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Workshop

Clinical Pharmacology & Modeling Strategies for your Drug Development Program: Fundamentals, Best Practices and Real World Applications


Speakers: Shawn Flanagan (Cidara Therapeutics), Geoff Banks (Nuventra), Mark Sale (Nuventra), Lauren Lohmer (Nuventra)
Organizers: Voon Ong
Date: 2018-06-15
Time: 8:45-17:00 Pacific Time
Registration fee (USD): Regular: $195; For unemployed or Academic: $30; For major-sponsor rep: $0; For vendor-show rep: $35
Location: Courtyard by Marriott San Diego Sorrento Valley, 9650 Scranton Rd, San Diego, CA 92121
Major Sponsor:
Vendor show vendors registered to date: (9)AIT Bioscience; Altasciences; BioreclamationIVT; Intertek Pharmaceutical Services; Medpace; MicroConstants; Quotient Sciences; Sekisui XenoTech, LLC; WORLDWIDE CLINICAL TRIALS
Registration: http://www.PBSS.org
Registration deadline:2018-06-14  (it will close sooner if the seating cap is reached)

About the Topic

Agenda

8:45 – 9:00     Welcome and Intro

9:00 – 10:30     Purpose of Clin Pharm Studies in Drug Development (Shawn Flanagan, Vice President, Clinical Pharmacology, Cidara Therapeutics)

  • 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     How to Form a Clin Pharm Strategy for your NDA / BLA (Geoff Banks, CEO, Nuventra)

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

12:30 – 1:30     Lunch

1:30 – 3:00     Modeling & Simulation / Population PK Fundamentals (Mark Sale, Senior Vice President, Pharmacometrics, Nuventra)

  • 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     Using Modeling & Simulation to Avoid Clinical Trials (Mark Sale and Lauren Lohmer, Manager, Clinical Pharmacology, Nuventra)

  • Overview and case studies
    • CQT
    • Exposure-response
    • Additional DDI studies

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