Joan Affleck, Senior Director, Clinical Documentation, Sanofi
Valerio Aimale, M.D., Chief, Advanced Projects, Qforma
Dr. Aimale has a diverse background in medicine, computer science and data analytics. For the past 15 years, he has contributed primarily to the technology sector in complexity science, strategic consulting, nanotechnology, automated trading of hedge funds and fingerprint biometrics. Dr. Aimale currently serves as Chief of Advanced Projects at Qforma, the leading provider of advanced analytics and predictive technologies for the health sciences industry.
Igor Altman, Product Manager, Study Planning, Medidata Solutions
Igor Altman is a Product Manager at Medidata Solutions, where he drives product direction for the company's study planning solutions, including Medidata Designer®, the industry's leading study design and protocol authoring tool. Prior to Medidata, Altman worked with numerous technology companies to help release better products faster to customers. Igor graduated from the University of Pennsylvania with a BS in Economics from the Wharton School of Business and a BA in Mathematics, summa cum laude, from the School of Arts and Sciences.
Brenda Atchison, Executive Director, Clinical Research, Alliance for Multispecialty Research
Brenda S. Atchison is the Executive Director of the Alliance for Multispecialty Research, LLC with national headquarters in Nashville, Tennessee. She holds a bachelor's degree in clinical microbiology and chemistry from the University of Tennessee where she was a laboratory instructor prior to accepting a clinical microbiology position with the Tennessee State Health Department. She was a clinical scientist with a cancer research center prior to joining Covance (formerly ICP, then Corning-Besselaar) as Sr. Global Director of Project Feasibility and Investigative Site Services from 1989-2000, at which time she joined AMR as Executive Director and head of the national headquarters staff.
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 Leading 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.
Joseph Bedford, Ph.D., Director, Marketing, Almac Clinical TechnologiesJoseph Bedford, Ph.D. is a Director at the Almac Group, where he is responsible mainly for strategy, marketing, and product management matters in the Clinical Technologies business unit. Prior to joining Almac, Dr. Bedford spent 6.5 years at Covance, where he held positions of Associate Director of Global Market Research and Director of Marketing and Strategy. Dr. Bedford has published several articles and spoken at industry conferences on topics such as biopharmaceutical drug development, R&D outsourcing, clinical technologies, and corporate strategy.
Stephanie Berger, Director, Clinical Training & Professional Development, The Clinical Research Group Institute for Clinical Education
Stephanie Berger currently serves as Director of Clinical Training and Professional Development with TCRG, Inc. Institute for Clinical Education. She has extensive experience coordinating clinical trials, managing clinical trial sites and post-secondary education.
Molly Blake-Michaels, Consulting Solutions Expert, Oracle Health SciencesMolly Blake-Michaels is a Consulting Solutions Expert for Health Sciences at Oracle, offering customers comprehensive and knowledgeable customer service built on more than 20 years of clinical operations experience. She also contributes to the continuous process improvement of Oracle Health Sciences ClearTrial software, acting as a clinical subject matter expert for the Product Management Team. She has extensive education and training in project management, training and relationship management and facilitation, clinical study design and optimization, strategic planning, SOP creation and re-engineering, and process improvement with a specialty in working across organizations (through mergers/acquisitions) in process and organizational integration.
Mark Booth, Chief Commercial Officer, Orexigen Therapeutics, Inc.
Mark D. Booth has served as our Chief Commercial Officer since August 2009. Mr. Booth brings over 25 years of commercial and business development experience to Orexigen. Most recently, Mr. Booth served as President of Takeda Pharmaceuticals North America (TPNA) from October 2001 to June 2008, where he presided over the commercial, medical and scientific affairs, business development and all support functions. Prior to his role at TPNA, Mr. Booth served as Senior Vice President, General Manager at Immunex Corporation from January 2000 to September 2001, where he was responsible for the sales, marketing and project management functions. Before joining Immunex Corporation, Mr. Booth was at Abbott Laboratories from 1983 to 2000, where he served in a range of leadership positions including Division Vice President, General Manager for the anti-infective franchise. Mr. Booth holds a BS in Biology from Northern Illinois University and an M.B.A from Northwestern University Kellogg School of Management.
Bonnie Brescia, Founding Principal, BBK Worldwide
As one of BBK's two founding principals, Bonnie guides BBK's continual evolution as a leader in marketing consultation for the patient recruitment industry. She manages and develops BBK's worldwide alliance of companies, ensuring a multinational foundation for initiatives like our global investigator network and Web-based recruitment portal. Bonnie co-authored the book Reinventing Patient Recruitment: Revolutionary Ideas for Clinical Trial Success, and regularly contributes to key industry publications. She is highly sought after as a guest speaker at patient recruitment and healthcare communications forums, and was selected as one of PharmaVOICE's 100 most inspiring people in patient recruitment in 2005. She is a member of the Drug Information Association and a past president of the New England Council of the American Association of Advertising Agencies
Rebecca Budd, Managing Director, Navita Clinical Strategy Group
Rebecca Budd currently serves as managing director and chief strategist for the Navita Clinical Strategy Group. Navita's mission is to increase participation of underrepresented populations such as women, children, and diverse racial and ethnic minority groups in clinical trials. Rebecca's insight into these population groups has been developed from years of experience in applied sociology, research and analytics, medical communication and site/patient recruitment strategy. Before founding Navita, she worked for global companies such as Iris Global Clinical Trial Solutions, the Omnicom Group, Hoffmann-LaRoche, Inc. and TrialAdvance, Inc. Rebecca received her bachelor's degree at Southern Methodist University in Dallas and her master of business administration degree from the Kellogg School of Management at Northwestern University in Evanston, Ill.She completed post-graduate studies and field research in applied sociology at the University of Texas at Dallas. She and her transracial family live in Dallas, TX.
Paul Bukowiec, Director, Oncology Standards Management, Millennium: The Takeda Oncology Company
Paul Bukowiec is the Director of Oncology Standards Management at Millennium: the Takeda Oncology Company. He has 17 years experience working in clinical trials and is also a member of the CDISC CDASH leadership team
Allison Burmeister, Manager, Clinical Contracts & Finance, Gilead Sciences
Allison Burmeister brings over seven years of experience in the biopharmaceutical industry Gilead Sciences.Most recently, Allison served as the Clinical Trial Manager of the Phase 2 bapineuzumab studies in the Janssen AI Clinical Contracts & Budgets group at Janssen. Prior to Janssen, Allison spent nearly three years at Amgen, Inc. both in clinical trial management and outsourcing roles. Allison also spent over two years as a coordinator in the Leukemia Program at Weill Cornell Medical College in New York, NY following time spent as an analyst in the Health Care Group at Harris Interactive, also in New York. She holds a bachelor's degree in Politics and a minor in French from Princeton University and is currently pursuing her MBA from UCLA Anderson School of Management.
Arlene Calvo, Ph.D., Research Assistant Professor, Community and Family Health, Global Health, University of South Florida
Arlene Calvo received her Bachelors in Arts degree in Interdisciplinary Natural Sciences with a concentration in Chemistry in 1994, and both her Master and Doctoral degrees in Public Health with a concentration in Community and Family Health and emphasis in Health Education, at the University of South Florida. She is also a Certified Health Education Specialist. Ms. Calvo research experience focuses on Latino women's health issues in the U.S. and in Latin America regarding cancer control and sexually transmitted diseases, community and population-based research, participatory processes among other topics. Most of her public health education work concentrates on social marketing, prevention research, and research-based health education and promotion interventions. She has been involved in coordinating systematic clinical trials and epidemiological studies among Latino populations in Latin America. Ms. Calvo currently resides in Panama, Central America and serves as Research faculty at the College of Public Health based out of the USF Panama Program at the City of Knowledge, Panama.
Yan Cardineau, Program Director, R&D & Clinical Research, Medtronic CardioVascular
Mr. Cardineau has 17 years of experience in medical device companies in the US and Western Europe (implantable chronic cardiac disease products: pacemakers, defibrillators, stents and angioplasty). His career spans a broad spectrum, including product, automation and technology development, program management and pilot plant management. He has also received 2 US patents. His motivation is developing best in class organizations, based on the blended application of process management (Six Sigma) and program/project management. He has also successfully implemented program management offices in various environments. His current PMO supports the "Innovation Value Stream" which includes research, product development and clinical studies. The approach combines Lean Product Development techniques with traditional Portfolio / Program / Project Management practices. Mr. Cardineau has a BS in Mechanical and Aerospace Engineering, and is a Stanford Program Management alumni.
Penny Carlson, Associate Director, Clinical Operations, Millennium: The Takeda Oncology Company
Penny Carlson is an Associate Director of Clinical Operations at Millennium Pharmaceuticals and is currently serving as the Program Director for a late-stage alliance program. Prior to joining Millennium, Ms. Carlson worked in a variety of roles and organizations, including large pharma, small biotech and CRO. Ms. Carlson began her career more than 15 years ago and spent the first 6-7 years focused on data management in a number of indications. However, in 2004, Ms. Carlson's focus changed to clinical operations and almost entirely oncology. Within the Oncology arena, the majority of Ms. Carlson's experience is with melanoma, lung cancer, early-stage solid tumor research and, most recently, various types of lymphoma.
Chris Chan, MBA, Senior Director, Clinical Finance, Finance, FibroGen, Inc.
Chris Chan is Senior Director of Clinical Finance at FibroGen, Inc, and has 20 years industry experience, including 15 managing clinical 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).
Adam Chasse, MHA, COO, RxTrials
Adam Chasse has had a long and distinguished career in clinical research since entering the industry in 1995. Since 2011 he has led the corporate development of RxTrials, a management/training/consulting firm that helps research sites optimize operational performance. Prior to that he pioneered the concept of strategic alliances between research sites and industry while with Quintiles, where his many management roles included leading the global program for strategic alliances with large health systems. Adam represents RxTrials on the Metrics Champion Consortium's clinical operations steering committee. He has served on the Multi-Regional Clinical Trials (MRCT) project steering committee, ACRP's membership committee, and the Site Solutions Summit advisory board. Adam holds a Master of Healthcare Administration degree from the Gillings School of Global Public Health at the University of North Carolina-Chapel Hill, and is a member of the Delta Omega public health honorary society.
Greg Cohee, Director, eClinical, PHARMICA Consulting
Greg is the Director of eClinical Services at PHARMICA Consulting, a firm which focuses on operational excellence and improving decision-making capabilities for organizations in the life sciences industry. He has over fifteen years experience working in the areas of discovery, clinical operations, and project management - always with a focus on technology. In his current role at PHARMICA, he helps small and large pharmaceutical companies with process improvement, collaboration, data systems implementation, and integrated reporting capabilities.
Paul Cook, Ph.D., Regional Operations Manager, Integrated Project Management
Dr. Paul Cook is a Regional Operations Manager at Integrated Project Management Company, Inc. (IPM), a leading provider of professional project management services to the life sciences industry. In his role, Dr. Cook has combined his scientific expertise with project management leadership skills to work side-by-side with client teams to successfully complete complex, cross functional projects. Working with global manufacturers and start-ups alike, projects have ranged from clinical program management to internal process improvement. As a certified Project Management Professional (PMP) with the Project Management Institute, Dr. Cook has taught project management courses for BU Global and BU Metropolitan College and is a frequent speaker at conferences on the subject of project management.
Reinerio Deza, M.D., Head Global Pharmacovigilance, Cubist Pharmaceuticals, Inc.
Dr. Reinerio A. Deza is currently Global Head of Pharmacovigilance at Cubist Pharmaceuticals. Dr. Deza has over 20 years of experience in the pharmaceutical industry which have been primarily in the area of Pharmacovigilance (PV) but has also included Medical Affairs. Most recently, Rene was at Merck (Schering-Plough) as the Sr. Director of Medical Services and the Clinical Risk Management Group with responsibility for their strategic products. Rene's prior work experience has included tenures at GlaxoSmithKline (Director of Medical Affairs and Drug Safety for North America Consumer HealthCare Division), Bristol-Myers Squibb (Squibb Diagnostics), Bracco Diagnostics, and Gilead Sciences with the latter two companies as Head of the Global Drug Safety departments. He has led PV activities in support of several successful NDAs and MAAs. He has overseen and/or coordinated the integration of the safety departments with several mergers and acquisitions, lead PV departments through both FDA and EU regulatory authority inspections, and implementation of several safety databases. Prior to joining the industry, Dr. Deza was a Research Scientist, in the Epidemiology Department with the CDC and the Division of AIDS, NJ Dept. of Health. Dr. Deza has an M.D. from the University of Santo Tomas Philippines with training and clinical practice in Occupational and Industrial Medicine.
Jim DiCesare, Vice President, General Manager, Contract & Regulatory Services, CFS Clinical
Mr. DiCesare leads the CFS Study Startup Services team which collects and manages essential site regulatory documents and negotiates Clinical Trial Agreements and investigator grant budgets for Sponsors. Mr. DiCesare joined CFS in 2006 as Director of the Pharmaceutical Services Group. Prior to CFS, Mr. DiCesare spent 9 years at Merck & Co., Inc., providing clinical trial financial management and commercial outsourcing services in support of the Clinical Development Programs Department.
Steven Du, M.D., Ph.D., Senior Director, Pharmacovigilance & Pharmacoepidemiology, AMAG Pharmaceuticals, Inc.
John Eckardt, M.D., CMO, DAVA Oncology
Dr. John Eckardt completed medical School at St. Louis University School of Medicine in 1987 followed by a residency in internal medicine at St. John's Mercy Medical Center in St. Louis. In 1995 thru 2008, Dr. Eckardt became the Director of the Research Program at the Center for Cancer Care and Research in St. Louis, Missouri opening a clinical research program in St. Louis to conduct phase I, II and III clinical trials thru both co-operative groups and pharma sponsored trials. He was formerly the Director of the outreach program at The Cancer Therapy and Research Center, San Antonio, Texas. He was involved in the development of a number of novel cancer agents including new drugs like topotecan, docetaxel, gemcitabine and irinotecan. Dr. Eckardt has been an author and published over 127 abstracts, 53 articles, 5 book chapters, 6 educational publications, and 1 editorial. He has presented 31 poster presentation, 2 ASCO podium presentations and over 300 invited lectures. He holds memberships in a number of professional societies, including the American Society of Clinical Oncology, the American Association for Cancer Research, and the International Association for the Study of Lung Cancer. In 2009, Dr. Eckardt joined DAVA Oncology as the Chief Medical Officer, a company dedicated to improving and accelerating drug development.
Marc Eigner, Partner, Polaris
Marc heads Polaris' technology and aggregate spend practice, and is a co-founder of Polaris Solutions. Marc is considered one of the leading experts in Pharma compliance technology, including HCP/HCO spend automation and aggregate spend systems. Marc has spoken at many conferences on these topics. Marc has helped grow Polaris' technology practice from a small team to one of the largest Pharma compliance focused technology groups in the industry. Marc has personally supported over 55 life science companies with their processes and systems for supporting payments and grants to healthcare providers. Before joining Polaris, Marc worked in Accenture's technology practice. Early in his career, Marc worked for IBM. He has an MBA in IT Management, an MS in Computer and Systems Engineering, and a BS in Computer Engineering from Rensselaer Polytechnic Institute.
Silke Ewald, M.D., Head, Trial Feasibility Assessment, Global Clinical Development, Bayer
Silke has more than 20 years of clinical research experience in CRO and in the pharmaceutical industry. She joined BayerHealthCare in 2007 as Global Clinical Leader and was responsible for clinical development of pharmaceutical products in Primary Care. She directed the completion of multiple clinical studies (Phases I-III). She is currently the Head of Study Feasibility Assessment for all global studies within BayerHealthCare. In her role she has set up a new feasibility process focusing on early strategic feasibility assessment of projects.
Nikki Fink, Director, Patient Access & Retention Services, PRA International
Nikki brings 14 years of recruitment specific clinical research experience, having held senior patient recruitment roles at Quintiles and PPD, working as a pharmaceutical recruitment consultant for Arthur Andersen LLP, and then leading N. America patient recruitment operations for GlaxoSmithKline. To round out her recruitment and retention expertise, she later worked as a senior strategist for a global patient recruitment supplier before returning to the CRO industry where she has been Director of Patient Access & Retention Services with PRA International since 2010. She brings a unique mix of CRO, sponsor and supplier experience and has worked on more than 300 recruitment and retention programs spanning all therapeutic areas. She is a proud graduate of the University of Florida with a BS in Communications.
Mary Flack, Vice President, Clinical Research, NanoBio
Dr. Flack has nearly 20 years of clinical research experience at the NIH and in the pharmaceutical industry. Before joining NanoBio in 2002, Dr. Flack was Clinical Director of Endocrinology and Women's Health Care at Pfizer (formerly Parke-Davis/Warner Lambert) where she was responsible for clinical development of pharmaceutical products for osteoporosis, hormone replacement therapy, fertility and contraception. She directed the completion of multiple clinical studies (Phases I-IV), leading to four approved NDA submissions, and has extensive experience with three different divisions of the FDA, including dermatology, endocrinology and reproductive health. She is currently Vice President of Clinical Research at NanoBio Corporation.
Bob Frick, Vice President, Technology, Optum
Bob leads the technology team responsible for OptumInsight's Smart Measurement System. In his role, he sets the direction for product design and functionality.With 20+ years of experience in software and hardware design, Bob has designed a multitude of hardware and software data acquisition and control systems on a variety of platforms. Previously, he has led technology teams at GE, Northrop, Collins Medical and Federal Products. Bob received his BS in Computer Engineering from Boston University.
David Fuhrman, President, sampleminded
David has over 23 years experience in the analysis, design, and implementation of software systems and solutions. He has demonstrated effective leadership in all phases of Software Development Cycle methodologies. Mr. Fuhrman has vast and diverse experience in creating software products, software systems integrations, and solutions in Genomics, Proteomics, Clinical Diagnostics, Clinical Research Informatics, Laser Optics, and Finance. David is a successful business entrepreneur having created and built a dynamic software development and consulting company that offers services in bioinformatics and clinical research informatics — Cimarron Software, Inc.. Before starting Cimarron, he was a key member of the informatics research team at the University of Utah Human Genome Center, providing leadership and technical insight in database design and software tools that were integrated into the high-throughput DNA Sequencing and Genotyping technologies developed at the Genome Center. Mr. Fuhrman also previously served in positions at TMA Technologies, Unisys Corp., and Wasatch Security Research.
Bruno Gagnon, Vice President, Clinical Operations, BioMarin Pharmaceutical, Inc.
Bruno is the Vice-President of Clinical Operations at BioMarin Pharmaceutical, Inc. He is accountable for development of strategies and execution of all clinical trials for rare genetic disorders. He is also responsible for the alignment and direction of the staff, systems and processes around site selection, patient recruitment, CRO management and the patient advocacy program at BioMarin. Prior to his current position, Bruno was heading the Clinical Operations group at Roche Molecular Systems, Inc. Functional areas under his responsibility have included: Clinical Trial Management, Medical Writing, Outsourcing and Contracts, Supply Chain Management, Clinical Data Management, Clinical Systems, Document Management and Training. Bruno has taken several teaching assignments and speaking engagements at professional meetings throughout his career. He has a bachelor degree from the School of Pharmacy, Laval University and a Masters in Pharmaceutical Sciences from University of Montreal, both in Quebec, Canada.
Lucas Garmon, Patient Engagement Advisor, BBK Worldwide
Lucas Garmon is a Patient Engagement Advisor with BBK Worldwide where he has worked in global project management, media strategy, and investigator service for many years. Prior to joining the clinical research industry, Lucas held marketing and communications positions in the film and music industry. Fluent in Italian, Lucas received his degree in Diplomacy and World Affairs from Occidental College.
Melynda Geurts, Vice President, Operations, DAC Patient Recruitment Services
During her 14 years of tenure with DAC, Melynda Geurts' has emerged as a driving force in the company's approach to project operations, site management, contract negotiations, and business development. She is credited with leading the project operations team in procuring and managing contracts spanning 100,000 patients at 16,000 clinical trials sites in 100+ countries. A recognized authority in the clinical trials industry, Geurts has presented at numerous conferences and seminars worldwide. She is widely published and was a contributing writer for "Global Issues in Patient Recruitment and Retention" and "A Guide to Patient Recruitment and Retention," both published by CenterWatch in 2012 and 2004, respectively. In 2008 PharmaVoice named her among the 100 Most Inspiring People in the Life-Sciences.
Alicia Gilsenan, Senior Director, Epidemiology, RTI Health Solutions
Alicia Gilsenan is a Senior Director of Epidemiology within RTI-HS and a licensed pharmacist. Dr. Gilsenan's primary area of expertise is pharmacoepidemiology and therapeutic risk management. Since joining RTI in 1997, she has applied state-of-the-art approaches to the design, conduct, and analysis of both retrospective and prospective epidemiologic studies focused on evaluating disease natural history and incidence of and risk factors for adverse outcomes potentially associated with use of medications. She has directed multidisciplinary international teams for large primary data collection studies in the United States and Europe. Currently she leads an international safety surveillance study and a US-based patient registry that are both part of a mandated risk management program and is involved in several Risk Evaluation and Mitigation Strategy (REMs) projects. Dr. Gilsenan has also led retrospective database studies designed to examine differences in risk factors and health care resource utilization between subgroups. She has led and conducted systematic reviews of the literature. Dr. Gilsenan has published within multiple therapeutic areas, including mental health, oncology, sexual functioning, cardiovascular health, respiratory health, and smoking cessation.
Gretchen Goller, Senior Director, Therapeutic Expertise, Patient Access and Retention Services, PRA International
Gretchen Goller is the Senior Director of Therapeutic Expertise - Patient Access and Retention Services, PRA International. Prior to that role, she was the Patient Recruitment/Compliance Strategist at sanofi-aventis since 2007. She went to sanofi-aventis after spending time at Wyeth as a Clinical Trial Manager and AstraZeneca as a Clinical Research Scientist. Prior to pharma operations, Gretchen was with the University of Pennsylvania for 9 years as Project Manager and Clinical Research Coordinator in cardiology, ophthalmology, and women's health. She has an MSW from the University of Pennsylvania with experience in HIV risk reduction, drug/alcohol abuse and victim crisis support. She has 15 years of experience in clinical research. Gretchen supports the US CRU at sanofi-aventis for recruitment and compliance strategy and works with their therapeutic teams to improve overall enrollment, retention, and site management.
Pablo Graiver, Co-Founder & CEO, Management, TrialReach
Pablo Graiver has over 12 years of entrepreneurial and management experience in the online industry. He was an early member of NetJuice, one of the largest Internet incubators in Europe; MD at Donde Comprar.com, the first e-commerce directory in Spanish; and later co-founder and VP Strategy at Kelkoo, acquired by Yahoo! in 2004. Pablo set up and launched Kayak.com in Europe, and most recently as served as European Sales Director at ValueClick (NASDAQ: VCLK). Pablo studied Biology and Business Administration at UAM in Madrid.
Andy Grygiel, Senior Director, Product Strategy, Oracle Health Sciences
Andrew Grygiel is Senior Director Product Strategy for Health Sciences at Oracle. He is responsible for developing and managing Oracle's clinical development product strategies. Prior to joining Oracle, Mr. Grygiel served as Chief Marketing and Product Officer at ClearTrial. In that capacity, he was responsible for ClearTrial's product strategy, product development and marketing organizations. Mr. Grygiel has more than 20 years of information technology product strategy, product development and management experience and deep knowledge of the Life Sciences industry and its ecosystem. He is a pioneer in the use of Software as a Service (SaaS) solutions in Life Sciences.
Abraham Gutman, President & CEO, AG Mednet
President and CEO Abraham Gutman leads AG Mednet in its mission to improve, automate and expedite outcomes in clinical trials by ensuring quality and compliance within critical medical imaging processes. Since founding AG Mednet in 2005, the company became the image collection, delivery and compliance service of choice for pharmaceutical, biotechnology and medical device companies, core labs and clinical research organizations in hundreds of global clinical trials. More than 15,000 registered users across thousands of investigator sites in 60+ countries use AG Mednet to participate in projects sponsored by each of the world's top 20 pharma, biotech and device companies.
Bill Gwinn, Vice President, Clinical Informatics Solutions, OptumBill supports the clinical trials of new drugs with medical statistics and other information. The metrics offer better planning for faster trials. Previously, Bill held positions as VP of New Product Development and VP of Product Marketing for Inclinix, a contract research organization specializing in patient enrollment. Bill's expertise lies in quantitative analysis for site selection and finding patients, and he provides the direction of technology and market research. Earlier, he was with Thomson Reuters, Healthcare Division, Medstat Group, where he was Director of Clinical Trial Solutions. He is a speaker at industry conferences and writer in trade journals. Bill holds an MBA from the University of Chicago and has held roles of leadership with Procter & Gamble, Schering-Plough, and IMS Health.
Dean Hakanson, M.D., Head, Health Economic & Outcome Research, US Medical and Drug Regulatory Affairs, Novartis Pharmaceuticals Corporation
Dean leads the Health Economic and Outcomes Research group for NPC and is committed to creating a strategic approach for US input into global development plans, health economic research, KOL management, comparative effectiveness research and communications. Previously at Novartis, Dean was the Medical Head for the West Operating Unit and responsible for medical affairs, KOL management, data generation and a communication strategy across the portfolio. A results-oriented professional, board certified physician with deep experience in critical care; Dean joined Novartis with significant experience in the commercial and medical affairs segments and is skilled in developing consensus among senior thought leaders, corporate executives and key stakeholders in health care. He creates portfolio value by the incorporation of customer needs into commercial strategies, research protocols, product development plans, publications and communication strategies. Dean was previously with BMS were he was part of the world wide executive leadership team which guided the global access initiatives for BMS. While at Genentech, Dean created a new department for this rapidly growing biotech company and led a multi-functional group dedicated to account management, formulary position, contract negotiations, customer solutions and health economic research for the private and public payers. This team was comprised of physicians, PhDs, health economists, marketing experts, and a national account sales force. Past board membership includes the Integrated Benefits Institute and he currently represents Novartis with the National Pharmaceutical Council and PhRMA Evidence Based Medicine Committee.
Paula Hale, M.D. Senior Medical Director, Diabetes—Clinical Development and Research, Novo Nordisk, Inc.
Maria Harrison, Vice President, Late Phase Services, PRA
Ms. Harrison has over 20 years of experience in managing all aspects of drug development in both the pharmaceutical and contract organization industries. Specifically in the last ten years, she has been responsible for overseeing global post-approval research in the areas of: product registries, disease registries, risk management programs (including REMS and EU-RMP), PASS, minimal risk diagnostic biomarker, retrospective chart review and Phase IV studies. The studies cover multiple indications, covering all services from protocol development through manuscripts.
Kate Harrop, Senior Clinical Project Manager, Seattle Genetics
Michael Haushalter, Head, CTMS, Boehringer Ingelheim
Colin Hayward, M.D., Head, Global Medical Affairs, Premier Research
Dr. Hayward is a Fellow of the Faculty of Pharmaceutical Medicine with 13 years international experience in pharmacovigilance, design and implementation of clinical programs and medical affairs. He started his career in industry joining Roche pharmacovigilance and quickly progressing through a series of positions with increasing responsibility to International Medical Leader before joining Prism Ideas as Executive VP in 2007. Colin joined Premier Research in January 2012 and in his current position is responsible for leading the company's global medical affairs and pharmacovigilance teams. He is a keen advocate of Higher Medical Training for physicians specializing in Pharmaceutical Medicine.
Nanette Hock, Regional Nurse Manager, Clinical Research Operations, Division of Research, Kaiser Permanente Northern CA
Nanette has many years of clinical research experience, starting as clinical research coordinator at Stanford University, and, prior to joining the Kaiser Permanente Division of Research (DOR) in 2008, as principal research project manager in the medical industry. Nanette has strong working knowledge of federal regulation and overall pharmaceutical and device industry standards and operations. Prior to joining clinical research, Nanette worked as an RN in various capacities, including as Nurse Manager and Director of Nursing Education. Nanette possesses a broad clinical background in multiple therapeutic areas including cardiovascular and cerebrovascular diseases, neurological trauma, post-cardiac surgery, and general critical care management. Nanette completed her Masters of Science in Nursing degree at the University of California, San Francisco. She is a fellow of the American Heart Association and has been involved in various national level AHA committee functions.
Rachael Holley, Project Director, Clinical Research Finance, U.T. MD Anderson Cancer Center
Ms. Holley has over 16 years nursing experience and has worked in the research arena for over 12 years. She offers a 360 degree perspective as she has worked in many facets of clinical research during her tenure from research nurse, auditor/ monitor, pharma, lab, management, and research finance. She is certified in health care and research compliance and well as clinical coordination and monitoring. In her current role one her responsibilities is programming and developing databases. She is a self-taught programmer and her databases are utilized institution wide by many areas and are the standard by which Medicare Coverage Analysis are created.
Kirstin Holzapfel, Regional Head, Clinical Data Center Berlin; Global Data Management, Bayer Pharma AG
Since 2008, Kirstin leads the regional team of Data Management Programmers in Global Clinical Operations at Bayer Pharma AG. This includes support of Study Teams with respect to process tools, applications and reports for all kinds of data handling for internal as well as external studies and the maintenance of SAS based Bayer Pharma Medical Standards in a global central integrated environment. From 2002-2007, she led a group coordinating Schering/Bayer Pharma R&D IT needs with innovation, implementation and maintenance with the Corporate IT department and relevant business functions. Previously in 1991, she joined Schering AG with a Computer Science degree as a system analyst. She was a project manager for various global projects supporting R&D departments in strengthen global processes and IT systems.
Denise A. Hopkins, Pharm.D., Senior Director, Life Sciences, Late Phase Research, OptumDenise A. Hopkins, Pharm.D. is a Senior Director in OptumInsight's Life Sciences, Late Phase Research, division. Dr. Hopkins utilizes her long standing experience in late phase research to provide oversight, guidance and support for OptumInsight's North American late phase business. Located in Ohio, Dr. Hopkins joined OptumInsight in 2008. Prior to assuming this position with OptumInsight, Dr. Hopkins headed global late phase studies for another CRO. Dr. Hopkins joined the pharmaceutical industry over 15 years ago with Procter and Gamble Pharmaceuticals (P&GP) Medical Affairs and held a variety of positions of increasing responsibility, including providing global medical affairs oversight across the P&GP gastrointestinal product portfolio. In addition to the gastrointestinal field, Dr. Hopkins also worked in the Endocrine & Women's Health fields while at P&GP. She has had additional therapeutic experience overseeing programs in the rheumatology, hematology, pain (cancer pain and chronic pain), infectious disease, neurology, respiratory, ophthalmology, and endocrine therapeutic areas. Her academic training includes a Bachelor of Science in Pharmacy from the University of Cincinnati and a Doctor of Pharmacy degree, also from the University of Cincinnati.
Robert House, M.D., President, DynPort Vaccine Company
Dr. House is President of DynPort Vaccine Company LLC, a CSC company. DynPort manages product development programs for government agencies, and provides consulting, technical and program management services to companies in the biotechnology and pharmaceutical industries. Prior to joining DynPort, Dr. House worked at Covance Laboratories in Madison, Wis., and IIT Research Institute in Chicago, Ill., where he managed highly successful programs in immunotoxicology assessment. He has nearly 30 years of experience in biomedical research and development, specializing in the assessment of inadvertent and therapeutic immunomodulation. Dr. House earned his Master of Science in Public Health (MSPH) and Ph.D. degrees in Medical Parasitology from the University of North Carolina School of Public Health, and is the author, co-author or editor of more than 100 journal articles and book chapters in the areas of immunotoxicology, host defense, cytokine biology and biodefense. Dr. House is also an adjunct professor at George Mason University where he teaches medical countermeasure development, and was recently named Vice President Elect of the Society of Toxicology's Biotechnology Specialty Section. He is a certified Project Management Professional (PMP) and a Fellow of the Academy of Toxicological Sciences.
Keith Howells, Senior Vice President, Product Development, OmniComm
Keith has led development efforts for clinical research applications for almost 20 years. He is the senior vice president in charge of development for OmniComm's EDC and eClinical products, and previously held similar positions at Medidata and Oracle.
Chris Hoyle, MBA, Executive Director, Elite Research Network
Mr. Hoyle entered clinical research in 2001 after obtaining his MBA. While working at a dedicated research site, he was involved in all aspects of investigator site management, including patient recruitment, budgets and contracts, and business development. He founded the Elite Research Network in 2004. Since then, Mr. Hoyle has been responsible for leading the company from a network of four sites to its current size of twenty-five sites based in the U.S., with two additional sites in Latin America. He earned his BS in Zoology from NC State University and his MBA from UNC – Wilmington.
John Hubbard, Senior Vice President, Research & Development; Head, Worldwide Development Operations, Pfizer, Inc.
Dr. Hubbard is Senior Vice President and Worldwide Head of Development Operations for Pfizer Inc. In this position, he is responsible for global clinical trial management from Phase I to IV, which includes more than 700 clinical projects across specialty care, primary care, oncology, established products, emerging markets, vaccines business units and pharma- and bio-therapeutic research units. He has been leading pharmaceutical research and development activity for more than 25 years and has held positions of increasing responsibility in the Pharmaceutical, SMO, and CRO industries. Prior to joining Pfizer, he was Group President Clinical Research Services at ICON Clinical Research where he was responsible for the global business and operations generating revenues of $725 million and 18% operating income in 2009. ICON was 49th on the FORTUNE list of the "100 Fastest Growing Companies" in 2009 (53% increase EPS, 31% increase in revenue and 16% increase in total return over three years).During his career, Dr. Hubbard has been directly responsible for drug discovery and non-clinical pharmacology, clinical pharmacology, project management, product development optimization, commercial assessment of new chemical entities, and clinical development operations. He has led several drug development teams to successful commercialization of new chemical entities (NCEs) and has participated at FDA meetings to support end of Phase II and end of Phase III data presentation for psychiatric, neurological, cardiovascular, and anti-infective drugs.Dr. Hubbard received a Bachelor of Science degree from the University of Santa Clara, a Doctorate from the University of Tennessee, and was a National Institute of Health Postdoctoral Fellow in Cardiovascular and Clinical Pharmacology at the University of Texas Health Sciences Center. He is a member of the Society of Clinical Pharmacology and Therapeutics, Drug Information Association and has served on the Special Interest Advisory Committee on Project Management. He is a Board Certified Diplomate in Applied Pharmacology and was elected to Fellow of the American College of Clinical Pharmacology (ACCP) in 1994. Dr. Hubbard was Chairman of the ACCP Public Policy Committee from 1999 to 2007, where he was active in reviewing FDA new drug development guidelines and related pharmaceutical policies which impact the delivery of healthcare and consumer safety. He has authored or co-authored three book chapters and 76 published articles and abstracts in the areas of cardiovascular and autonomic pharmacology, clinical pharmacology, and global drug development.He is a Scientific Advisory Board Member, MedAvante Corporation, Advisory Board Member and Fundraising Co-Chair for the Children's Brain Tumor Foundation, Board Member for the North Penn Korean Community Services Center, and President, American Delegation of the 21st Century America-Korea-China Leaders Society.
Carrie Hurwitz, Director, Corporate Strategy and Business Development, McKesson Corp.
Carrie Hurwitz is Director, Corporate Strategy & Business Development for McKesson. In this role she is responsible for the development and implementation of new business opportunities to meet evolving customer needs. During her first two years with McKesson, her primary focus was on McKesson's hospital and health system customers, with emphasis on ambulatory pharmacy. Her current responsibilities emphasize the creation of new capabilities for manufacturers to aid in drug development, specifically with respect to patient recruitment for clinical trials. Prior to joining McKesson, Hurwitz gained industry experience working for pharmaceutical and biotechnology manufacturers, primarily dedicated to clinical trial management and drug development strategy. Carrie holds a BS in Biology from the University of Massachusetts at Amherst and an MBA from the Haas School of Business at the University of California at Berkeley.
Rathna Iyer, Project Management Consultant, Integrated Project Management
Rathna Iyer is a Project Management Consultant at Integrated Project Management Company, Inc. (IPM), a leading provider of professional project management services to the life sciences industry. In this role, Rathna has combined her extensive drug discovery and development expertise with project management leadership skills, and along with client teams has successfully driven complex, cross functional projects. Working with global pharmaceutical companies and smaller "virtual" companies that operate predominantly through external resourcing, projects have ranged from clinical program management to process optimization. Rathna is a certified Project Management Professional (PMP) with the Project Management Institute.
Mary James, Senior Manager, Patient and Physician Services, United BioSource Corporation (UBC)
Ms. James works closely with UBC's clinical operations team and network of 17,000 nurses to execute a variety of clinical research support services for manufacturers of biopharmaceuticals and medical devices. Ms. James's 22 years of experience in the healthcare field includes serving as a nursing consultant on a number of patient access programs and managing the creation of clinical documents for home health agencies to submit to sites to meet study requirements. In previous work with UBC, Ms. James's responsibilities included developing custom programs and pricing plans for manufacturing partners, contract implementation, and program execution.
Todd Johnson, Global Head, Business Information Systems Management (BISM), Global Development Operations, Astellas Pharma Global Development, Inc.
Todd has worked in the pharmaceutical industry for 17 years and is currently the Global Head of Information Management at Astellas Pharma Global Development, Inc. He has a background in business and biostatistics and extensive experience in Clinical Operations. Todd holds a Bachelors degree in Biology, a Masters degree in Epidemiology and Biostatistics and an MBA in Econometrics, Entrepreneurship and Strategic Management.
Michael Kahn, M.D., Ph.D., Associate Professor of Pediatrics, Core Director, Biomedical Informatics, Colorado Clinical and Translational Sciences Institute, University of Colorado
Dr. Kahn's research interests include real-time clinical decision support linked to clinical outcomes monitoring, clinical data warehouses for both operational and retrospective research support, integration of electronic medical records with prospective research, and translational research informatics for both T1 (bench to bedside) and T2 (bedside to community) translational settings. Prior to his current positions, Dr. Kahn was faculty in the Departments of Medicine, Computer Sciences, and Biomedical Engineering at Washington University School of Medicine in St Louis, Director of Advanced Clinical Systems at BJC Health Systems, and was in the commercial clinical trials software industry before returning to academics. Dr. Kahn has been a member of the board of directors of the American Medical Informatics Association, the Board of Scientific Counselors of the National Library of Medicine and the editorial boards of the Journal of the American Medical Informatics Association and the International Journal of Medical Informatics. He is a member of the American College of Medical Informatics. Dr. Kahn received a BS in Biological Sciences, a BA in Chemistry from the University of California, Irvine and M.D. degree from the University of California, San Diego. He received training in internal medicine at St. Mary's Medical Center, an affiliate program of the University of California, Los Angeles. Dr. Kahn received a Ph.D. in Medical Information Sciences from the University of California, San Francisco.
Darlene Kalinowski, Associate Director, EDC Operations, Bristol-Myers Squibb Co.
Darlene has been working in the Pharmaceutical industry for the last 20+ years. She has worked in Database Development, Data Management (where she managed a clinical team), eDC Implementation and Adoption and is currently an Associate Director in the eClinical Operations group. Darlene is a member of the eClinical Forum, DIA, and currently the past Co-Chair of Oracle Health Science User Group. Darlene contributed to the CCHIT ANSI certified EHRCR Functional Profile to help connect EHR and eDC systems. She is a certified Lean Sigma Kaizen Leader and is currently co-lead of the CTMS implementation at BMS.
Suresh Kannan, Vice President, DecisionView Products, IMS Health - Clinical Trial Optimization Solutions
Suresh brings over 20 years of leadership experience delivering innovative, award-winning business intelligence applications and performance optimization solutions for the Life Sciences industry. Prior to DecisionView's acquisition by IMS Health in April, Suresh oversaw the development of the company's product suite of clinical trial optimization solutions, including StudyOptimizer, SiteOptimizer, and Enrollment Benchmarks. Before DecisionView, he served in various engineering leadership and senior management roles at Oracle spearheading development of Oracle's Business Analytics software including Oracle Discoverer, an award-winning application for ad-hoc query, analysis, and reporting solution. Suresh has a B.S. (Honors) in Computer Science & Engineering from the National Institute of Technology in India, and an MBA from the University of California at Berkeley.
Gary Kennedy, Founder and CEO, Remedy Informatics
Matt Kiernan, Partner, Pharmica Consulting
Matt Kiernan is a Partner at PHARMICA Consulting, a firm which focuses on operational excellence and decision-making capabilities for organizations in the life sciences industry. Mr. Kiernan has over fifteen years of industry expertise in operational excellence, collaboration, mobility, project management, portfolio management, resource management, metrics, and benchmarking within the pharmaceutical value stream. Mr. Kiernan has worked with many large and small life sciences firms to achieve operational excellence. Mr. Kiernan has Bachelor of Science degrees in Business, Psychology, and Chemistry. He participated in the chemistry PhD program at Purdue University. He earned an M.B.A. from Villanova University. In addition to these degrees, Mr. Kiernan earned a Black Belt in Six Sigma and has also earned a Project Management certification from the Project Management Institute.
Joseph Kim, Director, Clinical Operations, Shire
Joseph Kim serves as the Clinical Operations Director at Shire, focusing on developing and implementing innovative trial optimization solutions in an outsourced model. He has spent 14 years in the Pharma industry utilizing a unique approach that integrates his experiences working for Sponsors, CROs, and niche vendors. He has the rare combination of experience that includes early and late phase clinical research, and a command of IT related solutions and development models. Joseph holds a BS in Molecular Biology from Lehigh University and an MBA from Villanova.
Russell Knoth, Ph.D., Director, US Health Economics & Outcomes Research, Eisai, Inc.
Working primarily in Neurology and Oncology, Russell collects, analyzes and represents the pharmacoeconomic value of the Eisai product portfolio to the health care community. In addition, he supports collaborative HEOR projects with researchers examining outcomes related to these products and their associated disease states. Prior to joining Eisai, Russell served as a field-based Pharmacoeconomic & Outcomes Research Scientist at both Bristol-Myers Squibb and Johnson & Johnson. Prior to entering the pharmaceutical industry, he held various clinical research science roles at Pacificare (now United Healthcare), Kaiser Permanente, and in the California Managed Medicaid system. Russell received his Doctorate and Master's degree in Experimental Psychology from the University of New Hampshire in Durham, NH. He also holds a Bachelor's degree Psychophysiology from the California State University System.
Catherine Koepper, Director, Global Registry Operations, Evidence Based Medicine, Genzyme, a Sanofi Company
Catherine Koepper has over two decades of experience in registry management, biotechnology, clinical trial research, managed health care and hospital care. Her experience encompasses several therapeutic areas, including genetic diseases (e.g. Fabry, Gaucher, Mucopolysaccaridoses and Pompe), CNS (e.g. amyotrophic lateral sclerosis, spinal cord injury, anesthesia), oncology (e.g. colorectal, breast; endometrial screening device), cardiac, pulmonology, infectious disease, gastroenterology and urology. Ms. Koepper has worked with Genzyme Corporation's rare disease, lysosomal storage disorders, program since 2005 and is the Director of Global Registry Operations. In this role, she is responsible for all operational aspects of Genzyme registries, including such things as 1. Establishing the overall strategic direction of the registry program; 2. Aligning operations globally and across registries to ensure quality, consistency and efficiency; 3. Establishing and/or overseeing principles, policies, procedures and guidelines that encompass proper protection, handling and reporting of patient registry data. In addition, Ms. Koepper was a participating reviewer of the 1st and 2nd Editions of the "AHRQ Registries for Evaluating Patient Outcomes: A User's Guide."
Debi Koltenuk, Vice President, Products & Services, sampleminded
Debi Koltenuk has over 25 years experience with clinical and biological research data management issues, beginning when she left nursing to join GenBank®, just before the one millionth base pair celebration. After working on database design issues for genomics and genetics data at both GenBank and the Human Genome Information Resource, Debi spent seven years at the bench at the University of Utah conducting a DNA sequence-based evolutionary-developmental research project. Since 1998, Debi has provided domain expertise for numerous software development projects that span the genomics and proteomics laboratory data-management and clinical research data management domains.
Greg Koski. M.D., Ph.D., President and Co-Founder, Executive Office, Alliance for Clinical Research Excellence and Safety
Greg Koski, PhD, MD, is an internationally recognized leader in human research and subject protection and co-founder of the Alliance for Clinical Research Excellence and Safety (ACRES). As the first director of the Office for Human Research Protections at the U.S. Department of Health and Human Services, he established its Office for International Activities. While serving as director of OHRP, he chaired the inter-agency Human Subjects Research Subcommittee of the Committee on Science at the White House and served as Executive Secretary of the national Human Research Protections Advisory Committee. He is past President of the Academy of Pharmaceutical Physicians and Investigators, and formerly a member of the Board of Trustees of the Association of Clinical Research Professionals, international not-for-profit organizations promoting professionalism and excellence in human research. He continues to work to enhance capacity for quality human research and ethical review in developing countries around the world, chairing the advisory board for the Strategic Initiative for Developing Capacity for Ethical Review (SIDCER). He is also a member of the Executive Committee of the Multi-Regional Clinical Trials (MRCT) Center at Harvard and serves on the Executive committee of the International Federation of Associations of Pharmaceutical Physicians. He is Associate Editor of the Journal for Empirical Research in Human Research Ethics (JERHRE), and Associate Professor of Anesthesia at the Harvard Medical School where he practices and teaches anesthesia for cardiovascular and thoracic surgery at the Massachusetts General Hospital, and Senior Scientist at the Mongan Institute for Health Policy.
Anna Kravets, Director, User Experience Strategy, Merck
Nick Lagrotta, Principal Informatics Consultant, Pharmica Consulting
Nick has worked in life sciences for nearly 20 years working as a project and program manager, particularly with emerging technologies. Nick's extensive understanding of Microsoft SharePoint has been applied to a number of key client needs including a worldwide global collaboration portal for a major pharmaceutical company, a SharePoint based expense management system driven by Infopath, and an enterprise reporting application integrated with Crystal Reports. Nick is PMI and Microsoft Pro certified and has a BS in Biochemistry as well as a M.S. in Information Sciences from Stevens Institute of Technology.
Laurie Lebo, Ph.D., National Program Manager, Research Services, Vanderbilt University
Dr. Lebo serves as National program manager for ResearchMatch and Research Consultant in the Office of Research at Vanderbilt University Medical Center. She has 17 years of experience in program design, implementation and evaluation of epidemiological research, clinical trials and community-based research. Laurie is a certified Project Management Professional (PMP®) who utilizes her expertise in clinical project management to coordinate the start-up, training, education and support for 200 ResearchMatch Institutional Liaisons at 75 participating ResearchMatch sites nationwide.
Martin Lee, M.D., Executive Vice President, Clinical Trial Services, Accelerating Clinical Trials, DAVA Oncology, LP
Dr. Martin Lee is the Executive Vice President for Clinical Trial Services at DAVA Oncology, LP. Dr. Lee has more than twenty years experience in the clinical practice of hematology and oncology, including care of autologous and allogeneic transplant patients. A recognized expert in the field of clinical trial planning and feasibility, Dr. Lee joined DAVA Oncology, LP in 2011 from PPD, where he served as Vice President of Site and Patient Recruitment. In this role, Dr. Lee provided leadership to the feasibility, patient recruitment, strategic collaborations and the investigator database groups. Prior to this assignment, Dr. Lee served as medical director for global drug development at PPD, where he had responsibility for clinical development across multiple oncologic conditions. Prior to joining industry in 2006, Dr. Lee served as the Oncology Research Director at Park Nicollet Clinic in Minneapolis, MN. He also served as the chair of the Institutional Review Board for Park Nicollet Health Services. Dr. Lee attended Purdue University in West Lafayette, IN, where he obtained bachelor degrees in chemistry and foreign language. Dr. Lee attended medical school at the University of Texas Medical School at Houston. He served as a resident and fellow at the University of Kansas School of Medicine in Kansas City. Dr. Lee is board certified in internal medicine and medical oncology.
Daniel Lenihan, M.D., Director, Clinical Research, Cardiovascular Medicine, Vanderbilt University
Daniel Lenihan, M.D., has been active in clinical research in cardiology, and specifically in heart failure, for nearly 20 years. The main focus of these efforts have included hemodynamic assessments, angiogenic growth factor response, novel cardiac biomarkers as well as optimal methods to prevent or detect heart failure at the earliest stage possible in patients undergoing treatment for cancer. His current projects include early phase clinical trials in heart failure, including the ongoing Phase 1 trial of GGF2 in cooperation with Acorda, Inc., the Cardiology PI of a multicenter study (in conjunction with MD Anderson Cancer Center) using cardiac biomarkers to detect cardiotoxicity during anthracycline based therapy, and the site PI for a multicenter trial examining the cardiovascular effects of anti‐angiogenic therapy in patients with renal cell cancer. Dr. Lenihan is the USA based president of the International CardiOncology Society, a group of committed practitioners and researchers whose goal is to enhance and foster collaboration among cardiology and oncology colleagues throughout the world.
Gen Li, Ph.D., Founder & President, PhESi
Gen Li, PhD, MBA, is the founder and president of PhESi, LLC, which provides services to clinical development organizations around the world in the areas of investigator site selection, site activation process support, clinical trial planning, and business process improvement support. Previously, he was head of productivity for Pfizer Development Operations, director of performance management for medical development at Pharmacia, and senior resource manager for Bristol-Myers Squibb. He can be reached at firstname.lastname@example.org.
David Lilienfeld, M.D., Chief Medical Safety Officer, Ambit Biosciences Corporation
Victor Lobanov, Ph.D., Director, Informatics Center of Excellence, Johnson & Johnson
Victor holds a M.S. degree in chemistry from M.V. Lomonosov Moscow State University, Russia and a Ph.D. in computational chemistry from the University of Tartu, Estonia. After postdoctoral training with Alan R. Katritzky at the University of Florida, he joined 3-Dimensional Pharmaceuticals (3DP), where he worked on development and application of advanced computational methods for combinatorial chemistry, virtual screening and HTS data analysis. At Johnson & Johnson Pharmaceutical Research & Development L.L.C. (J&J PRD) Victor is currently Director of the Informatics Center of Excellence.
Robert Loll, Vice President, Business Development & Strategic Planning, Praxis
Robert Loll is the VP of Business Development and Strategic Planning for Praxis Communications, a leading Patient Recruitment Organization (PRO) that specializes in optimizing study enrollment for clinical research studies with award-winning creative, comprehensive patient insights and superior execution. Robert spent 18 years providing patient care for top collegiate, Olympic and disabled athletes around the world while managing business development for outpatient rehabilitation companies including Baxter, Caremark and NovaCare. Prior to joining Praxis, Robert lead international sales for a consumer loyalty technology company who specialized in direct-to-consumer marketing and loyalty initiatives for Fortune 100 companies and managed a patient recruitment company since 2004. Robert received a BA in Communication Studies from the University of Iowa and completed the Athletic Training Curriculum within the Department of Exercise Science and Physical Education. Post-graduate courses include exercise science and Clinical Pharmacology, Drug Development, and Regulation with the Center for the Study of Drug Development at Tufts University.
Richard Malcolm, Ph.D., CEO, Acurian, Inc.
Rick brings more than 22 years of experience in healthcare management to his role as CEO. Prior to joining Acurian, Rick was Vice President, Business Development for ICON Clinical Research, one of the world's largest Contract Research Organizations. Rick started his career in healthcare at SmithKline Beecham Pharmaceuticals (now GlaxoSmithKline) where he had product marketing responsibility for several cardiovascular, gastrointestinal, depression and anti-arthritic products. In addition to serving as the worldwide head for SBCL's Clinical Trials Center (now Quest's central laboratory), he has served in senior management and consulting roles at start-up pharmaceutical companies including The Medicines Company and Neutris Pharmaceuticals. Rick received his B.S. in Microbiology at the University of Michigan and his Ph.D. in Pharmacology at the University of Southern California.
Marina Malikova, Ph.D., PMP, Executive Director, Surgical Translational Research: Operations and Compliance, Adjunct Professor, Biomedical and Clinical Sciences, Boston University Medical Center
Marina has over seven years of experience in clinical research, including managing all phases of investigational drugs, devices and biologics (gene therapy, stem cells, growth factors) of both sponsored and Investigator initiated trials in the fields of Vascular Surgery, Neurosurgery Surgery, Cancer Diagnostics and Interventional Radiology. She has served as a co-investigator on multiple industry sponsored and Investigator initiated clinical trials involving, breast cancer diagnostics, gene therapy for peripheral arterial disease and critical limb ischemia, stem cell therapy for venous stasis ulcers, tissue regenerative medicine and limb preservation, vascular devices for bleeding prevention, hypertension and varicose veins. She has a MS in Biological Sciences, majoring in Biochemistry and Physiology, from Voronezh State University, Voronezh, Russia and a Ph.D. in Biochemistry from the Institute of Biochemistry, Russian Academy of Science, Moscow. Marina also holds a Certificate in Clinical Research a Masters of Art in Clinical Investigation, both from Boston University School of Medicine.
Aubrey Manack, Ph.D., Epidemiologist, Allergan
Dr. Aubrey Manack is the lead epidemiologist supporting the Neurology and Pain therapeutic area at Allergan, Inc. Her primary role is to provide strategic direction and an evidence-based understanding of the patient population in order to adequately measure efficacy, to evaluate and maintain the safety of a drug during development and to prepare for post-registration activities once a product is available in the market. She played an integral role in the recent FDA and global approvals for onabotulinumtoxinA (BOTOX®, Allergan, Inc., Irvine, CA, USA) for chronic migraine and neurogenic detrusor overactivity in neurologic overactive bladder.
Kathleen A. Mandziuk, RN, Senior Scientific Affairs Director, Late Phase Services, PRA
Ms. Mandziuk's professional research career has almost exclusively been in the area of late phase development. She has a background in both Data Management and Project Management of global post-marketing and minimal risk research. In her current role as Senior Scientific Affairs Director, Ms Mandziuk assists pharmaceutical, biotechnology and devices companies with strategic minimal risk and observational protocol design. In addition, she supports the sponsor and project team throughout the lifecycle of the project with proactive and innovative strategies to optimize study execution. Her specialty is blending scientific concepts with operational implantation to ensure the final data supports the objectives of the study.
Sylvia Marecki, Ph.D., Product Manager, Sitetrove, Citeline, Inc.
Sylvia Marecki, Ph.D. is Product Manager for Sitetrove at Citeline. Prior to assuming this role, she was Senior Director, Autoimmune/Inflammation & Process/Product Improvement, where she was responsible for overseeing and optimizing editorial operations in Sitetrove and the Autoimmune/Inflammation therapeutic area within Trialtrove. She received her doctorate in Pathology and Immunology from Boston University School of Medicine and has over 10 years of experience in pharmaceutical business/competitive intelligence and market research.
Brenda Medina, Director, Global Head, Clinical Business Operations & Meeting Planning, Eisai
Brenda Medina has 12 years of direct experience. Currently, she holds the position of Global Head of Clinical Business Operations responsible for the functions of Study Budget Management, R&D Aggregate Spend tracking and reporting, Investigators Fair Market Value Assessment & Benchmarking, Strategic Meeting Management, Clinical Insurance and Quickbase Implementation and Analysis all of these functions are focused on the Clinical/R&D business units of Eisai. She has been at Eisai six plus years and has fully developed the process and tools for study budget management process, including Investigator Benchmarking, Budget Negotiations, Reconciliation, and Aggregate Spend Reporting for Sunshine and State reporting. Previous to Eisai Brenda has a well balance mix of experience in Clinical Arena from Biotech and the Finance Arena from several auditing and private firms. Brenda's earned her degree in Accounting and Computer Information Systems from Dowling College and through her experience and education has been able to become a well-established Translator of the Clinical Development process for the Finance teams and a Financial Liaison to the Clinical Teams; a role and department (Business Operations) she has established at Eisai.
Sean Melville, Director, Business Development, BioPharm ClinicalSean Melville is the Director of Business Development for BioPharm Clinical™, an Infinata biopharma solution. Sean partners closely with global pharmaceutical and CRO customers to understand their requirements for more effective clinical operations support and ensures the database continues to exceed their expectations. Sean recently participated in a joint webinar with BBK Worldwide founding principal Bonnie A. Brescia to discuss how new sources of patient pool demographic data are improving study feasibility and investigator selection. A former attorney, Sean is based at Infinata's headquarters outside of Boston, MA and may be reached directly at smelville@biopharmclinical .com.
Christopher Milne, Ph.D., Professor, Director, Research, Center for the Study of Drug Development, Tufts University Medical School
Dr. Milne joined the Tufts Center for the Study of Drug Development (Tufts CSDD) in 1998 as a Senior Research Fellow in order to address legal and regulatory issues. His current research interests include: academic-industry collaborations; disease, demographic and market access factors in the emerging markets; incentive programs for pediatric studies, orphan products, and neglected diseases; and, tracking the progress of new regulatory and research initiatives such as Regulatory Science, Translational Medicine and Personalized Medicine. He is currently Director of Research at Tufts CSDD, Research Assistant Professor at Tufts University Medical School, a member of the Editorial Board of the Food & Drug Law Journal, and an Honorary Fellow at the University of Edinburgh.
Bruce A. Molitoris, M.D., Director, Indiana Center for Biological Microscopy and Professor of Medicine, Indiana University
Bruce A. Molitoris, M.D. received his M.D. from Washington University School of Medicine and completed his residency in internal medicine and fellowship training in nephrology at the University of Colorado. He remained on as a faculty member being promoted up through Professor of Medicine. He was Director of Nephrology from 1993 until 2011 at Indiana University School of Medicine and is Director of the Indiana Center for Biological Microscopy. His research expertise includes acute kidney injury from ischemia, sepsis and nephrotoxins, and the utilization of two photon microscopy to study in vivo cellular and subcellular processes within the kidney. He is using 2-photon microscopy to quantify the roles of glomerular permeability, proximal tubule uptake and transcytosis of albumin in determining albuminuria. He is a founding member of INphoton and a co-founder of FAST Biomedical. Dr. Molitoris is President-Elect of the ASN, a Foreign Adjunct Professor at the Karolinska Institute and is involved in numerous NIH committees and study sections.
Greg Moody, Director, Clinical Systems, Millennium: The Takeda Oncology Company
Kim Mooney, Manager, Patient Advocacy, Clinical Operations, BioMarin Pharmaceutical, Inc.
Kim Hart Mooney, MS, CGC, is the Manager of Patient Advocacy at BioMarin. Kim has been in the industry for over nine years and has worked on a number of clinical trials during that time, as well as the development of the clinical trials section of the corporate website, and the coordination of programs to increase patient education and enrollment in clinical trials. Kim is a Certified Genetic Counselor and worked as a Study Coordinator prior to her current industry experience.
Nancy Mulligan, Director, Operations, Patient and Physician Services, United BioSource Corporation (UBC)
Ms. Mulligan has more than 20 years of experience in medical and pharmaceutical communications. In her current position, Ms. Mulligan manages a team that designs and executes aggressive, multi-media initiatives and materials for various stakeholders (research sites, physicians, healthcare professionals, patients, and caregivers). She is responsible for PPS strategies and vehicles that support physicians and patients, including recruitment and retention programs for research studies. She has directed more than 100 patient recruitment projects for pharmaceutical clients and for agencies of the National Institutes of Health.
Nariman Nasser, Senior Director, Recruitment & Implementation Core, Clinical Research Services, Clinical & Translational Science Institute, University of California San Francisco
Nariman Nasser is the Senior Director of Participant Recruitment at the University of California, San Francisco's Clinical & Translational Science Institute. This campus-wide service assists researchers in recruiting study participants while improving communication and outreach about clinical research opportunities to the general public. Previously at the Immune Tolerance Network she was responsible for the development and implementation of clinical trials that define new tolerance biomarkers. Ms. Nasser's previous experience includes molecular immunology and stem cell biology bench research as well as industry-sponsored clinical research project and portfolio management, marketing, and technology.
Boris Nikolov, M.D., Research Manager, Clinical Research Department, Akta Medika Hospital
Boris graduated medical school 1994 in Bulgaria. He has more than 10 years of experience in clinical research and 18 years of experience in the medical field. Boris has led the successful development and expansion of a clinical trial department of a private hospital in Europe as well as the organization of a successful consulting business in clinical research.
John Oidtman, Vice President, Clinical Trial Support and Compliance, Pfizer
John Oidtman is responsible for overseeing the world-wide performance of monitoring activities of strategic partners and investigational sites' clinical activities to ensure Pfizer clinical development standards are achieved. In addition, his area provides in-process control of clinical monitoring and field operations. John received his Bachelor of Science degree in Zoology from the University of Maryland, specializing in vertebrate physiology. He joined Pfizer in 1997 through the Pfizer / Pharmacia merger.
Ozgur Ozkan, Ph.D., OR Scientist, Predictive Computational Science, AstraZeneca
Ozgur Ozkan, Ph.D. is a Principal Informatics Scientist in R&D Information group at AstraZeneca Pharmaceuticals. His work focuses on the application of modeling, simulation and optimization methods to improve decision making in the clinical development process. In addition to optimizing the allocation of clinical trial patients, he is involved in the development of analytical tools for planning and monitoring of clinical trials. Prior to AZ, Ozgur spent five years at Health Market Science developing strategic models integrating primary and secondary market research to capture patient, physician and payer dynamics in various therapy areas including diabetes, insomnia, vaccines and oncology. Earlier in his career, he led the development of simulation-based training and decision-support solutions at a consulting firm. Dr. Ozkan received his Ph.D. and M.S. degrees in Operations Research from the University of Southampton in the United Kingdom and his B.S. in Industrial Engineering from Bilkent University in Turkey.
Vadim Paluy, M.D., former Senior Director, Clinical Research, BHR Pharma, LLC
Vadim Paluy, MD has formal training as a Board Certified Internist with clinical practice and research experience in Russia and the US. Dr. Paluy has over 15 years of clinical research experience including all aspects of project management as well as audit and monitoring clinical trials, investigator/patient recruitment, protocol and CRF development, SOP writing, and development of study specific educational materials.
Darlene Panzitta, Founder & President, DSP ClinicalDarlene Panzittais an award winning pharmaceutical executive dedicated to improving outsourced clinical trial management for small to mid-size biopharma, device and life sciences companies. She is an expert in Phase I-IV drug development with therapeutic expertise including women's health, endocrinology, urology, pain, CNS, gastrointestinal, gynecology, dermatology, and devices. She has a BS in Science and a MS in Biology from Farleigh Dickinson University.
Jean Paty, Chief Scientific & Regulatory Advisor, ePRO Solutions, ERT
Dr. Paty has published extensively in the area of the regulations guiding development and implementation of ePRO, and has worked closely with industry and regulatory agency groups on ePRO best practices. His years of work developing eSolutions to study patient experience has been well-referenced in peer reviewed journals and in a variety of conferences and events, where he has presented his findings on the scientific, clinical, and regulatory implications of Clinical Outcome Assessment (COA) data collection in clinical trials. Dr. Paty has a B.S. in Psychology from University of Toronto and an M.S. and Ph.D. in Psychology from University of Pittsburgh.
Douglas Peddicord, Ph.D., Executive Director, Association of Clinical Research Organizations (ACRO)
Following a career as a clinical psychologist, Doug Peddicord was an American Association for the Advancement of Science (AAAS) Fellow in the U.S. Congress in 1994-1995. With policy expertise in the conduct and regulatory oversight of clinical trials, Dr. Peddicord serves as Executive Director of the Association of Clinical Research Organizations (ACRO). Founded in 2002 by leading clinical research organizations that provide a wide range of research and development support services to pharmaceutical, biotechnology and medical device companies, ACRO works to provide a heightened awareness of the critical role that CROs play in the development of new drugs, new devices, and new treatments. ACRO is an active participant in policy discussions that may lead to regulations, legislation or other policy initiatives that may impact the CRO industry, both in the US and globally. Dr. Peddicord speaks frequently on the subject of the particular role of the CRO (along with the sponsor, investigator, IRB, and regulator) in the 'system' that provides for the protection of human research participants, as well as on broader issues relating to the conduct of clinical research, including health information privacy, financial conflicts of interest, and the globalization of clinical trials.
Gerson Peltz, M.D., Medical Director, Global Pharmacovigilance and Epidemiology, Bristol-Myers Squibb
Gerson Peltz MD, MPH is Medical Director of Global Pharmacovigilance and Epidemiology at Bristol-Myers Squibb. Prior to join BMS, he was Senior Medical Advisor of Eli Lilly and Co, Associate Professor (tenure) of University of Texas at Brownsville, and Chair of the Department of Internal Medicine from the Brazilian National Institute of Cancer. He has a fellowship in Health Disparities from NIH-sponsored program offered by University of North Texas.
Jennifer Peterson, Senior Clinical Trials Manager—Site Start-Up, Clinical Operations—Site Start-Up, Duke Clinical Research Institute
Jennifer Peterson has been in the clinical research industry for over 12 years with a concentration in Regulatory Affairs and Study Start Up. She started with the DCRI in November 2008 and currently oversees the site start up activities across all projects within North America. Her goal is to continue improving upon the start-up process for sites, sponsors, and CROs/AROs by finding new ways to streamline activities and reduce time to site activation. Prior to entering the filed, Jennifer was a bench scientist with Novartis Agribusiness.
Emily Pfaff, Research Analyst, NC TraCS Institute
Christine Pierre, President & Leadership Council Chair, Society for Clinical Research Sites (SCRS)
Christine Pierre is internationally known for her experience and expertise in clinical research site management and patient recruitment and retention for the clinical trials industry. For the past 20 years Christine has been providing site management services to research sites in all types of settings, and additionally provides education, operation and clinical expertise, in addition to training and consultation services with sponsors and CROs. Christine is a frequent guest speaker at industry conferences, including those sponsored by the Drug Information Association (DIA) and the Association of Clinical Research Professionals (ACRP). Additionally, she has addressed audiences around the world on issues pertaining to human subject protection, site operations and subject recruitment and retention in Australia, Canada, Africa, Israel, and the United States. Additionally, Christine was the chair of the Association of Clinical Research Professionals (ACRP) in 2008, an editorial board member of Clinical Trials Advisor and eCliniqu, a member of the steering committee of the Clinical Trials Transformation Initiative (CTTI), and on the board of advisors for both the Center for Information & Study on Clinical Research (CISCRP) and Hands Across the Americas. Christine co-authored the book 'Responsible Research: A Coordinators Guide,' and is currently completing her second book on Clinical Research Site Management. Christine holds a degree in Nursing and has been committed to human subject protection and clinical site operations for more than 20 years.
Joe Popowicz, Director, Clinical Operations, Stryker Orthobiologics
Joe Popowicz is the Director of Clinical Operations at Stryker Orthobiologics (formerly Orthovita). In his current position, Joe is responsible for the study development and execution of the clinical development programs. Prior to Stryker, Joe held various positions in the areas of trial operations, enrollment planning, patient recruitment, and data management. Joe earned a Bachelor of Science degree in Psychology and a Master of Science degree in Experimental Psychology from Saint Joseph's University.
Teresa Raich, Ph.D., Senior Director, Clinical Affairs and Clinical Research, Nanosphere, Inc.
Dr. Terry Raich responsibilities include management of sponsored and investigator-initiated studies as well as clinical and scientific support of the Verigene System product portfolio. She previously was Director of Assay Development at HandyLab (now BD Diagnostics) and Director of Medical & Scientific Affairs at Roche Diagnostics. During her 8-year tenure at Roche Diagnostics, Dr. Raich managed multiple studies, advisory boards and speaker's bureaus in the areas of Oncology, Pharmacogenetics, Companion Diagnostics, Women's Health, Genetics, Microbiology, Clinical Chemistry, Blood Screening, Systems Automation and Virology. Dr. Raich received her Ph.D. in Microbiology from Colorado State University and her B.S. in Veterinary Sciences from West Virginia University. She completed an AAM/CPEP-approved Postdoctoral Training Fellowship in Medical and Public Health Laboratory Microbiology at Baylor College of Medicine in Houston, Texas. She received a MBA from Indiana Wesleyan University focusing on organizational leadership and management.
Marc Raman, Executive Director, IT Strategy Office, Merck
Marc Raman, Executive Director , IT Strategy Office at Merck, drives the agenda that helps shape strategy, provides translation into actionable plans, drives the portfolio management process, resolves the financial expression of the portfolio, and conducts operational oversight of the portfolio execution. In addition, this role is accountable internally, working with the Chief Information Officer and the Information Technology Leadership Team (ITLT), for managing the portfolio of new investments, transitioning systems and processes to a platform model, and exploiting these capabilities to maximize value for the enterprise. He is also currently leading the Integrated Development Platform Program, a large transformation program in Global Clinical Development IT, encompassing Global Clinical Trial Operations, Patient Data Acquisition and Management, Analysis and Reporting. Marc has held various leadership positions within Merck and Schering Plough. At Schering, he ran the operations for the Global IT PMO including leading the Schering-Organon post day-1 IT integration program. After the Merck-Schering merger, he managed the Global Regulatory IT portfolio for all aspects of Product Registration and Submissions Management. Prior to Merck/Schering he was an independent consultant in the Pharma vertical, with clients including Warner Lambert, Hoechst, Schering and Sanofi-Aventis.
Brion Regan, Head, Strategic Development, PharmaPros Corporation
Brion Regan has been working in the clinical trials industry for over 9 years. His recent focus has been on the evolving eClinical ecosystem. He has presented at numerous industry meetings and events over the years, with topics ranging from data integration and document collaboration, to leveraging analytics to support corporate metrics and industry benchmarks.
Arie Regev, M.D., Hepatology Chair, Liver and GI Safety Committee, Global Patient Safety, Eli Lilly and Company
Arie Regev, M.D., received his B.Sc. and M.D. degrees from the Hebrew University in Jerusalem, Israel. He completed residency in Medicine and fellowship in Gastroenterology at Rabin Medical Center and Tel Aviv University, where he continued working as attending physician and Associate Chief of Medicine. He subsequently completed clinical fellowship in Hepatology and Transplant Hepatology at the Division of Hepatology of the University of Miami, and Jackson Memorial Hospital in Miami, Florida. After his fellowship he continued working in the Division of Hepatology as full time faculty and subsequently Associate Professor of Medicine and Director of the Hepatology Fellowship Program until 2007. Dr. Regev has conducted numerous clinical trials in the field of viral hepatitis and liver transplantation. In January 2007 Dr. Regev joined Eli-Lilly in a Hepatology Consulting position and as Chair of the Liver and GI Safety Committee in the Global Patients Safety organization. He is currently an adjunct Associate Professor of Medicine at the Division of Gastroenterology and Hepatology of Indiana University, and he heads the Safety Advisory Hub at Eli Lilly and Company.
Badri Rengarajan, M.D., Medical Director, Archimedes, Inc.
Badri Rengarajan, MD is a medical director at Archimedes. His primary responsibilities include leading consulting engagements, providing clinical input to Model development efforts, and building relationships with clinical research leaders. Badri has over ten years of healthcare industry experience, including roles in product development strategy and new product planning, regulatory affairs, market research, and business development. Badri was previously a director of business development and market research at Nodality (personalized/predictive medicine), regulatory team leader at Genentech, and an engagement manager at McKinsey. Badri earned an AB in biology and public policy from Harvard University and an MD from Yale University.
Claire Reyneke, In-House Patient Recruitment Specialist, Centre for Clinical Research and effective practice (CCRep), Middlemore Hospital
Claire Reyneke is the in-house Patient Recruitment Specialist at the Centre for Clinical Research and effective practice (CCRep) at Middlemore Hospital in South Auckland, New Zealand. Claire was born in South Africa where she graduated with a Bachelor of Science in Chemistry and Genetics, a post-graduate teaching diploma and a Specialist Certificate in Training Management. Her career spans tertiary education (as a chemistry lecturer), pharmaceuticals (as a top sales representative with Eli Lilly, South Africa) and, following her migration to New Zealand in 2001, she continued to lecture chemistry before finding her niche in personnel recruitment. Whilst finding success in this latter field the opportunity to transfer her academic teaching and presentation skills; her scientific knowledge; her recruitment experience; and her public relations, sales and marketing skills to a Patient Recruitment Specialist role at CCRep presented itself. This is where Claire has found her new niche with it being an ideal match to her work and life experience, her skill set and her personality type.
Mark Ridge, MBA, Senior Director, Global Clinical Operations, CSL Behring
Evette Riegel, Head, Clinical Operations, Beardsworth Consulting Group
Jorge Rodriguez-Larrain, Head, Global Site Management, Global Clinical Operations, Alcon
Jorge Rodriguez-Larrain received his Medical Degree in 1986 from the Universidad Nacional Mayor de San Marcos, Lima - Peru. He is a member of the American College of Physicians and Fellow of the American College of Cardiology, as well as a member of several other international medical societies. In 1994 he was named member of the Alpha Omega Alpha Honor Medical Society. He joined Merck Sharp & Dohme (MSD) – Peru, subsidiary of Merck & Co., Inc., in 1998 as Clinical Research Manager and was promoted to Associate Director in year 2000. In 2002 he was transferred to MSD - Brazil as Director Clinical Research. In December 2004 he was transferred to MSD - Mexico as Medical Director, performing this role until September 2007, when he was promoted to the position of Regional Operations Director for the Latin America Region, he is currently based in Rahway, New Jersey.
Lakisha Rodwell, Global Trial Optimization Specialist, Global Trial Optimization, Merck & Co., Inc.
Lakisha Rodwell is a Global Trial Optimization Specialist with Merck & Co. Inc. where she conducts protocol feasibility and strategic enrollment planning for clinical trials in novel drugs and vaccines. As a Global Trial Optimization Specialist Lakisha designs strategies to ensure optimal enrollment of Merck's late phase clinical trials with a focus on pediatric trials. She also provides recruitment and retention mitigation strategies to ensure study timelines are met or exceeded. Prior to her work at Merck, Lakisha worked in clinical research operations for GlaxoSmithKline's Early Phase trials and conducted addictions research at the University of Pennsylvania.
Yaffa Rubinstein, Ph.D., Program Director, Patient Resources for Clinical and Translational Research, Office of Rare Diseases Research, NCATS/NIH
Yaffa Rubinstein is a Program Director for patient resources for clinical and translational research at the Office of Rare Diseases Research. Yaffa was trained as a molecular biologist. She received her M.S. from the Weitzman Institute (Genetics Department)/Hebrew University in Israel and received her Ph.D. from the University of Maryland. She completed her postdoctoral studies at the National Cancer Institute, at the Laboratory of Molecular Biology and at the Genetics Branch, Laboratory of Cellular and Molecular Biology Center for Cancer Research. While in the extramural program at NCI, Yaffa served as the program director for the Cooperative Human Tissue Network (CHTN) and founder of the NIH Biospecimens Interest Group. Currently Yaffa is the ORDR director for the Global Rare Diseases Patient Registry and Data Repository (GRDR) and the data base for the biospecimens and biorepositories for rare diseases (RD-HUB). Among her various activities, Yaffa is a board member of the NICHD Down Syndrome Patient Registry andthe NIH WG for Common Data Elements (CDEs). She is member of the trans-NIH Biomedical Informatics Coordinating Committee (BIMC), the European WG for rare diseases, (RD-connect), the NCI biospecimen coordinating committee (BCC) and a co-leader of the ISBER rare disease and the international specimen locator WGs.
Adam Ruskin, M.D., Director, Clinical Affairs, GenturaDx, Inc.
Dr. Ruskin has lead clinical affairs and operations at 4 successful start-ups, lead global trials at CROs and for a government contractor, for pharmaceuticals, medical devices, and diagnostics. With over 19 years experience and 65 trials, including many NDA and 510(k) approvals, he has developed and instructed on successful trial design and management techniques to many industry companies and organizations.
Lesley Schofield, Clinical Research Expert, US Medical, MS Unit, Novartis
Ms. Schofield has approximately 20 years of experience in drug development, part of which was spent in laboratory research and development. In her current position, Ms. Schofield manages cross functional clinical trial teams. She is responsible for clinical trial design and implementation, which includes support of investigators and coordinators in their conduct of their assigned clinical trials. In her role Ms. Schofield is involved in developing relationships between sponsor and CROs/vendors, sponsor and investigator sites, and between clinical and other internal line functions. Ms. Schofield is responsible for trial recruitment, budget and ensuring that trial milestones are met. She has managed large multicenter clinical trials, mega trials and investigator sponsored clinical projects in hypertension, type 2 diabetes, oncology and multiple sclerosis.
Tim Schuckman, Director, Business Development, Copernicus Group IRB
A clinical research veteran with more than a decade of industry experience, Tim Schuckman, Director of Business Development at Copernicus Group IRB (CGIRB), is responsible for cultivating new business and maintaining existing client relationships at the Research Triangle Park, N.C., company. Mr. Schuckman works with CGIRB clients to develop best practices, improve processes and gather input on the development of the award-winning CGIRB Connexus® web portal. His work is one of the many factors contributing to CGIRB's selection as a Triangle Business Journal "Fast 50 Company," an award given to the 50 fastest-growing private firms in the Raleigh-Durham area. Before coming to CGIRB, Mr. Schuckman held positions at Schulman Associates IRB and Global Language Solutions, a leading provider of translation services in the clinical research industry. This experience allowed Mr. Schuckman to develop a vast knowledge of regulatory requirements, form close relationships with CRO and Sponsor representatives and assist in the development of best practices and process improvement techniques. Mr. Schuckman holds a bachelor's degree from Wittenberg University.
Colin Scott, M.D., Senior Director Respiratory Development, Clinical Development, Forest Research Institute, Inc.
Colin Scott, MD is senior pharmaceutical industry executive with over 30-years of experience in international strategic pre-clinical, clinical and regulatory development. He has an established track record in the development and management of pre-clinical, medical and regulatory departments in both big pharma and biotech and has worked as an independent consultant. He is currently tasked with evaluation of early stage development compounds and is championing expanded approaches to patient recruitment for Forest Research Institute.
Lisa Sergas, Senior Manager, Strategic Outsourcing, Global Business Operations, Santen, Inc.
Lisa has over ten years of experience in global Clinical Development Outsourcing and Contracts primarily at small to mid-size biotech organizations. She has extensive experience establishing outsourcing strategy, in addition leading the vendor selection and vendor management activities. She has established Governance and oversight processes and models with key providers including the identification of valuable metrics, KPIs, and risk mitigation planning. She has held previous roles in both CRO and Sponsor organizations which give her valuable perspective from both sides of the industry. Lisa has managed Clinical Outsourcing at Amylin Pharmaceuticals, BioMarin Pharmaceutical, and is currently working to develop the Strategic Outsourcing function at Santen, Inc.
Mollie Shields-Uehling, President and CEO, Staff, SAFE-BioPharma Association
Mollie Shields-Uehling is president and CEO, SAFE-BioPharma Association, the non-profit consortium of biopharmaceutical and related companies that developed and manages the SAFE-BioPharma digital identity and digital signature standard for the biopharmaceutical and healthcare sectors. She has 20+ years experience in international trade and in the biopharmaceutical industry, including leadership positions with Bristol-Myers Squibb, Wyeth, the International AIDS Vaccine Initiative and the White House Office of the U.S. Trade Representative and the U.S. Foreign Commercial Service.
Alison Shurell, Vice President, Product Marketing, IntraLinksAlison Shurell is vice president of Life Sciences Product Marketing at IntraLinks. She is responsible for building on IntraLinks position as the leading software-as-a-service solution for secure information exchange in the Life Sciences industry. In this role, she works closely with industry leaders in pharmaceutical, biopharma and medical device companies, as well as investigative sites, IRBs/ECs and other members of the Life Sciences community to understand market trends, market problems and industry drivers to impact product strategy and direction at IntraLinks. Shurell's background includes 16 years of experience in corporate marketing in the B2B software and financial services markets. She holds an undergraduate degree from Miami University and an MBA from Baldwin Wallace University.
Jean Siebenaler, M.D., Medical Director, Optum
Dr. Siebenaler is a licensed Family Physician with over 20 years of inpatient and outpatient clinical experience in the care of adults and children. In addition to her medical degree, she completed a MPH degree with the University of West Florida and received the title of Certified Physician Investigator (CPI) by the Academy of Pharmaceutical Physicians and Investigators. She has almost 10 years of CRO leadership and experience, and currently provides strategic consultation and therapeutic guidance to the design and conduct of OptumInsight site-based studies in multiple therapeutic conditions.
Honorio Silva, M.D., President, Inter American Foundation for Clinical Research; Vice President, Systems Integration and Professionalism, Alliance for Clinical Research Excellence and Safety
Dr. Silva's professional career has focused on fostering clinical research and medical education with particular emphasis on emerging countries, in addition to serving the pharmaceutical industry, academia and various professional associations. After 30-years of service with Pfizer Inc, Dr. Silva retired as in 2008 Vice President, Science and Medical Professional Development, within the External Medical Affairs group. Dr. Silva began his career as Medical Director, Pfizer - Venezuela, his native country, before transferring to Pfizer's New York headquarters. Dr. Silva also served as Vice President, Medical and Regulatory Affairs, Japan, Asia, Africa & Latin America and Director/Team Leader Medical Operations, Latin America & Canada. Dr. Silva has received several awards for his contributions to clinical research, medical education and pharmaceutical development. He has contributed to the creation and development of a number of International Medical Societies and non-profit organizations, and has established multiple strategic alliances between medical associations, academic institutions and the pharmaceutical industry aimed at advancing and improving health care internationally.
Josephine Sollano, Dr.P.H., Head, Global Health Economics and Outcomes Research and Medical Communications, Pfizer Oncology Global Medical Affairs
Abbe Steel, Vice President, Patient and Physician Services, United BioSource Corporation (UBC)
Ms. Steel has over 22 years of experience working in the pharmaceutical industry in the fields of patient education and compliance, risk management, clinical trial management, and clinical trial patient recruitment and retention. Her responsibilities at UBC include managing a team of medical communication professionals that design and execute physician and patient communication programs to support clinical trials and post-marketing programs.
Stella Stergiopoulos, Project Manager, Tufts Center for the Study of Drug Development, Tufts University
Ms. Stella Stergiopoulos manages multi-sponsored and grant funded research projects at Tufts CSDD. She has experience conducting research on pharmaceutical industry practices and trends affecting pharmaceutical outsourcing practices, cycle time metrics, resource management, and protocol complexity. She has also been a speaker at conferences and has published articles in trade journals. Prior to joining Tufts CSDD, Ms. Stergiopoulos was a research associate at The Brattle Group and a researcher at Massachusetts General Hospital. She holds a B.A. from Brandeis University.
Eugene Storozynsky, M.D., Ph.D., Assistant Professor of Medicine, Program in Heart Failure and Transplantation Division of Cardiology, University of Rochester Medical Center
Dr. Storozynsky is originally from Cleveland, OH where he completed high school at St. Ignatius High School. He attended the University of Rochester, where he majored in Biochemistry and minored in English Literature. During his college years, he studied abroad at University College in Oxford, England studying Biochemistry. In addition, he was involved in immunology research, specifically studying cryoglobulinemia with Dr. George Abraham and the pluri-potential of CD34+ stem cells in the Bone Marrow Transplant Unit with Dr. John DiPersio. He was a varsity swimmer and earned a 'Blues' in Volleyball at Oxford University.
Thomas Sullivan, President, Rockpointe Corporation
Thomas Sullivan is the President and founder of Rockpointe Corporation, a leading medical education company headquartered in Columbia, MD. Rockpointe and its ACCME accredited subsidiary, PCME, are recognized for the scientific content of its programs, compliance with CME guidelines and practices, and creative approaches to instructional design. Tom is a graduate of the University of Florida in Economics and a hard core Gator fan. He has 15 years of experience in medical education and program development working with clients such as the American Heart Association, American College of Cardiology, American College of Chest Physicians, American College of Physicians, The Endocrine Society, American Diabetes Association, National Multiple Sclerosis Society, American Society of Clinical Oncology, as well as most of the major pharmaceutical companies. Tom is a recognized authority in the changing medical education environment and economy. He has parlayed his passion for the political process to inform the medical education community and other stakeholders of emerging trends, threats and changing practices. Recently, Tom launched www.policymed.com a website devoted to news and information about political events which effect CME providers and the pharmaceutical and device industries. Tom's leadership has helped to keep Rockpointe ahead of the curve in the changing regulatory environment.
Mark Summers, CEO and President, ThreeWire, Inc.
With nearly thirty years of experience in the pharmaceutical and medical device industries, Mark is widely recognized as a veteran entrepreneur and thought leader in the area of accelerating clinical trial patient enrollment. As the founder and CEO of ThreeWire, Inc., he has led the company through the development and patenting of its proprietary model for maximizing clinical trial patient enrollment. His clinical trial experience in the industry and at ThreeWire covers a wide range of therapeutic areas and including patient recruitment for more than 100 study protocols that have screened in excess of 250,000 patients in partnership with over 500 sites in 10 countries.Prior to founding ThreeWire, Mark held executive positions at two early stage medical device firms where he drove more than $100 million in global growth following completion of extensive clinical trials. Mark is a graduate of the University of Michigan and is also a United States Navy veteran where he spent 7 years flying F-14s from various aircraft carriers and at Topgun.
Gregory Suplick, Director, Clinical Operations, ViroPharma Incorporated
As a Director of Clinical Operations with ViroPharma Incorporated, Greg utilizes his expansive experience in product development ranging from clinical operations to commercialization. He has served various roles of increasing responsibility during his 18 years in the industry where he started as a clinical research associate for Phase I – III studies. Over the years, this grassroots background has enabled Greg to provide perspective to newly defined roles and positions associate with investigator initiated study programs as well as clinical finance initiatives. His management background includes companies varying in size from large pharma to private equity specialty pharma and encompasses the aspects from study start-up to product approval. Greg earned his Bachelor's of Science degree in Biology has conducted post-graduate work in Health Administration. He has also earned his Certified Clinical Research Contract Professional (CRCP) designation.
Steve Swanson, President & COO, Imperial
Prior to joining the Imperial Family of Companies, Steve Swanson had built a successful track record in mergers and acquisitions, joint ventures and strategic alliances within the United States, European Union, Mexico and Asia. He was group president of three operating divisions at Michigan-based JSJ Corporation, where he oversaw 12 production facilities in regions throughout the globe. Over the course of his career at Imperial, Swanson has developed sustainable business strategies through lean initiatives that have yielded double-digit growth in sales and net income. He is a respected thought leader in the clinical trials field, lending his insight and strategy to numerous publications such as PharmaVoice and Center Watch.
Steven P. Sweeney, Program Director, Arteaus Therapeutics, LLC
Steven is a clinical operations professional with over 15 years of industry experience in several therapeutic areas. The majority of this work has centered on Phase I through IIIb CNS, Oncology and Cardiovascular/Metabolic Disease studies. He has led large, complex multinational studies at the drug program level covering both clinical operations and data management. Since beginning his career in research he has led or participated in a variety of technology initiatives encompassing Electronic Data Capture, Clinical Data Warehousing, Clinical Trial Management, Contact/Relationship Management and Knowledge Management.
Sameer Tandon, Group Head, Outsourcing, Sourcing, Novartis Pharmaceuticals Corporation
Judith Teall, Director, Clinical Excellence, Exco InTouchJudith Teall is Director of Clinical Excellence at Exco InTouch. She has 20yrs of experience in clinical research from major pharmaceuticals, culminating in a Patient Recruitment focus, but originally graduated as an RGN nurse. Judith brings this multi-faceted background into her keen interest in patient-centric clinical research approaches.
Piet Theisohn, Director, Resource Management & Business Support, Global Clinical Development, Bayer Healthcare Pharmaceuticals
Since 2007, Piet built and led a dedicated team in Global Clinical Development (Bayer Pharmaceuticals) supporting the clinical teams in planning and tracking clinical trials timelines, recruitment, and cost. In parallel, he consolidated clinical trial and project planning information together with time recording data used to support the clinical functions with their Resource Management. From 2001-2006 he led a group coordinating Bayer Pharma Development's IT needs with strategy, implementation, maintenance and support with the Corporate IT department. In 1997 he joined Bayer with a Computer Science degree as a project manager for various projects supporting Bayer's R&D departments with innovative solutions.
Martin Tochacek, Ph.D., Patient Recruitment Specialist, PAREXEL
Martin Tochacek, PhD has over 6 years of clinical trial experience and over 14 years translational medicine experience both at CRO and clinical research site levels. Professional highlights include the establishment of a lupus patient registry at Duke University to observe patient outcomes which has since grown to one of the largest of its kind in the Southeast. Currently, Dr. Tochacek is a Patient Recruitment Specialist at PAREXEL, International managing recruitment for several Phase II-IV clinical trials in various therapeutic areas.
Kate Trainor, Vice President, PACE, Global Head PM & Technology, PAREXEL
Kate is currently Vice President, Global Head of Project Leadership and Technology, Peri Approval Clinical Excellence (PACE) at PAREXEL. She is responsible for the Project Manager Operations team worldwide, and for creating vision and leading the operational model for technology innovations in the late phase arena. Areas of focus include developing, delivering and measuring excellence in operations; innovative implementations in eClinical technologies, providing options facing sites, sponsors, and subject users for better decision making.
Kevin Ward, Ph.D., Director, Georgia Center for Cancer Statistics, PI, Georgia SEER Registry; Research Assistant, Professor, Epidemiology, Rollins School of Public Health, Emory University
Paul B. Watkins, M.D., Director, Hamner-UNC Institute for Drug Safety Sciences, University of North Carolina at Chapel Hill
Paul Watkins, M.D., is the Professor of Medicine, Professor of Toxicology, and Professor of Experimental Therapeutics at The University of North Carolina at Chapel Hill (UNC). As an internationally recognized expert in drug safety, Dr. Watkins has extensive research experience in drug-induced liver injury (DILI), which includes basic investigation in drug metabolism and transport, clinical studies, causation assessment, and regulatory affairs. He has been continuously funded for over 20 years by the National Institutes of Health for basic and translational research, and he is one of the most frequently cited authors in the field of pharmacology.
Nicole Weiskopf, Department of Biomedical Informatics, Columbia University
Nicole received her undergraduate degree in psychology from Wesleyan University in 2006. She spent the following year as a research assistant at the Centre for Addiction & Mental Health in Toronto. From 2007 to 2009, she worked at the Nathan Kline Institute in the Program in Cognitive Neuroscience and Schizophrenia. She entered the Ph.D. program in Biomedical Informatics at CUMC in the fall of 2009.
Gwen Welty, Global Clinical Site Developer, Global Clinical Site Development, Alcon Laboratories, Inc.
Gwen Welty, BS, MBA, has 16 years experience in Preclinical and Clinical Research as well as Regulatory Affairs working with both pharmaceuticals and medical devices. Gwen started her career working in Preclinical Sciences in a training and compliance capacity, and then spent the next 6 years in Regulatory Affairs registering drugs and devices globally. For the past 7 years, Gwen has worked in Clinical Research and joined the newly formed Alcon Global Clinical Site Development group in 2010. In that capacity, she identifies, evaluates, selects and develops sites working in Alcon clinical trials.
Chunhua Weng, Ph.D., Florence Irving Assistant Professor of Biomedical Informatics; Co-Director, Biomedical Informatics Core for CTSA, Columbia University
Dr. Weng's research goal is to design enabling technologies for clinician scientists. Her research addresses the socio-technical issues around sharing and reusing fragmented research sources, reusing clinical data for clinical research, facilitating interdisciplinary collaborations, and streamlining research workflows in busy clinical care settings.
June Bright White, Associate Director, Clinical Strategy Supply & Ops, Discovery Medicine & Clinical Pharmacology, Bristol-Myers Squibb
June started her career as a design engineer for the US Government, designing large caliber weapon systems. She moved to Program Management where she was responsible for military on board systems and then to satellite design and management. Currently, she works in Clinical Strategy and Supply Operations as the business relationship manager for all specialty labs.
Seth Whitelaw, Director, Health Sciences Compliance, Deloitte & Touche LLP
Seth Whitelaw is a Director in Deloitte & Touche's Enterprise Risk Services Group focusing on Health Sciences. He has more than 20 years of experience in the Life Sciences and Healthcare industries in the areas of food and drug law, and transparency as well as corporate governance and compliance for medical devices, pharmaceutical sales and marketing, and pharmaceutical R&D. A licensed attorney, most recently Seth served as Compliance Officer for GlaxoSmithKline R&D. Previously he was Legal Compliance Officer, Pharmaceuticals NA for SmithKline Beecham Pharmaceuticals and before that, Senior Attorney and Compliance Coordinator for C. R. Bard, Inc. where he was responsible for implementing and managing Bard's Global Compliance Program in addition to providing advice on various food and drug matters. Seth also was a former Food and Drug Law Institute Fellow (FDLI) and Intern with the FDA's Office of Chief Counsel. A frequent speaker and writer, Seth recently authored, "How Can FDA Improve Its Financial Disclosure Rules for Clinical Investigators in this New Era of Transparency?", for the FDLI Policy Forum in June 2011, and "Practicing Avoidance: Navigating Qui Tam and Consent Decrees," for Pharmaceutical Compliance Monitor in January 2012.
Kelly Willenberg, President, Kelly Willenberg, LLC, Research Compliance Advocates
Kelly Willenberg is President of Kelly Willenberg LLC. As a research compliance consultant, Kelly approaches clients as "advocates working together." Kelly has extensive knowledge in clinical trials management and compliance, including all aspects of billing compliance. She has nearly 30 years of clinical research experience with 15 of that in billing compliance. She is an experienced oncology nurse and has presented at HCCA, ONS, Academy of Health Care Administrators, ASCO, AHLA, MAGI, ExL Pharma and other professional organizations. She assisted in writing the Research Compliance Professional's Handbook for Healthcare Compliance Association (HCCA) and serves as a faculty member for HCCA's Research Compliance Academy. She is certified in Healthcare Research Compliance (CHRC) and Healthcare Compliance (CHC).
Kevin Williams, MBA, MS, Vice President, Corporate Development & Marketing, CFS Clinical (CFS)
In his current position, Mr. Williams is responsible for driving the continued growth of CFS Clinical through marketing and strategic enhancement of the CFS solutions. Mr. Williams joined CFS in 2006 as Director of Contracts and Client Services where he was charged with growing the investigator contract and grant payment services business. Prior to joining CFS, Mr. Williams worked for Merck & Co., Inc., where he held positions of increasing responsibility, providing financial and business support to its Clinical Development Programs Department. Prior to Merck, Mr. Williams was a financial administrator for Mercy Health System.
Heather Wolff, Director, Data Management, Infinity Pharmaceuticals, Inc.
Hank Wu, Director, Translational Informatics, Remedy Informatics
Hank Wu has broad experience in bioinformatics software development, life science database engineering, and developing research 'omics informatics infrastructure. Prior to joining Remedy, Hank served as Director of Operations at the National Cancer Institute's Frederick National Laboratory for Cancer Research, with responsibility for a $100M+ portfolio spanning discovery and clinical informatics, high-throughput biomedical computing, and IT and business information systems development. Earlier in his career, he led the adoption, architecture development, and expansion of open source relational database management systems at the J. Craig Venter Institute. At the Institute for Genomic Research at U.C. Berkeley, Hank published in bioinformatics projects in high-throughput cloning, global gene expression studies, and novel gene finding through comparative genomics. Hank is a computer scientist with degrees in electrical engineering and computer science from U.C. Berkeley.
Fei Xue, M.D., Observational Research Director, Center for Observational Research (CfOR), Amgen, Inc.
Fei Xue is an epidemiologist from the Center of Observational Research (CfOR) in Amgen Inc. She received medical degree in Nanjing Medical University in China and doctoral degree training in reproductive and cancer epidemiology in Harvard School of Public Health. She has published over 20 papers and book chapters based on her research in chronic disease epidemiology and pharmaciepidemiology. Her recent interest is in designing and implementing pharmacovigilance database studies to evaluate long-term drug safety in the post-marketing settings.
Joshua Zhang, M.D., Ph.D., Senior Medical Director, Clinical Research, ARIAD Pharmaceuticals
Joshua Zhang, MD, PhD, is the Senior Medical Director at ARIAD Pharmaceuticals, Inc. in Cambridge, MA. Prior to ARIAD, he was Sr. Medical Director at AVEO Pharmaceuticals and Sr. Director of Medical Affairs Oncology at Sanofi-Aventis. He was the Director and Head of Medical Affairs and Drug Safety at Otsuka Pharma USA and Clinical Project Leader at Merck. Dr. Zhang has over 12 years of experience in new drug development and clinical research with various large international pharmaceutical and biotech companies. His industrial experience spans from clinical research, drug safety and medical affairs to clinical operations and project management. Dr. Zhang completed his medical school and surgical training in China and earned his Ph.D. degree at Temple University School of Medicine in Philadelphia, PA, USA. He is an active member of American Society of Clinical Oncology and author of over 20 publications.
Sean Zhao, M.D., Ph.D., Vice President, Global Safety, Amylin Pharmaceuticals, Inc.
Yogesh Bahl, Partner, Deloitte Financial Advisory Services LLP
Yogesh Bahl is a partner in the Forensic & Dispute Services (F&DS) practice at Deloitte Financial Advisory Services LLP (Deloitte FAS) where he serves as the National Life Sciences Leader and Northeast Antifraud Consulting Leader for the practice. Yogesh has more than 16 years of experience providing forensic investigation, dispute consulting services, and risk advisory services. As a result of his experience in helping companies negotiate contracts and evaluate adherence to contract terms, Yogesh has been engaged to testify during breach of contract and damage actions. In addition, Yogesh has assisted companies in managing issues with respect to fraud allegations, strategic alliances, supply chain revenue leakage, intellectual property licensing, counterfeiting and grey market activity. Yogesh has helped companies mitigate the risk of fraud by providing advisory services involving antifraud programs and controls and risk assessments.