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

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

6:20 - 7:30 pm SCOPE’s Kick-Off Networking Happy Hour

(Co-Sponsorship Opportunities Available)

7:30 pm Close of Day

Wednesday, February 19

7:15 am Registration Open and Morning Coffee

8:15 Morning Opening Plenary Keynotes

9:40 Grand Opening Coffee Break in the Exhibit Hall

OPERATIONALIZING PRECISION MEDICINE TRIALS

10:40 Chairperson’s Remarks

Michael Tanen, MBA, Director, Clinical Biomarker Specimen Management, Merck Research Laboratories

10:45 Specimen Management and Innovation as an Integral Part of Biomarker and Drug Discovery

Piccoli_StevenSteven Piccoli, PhD, Senior Director, Precision Medicine, Experimental Medicine Unit, GlaxoSmithKline

Patient samples are the lifeblood (literally!) of successful clinical trials in the pharmaceutical/biotechnology industries. It is rare in the industry to acquire an efficient biobanking function without implementing serious changes. This presentation will overview the highs (and lows!) of establishing that function of Clinical Trial Biospecimen Management in reputable clinical organizations, including best practices and pain points, and how this enables facile patient testing for drug development.

11:10 Maximizing Specimen Assets in Oncology Clinical Trials

Tanen_MichaelMichael 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.

11:35 Operational Management of Biomarker Analysis for Submission-Ready Data

Shepard_DeborahDeborah Shepard, PhD, Senior Manager, Biomarker Assay Specialist, Global Product Development, Oncology, Pfizer Inc.

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.

12:00 pm 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

Rosenberg_LenLen 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 Presentation to be Announced

12:45 Transition to Lunch

12:50 Luncheon Presentation to be Announced

1:20 Coffee and Dessert Break in the Exhibit Hall

SUPPORTING INNOVATIVE AND VIRTUAL TRIALS

2:15 Chairperson’s Remarks

Brenda Yanak, Principal, Clinical Transformation Partners

2:20 Considerations for Biomarker Research in a Gene/Cell Therapy Clinical Trial

Hirsch_HeatherHeather 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

Bateman_KevinKevin 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

Harlin_MatthewMatt Harlin, Associate Director, Clinical Pharmacology, Otsuka Pharmaceutical Companies


Roth_SharinSharin 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 Sponsored Presentation (Opportunity Available)

INTERACTIVE BREAKOUT DISCUSSION GROUPS

4:20 Find Your Table and Meet Your Moderator

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

6:45 Close of Day

Thursday, February 20

7:15 am Registration Open

7:45 BREAKFAST PRESENTATION: Navigating the Patient Journey: A Responsibility all Technology Providers Share

Mike Nolte, Chief Executive Officer, Signant Health

8:15 Session Break

INFORMED CONSENT AND RETURN OF RESULTS POLICY

8:20 Chairperson’s Remarks

Karina Bienfait, PhD, Principal Scientist & Head, Global Genomics Policy, Process & Compliance, Merck

8:25 Returning Data and Results to Clinical Trial Participants

Leventhal_DavidDavid Leventhal, Senior Director, Clinical Innovation, Global Product Development, Pfizer Inc.

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.

8:55 Experiences in Individual Study Participant Clinical Data Return

Ribeiro_JenniferJennifer 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 Challenges in Returning Individual Results in Global Clinical Trials

Bienfait_KarinaKarina Bienfait, PhD, Principal Scientist & Head, Global Genomics Policy, Process & Compliance, Merck

Obtaining consent for research with biospecimens in global clinical trials is complex. This presentation will provide an understanding of the basics of consent for biospecimens, a background and several influential cases which have shaped the way we consent today, and an overview of today’s global challenges in obtaining consent for research use of biospecimens.

9:55 Sponsored Presentation (Opportunity Available)

10:25 Coffee Break in the Exhibit Hall

DATA OWNERSHIP AND RETURN OF RESULTS POLICY

11:20 Chairperson’s Remarks

Karina Bienfait, PhD, Principal Scientist & Head, Global Genomics Policy, Process & Compliance, Merck

11:25 What Should Industry to in Sharing Data/Results with Study Participants?

Scott_JessicaJessica 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?

Bienfait_KarinaModerator: Karina Bienfait, PhD, Principal Scientist & Head, Global Genomics Policy, Process & Compliance, Merck


Leventhal_DavidPanelists: David Leventhal, Senior Director, Clinical Innovation, Global Product Development, Pfizer Inc.


Ribeiro_JenniferJennifer Ribeiro, Informed Consent Process Lead, Global Clinical Documentation & Submissions, Global Clinical Operations, Bristol-Myers Squibb


Scott_JessicaJessica Scott, MD, JD, Head, R&D, Patient Engagement, Takeda


Yanak_BrendaBrenda Yanak, Principal, Clinical Transformation Partners


  • 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?

12:25 Transition to Lunch

12:30 Bridging Luncheon Presentation (Sponsorship Opportunity Available) or Enjoy Lunch on Your Own

1:00 Coffee and Dessert Break in the Exhibit Hall

2:00 Close of Conference


Stay on and attend Part 2: Clinical Biospecimens Technology and Outsourcing

PLENARY KEYNOTES

Tuesday Evening, Wednesday Morning, Wednesday Afternoon Plenary Keynotes Featuring:

SCOPE’s 2020 Participant Engagement Award, in Memory of Jerry Matczak
Patient Perspectives as an Input to Feasibility and Clinical Trial Design
Digital Trends that Are Changing Clinical Research
Health Literacy Throughout Drug Development – Why It Matters to Pharma and to Patients
Implementing an Innovation Methodology to Accelerate Clinical Trial Innovation within Your Organization

For more details on the Plenary Keynotes: www.scopesummit.com/keynotes
For more details on the Participant Engagement Award: www.scopesummit.com/participant-engagement-award

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: www.scopesummit.com/breakouts