PBSS Workshop Clinical Pharmacology & Modeling Strategies for your Drug Development -2017-12-11

Event Information
Event Name: 
PBSS Workshop Clinical Pharmacology & Modeling Strategies for your Drug Development
Event Date: 
12/11/2017 - 8:30am
Event Location: 
SF Bay Area: Foster City Crowne Plaza
Event Details
Event Type: 
Panel Discussions
Event Details: 

PBSS Workshop, Monday, Dec. 11, 2017

Event Name: 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)
Date and Time: Monday, Dec. 11, 2017, 8:45-17:00
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:
o CQT
o Exposure response
o Additional DDI studies
o Special population studies
o Renal impairment

Location: SF Bay Area: Foster City Crowne Plaza
Registration fee (US$): Academic: $125; Regular: $195; For unemployed or students: $30; For major-sponsor rep (incl lunch): $0; For vendor-show rep: $35;
Details and registration at http://www.pbss.org/aspx/eventInfo.aspx?eID=557
Registration deadline:12/8/2017 (it will close sooner if the seating cap is reached)
This is a friendly reminder that you have not registered for the following Workshop . If you plan to attend, please register at www.pbss.org before it is closed (it may close BEFORE the deadline if the seating capacity is reached early).