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Tuesday, June 16 • 4:00pm - 5:00pm
#249 L: Dynamic Multi-Disciplinary Collaboration for Aggregate Product Safety Assessment and Benefit-Risk Planning

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Component Type: Session
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-20-690-L04-P; CME 1.00; IACET 1.00; RN 1.00

This session discusses the work of the Drug Information Association - American Statistical Association Aggregate Safety Assessment Plan (ASAP) and Benefit Risk Assessment Planning (BRAP) task forces. The ASAP promotes a systematic approach to safety planning and evaluation via collaboration of statisticians, epidemiologists, clinicians and other functional experts. The BRAP task force is working to improve collaboration and communications between disciplines within an organization and with regulatory agencies regarding benefit-risk assessments.

Learning Objectives

Describe a model of multidisciplinary collaboration for program-level safety assessment and benefit-risk planning; Cite key aspects of safety planning to consider at various product lifecycle stages including determining reference event rates; Recognize the benefits of proactive safety planning and ongoing aggregate safety evaluations; Discuss ways to enhance communication and collaboration between disciplines and with regulatory agencies regarding benefit-risk assessments.


Barbara A. Hendrickson, MD


Aggregate Safety Assessment in Ongoing Studies
Greg Ball, PhD

Survey of Benefit Risk Assessment Planning Practices
Michael Wright Colopy, PhD, MPH

Role of Epidemiology in Aggregate Safety Assessments
Susan Colilla, PhD, MPH

Benefit-Risk Assessment Planning
Lisa R Rodriguez, PhD

avatar for Barbara Hendrickson

Barbara Hendrickson

Immunology Therapeutic Area Head, Pharmacovigilance and Patient Safety, AbbVie, Inc., United States
Dr. Barbara Hendrickson is the Immunology Therapeutic Area Head in Pharmacovigilance and Patient Safety. She is a physician with subspecialty training in pediatrics and infectious diseases and has over 16 years of pharmaceutical industry experience. In addition, Dr. Hendrickson participates... Read More →
avatar for Greg Ball

Greg Ball

Senior Principal Biostatistician, Merck & Co., Inc., United States
Greg served in the Navy and taught HS math and physics before earning his MS in statistics from Purdue and PhD in biostatistics from the University of Texas. His research on blinded safety monitoring procedures is being developed in collaboration with statistical and clinical scientists... Read More →
avatar for Michael Colopy

Michael Colopy

Safety Statistics and Decision Scientist, UCB Biosciences
Mike Wright Colopy, MPH, PhD is a statistical safety scientist at UCB Biosciences in Research Triangle Park, USA. His focus is on Benefit-Risk Assessment, Patient Preference Elicitation, Safety / Benefit-Risk Estimands and Visualization. Mike is an active member of the ASA Safety... Read More →
avatar for Susan Colilla

Susan Colilla

Director and Lead, Epidemiology and RWE, Teva Pharmaceuticals
Susan is currently at Teva Pharmaceuticals leading an Epidemiology & RWE team within its GHEOR Department supporting Clinical Development, Medical Affairs and PV groups. She currently covers Respiratory and Pain/Psychiatric therapy areas at Teva. Prior to that she was at CSL Behring... Read More →
avatar for Lisa Rodriguez

Lisa Rodriguez

Lead Mathematical Statistician, OB, OTS, CDER, FDA
Dr. Lisa R. Rodriguez is a Team Leader in the Division of Biometrics V, supporting Division of Oncology Products 2. She obtained her Ph.D. degree in Statistics from Cornell University in 2005 and recently obtained a Strategic Decision and Risk Management Certificate from Stanford... Read More →

Tuesday June 16, 2020 4:00pm - 5:00pm EDT
TBD Virtual Event Horsham, PA 19044
  11: Statistics, Session