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Achieving Proof-of-Concept Success Starts in Candidate Selection | Cambridge, MA Seminar

Join our complimentary lunch & learn seminar in Cambridge, MA

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 30th, 2019

Catalyst Restaurant*

11:00am - 11:30am - Registration & Lunch (will be provided)

11:30am - 12:30pm - Seminar

12:30pm - 1:00pm -  Q&A and Networking

300 Technology Square

Cambridge, MA 02139

*They validate parking for Technology Square Garage located behind the restaurant at 800 Technology Square, Cambridge

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Seminar overview

Utilizing a data-driven approach during candidate selection is key when trying to achieve 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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