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'Maximising formulation flexibility in First-In-Human trials'
Thursday 12 November, 10:00 - 11:00 GMT
Kindly hosted by Quotient Sciences

OBN Digital Event:
'Maximising formulation flexibility in
First-In-Human Trials' 

Kindly hosted by Quotient Sciences 


This edition of OBN’s Digital Event series is being organised in collaboration with Quotient Sciences and will highlight how a fully integrated development plan can bring together the needs of the drug product team and the clinical development team.

About the topic:

Proof-Of-Concept (POC) is a pivotal milestone in the drug development process and yet around 80% of drug candidates continue to fail by the end of Phase II.  As a result, biotech and pharma companies are continuously focused on shortening project timelines, reducing costs and starting clinical development as efficiently as possible.  

To identify molecules with the greatest chance of success, the transition of the molecule from candidate selection through First-In-Human (FIH) to Proof-of-Concept (POC) needs to be fast and cost effective.  A key step on the pathway to clinical success is formulation development.  The aim is to quickly and efficiently choose a dosage form that delivers the required bioavailability in order to achieve an adequate exposure of the drug.  The product also needs to be development to the correct quality specifications which is important irrespective of phase of development.

This webinar will describe how formulation flexibility can be built into FIH studies achieving key clinical development milestones whilst still managing CMC time and cost investments.
The session will explain how pharmacy preparations, formulation development, GMP manufacturing and clinical testing can be tightly integrated to screen different drug product formats within adaptive FIH protocols, so that early identification of patient friendly dosage forms can be selected for seamless transition into Phase II.  In summary, the webinar will highlight how a fully integrated development plan can bring together the needs of the drug product team and the clinical development team.


Keynote Learning Objectives

- Learn about accelerating formulation development with an integrated product development, manufacturing and clinical testing plan.
- Understand how it is possible to screen and evaluate multiple formulation technologies for poorly soluble molecules into a single clinical protocol.
- Hear how it is possible to bridge from 'fit-for-purpose' FIH formulations to 'patient ready' dosage forms without losing time in the development program.


Speakers

John McDermott, Executive Drug Development Consultant, Quotient Sciences

Tickets
OBN Members - Complimentary
Non-Members - £25+VAT

This digital event is kindly hosted by:


 

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