How to Reduce the Time and Cost for Optimizing Drug Product Formulations with RapidFACT® (Rapid Formulation Development and Clinical Testing)

RapidFACT accelerates the process for developing and optimizing drug product formulations. Real-time flexibility within the clinical study allows product compositions to be varied and performance attributes optimized in response to arising data.

The webinar will include expert presentations describing several applications of RapidFACT including:

• Solubility enhancement to improve oral bioavailability
• Development of Modified Release dosage forms and In Vitro In Vivo Correlations (IVIVCs)
• Taste assessments

RapidFACT programs have been used extensively by Pharmaceutical Development teams from more than 50 pharmaceutical and biotechnology companies worldwide as a key tool in developing optimized drug products, for all routes of delivery, with over 100 programs now completed.

RapidFACT is proven to accelerate program timelines by at least 50 percent, and deliver significant cost savings. This has been achieved by the integration of real-time GMP manufacturing and clinical testing, using Quotient’s Translational Pharmaceutics^® platform.

This webinar will showcase studies and metrics from two experts in drug delivery and drug product optimisation, illustrating the applications and benefits for a range of drug formulations.

Presentation Outline

• Introduction to Translational Pharmaceutics and RapidFACT
• Overview of the first 100 programs
• Scientific case studies
• Question and answer session

Speakers

John McDermott, Executive Director, Drug Product Optimisation, Quotient Clinical

John is the Executive Director of Drug Product Optimisation at Quotient Clinical. He has over 15 years industry experience in roles in Pharmaceutical sciences with Rhone Poulenc Rorer, Covance, and Quotient Clinical, which he joined in 2001. After fulfilling roles in the development and validation of radiolabelling methods for oral and inhaled dosage forms, and leading Quotients analytical group, John was appointed to his current position and now has overall responsibility for the for Quotients rapid formulation development and clinical testing (RapidFACT) programs.

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Kieran Crowley, Senior Scientific Director, Quotient Clinical

Kieran is a Senior Scientific Director of Translational Pharmaceutics at Quotient Clinical Ltd. He has over 15 years of experience leading Pre-formulation and Formulation Development teams in both innovator and contract manufacturing organisations. His expertise is in selecting and optimising drug delivery systems based on the physicochemical and biopharmaceutics properties of the active ingredient. Oral delivery of poorly soluble compounds is a particular field of experience and interest, in which he has successfully advanced products using hot melt extrusion, nanomilling and lyophilisation, among other techniques. Kieran 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, USA 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.

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