About this DMPK Webinar on how to Design a Successful Radiolabelled ADME Study

Designing a successful radiolabelled ADME study requires careful planning, from selecting the optimal 14C label position to generating meaningful metabolism and mass balance data. This interactive webinar will feature a panel of experienced ADME experts who will discuss key considerations for study design and execution, drawing on insights from both non-clinical and clinical programs.

Our webinar will not be your standard sit-and-listen presentation. We’re aiming for an interactive experience, so we’ll be posing questions, discussing the day-to-day issues you’ve run into, and offering helpful advice to ensure your radiolabelled ADME studies run smoothly.

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Key highlights:

By attending this webinar, you will learn:

Radiosynthesis Considerations
- Understanding 14C radiosynthesis: what’s possible, easy, hard and not likely
- Best practices for maintaining radiochemical purity and stability while minimising degradation.
Understanding 14C ADME Studies
- Overview of non-clinical ADME and clinical mass balance
Clinical Metabolism
- Considerations for designing a clinical metabolism study
- Design and dose

Meet our Speakers

Speakers:

James Travers – Director, C14 Chemistry at Pharmaron

Dr. James Travers first gained a BSc in Chemistry from Queen’s University Belfast in 1990, and then went on to gain a PhD in Phosphonate analogues of amino acids and incorporation into peptides in 1994. After having gained 30 years of experience in C14 labelling, James now oversees 41 Pharmaron staff, all of whom are involved in the production of C14 labelled products.

Philip Bond – Associate Director, ADME Metabolism at Pharmaron

Philip has been involved with drug metabolism for over 20 years, although all of his career has been spent in the CRO industry. Philip initially started up in Edinburgh at Inveresk, shortly before it became Charles River Labs.

Four years later, Philip moved to BioDynamics, which later became Quotient Bioresearch, and then Pharmaron, where he has now been for 19 years.

Whilst working in a CRO, he has acted as a study director for almost 150 studies in the duration of his career, across both non-clinical and clinical radio-labelled in vivo studies covering a wide range of drugs; small molecules, pro-drugs and biologics and even veterinary medicines.

Philip has been able to work with a wide variety of companies, from large pharma through to very small biotechs, encompassing clients with a career in drug metabolism to some with none. Each study has presented something different whether it’s a unique challenge, unexpected data or even a comparison study against a competitor product. He is pleased to lead a large team of scientists who perform our radio-labelled in vivo and in vitro ADME studies for the department.

Iain Shaw – Senior Director, 14C Enabled Drug Development at Quotient Sciences

Iain Shaw is Senior Director, 14C Enabled Drug Development at Quotient Sciences (Quotient). His primary role is providing subject-specific consultation to clients and the internal business regarding Quotient’s 14C services, assisting clients with appropriate designs for human ADME and other radiolabelled studies, and establishing project scope for the required integrated 14C programs of work.

Iain has performed this role for 18 years, has over 35 years’ industrial experience, having previously held programme management, clinical development and analytical chemistry roles in pharmaceutical and biotechnology companies and with contract research organisations.

Moderated by:

Ray Cooke – Scientific Director, Metabolism at Pharmaron

Ray is Scientific Director, Metabolism at Pharmaron Radiolabelled Sciences (RLS) UK site. He has been involved in radiolabelled studies since his Ph.D. (University of Manchester, 1989), initially with tritiated peptides, then more exotic isotopes (Technetium-99m and Chromium-51) during his postdoctoral research into the pharmacokinetics of ADCs in Professor Malcolm Rowlands’ group at Manchester. Ray joined BioDynamics in its infancy in 1993 and stayed throughout the organizational transformations resulting in the acquisition of the radiolabelled ADME business by Pharmaron. In this time, Ray has exclusively been involved with radiolabelled ADME. His first radiolabelled clinical study was in 1999, and since then he has supported over 200 radiolabelled clinical studies. More recently, Ray has been responsible for overseeing the non-clinical metabolism support for Pharmaron’s integrated human metabolism programs.