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


Preliminary Agenda


Specimen Management and Innovation to Biomarker Discovery and Utilization

Steven Piccoli, PhD, Head, Clinical Biomarkers, Experimental Medicines, GlaxoSmithKline

Operational Management of Biomarker Analysis for Submission-Ready Data

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

Biomarker Considerations in Gene and Cell Therapy Trials

Heather Hirsch, PhD, Head of Clinical Biomarkers and Exploratory Research, CRSPR Therapeutics

Maximizing Specimen Assets in Oncology Clinical Trials

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


Returning Data and Results to Clinical Trial Participants

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

Experiences in Individual Study Participant Clinical Data Return

Jennifer Ribeiro, Informed Consent Process Lead, Global Clinical Documentation & Submissions, Global Clinical Operations, BMS

Consent for Biospecimens: The Basics

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


Patient-Centric Sample Collection to Enable Virtual Trials

Kevin Bateman, Distinguished Scientist & Scientific Associate Vice President, Merck & Co., Inc.

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


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:
For more details on the Participant Engagement Award:


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:


Stay on and attend Part 2 (Thurs-Fri): Clinical Biospecimens Technology and Outsourcing

For more details on the conference, please contact:
Marina Fishtinsky, MD

Executive Director, Conferences

Cambridge Healthtech Institute

Phone: (+1) 781.972.5496



For partnering and sponsorship information, please contact:

Companies A-K

Ilana Quigley

Senior Manager, Business Development

Cambridge Healthtech Institute (CHI)

Phone: (+1) 781.972.5457



Companies L-Z

Patty Rose
Senior Manager, Business Development

Cambridge Healthtech Institute (CHI)

Phone: (+1) 781.972.1349