Cambridge Healthtech Institute's
Feasibility & Site Selection
November 10-11, 2020
The ability to identify and select high-performing sites is critical to clinical trial success. New technology and analytics create opportunity to predict site performance and make informed decisions on site success. Coupled with innovative, patient
centered protocol design and stakeholder collaboration in the feasibility process, pharma has the opportunity to measurably impact outcomes. 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 am 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
Christina Brennan, MD, MBA, Vice President, Clinical Research, Northwell Healthcare
11:20 Data Science in Protocol Optimization
Beth Mahon, Global Feasibility Therapeutic Area (TA) Head, Feasibility Center of Excellence (FCoE), Clinical
Insights and Experience, Oncology, Janssen
Potential to merge, overlay, and analyze data is proving to increase the ability to be predictive in achieving earlier and better outcomes in the area of protocol optimization. Janssen is using natural language processing in the development of benchmarks
for computing patient burden and site burden and the correlation of trial burden, trial costs, and actual enrollment with design parameters and amendments. Ultimately, this allows for protocol design with better consideration of patient and site
voice and fewer protocol amendments.
11:50 PANEL DISCUSSION: Incorporating Site Input into the Protocol Development Process
Moderator:
Christina Brennan, MD, MBA, Vice President, Clinical Research, Northwell Healthcare
Panelists:
MarieElena Cordisco, MA, APRN, NP-C, Nuvance Health; Director Clinical Trials, Western Connecticut Health
Network; Interim Director, Division of Research, Health Quest
Jane Hart, Vice President, Global Clinical Affairs, 3M Health Care
Beth Mahon, Global Feasibility Therapeutic Area (TA) Head, Feasibility Center of Excellence (FCoE), Clinical
Insights and Experience, Oncology, Janssen
We’ve all experienced the frustration of an “ideal” sponsor protocol that is challenging for sites to execute or for patients to participate in. This panel discussion will provide interactive insights into how sites and industry
can partner together more effectively to design relevant clinical trial protocols and optimize study execution for all stakeholders.
12:35 pm 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 (Sponsorship Opportunity Available)
1:55 Expediting Study Start-Up in Global Clinical Trials
Amanda Hayden, Senior Director, Global Clinical Services, Clinical Operations, Alkermes
When planning for study start-up in Ex-US countries, sponsors focus on regulatory approvals, site level clinical trial agreements, study drug shipment availability and study equipment readiness to allow for timely site activations. Sometimes there
are hurdles in regulatory pathways that delay start-up whereas other times there could be issues with shipping equipment or drug supply. As a sponsor company, one needs to stay on top of the changing regulatory and compliance landscape and clinical
site level complications for study conduct. CROs play a vital role in overseeing local activities supporting start-up and partnering with them effectively is key to ensure sponsor companies meet start-up objectives and goals. This presentation
will share obstacles in planning Ex-US clinical studies and how to plan efficiently to meet your site activation goals.
2:20 PANEL DISCUSSION: Building and Implementing an IT Ecosystem for Master Trials
Moderator:
Len Rosenberg, PhD, RPh, Head, Clinical Operations, Beat AML/LLS
Panelists:
Rick Arlow, CEO, Complion, Inc.
We are in the age of information, but we don’t necessarily use, analyze, or share data in the most effective way. What would happen if pharma routinely participated in Master Trials managed by non-profits as an alternative to traditional
clinical trials? Should it be a core element of their pipeline strategies? A centralized resource to quickly and efficiently examine drug candidates. What if our collaborative efforts would streamline decision-making so that the most effective
drugs could be fast-tracked into clinical trials? Could we save time, money, and other resources if our go/no-go decisions were made in months instead of years? This panel will describe a novel approach to genomic-based decision-making to
optimize breakthrough therapeutics. This drug development model combines scientific innovation and next-gen e-clinical technologies to radically change the drug development landscape.
2:50 Solving Protocol Deviations Challenges: from Protocol Creation to CSR
Laura Galuchie, Merck, TransCelerate Oversight Committee Member and TransCelerate Program Lead
This discussion will clarify the definition of “protocol deviation”, review support classification of “important” and “non-important” protocol deviations, and provide a toolkit to support multiple processes
associated with protocol deviation management from identification through reporting, including several feedback loops.
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
Sandra Smyth, Head, Global Feasibility & Site Intelligence, AstraZeneca
8:35 A Collaborative Approach to Ensure Trial Success – A Site Perspective
Lale Akca, MBA, CCRA, Executive Director, Clinical Trials Unit, University of Louisville
Both sponsors and sites have a common goal: a successful trial. Success can only be achieved if multiple perspectives are considered. A collaborative approach in site selection leads to increased success in study enrollment. After being selected
as a site by the sponsor, UofL Clinical Trials Unit uses its own sponsor questionnaire to evaluate the project from the site perspective. The goal is to make sure that the study is the right one both for the sponsor and the site.
9:00 Shifting the Paradigm in Building Evidence-Driven Site Profiles for Clinical Trial Participation
Justin Hensperger, MS: Clinical Trial Science, Site Intelligence Lead
– Associate Director, Internal Medicine, Pfizer
Can we challenge the status quo to effectively develop predictive algorithms to build an ideal site profile based on key indicators on performance, start-up, quality and competitive intelligence? This presentation will provide a real-world
demonstration on how a new methodology can improve transparency and collaborative efforts to optimize study execution. We have developed an innovative approach that aims to change the paradigm in site selection.
9:25 CO-PRESENTATION: Challenges and Successes in Building and Implementing a Data-Driven Site Selection Approach
Sandra Smyth, Head, Global Feasibility & Site Intelligence, AstraZeneca
Gabriela Feldberg, Practice Leader, Applied Analytics & Artificial
Intelligence, AstraZeneca
In an environment of growing complexity, the need to utilize advanced analytical techniques is more pressing now than ever to ensure selection of the optimal investigators for a study. This presentation will be a lively discussion sharing
the challenges and successes in building and implementing data-driven site selection to ensure that teams have meaningful information needed, at the time needed, to make the best decisions for their studies.
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