SEMINAR

Register now for our 'Achieving Proof-of-Concept' US Seminar Series

Achieving Proof-of-Concept US Seminar Series

Join our complimentary US seminar series


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


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?

Locations

South San Francisco, CA - Tuesday, May 14th, 2019     Learn more 

San Diego, CA - Thursday, May 16th, 2019   Learn more 

Cambridge, MA - Thursday, May 30th, 2019   Learn more

Garnet Valley, PA - Monday, June 24th, 2019   Learn more

Drug product development

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