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Thursday, June 28 • 9:00am - 10:15am
#404: Biologics and Biosimilars: Payers, Industry, and Academia Collaborating on Post-Marketing Surveillance

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Component Type: Forum
Level: Basic
CE: ACPE 1.25 Knowledge UAN: 0286-0000-18-688-L04-P; CME 1.25; IACET 1.25; RN 1.25

Once seen as unreliable when compared to randomized control trials, use of real world evidence (RWE) beyond traditional observational studies is gaining traction. The focus of this forum is to describe how a collaborative effort—involving payers, industry, academia, medical societies, and regulators—strategically influences real world data (RWD) and RWE improvements that are achievable in the near term. The panel’s focus will be on real-life examples from our multi-stakeholder collaboration.

Learning Objectives

Analyze the payer/industry/academia collaboration on surveillance of biologics and biosimilars and the fit-for-purpose outcomes from this collaboration; Discuss the role of BBCIC's multi-stakeholder approach to driving solutions for FDA regulatory use cases; Describe real world evidence (RWE) and real-world data (RWD) and how they intersect to reduce time and cost of creating evidence.


Charles E Barr, MD, MPH


Payer Contributions to Biosimilar Safety Surveillance
Kevin Haynes, PharmD

Pharmaceutical Industry Experience With Biosimilar Post-Marketing Safety
Hillel Cohen, PhD

Research Challenges in Biosimilar Safety and Surveillance
Nancy Lin, DrSc, MS

avatar for Charles Barr

Charles Barr

Chief Science Officer, BBCIC, AMCP BBCIC, LLC
Dr. Charles Barr is Chief Science Officer at AMCP Biologics and Biosimilars Collective Intelligence Consortium. He worked in academic medicine, industry and research (clinical trials, registries & RWD). He was Group Medical Director and Head, Strategy & External Relationships in US... Read More →
avatar for Hillel Cohen

Hillel Cohen

Executive Director, Scientific Affairs, Sandoz Inc., United States
Dr. Hillel P. Cohen PhD is Executive Director of Scientific Affairs at Sandoz, helping explain the principles of biosimilars and biosimilar policies to the healthcare community, patient advocacy groups, and health authorities. He has published and given presentations in the areas... Read More →
avatar for Kevin Haynes

Kevin Haynes

Director of Clinical Epidemiology, HealthCore Inc.
Kevin Haynes, PharmD, MSCE is a Director of Clinical Epidemiology at HealthCore, Inc. and Adjunct Scholar and an Adjunct Assistant Professor of Epidemiology at the University of Pennsylvania Perelman School of Medicine. He has had extensive collaborations with the FDA and serves as... Read More →
avatar for Nancy Lin

Nancy Lin

Senior Scientist, Epidemiology, Optum
Nancy Lin, ScD, is Senior Scientist, Epidemiology at Optum. A pharmacoepidemiologist, her primary research interests include applications for enriched electronic healthcare data systems to enhance surveillance and assessment of drug and biologics use, safety, and effectiveness. At... Read More →

Thursday June 28, 2018 9:00am - 10:15am EDT
Room 204AB Boston Convention and Exhibition Center 415 Summer Street, Boston, MA 02210 USA
  01: ClinSafety-PV, Forum
  • Level Beginner
  • Featured Topics Biosimilars
  • format json
  • Featured Topics Real World Evidence,Biosimilars
  • Credit Type ACPE, CME, IACET, RN
  • Tags Forum