Integrated Pre-Formulation Studies for Fast Advancement of Drug Candidates to Human Clinical Studies

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Looking for a fast pathway to an investigational new drug application (IND) for your new drug candidates? This webcast will discuss strategies to select the most developable molecules and quickly develop an IND-ready formulation within 8–12 weeks using real-world case studies. Live: Wednesday, April 15, 2020 at 11am EDT | 8am PDT | 4pm BST | 5pm CEST On demand available after airing until Apr. 15, 2021 Register free

Register free: http://www.pharmtech.com/pt_w/pre_formulation

Event Overview:

The development cost and timeline for a new drug is increasing due to high attrition rates caused by inadequate physicochemical and biopharmaceutical attributes, unacceptable safety, and sub-marginal efficacy. This development attrition rate can be reduced by strengthening efficacy and toxicity screens and establishing a developability screen to enable selection of developable compounds to move to the clinic. It is critical to select right formulation principles for efficacy and toxicity screens, and equally important to run developability screens by:

  • Physicochemical characterization of new chemical entities

  • Salt form and polymorph form selection

  • Preclinical formulation development

  • Integrated pharmacokinetic testing and profiling

  • Drug delivery technologies to enable oral bioavailability of poorly water-soluble compounds

Key Learning Objectives:

Learn how to select the most developable drug candidate for development

Learn how to quickly develop Phase 1 formulation

Learn how to apply drug delivery technologies for enhancing the oral bioavailability of poorly water-soluble molecules

Speakers: Liang Mao, Director, Developability and Formulation Research, WuXi STA

Andrew Phimister, CMC Consultant, WuXi STA

Time and date: Wednesday, Apr. 15, 2020 at 11am EDT | 8am PDT | 4pm BST | 5pm CEST

On demand available after airing until Apr. 15, 2021

Sponsor: STA Pharmaceutical Co., Ltd., a subsidiary of WuXi AppTec (WuXi STA)

Register free: http://www.pharmtech.com/pt_w/pre_formulation