How to Accelerate Modified Release Drug Product Development
Sponsored by: Quotient Sciences
- Clinical Optimisation
- Modified Release Formulation
Date: 28 September
Time: 4PM London/11AM New York
Are you struggling with your drug product development timeline? Are ongoing drug formulation issues leading to escalating costs and missed deadlines? RapidFACT significantly accelerates the process of optimising modified release drug products, both to improve oral bioavailability and/or achieve targeted GI delivery. Drug products can be optimised within a clinical study by the use of a continuous formulation design space, rather than undertaking cycles of formulation development and multiple clinical PK studies. A range of product performance attributes can also be investigated within a program, by varying the quantitative composition of one or more formulation components in response to emerging clinical data.
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 optimised drug products, for all routes of delivery, with over 100 programs now completed.
The webinar will include a presentation from Dr Peter Timmins, formerly of Bristol-Myers Squibb, describing the key variables that must be considered in the development of modified release formulations, and discuss strategies to understand the key relationships between formulation parameters and product performance using clinical data.
This webinar will showcase case studies and project metrics, illustrating the applications and benefits when developing modified release drug formulations.
Former Executive Director, Drug Product Science and Technology at Bristol-Myers Squibb
Peter Timmins was, until his recent retirement, Executive Director in Drug Product Science and Technology at Bristol-Myers Squibb Research and Development. That group, based in Moreton, UK, and New Brunswick, USA, is engaged in creating, adapting and applying drug delivery technology for oral and non-orally delivered drug candidates, including those requiring modified release technologies or devices.
He has a degree in pharmacy and a PhD in pharmaceutical chemistry, both from the University of Bradford. Professor Timmins is a Fellow of the Royal Pharmaceutical Society of Great Britain. He has many ongoing academic collaborations in the area of drug delivery and is a visiting or honorary full professor at the schools pharmacy at Aston, Bradford, Huddersfield and Nottingham. He is an author or co-author of more than 80 publications, including several books and book chapters and an inventor on 30 patents, with many of these publications or patents being on oral extended release technology.
Executive Director, Drug Product Optimisation
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 Quotients rapid formulation development and clinical testing (RapidFACT) programs.
Key Learning Objectives
- Learn about new ways to evaluate formulation performance using clinical data
- Understand key variables in the development of modified release formulations
- Examine the relationships between formulation parameters and in-vivo performance
- Listen to case studies on accelerating formulation optimisation using clinical data
- Head of Formulation
- Head of Research
- Head of Development
- Formulation Manager
- Research Manager
- Development Manager
- Principal Scientist