Cambridge Healthtech Institute’s 5th Annual
Clinical Biomarkers Operations and Innovation
Enabling Precision Medicine Trials
February 19-20, 2020
The concept of personalized or precision medicine has brought to life several types of clinical trials that involve biomarkers and require biospecimen collection and management. Effective management of these trials can be complicated and requires specific
operational approaches. CHI’s 5th Annual Clinical Biomarkers Strategy and Innovation conference is designed to exchange solutions to overcome operational and scientific challenges with various types of studies, including trials with biomarker-based
stratified trials, biomarkers as end points, etc. Informed consent, innovative solutions for biospecimen management, and other important topics will be discussed by leading experts from top pharmaceutical companies.
Stay on and attend Part 2 (Thurs-Fri): Clinical Biospecimens Technology and Outsourcing
Scientific Advisory Board
Brenda Yanak, Principal, Clinical Transformation Partners
Michael Tanen, MBA, Director, Clinical Biomarker Specimen Management, Merck Research Laboratories
Final Agenda
Tuesday, February 18
9:00 am - 7:15 pm Registration Open (Regency Rotunda)
2:00 - 5:00 pm User Group Meetings
2:00 - 5:00 pm The NEW SCOPE China Clinical Development Partnering Forum and The NEW SCOPE Scientific
Symposium*
*Separate registration required. Must be a Best Value registered attendee.
5:00 - 6:20 pm Evening Kick-Off Plenary Keynote and Participant Engagement Awards (Regency Ballroom S)
6:20 - 7:30
pm SCOPE’s Kick-Off Networking Happy Hour (Upper Pool Deck, 4th Floor)
(Co-Sponsorship Opportunities Available)
7:30 pm Close of Day
Wednesday, February 19
7:15 am Registration Open (Regency Rotunda) and Morning Coffee (Regency Ballroom S Foyer)
8:15 Morning Opening Plenary Keynotes with Light Refreshments (Regency Ballroom S) provided by 
9:40 Grand Opening Coffee Break in the Exhibit Hall (Windermere Ballroom)
10:40 Chairpersons' Remarks
Michael Tanen, MBA, Director, Clinical Biomarker Specimen Management, Merck Research Laboratories
Brenda Yanak, Principal, Clinical Transformation Partners
10:55 Maximizing Specimen Assets in Oncology Clinical Trials
Michael Tanen, MBA, Director, Clinical Biomarker Specimen Management, Merck Research Laboratories
Immuno-oncology clinical trials have shifted toward more innovative clinical trial designs, such as Basket, Umbrella and Adaptive methodologies that create increased complexity and demands on supporting functions. These trial designs are frequently
biomarker-intensive and need to be managed with a specimen-centric perspective to maximize collected bio-specimen assets. Innovative bio-specimen management approaches are becoming an essential part of empowering clinicians and researchers
to better understand the individualized connections between biomarkers and human disease.
11:25 Operational Management of Biomarker Analysis for Submission-Ready Data
Deborah
Shepard, PhD, Senior Manager, Biomarker Assay Specialist, Global Product Development, Oncology, Pfizer
Generation of high-quality biomarker data for a clinical trial requires more than selecting a lab and assay and transferring the data. It requires careful selection and qualification of the lab, fit-for-purpose assay validation, and ongoing oversight
of analysis and data. Aligning expectations and building a collaborative relationship between the sponsor and the lab is the key to success.
11:55 Biomarker-Driven Clinical Trials: Challenges and Solutions: The Beat AML Master Trial – Simplifying Complex Precision Medicine with a Focus on Sample Flow and Laboratory Information
Len Rosenberg,
PhD, RPh, Head, Clinical Operations, The Leukemia & Lymphoma Society/Beat AML LLC
AML is a heterogeneous disease with mutational heterogeneity and different rare genetic subtypes. The challenge is to apply precision-based enrollment to evaluate new targeted therapies in an efficient manner. This presentation will illustrate
the complexity of the trial by mapping the flow of samples and information to support centralized treatment assignments to eleven sub-studies and then continue to process ongoing laboratory data for dose-escalations, cohort expansions
or futility benchmarks.
12:15 pm CASE STUDY: Utilizing Laboratory Results to Identify and Enroll Patients and Investigators in a Rare Disease Study
Bernadette Tosti, Executive Director, Information Ventures, Quest Diagnostics
12:45 Transition to Lunch
12:50 LUNCHEON PRESENTATION: Considerations for Conducting Flow Cytometry Analysis in Multi-centre Clinical Studies
David Lanham, BSc (Hons), MSc, Principal Scientific Director, Eurofins Pharma
Bioanalysis Services UK Limited, Eurofins BioPharma Services
1:20 Coffee and Dessert Break in the Exhibit Hall (Windermere Ballroom)
2:15 Chairperson’s Remarks
Brenda Yanak, Principal, Clinical Transformation Partners
2:20 Considerations for Biomarker Research in a Gene/Cell Therapy Clinical Trial
Heather Hirsch, PhD, Senior Director, Translational Pharmacology, Head of Clinical Biomarkers and Exploratory Research, CRISPR Therapeutics
Translational research can provide key insight into the activity of a therapeutic in a clinical trial. In this session, we will discuss strategies for implementing biomarker work within the context of a gene/cell therapy clinical trial.
We will also focus on important considerations specific to gene/cell therapies that differ from traditional small molecule therapeutics.
2:50 Patient-Centric Sample Collection to Enable Virtual Trials
Kevin
Bateman, Distinguished Scientist & Scientific Associate Vice President, Merck
Traditional approaches for measurement of drug exposure in clinical trials involves having the patient travel to a clinical site for collection of venous blood. This puts a burden on the patient while also limiting the opportunities for
assessment of drug exposure or other measurements to these clinical visits. The ability to collect samples at home would provide a more patient-centric approach, enabling remote/virtual trials. This talk will share results from recent
clinical pilot studies employing at-home sampling technologies.
3:20 CO-PRESENTATION: Biospecimen Collection in Virtual Clinical Trials
Matt Harlin, Associate Director, Clinical Pharmacology, Otsuka Pharmaceutical Companies
Sharin
Roth, Director, Clinical Pharmacology, Bioanalysis, Otsuka Pharmaceutical Companies
As the pharmaceutical industry begins the transition to virtual or “siteless” clinical trials, how will routine clinical trial procedures, such as blood sample collection, be performed in a consistent and reliable manner? This
talk will share experiences to date, including what has worked and areas for future improvement.
3:50 Q&A with Speakers
4:20 Find Your Table and Meet Your Moderator
For more details on the Breakout Discussions: https://www.scopesummit.com/breakouts
4:25 Interactive Breakout Discussion Groups
Concurrent breakout discussion groups are interactive, guided discussions hosted by a facilitator or set of co-facilitators to discuss key issues presented earlier in the day’s sessions. Delegates will join a table of interest and
become an active part of the discussion. Bring your pharma, biotech, CRO, site, hospital or patient perspective to each of the discussions. 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.
5:10 Welcome Reception in the Exhibit Hall (Windermere Ballroom)
(Co-Sponsorship Opportunities Available)
6:45 Close of Day
Thursday, February 20
7:15 am Registration Open (Regency Rotunda)
7:45 BREAKFAST PRESENTATION: Navigating the Patient Journey: A Responsibility all Technology Providers Share (Regency Ballroom T)
Mike Nolte, Chief Executive Officer, Signant Health
8:15 Session Break
8:20 Chairperson’s Remarks
Karina Bienfait, PhD, Principal Scientist & Head, Global Genomics Policy, Process & Compliance, Merck
8:25 Considerations in Returning Individual Biomarker Results from Global Clinical Trials
Karina Bienfait, PhD, Principal Scientist & Head, Global Genomics Policy, Process & Compliance, Merck
Returning individual biomarker results, particularly from genetic tests, in global clinical trials remains a hot topic. This talk will highlight various aspects of returning results that need to be considered in the context of industry
sponsored trials.
8:55 Experiences in Individual Study Participant Clinical Data Return
Jennifer Ribeiro, Informed Consent Process Lead, Global Clinical Documentation & Submissions, Global Clinical Operations, Bristol-Myers Squibb
This presentation will review the experiences that BMS has had in the last 2 years returning clinical trial data to individual study participants.
9:25 Return of Research Results to Participants in Clinical Trials - Case Studies and Associated Challenges
Delphine Lagarde, PhD, Ethics Lead in Biosample & Repository Management, F. Hoffmann-La Roche AG
The growing demand from Ethics Committees & review bodies, patient advocates, policy makers and country regulations to provide study participants access to their genomic results led Roche to rethink their position on return of
research results. This talk will present three examples where Roche has either returned research results or set up a process that could be implemented in Roche clinical trials to return genomics research results to study participants.
9:55 Returning Data and Results to Clinical Trial Participants
David Leventhal, MBA, Senior Director, Clinical Trial Experience, Pfizer
Clinical trials rely on the participation of patients who are willing to have data collected about them, as these complete results are posted online and published in scientific journals. Little, however, is routinely given back
to the patient to acknowledge their contribution. Pfizer has pioneered the returning of data to patients by making plain-language summaries of study results available to participants, as well as returning individual patient
data to clinical trial volunteers.
10:25 Coffee Break in the Exhibit Hall (Windermere Ballroom)
11:20 Chairperson’s Remarks
Karina Bienfait, PhD, Principal Scientist & Head, Global Genomics Policy, Process & Compliance, Merck
11:25 What Should Industry Do in Sharing Data/Results with Study Participants?
Jessica Scott, MD, JD, Head, R&D, Patient Engagement, Takeda
Hearing rumblings from patients, patient organizations and even other pharmaceutical companies? Better understand what’s the buzz and why you need to start thinking about your approach. Navigating the return of individual
data/results is nuanced, but doable. How you can better understand the benefits and also the challenges.
11:45 Return of Individual Research Results: Recommendations of the National Academies of Science, Engineering and Medicine
Jeffrey Botkin, MD, Professor, Pediatrics and Medical Ethics, University of Utah
The return of individual research results to research participants raises a complex and controversial set of issues for investigators, participants, sponsors and research institutions. The benefits of disclosure and the desire
for greater transparency by many participants must be balanced with concerns over the validity of research results and the burdens associated with the oversight and disclosure process. The National Academies of Science,
Engineering and Medicine convened a consensus committee that published a report on these issues in 2018. This presentation will provide an overview of the issues and recommendations addressed by the NASEM report.
12:05 pm PANEL DISCUSSION: How Can Industry Enable Responsible Sharing of Individual Biomarker Data in Sponsored Clinical Trials?
Moderator: Karina Bienfait, PhD, Principal Scientist & Head, Global Genomics Policy, Process & Compliance, Merck
Panelists: David Leventhal, MBA, Senior Director, Clinical Trial Experience, Pfizer
Jennifer Ribeiro, Informed Consent Process Lead, Global Clinical Documentation & Submissions, Global Clinical Operations, Bristol-Myers Squibb
Jessica Scott, MD, JD, Head, R&D, Patient Engagement, Takeda
Jeffrey Botkin, MD, Professor, Pediatrics and Medical Ethics, University of Utah
Delphine Lagarde, PhD, Ethics Lead in Biosample & Repository Management, F. Hoffmann-La Roche AG
- Who owns the patient data in clinical research?
- How can Sponsors facilitate the return of biomarker data?
- What are the opportunities for transparent sharing of biomarker data?
12:30 Enjoy Lunch on Your Own
1:00 Coffee and Dessert Break in the Exhibit Hall (Windermere Ballroom)
2:00 Close of Conference
Stay on and attend Part 2: Clinical Biospecimens Technology and Outsourcing