NOAC Reversal Agent Think Tank Follow-up: Post Approval Safety and Effectiveness

White Oak Facility, FDA Headquarters • Silver Spring, Maryland• February, 3 2015
Meeting Agenda

Session TimeTopics & Speakers
8:00am-8:15am-Introduction– Philip Sager, MD (Stanford University/Sager Consulting Experts)
8:15am-8:30am-Projecting to the future: Peter Kowey, MD (Lankenau) (15min)
– Using PK/PD to inform NOAC reversal agent dosing: Should we consider pharmacometric-guided dosing of NOAC reversal agents to maximize the benefit: risk relationship?
– Post-marketing assessment of use in life-threatening bleeding situations will be critical for appropriate monitoring.
8:30am-10:15amUsing Pharmacokinetic and pharmacodynamic parameters to inform NOAC dosing: Should we consider pharmacometric-guided dosing of NOAC agents to maximize the benefit: risk relationship?
Lead Discussant- Philip Sager, MD (Stanford University/Sager Consulting Experts)
– Regulatory Considerations-Robert Temple, MD, PhD (FDA, CDER) (15min)
 Industry Considerations– Paul Reilly, PhD (Boehringer-Ingelheim)(15min)
– Clinical Perspective: What are the opportunities and challenges of using a pharmacometric approach? Jeffrey Weitz, MD (McMaster University) (15min)
Discussion (60min)10:15-10:30am Break (15min)
10:30am-12:45pmDefining the Data Elements for Safety and Effectiveness Monitoring of the NOAC Reversal Agents: For each perspective: What are examples of post marketing data you think are most appropriate to these types of products? What indications should be tracked and what information is needed for these indications? How strong does the level of evidence have to be to support safety? How strong to rule out inappropriate use?
Lead Discussant- Mitchell Krucoff, MD (Duke University)
– Clinical Considerations: Academic-James Reiffel, MD (Columbia University) (10min)
– Clinical Considerations: Emergency Medicine- Charles Pollack, MD (University of Pennsylvania) (10min)
– Regulatory Considerations– Victor Baum, MD (FDA Office of New Drugs/Biologics) (10min)
– Regulatory Considerations– Peter Waldron, MD (FDA CDER Office of Surveillance and Epidemiology/ CBER Office Of Biostatistics and Epidemiology) (10min)
– Payer Consideration: Private Payers, Hospital Systems
Lewis Sandy, MD (United Health Group) (10min)
Brian Caveney, MD (Blue Cross Blue Shield) (10min)
Discussion (75min)12:45pm- 1:15pm- Lunch Break (30min)
1:15pm- 2:45pmPotential Data sources for Surveillance: What are the advantages and disadvantages of each type of data? Can they provide what is required from earlier sessions? Implementing an Effective Post-Approval Active Surveillance Strategy: How can we best achieve the goals for safety and effectiveness monitoring? What types of data sources are out there? What are the strengths and weaknesses? What are acceptable methodologies for surveillance? What are the success cases/failures? What are limitations?
Lead Discussant- Troy Sarich, PhD (Janssen)
– Current Methodologies for Safety Surveillance
-AERS Reporting- Anne Tobenkin, PharmD (FDA)(10min)
Sentinel approach– Marsha Reichman, PhD (FDA) (10min)
-Direct-from-Patient Data Integrated with Electronic Medical Record Information- Kenneth Borow, MD (MediMergent) (10min)
Active PM surveillance and considerations for an active comparator – Paul Stang, PhD (Janssen)(10min)
Pharmacoepidemiology approaches and Big Data– Nancy Dreyer, PhD (Quintiles) (10min)
Discussion (40min)
2:45pm-3:30pmSummary- What should be our recommended Approach: Options for NOAC Reversal Agents: A Structured Roundtable Discussion
Moderator-Jonathan Seltzer, MD, MBA (ACI Clinic)