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Small Molecule Formulation Development: Strategies for challenging APIs (jointly with AAPS-BADG)

Speakers: Tom Chiang (Genentech), Vahid Zia (Gilead), Andrew Phimister (Seaview Pharma Solutions), et al.
Organizers: Vibha Puri (Genentech), Edward Yost (Genentech), Lu Lu (WuXi AppTec), Rajiv Nayar (HTD Biosystems Inc.), Shichang Miao (ChemoCentryx)
Date: 9/27/2018
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; Quotient Sciences
Vendor show vendors registered to date: (9)Absorption Systems; BioDuro; Concept Life Sciences; CoreRx, Inc.; Foster Delivery Science, Inc; Nitto Avecia Pharma Services; Pion Inc.; Q2 Solutions; Zef Scientific
Registration deadline:9/26/2018  (it will close sooner if the seating cap is reached)

About the Topic

The pharmaceutical industry is focusing on more challenging biological targets to address unmet medical needs. These new targets are increasingly more difficult to drug due to their lipophilicity and complex mode of actions. Medicinal chemists are therefore creating new molecular entities that often have low solubility, permeability, or both low solubility and permeability. This requires scientists to challenge the current formulation development paradigm.  Identifying innovative strategies for drug development helps to shift the industry from empirical to more mechanistic approaches. The benefit is the ability to have flexible formulation strategies that can adjust to meet pre-clinical and clinical demands, while also meeting the requirements of a dynamic regulatory environment. This workshop will survey current formulation practices and how they are changing to address challenging APIs.  The evolving science includes knowing new technologies and how to take advantage of them.  Furthermore, discussions will focus on the mechanistic understanding of formulations which help to ensure successful drug products that meet quality-by-design (QbD) regulatory requirements.

This workshop will cover the following topics:

  • Overview of formulation development — pre-clinical to market image formulation
  • Essential DMPK concepts for the formulation scientists
  • New analytical tools and strategies for formulation development
  • Material sparing approaches to reduce cost and time while increasing formulation understanding
  • Particle engineering to address poor API PK properties
  • Regulatory and clinical requirements for a successful drug product

Workhop Agenda

8:00 – 8:45 am   Registration

8:45 – 9:00 am   Introduction

9:00 – 9:50 am   “Practical Application of Biopharmaceutical Tools to Guide Formulation Strategy” - Andrew Phimister – Seaview Pharma Solutions

9:50 – 10:40 am   “An integrated approach to evaluate the solubility target for salts for the oral drug delivery” - Tom Chiang - Genentech

10:40 – 11:00 am   Break

11:00 – 11:10 am   Sponsor presentation

11:10 – 12:00 pm   “Enhancing Biopharmaceutical Properties of Poorly Soluble Compounds: Formulation and Process Development” - Vahid Zia – Gilead

12:00 – 1:20 pm   Lunch

1:20 – 2:10 pm   “Formulation Strategies for High Dose Toxicology Studies” Dennis Leung – Genentech

2:10 – 3:00 pm   “Formulating Challenging API with Liposomal technologies:  Challenges, Limitations, and Opportunities” - Rajiv Nayar – HTD Biosystems

3:00 – 3:15 pm   Break

3:15 – 3:25 am   Sponsor presentation

3:25 – 4:15 pm   “Late-Stage Formulation Development Challenges” - Ravi Mahalingam – ReechPharma

4:15 – 4:45 pm   Panel Discussion

4:45 – 5:00 pm   Closing Remarks

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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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