Cambridge Healthtech Institute's
Engagement & Enrollment
( 관여와 등록 )
2020년 4월 7-8일
Recruitment, retention and continued engagement of clinical trial participants is essential to successfully completing a clinical trial on time. With the rise of social media platforms and digital technology, the pharma industry stands to leverage these to improve patient experience, engagement, and adherence. Learn more at this lively conference program at CHI's 9th Annual Clinical Trial Innovation Summit.
첫째날 | 둘째날
2:30-5:30 pm Pre-Conference Workshops
Workshop 1: Identifying High-Value Patient Engagement Opportunities: A Collaborative Approach
Workshop 2: Data-Driven Clinical Development: Tutorial and Case Studies
Workshop 3: Inspection Readiness in Changing Global Regulatory Environment
*Workshops are included in your registration. However, please RSVP to reserve your seat.
8:15 am Registration and Morning Coffee
임상 개발을 변화시키는 RWDREAL WORLD DATA, 인공지능, 분석법
9:00 Organizer’s Opening Remarks
Micah Lieberman, Executive Director, Conferences, Cambridge Healthtech Institute (CHI)
9:05 Chairperson’s Remarks (Sponsorship Opportunity Available)
9:10 Digitalization of Clinical Trials: Breakthroughs in Technologies and Data
Peter Bergethon, MD, Vice President, Head of Digital and Quantitative Medicine, Biogen
Medicine as systems science characterizes the health state by measurable properties. Changes in state over time (dynamics) define trajectories through growth, health and disease. Dynamic transitions define trajectories between health, illness and therapeutic interventions. Capturing time dependence is the power of digital technology. Herein lies the power of digital medicine. We will review specific cases showing how this paradigm is transforming our clinical trial landscape.
9:30 CO-PRESENTATION: The Role of Real-World Data in Creating New Pathways to Biopharma Industry Transformation
Alan Louie, PhD, Research Director, Life Sciences, IDC Health Insights
Charles Makin, Global Head, Real World Evidence Strategy, Biogen
In parallel to other industry best practices, the biopharmaceutical industry is embracing digital transformation as it seeks to better leverage data across the life science ecosystem. In conjunction with these efforts, increasingly available real-world data (RWD) promises to bring new patient-specific data and insights to the industry, data which bring researchers closer to understanding patient-level treatment responses while also opening new channels to engagement. With strong support from regulators, real-world evidence offers significant potential to accelerate new drug discovery and development, improve process efficiencies, and improve patient outcomes over the near term.
9:50 AI in Human Health – Connecting Data Modules from Discovery Biology to Clinical Development
Rangaprasad Sarangarajan, PhD, CSO & Senior Vice President, Clinical and Translational Sciences, Research & Development, BERG
Drug development programs in companies are predicated on biological insights supporting a hypothesis of target and its role in disease etiology. This presentation will focus on the data modules essential for linking discovery biology to early/late stage clinical development and the leveraging of AI in the integration of the various dataflow to make data-driven informed decisions and ensure success. It will outline how to utilize data, AI analytics with RWD-based support for planning drug development to propel products all the way through the clinic.
10:10 Grand Opening Coffee Break in the Exhibit Hall (Sponsorship Opportunity Available)
환자로부터의 파악과 환자 중심 주의의 실현에 의한 피험자 관여와 모집의 개선
11:10 Chairperson’s Remarks
Jonathan Andrus, Chief Business Officer, Clinical Ink
11:20 A One-on-One Conversation: What We Can Learn from a Candid Conversation with a Clinical Trial Participant
Bonnie Brescia, Founding Principal, BBK Worldwide
Richard Brescia, Cancer Survivor and Three-Time Clinical Trial Participant
This presentation will get to the heart of the clinical trial patient experience with a one-on-one conversation between an industry expert and a family member who has participated in multiple clinical trials. It will offer first-hand insight into the clinical trial experience, including the decision to enroll, the impact on family members and loved ones, and whether the experience matched expectations. Attendees will gain: 1) Greater understanding of the patient experience and how to leverage insights for enrollment and engagement success, 2) Insight into specific engagement challenges (e.g., travel and reimbursement, burdensome appointment schedules, caregiver responsibilities) and strategies for overcoming them, and 3) Insight into the patient narrative to ensure studies are patient-centric.
11:45 Benchmarking Patient Recruitment and Retention Practices
Mary Jo Lamberti, PhD, Associate Director and Research Assistant Professor, Tufts Center for the Study of Drug Development (CSDD)
Tufts CSDD gathered recent data on nearly 90 global clinical trials from a working group of pharmaceutical companies and CROs to benchmark metrics on patient enrollment and quantify the use of patient recruitment and retention tactics. Results will show the most common patient recruitment and retention tactics used across studies as well as highlight any trends and innovation in recruitment and retention practices. Metrics on patient enrollment rates and timelines by global region and therapeutic area as well as drop out and completion rates will be shared. Comparisons will be made to a previous Tufts study benchmarking patient recruitment practices.
12:10 pm PANEL DISCUSSION: A Comprehensive Approach to Patient Centricity: Case Study and Data Review of a Joint Pharma, Advocacy, and Partner Effort
Michael Keens, COO, Firma Clinical
Rodrigo Garcia, MD, Head, Clinical Innovation, EMD Serono
Hollie Schmidt, Vice President, Scientific Operations, Accelerated Cure Project for MS
This panel will discuss an innovative partnership between sponsor, advocacy, and partner companies who collectively aligned in the development of a partnership collaboration supporting community events, protocol feedback, and inclusion of a unique and comprehensive training manual for home care nurses integrating the patients’ perspective and experiences to enhance the clinicians’ understanding of the “lived experience” by someone who endures the pains and challenges that come with a rare disease diagnosis. In addition to a unique approach to actualizing patient centricity, the presentation includes perspectives from the Pharma Sponsor, patients, an advocacy organization, and partner company supporting patients. We will share a comprehensive review of a real-world approach to patient centricity in clinical trials, along with an evaluation of the method, measurements, and details of this effort. Audience members will also have an opportunity to discuss areas of improvement so they can apply this approach to their own clinical trials (regardless of role).
12:35 Transition to Luncheon Presentation
12:40 Luncheon Presentation (Sponsorship Opportunity Available) or Enjoy Lunch on Your Own
1:25 Coffee & Dessert Break in the Exhibit Hall (Sponsorship Opportunity Available)
다양한 환자 집단의 모집, 피험자 등록의 예측, 처방 준수(ADHERENCE)의 달성
2:00 Chairperson’s Remarks
Gayle McCracken, Vice President, Market Innovation, Spencer Health Solutions, Inc.
2:10 CO-PRESENTATION: Designing and Implementing Practical Approaches to Support More Diverse Recruitment
Helen Kellar-Wood, PhD, Associate Director, Oncology and Immunoscience Lead, Diversity & Patient Engagement, Bristol-Myers Squibb
Mary Murray, Associate Director, Oncology Lead, Diversity & Patient Engagement, Bristol-Myers Squibb
The need to ensure diverse participation in clinical studies has been well documented on the FDA’s Snapshots website and in many recent publications, and yet this issue has not been successfully addressed by sponsors. As we see diseases associated with western life styles become more frequent on a global scale, increasingly diverse patient populations in the US, and health authorities introducing new guidance on the significance of inclusivity in clinical trial recruitment considerations, the need to act becomes more acute. At the same time, payers are requiring evidence-based reimbursement models. Examining the impact of these changes at the clinical study level we will address how sponsors can design and implement practical approaches to support more diverse recruitment in our research studies. We will share examples of engagement and recruitment approaches leveraged in a disease area disproportionately impacting diverse patients. We will discuss the importance of community interactions, and ways to engage the health care practitioner communities involved in clinical research.
2:35 CASE STUDY: Why Patient Engagement Is Key to Achieving 95% Medication Adherence
Gayle McCracken, Vice President, Market Innovation, Spencer Health Solutions, Inc.
What is the impact of adherence on recruitment, retention, cost for successful trial? As we consider the intersection of healthcare and research, especially in hybrid and virtual models, what is the impact of habit-forming in-home technology for clinical trials? Digital technology solves key problems for pharma as well as for the patients. It reduces patient burden (travel, time, stress), increases patient access, and by gathering data in the patient’s natural environment there’s greater evidence for payers to support formulary inclusion for approved drugs. This case study features 95% medication adherence and 81% engagement of chronically-ill patients applied as clinical trial simulation findings.
2:50 PANEL DISCUSSION: Impact of Technology on Rare Disease Research, Engagement and Retention (Lessons Learned BEYOND Rare Disease)
Joan Chambers, Senior Director, Marketing & Outreach, CISCRP
Karen Anderson, Senior Director, Medical Affairs, Rare Genetic Disease, Agios Pharma
Nan Doyle, R&D Patient Engagement Lead, Rare Disease, Takeda
Patricia Weltin, CEO/Founder, Beyond the Diagnosis
Pharma is transforming its business model with biomarker and genetic data as it is playing a more significant role on drugs being approved and drugs in active R&D. The level of biomarker and genetic data collected adds more focus to Rare Diseases and Personalized Medicine; 58% of total approvals are for Rare Disease. Companies are focusing on internal infrastructures and engaging in more partnerships and collaborations to expand the pipelines. There are more than 7,000 identified rare diseases, affecting a relatively small population. Companies are looking at new technologies and platforms to target, engage and retain Rare Disease patients and communities. The panel session will discuss the increased growth, innovations supporting this growth and the challenges.
3:25 Transition to Keynote
임상시험이 성공하는 이유와 실패하는 이유 - 업계와 학계의 견해
3:35 Organizer’s Opening Remarks
Marina Filshtinsky, MD, Executive Director, Conferences, Cambridge Healthtech Institute
3:40 Chairperson’s Remarks (Sponsorship Opportunity Available)
3:45 BEST CLI Trial: Lessons Learned From Execution Of A Complex Multicenter RCT
Alik Farber, MD, Chief, Division of Vascular and Endovascular Surgery, Associate Chair for Clinical Operations, Department of Surgery, Boston Medical Center; Professor of Surgery and Radiology, Boston University School of Medicine
The BEST-CLI trial is the largest RCT ever undertaken to evaluate strategies for treatment of critical limb ischemia (CLI). This study is an international, multispecialty, prospective, multicenter, randomized comparative effectiveness trial of endovascular versus open surgical revascularization in patients with CLI who are candidates for both procedures. The study has been performed at 134 sites and has enrolled 1843 patients. Its execution had had multiple obstacles and challenges that the trial leadership team has successfully navigated.
4:15 CO-PRESENTATION: What Causes Studies to Fail? Understanding Causal Drivers of Operational Success Using Machine Learning
Marcy Kravet, BS, MBA, Head, Operational Design Center (ODC), Global Clinical Operations, EMD Serono, Inc., an affiliate of Merck KGaA, Darmstadt, Germany
Sylvia Marecki, PhD, Design Analyst, Operational Design Center (ODC), Global Clinical Operations, EMD Serono, Inc., an affiliate of Merck KGaA, Darmstadt, Germany
It is currently unknown what drives successful study enrollment despite extensive analysis conducted across the industry, which largely has focused on correlations. The Operational Design Center at EMD Serono has leveraged causal machine learning to analyze hundreds of variables across thousands of clinical trials with the objective of identifying causal drivers of enrollment success, which can be optimized to conduct faster, less expensive trials. Early insights will be shared.
4:45 Welcome Reception in the Exhibit Hall (Sponsorship Opportunity Available)
5:45 End of Day
첫째날 | 둘째날
7:45 am Breakfast Presentation (Sponsorship Opportunity Available) or Morning Coffee
PARTNERING WITH PATIENTS AND ADVOCACY ORGANIZATIONS TO IMPROVE TRIAL DESIGN AND ADVANCE YOUR STUDY
8:25 Chairperson’s Remarks (Sponsorship Opportunity Available)
8:35 CO-PRESENTATION: Utilizing Patient Expertise in Trial Design
Christina Roman, MPH, Senior Manager, Community Engagement, Community Partnerships, Cystic Fibrosis Foundation
Emma D’Agostino, CF Patient, Member of FDA Review Committee
This session will cover how the cystic fibrosis community is helping to shape clinical trial designs and inform researchers on what outcome measures are most important to researchers and the CF Foundation is facilitating meaningful partnerships between researchers and patients. It will showcase two studies with different models for patient engagement. One where broad input from the patient community was utilized in selecting PROs and another model where a small group of patients served as study advisory. The audience will be able to see how different patient engagement strategies can work for different kinds of studies. They will also get ideas for how they may be able to partner with patient organizations to improve engagement strategies and improve enrollment.
8:55 CASE STUDY CO-PRESENTATION: Learning Engagement from a National Advocacy Org and Patient Community: Communicating and Listening to Participants
Len Rosenberg, PhD, RPh, Head, Clinical Operations, Beat AML, a division within the Leukemia and Lymphoma Society
Leah Szumita, MSN, Associate Director, Nursing, Clinical Trial Support Center, Beat AML, a division within the Leukemia and Lymphoma Society
This presentation will share our experience and learnings as a national organize with ties to researchers, caregivers, patients and industry. Attendees will learn how to: 1) Assist patients through cancer treatment, financial and social challenges, and give accurate, up-to-date disease and support information through experienced oncology social workers, nurses and health educators; 2) Create an online presence where patients can connect with others who are going through the same challenge; and 3) Assist family support groups where patients and their families can go and share information, education and feelings in a comfortable and caring environment.
9:15 PANEL DISCUSSION: Understanding the Role of Community Oncology in Clinical Trials & Patient Engagement
Moderator: Rose Gerber, Director, Patient Advocacy and Education, Community Oncology Alliance (COA); 3x Clinical Trial Participant
Panelist: Katie Goodman, RN, Director, Clinical Research, Florida Cancer Specialists & Research Institute
Participation in clinical trials provides great value to patients, clinicians and researchers. With community oncologists treating the majority of cancer patients in the US, their role is critical in clinical trial recruitment and enrollment. Hear from clinicians and clinical trial participants about the importance of bringing trials to where the patient is being treated. Topics to be discussed: 1) Understanding the value of clinical trials offered in the community (independent physician owned) cancer setting, 2) Learn how to engage clinical trial participants to act as ambassadors in increasing enrollment in clinical trials, and 3) Gain insight from community oncology patients and clinicians about the clinical trial experience in a community setting vs. the academic settings.
ACCESSING MULTIPLE PATIENT DATA SOURCES TO ENHANCE GENERATION OF REAL-WORLD EVIDENCE, OUTCOME RESEARCH AND NON-RESEARCH EVALUATIONS
9:40 PANEL DISCUSSION: Accessing Multiple Patient Data Sources to Enhance Generation of Real-World Evidence, Outcome Research and Non-Research Evaluations
Ian Rentsch, CEO, Clinerion Ltd.
Keyla Deucher, Head, Clinical Trial Unit, Hospital Sao Vicente
Speaker to be Announced, Roche
Ben Illigens, MD, PhD, CEO, UniMedIT Germany; Professor, Harvard Medical School
Speaker to be Announced, AstraZeneca
Real-World Evidence (RWE) research has been positively impacted by the diversity of possibilities and rapid technology advances, but also negatively impacted by the short lifetime of some developments and, in some cases, a lack of scientific rigor. A systematic evaluation of alternatives, combined with thorough strategic planning and a flexible implementation plan, is the key to success. The goals are the achievement of better-quality evaluations, representative data, and external validity, while balancing costs and resource utilization. The lessons learned with the implementation of new tech design technology, addressing scientific requirements, creating operational solutions and developing thorough strategic planning will be discussed, and complemented with our vision of the evolution of digital health, its benefits and risks.
9:50 Coffee Break in the Exhibit Hall (Sponsorship Opportunity Available)
USE OF REAL-WORLD DATA (RWD) TO ENHANCE RECRUITMENT & EXPEDITING THE IMPLEMENTATION OF E-SOURCE
10:40 Chairperson’s Remarks (Sponsorship Opportunity Available)
10:50 CO-PRESENTATION: CTTI Recommendations: Use of Real-World Data to Plan Eligibility Criteria and Enhance Recruitment
Jane Perlmutter, PhD, MBA, Independent Patient Advocate, Advisor, Patient-Centered Outcomes Research Institute (PCORI)
Cathy Critchlow, PhD, Vice President, Center for Observational Research, Amgen
The growing availability of real-world data (RWD) creates opportunities to potentially improve the feasibility, efficiency, and generalizability of clinical trials. Increasingly, sponsors are turning to electronic health record, claims, and other RWD sources to help achieve these goals. Until now, there have been few resources available to help sponsors and others optimally integrate the use of RWD into their trial design. This presentation will provide actionable tools, case studies, and multi-stakeholder recommendations developed by the Clinical Trials Transformation Initiative (CTTI).
11:15 CO-PRESENTATION: The Future Is Now: EMA Qualification Favors Clinical Trial eSource Solutions Over Outdated Processes
Jonathan Andrus, Chief Business Officer, Clinical Ink
Angela Lee, Associate Director, Data Management, Otsuka
In late September, the EMA released an important qualification opinion signaling its support of the use of eSource direct data capture (DDC) in clinical trials. Although the FDA had previously expressed support for clinical eSource solutions, the EMA had been cautious. The EMA’s opinion identifies many areas where eSource DDC captures source data more efficiently than traditional electronic data capture. However, despite growing evidence to support the use of eSource solutions for clinical trials, industry acceptance has been slow — mostly due to outdated process models. Join this presentation to learn about the implications behind the EMA’s qualification opinion. We’ll share an Otsuka case study that articulates the benefits of using eSource solutions and discuss how the industry can expedite the implementation of eSource.
11:40 Transition to Breakout Discussions
11:45 Find Your Table and Meet Your Moderator
11:50 Interactive Breakout Discussion Groups
Concurrent breakout discussion groups are interactive, guided discussions hosted by a facilitator or set of co-facilitators to discuss some of the key issues presented earlier in the day’s sessions. Delegates will join a table of interest and become an active part of the discussion at hand. Bring your pharma, biotech, CRO, site, hospital or patient perspective to each of the discussions below. To get the most out of this interactive session and format, please come prepared to share examples from your work, vet some ideas with your peers, be a part of group interrogation and problem solving, and, most importantly, participate in active idea sharing.
12:30 pm Community Networking Lunch in the Exhibit Hall (Sponsorship Opportunity Available)
1:40 Transition to Plenary Keynote
환자 여정PATIENT JOURNEY의 이해를 통한 임상시험의 개선
1:45 Organizer’s Opening Remarks
Kaitlin Searfoss Kelleher, Senior Conference Director, Cambridge Healthtech Institute
1:50 Chairperson’s Remarks (Sponsorship Opportunity Available)
1:55 The Journey from Patient to Advocate to Leader: Changing the Clinical Research Game
Rob Long, Executive Director, Uplifting Athletes
I will talk about my journey from Division I football and top NFL prospect to cancer patient. My experience of undergoing chemo and radiation and fighting through a battle with brain cancer has enabled me to leverage my story to make a difference in the lives of those affected by rare diseases. The attendees will gain insights into what it means to be a volunteer at the front lines of oncology research and clinical trials. New approaches to partnering with advocates, disease communities and young researchers will be shared. In addition, we will discuss the future of rare disease research and outreach and illustrate where industry and the patient community can go together in collaboration. Read an article published about Rob Long's journey, Ex-Syracuse punter Rob Long takes on cancer, survival and what comes next
NOTE: Uplifting Athletes and Cambridge Healthtech Institute are proud to include some new young researchers in rare disease at this conference. They are our future partners. Advocacy groups interested in nominating young researchers for the Uplifting Athletes Young Investigator Draft can submit to: ; Nominations open on November 21, 2020. Click here for additional information on applying for a guest pass directly.
2:10 PATIENT CO-PRESENTATION: The Patient’s Point of View: Clinical Trial Perceptions and Experiences
Annick de Bruin, MBA, Director, Research Services, Center for Information & Study on Clinical Research Participation (CISCRP)
Phyllis Kaplan, Trial Volunteer and Patient with T1D
Results from a large-scale global study conducted in 2019 among patients and the public offer robust insights into the latest perceptions of clinical research and enrollment barriers, as well as patient engagement preferences (exploring patient receptivity to virtual trial models and the latest technologies). The 2019 CISCRP Perceptions & Insights study is the largest global study of its kind (over 12,400 responses from around the world, including experiences of 3,600+ prior study participants), offering robust global insights that audience members can directly apply within their own organizations. Learn what information is critical to support the participation decision-making process from the patient’s point of view. Identify key participation elements which matter most to patients and their support network. Determine which convenience-enhancing solutions create the biggest impact on overall experiences.
2:30 CASE STUDY CO-PRESENTATION: Co-Creating with Patients to Create a Better Clinical Trial Experience
Jackie Zimmerman, Patient Advocate
Maura Snyder, MBA, Global Head, Clinical Trial Engagement, Clinical Insights and Experience, Janssen Pharmaceuticals
Janssen, in partnership with one of our patient advocates, will co-present on an initiative established in 2019 to bring the global patient perspective and input into the Janssen patient engagement plans in immunology. While it’s important to hear about the strides that the industry is making in the areas of patient engagement – it’s more important to hear directly from the patients about their perspective on this. This discussion will provide the audience practical, tangible ways to approach patient engagement. There are a variety of methodologies to approach this patient voice work and we will share one way that we have found to be very beneficial and successful.
2:55 Closing Remarks
Micah Lieberman, Executive Director, Conferences, Cambridge Healthtech Institute
3:00 Close of Conference
* 주최측 사정에 따라 사전 예고없이 프로그램이 변경될 수 있습니다.
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