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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