principal, BBK Worldwide

Bonnie A. Brescia is a founding principal of BBK Worldwide, and a leader in patient recruitment and engagement for more than 35 years. Widely recognized for helping to shape the recruitment discipline and a preeminent voice for patient centricity, her insights regarding the global clinical research community inform the industry and help fuel BBK’s leadership, innovation and global expansion. She leads the company’s involvement in its efforts dedicated to global excellence in clinical research, and was recently honored by the Boston Globe Magazine with a Top 100 Women-led Business award. Bonnie speaks at several industry events and conferences each year, and has conducted many forums on strategies for clinical trial marketing to diverse audiences. She is frequently quoted in the media on a broad range of industry topics including patient centricity and mHealth and was named to the PharmaVOICE 100 for her leadership. A mother of two daughters and mentor to many young professionals, Bonnie is committed to equal opportunities for diverse perspectives in business and community life.

Bob Brindle, Venture Leader, Life Sciences, Cognizant

Bob Brindle has 20+ years' experience in the pharmaceutical industry and extensive background in clinical trials process and technology improvement projects. Today, he focuses on solving the issues he previously observed in his career in the industry. Now leading the development of Protocol Creator, he primarily works with clinical trials leaders and protocol authors finding ways to simplify this complex and critical process and enabling digital adoption in the life sciences industry.

Jennifer Byrne, Founder and President, Greater Gift

Jennifer Byrne is the Founder of Greater Gift. To date, Greater Gift has been responsible for the donation of over 80,000 vaccines to children in need in developing countries in honor of clinical trial participants. Formerly, Jennifer was the Chief Executive Officer of PMG Research, Inc (PMG) expanding it from its inception as a single center site to a vast network of integrated research site partnerships. During her 28-year tenure, Jennifer and her team transformed PMG into an industry market leader and health care institution partner of choice, conducting over 7,500 clinical trials with the inclusion of 150,000 trial participants. Jennifer is highly committed to building better bridges between patients, health care providers, and the life science community. Her guiding mission is to mainstream the transformation of clinical research as a care option for all patients; improving the delivery model of research and creating space to match the right trial, to the right patient, at the right time. Jennifer was recognized as a CenterWatch Top 25 Innovator and currently serves as an Advisory Board member to CISCRP, the Wake Forest Institute of Regenerative Medicine, and NC Biotech Piedmont Triad."

Hui Cao, MD, PhD, Executive Director, Real-World Evidence, COE for RWE, Global Medical Affairs, Novartis Pharmaceuticals Corporation

Hui Cao's career spans over 15 years in medicine, consulting and life sciences with a track record of accomplishment in these areas. She brings her comprehensive knowledge of medicine, healthcare systems, pharma R&D and data science to develop innovative solutions to solve R&D and business challenges. As a medical doctor and an expert in RWE and research methodologies, she has applied her creative thinking and used a holistic approach in medical and payer evidence generation, to support product medical and payer strategy. She led the development of RWE platform at a top pharmaceutical company and brought creative RWE solutions to optimize trial feasibility, accelerate patient recruitment, and build disease-area strategy. She is results-driven and known for her energetic management style and skilled collaboration, leading and motivating cross-functional teams to execute challenging, global, large-scale projects. Dr. Cao received her M.D. and a M.S. in medical genetics in China, and a Ph.D. in medical informatics from Columbia University. Specialties include Real-world Evidence (RWE), Payer & Medical Evidence Generation, Observational Research, Evidence-based medicine, Real-world data analytics, Health IT, R&D, clinical decision support, and data & text mining,

Diane Carozza, Managing Senior Engagement Consultant, Medidata Solutions

Diane is a Managing Sr Engagement Consultant responsible for leading the Study Planning and Feasibility offerings at Medidata. Diane is a subject matter expert in study and site qualification/selection and the optimization of business processes relative to technologies that support clinical operations. Diane possesses 25 years of diverse experience in the pharmaceutical industry where she held various roles across R&D, Clinical Operations and R&D Information Systems. Prior to joining Medidata, the majority of her career was spent in Clin R&D and Clin Ops at Pfizer and subsequently Allergan where she supported Therapeutic Operations and the Site and Study Management organizations in R&D IS and was a lead contributor on the TransCelerate Biopharma Shared Investigator Platform and Investigator Registry initiatives. Diane is an SME in the development and implementation of web-based investigator portals and was the Director of the InnovoCommerce clinical portal solution where she focused on developing technical solutions to optimize business processes and create efficiencies for sponsors, CROs, and sites.

Elisa Cascade, President, Data Solutions, DrugDev

As Chief Product Officer, Elisa is responsible for the overall development and growth of the DrugDev Spark clinical operations suite. In addition, Elisa served as architect of the award-winning DrugDev Golden Number, the industry’s universal identifier for global site facilities and personnel used by the Investigator Databank, the TransCelerate Investigator Registry, and leading pharmaceutical companies and CROs. Elisa’s personal mission is to significantly reduce the time required to integrate disparate data sources to help pharmaceutical companies make better decisions in clinical study planning, feasibility, and site selection and decrease the administrative burden for investigators.

Jamie Cash, Section Manager, Clinical Planning & Resource Management, Abbott Nutrition

Jamie earned her Bachelors of Science in Allied Medical Professions degree (Health Information Management and Systems) from The Ohio State University. She has been working for Abbott Nutrition for over 16 years where she has held positions of increasing clinical, operational, budgetary, and leadership responsibilities. In her current role, Jamie manages the Clinical Planning and Resource Management department. This group is mainly responsible for project management activities, ranging from creating project plans (cost, timing, resources) for potential clinical studies to negotiating study budgets and contracts for approved clinical studies. The group acts as a clinical research liaison for many departments, including Project Management, Clinical Operations, Legal, Procurement, Nutrition Science, and Finance.

Chris Chan, Executive Director, R&D Finance, Finance, FibroGen, Inc.

Chris Chan is Senior Director of R&D Finance at FibroGen, Inc, and has over 25 years industry experience, including 20 managing clinical trial & R&D finances for biopharmaceutical companies of various sizes. He holds an MBA from UC Berkeley’s Haas School of Business and is a Certified Management Accountant (CMA) & Certified Financial Manager (CFM). Chris is participating in his 6th SCOPE conference as a speaker.

Teri Chou, PhD, CEO, Modus Health

Teri became CEO of Modus Health in 2017.  She previously served as Chief Scientific Officer and was instrumental in obtaining the funding and leading product development efforts that resulted in StepWatch4, Modus Health’s innovative mobile health solution for clinical and research markets. Teri received her doctorate in bioengineering in 2007.

Jerome Chiaro, Chief Patient Advocate, Co-Founder, StudyKIK

Jerome Chiaro is Chief Patient Advocate at StudyKIK and regularly presents workshops for a non-profit, SCORE in Orange County, CA. Previous to the clinical trial industry, Jerome was a social media consultant for businesses across the nation and he has published multiple e-books and video training series' on the topic of social media marketing.

Kyle Christopherson, Director of Clinical Affairs, Cardiovascular Systems, Inc.

Kyle Christopherson, MPH, leads the Clinical Study Management and Clinical Operations functions at CSI. Her prior academic and industry roles in study leadership, portfolio management and field operations have contributed to her broad perspective on how metrics can be applied to drive action and decision-making. Kyle is passionate about creating a culture of data-driven leadership and works to accelerate individual and team transformations through metrics integration.

Jae Chung, President & Founder, goBalto

Jae Chung is the founding visionary of goBalto. A startup evangelist, Jae works with Rock Health to mentor healthcare technology startups. Jae previously co-founded Celltrion, a leading biopharmaceutical manufacturing company and was a strategy consultant with McKinsey & Company. Jae holds an MBA from New York University.

Sarah Clark, BSc, Stats and Computing, Global Head of Data Management, Novartis

Sarah started her career as a statistical programmer, moving to data management in it’s infancy. Sarah has held various positions of increasing authority within Novartis and is currently the Global Head of Data Management where she is on a two year international assignment in India.

Ivor Clarke, CEO, SubjectWell

Ivor Clarke is the CEO of SubjectWell, the risk-free clinical trials marketplace for patient recruitment. SubjectWell engages the 96% of Americans who have never participated in a clinical trial and only charges for patients who randomize. Ivor has over 12 years of C-suite experience in online marketing and specializes in the creation and operation of enterprise-class SaaS solutions. Ivor graduated from Carnegie Mellon University, earning degrees in Human Computer Interaction and Information and Decision Systems.

Bill Coakley, Senior Director, Global Supply Chain Planning, BioMarin Pharmaceutical Inc.

Bill is currently responsible for global commercial and clinical planning at BioMarin Pharmaceuticals, including Demand and Supply Planning, S&OP, and Clinical Supply Chain. He has over 30 years of executive supply chain experience in Life Science companies, and was the first chairperson for the Massachusetts Biotech Council and for BIO’s Purchasing Committees, and for the Bio Supply Management Alliance’s Clinical Supply Chain Steering Committee. Bill holds an MBA from Anna Maria College and BA from University of Massachusetts at Amherst.

Craig Coffman, Executive Director, Clinical Business Operations & Outsourcing, Nektar Therapeutics

Craig Coffman is currently Executive Director, Clinical Business Operations & Outsourcing at Nektar Therapeutics. He is focused on providing strategic direction, oversight and expertise to the organization in order to bring operational excellence to the business planning and financial management of clinical trials; and to the identification, selection and management of external service providers. Prior to his career in outsourcing, Craig has held senior management and leadership positions with CROs in a variety of functions including Business Development, Corporate Marketing, and Clinical Operations across pre-clinical, clinical, and contract manufacturing service providers.

Jonathan Cohen, Executive Director, Business Operations, Regeneron

Jon Cohen is Executive Director of Business Operations at Regeneron. He is responsible for Vendor Management, Cost Management, Metrics & Analytics, Resource Planning and Site Budgets & Contracts for Global Development. Prior to joining Regeneron in May 2016, Jon was at Pfizer for 17 years where he held numerous jobs of increasing responsibility in the US and UK in Strategic Management, Finance, and Development Operations. Jon holds a BA with a double major in History and Political Science from Tufts University, a Master in Internal Affairs from SIPA at Columbia University and an MBA from Columbia Business School.

Jill Collins, Executive Director, Global Operations Management, Syneos Health

Jill Collins, Executive Director, Global Operations Management, at Syneos Health, has over 20 years of experience in clinical operations. She leads the development of transformative approaches to trials with a focus on data-driven process optimization, including Syneos Health’s RBM solution and ICH E6 R2 readiness. She is an active member of the ACRO-Transcelerate CRO Forum on the Risk-Based Monitoring Working Group. Prior to joining Syneos Health, Jill held senior management positions in Clinical Operations Quality Management and Clinical Operations. Jill received a Masters in Clinical Research Administration from the George Washington University and a Masters in Education from Rhode Island College.

Anca Copaescu, CEO, Strategikon Pharma

Anca leads Strategikon Pharma, the creator of Clinical Maestro™, the industry’s only end-to-end digital planning, budgeting, procurement and contract management platform, serving both Sponsors and CROs. Anca is passionate about applying modern technologies to clinical trials management and is a domain expert in clinical outsourcing, clinical finance and strategic alliance management. She was previously Head of Outsourcing and Biomarin Pharmaceuticals and served in corporate development positions for major CROs.

Christine Crandall, Head of Strategic Clinical Planning, Study Start Up, R&D Projects Clinical Platforms & Sciences, GSK

Christine Meyer Crandall is the Head of Strategic Clinical Planning at GSK with over 19 years of experience in project management and clinical operations. She is responsible for a team focused on the delivery of robust, quality data to optimize trial scenario planning and improve clinical development plans. Christine has extensive knowledge and expertise in designing and deploying innovative and transformative strategies concentrating on protocol feasibility, site selection, recruitment planning, budget estimates and timelines. She has the ability to work with matrix team members towards the successful completion of project goals. Christine has had previous positions at AstraZeneca and Covance. She holds a B.A. in Neuroscience from the University of Pennsylvania with a M.S. in Pharmaceutical Sciences from Temple University."

Cathy Critchlow, PhD, Vice President, Center for Observational Research, Amgen

As Head of the Center for Observational Research (CfOR), Dr. Critchlow provides operational and strategic leadership for the design and conduct of observational research within Amgen. The CfOR Real World Data (RWD) Platform provides widespread access to patient health data and visualization and analytic tools based on innovative technologies to aid teams in the generation of real world evidence in support of drug development and commercialization of Amgen products. Dr. Critchlow joined Amgen in 2004 where she led a number of Therapeutic Areas within Global Epidemiology prior to being named Head of CfOR in 2012. Prior to joining Amgen, Dr. Critchlow was a faculty member in Epidemiology at the University of Washington. Dr. Critchlow was a member of the Endocrinologic and Metabolic Advisory Committee of the Food and Drug Administration and has served on a number of research review committees for the National Institutes of Health. Dr. Critchlow earned her bachelor’s degree from Stanford University, and both her master’s degree in biomathematics and her doctorate degree in epidemiology from the University of Washington. Dr. Critchlow is an Affiliate Professor of Epidemiology at the University of Washington and a Fellow of the American College of Epidemiology.

Michelle Crouthamel, Digital Platform Leader, GSK

Michelle Crouthamel is the digital platform leader of the Clinical Innovation Unit at GlaxoSmithKline (GSK). Michelle’s passion for driving patient-centricity in the pharmaceutical industry led her to become an ‘Intrapreneur’ at GSK, and the founding member of the Clinical Innovation Unit, which focuses on harnessing digital technologies and platforms to improve patient engagement and clinical trials. Michelle is currently leading the strategy and pilot programs of e-Recruitment and m-Health platforms, and is involved in the industry-wide consortium, TransCelerate, eSource work stream. Over past 15 years, Michelle led many successful programs in discovery and development at both Merck and GSK, is an inventor who holds multiple patents, and has published extensively in the areas of Neuroscience, Oncology, and Digital Health. Michelle has a Master’s degree from the Institute of Neuroscience, and a Bachelor’s degree in Nursing from the National Yang-Ming University, Taiwan. She is currently pursuing a doctoral degree at Fox Business School, Temple University with a research focus on the Patient-Centricity in the pharmaceutical industry.

Karim Damji, Senior Vice President, Products and Marketing, Saama

Karim plays a pivotal role in helping Saama realize its audacious goal of enabling pharmaceutical and biotechnology companies to accelerate the development of life-saving and life-altering therapies. He is responsible for driving product strategy for Saama’s AI-enabled data analytics solutions and identifying opportunities that lead to successful market share growth.

Olaf Danner, Global Studies Manager, Roche

Olaf is an experienced Global Studies Manager leading the global operational team at Roche. He is skilled in all aspects of Global Study Management in Oncology. He has former experience as a Clinical Monitor, CRA Manager and EDC Trainer. He has worked within a global, multi-cultural pharma environment across Phases I to IV studies in various therapeutic areas including Urology, CNS and Oncology. He has a high level of agility and customer-focused mindset.

Gregory Daniel, PhD, Deputy Center Director, Duke-Margolis Center for Health Policy, Duke University

Dr. Gregory Daniel, PhD, MPH is the Deputy Director of the Duke-Robert J. Margolis, MD Center for Health Policy and a Clinical Professor in Duke's Fuqua School of Business. Dr. Daniel directs the DC-based office of the Center and leads the Center's pharmaceutical and medical device policy portfolio, which includes developing policy and data strategies for improving development and access to innovative pharmaceutical and medical device technologies. This includes post-market evidence development to support increased value, improving regulatory science and drug development tools, optimizing biomedical innovation, and supporting drug and device value-based payment reform. Dr. Daniel is also Adjunct Associate Professor in the Division of Pharmaceutical Outcomes and Policy at the UNC Eshelman School of Pharmacy. Previously, he was Managing Director for Evidence Development & Biomedical Innovation in the Center for Health Policy and Fellow in Economic Studies at the Brookings Institution and Vice President, Government and Academic Research at HealthCore (an Anthem, Inc. company). In addition to health and pharmaceutical policy, Dr. Daniel’s research expertise includes real world evidence (RWE) development utilizing electronic health data in the areas of health outcomes and pharmacoeconomics, comparative effectiveness, and drug safety and pharmacoepidemiology. Dr. Daniel received a PhD in pharmaceutical economics, policy and outcomes from the University of Arizona, as well as an MPH, MS, and BS in Pharmacy all from The Ohio State University.

Mano Das, IT Business Partner, Clinical Patient and Site Operations, Bristol-Myers Squibb

Mano Das is an IT Business Partner for Clinical Patient and Site Operations at Bristol-Myers Squibb. He is focused on enabling digital capabilities for patients and sites to support and accelerate global clinical operations. He is passionate about incubating innovative technologies in clinical trials through ideation, pilot and scale-up; cross-pharma collaboration and embracing analytics for business decisions. His most recent milestone was the successful launch of BMS Study Connect, an industry leading patient engagement platform. Prior to BMS, he has worked in the pharma industry supporting clinical and commercial business digital solutions.

Julie VanOrsdel Daves, Director of Clinical Outsourcing, miRagen Therapeutics, Inc.

Julie Daves began her clinical career over sixteen years ago and has become a leader in the clinical operations and outsourcing community. She brings a unique perspective to the table because of her in-depth understanding of the challenges of clinical program operational delivery from both the vendor perspective and the sponsor perspective. While at CROs, she progressed from CRA to PM to global department head, responsible for vendor selection, management, budgets, timelines and quality. Within a sponsor environment, she is passionate about building mutually beneficial partnerships between sponsors, CROs and vendors as a critical component to move important medical research forward. She is currently the Director of Clinical Outsourcing for miRagen Therapeutics, Inc. Julie received her MSHS in Clinical Research Administration from The George Washington University School of Medicine and Health Sciences, and BS in Zoology & Genetics from North Carolina State University.

Ashley Davidson, Director, Vault Study Startup, Veeva Systems

Ashley Davidson brings over 16 years of clinical research experience to her role as the strategy lead for Veeva Vault Study Startup. Her industry experience encompasses all phases of research and therapeutic areas, having specialized in study start-up, regulatory affairs, proposal, and contract management. Ashley holds a bachelor’s degree in English from The University of North Carolina at Chapel Hill. Before joining Veeva, Ashley spent over 12 years in executive management-level positions overseeing global study start-up groups of mid-sized and large contract research organizations.

Catherine Deacon, Director, Finance Global Development and CEI, Takeda

Biography coming

Cynthia de Luise, PhD, MPH, Senior Director, Epidemiology, Worldwide Safety and Regulatory, Pfizer, Inc.

With a background in clinical medicine and public health, I have almost two decades of experience leading pharmacoepidemiology studies and programs that inform the safety profile of a wide range of pharmaceutical products in oncology, neuroscience, inflammation and rare diseases. I have significant expertise in the use of a variety of automated healthcare databases across North America and Europe in the conduct of drug safety research, and am leading a long term initiative to develop our pharmacoepidemiology capabilities in Japan. I am an Adjunct Assistant Professor in the Dept. of Epidemiology at Rutgers School of Public Health. I hold a PhD in Public Health and Epidemiology from Rutgers School of Public Health and a MPH in Epidemiology from Columbia Mailman School of Public Health.

Vinay Dheer, Director, Global Development Systems, Regeneron Pharmaceuticals Inc.

Vinay Dheer is Director of Global Development Systems at Regeneron. Vinay is accountable for technology solutions to support the large and growing clinical trial portfolio with operational data integration, clinical trial management system, innovation in trial execution, analytics and other capabilities to enable Regeneron's success in developing and delivering our therapies to patients. Prior to Regeneron, Vinay has worked with Pfizer and other companies ranging from startups to global technology integrators.

Rob DiCicco, Principal Consultant, TransCelerate Biopharma, Inc.

Rob DiCicco is an executive consultant for TransCelerate. He is the Executive Sponsor for the Common Protocol Template Project and was one of the Team Leads on CTTI’s Mobile Clinical Trials Novel Endpoints Project. He has over 25 years of experience in clinical development. His area of expertise includes clinical pharmacology and experimental medicine, clinical trial design and project management. In his former role at GSK, Rob was integral in pioneering the use of new digital technologies.

Julie Dietrich, Director, Center for Design & Analysis, Amgen

Julie Dietrich is a former Director in Amgen’s Center for Design & Analysis, where she partnered with product teams to design optimized clinical programs and implement innovative solutions. She also headed the Patient Experience Program for Amgen’s Clinical Technology & Experience Lab, where they partner with patients to co-design and leverage digital health technology to transform the clinical trial experience. Julie led company-wide initiatives related to patient centricity and evidence generation planning and is committed to advancing ideas for how to collaborate with patients throughout drug development."

Angela Dimitrova, MD, Senior Director, Feasibility Group Lead Rare Diseases, Study Optimization, Pfizer

Angela is a physician with over 20 years of pharmaceutical industry experience. Her career at Pfizer started in the Bulgarian country office. Under her leadership, the Pfizer Medical department and Clinical operations in Bulgaria were established and excelled. Since 2012, when Angela moved to the Pfizer office in Cambridge, MA, USA, she has held various positions with increasing responsibility such as ClinOps Strategy Lead, Feasibility Lead in Inflammation & Immunology and Rare Diseases and currently, as a Senior Director, Feasibility Group Lead in Rare Diseases."

Mary Dixon Drake, CEO & Founder, Innovenn

Mary E. Dixon has over 25 years of experience in Clinical Research where she has managed successful cross-functional teams and implemented development plans for multiple compounds, contributing to the development of 14 marketed compounds. Ms. Dixon has lead disruptive innovation teams at pharmaceutical companies, inspiring them to leverage natural history data to deliver new disease management tools including clinical decision support software that complement new therapies. Her motto is “we can do more” with the valuable data we accumulate in clinical trials. Ms. Dixon is the founder of two companies. Following a career at Merck & Co., Inc., she established her first business, Cogent Pharma Consulting. In 2013, Ms. Drake founded her second company, Innovenn, Inc. Innovenn’s mission is to partner with advocacy organizations, pharmaceutical, biotechnology, and device companies to support the development of innovative patient care solutions that complement new therapies.

Hansu Dong, Director, Outsourcing, MedImmune

Biography coming

Ronald Dorenbos, PhD, Associate Director, Materials and Innovation, Takeda Pharmaceuticals

Ronald is Associate Director at Takeda’s Materials & Innovation team and part of the digital strategy group for neuroscience. During his appointment at the Life Science division of PA Consulting Group, a British Consulting firm, he led projects for some of the world’s top 10 pharmaceutical companies around strategy, commercialization and digital health. At his company BioFrontline he provides management, strategy and commercial advice to life science companies around the world. Ronald received MAs in Biotechnology and Molecular Biology and after obtaining a PhD in Pharmaceutical Biology spent six years at Harvard to study Parkinson’s, Schizophrenia and the genetics of aggressive behavior before making the transition to industry. Ronald is a keen follower of developments in the field of Artificial Intelligence (AI) and regularly invited as speaker to present on topics related to pharma, healthcare and AI.

Julie Dubourg, MD, Medical Director, Clinical Development, Poxel

Julie Dubourg, MD, is medical director in Poxel and in charge of clinical development from phase 1 to phase 3. She is an endocrinologist, pharmacologist and public health specialist graduated from Claude Bernard University, Lyon, France."

Pam Duffy, IT Lead, Core Clinical Solutions & Services, Pfizer

Pam Duffy, B.S., M.S, is the IT lead for Clinical Development Operations and Clinical Pharmacology at Pfizer. She has worked in Clinical IT for the last decade with previous experience in IT supporting both molecular and animal models. Pam holds a B.S from the University of Connecticut in Marketing and Business Management and an M.S. from Columbia University NYC in Technology Leadership.

Bhaskar Dutta, PhD, Principal Scientist, Advanced Analytics Center, AstraZeneca

Dr. Bhaskar Dutta is an analytics expert with specific interest in digital health. He completed his undergraduate education at the Indian Institute of Technology (IIT) and perused graduate studies at the University of Maryland. Throughout his career, he has led projects on analysis, interpretation, and visualization of multi-dimensional data from genomics, proteomics, metabolomics, clinical trials, and streaming data from wearable sensor. Currently, he is actively involved in end-to-end design, development, and deployment of a digital health study at AstraZeneca.

Michael Kelley Erb, PhD, Director, Digital Medicine, Early Clinical Development, Pfizer

At Pfizer, Kelley serves as project leader for digital medicine programs aimed at developing, validating, and implementing novel digital endpoints for asset teams across the portfolio. In that role he has led and managed research collaborations, technology selection, and project execution toward the development of novel endpoints for psychiatric and movement disorders indications. Kelley has a background in engineering and neuroscience, with experience in both the defense and medical device industries before coming to the pharmaceutical industry. He holds a B.S. in mechanical engineering and a Ph.D. in Anatomy and Neurobiology.

Ivette Estay, PhD, Biomarker Operations Program Leader, Product Development Global Clinical Operations, Oncology, Genentech

Ivette Estay is a Biomarker Operations Program Leader (BOPL) in Oncology Product Development Global Clinical Operations at Genentech (a member of the Roche group). As a BOPL, she leads the execution of biomarker strategies for drug and companion diagnostic development. She has over 6 years of biomarker operations experience in Phase I, II, and III oncology clinical trials across hematology, multiple solid tumors, and immunotherapy programs. Ivette has a Ph.D. in Cancer Biology from Stanford University and worked as a Clinical Research Associate and Clinical Research Coordinator before joining Genentech.

Mark Evans, Managing Director, Faze - Havas Lynx

Biography coming…

Paul Evans, formerly Corporate Vice President, Global Site Solutions, Parexel

Biography coming…

Michelle Everill, Senior Director, Head of Global Feasibility, Janssen

Michelle Everill, Global Head of Feasibility at Janssen, is developing a global feasibility center of excellence with a significant focus on data analytics and strategic application. She has been working to improve feasibility and site selection in both pharma and CROs since 2010. Before then, her career started working as a study coordinator and patient recruitment specialist at a site and then in Clinical Operations at CROs. Michelle’s passion is developing people and teams to discover new ways of brining more impactful products to market more efficiently, increasing quality of life and finding cures for patients across the world."

Jane Fang, MD, MS, Head of Research & Development Information for Clinical Biologics, Medimmune Biologics Science Unit of AstraZeneca

Jane is the head of AZ/MedImmune R&D Information for Clinical Biologics. She is a physician scientist with training in healthcare management and informatics. She has 25 years of broad experiences across from medical practice, clinical research to eClinical strategy and information analytics in healthcare and biopharmaceutical industries.

Trent Farmer, Contract Manager, Attorney, CSL Behring

Trenton began his career as an attorney litigating contracts for credit card issuers before transferring to the pharmaceutical field in 2013. As a part of CSL Behring since 2016, Trenton now oversees all budget, contracts, and payments for CSL’s first mega trial. Tasked with creating a new contract and budget process to account for the mega trial, he has implemented several new processes, streamlined existing processes, created new reporting forms, and built workflows in their study startup platform. He also continues to focus on building strong relationships with investigative sites across the Clinical R&D portfolio. He completed his undergraduate degree from West Chester University and a law degree from Widener University.

David Fauvart, PMP, Associate Director, Janssen Clinical Innovation, Johnson & Johnson

David holds Master degrees in Physical Therapy and Management and is a PMI certified Project Management Professional. After several years working as a Physical Therapist, he joined the pharmaceutical industry in 2003, holding various positions in management and clinical operations at various pharmaceutical companies and clinical research organizations. In his current role at Janssen Clinical Innovation, David combines his expertise and passion in clinical operations, innovation and project management to develop and deploy new innovative capabilities which will make clinical trial execution more effective and efficient for patients, sites and sponsors.

Rosalie Filling, Vice President, Clinical Operations, Endo Pharmaceuticals

Rosie earned her B.S. in Biology, Minor in Chemistry from the University of Pittsburgh. She has 19 years of clinical trial experience. Rosie began her career at PPD as a Research Assistant and moved into her first management position at PPD. She was responsible for the rapid site start-up and ongoing management of enrollment and site regulatory requirements across all therapeutic areas. After 5 years, she left PPD and began her pharmaceutical Sponsor career at Guilford Pharmaceuticals in Baltimore, MD. At Guilford, Rosie was responsible for the overall strategy for execution of clinical trials including the outsourcing needs and overall budget management for all of Research & Development. Guilford was acquired by MGI Pharma. Post the acquisition, Rosie was chosen to lead the new Clinical Operations team to establish a new set of processes and strategy for the new organization. MGI’s focus was on acute care and oncology. The new organization was very successful and was later acquired by Eisai. During Rosie’s tenure at Eisai, she moved into post-marketing and was responsible for executing Oncology and CNS post-marketing trials. Rosie then joined Teva in 2009, where she was the US site head of Clinical Operations and was responsible for the successful delivery of Inhalation, Women’s Health, and Cardiovascular clinical trials. Rosie joined Lupin in August 2014 to stand up the Clinical Operations Division. She recently joined Endo Pharmaceuticals in February 2018 as Vice President, Clinical Operations accountable for Clinical Operations, Biometrics, and Medical Writing. She has surrounded herself with highly skilled and energized colleagues and has laid the foundation for a successful clinical operations department. Rosie has been an active contributor to 6 NDAs, 8 SNDAs, and 6 ANDAs. Rosie resides with her husband of 18.5 years, Josh. They have 2 daughters Marlee (17) and Chloe (13) and two adorable boxer puppies, Brutus and Bodi. In her spare time you can find her at the gym, hiking or on the sidelines watching her daughters play soccer!

Gerald Finken, CEO, Center Point

Gerald Finken, R.Ph., M.S., is a licensed pharmacist and has over 36 years of experience in the biotechnology and pharmaceutical industries focusing entirely on pharmacist related activities. He has worked as a community pharmacist, an independent clinical supplies consultant and has held management positions with Bristol-Myers Squibb Company and PRACS Institute, Ltd. In 1997, he founded CSM, where he invented On-Demand packaging and labeling, Clinical Trial Research Pharmacist (CTRP®) services and pioneered Direct-to-Patient services. In 2013, he founded Center Point Clinical Services and subsequently created the innovative Siteless CRO model. He now serves as CEO for Center Point. Mr. Finken focuses on innovation, disruptive business strategies, and growth opportunities—including the further development of the role of the pharmacist in clinical research. Mr. Finken received his Bachelor of Science degree from Rutgers College of Pharmacy, in New Brunswick, NJ; and his Master of Science degree from Kean College, in Union, NJ, where he graduated Magna Cum Laude.

Michael Fites, Senior Feasibility Strategist, Global Clinical Trial Services, Bayer

Michael Fites is a Senior Feasibility Strategist at Bayer. MS from Ohio University. Over 20 years in the pharmaceutical industry."

Balazs Flink, MD, Head, Clinical Trial Analytics, Bristol-Meyers Squid

Graduated as a physician, explored medicine from the academic perspective before joining BMS in 2005. Held roles with increasing responsibilities in R&D most recently have led the full integration of the Clinical Trial Analytics group in the newly formed Business Insights and Analytics organization. My main goal in this new corporate wide analytics group is to challenge the status quo, establish common consciousness in R&D and to drive strategy and execution through data and insights.

Emmanuel Fombu, MD, MBA, Director, Digital Health Solutions, Novartis

Dr Fombu is a recognized authority on the convergence of digital technologies and healthcare. He is an author, physician and medical futurist with over 10 years combined experience in clinical medicine, drug development, medical affairs, research, pragmatic trials and product lifecycle management strategy in biopharmaceutical industry and private equity. His current focus for Novartis is how digital technologies can be leveraged to better measure Novartis product’s real world effectiveness and value, and also to design more comprehensive disease management systems in partnership with digital health startups, payers and providers. In addition to his book, The Future of Healthcare: Human and Machine Partnering for Better Outcomes, Dr. Fombu has authored multiple research papers and abstracts in renowned peer reviewed journals. As a medical futurist and 2017 winner of the prestigious New York City Health Business Leaders Boldest Digital Health Influencer Award, Dr Fombu is a champion and advocate for value based healthcare, personalized medicine, mhealth, nanotechnology, big data, artificial intelligence, machine learning and digital medicine. He serves as an external advisory board member at the Massachusetts Institute of Technology’s MIT.nano project. Dr Fombu did his clinical training at Emory-Crawford Long Hospital and holds an MBA from Cornell University’s Johnson School of Business and a certification in Artificial Intelligence: Implications for business strategy from MIT’s Sloan school of management and Computer Science Artificial Intelligence Lab. He lives in New York City.

Eric Forsthoffer, Global VP, Business Development, Bioclinica

Eric is a clinical trial project management professional with more than 15 years of clinical trial experience. He currently oversees Global Business Development for Bioclinica's industry-leading Medical Imaging & Biomarkers segment. Since joining the Company (formerly Bio-Imaging Technologies, Inc.) in April 2002, as a Site Administration Associate, Eric has held numerous positions including Assistant Clinical Project Manager, Clinical Project Manager, Strategic Relationship Director, and Business Development Director. Previously, Eric worked at Bracket (formerly UBC) as a Project Manager, Senior Project Manager, and Account Manager on key accounts. He authored a chapter in the book, "Medical Imaging in Clinical Trials," focused on best practices for evaluating and selecting an imaging core lab consistent with Good Clinical Practice and regulatory compliance. As a member of the Metrics Champion Consortium (MCC), Eric contributed to the development of the Medical Imaging version 2.0 MCC Metrics.

Emily Freeman, MSc, PhD, Director, Patient Centered Outcomes, HEOR, Abbvie

Dr. Emily Freeman is a social/behavioral scientist interested in the development of evidence based communication tools to facilitate decision making between patients and healthcare providers. Dr. Freeman is exploring how medical evidence (i.e. risk, benefit, and health outcomes) is constructed and communicated within a patient-healthcare provider clinical encounter.

Charlotte French, Principal, CAF Consulting LLC; Former Executive Director, Portfolio Relationship & Sourcing Management, Medical and Development, Astellas

Charlotte has over 30 years of healthcare experience, participating in the evolution of all aspects of business operations for research and development, medical affairs and post-approval activities, inclusive of strategic partnership and alliance management in the biopharma industry. She has held global leadership roles with both service providers and in biopharma companies to deliver initiatives focused around change management, oversight, business and commercial management, portfolio delivery, and innovation. Prior to the launch of CAF Consulting LLC, Charlotte’s most recent roles include Executive Director, Portfolio Relationship and Sourcing Management at Astellas. In this role she led the service provider relationship management team together with the outsourcing and contracts. Charlotte also led the implementation of a tripartite sourcing strategy for the Development organization. Prior to joining Astellas, Charlotte was Senior Director, Contracting and Outsourcing within Global Clinical Operations at EMD Serono. In this role she led the team of contract and outsourcing managers responsible for supporting the commercial aspects across both the Regional and Global Clinical Operations portfolio.

David Fuehrer, CEO, GRYT Health

Dave Fuehrer is a two-time cancer survivor, patient-experience researcher and digital health innovator. He is co-founder and CEO of GRYT Health, a digital health company that connects individuals with similar experiences and engages them to inform, support and facilitate improved disease management and patient well-being. In his recent TED Talk, Dave describes how he has catalyzed personal adversity, patient experience research and digital technology to create an app to connect, empower and transform the living-with-cancer experience. https://www.youtube.com/watch?v=RejrG2uyra0. Dave has a BS in Technical Communication and MBA in Technology Management, from Rochester Institute of Technology. He has completed Executive Education at Harvard Business School in Building New Ventures and at MIT in Corporate Strategy.

Laura Galuchie, Director, Global Clinical Trial Operations, Merck & Co., Inc.

Laura has a unique role which blends internal and external components. Laura is Merck & Co., Inc.’s assigned leadership to the Oversight Committee of TransCelerate BioPharma Inc. The Oversight Committee is the primary governing body for decisions related to the operational direction of TransCelerate, including project direction and expected outcomes. Laura draws on her experience as Director of Clinical Operations for a busy therapeutic area and Head of Clinical Performance, Analytics and Innovation to provide this perspective. Within Merck, she has responsibility for driving internal engagement with key stakeholders. She facilitates adoption and internalization of TransCelerate solutions in alignment with Merck’s objectives. Finally, she watches for opportunities to match innovative approaches to potential process improvement initiatives or other areas of focus.

Victoria Gamerman, PhD, Head, US Health Informatics & Analytics, Boehringer-Ingelheim Pharmaceuticals, Inc

The US Health Informatics & Analytics (HIA) team has expertise in advanced statistical methodologies and capabilities to generate evidence from external clinical data and real-world health care data in support of clinical drug development, drug life-cycle and commercialization. The team handles projects in close partnership with local and global Medical & Commercial functions to apply advanced analytics, casual inference and machine learning methods generating evidence. This team builds on the clinical biostatistics combined with a specialization in statistical and data analysis capabilities in Big Data and Machine Learning with a focus on external clinical data and real-world data such as electronic health records, observational clinical databases, claims databases as well as other Big Data sources. As Head of the US HIA team, Victoria leads a team of experts in cross-functional collaborations on various initiatives within the competitive environment to optimize BI's ability to meet current and emerging needs for real world evidence and to engage medical customers through an integrated environment delivering scientific/medical content and information to help meet patients’ needs. Prior to leading the US HIA team, Victoria worked as both a project and trial statistician providing expert advice in designing and analyzing data from various sources using appropriate analytic and statistical techniques. She earned her PhD in Biostatistics and Master’s in Biostatistics from the University of Pennsylvania’s Perelman School of Medicine to study Biostatistics and a Master’s and Bachelor’s in Mathematics from Boston University.

Luis Garcia-Gancedo, PhD, Director, Clinical Sensors & Data Analytics, GSK

Dr Luis Garcia-Gancedo is a Director of Clinical Sensors & Data Analytics at GlaxoSmithKline (GSK).

With a background in Physics and Electronic Engineering, Luis spent a number of years as a Research Associate in the Engineering Department at the University of Cambridge and as a College Lecturer at Newnham College (Cambridge University) before joining GSK. At GSK, Luis leads the implementation of wearables and other patient centric technologies in clinical trials to enable continuous or semi-continuous objective data collection in-between clinical site visits. The mid-to-long term vision is to remotely collect ‘real-world’ data that reflects a reasonable approximation of how study participants usually live their lives, ultimately enabling a better understanding of disease manifestation and a better assessment of drug efficacy.

Madeline Geday, Associate Director, Patient Engagement & Diversity, Global Clinical Trial Operations

Madeline is an Associate Director for the Global Trial Optimization Group within GO (Global Operations) at Merck and Co., Inc. She serves as the Patient Engagement Lead for her organization. In this role she is responsible for optimizing clinical trial feasibility and execution through integrated data-driven expert analysis and recommendations, while promoting its engagement, development, and opportunities for innovation in recruitment and retention. With a keen focus on the perspective of the patient, she is intent on capturing and integrating the voice of the patient into operational aspects of clinical trial design, feasibility, and recruitment and retention. She also leads several collaborative projects surrounding Diversity in Clinical Trials. Her efforts are targeted at educating and creating awareness of the need for heightened inclusion and diversity in our clinical trials. Trained in Health Literacy principles, she has used her knowledge and expertise to champion changes to patient facing materials to ensure health literacy for clinical trial participants and their families around the world. Madeline received a dual degree, B.S. in Psychology and B.S. in Health/Exercise Physiology, from Ursinus College in Collegeville, Pennsylvania and is pursuing graduate coursework in Marketing from Temple University.

Rashieda Gluck, Senior Vice President, Global Clinical Operations, Aurinia Pharmaceuticals

Rashieda Gluck has over 25 years of pharmaceutical and biotech industry experience specializing in strategic planning and delivery of global clinical development programs. During this time, she has built and led a number of high performing teams to success. Rashieda has held the roles of Vice President of Clinical Operations for a privately held clinical stage biopharmaceutical company, responsible for strategy and leadership in the clinical development of their platform immunotherapeutic treatments as well as Vice President and Head of Global Clinical Operations at Vifor Pharma, based in Zurich, Switzerland, where she retained overall accountability for the execution and delivery of the company’s global development programs. Previously, she held the position of Vice President of Clinical Operations at Aspreva Pharmaceuticals in New Jersey and was responsible for the successful transition and integration of the global clinical department post acquisition. Earlier in her career, Rashieda served in increasingly senior positions at major pharmaceutical companies including Novartis, GSK, and Organon. In her role at Aurinia, Rashieda leads the company’s clinical programs.

Kathy Goldstein, PharmD, Sr. Director, Head, Quality Management Lead, Regeneron Pharmaceuticals

Kathy Goldstein is currently the Sr. Director, Head, Quality Management Lead at Regeneron Pharmaceuticals. In this position, Dr. Goldstein leads a team of Quality Management Leads who ensure quality and compliance for all global clinical study activities. The quality management lead team is responsible for providing guidance, interpretation, support, training and key input to clinical study teams on GCP regulations, guidelines, corporate standards and policies. The team also participates in GCP inspections and leads inspection preparation activities with clinical study teams. Dr. Goldstein has more than 20 years of experience in the biotech, pharmaceutical and medical device industries, with positions in pharmacokinetics and drug metabolism research, clinical operations, quality and compliance, and project management. Prior to joining Regeneron Pharmaceuticals, she has held quality and compliance roles, along with extensive operational experience as a CRA and clinical program manager. Dr. Goldstein holds a B.S. in pharmacy from the University of Minnesota and a Doctor of Pharmacy from the University of Florida. She has also completed a Pharmacy Practice residency program accredited by the American Society of Health-System Pharmacists (ASHP). Dr. Goldstein has also earned ACRP’s Certified Clinical Research Associate (CCRA) designation.

Lorena Gomez, Director, Global Study Start Up & Essential Documents, Global Site Management Operations, Allergan

Lorena has more than 20 years of experience in clinical development, having started her career as a phase I coordinator in 1996. She has gone on to hold leadership roles in both Clinical Operations and Project/Program Management and is currently the Global Director of Strategic Start Up and Essential Documents at Allergan. Prior to starting with Allergan in 2016, Lorena oversaw Start Up Strategy and Clinical Outcomes Assessment Management across all therapeutic areas at AbbVie. Lorena holds a BS in Microbiology, a BA in Molecular Biology, and was an NIH fellow in the University of Texas at Austin Pharmaceutics PhD program. In 2011, she was awarded the PharmaTimes Clinical Researcher of the Year silver medal in the Project Management Category. She has been a team member for the TransCelerate Shared Investigator Platform and Investigator Registry Initiatives since 2013.

Melanie Goodwin, Director, Patient Recruitment Programs, Clinical Development & Operations, Global Product Development, Pfizer

Melanie Goodwin is the Director of Patient Recruitment Programs at Pfizer and has been focused on clinical trial enrollment and retention in the pharmaceutical industry for 20 years. Her recruitment and retention experience spans across sponsor, CRO, Patient Recruitment agency, and research site, providing a unique and rounded view of the challenges and solutions. She has developed enrollment and retention strategies for over 200 clinical trials across all study Phases and therapeutic areas. Melanie holds a B.Sc. and M.Sc from Saint Joseph’s University in Philadelphia, Pennsylvania.

Christian Gossens, PhD, MBA, Global Head Early Development Workflows, Research & Early Development Informatics, F. Hoffmann-La Roche Ltd

Christian is leading an informatics team supporting the global early development function in Roche’s Research and Early Development (pRED) organization. A computational biochemist PhD and MBA by training, he started his career in a leading management consultancy before joining Roche as a director in the Emerging Technology team in the Group Research department - identifying strategic, game changing trends in the pharma information/informatics space and developing strategies to act on those.

Natalia Grassis, Vice President, Clinical Operations, Parexel

Biography coming

Jeff Greene, VP, Digital Strategy & Insights, Decision Resources Group

Jeff Greene's digital journey began with a Texas Instruments 99/4A and a subscription to CompuServe. He's never looked back. A strategist, writer, speaker, and marketing innovator, Jeff has spent more than 20 years guiding clients into the digital age. For the past 8 years, he's worked with pharmaceutical manufacturers to evolve their multichannel approaches, harnessing the power of customer data to make programs and teams more effective. In his new role at DRG Digital, Jeff gets to dive headlong into several terabytes-worth of digital insights and real-world evidence. He plans to emerge with powerful opportunities for life sciences companies to accelerate their digital transformation.

Sean Grullon, PhD, Machine Learning Data Scientist, Data Centre of Excellence, GSK

Sean Grullon is a Machine Learning Data Scientist at GlaxoSmithKline who blends over twelve years of experience in machine learning and data analysis in a particle physics research setting with pharmaceutical and health care experience. His expertise includes deep learning and machine learning, statistical inference, and big data technologies.

Amit Gulwadi, Senior Vice President, Clinical Innovations, Saama

Amit executes Saama’s clinical analytics innovation roadmap by identifying and integrating emerging concepts across the clinical research value chain, fostering and strengthening clinical ecosystem relationships, and communicating Saama’s strategy to key stakeholders. Amit works closely with internal business and technology groups to understand and help shape their strategies and goals related to AI and machine learning, clinical technology, enhanced user experiences, collaboration, wearables, and big data.

Basker Gummadi, IT Strategy & Digital Transformation, Digital Innovation, Bayer U.S. LLC

Basker is a great visionary with a proven track record of identifying technology enablers that meet the strategic business objectives. He has vast experience in executing key strategic projects and cross-departmental programs across pharmaceutical research and development. His current focus areas are as follows: Optimizing Clinical Trials with Block Chain, AI, Robotic Process Automation, and Big data; Enabling innovation to drive new business models.; Leading a non-profit forum for digitalizing drug development and enabling precision medicine initiatives. Basker is a resident of Basking Ridge, New Jersey and enjoys volleyball, cricket, volunteering his time in coaching, mentoring within the community, and serving Habitat for Humanity & Boy Scouts of America.

Mary Hall Gregg, PhD, Vice President, Business Technology, Research & Development, Pfizer

Dr. Hall Gregg is Vice President of Business Technology, Research & Development at Pfizer. She works closely with the heads of Worldwide Research and Development and Global Product Development and the CIO to provide information technology strategic and operational leadership in support of Pfizer’s worldwide initiatives in drug discovery and clinical development. Before joining Pfizer, Hall served as the Vice President Information Systems, Research and Development Informatics at Amgen where she was responsible for providing all information technology solutions and services to Amgen’s R&D functions. She sponsored and led initiatives across R&D that delivered information search, data discovery and analytics, and integrated, cloud-based platform capabilities for research and clinical development. Prior to Amgen, Hall held a variety of roles in information technology and business functions at Quest Diagnostics, including CIO and VP for global central laboratory services and South American laboratory operations. While at Quest Diagnostics, Hall was appointed by the Governor of New Jersey to serve on the New Jersey Healthcare IT Commission. She also served as the Vice President of Business Information Systems and Deputy CIO at the American Red Cross. Hall received her Ph.D. in biostatistics from Virginia Commonwealth University and her bachelor’s degree in mathematics from Vanderbilt University.

Shwen Gwee, General Manager, Digital Accelerator, Novartis

Shwen Gwee is a recognized pioneer in digital health and social pharma. An industry thought-leader, he was named a Top 40 “Healthcare Transformer” by MM&M in 2015, and a MM&M and PR Week Health Influencer 50 in 2017. Shwen brings over a decade of experience leading commercial/brand digital strategy and driving innovation across both client-side biopharma organizations and at leading advertising agencies. He currently serves as Head of Digital Strategy for Novartis and sits on various advisory boards, including: Google (Healthcare), SXSW (Health), MM&M Healthcare Transformers, emojiHEALTH, and the Digital Health Coalition. He is often featured in industry publications, speaks regularly at industry events and chairs the Social Innovation Day for the Digital Pharma Series (East, West and EU). A passionate contributor to the digital health startup community, Shwen organizes startup bootcamps, runs startup pitch contests and plays an active role running healthcare hackathons around the world as part of the MIT Hacking Medicine team.

Adam Halbridge, Principal of Digital Health, PRA Health Sciences

Biography coming

Matt Harlin, Associate Director, Clinical Pharmacolgy, Otsuka Pharmaceutical Companies

Matt Harlin is Associate Director, Clinical Pharmacology at Otsuka Pharmaceutical Development & Commercialization, where he has worked for over 9 years. During that time, he has held several roles within Clinical Pharmacology, including leading an initiative to implement collection of biospecimens for future use during all interventional clinical trials. He obtained a Master’s in Biotechnology from John’s Hopkins University, and is currently a Clinical Pharmacology lead on several early and late-phase compounds.

Beth Harper, MBA, Workforce Innovation Officer, Association of Clinical Research Professionals (ACRP)

Beth Harper is the Workforce Innovation Officer for the Association of Clinical Research Professionals (ACRP). She has passionately pursued solutions for optimizing clinical trials and educating clinical research professionals for over three decades. Beth is also an Adjunct Assistant Professor at the George Washington University who has published and presented extensively in the areas of protocol optimization, study feasibility, site selection, patient recruitment and sponsor-site relationship management. Beth is currently serving on the CISCRP Advisory Board as well as the Clinical Leader Editorial Advisory Board among other industry volunteer activities. Beth received her B. S. in Occupational Therapy from the University of Wisconsin and an M.B.A. from the University of Texas. (She can be reached at 817-946-4728 bharper@clinicalperformancepartners.com or beth.harper@acrpnet.org)

Maria Harrison, Vice President, Real World Solutions, PRA Health Sciences

Bio coming soon...

Tony Hebden, PhD, Vice President, Health Economics & Outcomes Research, AbbVie

Dr. Hebden joined Abbvie in 2013 as Vice President of Global Health Economics and Outcomes Research. As a senior leader at Abbvie, he sits on a number of key decision making bodies responsible for defining the current and future direction of the company. Prior to joining Abbvie, Tony held several leadership roles at Bristol Myers Squibb in Princeton New Jersey, including Executive Director, Health Economics and Outcomes Research and Global Head of Medical Affairs for Clopidogrel (Plavix). Dr. Hebden attended The University of London where he received a BSc (Hons) in Physiology and MSc in Applied Physiology, and The University of Nottingham where he received a PhD in Pharmacology. Following this he completed a post-doctoral fellowship at The University of British Columbia, Canada and a second at Tripler Army Medical Center, Hawaii, before taking a faculty position at the University of Ottawa Heart Institute. He has over 100 scientific publications in the areas of cardiovascular and renal physiology and pharmacology as well as Health Economics and Outcomes Research.

Ann Hegarty, Executive Director, GSMO, Head PLs, CRO Oversight & Ph I Site Management, Allergan

Ann has worked in the field of Clinical Research for more than 25 years. Her time in the industry has been roughly divided in half between supporting clients as part of a CRO, and partnering with CROs as a manager in a Sponsor organization. Through these experiences, Ann has acquired a unique perspective for articulating expectations and evaluating outcomes. She’s worked across all phases of research beginning her career at what was, at the time, the largest Phase I center in the world. Since then, she’s had the opportunity to span various functions: Study Coordinator, CRA, Project Manager and Regional Operations Manager of CRA staff. She’s directly supported several FDA inspections and collectively worked to bring many important new products to market. Ann’s had the opportunity to watch the evolution of ICH GCP from its initial rollout through its most recent revision and had the good fortune to share her insights on these guidances with colleagues around the world. She is a member of ACRP and Austin Film Society.

Kyle Hogan, Director, eClinical Solutions, Clinical Ink

Kyle is responsible for the strategic alignment of the Engage native mobile application for clinical trials, and overall ePRO/eCOA and Patient Engagement support. He brings 12+ years of experience in ePRO/eCOA and over 20 years of experience in delivering software technology solutions, has managed numerous global clinical trial deployments (with 2 known FDA approvals) and developed a mobile patient training solution for use by sites and patients.

Kyle Holen, MD, Head, Development Design Center, AbbVie

Trained as a medical oncologist at Columbia University and Memorial Sloan-Kettering Cancer Center, Kyle began his career treating patients with GI tumors at the University of Wisconsin. There, his research interests included early phase trials and novel therapies for GI and neuroendocrine tumors. His educational responsibilities included leading the UW medical oncology fellowship program. He left academia to pursue drug development at AbbVie in 2009 and has since had roles as medical director, senior medical director, senior project lead, and executive medical director. He is currently the Head of the Development Design Center, a center that assists clinical teams with their programs and trials using big data/predictive analytics and innovative strategies.

Kirstin Holzapfel, Head of Clinical Data Process Technology, Data Sciences & Analytics, Bayer AG

Kirstin Holzapfel in her position as Head of Clinical Data Process Technology is leading the Application Integration Workstream of Bayer's Mountain View project 'K2' and is responsible for establishing the integration of internal systems with Accenture's Life Sciences Cloud. Prior to this, she held leading positions and roles in other strategic and technology driven projects and initiatives within the Data Sciences & Analytics area.

Kevin Hudziak, Consultant, Innovation Lead, Patient Experience and Design Innovation, Eli Lilly & Co.

Kevin works in the Patient Experience & Design Innovation team at Eli Lilly and Company. His primary focus is on improving Recruitment and Retention of clinical trials via exploration of innovative solutions. "

Melissa Hurst, MSM, MBA, Clinical Outsourcing Manager, CSL Behring

Biography coming…

Adama Ibrahim, Associate Director, Clinical Operations, Biogen

An innovation award winning operational strategy expert, blockchain advocate and patient engagement thought leader with over 17 years in the NHS on commission by the DOH and in Industry (Hoffman La-Roche, Amgen, ALMAC, ICON and Biogen). An R&D transformation change champion. Currently part of the DIA Patient Engagement Voluntary Community Leadership team. Experience across various therapeutic areas and phases of trials in drug development include creation and execution of successful strategies for research protocols and CRO oversight, patient and site feasibility, expertise in technologies such as eCOA and IVRS, creation of optimal drug packaging and administration concepts, mapping the patient journey, planning and executing effective global site and patient engagement campaigns using direct to patient methods, leading and coaching remote and complex global teams.

Edmund Jackson, PhD, Chief Data Scientist, Vice President, Clinical Services Group, HCA Healthcare

Dr. Jackson is the HCA Chief Data Scientist and Vice President within the Clinical Services Group. His education is a BscEng and MScEng both in electronic engineering, followed by a PhD in statistical signal processing from Cambridge University. In that work, Edmund focused on applications of sequential Markov chain methods in bioinformatics. He pursued a career as a quantitative analyst in the hedge fund industry for several years. At HCA Edmund leads teams of analysts, data scientists and engineers that create products improving the quality of clinical care, operational efficiency and financial performance of the firm. Edmund and his teams are inspired each day by the positive impact of these products on our patients’ and caregivers’ lives. In his spare time Edmund enjoys CrossFit.

Pravin Jadhav, PhD, Senior Director, Innovation and Business Transformation, Corporate Projects, Otsuka Pharmaceutical Dev & Commercialization Inc.

Dr. Pravin Jadhav is Senior Director of R&D Innovation and Business Transformation within Otsuka Pharmaceutical Development and Commercialization (OPDC) Corporate projects. He leads a multi-disciplinary team of data, information and knowledge experts to create science-driven, technology-enabled solutions of clinical and economic utility. The team is focused on clinical trial transformation and new business model by leveraging digital technology to bring therapeutic solutions for customers. Before joining Otsuka, he worked at Merck and Office of Clinical Pharmacology (OCP) at the US food and Drug Administration (FDA) in different leadership roles. Pravin received his BPharm and MPharm from India, PhD in Pharmaceutical Sciences from the Medical College of Virginia Commonwealth University (VCU) and MPH from Johns Hopkins University, Bloomberg School of Public Health. He has an adjunct faculty appointment in the College of Pharmacy at University of Florida and member of the Graduate Advisory Board of VCU School of Pharmacy.

Liping Jin, Data-Driven Recruitment Lead, Pharmaceutical Research & Early Development, Roche Innovation Center New York

Liping is leading Data-Driven Recruitment at Roche pRED organization. He has been working at Roche Pharmaceutical for more than 15 years in different settings (e.g. clinical informatics, data science, and bioinformatics)

Keith Jones, Director, Financial Planning and Analysis, Ovid Therapeutics

Biography coming…

Kristijan Kahler, RPh, PhD, Head, Outcomes Evidence & Analytics, RWE & Digital, Global Medical Affairs, Novartis

Kristijan (Kris) Kahler is Executive Director, and the Global Head of Outcomes Evidence & Analytics group within Real World Evidence & Digital at Novartis Pharmaceuticals. In this role he leads a team of RWE Scientists responsible for real world evidence generation across the organization; largely conducting non-interventional studies with secondary data sources.

Kris has been with Novartis since January 2001, and prior to his current role, was responsible for the development and implementation of health economics and outcomes research strategies for both marketed and developmental products for various therapeutic areas in the US organization. Kris has a Pharmacy degree from the University of Rhode Island, a Masters in Epidemiology from the Harvard School of Public Health, and received his Ph.D. in Epidemiology from the UMDNJ School of Public Health.

Bill Karich, Strategic Business Operations, CSL Behring

Biography coming…

Nechama Katan, Associate Director, Data Monitoring and Management, Clinical Sciences and Operations, Global Product Development, Pfizer

Nechama Katan, Associate Director at Pfizer, is a “Data Wizard with Personality.” She helps organizations access and use their data to drive business decisions. Nechama blends an ability to write code and provide prototypes with an interest in driving the “business conversation." In addition to working with various organizations, she is an experienced instructor in Statistics, Operations, Data presentation and Metrics development. Her education includes an MSc from NYU in Mathematics and an MA from Columbia University in Statistics.

Nareen Katta, Director, Operations Analytics, Data Sciences, AbbVie

Nareen Katta works as a Director, Clinical Analytics in Data Science organization at AbbVie. Nareen has over 15 years of experience in the pharmaceutical industry. In his current role, Nareen is responsible for building and executing the analytics strategy in support of Risk Based Monitoring and Centralized Monitoring. In addition to Clinical Analytics, Nareen is actively engaged in evaluating the technology trends like big data, automation, machine learning and AI, digital health etc.

Ly Kawaguchi, Senior Director, DBO-Outsourcing, Site Budgets, and Business Analytics, MyoKardia, Inc.

Biography coming…

Elise Kayson, Director, Clinical & Strategic Initiatives, University of Rochester, Center for Health & Technology (CHeT)

Elise Kayson, Director of Clinical and Strategic Initiatives at the Center for Health + Technology (CHeT), Assistant Professor of Nursing and Senior Associate in Neurology at the University of Rochester has been involved in the care and research of Parkinson disease (PD) and Huntington disease (HD) patients for over 20 years. Kayson played a key role in the pivotal trials that resulted in the only two FDA approved drugs for HD. She currently serves as the Huntington Study Group (HSG) Co-Chair and other leadership positions including HSG Credentials Committee Chair, and co-chair of the HSG Educational Committee. She was recognized in 2016 with a Lifetime Achievement Award from the HSG. Kayson has led and managed over 50 clinical trials operationally and administratively for Parkinson disease, Huntington disease and other rare disorders. Through her tenure in industry and academia, she served as director of project management, and is well versed in clinical trial design, organization and conduct, and regulatory management.

Helen Kellar-Wood, PhD, Associate Director, Oncology and Immunoscience Lead, Diversity & Patient Engagement, Bristol-Myers Squibb

Helen Kellar-Wood, Associate Director, Oncology and Immunoscience lead for Diversity & Patient Engagement at Bristol-Myers Squibb. In this role Helen creates and facilitates collaborations with a broad variety of patient facing and diversity organizations to identify ways clinical development team members can better understand and incorporate patient, caregiver and advocacy perspectives in order to improve our clinical studies.

Francis Kendall, Director Biostatistics & Programming, Cytel Inc

Francis has been working in the Life Sciences industry for over 30 years working in and leading Biometrics functions for larger companies like Pfizer, Novartis and Roche. He has always been interested in how new technology and access to data can improve Health care and how Life Sciences will have to adjust to the new paradigms that are created by these factors. Francis has a keen focus on Innovation and how Data can help improve the Healthcare ecosystem.

John Kim, Senior Manager, Clinical Development & Operations Business Technology, Pfizer

John Kim is currently the Business Technology Business Partner focused on Clinical Site Monitoring solutions specifically around Risk Based Monitoring and Site Oversight capabilities for Clinical Development Operations at Pfizer. John has worked for the past 20 years enabling Research, Pre-clinical and Clinical development capabilities with technology solutions. John holds a B.S in Bioengineering from the University of California, San Diego.

Joseph Kim, MBA, Senior Advisor, Patient Experience and Design Innovation, Eli Lilly

Joseph Kim serves as a Senior Advisor in Clinical Development Innovation at Eli Lilly, focusing on developing and implementing innovative patient engagement solutions. He has spent more than 15 years in the pharma industry utilizing a unique approach that integrates his experiences working for Sponsors such as Shire and Merck, CROs, and technology vendors. He has a robust combination of experience that includes early and late phase clinical research, and a well-known history of innovation in the clinical research industry, recognized as one of “20 Innovators Changing the Face of the Clinical Trials Industry” by CenterWatch in 2013. He holds a B.S. in Molecular Biology from Lehigh University and an MBA from Villanova.

Allen Kindman, MD, FACC, Vice President, Clinical Planning and Analytics, IQVIA

L. Allen Kindman leads a team to confirm protocol feasibility, and find the right patients, investigators, and sites around the world, leveraging vast data sets of anonymized patient information. Allen was a Clinical Professor of Cardiology at UNC, a site investigator and practiced general and interventional cardiology. His research interests range from clinical heart failure to intracellular Calcium signaling. Allen attended medical school at Mount Sinai, medical residency at New York Hospital and Stanford University, and cardiology fellowship at Stanford.

Brett Kleger, Chief Commercial Officer, DrugDev, An IQVIA Company

As DrugDev’s CCO, Brett Kleger is responsible for leading DrugDev’s commercial strategy and development. He spearheads the DrugDev initiative to bring new capabilities to market, and “puts his money where his mouth is” to take responsibility for the success of new DrugDev solutions or businesses, including a seamless customer experience. Brett enjoys challenging the status quo and creating solutions that improve critical business processes. Prior to DrugDev, he created global solutions for IMS Health, a market leading healthcare analytics provider, where he founded a division focused on clinical trials. Previously he was a leader at Acurian, growing the company from its infancy, startup stage to a market leader in patient recruitment. Brett holds a business degree from the University of Maryland, and a juris doctorate from Villanova School of Law. His type-A personality brings structure to everything in life, while his humor allows him to never take life too seriously. He is a proud father of two boys, caring husband to one wife, devoted dog owner, and an avid sports enthusiast. When not working you can find Brett on the sports fields or courts as a coach, participant, or fan.

Todd Kole, RPh, Vice President, Clinical Project Services, Almac Clinical Technologies

Todd is Vice President of Clinical Project Services for Almac Clinical Technologies. After obtaining his Pharmacy degree from Rutgers University, Todd spent 8 years in Clinical Logistics working for Bristol Myers Squibb and Amgen. He then made the switch to the vendor side and has been working in the IRT field for the past 19 years. He currently oversees global project management, key client account management and he is the executive sponsor at Almac for the Merck relationship.

Bari Kowal, Vice President, Global Head of Clinical Project Management and Operations, Regeneron

Bari is responsible for global operational leadership for the clinical development of Regeneron’s pipeline of important new medicines. She oversees all facets of clinical operations, including operational design, planning and execution of clinical studies. Her team also supports Global Development needs for Project Management, Training, Process & Procedures, Clinical Logistics, Business Operations, Analytics & Reporting, Vendor Management, Continuous Improvement, and Clinical Systems. Bari was previously at Pfizer where she held positions including Vice President, Business Operations and Analytics and Vice President, Strategic Alliance and Development Operations Lead. Bari also has a thorough knowledge of Clinical Research Organizations as she held roles of increasing responsibility in clinical operations and strategic alliances up to the Vice President level at ICON PLC. Bari holds a Master of Science degree from New York University with a concentration in Neuroscience.

Jim Kremidas, Executive Director, Association of Clinical Research Professionals (ACRP)

Jim Kremidas is currently the Executive Director for ACRP, a nonprofit association the represents the clinical research enterprise. Prior to that he conducted consulting services for a variety of clients, including support for investigator sites, academic institutions, sponsors and suppliers. He was the SVP of Patient Recruitment at two large CROs for more than six years, where he and his team were responsible for developing and implementing patient enrollment strategies for global clinical trials. Prior to that, he spent 24 years with Eli Lilly and Company. From 1999 to 2008 he led their clinical trial patient recruitment and retention efforts. In this role, he focused on predicting and accelerating the enrollment rates for all corporate studies. While in Strategic Sourcing he was responsible for the outsourcing of clinical development projects to strategic suppliers, including CROs, scientific staffing firms and patient recruitment suppliers. Before his assignment in clinical development strategic sourcing, Mr. Kremidas led Lilly’s efforts to select and establish relationships with direct to consumer and professional advertising agencies, as well as to implement standardized processes for the development and implementation of marketing materials. He is on the advisory board of CISCRP (a nonprofit organization focused on enhancing patient participation in clinical trials) and is also a volunteer for the Clinical Trial Transformation Initiative (CTTI) with Duke and the FDA. He is a frequent presenter at industry conferences and his articles/papers have been published in a wide variety of trade journals."

Sheri Kuss, Director, Clinical Quality Management, Pfizer

Sheri Kuss has over 25 years of clinical research experience in the industry working at pharmaceutical, medical device, CRO and biotechnology companies. Sheri's vast range of expertise has developed from her roles within clinical trial monitoring, clinical trial management, operations, clinical quality assurance, compliance, training and continuous improvement. Sheri has a proven track record of establishing and delivering inspection readiness and regulatory compliance training tools and programs as a direct result of her experiences hosting and preparing for regulatory agency inspections. In the area of operational excellence, she demonstrated success in leading business process teams and improving upon existing quality management systems through continuous improvement initiatives. Sheri's Sponsor and CRO experiences give her a unique quality insight and a practical approach to the risks and operational compliance issues related to the conduct of clinical trials and quality management systems.

Mary Jo Lamberti, PhD, Professor, Associate Director, Sponsored Research, Tufts CSDD

Mary Jo Lambert, PhDi leads multi-company sponsored and grant funded research studies at the Tufts Center for the Study of Drug Development (CSDD) at Tufts University School of Medicine. She has extensive experience conducting research on pharmaceutical and biotechnology industry practices and trends affecting contract research organizations and investigative sites. She has been a speaker at industry conferences and has published articles in trade and peer-reviewed journals. Prior to joining Tufts, Dr. Lamberti was director of market research at CenterWatch. She has also worked on federally funded research studies in science education reform and has taught undergraduate courses at Boston University. She holds a B.A. from Wellesley College and a Ph.D. in psychology from Boston University.

Alyssa Lanzi, MS, University of South Florida, Ambassador & Researcher, Patient-Centered Outcomes Research Institute (PCORI)

Alyssa Lanzi M.S., CCC-SLP, is a Ph.D. Candidate in the Department of Communication Sciences and Disorders, University of South Florida with mentor Dr. Michelle Bourgeois. She graduated with her M.S. in Speech-Language Pathology from Duquesne University and completed a Master’s Thesis entitled, Group External Memory Treatment for Mild Cognitive Impairment. She is interested in community-based research investigating person-centered assessment and intervention approaches for individuals with progressive cognitive communication impairments and their caregivers. In addition, she specializes clinically in caregiver support groups and caregiver education sessions on strengths-based approaches to dementia care. She is also the founder of Forever Friends: a student organization that focuses on building friendships between university students and senior citizens to enhance overall quality of life. The organization currently has over 100 student members.

Jake LaPorte, PhD, Vice President, Global Head, Digital Development, Novartis Pharmaceuticals Corporation

Jake LaPorte, PhD, is Global Head of Digital Development at Novartis and responsible for leading the company’s digital efforts within their Global Drug Development organization. Jake began his career at McKinsey & Company, where he was a leader in their Pharmaceutical R&D practice, during his six-year tenure, developing an expertise in large, complex transformations and innovation. It was on a fateful, extended journey in Asia-Pacific, however, where Jake read Ray Kurzweil’s The Singulatiry is Near and became captivated by the possibility of digitalizing the Pharmaceutical R&D engine – he has focused his career to the realization of this concept ever since. He co-founded Snapdragon Chemistry, with the Head of the Chemistry Department at MIT, which seeks to enable companies to implement continuous flow chemistry in discovery, development and manufacturing, with the ultimate goal of fully digitalizing chemical synthesis. Most recently, Jake has held various leadership positions at PPD, Inc., where he collaborated with executives to develop and implement C-level, strategic initiatives, including a long-term transformation to create industry-leading approaches to clinical development in key therapeutic areas. Jake completed his Ph.D. in Organic Chemistry from Harvard University, where he was an HHMI doctoral fellow, and received his B.Sc. in Biochemistry and Mathematics, summa cum laude, from the University of Delaware.

Jason LaRoche, Clinical Innovation Leader, Janssen Research & Development

Jason LaRoche is a Clinical Innovation Leader at Janssen Pharmaceuticals. He has more than 14 years of experience in the pharmaceutical industry where he has held various positions in supply chain management, clinical operations, and innovation. In his current role, Jason is responsible for leading smart packaging development and pilot executions for Janssen's iSTEP platform to modernize Janssen’s clinical trials and improve the experience of patients and investigators. Previously, he completed a secondment to TransCelerate where he led the successful expansion and growth of the TransCelerate Comparator Network. His work with TransCelerate won the Council of Supply Chain Management Professionals’ 2017 Supply Chain Innovation of the Year award. Jason holds a BS in Materials Science and Engineering from the Georgia Institute of Technology and an MS in Operations Research from the University of Florida. He is also APICS CSCP certified.

Andy Lawton, Director & Consultant, Risk Based Approach Ltd.

Andy Lawton was most recently at Boehringer-Ingelheim for 28 years ago. At BI Andy was responsible for managing the statistics, data management and programming groups with BIs UK operation. The group has specialised in the management of large scale trials and the implementation of risk based approaches within them. His experience covers over 33 years in clinical trials, but he also has extensive experience in the areas of computing, statistics, Data Management, RDE and system design. Andy was a founding Committee Member of ACDM and aided in the initiation of CDISC with the provision of the business model. Before joining BI, Andy worked as a statistician in the NHS and in computing in a geophysical exploration company.

Hugh Levaux, PhD, Founder and CEO, Protocol First

Dr. Hugh Levaux is Founder and CEO of Protocol First. The company offers an innovative EDC Platform for Oncology trials, Protocol First EDC and a stand-alone EHR-to-EDC adaptor app, Clinical Pipe. Dr. Levaux brings to Protocol First 20 years of experience in clinical trial design, operations, and related web-based technologies—notably, SVP at United BioSource Corporation (UBC), VP of Product Strategy at Medidata Solutions; CEO of Ninaza, a web-based EDC provider; and SVP at Quintiles Transnational.

David Leventhanl, Director, Clinical Innovation, Global Product Development, Pfizer

David leads Pfizer’s Patient Engagement activities within the Clinical Innovation group in Global Product Development at Pfizer, Inc. In this role, he is responsible for a portfolio of innovative approaches to address vital patient engagement challenges across Global Product Development. These challenges span the entire patient journey from before an individual might consider a clinical trial, their experience during a trial, and after they completed their participation experience.

This work is quite personal to David. His father is a 12 year cancer survivor and Pfizer Clinical Trial Alumni. His Dad participated in a clinical trial between 2005 – 2008. David has been with Pfizer for 23 years, and in that time has served in a variety of R&D and innovation functions including program management, business management, and Clinical Trial operations.

Tine Lewi, PhD, MBA, Scientific Director, Janssen R&D/Clinical Innovation

Tine Lewi is a Scientific Director at Janssen Global R&D/Clinical Innovation. For over 15 years, she led projects in the area of data and insight generation for healthcare. Tine currently leads the Hospital Network within Janssen R&D, covering a number of novel solutions within the real world data portfolio. She is active in developing data science capabilities within Janssen R&D and has a passion for disease interception and various initiatives around “a world without diseases“. Tine has a background in medical informatics and applied economics. She completed a PhD on patient insights and health communication for disease prevention.

Holger Liebig, Senior Director, Strategic Partnerships, PAREXEL

Holger creates infrastructure and intellectual property to support the pursuit, growth, quality and execution for PAREXEL’s Strategic Partnerships. He is a member of the core partnership teams with involvement in internal and external governance, KPI definition, change management and process alignment. Holger is a certified Lean Six Sigma Black Belt with more than 28 years experience where he has been accountable for processes and systems for operations, global project management and Phase I-III clinical research.

Alexander Lituev, MD, Practice Leader, Biorepository Head, Kaiser Permanente Research Bank

Dr. Lituev has over 20 years of combined clinical and research experience. He served as a Medical Director at Epigene Diagnostic, molecular diagnostics company, Director of Biospesimen Repository at the Center for Translational Research at CHI, one of the nation’s largest health systems; Senior VP at Cureline, a biopharmaceutical services company; CMO at the Medical center of Neuro-technology. In addition, Dr. Lituev served as a Principal and Co-principal Investigator for number of studies including TCGA, NCI-NIH, CHI/CTR multicenter pre-clinical Oncology and Autoimmunity. He received his MD from Pavlov's Medical University, St. Petersburg, Russia with Residency in Internal Medicine and Anesthesiology and completed postgrad program - Clinical Research Conduct and Management at UC Berkeley.

Ankit Lodha, MS, MBA, Associate Director, Clinical Analytics & Innovation, Global Development Operations, Shire

Ankit Lodha has high-end expertise in clinical analytics and interpretation of clinical operations data in the pharmaceutical/ biotechnology industry. In his current position, Ankit is responsible for building the Shire organization capability as a world-class leader in measuring CROs clinical analytics performance metrics and reporting. He is also responsible for designing meaningful metrics, setting the data strategy supporting the measurement of CRO performance, generating real-time dashboard for patient enrollment, site quality and forecasting study start-ups and cycle times. Before this position he has worked at Amgen, AstraZeneca and Pfizer within their respective Analytics and Innovation groups providing strategic services, supporting the metrics and data management needs of senior leadership. He holds a Bachelors in Biotechnology Engineering from Dr. D.Y. Patil University, Masters in Business of Bioscience from Keck Graduate Institute and MBA from University of Redlands – School of Business.

Robert Loll, Senior Vice President, Business Development & Strategic Planning, Praxis Communications, LLC

Robert Loll has more than 25 years of healthcare and sales management experience, assisting pharmaceutical, biotechnology, and medical device companies with patient enrollment solutions for global research studies. Robert is also an Advisory Board member for The Center for Information and Study on Clinical Research Participation (CISCRP) an independent non-profit organization dedicated to educating and informing the public and patients about clinical research

Charles Liu, Senior Product Manager, Cytel

Statistician Charles Liu manages the development, testing and support of key Cytel software products. These include the East® ESCALATE module for Phase 1 dose escalation designs, and EnForeSys®, the predictive patient enrollment software.

Robert Loll, Senior Vice President, Business Development & Strategic Planning, Praxis Communications, LLC

Robert Loll has more than 25 years of healthcare and sales management experience, assisting pharmaceutical, biotechnology, and medical device companies with patient enrollment solutions for global research studies. Robert is also an Advisory Board member for The Center for Information and Study on Clinical Research Participation (CISCRP) an independent non-profit organization dedicated to educating and informing the public and patients about clinical research.

Kelly Loughner, Senior Associate Director, Site Enablement, Boehringer Ingelheim

Kelly Loughner is an experienced Senior Associate Director Of Clinical Contracting with a demonstrated history of working in the pharmaceuticals industry. Skilled in Negotiation, Medical Devices, Biotechnology, Management, and Healthcare.

Charles Makin, Vice President and Global Head, RWE & Late Phase Research, Icon

Charles Makin is a leader in RWE and HEOR, with two decades of experience developing and implementing roadmaps for demonstrating drug value, safety and effectiveness. He has served as Principal Investigator on 100 + research projects in prospective and retrospective RWD collection, with 70 peer-reviewed publications. He leads late phase research at ICON, one of the industry’s largest research teams dedicated to patient and disease registries, phase IIIb/IV (pragmatic) clinical trials and expanded access programs.

John Makowski, Head, Clinical Operations, Audentes Therapeutics

John is currently the Head of Clinical Operations at Audentes Therapeutics, which mission is to treat rare unmet medical needs through gene therapy. John has over 25 year of experience in clinical drug development, with a primary focus on trial execution and the simplification of the drug development lifecycle through people, process and technology. John has a unique perspective and passion from his site, CRO and multiple BioPharma company experiences and looks to continue to leverage these experiences to bring life-saving medicines to patients as quickly as possible.

Marcin Makowski, Head, Risk Based Monitoring & Standards, UCB

Marcin Makowski, MD, PhD graduated from the Faculty of Medicine at Warsaw Medical University. After a successful scientific career in the fields of in immunology and experimental cancer therapy he moved to the pharmaceutical industry and worked for AstraZeneca (AZ) for 11 years. During that time, he took on various roles within Clinical Operations: monitor, local study team leader, study physician, and line manager. Since 2011, Marcin Makowski’s focus was on new monitoring approaches in clinical trials. He worked on one of the first industry implementations of Medidata’s Targeted Source Data Verification (TSDV) module. More recently, Marcin established and led AZ’s Centralized Monitoring group within the Risk-Based Monitoring (RBM) framework. He co-led the TransCelerate working group that prepared the framework paper on predefined Quality Tolerance Limits (QTLs). Currently, Marcin Makowski is the head of the Risk Based Monitoring and Standards group at UCB.

Marina Malikova, PhD, Executive Director, Research, Boston University

Marina Malikova, Ph.D., MSci, MA, CCRA, RAC Executive Director, Surgical Translational Research: Operations and Compliance. Dr. Malikova has over 14 years of experience in the clinical research field. She has managed Phase I – IV studies involving investigational drugs, devices and biologics. She has worked on Industry-sponsored and Investigator-initiated trials in the fields of Surgery, Cancer Diagnostics and Interventional Radiology. Dr. Malikova graduated from the Institute of Biochemistry, Russian Academy of Science, in Moscow, Russia with a PhD in Biochemistry. She has a strong background in biomedical sciences and has completed her postdoctoral fellowship in the field of cell signaling and cell migration. She also holds a Master’s Degree in Clinical Investigation, Certification in Project Management from Boston University and board certified in Regulatory Affairs (RAC). In her current role as Executive Director, Dr. Malikova manages research efforts in 13 divisions of the Department of Surgery at Boston Medical Center. She is responsible for clinical trials and basic biomedical research operations, quality assurance, risk management, strategic planning, and macro-management of research programs. She advises faculty/staff on protocol and informed consent writing; assists with BU IRB applications and submissions; provides oversight for data user agreements, cost coverage analysis and budgets development, contracts and licensing for clinical research; and ensures compliance. Dr. Malikova has 12 years of teaching experience as an Instructor for Clinical and Biomedical Sciences Program, Metropolitan College. She has developed and taught several courses such as: Design and Conduct of Clinical Trials, Drug Development, Introductory Pharmacology, Clinical Trials Management at Boston University, School of Medicine. She also serves as an Instructor of the Good Clinical Practices (GCPs) course for the Master of Science Program in Clinical Investigation, Division of Graduate Medical Sciences, Boston University, School of Medicine. Dr. Malikova is a member of Association for Clinical Research Professionals (ACRP), Drug Information Association (DIA), Regulatory Affairs Professionals Society (RAPS) and European Society of Radiology (ESR).

Kathleen Mandziuk, Vice President, Patient Strategy, PRA Health Sciences

Bio coming soon...

Martin Marciniak, RPh, MPP, PhD, Vice President, US Medical Affairs, Customer Engagement, Value, Evidence & Outcomes, GSK

Martin Marciniak, MPP, PhD is Vice President, US Medical Affairs responsible for Customer Engagement, Value, Evidence and Outcomes within GlaxoSmithKline. His leadership and research experience has included specific therapeutic area focus in oncology, neuroscience, cardiovascular disease, policy and economics. He has published in peer-reviewed journals and has been invited to present clinical, health outcomes, and economic results at both national and international meetings. In addition to his research activities, Martin has previously served as a nonvoting industry representative to the Medicare Evidence Development & Coverage Advisory Committee (MEDCAC) for the Centers for Medicare and Medicaid Services and as a board member for the National Pharmaceutical Council (NPC) Board of Directors. Presently, he serves as a member of the National Quality Forum Efficiency Steering Committee, the Editorial Advisory Board for Value and Outcomes Spotlight (an ISPOR publication), and on the advisory board for the Institute for Clinical and Economic Review (ICER). In addition to these activities, he has also served the broader healthcare community in several different ways, most recently through invitations to engage in public forum discussions at BioCentury TV and the FDA/CMS Summit. Martin holds a position of Adjunct Assistant Professor in the Division of Pharmaceutical Outcomes and Policy at the University of North Carolina’s Eshelman School of Pharmacy. He received his Ph.D. from the University of California at Berkeley, his masters’ degree in Public Policy from Harvard University, and his BS in Pharmacy from Purdue University.

David Martin, MD, MPH, Associate Director, Real World Evidence Analytics, Office of Medical Policy, US FDA Center for Drug Evaluation & Research

David Martin is the Associate Director for Real World Evidence Analytics in the Office of Medical Policy at the FDA Center for Drug Evaluation and Research. He oversees demonstration projects intended to support the agency’s evaluation of real world evidence, evaluates real world evidence submissions, and contributes to medical policy development mandated by the 21st Century Cures Act. Key focus areas include FDA-Catalyst and PCORI pragmatic trials as well as replication of clinical trial results with non-interventional study designs. He is also the principal investigator for the first study to capture patient-provided primary data through a mobile device application, store it in a secure cloud based repository, and link it to secondary electronic data in Sentinel and PCORnet.

Angie Maurer, RN, BSN, MBA, Clinical Quality & Risk Management Consultant, GRAIL, Inc.

Angie has spent over 19 years in healthcare and 15 years in the drug development and medical device industries spanning biopharmaceutical, medical device and CRO organizations. Her experiences include drug safety, study monitoring, study and program management, process development, therapeutic area and clinical operations training, and risk management. Over the past several years Angie has concentrated her efforts on clinical operations process development and implementation of risk management tools and trainings to support risk management programs.

Stuart McCully, PhD, Vice President, Regulatory Advisory Services, Syneos Health

Stuart McCully is an internationally recognized expert on NIS regulatory intelligence, and the founder of CHCUK Ltd (www.chcuk.co.uk), an on-line service specializing in regulatory intelligence for non-interventional studies. Stuart has more than 15 years’ experience in biomedical research regulatory compliance and is responsible for NIS regulatory advisory services, training and real world & late phase quality improvements. He manages a team of NIS regulatory advisors.

Amy McCormick, Innovation Lead, Patient Experience and Design Innovation, Eli Lilly & Co.

Amy works in the Patient Experience & Design Innovation team at Eli Lilly and Company as an Innovation Lead focusing on Recruitment & Retention. Before joining Lilly Amy was an Oncology Nurse with experience as a bedside nurse, clinical research nurse, and manager.

Kelly McKee, Head, Patient Recruitment, Vertex; Co-Creator of the SCOPE Participant Engagement Award

Kelly Johnston McKee is a clinical trial innovator and problem solver with a focus on patient recruitment and engagement and currently serves as the Head of Patient Recruitment for Vertex Pharmaceuticals. Kelly has been in the industry for over 18 years with previous positions at Lilly, Merck, and Sanofi-Aventis. She has an in-depth understanding of novel tactics and technology in protocol feasibility, site selection, and patient recruitment as was named Clinical Researcher of the Year by Pharma Times in 2012 and one of Centerwatch’s Top Innovators in 2018.

Brenda Medina, Director, Development Science Business Operations, BioMarin

Biography coming...

Dmitri Mikhailov, PhD, Biomarker Development, Novartis Institutes for BioMedical Research, Inc.

Dmitri Mikhailov is the global Head of Biomarker Study Coordination, Translational Medicine at Novartis. His team is responsible for clinical biomarker study setup across multiple therapeutic areas, and for developing new processes and technologies to improve clinical study conduct. Dmitri is also the global lead for Novartis Human Tissue Network, the company wide effort to develop risk-based strategy and efficient processes to enable translational research using human samples. Since joining the industry Dmitri had several positions of increasing responsibility in early biology, lead discovery, safety pharmacology and drug repositioning. Dmitri Mikhailov holds Ph.D. in Biology and M.S. in Physics & Applied Math.

Matt Miller, President, Co-Founder, StudyKIK

Matt Miller is President at StudyKIK and has been a leader in the use of digital and social media campaigns for patient recruitment on a single site and multi-site level with experience at a major CRO. Matt has developed cutting edge techniques to patient recruitment using social media for various therapeutic areas and disease states

Lisa Moneymaker, CTMS Process Architect, Amgen

Lisa is an Process Architect within the Development Information Systems organization at Amgen, specializing in Clinical Trial Management ecosystems. She additionally supports TransCelerate in both the Investigator Registry and Shared Investigator Platform initiatives, and is the TransCelerate Shared Investigator Platform Workstream Lead for 2018. She holds a BS from the University of Southern California in Biomedical/Biochemical Engineering.

David Morin, Director, Research, Holston Medical Group

Dr. David Morin has participated as a Principal Investigator in hundreds of studies (Phase I-IV) since 1989. A Certified Principal Investigator (CPI) since 2007 and an ACRP Credentialed Clinical Research Trainer (CCRT) in 2010. He received the “Outstanding Physician Leadership in the Profession” award by ACRP 2012. He currently serves on the ACRP Board of Trustees and the Academy Board. He is a member of the ACRP Governance and Awards &Recognition Committee. He also served on the CPI committee. He is a chief instructor for ACRP and also assists with the development of educational programs. He achieved his pharmacy and medicine degree with honors, and completed residency training at the University of Virginia in Charlottesville. More recently, he studied computer science at Northwestern University. He is Board Certified in Internal Medicine and is a Fellow of the American College of Physicians. He continues to practice medicine and is the Director of Research for Holston Medical Group, a large physician owned multispecialty practice headquartered in Kingsport, TN. He co-founded several companies including Trike, LLC which developed SiteOptex™ software, a proprietary methodology aimed at improving the efficiency of clinical research.Past activities included serving as a teaching attending for the ETSU College of Medicine, employee health director for a large hospital system, medical director of a CRO and an Accountable Care Organization. Also as a pharmaceutical consultant, speaker, author, and protocol writer.

Matthew Moyer, Director, Clinical Supply Technology, Merck

Matthew Moyer has 15 years of pharmaceutical development experience, and is Director of Clinical Supply Technology for Merck. Matt is the central point of contact for all of Merck’s clinical supply innovation efforts, leading the incorporation of new packaging, labeling, distribution, and other enabling technologies to drive more informed and timely decisions related to the conduct of clinical trials. He champions novel technologies to drive improved clinical trial execution, and pilots these need-driven technologies to determine feasibility for formal clinical install. Matt also leads the TransCelerate Patient Technology initiative, aimed at enabling and accelerating the use of patient-facing technology to improve the science and convenience of clinical trials. Matt earned a B.S. in Chemistry from Albright College, an M.S. in Pharmaceutical Sciences from Temple University, an M.B.A. from Lehigh University, and is certified in Project Management (PMP).

Mary Murray, Associate Director, Oncology Lead, Diversity & Patient Engagement, Bristol-Myers Squibb

Mary Murray, Associate Director, Oncology lead for Diversity & Patient Engagement at Bristol-Myers Squibb. In this role Mary creates and facilitates collaborations with a broad variety of patient facing and diversity organizations to identify ways clinical development team members can better understand and incorporate patient, caregiver and advocacy perspectives in order to improve our clinical studies.

Leigh Anne Naas, Community Manager, Patient Experience and Design Innovation, Eli Lilly & Co.

Leigh Anne works in the Patient Experience & Design Innovation team and manages the @LillyTrials social media strategy and execution in addition to our Lilly Blog. Leigh Anne also manages our partnerships with patient communities.

Ramzi Najm, Senior Associate, Waife & Associates

Ramzi Najm, Senior Associate, joined Waife & Associates, Inc. in 2015. He has over thirty years of experience in the biopharmaceutical industry, both in biopharmas and CROs, and his work experience has ranged from clinical data management to information technology and strategic innovation for clinical development. He served in senior roles at IBRD, Paragon, Concensys and Baxter Bioscience, before spending 14 years at Allergan. He compiled a strong track record of significantly raising the performance of organizations and delivering value through teams and individual contributions, through hands-on and energetic engagement. When Mr. Najm joined W&A from Allergan, he was Vice President, Strategic Analysis and Process Innovation, a role in which he was responsible for providing strategic direction to various R&D business functions and services, including Resource Management, IT Portfolio and Planning oversight, Analytics and Metrics, and Performance Management. Mr. Najm provides our clients particular expertise in process analysis, innovation implementation, CTMS’s, eTMF’s, CRO management, eClinical vendor management, and executive strategy consultation. Mr. Najm earned his undergraduate degrees in biology and computer sciences at UC Irvine, and his MBA from Pacific States University. He is based in Southern California.

Amy Neubauer, Associate Director, Data Management, Alkermes, Inc.

Amy Neubauer serves as Associate Director, Clinical Data Sciences at Alkermes, a company developing innovative medicines that address the unmet needs and challenges of people living with debilitating diseases, such as schizophrenia, depression, addiction, multiple sclerosis, and cancer. She has over 14 years of experience in clinical research with expertise in data management, project management, and vendor management, and is an experienced auditor of clinical trial systems, technologies, services and software. In her current role, Amy is responsible for the development of a clinical data sciences team to lead Risk-Based approaches and strategic data quality efforts for the organization through development and interpretation of algorithms, code, reports and visualizations in support of clinical trial operations activities with a focus on impactful data insights and clinical data review.

David Nickerson, ‎Head of Clinical Quality Management, EMD Serono

Dave has 30 years of industry experience spanning the disciplines of Drug Metabolism & Pharmacokinetics, Project/Program Management, and Clinical Quality Management. He joined EMD Serono (a business of Merck KGaA, Darmstadt, Germany) in November 2016 as Head of Clinical Quality Management. His previous 23 years had been with Pfizer. Dave was a member of the Expert Working Group that was responsible to develop the addendum to ICH E6 (ICH E6 R2).

Brian Nugent, Senior Director, Clinical Compliance, GRAIL, Inc.

Brian has spent over 30 years in health care and 15 years in the drug development industry spanning both biopharmaceutical and CRO organizations with director-level responsibility for quality, clinical operations, process development, TMF and safety. Over the past several years, Brian has concentrated his efforts on clinical operations process development and the establishment of quality systems to include QRM/QbD, as well as the standardization of risk management plans.

Erin O’Boyle, Senior Director, Clinical Contracts and Outsourcing, FibroGen, Inc.

More than 15 years of operational and management experience in conducting all phases of clinical trials. I am currently responsible for providing leadership and management of all outsourced clinical vendors that are working with FibroGen on a variety of studies. These studies range from large Phase 3 global studies to small Phase 2 rare disease studies. While at FibroGen, I have successfully collaborated with the clinical teams and vendors to implement processes (i.e. translation, on-site monitoring expectations, drug destruction) that have saved significant costs, reduced timelines and improved consistency. Prior to joining FibroGen, I worked at Heron Therapeutics as the Associate Director of Clinical Development and ran the clinical program for Sustol®, from the first Phase 1 study up through the NDA. Over the years, I have fostered and maintained relationships with vendors and sites. I learned that in order to continue to have a support team that is happy and wants to work on your study(s), communication, a contract that clearly outlines the roles & responsibilities of each party and working hard with your vendors will be your strongest and best assets for achieving study goals.

Chris O'Brien, MBA, Vice President, myHealthTeams; Board Member, MHE Research Foundation

Chris O’Brien is the VP of Strategic Partnerships for myHealthTeams; a social networking company with a focus on connecting people with chronic health conditions. He is also a board member for the MHE Research Foundation dedicated to the pursuit of a cure for Multiple Hereditary Exostoses (MHE) of which his youngest son Dawson suffers and is currently participating in a clinical trial. He has an extensive history serving many different facets of the healthcare industry including the Pharmaceutical industry, ambulatory and acute healthcare networks and ACO’s supporting electronic health record initiatives and acute care health information management support. He holds an Executive MBA focused in Systems Thinking from Villanova University.

Faye O’Brien, Director, Metrics and Performance, GMD, AstraZeneca

https://www.linkedin.com/in/fayeobrien/

Richard O’Hara, Associate Director, Clinical Outsourcing, Endo Pharmaceuticals

Biography coming…

Carlos Orantes, CEO, Accel Research Sites

As CEO, Mr. Orantes provides strategic direction and leadership to Accel Clinical Research Sites and its affiliates. Bringing 24 years of experience of CRO and life sciences, his background includes executive/operational management, process re-engineering, compliance and business development. Prior to joining Accel, he was COO of Frontage Laboratories, where he led efforts to expand the company’s capacity of services and managed the business that led to a successful recapitalization. Mr. Orantes was previously CEO of AVANZA Laboratories. He developed the company’s strategy and led the business to a successful asset purchase by the Smithers Group. Prior to AVANZA, he was GM/VP for Bridge Laboratories, a toxicology and immunology testing laboratory where he managed the US operations. Earlier positions included 10 years of operational, quality assurance, process improvement and management roles of increasing responsibility at Covance. Mr. Orantes earned an MBA from Old Dominion University, and a BS in biology from George Washington University. He is Six Sigma Black Belt certified from the Six Sigma Academy.

Oriol Serra Ortiz, MBA, Senior Director, Head Site Intelligence & Selection, Study Optimization, Clinical Development & Operations, Pfizer

A leader in Strategic Planning and Optimization of R&D Portfolios. As functional Head for Site Intelligence & Site Selection based in La Jolla, CA, Oriol provides leadership, strategic direction and oversight to effectively deliver country and site feasibility globally. Oriol´s interest in Protocol and Site Optimization started early in his career, since then as a change agent he has Led multiple cross-portfolio / cross-functional strategic projects in all the organizations he has worked with, innovating about the engagement of key stakeholders and utilization of data to predictably deliver clinical trials. Oriol holds a Bachelor in Biological Sciences from the Fairleigh Dickinson University, MS Clinical Trials Management from the International University Barcelona and an Executive MBA from University of California San Diego-Rady School of Management.

Kevin Ott, Clinical Operations Data Analyst, Cardiovascular Systems, Inc.

As Clinical Operations Data Analyst at CSI, Kevin leads the strategy, implementation, and integration efforts for metrics and analytics within Clinical Affairs. With a background in IT and over 12 years of experience in Clinical Research, he utilizes his extensive understanding of Clinical Operations to advance the efficiency and quality of the Clinical workflow through technical solutions and process improvement. Kevin's current area of focus is leading working sessions with cross-functional teams to drive the use of data to discover insights and inform decisions.

Jon Paras, Senior Manager, Electronic Trials Operations, Amgen

Jon Paras leads a team that oversees the design and provision of IRT systems for Amgen’s clinical trial portfolio. He has over 15 years of IRT experience in software testing, project management, design management, business process improvement, and has a holistic view of IRT’s impact on clinical trials. Prior to joining Amgen, Jon held leadership roles at IRT providers as well as an IRT group within a CRO.

Kinjal Patel, Senior Study Manager, Research & Development, Bayer

15-years of progressive experience in bio-pharmaceutical and healthcare industry in managing diverse therapeutic areas and stages of new drug research and development for Global Medical Affairs, US Medical Affairs, Global Project Management, Global Clinical Sciences, and Medical Data Operations.

Anita Pascarella Cole, Consultant, LRL Sourcing, Eli Lilly and Company

Anita Pascarella Cole, B.S. in Biology is the Consultant in LRL Sourcing responsible for overseeing the cross-functional vendor qualification forum, overseeing the management and on-boarding of numerous external vendors. Anita has worked at Eli Lilly for 20 years. During her career at Eli Lilly she has directed clinical laboratory and diagnostic services in support of all therapeutic areas and phases of clinical development in support of global biomarker operations and central clinical sample storage. In addition, she served as an Advisor in the Product Delivery area of Eli Lilly. In her current role, she is responsible for managing and helping to create outsourcing strategies across various fuctional areas, overseeing vendor on-boarding activities and assessing vendor risk related to Privacy, Information Security and Quality in determination of associated qualification assessments of those vendors.

Rajneesh Patil, MBA, Global Head, Process Design and Analytics, Clinical Operations, IQVIA

Patil is a Senior Director with expertise spanning process design, project portfolio management, risk based monitoring and advanced analytics for clinical trial application. He recently led the development of an automated centralized monitoring organization using artificial intelligence and machine learning. He is a Dental Surgeon by training, a Six Sigma Greenbelt with an MBA in operations management.

Gisele Paule, Contract Coordinator, Clinical Planning & Resource Management, Abbott Nutrition

Gisele is a Contract Coordinator who works with Abbott Nutrition’s R&D Scientific & Medical Affairs department managing resources and projects. Gisele believes mastering resource management is the key to happiness. Gisele has worked at Abbott Nutrition for over 10 years. Gisele holds a Masters of Business Administration from the Ohio University.

Morten Thorup Pedersen, Risk Based Monitoring Specialist, Centralised Monitoring Unit, Clinical Systems, Data & Trial Management, Novo Nordisk A/S

With a background as a site monitor I have worked 6 years in clinical trial management of large phase 2-4 trials before taking on the job as RBM Specialist implementing risk based monitoring in a large pharmaceutical company. With a solid understanding of the data collection processes at sites combined with my thorough understanding of Novo Nordisk data systems I am now designed the reports used for centralized monitoring as part of the risk-based approach.

Pamela Penman, CTMS Business Development, BSI Business Systems Integration AG

Pamela Penman has spent most of her career as a biotech professional, most recently working with the world’s largest biotech company where she helped bring a much-anticipated product to Europe that treats an orphan disease. Pamela has a special interest in data and customer insights and spends much of her time helping the team to deliver products that dramatically help simplify her customers’ lives.

Jeewa Perera, CEO, Champ IT Solutions

Biography coming…

JoAnn Pfeiffer, DrSC, Director, Clinical Research Management, Arizona State University

JoAnn Pfeiffer is currently Director and Associate Professor, Clinical Research Management and Regulatory Science Graduate Programs at Arizona State University. She works nationally and globally with regulatory leaders, designing courses and programs to develop global thinkers and leaders who are able to address and impact the global regulatory landscape, issues, and initiatives faced by the pharmaceutical industry. She has a diverse background and experience in clinical research including clinical trial operations with emphasis on contract and budget development and management. She is an author and co-author of multiple resources, articles, and textbooks related to clinical trial operations, quality in research, study site operations, effective site-sponsor communications, as well as developing training materials and course content. Dr. Pfeiffer is a member of the Association of Clinical Research Professional Association Regulatory Affairs Committee; the Consortium of Academic Programs in Clinical Research, serving on the Accreditation Self Study Report Committee, the Website Committee and as an Accreditation Site evaluator; and the Association of Graduate Research Education Programs. She is certified by the Regulatory Affairs Professional Society and the Association of Clinical Research Professionals.

David Posselt, Director, Global Contract Management - Drug Development Operations, Allergan

A strategic, results driven finance and operations executive leader with significant diversified global experience with increasing levels of managerial responsibility in the pharmaceutical, life sciences and biotech industries. Experience in financial management, controlling, R&D, financial planning & analysis, budgeting & forecasting, accounting, clinical development, process improvement, project management, contract management and change management. Customer focused, innovative, strategic, hands-on manager with strong communication and leadership skills and a record of success in directing, motivating teams to achieve results in a multi-national matrix corporate environment.

Mal Postings, Vice President, Head, Innovation/Emerging Technologies & Chief Architect Research & Development Solutions, IQVIA

As an industry-leading architect bridging business and IT, Mal has extensive experience building next generation business models enabled through emerging technologies, with focus on Information Services/Technology business architecture – and on new IT trends including cognitive/AI, digital, cloud computing, social networking, mobile computing, ‘Internet of Things’ and innovation. Throughout his career he has established a consistent record of leading innovative global transformation programs and alliances for complex, multi-billion dollar global organizations, while generating consulting firm revenues in excess of €1.7 billion. In his current position as Vice President, Head of Innovation and Emerging Technology at IQVIA, which he joined in June 2015, to bring new IT thinking; building and leading a new Solution Design Studio; managing the new wave of cognitive and robotic solutions; launching new agile based accelerator methods. Major accomplishments include delivery of over 30 innovation solutions through the studio including the open source code for Apple Research Kit and initial voice recognition solution with Amazon Echo device; research and delivery of big data/cognitive and robotics strategy and accompanying early business value use cases; maturing the company’s architecture capabilities through delivery of a new architecture framework.

Gian Prakash, Assistant Director, Data and Statistical Sciences, Abbvie

Gian Prakash has 12+ year of experience in pharmaceutical R&D technology and business process space. Gian works as Assistant Director in Data Science organization at Abbvie. In his current role, Gian is responsible for innovation, implementation, and operation of clinical technologies to enable the clinical data collection, aggregation & submission. Gian is currently working on the implementation of integrated clinical data review platform using emerging technology like big data/machine learning and integration of EHR data into Clinical Data Warehouse.

Jane Quigley, Senior Vice President, Medical Informatics, PRA Health Sciences

Bio coming soon...

Marisa Rackley, Director, Clinical Development Execution, Vertex Pharmaceuticals

Marisa Rackley is the Director Clinical Development Execution /Head of Site Engagement at Vertex. In this role she oversees the country and site allocation process for all studies across the portfolio. She serves as lead of the Regional Site Advocate group for North America. Prior to joining Vertex, Marisa was a Director at Merck & Co. where she worked for over 16 years with increasing areas responsibilities within Global Clinical Trial Operations. She has led cross functional development teams in bone, endocrine, metabolism, cardiovascular and atherosclerosis in end to end development.

Angela Radcliffe, GM, Clinical Trial Solutions, PulsePoint

Biography coming…

Sundaram Ramakrishnan, Venture Leader, Life Sciences, Cognizant

Sundaram Ramakrishnan has 16+ years of experience in Clinical informatics, Clinical trial design and data management. Sundaram specializes in Clinical Operations technology, data & analytics and is passionate about bringing disruptive technologies to streamline clinical trial operations. Sundaram is currently the venture leader and Product owner for Cognizant SmartTrials - a Clinical Performance management solution that streamlines clinical trial operations.

Ratan Ratnesh, Director & Head, Clinical Outsourcing, Otsuka

Ratan Ratnesh is a director and head of clinical outsourcing at Otsuka. Prior to joining Otsuka, Ratan worked at Wyeth and Novartis where he managed different categories related to clinical outsourcing. Ratan has broad experience in strategic sourcing, clinical outsourcing, operations and supply chain improvements in Fortune 500 and growth companies. He started his career in management consulting specializing in supply chain across different industries and moved to clinical outsourcing in early 2000. He received his Bachelors in Mechanical Engineering from National Institute of Technology, India and an MBA from University of Louisiana.

Melissa Rawley-Payne, Executive Director, Biospecimen Operations, Celgene

Melissa Rawley-Payne is Executive Director of Biospecimen Operations at Celgene. Prior to joining, she was Senior Director at Global Specimen Solutions, Inc. and was previously Head of BioBank at Pfizer for three years. She is an expert in the field of biobanking and has been asked to present at conferences nationally and internationally.

Brion Regan, Director, Product Management, ERT

Brion Regan has over 13 years of industry experience and has established himself as a thought leader in the application of data-driven process optimization and cloud-based technologies to the clinical research space. As the Director of Product Management for ERT’s Trial Oversight Suite, he is leading the commercial development and management of the company’s growing portfolio of Software-as-a Service (SaaS) solutions.

Debra Reinhard, Head, Translational Medicine Enabling Solutions, Bristol-Myers Squibb Company

A sought-after speaker and subject matter expert with over 29 years’ experience in the Pharmaceutical industry, Deb’s career has spanned Corporate and R&D Finance and strategy, as well as broad Informatics roles in support of Research and Development. Leveraging her training as a Six Sigma Black Belt and a Lean Sigma Kaizen Leader, she brings to her current role as Head of Translational Medicine Enabling Solutions a strong process and program management background. Her organization drives the development and execution of translational and clinical sampling strategies from Discovery through Life Cycle management trial execution as well as Translational Research and Integrated Sciences. She is responsible for evolving the capability of the BMS biorepository, redesigning informed consent processes and tools, and ensuring robust operational interfaces with specialty labs, academic labs and key opinion leaders for Clinical Biomarkers and Imaging modalities. Her experience led to Deb’s appointment as a core member of TransCelerate’s eConsent initiative to create an industry aligned position on consent processes and technologies.

Alexa Richie, DHSc, Research Operations Manager, Research Administration, Mayo Clinic

I am the Manager of Clinical Trial Operations for the Mayo Clinic Florida campus. I have 15 years of experience in clinical research in study coordination, site monitoring, operational management and leadership development.

Andrew Roddam, DPhil, Vice President, Head Epidemiology, RWE & Digital Clinical Platforms, GSK

Andrew is currently Vice President and head of Epidemiology, RWE and Digital Clinical Platforms at GSK, and is a renowned expert in epidemiological research with specific interest in the utilisation of routine data for research purposes. Andrew obtained his DPhil in Statistics at the University of Oxford and completed a post-doc in Infectious Disease Epidemiology. He was a Senior Researcher at the CRUK Cancer Epidemiology Unit at the University of Oxford before taking up an appointment at Amgen where he was most recently Regional Head (EU, EEMEA) in the Center for Observational Research. In his current role, he oversees the teams responsible for the epidemiological input into the discovery and development of new medicines as well as the real-world data and analytics group and the team charged with delivering innovation in real-world study execution. Andrew is a participant on several expert groups and advisory committees both in the UK and internationally where his expertise in epidemiological methods and health informatics are highly regarded.

Andrew Rohrbaugh, Director, Client Delivery, Cenduit

Andrew Rohrbaugh is a Director of Client Delivery at Cenduit. He brings more than 9 years of industry experience including project and account management of IRT, eSource, eCOA and Connected Devices. Andrew has extensive experience in implementing enterprise level solutions, focused on standardization within unique customer needs. He has served as a past presenter within numerous eClinical solutions events and webcasts, including IRT USA, Applied Clinical Trials, among others.

Sharin Roth, Director, Bioanalysis, Otsuka Pharmaceutical Development & Commercialization, Inc.

Sharin Roth is Director of Clinical Pharmacology, Bioanalysis and Biomarkers at Otsuka Pharmaceutical Development & Commercialization. She has worked in the pharmaceutical industry for 14 years on development of both small chemical entities and biologics. She received a Master’s in Analytical Chemistry at University of California, Riverside where she studied separation sciences. She currently manages a biorespository at Otsuka, which includes specimens collected in clinical trials.

Josh Rose, Vice President, Global Head, Strategy, Research and Development Solutions, IQVIA

As Vice President, Global Head of Strategy for the R&D Solutions at IQVIA, Mr. Rose is responsible for building the overarching clinical development business strategy, establishing and governing strategic initiatives, and leading the identification of acquisition candidates. He focuses on bringing innovative solutions that drive growth and differentiation to the market. Rose earned his MBA from Duke University and a Bachelor of Science in Chemical Engineering from the University of Illinois at Urbana–Champaign.

Anthony Rowe, PhD, Director, Business Technology Leader, R&D IT, Janssen R&D

Dr Anthony Rowe is currently a Business Technology Leader at Janssen Research and Development where he is responsible for defining the digital strategy for the Janssen’s Immunology Therapeutic Area, ImmunoScience Centre of Excellence, Disease Prevention Centre and Human Microbiome Institute. He is passionate about Digital Health and Precision Medicine and its use in developing patient centric healthcare solutions. Prior to joining Janssen he was a Director of Product Management & Founding Member of InforSense Ltd an innovative big data analytics company that provided Pharmaceutical, Financial Services and Telecommunication customers access to machine learning and high performance computing technology. During his tenure at InforSense he had roles leading Engineering, Marketing, Technical Sales as well as Product Management and was involved in both fund raising, growing the company from 7 to 150 people and a successful exit of the company. Dr Rowe holds a PhD in Computer Science and an MSc in Artificial Intelligence from Imperial College London and a BEng in Computer Systems Engineering from the University of Warwick.

Jonathan Rowe, PhD, MS, MA, Executive Director, Head of Clinical Development Quality Performance and Risk Management, Pfizer

Jonathan Rowe has 20 years of experience supporting pharmaceutical companies in the development of medical therapies from the clinical, operational and business perspectives. Currently, Jonathan holds the position of Executive Director, Head of Clinical Development Quality Performance and Risk Management at Pfizer, where his responsibilities include monitoring, modeling and predicting the Pfizer GCP Quality Management System, leading the analysis of Pfizer’s Clinical Trial Quality Performance and ensuring clinical trial quality risk management is built into all trials. At Pfizer he has held a number of roles including Clinical Director, with responsibility for the Phase IIIb and IV Lipitor program; Director, Intellectual Property Strategy Management; and Senior Director of Process and Performance. Jonathan spent a number of years in “small pharma” as the Head of Intellectual Property and Portfolio Strategy for Amarin and Dignity Sciences. Jonathan earned his Ph.D. and M.S. at the Albert Einstein College of Medicine and his M.A. from Binghamton University.

Thorsten Ruppert, MD, Senior Manager, Research, Development and Innovation, Association of Research-Based Pharmaceutical Companies (vfa)

Dr. Thorsten Ruppert is senior manager for research, development and innovation in the Association of Research-Based Pharmaceutical Companies - vfa. In 1999 he received a doctorate in biochemistry at the Free University in Berlin. Also in 1999 he joined NOXXON Pharma AG as a scientist in the Department of Research & Development. From there he moved internally in the clinical research department and in 2002 he became Director of Scientific Marketing, Division of Business Development. In 2004 he joined the vfa, where as Senior Manager Research, Development & Innovation he is responsible for a clinical trials, personalized medicine and biobanking.

Kavita Sail, PhD, Associate Director, Health Economics and Outcomes Research, AbbVie

Dr. Kavita Sail joined AbbVie in January 2013 and is currently the global HEOR lead for chronic lymphocytic leukemia (CLL) and lymphoma indications of Venetoclax. In this role she has successfully supported the launch of Venetoclax across several markets. Dr. Sail has previous experience working in the AbbVie Neuroscience franchise and has served as the global lead for Duodopa and pipeline products such as ABV-951 for Parkinson’s disease and ABV-8E12 for Progressive Supra-Nuclear Palsy (PSP). Over her 5 year career at AbbVie, Dr. Sail has developed strong research partnerships with several key national and international organizations to maximize real world evidence generation. Prior to joining AbbVie, Dr. Sail held the position of outcomes researcher at McKesson Specialty health and subsequently joined Xcenda as a consultant. In these roles, Dr. Sail consulted for major pharmaceutical and biotechnology companies where she helped develop the evidence strategy and value proposition for the launch of several oncology products. Dr. Sail received her Ph.D. in Health Economics from the University of Texas Health Science Center (UTHSC) through the prestigious Susan G Komen pre-doctoral fellowship award. She also has a Masters in Pharmacoeconomics and Outcomes Research and a Bachelor of Pharmacy degree. Dr. Sail has previously served as the Founder and President of the Student Chapter network of the International Society for Pharmacoeconomics and Outcomes Research (ISPOR) and has served as a judge at the ISPOR congress sessions. She has several peer reviewed publications and has presented at numerous national and international Oncology and Neuroscience conferences. She loves to read, paint and meet new people.

David Sall, President & CEO, Patient Enrollment Advisors; Co-Creator of the SCOPE Participant Engagement Award

Biography coming…

Malaikannan Sankarasubbu, Vice President, AI Research, Saama Technologies

Malai Sankarasubbu is currently working on optimizing and accelerating clinical trials using Artificial Intelligence. He specializes in deriving insights with unstructured data like text and images. He previously was Founder and CTO for Datalog.ai creators of MyPolly, a chatbot building platform with its own Natural Language Understanding Engine where he built a community of 1,200 active developers, aka chatbot builders, around MyPolly.

Maryanne Santilli, Director, North America Clinical Finance & Operations, Novo Nordisk

Biography coming…

Anamika Sarkar, PhD, Manager, Global Development Systems, Regeneron Pharmaceuticals Inc.

Anamika is working as Business Relationship Manager in Global Development Systems, responsible for Clinical Systems, at Regeneron since June 2017. Prior to Regeneron she worked at Paragon Solutions (currently CGI) where she had been providing strategy consulting in the clinical and regulatory operations spaces for both Biotechs and CROs. Some of her past experience in consulting includes as IT consulting role at Daiichi Sankyo Pharma and Domain Consultant for big Pharma Companies at Wipro Technologies. At Wipro, her experience varied from developing platforms in clinical trial space to presales role. Anamika is a PhD and MBA (Pharma Industry Management, Rutgers University, NJ) who started her scientific career as Computational Biologist, after her PhD, in the same field, from IITD (Indian Institute of Technology Delhi, India). She has worked as scientist both in academia (University of Washington Seattle, Memorial Sloan Kettering Cancer Center, Mt. Sinai School of Medicine) as well as pharma industry (Novartis Inc.). She has been consulting as a bridge between Business, Technology and Science since 2012.

Doug Schantz, Executive Director, Clinical Operations, AstraZeneca

Doug Schantz is an executive director in clinical operations at AstraZeneca since 2015 and has responsibility as the US Country Head, overseeing site identification, startup, management and monitoring. He has an interest in clinical research site success, loves to continually improve his company’s ability to be “sponsor of choice” and serves on the Leadership Council for the Society for Clinical Research Sites. Prior to AZ, Doug worked at Pfizer for 17 years in areas including data management, project management and portfolio management, and Eli Lilly and Company for 8 years, starting as a regional monitor. Prior to work in clinical research, Doug was a paramedic for 9 years and holds a degree in healthcare management.

Steve Schwager, Professor Emeritus, Cornell University

I joined the Cornell faculty in 1978 as a member of the Biometrics Unit in the Department of Plant Breeding and Biometry; this became the Department of Biometrics, and subsequently the Department of Biological Statistics and Computational Biology. I am also a faculty member in the Department of Statistical Science. I was the Director of Undergraduate Studies for the Biometry and Statistics program from 1991 to 2009. I retired from active faculty status in December 2011. My professional activities are centered on the application of statistical methodology to research questions from a wide range of areas in the biological, physical, and social sciences and business. This can involve the use of existing methods and techniques, the development of new methods better suited to the questions of interest, or a combination of the two. I am interested in statistical approaches and techniques for collecting the proper data, including experiment design and sampling design, and for analyzing data in order to draw appropriate conclusions through statistical inference.

Mark Scullion, Executive Vice President, Strategic Resourcing, Clinical Solutions, Syneos Health

Bio coming soon...

Bella Sessoms, MPH, Director, Portfolio Sourcing Management, Portfolio Sourcing and Relationship Management, Astellas Pharma Global Development

Bella Sessoms is the Director of Portfolio Sourcing Management at Astellas Pharma Development, where she leads the sourcing and contracting activities for the Development organization. Prior to joining Astellas, Bella spent more than 15 years in various roles within the healthcare industry. The last ten years were in roles of increasing responsibility at a global Contact Research Organization. Over her career, Bella has had the opportunity to collaborate on a global basis with CROs, biotech companies and some of the largest pharmaceutical companies.

Jyoti Shah, Associate Director, Data Development, Merck

Jyoti Shah is an Associate Director of Scientific Data Development within Research & Development IT at Merck. She has a Master’s in Biomedical Engineering from UT Southwestern Medical Center in Dallas, Texas, specializing in computational biology. Jyoti started her career at Merck in 2006 as a Bioinformatics scientist and has since successfully led several bioinformatics, translational informatics and early development scientific data products and tools. During Jyoti's 12+ years at Merck, she has worked on numerous innovation opportunities geared towards exploring new technologies and methodologies, determining their feasibility and implementing them to solve scientific problems in creative ways. For example: Mining data from wearables/social-media platforms, improving data interoperability with crowd-sourcing technology and machine learning techniques as well as utilizing mobile health technologies to improve current clinical trial paradigms.

Michelle Shogren, Head, Innovation, Portfolio and Operations, Pharma Development, Bayer

Michelle Shogren is the Head of Innovation in Portfolio and Operations for Pharma Development at Bayer. She has over 20 years of experience in Clinical Research across many different roles. She began her journey as a research nurse and site director. From there she became a Clinical Research Associate at a CRO, and finally joined Bayer in 2008 where she has held multiple roles in Clinical Operations, Training and Quality, and now in Business Excellence and Innovation. Michelle’s greatest passion is customer focused innovation and responding to the voice of the patients and sites.

Scarlet Shore, Product Manager & Platform Lead, Project Baseline, Verily

Scarlet is the platform lead for Project Baseline, Verily's bold initiative to map human health. She previously served as Vice President of Strategy, Marketing and Communications for Alexandria Real Estate Equities and is a co-founder of Riverpark Farm in New York. Scarlet received her B.A. from the University of Pennsylvania and was a faculty scholar at NYU Stern School of Business.

Sandra Shpilberg, MBA, President & Founder, Seeker Health

Sandra Shpilberg is the Founder and President of Seeker Health, which is part of EVERSANA. She founded Seeker Health to harness the power of technology to connect patients to clinical trials and help the biopharmaceutical industry accelerate drug development and innovation. Medical Marketing & Media named her at Top 40 Healthcare Transformer and she was a featured speaker at 2018 SXSW.

Greg Silvesti, Head, Digital Health & Innovation, AbbVie

For more than 15 years, Greg has been at the forefront of the Digital Health revolution. He has held various Digital Health, Innovation, and New Product Development roles at Johnson & Johnson, Bristol-Myers Squibb, and Teva Pharmaceuticals; with a focus on smart medical devices and solutions, companion apps, wearables, 3D Printed solutions, and developing novel business models. Greg has recently joined AbbVie as their Head of Digital Health & Innovation for the Development Design Center, where he is building out their strategic approach to Digital Health and implementation of enabling technologies into clinical trials. Greg holds a MBA from The Fox School of Business at Temple University, a BA in Business Administration from Muhlenberg College and lives in Philadelphia, PA with his wife and two children.

Joachim Silber, Scientific Director of Operations, Precision Pathology Biobanking Center, MSKCC

https://www.linkedin.com/in/joachimsilber/

Adam Simmons, Clinical Program Manager, Alkermes

Biography coming

Catherine Sinclair, Manager, Quality and Capability, Risk Based Monitoring and Data Digital Analytics, GlaxoSmithKline, Inc.

Catherine is based in Montreal, Canada with a Nursing background. She has been at GSK for 20 years, of which 18 years have been in clinical operations with roles in monitoring, and study management. Since 2015 she has been the global RBM Lead, currently the global lead for implementation of data digital analytics and central monitoring.

Cassandra Smith, MBA, Associate Director, Investigator and Patient Engagement, Janssen

Cassandra Smith is currently an Associate Director of Investigator & Patient Engagement at Janssen, focusing on Patient Engagement strategies. In this role, Cassandra is currently working on Informed Consent and eConsent initiatives.

Kelly Smith, CCRP, Senior Solutions Consultant, Bio-Optronics

Kelly Smith, CCRP has been in research for the past 10 years. Kelly joined Bio-Optronics as an Solutions Consultant in 2016 bringing with her an understanding of the problems facing the sites today. Kelly previously worked as the CTMS Administrator for PMG Research in North Carolina. She started as a Reg Doc Specialist and has also been QA Coordinator for a small dedicated research site.

Kevin Smith, Vice President, Technology & Data Solutions, Eurofins Central Laboratory

Biography coming… 

Sandra Smyth, Director, Central Feasibility and Recruitment Group, AstraZeneca

Sandra has over 20 years Clinical Operations experience at AstraZeneca. During this time she has held various roles of increasing leadership from Data Management, Monitoring Management, Study Leadership and Management, Regional Business Strategy & Planning Director Americas, and has been leading Patient Centricity and Sponsor of Choice strategy, driving adoption of patient and site centric practices across AZ global Clinical Operations business. Most recently, Sandra has been leading the Central Feasibility and Recruitment Group to drive optimization in feasibility and site selection processes at AZ.

Maura Snyder, MBA, Director, Patient Engagement Strategy & Portfolio, Janssen

Maura is the Director, Patient Engagement Strategy & Portfolio within the Investigator & Patient Engagement organization at Janssen. In this role, Maura oversees the IPE Portfolio team, Janssen's dedicated trial recruitment and retention experts, responsible for turning insight into action to design and implement impactful solutions that will enhance the clinical trial experience for the patient, their caregivers and clinical research sites. Prior to joining the Investigator & Patient engagement team, Maura served as Strategic Lead for Value Excellence team within Janssen’s commercial organization, launching a strategic marketing framework based on delivering customized value to stakeholders, based on stakeholders’ needs. Maura has held various positions within the clinical and commercial sides of the business. Through these roles, she has contributed to key decisions across the all product stages, pre-clinical through in-line. Maura holds a Bachelor of Arts degree from Villanova University and her Masters of Business Administration from Seton Hall University.

Antonieta Sosa, MSc, Director, Clinical Innovation, Janssen Pharmaceutical Companies

Antonieta Sosa has over 20 years of experience in the pharmaceutical and biotech industry holding positions in Safety, Regulatory Compliance and Clinical Operations in both small biotech and large pharma. In her current role as Director in the Clinical Innovation group, she is responsible for leading the strategy and hands-on execution of a portfolio of transformational projects dedicated to driving innovation into the clinical operating model. She holds degrees in Biology and Health Sciences from the University of Southern California.

William Spalding, MS, Director, Global Health Economics & Outcomes Research-Epidemiology, Shire

William Spalding received his MS in epidemiology from Michigan State University College of Human Medicine, and has over 30 years of experience in the pharmaceutical industry, and is currently Director and Epidemiology Lead for neuroscience and internal medicine at Shire. William is responsible for development and execution of post-approval safety studies, design and execution of studies to demonstrate clinical benefit of Shire drugs, and contributions to the development of risk mitigation plans (RMP) for countries requiring and RMP as part of drug approval. Prior to working for Shire, William has held various roles in epidemiology, health economics and outcomes research, and biostatistics where he has designed and executed large observational outcomes database studies, and also double-blind randomized controlled clinical trials. William was the lead statistician for the design of the Pfizer sponsored “Prospective Randomized Evaluation of Celecoxib Integrated Safety vs. Iburprofen or Naproxen” (PRECISION) study which evaluated CV safety of Celecoxib, and so has experience evaluating CV safety from the perspective of both randomized controlled trials and observational research.

Nina Spiller, Vice President, Clinical Management, Otsuka Pharmaceutical Companies

Nina Spiller is Vice President, Clinical Management at Otsuka Pharmaceutical Development and Commercialization, Inc. (OPDC). In this role, Nina is responsible for the oversight of Clinical Management, Clinical Outsourcing, and R&D Innovation. In this role, Nina oversees efforts to innovate the clinical trial process and to implement new technologies into trial execution. Nina has over 25 years of experience in the pharmaceutical industry, largely within clinical development, and has worked previously at Bristol-Myers Squibb and SCIREX Corporation. She has a Doctor of Pharmacy degree from the University of Maryland.

Michael Stadler, CEO & Co-Founder, Clariness
Michael Stadler is the CEO of Clariness, providing executive leadership and strategic direction to the company and its subsidiaries. He brings more than 20 years of experience in launching and strategic management of organizations across consumer and business-to-business industries. Prior experience includes Managing Director for Deltavista, a provider of risk management software and services, CFO at Tele2, an international telecommunications company, financial analyst at Procter & Gamble.

Deepa Subramanian, Senior Manager, Development Information Systems, Amgen

Deepa Subramanian leads the design and implementation of systems / integrations related to clinical trial design, study startup and study conduct for Amgen’s Clinical Development portfolio. She has over 24 years of experience delivering technical solutions to transform business processes and is experienced in managing services and programs, multiple managed service providers across IT functions.

Anand Subramony, PhD, Vice President, New Product Technologies, MedImmune

Anand Subramony is Vice President of Novel Product Technologies at MedImmune, the global biological arm of AstraZeneca. In this role, Anand heads the function from the CTO office and oversees efforts for creating patient centric products that rely on the principles of digital health, connected devices and other novel technologies including breathomics, sensors, wearables and novel diagnostics towards enabling improved patient outcome. In his prior roles, Anand headed the drug delivery and device development at Medimmune and was Principal Fellow and Head of the Novel Delivery Technologies & Therapeutics within Development at the Novartis Institute for BioMedical Research where he established and managed a high performing cross functional team. Previously, Anand led the Materials Science function of the Biomedical Engineering group at Alza /J&J, and was Director of Materials Science & Drug delivery at Dr. Reddy’s Laboratories. With his broad experience in pharma/ biotech, Anand brings innovation and scientific rigor coupled with execution excellence, and sense of urgency towards product development. Anand has over 25 refereed publications and several patents in the area of drug delivery and holds an MS in Materials Sc. Engineering from IIT Bombay and PhD from Purdue University.

Linda Sullivan, Co-Founder & President, Metrics Champion Consortium LLC

Linda B. Sullivan is Co-Founder & President of the Metrics Champion Consortium (MCC), an industry association dedicated to leading the drug-development enterprise in the adoption and utilization of standardized metrics and benchmarks to drive performance improvement. She has been a featured speaker at Performance Metrics, Risk-Based Monitoring, Quality Management & Clinical Trial Oversight industry meetings. Ms Sullivan received a B.S. in Biology from Trinity College and a M.B.A. from Dartmouth College where she was named a Tuck Scholar.

Judy Swilley, PhD, Executive Vice President, Head of Strategic Alliance Management, Syneos Health

Judy Swilley, Executive Vice President, leads the strategic alliance management team for Syneos Health. This is a key customer relationship management team working strategically and collaboratively with customers to drive value and optimize portfolio delivery. She brings extensive experience at the executive leadership level in both global clinical operations as well as management of significant relationships within both the pharma and biotech industry. With over 31 years in the industry, Judy has filled multiple roles, having started her career as a PhD pharmacologist.

Michael Tanen, MBA, Director, Clinical Biomarker Specimen Management, Merck Research Laboratories

Michael Tanen is the director of the Clinical Biomarker Specimen Management group at Merck Research Laboratories. Michael leads a group that is responsible for collection, tracking, and storage of clinical biomarker specimens collected in clinical trials. During his 20 years at Merck he has been involved in the utilization of clinical biomarker specimens from the prospective of biomarker discovery through the usage for diagnostic development. His team has established industry leading specimen management solutions that support data integration between clinical data, consent and specimens, delivering specimen analytics that drive decisions in the complex area of biomarker research.

Shawn Tedman, MBA, Head, Trial Optimization Offerings, Clinical Trial Optimization Solutions, IQVIA

Shawn Tedman is Head of Trial Optimization Product Offerings within the Clinical Trial Optimization Solutions (CTOS) group at IQVIA. Shawn’s background is largely in clinical operations – as a clinical monitor, project manager, and auditor. His particular area of interest has long been the optimization of site/country selection strategies as well as enrollment modeling to inform strategic operational planning. In his current role at IQVIA, Shawn leads the team directing the content and roadmap for the industry-leading CTOS Trial Optimization suite of products – including StudyOptimizer, SiteOptimizer, and Enrollment Benchmarks.

Michele Teufel, Patient Engagement Lead, Clinical Operations, AstraZeneca

Over 17 years working within Clinical Operations in various roles where I successfully planned and led the delivery of multiple clinical studies across various therapeutic areas. I was responsible to ensure project standards and scientific requirements from study design concept through study closeout. Currently, I am working in the Central Feasibility and Recruitment Group where I support project teams in the conduct the global feasibility and strategic planning of clinical studies. This includes review of internal and industry benchmarking data to help support country and site selection. Once all countries are selected recruitment and retention discussion occur to determine what tactics are appropriate for the patient population. In addition to this role I also lead Patient and Site Engagement for Clinical Operations. In this role I work with teams to determine what insight approaches they can use to learn the most about the impact of their study design and which patient engagement tools they should use during study conduct.

Piet Theisohn, Director, Resource Management, R&D - Portfolio & Operations, Bayer Pharma

I have almost 20 years experience in the Pharma industry. Since more than 10 years I'm heading Resource Management in Bayer's clinical development.

David Thompson, PhD, Senior Vice President, Real World Evidence Advisory, Syneos Health

David is a health economist with 30+ years of experience in the health economics arena. Prior to joining Syneos Health, he held leadership positions at Quintiles (2012-2016), i3 Innovus/OptumInsight (2000-2012) and PAI (1988-2000). He is also a current committee member of the Clinical Trials Transformation Initiative (CTTI) in real-world evidence (RWE). His areas of expertise include work in economic modeling, retrospective database analysis, trial-based economic evaluations and patient-reported outcomes.

Jens Thuesen, CTMS Business Development, BSI Business Systems Integration AG

Jens B. Thuesen is a CTMS and CRM pioneer, having 25 years of experience with such software systems. Jens founded BSI Business Systems Integration AG in 1996 after recognizing the need to provide open architecture products with both high functionality and an intuitive UI. He now plays an active role in business development: He focuses on best practice processes for clinical operations and introduces technologies such as Blockchain or Machine Learning to the pharma industry.

Aman Thukral, Assistant Director, DSS, AbbVie

Aman Thukral is an Assistant Director, Strategy & Innovation in Development Operations at AbbVie. He has over ten years of experience in clinical development, technology planning & business-technology alignment. In his current role, he is responsible for eClinical strategy, piloting new technology initiatives & digital partner for patient engagement group. Before this position, he had worked in Deloitte, Cognizant & GlaxoSmithKline at various levels.

Marija Todorovic, MSc Pharm, Hospital Engagement Lead/Data Sciences, Janssen R&D/Clinical Innovation

Marija holds a MSc Pharm degree from Pharmacy Faculty in Belgrade, Serbia and she has also specialized in Pharmacoeconomics and Pharmaceutical Legislative. She is currently finishing her PhD in Pharmacology. Marija brings along over 12 years of experience in clinical research operations, and for the last 8 years she was responsible for the global coordination of clinical trial management activities within Janssen. She was involved in several strategic enterprise-wide initiatives and served as subject matter expert evaluating novel technology solutions to support site selection and site activation. She has recently joined Patient Data for Research group within Janssen Clinical Innovation and leads a workpackage within the eIT funded EHR2EDC project.

Jennifer Trevor, PhD, Senior Portfolio Sourcing Manager, Portfolio Sourcing and Relationship Management, Astellas Pharma

Dr. Trevor received her Ph.D. in Chemistry in 1999 from the University of Illinois at Chicago from the culmination of biosensor research in the Materials Science and Chemistry Division at Argonne National Laboratory. The first stage of her career took place as a Forensic Chemist with the Drug Enforcement Administration, which led to an eventual leadership position with responsibilities including: managing a chemistry group of 10 and delving unto more administrative areas around Quality Assurance program management, auditing, procurement and contracting. In her next role at Amylin Pharmaceuticals (now Bristol-Myers Squibb), she made the leap to Active Drug Substance (API) Development Manager with a responsibility to select, manage the tech transfer, and contract with API manufacturers for pipeline drugs. She then transitioned to a Business Development role in the pharmaceutical division at Ferro Corporation working in licensing, tech transfer, and technical sales for the company. The journey eventually brought her to Astellas Pharma Inc., where she joined the Finance Department as a Strategic Sourcing Manager. Dr. Trevor is currently a Sr. Portfolio Sourcing Manager at Astellas Pharma.

Caoimhe Vallely-Gilroy, Director, Global Head, Clinical Trials Biosample Management, Global Clinical Operations, Merck KGaA

Caoimhe is currently the Global Head of Clinical Trial Biosample Management at Merck KGaA, leading a team of biosample operational experts in the feasibility and execution of biosampling strategy in clinical trials, across all trial phases and indications. Caoimhe has a particular interest in the complexities of trials with companion diagnostic components, education of patients and ethics committees on the need for optional biosample for future research, and has previously worked in a variety of clin ops roles across several companies including Roche, Novartis, Actelion and Fisher.

Ronald Waife, MPH, President, Waife & Associates, Inc.

Ronald S. Waife is President, Waife & Associates, Inc., a change management consultancy focusing on clinical research in the pharmaceutical industry. Since 1993, Waife & Associates has been helping health care companies build competitive advantage through process improvement and technology. The company has served over two hundred clients, including biopharmaceutical research sponsors, CROs, AROs, technology vendors and investors. Services include clinical operations and drug safety process improvement, technology strategy, Organizational Preparedness™ for technology and process implementation, virtual executive services in clinical operations and CDM, vendor selection and implementation management, general management of application development projects, and investor advising. Mr. Waife is also Executive Director of The Clinical Research Executive Forum®, a seminar series for industry executives exploring how to improve the clinical research process. He has been Chair of the Editorial Board of the Association of Clinical Research Professionals (ACRP), the first Chair of its Technology Forum, and writes a bimonthly column for their Monitor. He also wrote a regular column on process improvement for Applied Clinical Trials. Mr. Waife's previous experience includes a decade of executive positions in high technology, and a decade in international public health. Mr. Waife has also been an instructor and facilitator in Total Quality Management (TQM) techniques, and is a frequent lecturer at international conferences. Mr. Waife is listed in the PharmaVOICE 100 for 2008, and received The Meritorious Service Award from the ACRP in 2006. He previously won numerous awards for medical education filmmaking. Mr. Waife received his undergraduate degree in social and behavioral sciences from The Johns Hopkins University, and his masters in public health from Harvard.

Ken Walsh, Operations Planning and Analysis Lead, R&D Clinical Development, CSL Behring

Biography coming

Jian Wang, PhD, CEO, BioFortis

Dr. Jian Wang received his Ph.D. in Bioengineering from the University of Washington. For the past 20+ years, Dr. Wang developed several software products with customers in academia, government and the pharmaceutical industry. Jian has deep knowledge in the rapidly evolving field of precision medicine and its associated biomarker-driven clinical trials. As CEO of BioFortis, a Q2 Solutions Company, Jian delights in applying his experience to help researchers solve real-world problems.

Xia Wang, PhD, Director, Health Informatics & Global Medicines Development, AstraZeneca

Xia holds a Director position at Health Informatics group within the AstraZeneca clinical development unit. Xia has records of accomplishment in applying novel informatics solutions and real-world data analytics to all phases of medicines development life cycles, spanning diabetes, respiratory and autoimmune therapeutic areas. Currently Xia is leading informatics efforts in AstraZeneca Real World Evidence (RWE) studies to support clinical studies design, patient safety, epidemiology, comparative effectiveness, payer & pricing strategy and marketing research. Prior to stepping into the clinical domain, Xia was with the AstraZeneca drug discovery unit in the areas of informatics and computational modeling to support candidate drug identification and optimization. Xia holds a Ph.D. in computational chemistry and has extensive training in broad areas of Informatics.

Tara Warren, Strategic Feasibility Manager, UCB Biosciences, Inc.

Tara Warren is a Strategic Feasibility Manager with UCB Biosciences, Inc, located in Raleigh, NC. She has nearly 20 years of experience in clinical research, starting as a Clinical Data Manager and working her way up to leadership roles, then reinventing herself in the feasibility space over the last few years as the company landscape has shifted and changed. Feasibility has proven to be the best of both worlds for Tara – a combination of the data space, where she is very comfortable, and the stakeholder management, where she thrives. Tara holds a Masters of Public Health in Public Health Leadership and a B.S. in Biology.

Chris Watson, PhD, Director, Product Strategy, eCOA, Product Management, ERT

Chris is an experienced Product Strategist with 20 years’ experience in the delivery of business and consumer-based solutions, the last 10 of which have been focused on the clinical technology industry. He has an extensive knowledge of product and software development processes and is responsible for implementing the product strategy for ERT’s Digital Patient business.

Neil Weisman, Executive Vice President, Continuum Clinical

Neil Weisman, EVP and General Manager of Continuum Clinical, helps pharmaceutical and biotech companies bring new therapies to market faster and more efficiently by solving critical communication challenges that impact the clinical development process. With more than 15 years of experience, Neil leads the strategic direction for Continuum Clinical clients and oversees a global team of dedicated healthcare marketers, clinical trial experts, and patient advocates.

Lynn Wetherwax, BS, Senior Manager, Translational Sciences Operations, Biobank, Amgen

Lynn is a Senior Manager at Amgen with over 25 years of experience in multiple aspects of clinical trials including bioanalytical testing, clinical drug supplies and specimen management. She is currently leads Biological Sample Management and is responsible for managing Amgen’s biobank as well as informed consent tracking related to specimens and use of banked specimens and data for research.

Ashley Williams, Associate Director, Global Clinical Operations, Biogen
Biography coming...

Ronald Williams, CEO, Business Evolution (BE)

Ron Williams is the Chairman of a portfolio of high growth and distuptive companies & CEO of Global Business Evolution (BE). He is the trail-blazer who foresaw the approaching explosion of Big Data Analytics enhanced by Artificial Intelligence. He then created a dynamic business model to deliver real-time soltutions in anticipation of the deluge of demand for data driven solutions, products and services. The common thread throughout the portfolio of companies is his data-centric, platform – all the companies are powered by the BE-Data platform. As a self-defined “Theoretical Technologist”, Ron’s extensive experience in the areas of Cloud & Managed Services Outsourcing, CRM, ERP, and SCM systems integration, as well as discreet manufacturing, makes him uniquely qualified to lead executives into the Big Data arena. In fact, others refer to Ron as the ultimate “Data-Ninja”. As a thought leader and visionary in the Big Data arena, Ron recently completed the first definitive book on Big Data for Executives titled, “Turning Big Data into Your Data” (to be published mid-2017). It is a must-read for executives and companies who want to remain competitive in today’s data-driven global economy. He has also published numerous articles on Big Data in Forbes and CNN iReports, as well as several white papers on Big Data, Pharmacogenetics and Interoperability.

Stuart Williams, Impact Ecosystems Architect, Inplace Impact

In 1993 Stuart Williams co-designed the thesis of "Making A Profit While Making A Difference" which to many was one of the true catalysts behind the growth in Impact Entrepreneurship. Today, Stuart remains a visionary and leader who creates, and or redesigns private and public ecosystems built to succeed through an alignment with the values and virtues of the Millennial and future generations. After enjoying a successful career as a business builder, owner and executive ($800m in realized value for the companies he started, ran and or worked with as an executive) Stuart has spent the past 8 years purposed to help any private or public ecosystem embrace the business, investment, humanitarian and environmental thesis of "Making A Profit While Making A Difference". Stuart is one of the world's leading experts on how to generate the highest and most sustainable corporate profits and investment returns by creating innovations that are solutions for specific segments of humanity and the environment. He is a trusted advisor to recognizable US Families, and the impact initiatives they develop and manage. Stuart has presented his work to The Elders and at The United Nations.

Cara Woodruff, Trial Optimization Product Manager, Clinical Trial Optimization Solutions, IQVIA

Biography coming…

Alana Wriggins, Head, Site Management, Allergan

Alana has more than 20 years of clinical research experience and has lead both regional and global cross-functional staff across project teams and facilitated numerous process improvement initiatives. She has been involved at the front-line of numerous FDA inspections. In her current role at Allergan, she leads the group responsible for the global oversight of TMF management and archiving, as well as, inspection readiness and acquisition activities. She is also responsible for site management activities in North America. Alana received her Bachelor of Science degree in Nursing from the University of South Carolina and her Master’s degree in health science, Clinical Research Administration from George Washington University. She is a member of ACRP and the Regulatory Affairs Professional Society.

Songlin Xue, MD, PhD, Executive Vice President, Head, Global Pharmacovigilance, Astellas.

Songlin Xue, M.D., Ph.D., is Executive Vice President and Head of the global Pharmacovigilance in Astellas. In this position, he leads a global pharmacovigilance organization that includes pharmacovigilance operation and processes, medical safety, risk management, and epidemiology functions as well as pharmacovigilance functions in all affiliate countries. This global pharmacovigilance organization has the primary responsibilities for safety and pharmacovigilance compliance of all clinical development compounds and post-approval products worldwide. Before he joined Astellas in early 2013, Dr. Xue served in a number of positions such as Clinical Epidemiologist, Associate Medical Director, Medical Director, Senior Medical Director, Assistant Vice President, Vice President, and Senior Vice President at several international pharmaceutical companies including Hoffman-La Roche, Pfizer, Wyeth, Novartis, and Takeda. Dr. Xue received his medical training in China and epidemiology training in the United States. He developed his core career in the areas of clinical drug safety and pharmacoepidemiology. He also developed interest and expertise in risk management and benefit-risk assessment. Dr. Xue has been involved in several organizations and committees including International Society for Pharmacoepidemiology (as a Board Director 2007-2010), US PhRMA/FDA Liver Toxicity Steering Committee (2010-2007), PhRMA Pharmacovigilance and Epidemiology Committee (2001-2008), Think-Tank member for the World Health Organization Collaborating Center for International Drug Monitoring (2003-2010), WHO CIOMS VIII Working Group (2007).

Brenda Yanak, Global Head, Specimen Strategy and Innovation, Q2 Solutions a Quintiles Quest Joint Venture

Ms. Yanak is an award-winning, cross-functional Pharmaceutical and Central Lab executive who has held leadership positions in laboratory, technology, clinical operations, and innovation domains. Recognized in the industry as a subject matter expert in consent management, specimen management, and virtual specimen tracking, she has been responsible for enterprise wide specimen and technology strategy at more than one company. She was one of the first to pilot uses of artificial intelligence within clinical trials, and drove the operationalization of precision medicine at one of the world’s largest pharmaceutical companies, enabling value capture of advancements in genetics and biomarkers. Brenda is often asked to speak at conferences and chair panels to discuss innovative ways to translate scientific strategy into clinical trial operations.

Stephen Yates, Clinical Program Director, UCB

Stephen L. Yates, PhD is a Clinical Program Director (CPD) and Head, Patient Engagement Strategy with UCB Biosciences, Inc. He has been with UCB for over 15 years. He provides strategic oversight of Ph2 through 3b clinical studies focused in epilepsy. Stephen also provides oversight of UCB’s strategy for the engagement of patients throughout the clinical development continuum and is leading a team at UCB to establish a strategy for consistent patient partnering. He has been a leader in UCB’s evolving culture toward delivering Patient Value as the core of its business operations. Stephen holds a B.S. in biology and biochemistry from the University of Tampa and a Ph.D. in neuropharmacology from UCONN.

Richard Young, Vice President, Vault EDC, Veeva Systems

With almost 25 years of experience in life sciences, Richard is known for his executive vision and proven operational experience in data management, eClinical solutions, and advanced clinical strategies. Most recently, Richard served as vice president of global consulting partners at Medidata Solutions, consulting on adaptive trials, risk based monitoring, big data, mobile health, and other major data strategies with sponsors and partner organizations across the globe.

Beth Zaharoff, Director, Patient Focused Clinical Trial Engagement, TESARO

Beth began work at TESARO in January, 2014 when it was a company of approximately 75 associates. Four years later, TESARO has grown to more than 700. Her role grew out of one of TESARO’s corporate values - the patient - and the desire to be a company that does more than just talk about putting patients at the center of everything they do. Before TESARO, Beth worked as the Associate Director, Medical Affairs for Spectrum Pharmaceuticals and as an MSL for MedImmune, MGI Pharma and Allos. She spent 4 years as the Manager, Oncology Operations and Clinical Trials at New England Medical Center. Early in her career Beth worked as the IRB Administrator at Boston City Hospital where she found her passion for clinical research.

Sean Zhao, PhD, Head, US Patient Safety Surveillance, US Medical Affairs, AstraZeneca Pharmaceuticals, Inc

Dr. Zhao is a senior pharmaceutical executive with over 20 years of diverse working experience. He possesses proven abilities in clinical development, pharmacovigilance, pharmacoepidemiology, observational study, post marketing evidence generation, risk evaluation, management and mitigation, post marketing safety studies, safety process development and refinement, and health economic and outcome research. Dr. Zhao has successfully built and led a global safety department, safety surveillance teams, and pharmacoepidemiology teams, as well as effectively managed safety business alliances and outsourcing vendors in various mid- and large-size biotech and pharmaceutical companies. He possesses deep knowledge of the safety regulations and guidance, and experience of appropriate regulatory interactions with FDA, EMA, CFDA, Health Canada, and Japan Regulatory Authorities. He has participated in pharmaceutical industry wide and regulatory agencies’ safety initiatives, activities, working groups, and expert panels. Most recently, has been invited by Chinese FDA to provide input to its post marketing research guidance development. He is also a member of US PhRMA Safety and Pharmacovigilance Work Group since 2017. Dr. Zhao currently leads US Patient Safety Department in AstraZeneca

Mary Zuniga, Consultant, Translational Science, Immunology, Eli Lilly and Company

Mary Zuniga, B.S. in Biology, is the Operational Consultant in the Translational Science, Immunology department at Eli Lilly and Company. Mary has worked at Lilly for the past twenty-two years. During her career, she collaborated both internally and externally to establish the first Lilly long term sample storage process and IT infrastructure for the collection and management of clinical trial samples across more than 30 countries. In her current role, her focus encompasses BioSpeciman sample strategy, standardization, process improvement, and operational support for outsourcing pharmacodynamic biomarkers for assets in Lilly’s immunology pipeline.

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“SCOPE Featured Author”
Emmanuel Fombu, MD,
Director, Digital Health Solutions
Novartis


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