Workshop
Clinical Pharmacology & Modeling Strategies for your Drug Development Program: Fundamentals, Best Practices and Real World Applications
Speakers:
David Lau (Foresee Pharmaceuticals), Geoff Banks (Nuventra), Mark Sale (Nuventra), Lauren Lohmer (Nuventra)
Organizers:
Kelly Gelinne (Nuventra), David Lau (Foresee Pharmaceuticals)
Date:
2017-12-11
Time:
8:45-17:00 Pacific Time
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:
(4)Altasciences; Applied BioMath; Spaulding Clinical Research; WORLDWIDE CLINICAL TRIALS
Registration: http://www.PBSS.org
Registration deadline:2017-12-08
(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
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