EmBRACEing Collaborations for Benefit-Risk Decision Making

Moderator(s)

• 

  Priya Bahri, PhD

  Senior Lead
  European Medicines Agency (EMA)
  Amsterdam, Netherlands
• 

  Caitlin Knox, PhD MPH FISPE (she/her/hers)

  Sr Dir, Pharmacoepidemiology
  Regeneron Pharmaceuticals, United States

Presentations:

• 1:30 PM – 1:45 PM CEST

  Use of Hydrochlorothiazide in the United States Following Label Update About Skin Cancer Risk
  

  Co-Author: Cheng Chen, PhD – Office of Surveillance and Epidemiology, Center for Drug Evaluation and Research, Food and Drug Administration, Silver Spring, MD, USA

  Co-Author: Efe Eworuke – Epidemiology and Drug Safety, Real World Solutions, IQVIA, Washington DC, USA

  Co-Author: Ashish Rai, PhD, MSPH, MBBS – Department of Population Medicine, Harvard Pilgrim Health Care Institute

  Co-Author: Laura Hou – Department of Population Medicine, Harvard Pilgrim Health Care Institute, Boston, MA, USA

  Co-Author: Jenice S. Ko – Department of Population Medicine, Harvard Pilgrim Health Care Institute, Boston, MA, USA

  Co-Author: Mary Ross Southworth – Division of Cardiology and Nephrology, Center for Drug Evaluation and Research, Food and Drug Administration, Silver Spring, MD, USA

  Co-Author: José J. Hernández-Muñoz, RPh, MPH, MSc, PhD – Office of Surveillance and Epidemiology, Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, USA

  Presenting Author: Mingfeng Zhang, MD, PhD – Office of Surveillance and Epidemiology, Center for Drug Evaluation and Research, Food and Drug Administration
• 1:45 PM – 2:00 PM CEST

  The Teratogenic Risk Impact and Mitigation (TRIM) Tool: Development of explicit criteria for teratogenicity risk mitigation programs
  

  Presenting Author: Celeste LY Ewig, PharmD – University of Florida

  Co-Author: Yanning Wang, MS – University of Florida, Department of Pharmaceutical Outcomes & Policy

  Co-Author: Nicole E. E. Smolinski, PharmD – University of Florida

  Co-Author: Gita A. Toyserkani, PharmD, MBA – US Food and Drug Administration

  Co-Author: Cynthia LaCivita, PharmD – US Food and Drug Administration

  Co-Author: Leila Lackey – Center for Drug Evaluation and Research, U.S. Food and Drug Administration

  Co-Author: Sara Eggers – Center for Drug Evaluation and Research, U.S. Food and Drug Administration

  Co-Author: Thuy N. Thai, MPH, PhD (she/her/hers) – Department of Population Medicine, Harvard Medical School and Harvard Pilgrim Health Care Institute

  Co-Author: Judith C. Maro, PhD – Department of Population Medicine, Harvard Medical School and Harvard Pilgrim Health Care Institute

  Co-Author: Sonja A. Rasmussen, MD – Department of Genetic Medicine, Johns Hopkins School of Medicine

  Co-Author: Almut G. Winterstein, PharmD, PhD, FISPE (she/her/hers) – University of Florida, Pharmaceutical Outcomes & Policy and Center for Drug Evaluation and Safety
• 2:00 PM – 2:15 PM CEST

  Risk of Prenatal Exposure to Teratogenic Medications: Development of Evidence for the Teratogenic Risk Impact and Mitigation (TRIM) Tool
  

  Presenting Author: Yanning Wang, MS – University of Florida, Department of Pharmaceutical Outcomes & Policy

  Co-Author: Celeste LY Ewig, PharmD – University of Florida

  Co-Author: Nicole E. E. Smolinski, PharmD – University of Florida

  Co-Author: Gita A. Toyserkani, PharmD, MBA – US Food and Drug Administration

  Co-Author: Cynthia LaCivita, PharmD – US Food and Drug Administration

  Co-Author: Esther H. Zhou, MD, PhD – U.S. Food and Drug Administration

  Co-Author: Thuy N. Thai, MPH, PhD (she/her/hers) – Department of Population Medicine, Harvard Medical School and Harvard Pilgrim Health Care Institute

  Co-Author: Judith C. Maro, PhD – Department of Population Medicine, Harvard Medical School and Harvard Pilgrim Health Care Institute

  Co-Author: Sonja A. Rasmussen, MD – Department of Genetic Medicine, Johns Hopkins School of Medicine

  Co-Author: Almut G. Winterstein, PharmD, PhD, FISPE (she/her/hers) – University of Florida, Pharmaceutical Outcomes & Policy and Center for Drug Evaluation and Safety
• 2:15 PM – 2:30 PM CEST

  The Teratogenic Risk Impact and Mitigation (TRIM) Tool: Development of Scoring Weights to Prioritize Medications for Risk Management Beyond Labelling
  

  Presenting Author: Judith C. Maro, PhD – Department of Population Medicine, Harvard Medical School and Harvard Pilgrim Health Care Institute

  Co-Author: Celeste LY Ewig, PharmD – University of Florida

  Co-Author: Yanning Wang, MS – University of Florida, Department of Pharmaceutical Outcomes & Policy

  Co-Author: Nicole E. E. Smolinski, PharmD – University of Florida

  Co-Author: Gita Toyerskani – Center for Drug Evaluation and Research, U.S. Food and Drug Administration

  Co-Author: Cynthia LaCivita, PharmD – US Food and Drug Administration

  Co-Author: Leila Lackey – Center for Drug Evaluation and Research, U.S. Food and Drug Administration

  Co-Author: Sara Eggers – Center for Drug Evaluation and Research, U.S. Food and Drug Administration

  Co-Author: Esther H. Zhou, MD, PhD – U.S. Food and Drug Administration

  Co-Author: Thuy N. Thai, MPH, PhD (she/her/hers) – Department of Population Medicine, Harvard Medical School and Harvard Pilgrim Health Care Institute

  Co-Author: Sonja A. Rasmussen, MD – Department of Genetic Medicine, Johns Hopkins School of Medicine

  Co-Author: Almut G. Winterstein, PharmD, PhD, FISPE (she/her/hers) – University of Florida, Pharmaceutical Outcomes & Policy and Center for Drug Evaluation and Safety
• 2:30 PM – 2:45 PM CEST

  The nature of uncertainties on the benefit-risk balance of anticancer medicines at initial marketing authorisation in the European Union
  

  Presenting Author: Anne Taams, MSc – Dutch Medicines Evaluation Board

  Co-Author: Carla Herberts – Department Regulatory affairs, uniQure, Amsterdam, The Netherlands

  Co-Author: Lourens T. Bloem, PharmD, PhD (he/him/his) – Division of Pharmacoepidemiology and Clinical Pharmacology, Utrecht Institute for Pharmaceutical Sciences (UIPS), Utrecht University

  Co-Author: Toine Egberts – Division of Pharmacoepidemiology and Clinical Pharmacology, Utrecht Institute for Pharmaceutical Sciences, Utrecht University, Utrecht, the Netherlands

  Co-Author: Francesco Pignatti, MD – European Medicines Agency

  Co-Author: Nikolaos Zafiropoulos – European Medicines Agency, Amsterdam, the Netherlands
• 2:45 PM – 3:00 PM CEST

  Impact of Risk Evaluation and Mitigation Strategies on Teratogenic Medications Among Publicly and Privately Insured Reproductive-Age Women
  

  Presenting Author: Yanmin Zhu, MS, PhD – Brigham and Women's Hospital and Harvard Medical School

  Co-Author: Priyanka Anand, MBBS, MPH – Division of Pharmacoepidemiology and Pharmacoeconomics, Dept of Medicine, Brigham and Women's Hospital

  Co-Author: Ameet Sarpatwari, PhD, JD (he/him/his) – Brigham and Women's Hospital / Harvard Medical School

  Co-Author: Sonia Hernandez-Diaz, MD, DrPH – Harvard T.H. Chan School of Public Health

  Co-Author: Katsiaryna Bykov, PharmD, ScD – Division of Pharmacoepidemiology and Pharmacoeconomics, Department of Medicine, Brigham and Women’s Hospital and Harvard Medical School

  Co-Author: Mufaddal Mahesri, MD, MPH (he/him/his) – Division of Pharmacoepidemiology and Pharmacoeconomics, Department of Medicine, Brigham and Women's Hospital, Harvard Medical School

  Co-Author: Elyse C. DiCesare, BA – Division of Pharmacoepidemiology and Pharmacoeconomics, Brigham and Women's Hospital and Harvard Medical School

  Co-Author: Heidi Zakoul, BA – Brigham and Women's Hospital - Division of Pharmacoepidemiology

  Co-Author: Seanna Vine – Division of Pharmacoepidemiology and Pharmacoeconomics, Department of Medicine, Brigham and Women’s Hospital

  Co-Author: Helen Mogun – Brigham and Women's Hospital

  Co-Author: Gita A. Toyserkani, PharmD, MBA – US Food and Drug Administration

  Co-Author: Cynthia LaCivita, PharmD – US Food and Drug Administration

  Co-Author: Esther H. Zhou, MD, PhD – U.S. Food and Drug Administration

  Co-Author: Claudia B. Manzo, PharmD – FDA

  Co-Author: Gerald J. Dal Pan, MD, MHS – US Food and Drug Administration

  Co-Author: Krista F. Huybrechts, PhD, MS – Division of Pharmacoepidemiology and Pharmacoeconomics, Department of Medicine, Brigham and Women’s Hospital and Harvard Medical School