Speakers: David Lau (Foresee Pharmaceuticals), Geoff Banks (Nuventra), Mark Sale (Nuventra), Lauren Lohmer (Nuventra)
Organizers: Kelly Gelinne (Nuventra), David Lau (Foresee Pharmaceuticals)
Date: 12/11/2017
Time: 8:45-17:00
Registration fee (USD): Academic: $125; Regular: $195; For unemployed or students: $30; For major-sponsor rep (incl lunch): $0; For vendor-show rep: $35;
Location: SF Bay Area: Foster City Crowne Plaza
Major Sponsor: 
Vendor show vendors registered to date: (3)Applied BioMath; ICON PLC; WORLDWIDE CLINICAL TRIALS
Registration: https://www.PBSS.org
Registration deadline:12/8/2017  (it will close sooner if the seating cap is reached)

About the Topic

Preliminary Agenda

8:45 – 9:00 Welcome and Intro

9:00 – 10:30 – David Lau (Senior Vice President, NCE Preclinical and Clinical Development, Foresee Pharmaceuticals)

Purpose of Clin Pharm Studies in Drug Development

Type of Clin Pharm studies (SAD, MAD, BA/BE, DDI, Disease population, QT, etc)

• What are these studies
• When to do the studies
• Typical study design
• Examples

10:30 – 11:00 – Break and Vendor Presentation

11:00 – 12:30 – Geoff Banks (CEO, Nuventra)

How to Form a Clin Pharm Strategy for your NDA / BLA

• What studies you do & don’t need
• “Gap analysis” in your program
• Real world examples

12:30 – 1:30 – Lunch

1:30 – 3:00 – Mark Sale (Senior Vice President, Pharmacometrics, Nuventra)

Modeling & Simulation / Population PK Fundamentals

• What is it?
• How do you do it?
• Allometric scaling
• How do you use it for safety and efficacy?

3:00 – 3:30 Break and vendor presentation

3:30 – 5:00  – Mark Sale and Lauren Lohmer (Manager, Clinical Pharmacology, Nuventra)

Using Modeling & Simulation to Avoid Clinical Trials

• Overview and case studies:
  • CQT
  • Exposure response
  • Additional DDI studies
  • Special population studies
  • Renal impairment