2023 Fierce Drug Safety Summit Presentations

Monday, February 27

• FDA Opening Presentation: Current State of REMS Initiatives

  • Claudia Manzo, Director, Office of Medication Error Prevention and Risk Management, FDA and Edward Millikan, PharmD, Senior Informatics Pharmacist Division of Mitigation Assessment and Medication Error Surveillance, OMEPRM, OSE, CDER, FDA

• Gain an Overview of Common Hidden REMS Costs and Learn How to Mitigate Them

  • Melissa Landers, Senior Principal, Shepherd Safety Services at Two Labs

• Case Study: Challenges and Opportunities with Development and Safety Surveillance in Low- and Middle-Income Countries (LMIC’s)

  • Jamie Wilkins, Head- Risk Management Center of Excellence- Worldwide Safety, Pfizer and Ekong Ekong, Disease Area Cluster Lead – Heme-Oncology, Pfizer

• Understand the Evolving Role Epidemiology has within Drug Safety in Creating Deeper Safety Profiles

  • Ryan Kilpatrick, Vice President & Head, Global Epidemiology, AbbVie

• MHRA Session: SafetyConnect – Transforming Our Vigilance System Capability

  • Kendal Harrison, Vigilance Collaborations Specialist, Medicines and Healthcare Products Regulatory Agency (MHRA)

• UBC Partnered Keynote: When to Start REMS Development and How to Create a Contingency Plan

  • Rachel Bonfanti, Director, Risk Management & Scientific Consulting, UBC

Tuesday, February 28

• Cross-Functional Initiatives for Risk Management Activities Across a Product’s Lifecycle

  • Cristina Damatarca MD, Senior Vice President, Drug Safety and Pharmacovigilance, Xenon Pharmaceuticals

• Navigate the Challenges within PV Agreement Development and Implementation to Comply with PV Regulations

  • Suzanne Guidera, Executive Director Pharmacovigilance Operations, Jazz Pharmaceuticals

• Completing the Risk Management Cycle: Risk Management Effectiveness Across US and EU

  • Lubna Merchant, MS, PharmD, Director at Risk Management Center of Excellence, Pfizer

• Completing the Risk Management Cycle: Risk Management Effectiveness Across US and EU

  • Gita Toyserkani, PharmD, MBA, Associate Director, Strategic Initiatives and Research, Office of Medication Error Prevention and Risk Management, Division of Mitigation Assessment and Medication Error Surveillance, FDA

• Meet Evolving FDA Computer System Validation Regulations by Revamping your Teams Data Integrity, Audit Trails, Workflows and Compliance Standards

  • Bill Haddock, VP of Safety and Quality, Ovid Therapeutics

•  Challenges and Lessons Learned in Applying Machine Learning to Pharmacovigilance

  • Shaun Comfort, Principal Science Enablement Leader, Genentech

• Best Practices to Consider when Conducting Post-Market Studies and REMS Activities in Combination Products

  • Khaudeja Bano, Vice President Combination Product Quality, Amgen

• Employ a Predictive Safety Mindset Early in a Drug’s Lifecycle to Develop a More Proactive and Comprehensive PV Plan

  • Michelle Geller, MD, Executive Medical Director, Global Patient Safety, Amgen

• Develop A Signal Evaluation Report for an Accurate Description of Signal Detection and Management

  • Ludmila Anderson MD, MPH, Medical Director, Risk Management Lead, Deciphera Pharmaceuticals

• Setting the Right Expectations for the Resources and Workload Involved in Developing a REMS Program

  • Suzanne Marinello, Senior Director, Risk Management and Patient Support, Chinook Therapeutics