View more job listings or post a job
Genentech Scientist/ Senior Scientist, Small Molecule Pharmaceutics 
Genentech Senior Scientific Researcher_Bioanalysis
Jazz Pharmaceuticals Associate Director, Early Development Pharmacologist
UC Davis - Equine Analytical Chemistry Program LC/MS CHEMIST - STAFF RESEARCH ASSOCIATE 3        
Genentech Associate Scientist/Scientist - Biotransformation, Drug Metabolism And Pharmacokinetics (DMPK)
Jazz Pharmaceuticals Head of Toxicology
Dow Development Laboratories Formulation Chemist
Genentech Scientist, DMPK
Post a job


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; BioreclamationIVT; ICON PLC; Intertek Pharmaceutical Services; Medpace; MicroConstants; Quotient Sciences; Sekisui XenoTech, LLC; WORLDWIDE CLINICAL TRIALS
Registration deadline:2018-06-14  (it will close sooner if the seating cap is reached)

About the Topic


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

2019-10-11, Preclinical Development & IND (Investigational New Drug) Filing
┬ęPharmaceutical & BioScience Society, International; Last Modified: 8/20/2019; Visited: 1218; Admin Logon
Ads (in random order)
Submit a Text Ad
($250 for 2 months)

BIOTECH WEEK BOSTON - Sept. 9-12 Access over 5,000 of the most innovative scientific minds & business leaders in Boston and around the world. Learn More.
XCELERATE at Biotech Week Boston Driving the Future of the Life Science Industry. Sept. 11 at BCEC. Learn more.
UC Davis UC Davis LC/MS Confirmation Supervisor (Lab Rsch Supv 2) Apply Online: UC Davis is an AA/EOE
Submit a Text Ad