Jobs
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)
UC Davis - Equine Analytical Chemistry Program LC/MS CONFIRMATION SUPERVISOR (LABORATORY RESEARCH SUPERVISOR 2)  
Jazz Pharmaceuticals Head of Toxicology
Dow Development Laboratories Formulation Chemist
Genentech Scientist, DMPK
Post a job

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)Applied BioMath; ICON PLC; 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


2019-09-13, Biotransformation and Disposition of Larger Molecules: Peptides, Nucleotides, Proteins, mAbs, and ADCs
2019-10-03, Small-Molecule Bioanalytical Method Validation & Regulated Bioanalysis: Fundamentals, the New FDA Guidance and Regulatory Trends
2019-10-18, Physiologically Based Pharmacokinetic (PBPK) Modeling: Fundamentals, Regulatory Guidance & Applications
2019-11-12, Antibody Drug Discovery and Development: Hit Generation, Engineering, Cell-line Development, IND enabling studies, and Biosimilars
2019-12-10, In Vitro Diagnostics, Companion Diagnostics and Precision Medicine
2020-01-21, Best Practices for Clinical Trial Design
2020-02-11, Drug-Device Combination
2020-02-24, Advanced LC-MS/MS (Day1) & Interpretation of MS/MS CID Spectra (Day2)
2020-05-12, Regulated Large Molecule Bioanalysis: Fundamentals, the New FDA Guidance and Beyond
2020-05-22, No More Undruggables: Unconventional Approaches for Drug Discovery and Design - prodrugs, PROTACS, fragment-based design, directed evolution and beyond
2020-06-23, Advances in Immuno-Oncology (A Joint Symposium by PBSS and BioScience Forum)
┬ęPharmaceutical & BioScience Society, International; Last Modified: 8/20/2019; Visited: 1235; Admin Logon
Ads (in random order)
Submit a Text Ad
($250 for 2 months)

UC Davis UC Davis LC/MS Confirmation Supervisor (Lab Rsch Supv 2) Apply Online: http://50.73.55.13/counter.php?id=165482 UC Davis is an AA/EOE
XCELERATE at Biotech Week Boston Driving the Future of the Life Science Industry. Sept. 11 at BCEC. Learn more.
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.
Submit a Text Ad