Cambridge Healthtech Institute's
Data & Technology, Monitoring
November 10-11, 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 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
Chairperson to be Announced, Complion, Inc.
11:20 Simulating Patient Matching to Clinical Trials Using a Property Rights Blockchain: A Study in Applying Blockchains to Biomedical Data Processing
Jay 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.
11:45 CO-PRESENTATION: Advances in Personalized Medicine: How Technology Based on Predictive Power Can Advance Clinical Trials
Matt De Silva, Founder and CEO, Notable
Don 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.
12:10 pm Technology Integration- Delivering Real Time Data Access and Oversight
Lucien Agnant, Technology Integration Specialist, Clinical Management, Otsuka Pharmaceutical Development & Commercialization, Inc.
By integrating tools such as eSource, eConsent and IRT, sites will experience efficiencies with data entry and sponsors will benefit from having access to near real-time data. The presentation will provide a brief overview of how Otsuka has worked
with vendors to integrate systems, the lessons learned, and valuable outcomes.
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.
3:10 Refreshment Break in the Exhibit Hall
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
Ronald Dorenbos, PhD, Head, Innovation Management & Scouting, Innovation & Technology Science, Takeda
8:35 AI in Pharma & Clinical Trials
Ronald 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.
9:00 Your Brain at Your Fingertips
Ijah 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.
9:25 Developing and Driving a Robust Clinical Development Quality Risk Management Program
Jonathan Rowe, PhD, Associate Principal, ZS Associates
ICH E6 R2 calls for the establishment of a system to manage quality throughout all stages of the trial process. This presentation will describe elements of a protocol to CSR quality management process that allows sponsors/CROs to understand
risks to GCP and proactively mitigate those risks.
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