Fireside Chat: Synthesis-to-Clinic®: Accelerating 14C Human ADME by Integrated Radiosynthesis, GMP Manufacture, and Clinical Delivery
Basel, Switzerland | 1 July 2026Fireside Chat: Synthesis-to-Clinic®: Accelerating 14C Human ADME by Integrated Radiosynthesis, GMP Manufacture, and Clinical Delivery
Join us for a focused scientific panel discussion exploring how an integrated Synthesis-to-Clinic® approach can streamline the delivery of 14C enabled studies in human participants—reducing the complexity of multi-vendor coordination while maintaining the high-quality outputs required for global regulatory submissions.
A robust understanding of absorption, distribution, metabolism, and excretion (ADME) is essential to support NDA and MAA filings, and evolving regulatory guidance increasingly encourages these studies to be completed earlier in development to mitigate downstream risk. However, human ADME programs are often complex, time-intensive, and can take up to 12 months to complete, typically involving multiple specialist partners and placing significant pressure on timelines and resources.
In this seminar, Quotient Sciences’ scientific experts will demonstrate how Synthesis-to-Clinic® was developed to address these challenges—delivering an end-to-end, integrated program that spans radiosynthesis of the 14C-labelled drug substance, GMP drug product manufacture, clinical conduct, mass balance analysis, metabolite profiling, and final clinical reporting. Through this streamlined approach, attendees will gain practical insight into how integrated delivery via an experienced vendor can accelerate timelines, simplify program execution, and support stronger development outcomes.
Key learning objectives
By the end of this seminar, attendees should be able to:
- Understand the various applications of 14C enabled drug development including human ADME and ivMicrotracers
- Explain why and when human ADME studies are needed within development programs and how earlier execution can reduce regulatory and program risk
- Describe the core regulatory drivers and considerations shaping radiolabeled mass balance/human ADME expectations
- Identify the critical design inputs for a human ADME program (safety/PK, non-clinical metabolism data, synopsis development, radiolabelled API needs, and drug product considerations across oral/IV dosing
- Compare conventional ADME vs microADME approaches and understand when microADME (≤1 µCi, no dosimetry requirement) may be appropriate
- Learn about the key analytical challenges associated with 14C driven programs
| Date/Time | Location |
|---|---|
| Wednesday, July 1, 2026 18:00 GMT | Bohemia Bar - Hotel Märthof Basel MARKTGASSE 19 | CH-4051 BASEL – SCHWEIZ |
| Time | Agenda |
|---|---|
| 18:00 – 18:10 | Welcome drinks: Opening Remarks & Setting the Scene |
| 19:30 – 19:50 | Panel Discussion & Audience Q&A Moderated by John McDermott Interactive discussion across speakers, including case study insights and audience questions |
| 19:50 – 20:00 | Closing Remarks Summary of key takeaways and final reflections |
| 20:00 onwards | Networking Reception & Drinks Opportunity for further discussion with speakers and peers |
Space is limited! Register your interest to attend our seminar. If you have any questions or difficulty registering, reach out to [email protected].
*We reserve the right, at our sole discretion, to deny registration or remove any individual who is not a confirmed current or potential client/partner of Quotient Sciences.