Cambridge Healthtech Institute's

Data & Technology

April 7-8, 2020

Technology and data are at the forefront driving clinical trial decision-making. With further advancements in new technologies (such as mobile devices and wearables) and the rise of online communities, the pharma and biotech industries are poised to capitalize on these advancements to innovate existing clinical trial processes and systems. Learn more at this lively conference program at CHI's 9th Annual Clinical Trial Innovation Summit.


Final Agenda


2:30-5:30 pm Pre-Conference Workshops

Workshop 2: Digital Clinical Development: Tutorial, Case Studies, and Future Readiness

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

Real World Data, Artificial Intelligence and Analytics to Reshape Clinical Development

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 BergethonPeter 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 LouieAlan Louie, PhD, Research Director, Life Sciences, IDC Health Insights

Charles MakinCharles 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 SarangarajanRangaprasad 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)

eData, blockchain, adaptive trials

11:10 Chairperson’s Remarks

Chairperson to be Announced, Complion, Inc.

11:20 DMD Phase II and Phase III Study Lessons Learned with Various eData Collection

Susan BornsteinSusan Bornstein, MPH, Senior Director, Data Monitoring and Data Management, Global Product Development, Pfizer Inc.

The Phase II study collected 12 types of eData, including activity monitoring (wrists and ankles), ePRO, biomarkers, immunogenicity, imaging, labs and biopsy data. This presentation will review the process of how Pfizer decides on the data collection strategy through the data analysis. With >70% of the data collected in our trials coming direct from source, we need to change how we manage our data. This presentation will highlight how we work today and where we are going.

11:45 Simulating Patient Matching to Clinical Trials Using a Property Rights Blockchain: A Study in Applying Blockchains to Biomedical Data Processing

Jay BergeronJay Bergeron, Director, Pfizer Digital, Pfizer Inc.

Biomedical data processing typically requires the secure stepwise transfer of sensitive personal information across multiple parties. In an effort to explore alternatives without supplemental peer-to-peer communications, the Bitmark property rights blockchain was used to design and simulate the process of assessing the suitability of individuals to enroll in specific clinical trials.

12:10 pm CO-PRESENTATION: Advances in Personalized Medicine: How Technology Based on Predictive Power Can Advance Clinical Trials

Matt De SilvaMatt De Silva, Founder and CEO, Notable

Don BerryDon Berry, PhD, Founder & Senior Statistical Scientist, Berry Consultants, LLC; Professor, Biostatistics, University of Texas MD Anderson Cancer Center

Effective treatment and time-to-treatment are both essential elements of fighting cancer. Advances in personalized medicine now make it possible to analyze samples for individual patients and point physicians and patients towards the drugs, drug combinations and clinical trials that are likely to be most effective for their unique cancer. New technology platforms and techniques have the potential to drastically improve the way physicians treat cancers and save more lives.

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)

Digital Technologies to reshape clinical trials

2:00 Chairperson’s Remarks (Sponsorship Opportunity Available)

2:10 PANEL DISCUSSION: Accelerating Adoption of Digital Biomarkers and RWE in Clinical Research

Robert WilsonModerator: 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?


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 LaPorteJake LaPorte, Co-Founder & Global Head of the Novartis Biome, Novartis

Considerations in Adoption of Remote Digital Patient Data Capture in Clinical Trials

Peter BergethonPeter Bergethon, Vice President, Head of Digital and Quantitative Medicine, Biogen

RWE Created by Sensors: The Use of Sensor Technologies in Clinical Trials

Judith KornfeldJudith Kornfeld, MBA, Chief Business and Operations Officer, ORCATECH, Oregon Health and Sciences University

Reducing Friction in Adaption of RWE and Remote Sensors in Clinical Trials

Sam RooszSam Roosz, Co-Founder, Head of Life Sciences, Datavant

3:10 Sponsored Presentation (Opportunity Available)

3:25 Transition to Keynote

Why Do Trials Succeed and Why do they Fail? Insights from Industry and Academia

3:35 Organizer’s Opening Remarks

Marina Filshtinsky, MD, Executive Director, Conferences, Cambridge Healthtech


3:40 Chairperson’s Remarks (Sponsorship Opportunity Available)

3:45 BEST CLI Trial: Lessons Learned From Execution Of A Complex Multicenter RCT

Alik FarberAlik 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 KravetMarcy Kravet, BS, MBA, Head, Operational Design Center (ODC), Global Clinical Operations, EMD Serono, Inc., an affiliate of Merck KGaA, Darmstadt, Germany

Sylvia MareckiSylvia 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


7:45 am Breakfast Presentation (Sponsorship Opportunity Available) or Morning Coffee


8:25 Chairperson’s Remarks (Sponsorship Opportunity Available)

8:35 AI in Pharma & Clinical Trials

Ronald DorenbosRonald Dorenbos, PhD, Head, Innovation Management & Scouting, Innovation & Technology Science, Takeda

The presentation will discuss how AI-related approaches are changing the way clinical trials are executed. The patient’s perspective on implementation of AI in clinical trials will briefly be reviewed and the presentation will highlight implementation of AI in a variety of areas within the pharma value chain. The presentation will be concluded with a brief look into the future.

8:50 Your Brain at Your Fingertips

Ijah Mondesire-CrumpIjah Mondesire-Crump, MD, Research Director, nQ Medical Inc

At nQ medical we have discovered a powerful source of information in the way we interact with our personal devices. Typing is a complex task that relies on intact motor and cognitive pathways. Impairments in any part of these pathways (such as motor impairments seen in neurodegenerative diseases) are detectable through the way our fingers interact with a computer keyboard or a smartphone screen. As personal devices become more and more frequent, we now have the opportunity to evaluate ourselves on-the-go with continuous, objective and passive monitoring.

9:05 CO-PRESENTATION: The Future is Now: Using Predictive Algorithms and Machine Learning to Identify the Best Sites for Your Studies

Liz Beatty, Chief Strategy Officer, Inato

Robert Howal, US Site Partnership Manager, Oncology, Sanofi

Industry reports estimate that by 2020, medical data will double every 73 days and there could be $100 billion in annual savings by leaning on big data as well as the artificial intelligence and machine learning tools to process it. To test these new approaches for study planning, Sanofi partnered with Inato to deploy its algorithm across several studies in order to predict site performance. The algorithm was able to accurately tier sites by performance, which provides the opportunity to significantly reduce the number of sites needed to meet the trial timelines and reduce study costs.

9:20 PANEL DISCUSSION: AI for Clinical Trials: Adaptation, Hurdles and Advantages


Ronald DorenbosRonald Dorenbos, PhD, Head, Innovation Management & Scouting, Innovation & Technology Science, Takeda


Ijah Mondesire-CrumpIjah Mondesire-Crump, MD, Research Director, nQ Medical Inc

Liz BeattyLiz Beatty, Chief Strategy Officer, Inato

Eric GildenhuysEric Gildenhuys, Vice President, Business Development, Deep 6 AI

Topics to be discussed: How do you see adaptation of AI in clinical trials from perspective of Patients, Health care providers, Regulatory agencies? What are the biggest hurdles for implementation of novel tools based on AI and ML? Apart from increased efficiency and lowering the costs, what other advantages does AI bring to the clinical trials and the various stakeholders? Where do you see the biggest impact? Can you share with us some of the concerns that you, or the people you are working with, may have in relation to the use of AI in clinical trials? What will the clinical trials look like 5 years and 15 years from now?

9:50 Coffee Break in the Exhibit Hall (Sponsorship Opportunity Available)


10:40 Chairperson’s Remarks (Sponsorship Opportunity Available)

10:45 Practical RWD/RWD – Expectations for Real Change

Alan LouieAlan Louie, PhD, Research Director, Life Sciences, IDC Health Insights

This presentation will discuss key applications of RWD such as: improving patient recruitment for clinical trials, creating synthetic control arms in clinical trials, fulfilling the regulatory requirements for post-approval Phase IV trials and uncovering new uses for existing drugs (and potentially using RWD to accelerate label extensions).

11:05 Advancing Real-World Evidence to Incorporate Patient-Generated Health Data

Deborah KilpatrickDeborah Kilpatrick, PhD, CEO, Evidation Health

The talk will highlight how patient-generated health data is the RWD that is more reflective of actual day-to-day health and outcomes. Patient-generated data helps us understand what works for whom, how much it works and when. For companies across the health care ecosystem, claims and EHR data have been bedrock data sources, but they are not sufficient to change how health is measured and how diseases are diagnosed, treated, and monitored.

11:25 Sponsored Presentation (Opportunity Available)

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

Understanding the Patient Journey to Improve Trials

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 LongRob 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 BruinAnnick de Bruin, MBA, Director, Research Services, Center for Information & Study on Clinical Research Participation (CISCRP)

Phyllis KaplanPhyllis 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 ZimmermanJackie Zimmerman, Patient Advocate

Maura SnyderMaura 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

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