Join us on Feb. 10th at 11:30am EST for an interactive, hour-long complimentary live Q&A webinar entitled: "ADME Q&A Roundtable: Leveraging a Synthesis-to-Clinic® approach to rapidly support regulatory approval"
Approaching the end of your Phase II milestone & gearing up for phase III and beyond? For most drug programs, a key step for inclusion in a successful global regulatory filing is to conduct a human ADME study. Regulatory agencies require ADME studies in order to demonstrate the disposition of the drug after it’s been dosed in human subjects.
The timing and planning of these programs is critical. At Quotient Sciences, our Synthesis-to-Clinic® approach supports human ADME studies from radiosynthesis to the final clinical report, all under a single program manager and single contract. This efficient approach allows for 14C drug substance to be efficiently synthesized to support nonclinical and clinical requirements. Integrated pharmaceutical sciences facilities provide formulation development, real-time GMP manufacturing and QP release of 14C drug products, which enable us to seamlessly supply formulations for ADME studies to our in-house clinics or to patients at specialist clinics.
Join Iain Shaw, Sr. Director of 14C Drug Development at Quotient Sciences, along with a panel of experts from our drug development, radiosynthesis and clinical pharmacology teams for a Q&A roundtable focused on streamlining human ADME studies. Learn more about our unique Synthesis-to-Clinic approach and engage with our panelists as they discuss such topics around efficient ADME study design, common challenges that can occur and mistakes to avoid, and how human ADME studies can improve decision making at critical drug development milestones.
Key topics covered:
- Why are 14C ADME studies required and what are their regulatory requirements?
- How are these studies conducted & when?
- What are the common challenges that can occur during these studies?
- What are some of the CMC and drug product considerations?
- The benefits of an integrated Synthesis-2-Clinic® approach
Quotient Sciences roundtable guests will include:
- Human AME expert- Iain Shaw, Sr. Director of 14C Enabled Drug Development
Iain Shaw is the Senior Director of 14C Enabled Drug Development at Quotient Sciences. He has over 20 years drug development experience having previously held early development program management, clinical development and analytical posts in the pharmaceutical industry and contract research organisations. Prior to his current role he was a Program Manager in early drug development at Covance. He has previously held various analytical, project management and clinical development posts in the pharmaceutical, agrochemical and contract research industries. In total he has 30 years industrial experience. Iain’s responsibilities at Quotient Sciences include all 14C clinical activities since April 2009.
- Radiosynthesis expert- Andrew Kohler, Isotope Labelling Specialist
Andrew is a PhD Organic Chemist with 25 years’ experience in the synthesis of radiolabelled and stable labelled compounds. He has experience of working for a large Pharma organisation, Sanofi, and for contract organisations. At Quotient Sciences, Andrew works in the Isotope Labelling team at the Alnwick, UK site where his focus is delivering C-14 materials to support ADME studies for clients from across the world. He has extensive experience of working in a GMP regulated environment, involved in both setting up and managing the GMP radiosynthesis laboratory.
- Drug development expert- Justin Holland, Sr. Director of Pharmaceutical Sciences
Justin Holland is the Senior Director, Analytics at Quotient Sciences. In this role he has overall responsibility for the analytical department at the Nottingham site, which is involved in all aspects of analytical method development, validation, stability and QC release testing, to support drug product development for primarily Phase I clinical trials. Justin has worked at Quotient since 2009 and in total has 19 years industrial experience.
- Clinical pharmacology expert- Ashley Willson, Research Fellow
Ashley Willson is the Research Fellow responsible for supporting clinical pharmacology programs at Quotient Sciences. He works as Scientific Lead on complex clinical pharmacology projects and is responsible for project design and review. Ashley has specific experience in the design and data review of typical Phase I programs, including first-in-human, drug-drug interaction, thorough-QT, bioequivalence, taste assessment and ADME studies. Ashley has been with Quotient Sciences since 2016.