Dosimetry In Radiolabelled Clinical Study Design

Webinar promotional image featuring three speakers. The text reads: "DMPK Webinar Series - Understanding Dosimetry: A Key Consideration for Radiolabelled ADME Clinical Studies." Speakers include Dennis Heller, Iain Shaw, and Claire Henson, with their titles and affiliations.

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Non-clinical ADME with Radiolabelled Compounds

Recorded: February 2024

This webinar will discuss the key elements of a Dosimetry Assessment from non clinical to clinical application and how this influences radiolabelled clinical study design.

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Agenda

Introduction on Dosimetry Assessment
- Theory and Applications of Dosimetry Assessment
- International Exposure Limits for radiolabelled clinical studies
Non Clinical Considerations/Study Design
- What non clinical studies are required and study design input
- How ADME characteristics of radiolabel can influence Dosimetry output
Clinical Application of Dosimetry Assessment
- Application of Dosimetry Report on radioactive dose selection
- Considerations for radiolabelled clinical study design

Meet our Speakers

Moderated by:

Ragu Ramanathan – Vice President, DMPK Business Operations at Pharmaron

Speakers

Dennis Heller – Director, Early Drug Development Services at Certara

In his current role with Certara, Dr. Heller provides consultancy services and project team support to pharmaceutical and biotech companies in the areas of non-clinical and clinical ADME/DMPK, bioanalysis, radiolabel study design and dosimetry estimations. Dr. Heller has over 20 years’ experience providing scientific/technical leadership, technical sales/consultancy and operational management in the CRO environment to enable a platform of ADME and bioanalytical services, with depth in radiolabel studies from in vitro, non-clinical to clinical hAME studies and dosimetry.

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 programmes of work. Iain has performed this role since 2009 and 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.

Claire Henson – Team Leader in Pharmaceutical Metabolism at Pharmaron

Claire has worked in Drug Metabolism for more than 25 years, beginning her career in the DMPK department at Huntingdon Life Sciences, where she developed a particular interest in tissue distribution using autoradiography imaging techniques. Having joined Biodynamics (now Pharmaron UK) in 2000, Claire is now a Team Leader within the Metabolism group, primarily focussed on the management and delivery of whole-body autoradiography and micro-autoradiography studies. Claire has served on the management committees of both the ESA (European Society for Autoradiography) and the DMDG, and is currently a tutor for the DMDG’s Tissue Distribution and Imaging training course.