Join our complimentary lunch & learn seminar at our new Garnet Valley, PA facility
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
Monday, June 24th, 2019
|Quotient Sciences - Garnet Valley Facility|
11:00am - 11:30am - Registration & Lunch (will be provided)
11:30am - 12:30pm - Seminar
12:30pm - 1:30pm - Q&A and Facility Tour
3080 McCann Farm Drive
*There will be plenty of self-parking spaces available for all attendees
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?