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Achieving Proof-of-Concept Success Starts in Candidate Selection | San Diego Seminar

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Title: Achieving Proof-of-Concept Success Starts in Candidate Selection

How correlating your API characteristics with your drug product goals supports efficient transition from candidate selection through to Proof-of-Concept


Date /Time Location

Thursday, May 16th, 2019

Green Acre Nautilus*

3:00pm - 3:30pm - Registration

3:30pm - 4:30pm - Seminar

4:30pm - 6:00pm -  Cocktail and Appetizer Networking Reception

Nautilus B,

3535 General Atomics Ct,

San Diego, CA 92121

*Parking is available on all sides of the Nautilus 3 building and between buildings 2, 3, & 4.

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Seminar overview

Utilizing a data-driven approach during candidate selection is key when trying to acheive proof-of-concept success. By applying key strategies during the preclinical stage, such as salt and polymorph screening and prototype selection, you are able to gain a complete understanding of the characteristics of your API which will help determine your target product profile and dosage form selection. Getting a clear picture early on of the safety and efficacy of your drug product will help your program advance effectively and efficiently into first-in-human and then quickly transition through to proof-of-concept and beyond.

Key learning objectives:

•  The importance of salt and polymorph screening and prototype selection for pre-clinical assessment

•  DCS assignment with in-vitro techniques and modelling data to drive clinical formulation technology selection

•  Choosing the appropriate dosage form for first-in-human/Phase I trials (Compounding or GMP manufacturing) – how to balance cost, time and dose flexibility?

•  Challenges with poorly soluble molecules in early development – what technologies can we deploy?

•  Bridging to robust and scalable Phase II drug products – how to avoid losing time in development?

Drug product development

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