Cambridge Healthtech Institute's
Engagement & Enrollment
November 10-11, 2020
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 CHI's 9th Annual Clinical Trial Innovation Summit.
Final Agenda
Day 1 | Day 2
TUESDAY, november 10
7:45 am Registration and Morning Coffee
8:45 Organizers' Welcome
Micah Lieberman, Executive Director, Conferences, Cambridge Healthtech Institute (CHI)
8:55 Chairperson's Opening Remarks
Beth Mahon, Global Feasibility Therapeutic Area (TA) Head, Feasibility Center of Excellence (FCoE), Clinical Insights and Experience, Oncology, Janssen
9:00 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 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.
10:00 Impact of the COVID-19 Pandemic on ClinicalTrials and Monitoring: Challenges and Solutions
Moderator:
Laurie Halloran, CEO, Halloran Consulting Group, Inc.
Panelists:
Kevin Douglass, Associate Director, Process Excellence & Risk Management, Daiichi Sankyo, Inc.
Carrie Melvin, Vice President, Clinical Operations, TESARO
Marissa Volpe, Vice President, Global Clinical Development Operations, Sarepta Therapeutics
Discuss the impacts of COVID-19 on clinical trials, including delays in patient enrollment and study initiation, inability of patients or sites to comply with scheduled visits, impacts of limited staffing and study materials due to reprioritization,
and more. Discuss how best to address statistical implications from missed patient visits, tests, and increased protocol deviations; strategies to advance decentralized trials and remote monitoring; and near-term and longer-term strategies
to mitigate the impacts of COVID-19 on clinical trials.
10:30 Grand Opening Coffee Break in the Exhibit Hall (Sponsorship Opportunity Available)
11:10 Chairperson’s Remarks
Bonnie Brescia, Founding Principal, BBK Worldwide
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 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.
12:10 pm 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.
12:35 Transition to Luncheon Presentation
12:45 Luncheon Presentation (Sponsorship Opportunity Available) or Enjoy Lunch on Your Own
1:15 Session Break
1:45 Chairperson’s Remarks
Robert Wilson III, Consultant, Wilson Digital Health Consulting
1:55 PANEL DISCUSSION: Accelerating Adoption of Digital Biomarkers and RWE in Clinical Research
Moderator: Robert Wilson III, Consultant, Wilson Digital Health Consulting
Digital clinical endpoints derived from wearables and other mobile and remote sensors hold great promise to improve clinical trial efficiency and patient outcomes. However, real issues regarding scientific validation, operational deployment,
regulatory oversight and patient engagement and compliance pose significant challenges that must be overcome. In addition, real-world evidence (RWE) from remote sensors can be combined with other data streams in the health ecosystem (EMR,
lab, claims, genomic data) to help improve patient care and clinical trial efficiency and effectiveness. What can we learn from what has been done to date and how do we position ourselves to accelerate the adoption of these tools in the
future?
Panelists:
The Small and Big Picture – An Example of Remote Device and Digital Data Adoption Considerations in Clinical Trials and a View on How Pharma Can Transform Their Approach to Digital Adoption
Jake LaPorte, Co-Founder & Global Head of the Novartis Biome, Novartis
Considerations in Adoption of Remote Digital Patient Data Capture in Clinical Trials
Peter Bergethon, Vice President, Head of Digital and Quantitative Medicine, Biogen
RWE Created by Sensors: The Use of Sensor Technologies in Clinical Trials
Judith Kornfeld, MBA, Chief Business and Operations Officer, ORCATECH, Oregon Health and Sciences University
1:45 Chairperson’s Remarks
Speaker to be Announced
1:55 Building a Data Sciences Team for Risk-Based Study Execution
Amy Neubauer, Director, Data Quality Oversight, Alkermes
When looking to create a team to manage risk-based study execution, what are the skills and experience needed? How can roles and responsibilities be managed across the team to cover everything from performing risk assessments, KRI selection
and programming, issue detection/action/escalation, QTL selection and tracking, to documentation of actions? We will share our experience and best practices in building a data sciences team and managing risk-based study execution processes.
2:20 Review of ICH E8 R1 – The Developing Regulatory Direction and How to Address
Andy Lawton, Director & Consultant, Risk Based Approach Ltd.
The release of ICH E8 R1 (draft) has cemented the direction that the Regulatory bodies want us to follow, that is towards a Quality by Design process, rather than “Quality by Accident” as some regulators have expressed. A background
of the Regulatory presentations, guidances and discussions at meetings will be brought together to give their path of attack initially via RBM and now cemented in a compelling need for QbD. This presentation will take you stepwise
through the following topics: 1)Regulatory background from “crumbs on the ground” to clear direction; 2) From early presentations from 2000 to recent (2019) Regulatory Guidance; 3) What is Quality by Design; 4) How can
QbD principals be incorporated into RBM with an example
2:45 Is Your Centralized/Onsite Site Monitoring Program Being Implemented per ICH E6(R2)? How Do You Know?
Linda Sullivan, Co-Founder & Executive Director, WCG - Metrics Champion Consortium
The revision to ICH E6 has spawned a transformative approach to monitoring safety and data quality at investigational sites. As new centralized/remote/site monitoring models are being implemented, organizations are considering the perplexing
question about how to oversee and manage these models. For example, what should be measured and reviewed to ensure the process is being implemented according to the plan? What metrics could be used to provide insights about the process
and future process improvements? Members of an industry consortium are developing consensus-based metrics by considering the process steps, critical success factors, key performance questions, and by using the process analysis technique
Failure Mode and Effects Analysis (FMEA). This session will provide insights on the progress to date and plans to obtain additional industry feedback.
3:45 Find Your Table and Meet Your Moderator
3:50 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.
4:25 Organizer’s Opening Remarks
Marina Filshtinsky, MD, Executive Director, Conferences, Cambridge Healthtech Institute
4:30 Chairperson’s Remarks (Sponsorship Opportunity Available)
Speaker to be Announced
4:35 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.
5:05 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.
5:35 Welcome Reception in the Exhibit Hall
6:30 End of Day
Day 1 | Day 2
WEDNESDAY, november 11
7:45 am Breakfast Presentation (Sponsorship Opportunity Available) or Morning Coffee
8:25 Chairperson’s Remarks (Sponsorship Opportunity Available)
Spencer Health Solutions, Inc.
8:35 CASE STUDY: Why Patient Engagement Is Key to
Achieving 95% Medication Adherence
Speaker to be Announced, Spencer Health Solutions, Inc.
9:00 Understanding the Role of Community Oncology in Clinical Trials & Patient Engagement
Rose Gerber, Director, Patient Advocacy and Education, Community Oncology Alliance (COA); 3x
Clinical Trial Participant
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.
9:25 PANEL DISCUSSION: Impact of Technology on Rare Disease Research, Engagement and Retention (Lessons Learned BEYOND Rare Disease)
Joan Chambers, Senior Director, Marketing & Outreach, CISCRP
Nan Doyle,R&D Patient Engagement Lead, Rare Disease, Takeda
Christian Rubio, Vice President, Strategic Advancement, Global Genes
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
9:50 Coffee Break in the Exhibit Hall (Sponsorship Opportunity Available)
10:35 Chairperson’s Remarks
Hollie Schmidt, Vice President, Scientific Operations, Accelerated Cure Project for MS
10:45 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.
11:10 Digital Clinical Development: Case Studies, and Future Readiness
Munther Baara, Vice President, Product Strategy and Innovation, EDETEK, Inc.
Craig Lipset, Independent Adviser, Former Head of Clinical Innovation, Pfizer
Our industry is at a critical juncture for disruption and opportunity to change the clinical trials execution model. Today, we can re-define digital clinical trials from the point of view of Patients, Sites, Sponsors and Regulators: What
is a digital clinical trial? What are the strengths and limitations of digitization? What has been implemented and what has been learned? What are the obstacles to successful implementation? How can we advance digital clinical trials
as a community together? What are the practical steps that you can take back and apply? Attendees will learn the role of digital in impacting end-to-end clinical development inclusive of recruitment, engagement, ongoing data collection,
and the predictive models to reduce the research cycle time, reduce the number of participants and lowers the cost of bringing medicine to market.
10:35 Chairperson’s Remarks
Debora Araujo, Founder & CEO, ClinBiz
10:45 PANEL DISCUSSION: Budgeting for and Contracting with Emerging Technology and Service Providers
Moderator: Debora Araujo, Founder & CEO, ClinBiz
Panelists:
Marina Malikova, PhD, Executive Director, Surgical Translational Research: Operations and Compliance, Boston University School
of Medicine
Scott Sawicki, R&D Sourcing Consultant, Adare Pharmaceuticals
Cameron McClure, PMP, PMI-ACP, CSM, CCRP, Senior Manager, Clinical Business Operations, BeiGene
There are so many new technologies and services being integrated into clinical trials, with many new companies popping up and many traditional service providers pivoting to address these growing needs. How can sponsors determine fair market
value for these types of companies, and how does this affect overall forecasting, budgeting, and contracting activities? Panelists will discuss the impact of changing technologies and study design.
11:10 PANEL DISCUSSION: Effective Contracting as a Vehicle to Increase Quality and Mitigate Risk
Moderator: Mai Nguyen, MPH, Senior Consultant, The Avoca Group
Panelists:
Chuck Bradley, Vice President, Clinical Development, FibroGen, Inc.
Andy Lawton, Director & Consultant, Risk Based Approach Ltd.
Clinical trials rely on vendors and partners to carry out numerous tasks, something that comes with an inherent risk. This panel will discuss the latest trends in vendor oversight and contracting, and how to mitigate risk and build in
quality by design with vendors and partners using effective contracting strategies. Panelists will discuss the pros and cons of common oversight and risk mitigation approaches supported by effective contracting including quality agreements,
metrics, and incentive/penalty clauses, as well as the impact these have on the contracts process and downstream clinical operations.
11:55 PANEL DISCUSSION: Clinical Trials Impact and Risk Mitigation in COVID-19 Pandemic
Moderator:
Marina Malikova, PhD,
Executive Director, Surgical Translational Research: Operations and Compliance, Boston University School of Medicine
Panelists:
Sheri Kuss, Clinical Quality Lead, Clinical Development Quality, Global Product Development, Pfizer, Inc.
Kelly Loughner, Senior Associate Director, Site Enablement, Boehringer Ingelheim Pharmaceuticals Inc.
We’ve seen an immediate impact on clinical trials due to challenges coming from the COVID-19 travel bans, hospital/clinic visitation restrictions, social distancing precautions and shifting operations to work remotely on a short notice,
etc. These factors have translated into the issues challenging clinical trials such as operations, milestones, budgets, data integrity, etc. Best practices to mitigate risks and adjust clinical operations in these unprecedented times will
be shared. Issues, potential solutions and risk mitigation strategies to address delays in patient enrollment, study initiation and clinical materials distribution, impacts on clinical operations, sponsor/investigator/CRO alignment strategies,
and implications of the FDA's guidelines during the pandemic will be discussed.
12:20 pm End of Session and Transition to Sponsored Luncheon Presentation
12:25 Luncheon Presentation (Sponsorship Opportunity Available) or Enjoy Lunch on Your Own
12:55 Coffee and Dessert Break in the Exhibit Hall
1:50 Organizer’s Opening Remarks
Bridget Kotelly, Conference Director, Cambridge Healthtech Institute (CHI)
1:55 Chairperson’s Introduction
2:00 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.
2:30 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.
3:00 The Journey from Patient to Advocate to Leader: Changing the Clinical Research Game & Impact of Rare Disease Research on COVID-19
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 the impact that this research is having in the world of COVID-19.
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: https://www.upliftingathletes.org/rare-disease-research; Nominations open on November 21, 2020.
Click here for additional information on applying for a guest pass directly.
3:30 Closing Remarks
Micah Lieberman, Executive Director, Conferences, Cambridge Healthtech Institute (CHI)
3:35 Close of Conference
Day 1 | Day 2