Cambridge Healthtech Institute’s 13th Annual

Enrollment Planning and Patient Recruitment

Predicting and Improving Enrollment through Evidence, New Tech, and Creative Engagement

March 2 - 3, 2021 ALL TIMES EST

We are pleased to announce CHI’s 13th Annual Enrollment Planning and Patient Recruitment conference being held March 2-3, 2021 as part of the 12th Annual Summit for Clinical Trials Operations Executives (SCOPE), a three-day cluster of events that attracted 2,200 leaders in clinical innovation, operations and research in 2020. SCOPE 2021 takes place March 2-4, 2021 as a fully virtual event and we hope to reach more people than ever. During these difficult times of a global pandemic, the work this clinical research community does is more important than ever and requires collaboration and innovation.

Tuesday, March 2

THE ACCELERATION OF DRUG DEVELOPMENT DUE TO THE PANDEMIC

8:00 am LIVE PLENARY PRESENTATION:

Delivering When It Matters, COVID-19 Edition: Pfizer’s Vaccine Trial Execution Strategies and Technology-Enabled Operations

Panel Moderator:
Demetris Zambas, Vice President & Global Head, Data Monitoring & Management, Pfizer Inc.

Pfizer has been collaborating across the healthcare innovation ecosystem to address the COVID-19 global health care crisis. Pfizer’s stage III coronavirus vaccine trial has enrolled more than 44,000 volunteers and will be completed by the time of the conference. This outstanding effort required leadership, focus and dedication of the entire company and critical stakeholders. All of the industry’s and company’s previous work and innovations were pressure tested to meet the challenging scope of the trial. With a critical global need, the only gauge had to be the “speed of science” with all appropriate quality controls. This panel will discuss Pfizer’s vaccine trial execution strategies and technology-boosted operations.

Panelists:
Brett Wilson, Senior Director, Vaccines TA Lead Data Monitoring & Management, Global Biometrics & Data Management, Global Product Development, Pfizer Inc.
Ralph Russo, Senior Director & Global Head, Clinical Database Management, Pfizer Inc.
Nicholas Kitchin, MD, Senior Director, Vaccine Clinical Research and Development, Pfizer
Helen Smith, Senior Director, Clinical Study Team Lead, CD and O, Pfizer
Liping Zhang, Senior Director, Vaccines Statistical Programming and Analysis Lead, Pfizer Inc
Darren Cowan, Executive Director & Area Head USA, Canada, Pfizer
Beth Paulukonis, Executive Director, Study Management Group Lead, Clinical Development and Operations, Pfizer
9:30 am

PLENARY PRESENTATION: Fireside Chat: Accelerated Drug Development in Response to the Pandemic: Lessons Learned and Key Drivers

Panel Moderator:
Deborah Borfitz, Lead Contributor, Publications, Cambridge Healthtech Institute

Companies adopting tech per Covid, perpetual proof of concept and pilot mode needs to stop, is response to Covid temp or a new normal? Lessons learned is important, but look ahead to 4,000+ active studies still happening in other indications/diseases! Covid burn out. The drug dev paradigm is out of date! What were the accelerants? So, lasting lessons from pandemic are not tactics but behaviors. The cat is out of the bag on the need and desire for more remote/virtual trials – especially if you ask a patient!

Panelists:
Ken Getz, MBA, Founder, CISCRP; Deputy Director, Center for the Study of Drug Development, Tufts University School of Medicine
Leonard Sacks, MD, Associate Director, Clinical Methodology, Office of Medical Policy, CDER, FDA

STRATEGIES FOR PATIENT-CENTRIC PRIAL PLANNING AND DIGITAL PATIENT ENGAGEMENT

9:55 am

How Patient Voice Informed a More Immersive Clinical Trial Experience

Kafayat Babajide, MBA, Associate Director, Patient Portals, Janssen Research & Development, LLC

My Trial Community is an insights-driven patient platform that is shaping the clinical trial process by: educating Janssen trial participants on the intricacies of clinical trials, empowering them with a selection of their own personal data and study results, and engaging them as valued stakeholders through more regular feedback loops. Janssen is proud to share the development and launch journey of this patient-centered and insights-based solution.


10:15 am

Improving Study Participant Experience through Consistent and Early Engagement

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

This session will look to explore how early and consistent engagement with potential trial participants will support higher enrollment and retention rates, while also positively impacting screen failures.  It will address how this is accomplished as well as a case study demonstrating early results.

Mwango Kashoki, MD, MPH, Vice President, Technical, Parexel

During this session, compelling insights from discussions with patients on barriers to trial participation will be reviewed. We will also explore feedback as to how research access and the trial experience can be improved and discuss practical methods for addressing these challenges.

10:55 am

Pushing Past Quick Fixes: Lessons Learned from Engaging Diverse Patient Populations in COVID-19 Clinical Trials

Tesheia Johnson, MBA, Deputy Director and COO, Yale Center for Clinical Investigation (YCCI)

COVID-19 racial and ethnic disparities have laid bare the need for clinical trial infrastructures that are responsive to the needs of underrepresented patient populations. Short-term, study-level strategies to increase diversity in clinical trials are inadequate to address complex barriers that limit minority patient populations’ participation in COVID-19 clinical trials. Panelists will discuss lessons learned about the unique role that sponsors and sites can play in mobilizing long-term, multi-stakeholder strategies to increase diversity in COVID-19 clinical trials and beyond.

Erica Prowisor, Global Head, Recruitment and Retention, Global Patient & Site Solutions, IQVIA
Martin Collyer, Global Head, Orchestrated Patient Engagement, IQVIA

Connecting with empowered communities to develop trusted long-lasting relationships, utilize patient targeting to create communities of engaged, educated, and willing patients for increased efficiency in patient and site enrollment for clinical trials. Understand and consider unique, complex and multi-dimensional Patient journey variables; harmonize different systems, processes and databases to highlight the criticality of clinical research for patients and ensure their voice; discuss a “LinkedIn approach" to educate, inform and engage patients with common needs.

11:35 am Tech Break, Transition to Live Q&A
11:45 am LIVE PANEL DISCUSSION:

Integrating Data and Patient Insights into Early Trial Design: Optimize Protocols, Reduce Patient Burden, Deepen Engagement

Panel Moderator:
Michelle Shogren, Senior Director Innovation, Pharma R&D Clinical Operations, Bayer HealthCare
Panelists:
Oriol Serra Ortiz, Head, Site Intelligence & Site Selection, Study Optimization Global Product Development, Pfizer Inc.
Kafayat Babajide, MBA, Associate Director, Patient Portals, Janssen Research & Development, LLC
Daniela Franschman, Global Head, Patient Recruitment & Retention, Bayer
Melanie Goodwin, Director, Patient Recruitment Programs, Clinical Development & Operations, Global Product Development, Pfizer Inc.
Evi Cohen, Vice President, Global Life Sciences and Healthcare, Appian
Allam Fakhoury, PharmD, Head, Portfolio Design and Execution, AbbVie
12:10 pm Session Break - Visit Our Virtual Exhibit Hall
Billy Byrom, VP Product Intelligence & Positioning, Marketing, Signant Health

CLINICAL TRIAL DIVERSITY AND INCLUSION FOR EFFECTIVE AND ETHICAL PATIENT-FOCUSED DRUG DEVELOPMENT

1:00 pm

Advancing Equity in Research and Development

Charlotte Jones-Burton, MD, MS, Vice President Global Clinical Development, Otsuka & Founder and President, WOCIP

Despite known differences in disease prevalence and therapy response across ethnicities and genders, women and minority groups have been historically underrepresented in clinical trials, limiting findings on response from the full breadth of potential patients. How can we ensure that our commitment to addressing unmet need is reflected in complete, diverse patient datasets? The solution begins long before the first patient is enrolled in a trial. This talk will discuss the urgent need for increased diversity within the clinical trials space at every level, from initial study design through final read-out.

1:20 pm

A Biotech's Journey to Build Diversity into Our Trial Design: Relationships, Technology and Leadership

Jocelyn Ashford, Global Patient Advocacy, Cardio-Renal, BridgeBio Pharma

Designing an inclusive clinical trial that is representative of the population being studied might feel daunting, but with planning and thoughtful collaborations, it can be achieved. Hear about various ways to better engage the communities you are looking to serve so that a diverse, representative population has the opportunity to participate in the process of bringing treatments to market to address unmet need.

Ivor Clarke, CEO, SubjectWell

Join us as we dive into the data from multiple recent direct-to-patient surveys to reveal how opinions from diverse population segments impact study recruitment. In this session we’ll discuss the varied concerns around participation as well as what we can do to address them.

2:00 pm LIVE PANEL DISCUSSION:

Utilizing Patient Expertise in Trial Design: Lessons Learned from Patients and Advocacy Orgs in Research, Engagement and Retention

Panel Moderator:
Nan Doyle, Associate Director & Lead Rare Genetics & Hematology, R&D Patient Engagement Office, Takeda Pharmaceuticals Inc.

This panel will discuss how industry and advocacy can better collaborate to further research. Lessons can be learned in patient engagement, role of patients, advocates and disease community leaders in trial design, and approaches to improve trial outcomes for all involved with up-front planning. Panelists will discuss: How to create a win-win in industry-advocacy collaborations; Utilizing patient expertise in trial design; Examine engagement  models including novel and creative approaches; Working with advocacy organization to better recruit diverse populations for studies; How do pharma companies justify working with advocacy orgs and vice versa? What is the evidence to support the value proposition?

Panelists:
Hollie Schmidt, Vice President, Scientific Operations, Accelerated Cure Project for MS
Phyllis Kaplan, Trial Volunteer and Patient Advocate; Senior Manager, Events & Community Engagement, Center for Information & Study on Clinical Research Participation (CISCRP)
Paul Kamudoni, PhD, Scientific Director, Patient-Centered Research, Global Evidence and Value Development, EMD Serono
Clare Grace, Chief Patient Officer, Parexel
Ivor Clarke, CEO, SubjectWell
Tricia Barrett, Senior Vice President, Managing Director, Praxis Communications, LLC
Diane Montross, Sr. Director, Patient Recruitment and Retention, Moderna

Join us as we take a look at what it took to launch the recruitment and retention campaign for Moderna’s COVE Study – a phase 3 COVID-19 vaccine trial.

2:40 pm Tech Break, Transition to Live Q&A
2:50 pm LIVE PANEL DISCUSSION:

Clinical Trial Diversity for Patient-Focused Drug Development 

Panel Moderator:
Emily Freeman, PhD, Senior Director, Patient Insights, Global R&D, Lundbeck

A lack of diversity in clinical trial populations is a moral and a scientific issue. The main purpose of this panel discussion will be to: 1) Identify underrepresented groups in clinical development (i.e. discussion of draft FDA guidance, who counts as an underrepresented group); 2) Discuss strategies of how to overcome challenges internally at a sponsor company, and; 3) How to execute a successful engagement strategy for drug development.

Panelists:
Jocelyn Ashford, Global Patient Advocacy, Cardio-Renal, BridgeBio Pharma
Charlotte Jones-Burton, MD, MS, Vice President Global Clinical Development, Otsuka & Founder and President, WOCIP
Jameka Hill, Director, Patient Engagement & Advocacy, Moderna
Ramona Burress, Assoc Dir, Diversity & Inclusion in Clinical Trials, Janssen R&D LLC
Jackie Kent, Chief Customer Officer, Medidata, a Dassault Systèmes company
Melissa Herman, Specialist, Global Patient Insights, Lundbeck A/S
Sandra Amaro, Director, Diversity in Clinical Trials Operations, Pfizer

CREATIVITY AND ENGAGEMENT IN RECRUITMENT AND RETENTION COMMUNICATIONS: SCOPE’S PARTICIPANT ENGAGEMENT AWARDS

3:15 pm LIVE:

SCOPE’s 2021 Participant Engagement Awards

Panel Moderator:
David Sall, President & CEO, Marketing, Patient Enrollment Advisors LLC

Designed to inspire innovation and change in how the industry communicates with participants in the fields of recruitment and retention in clinical trials, this award embodies the values and personal accomplishments of Jerry Matczak, who sadly passed away soon after receiving the 2017 award. We dedicate this award to Jerry in the hope that it will serve as a reminder of his ideals and accomplishments.

SCOPE’s 2021 Participant Engagement Award program is brought to you by Cambridge Healthtech Institute (CHI)’s SCOPE.

Panelists:
Kelly McKee, Senior Director, Patient Recruitment and Registries, Medidata Solutions
Ramona Burress, Assoc Dir, Diversity & Inclusion in Clinical Trials, Janssen R&D LLC
Irfan Khan, CEO, Circuit Clinical
Phyllis Kaplan, Trial Volunteer and Patient Advocate; Senior Manager, Events & Community Engagement, Center for Information & Study on Clinical Research Participation (CISCRP)
4:05 pm Interactive Breakout Discussions - Visit Our Virtual Exhibit Hall

Join your colleagues and fellow delegates for a focused, informal discussion moderated by a member of our speaking faculty. A small group format allows participants to meet potential collaborators, share examples from their own work and discuss ideas with peers. View all topics here.

BREAKOUT: Strategies for Patient-Centric Trial Design and Digital Patient Engagement

Oriol Serra Ortiz, Head, Site Intelligence & Site Selection, Study Optimization Global Product Development, Pfizer Inc.
Jeffrey Siracuse, MD, MBA, Associate Professor, Surgery, Boston University
Jane Hart, Senior Director, Clinical Affairs, Exact Sciences
Kafayat Babajide, MBA, Associate Director, Patient Portals, Janssen Research & Development, LLC
Khaled Mowad, JD, Associate, Moses & Singer LLP
Laura Whitmore, Head, Clinical Operations, Cerevel Therapeutics LLC
Aman Thukral, Director & Head, Clinical Systems & Digital Operations, AbbVie, Inc.
Michele Teufel, Patient & Site Engagement Lead, Development Operations, AstraZeneca Pharmaceuticals Inc.
Michael Mclaughlin, Associate Director, Clinical Operations, Dermavant Sciences Inc.
Robert Loll, Senior Vice President, Business Development & Strategic Planning, Praxis Communications, LLC
Alicia Staley, Senior Director, Patient Engagement, Medidata, a Dassault Systèmes Company
Meliss Nezos, Vice President, Clinical Operations, Firma
Nazneen Qureshi, Director of Patient Recruitment, Accellacare
Christina Fawcett, Senior Director, Decentralized Clinical Trials Operations, PRA Health Sciences
Melissa Harris, AD Patient Relations, Patient Engagement, Covance by Labcorp
James Streeter, Global Vice President, Life Sciences Product Strategy, Oracle Health Sciences
Amy Franzen, General Manager & Vice President, Clinical Trials Solutions, Tempus

Overview of the Clinical Trial Solutions at Tempus which support precision patient identification and recruitment for oncology clinical trials through the TIME Trial program, a rapid activation Just-in-Time network of research-experienced clinical trial sites

Bernadette Tosti, Vice President, Patient Experience, Science 37
Lindsay Singler, Director, Research Communications & Engagement, Operations Management Team, Duke Clinical Research Institute

Current events have driven pediatric clinical research to be more flexible and efficient—to increase patient access and enhance the patient experience both during the COVID-19 pandemic and beyond. With increased regulatory support for direct-to-family (decentralized) trials, learn how to leverage technology to safely and efficiently conduct research using a current, real-life example of trial design.

Rutendo Kashambwa, MS, Senior Clinical Analyst, Clinical Sciences, TriNetX

Watch a live demonstration of protocol design utilizing real-world data on the TriNetX platform for a phase III cardiovascular randomized controlled trial, and a subsequent label expansion.

4:40 pm Close of Day

Wednesday, March 3

MODELLING AND QUANTITATIVE DECISION-MAKING TO BETTER PREDICT AND PLAN ENROLLMENT

9:00 am

Quantitative Decision-Making for Enrollment Prediction

Jamie Lorimer, Director Delivery Optimization & Informatics, Global Clinical Sciences & Operations, GlaxoSmithKline

Clinical trial planning is one of the most complex and difficult aspects of the clinical trial process, with multiple factors impacting enrollment. Inaccurate forecasting can lead to misallocation of resources and downstream bottlenecks. How can we use the data we have to do a better job of predicting enrollment?

Klaira Simon, Managing Director, Clinical Trial Experience, Langland | A Publicis Health Company

Study enrollment planning shouldn’t be based on clinical data alone. How can we utilize the wealth of lifestyle and behavioral data available to better understand the factors that will influence an individual’s decision to participate in a clinical trial? Let’s explore the data healthcare marketers commonly analyze to develop audience models in the context of clinical trial enrollment planning.

The video for this session isn’t available here; to access a recording of this session, please email Sarah McKeown-Cannon at sarah.mckeowncannon@publicislangland.com.

9:40 am

Building an Enrollment Modeling Tool that Not Only Predicts Trial Enrollment, but Offers 95% Confidence Intervals

Kim Crimin, Head Advanced Analytics, AbbVie Inc.

This case study will share the strategy behind the building of an enrollment modelling tool, detailing each step throughout the process.  Gain lessons from AbbVie’s experience building and implementing the tool, steps taken to improve its predictive power and accuracy, and results to date.

Molly Hair, Director, Site Engagement and Management, WCG
10:20 am Tech Break, Transition to Live Q&A
Panel Moderator:
James Riddle, Vice President, Research Services & Strategic Consulting, Advarra
Panelists:
Beth Mahon, Global Feasibility Therapeutic Area (TA) Head, Feasibility Center of Excellence (FCoE), Clinical Insights and Experience, Oncology, Janssen Research & Development, LLC
Jamie Lorimer, Director Delivery Optimization & Informatics, Global Clinical Sciences & Operations, GlaxoSmithKline
Jason Gubb, Head Delivery Optimization & Informatics, Global Clinical Operations, GlaxoSmithKline
Kim Crimin, Head Advanced Analytics, AbbVie Inc.

ENHANCING PATIENT-SITE CENTRICITY AND CLINICAL INNOVATION THROUGH TECHNOLOGY

10:55 am KEYNOTE PRESENTATION:

COVID-19: How an External Event Redoubled Janssen’s Culture of Innovation

Darren Weston, Vice President, Integrated Data Analytics & Reporting (IDAR), Janssen

The external threat posed by the pandemic forced Janssen to reckon with longstanding cultural barriers to innovation. Faced with an urgent need to ensure patient safety and continuity of care, Janssen found a way to overcome these barriers and evolve the way they conduct clinical trials. Not only did Janssen minimize overall trial impact, but Janssen’s clinical operations have become more efficient and resilient in the face of future challenges. We will discuss the cultural and operational adaptations Janssen undertook to adapt to the pandemic environment and how we see these actions positioning us for the future.

11:20 am KEYNOTE PRESENTATION: KEYNOTE PRESENTATION: Virtual Investigator Meetings During COVID-19 & Beyond
Steven Sulkin, Founder & CEO, SimuLyve International, Inc.®

Steven Sulkin, CEO, SimuLyve International

Marina Ziehn, PhD, Global Med. Affairs Dir. Neuroscience, Novartis

Markus Krüer, PhD, Head Clinical Project Mgt, Merz

Nico Wegener, PhD, Senior Clinical Project Mgr, Merz

Dave Matthews, Clinical Project Dir., Merz

 

Training worldwide staff on complicated protocols virtually with the added issue of language barriers can seem daunting. Our panel of virtual experts will show you how to perfect virtual skills and enhance virtual meetings.

 

11:20 am KEYNOTE PRESENTATION:

Option 2: New Players and Innovators in Clinical Trials, the Impact of Non-Pharma Entrants...Meet Salesforce and CVS Health

Shwen Gwee, Vice President & Head, Global Digital Strategy, Bristol-Myers Squibb Co.
Gary Gabriel, PhD, Healthcare and Life Sciences Lead, Salesforce
Lou Sanquini, Vice President, Life Sciences Group, CVS Health
11:45 am Tech Break, Transition to Interactive Breakout Discussions
12:00 pm Interactive Breakout Discussions - Visit Our Virtual Exhibit Hall

Join your colleagues and fellow delegates for a focused, informal discussion moderated by a member of our speaking faculty. A small group format allows participants to meet potential collaborators, share examples from their own work and discuss ideas with peers. View all topics here.


BREAKOUT: Decentralized and Hybrid Trials: COVID-19 as an Accelerator

Jane Jacob, PhD, Vice President, Research & Clinical Affairs, Synergy Disc Replacement, Inc.
Laurie Halloran, President & CEO, Halloran Consulting Group Inc.
Matthew Moyer, Director Clinical Supply Technology, Global Clinical Supply, Merck & Co. Inc.
Vani Nilakantan, PhD, Vice President, Research, Allina Health System
Laura Whitmore, Head, Clinical Operations, Cerevel Therapeutics LLC
Nikala Kwech, eCOA Operations Lead, Data Sciences, AbbVie Inc.
Hassan Kadhim, Director & Head, Clinical Trial Business Capabilities, Bristol-Myers Squibb Co.
Angie Botto-Van Bemden, PhD, Patient Advocate, Musculoskeletal Research International
David Fauvart, Associate Director, Janssen Clinical Innovation, Johnson & Johnson Pharmaceutical R&D
Michele Teufel, Patient & Site Engagement Lead, Development Operations, AstraZeneca Pharmaceuticals Inc.
Michael Mclaughlin, Associate Director, Clinical Operations, Dermavant Sciences Inc.
Anthony Costello, President, Patient Cloud, Medidata, a Dassault Systèmes Company
Robert Loll, Senior Vice President, Business Development & Strategic Planning, Praxis Communications, LLC
Isaac Rodriguez-Chavez, Senior Vice President for Scientific and Clinical Affairs, Digital Health, PRA Health Sciences
Chris Varner, Associate Director, Virtual Trial Solutions, IQVIA
12:30 pm Session Break - Visit Our Virtual Exhibit Hall
Leon Sun, Chief Science Officer, RA,PV,MD, Beijing Highthink Technology Co., Ltd

Founded in 2006, Highthinkmed is the fastest growing clinical CRO in China with over 800 full time employees, providing one-stop clinical services including clinical operation, medical affairs, data management, biostatistics, pharmacovigilance, regulatory affairs etc. Highthinkmed owes its own eCTD system meeting requirements of FDA, EMA and NMPA with a professional team providing eCTD submission services. Highthinkmed welcomes all partners across the world for international collaboration.

Geoff Gill, President, Shimmer Americas, Shimmer Research

Different endpoints derived from wearables can require very different wearable sensors.  Unfortunately, qualifying and integrating different wearables often from different vendors can be time-consuming and uncertain.  Learn how Shimmer Research is addressing this challenge by introducing a series of wearables that are all part of its highly flexible Verisense platform.

Tim Corbett-Clark, BA, MA, DPhil (oxon), Chief Technology Officer, Cmed Technology

Cmed Technology CTO, Dr. Tim Corbett-Clark shares his views on the current landscape within clinical trials, discussing the challenges that point and unified solutions bring. He also examines how to best optimize clinical trial data workflows by bringing the tech to data, removing the silos, and eliminating the barriers to getting holistic data for total control and visibility from phase one to four.

1:15 pm Close of Enrollment Planning and Patient Recruitment Conference





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