6th American Conference on Pharmacometrics (ACoP6)
Pre-conference

“Enabling Environments in Which Pharmacometrics and Biostatistics Help Produce Robust Development and Regulatory Strategies”

Co-chairs: Vikram Sinha (FDA) and Brian Smith (Novartis)

October 4th, 2015 in Arlington, Virginia

This preconference meeting will address the role and scope of modeling and simulation (M&S) throughout the drug development process with a focus on the role of pharmacometrics and biostatistics. Challenges faced by pharmacometricians and statisticians regarding modeling and simulation in drug development and strategies to foster and advance appropriate use of modeling and simulation across disciplines will be discussed.

Specific use of M&S in the following areas will be discussed:
  • Role of M&S for a trial/program design (e.g. pediatrics)
  • Subgroup analysis
  • Case Studies
Speakers will include experts from pharmacometrics and biostatistics from industry, regulatory agencies and academia. The format will be brief presentations on the following topics and a panel discussion on specific topics with three panel sessions.
  1. Structure and role of groups connected to modeling and simulation in industry and regulatory agencies 
  2. Trial Simulation, Sub-group Analysis
  3. Case studies
Sunday October 4, 2015
7:00 AM  8:00 AM  Breakfast and Registration for ACoP6 Pre-conference      
8:15 AM 8:30 AM Opening Session Vikram Sinha and Brian Smith, Pre-conference Co-chairs
8:30 AM 11:30 AM Groups Connected to Modeling and Simulation: Role, Accountability, and Skill Sets Hosted by Vikram Sinha (FDA), Brian Smith (Novartis)
   

Notable Contributor Presentation (30 min)

Gary Rosner (Johns Hopkins University)
   

What We are Trying to Do – Industry Perspective (30 min)

Peter Bonate (Astellas)
   

What We are Trying to Do – EMA Perspective (30 min)

Ine Skottheim Rusten (MSWG, EMA)
   

What We are Trying to Do – FDA Perspective (30 min)

Lisa Lavange (FDA)
   

Break (15 min)

  
   

Panel Discussion (45 min)

All AM Speakers, Issam Zineh (FDA)
11:00 AM 1:15 PM

Lunch / Poster Session

  
1:15 PM 2:15 PM Trial Simulation and Sub-group Analysis Hosted by Vikram Sinha (FDA), Brian Smith (Novartis)
    Identifying subgroups in an era of personalized medicine: Impact on drug development – Industry Perspective (30 min) Ilya Lipkovich (Quintiles)
    Subgroup identification: challenges to the current regulatory paradigm and potential solutions offered by modeling and simulation – Regulatory Perspective (30 min) Yaning Wang (FDA)
2:15 PM 3:15 PM Case Examples: Close Collaborations, Positive or Negative, and How Should It be Resolved Hosted by Vikram Sinha (FDA), Brian Smith (Novartis)
    Industrial Case Example (30 min) Jose Pinheiro (Johnson & Johnson)
    Regulatory Case Example (30 min) Aloka Chakravarty (FDA)
3:15 PM 4:00 PM

Panel Discussion:

  • Challenges faced by pharmacometrics and statisticians regarding M&S in drug development
  • Strategies to foster appropriate use of M&S across disciplines as well as strategies to advance M&S efforts
  • Regulatory acceptance

Hosted by Vikram Sinha (FDA), Brian Smith (Novartis)

All PM Speakers
4:00 PM 4:15 PM

Closing Remarks

Vikram Sinha (FDA), Brian Smith (Novartis)
 
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