Pre-clinical screening of oral small molecules and assessing multiple technologies in parallel
As an industry, there is a relatively high failure rate in bringing new molecules from discovery to a successful conclusion in phase 1. The reasons for this are rather complex, and combined with a need for secrecy, it can be difficult to understand how to avoid repeating mistakes in future programs. This talk will provide an overview of a structured approach that can be applied to oral small molecules where there is interest in progressing from discovery to phase 1 clinical studies, with a view to preventing some of the more likely problems, and to utilize commercially proven technologies and excipients with an efficient path to commercialization. The key steps are:
- Choose the right molecule. Advice on how to evaluate molecules from a shortlist of a “best few” using in-silico evaluation.
- Know your molecule. The importance of API form and properties on Bioavailability and dosage form development.
- Select the right formulation technology. Complex molecules require a sophisticated toolkit. How to select a delivery technology that will accelerate development, optimize exposure and enable dose-escalation.
- Optimize your molecule’s potential. Why applying the right technologies early in the process can optimize the drug development process.
Key Learning Objectives
- In-silico tools to decide which molecule to progress to dosage form development.
- Use of molecule characterization as a way to de-risk a program from a dosage form development perspective.
- Understand how a structured, high throughput, parallel screening approach can expedite preclinical development
- Learn how enabling technologies such as lipid based formulation, solid dispersion and particle size engineering can be applied.
Date and Location
Thurs Mar 15th, 2018
Registration: 5:30 PM
Hanover Marriott1401 Rt 10 East,
Whippany, NJ 07981
About the speaker
Stephen holds a Bachelor’s degree in Chemistry and Analytical Science from Loughborough University, UK. He has worked at Catalent for 30 years, holding positions in R&D responsible for Formulation, Process Development and also for clinical and commercial Operations. Stephen specializes in solving complex data analysis challenges such as low bioavailability and atypical analytical data (such as investigations for OOS Dissolution or related substances). Stephen is part of Catalent’s Science and Technology Team and is based at the Company Headquarters in Somerset, New Jersey.
Registered and paid online: $50.00
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