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Understanding and Overcoming High Clearance and Poor Bioavailability: Fundamentals, Investigations and Strategies for Drug Discovery

Speakers: Matthew Wright (Genentech), Vahid Zia (Gilead), Simon Wong (Genentech), Eugene Chen (Genentech), Jaochim Rudolph (Genentech), John Link (Gilead), Fabio Broccatelli (Genentech), Bernard Murray (Gilead)
Organizers: Matthew Wright (Genentech)
Date: 5/22/2018
Time: 8:45-17:00
Registration fee (USD): Regular: $195; Academic: $125; For unemployed or students: $30; For vendor-show rep: $35; For major-sponsor rep (incl lunch): $0;
Location: SF Bay Area: Foster City Crowne Plaza
Major Sponsor: (2)Catalent Pharma Solutions; Worldwide Clinical Trials
Vendor show vendors registered to date: (18)Absorption Systems; ACROBiosystems; BioDuro; Celerion; ChemPartner; Cyprotex; Cytovier; Foster Delivery Science; Intertek; Pacific BioLabs; Pion Inc.; Q2 Solutions; QPS; Quotient Sciences; Sekisui XenoTech, LLC; Selvita Inc.; Seventh Wave; Simulations Plus, Inc.
Registration deadline:5/21/2018  (it will close sooner if the seating cap is reached)

About the Topic

Poor exposure following oral administration is a common challenge facing discovery programs and consequently a frequent focus for DMPK scientists. Frequently, potent compounds cannot be further developed due to less-than-ideal ADME (absorption, distribution, metabolism, and excretion) properties that prevent the compounds to be available following oral administration. Beyond the discovery phase the importance of understanding and optimizing oral exposure continues in the preclinical and ultimately clinical phases of drug development. Inadequate oral exposure could be due to suboptimal physicochemical properties, or problems in absorption from the gut, or first-pass metabolism in the gut and liver, or high intrinsic clearance of the compounds.

The focus of this workshop/symposium is on: 1) to identify and learn about the issues that contribute to low oral exposure, 2) to discuss approaches that one could use to overcome those challenges, 3) to present additional methodologies that can aid in solving exposure problems and 4) to provide suggestions on how to work with partners in Medicinal Chemistry and Biological Sciences within Project Teams.

This workshop/symposium will cover the following topics:

  • Pharmacokinetic concepts – absorption, bioavailability, and clearance factors contributing to low oral exposure
  • Physiological factors that affect oral exposure
  • Physicochemical factors that influence oral exposure
  • Metabolism-based issues that give rise to poor oral exposure
  • Transporter-based issues that give rise to poor oral exposure
  • How to identify the source of problem in oral exposure – properties of the molecules or conditions of the experiment?
  • Biopharmaceutical Aspects of oral drug exposure
  • Approaches to overcome oral exposure issues, including case studies
  • Enabling Exposure of ADME Challenged compounds
  • What do Medicinal Chemists/Biologists want and how can we work with them

Workshop Agenda:

8:45 - 8:50am  PBSS Welcome M. Wright

8:50 - 9:25am  1. Pharmacokinetic Concepts (Matthew Wright)

9:25 – 10:00 am  2. Absorption of Drugs from the GI Tract (Vahid Zia)

10:00 - 10:20am  Major Sponsor Presentation Worldwide Clinical Trials

10:20 - 10:35am  Break

10:35 - 11:20pm  3. Metabolism-based issues in oral bioavailability (Simon Wong)

11:20 – 12:00 pm  4. Transporter-based issues in oral bioavailability (Eugene Chen)

12:00 - 1:00pm  Lunch

Minisymposium Agenda:

1:00 – 1:45 pm 1. Enabling Technologies to achieve oral exposure (Jaochim Rudolph)

1:45 – 2:30 pm  2. Working in non-Lipinski Space - Discovery of GS-5885 (Ledipasvir) (John Link)

2:30 - 2:45pm  Major Sponsor Presentation Vendor name TBD

2:45 - 3:00pm  Break

3:00 - 3:45pm  3. In silico applications (Fabio Broccatelli)

3:45 – 4:00 pm Break

4:00 - 4:45pm  4. Characterization and differentiation of apparently metabolically stable compounds (Bernard Murray)

4:45 - 5:00pm  Wrap-up (Matthew Wright)

2019-02-07, Covalent Inhibitor Drug Discovery & Development: Biology, Chemistry, PK, Safety and Case Studies (Jointly with Bay Area PKPD Network)
2019-03-07, Promising Therapeutic Approaches and Translational Medicine to Advance Novel Therapeutics (A Joint Symposium by PBSS and Stanford SPARK Program)
2019-03-11, Clinical Trials Essentials: An Intensive One-Week Course (register for the full week or half day sessions)
2019-04-25, Save the Date: Tox-21 (jointly by SOT-NorCal & PBSS)
2019-05-06, CMC Development for Biologics
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