Using Real-Time Manufacturing to Accelerate Drug Product Development
Kieran Crowley, Ph.D.,
Advancing a drug delivery concept into a viable product can be a lengthy and costly process. In particular, the unreliability of non-clinical screening models used to predict human outcomes often lead to multiple cycles of product development and optimization. An integrated formulation development, manufacture and clinical testing model can overcome many of these challenges and accelerate the development of both simple and complex drug delivery projects. The integrated approach allows a development team to make adjustments to optimize a product or respond to new considerations / risks during a clinical study.
This presentation will review the RapidFACT platform of integrated formulation and clinical capabilities, specifically addressing the following topics:
- Constraints of current development processes
- Benefits of real-time adaptive product manufacturing
- Examples of integrated formulation and clinical programs designed to develop and optimize both oral and non-oral formulations
Dec 8th, 2016
Registration: 5:30 PM
Dinner: 6:30 PM
644 Pascack Road, Washington Township, NJ 07676
About the speaker:
Dr Crowley is Senior Scientific Director at Quotient Clinical Ltd. He has 15 years experience leading Preformulation and Formulation Development teams in both innovator and contract manufacturing organizations. His expertise is in selecting and optimizing drug delivery systems based on the physicochemical and biopharmaceutics properties of the active ingredient. Oral delivery of poorly soluble compounds is a particular area of interest, in which he has successfully advanced products using hot melt extrusion, nanosizing and lyophilization, among other techniques. Dr. Crowley received his Ph.D. in solid-state pharmaceutics in 1999 from the University of Bradford U.K. and was a post-doctoral researcher at the University of Wisconsin-Madison from 1999-2001. His responsibilities at Quotient Clinical include the design and implementation of integrated pharmaceutical and clinical development programs, utilizing Quotient’s ability to manufacture drug products in real-time in response to arising human data.
Register here where you can prepay by credit card. Payment can also be made at the event.
Registered and paid online: $50.00
Between-positions, Retirees & Students (WITH ADVANCE REGISTRATION ONLY): $45.00
ADVANCE REGISTRATION WILL END AT 5:00 PM ON TUESDAY DEC 6th. AFTER THAT YOU MUST PAY AT THE DOOR