Michael Groaning
Chief Scientific Officer Soricimed Biopharma Inc.
Dr. Groaning received his PhD in Organic Chemistry at Colorado State University before moving on to the ETH in Zurich, Switzerland for his postdoctoral research in natural product total synthesis. From there he started his career at Roche initially in medicinal chemistry before moving to Roche Colorado where he transitioned to process research. In 2008, he moved to Endocyte and began his tenure there in process development before transitioning into regulatory affairs and finally clinical development. He lead the prostate cancer program exploring EC1169, a PSMA targeted small molecule drug conjugate, before Endocyte in-licensed PSMA-617 which became the approved drug Pluvicto. After the acquisition of Endocyte by Novartis, Dr. Groaning spent three years at Amgen working on the STEAP1 targeted T-Cell engager program before moving back into the radioligand space. He joined Fusion in January, 2024 as the Global Program Leader for the Ac-225-PSMA program until Fusion was acquired by AstraZeneca. In September 2025, he moved to Soricimed Biopharma as CSO focusing on the development of TRPV6 targeted radioligand therapies.
Seminars
Accurate dosimetry translation from animal models to humans is crucial for the safe and effective clinical application of targeted radiopharmaceuticals. This workshop delves into the methodologies, challenges, and best practices in extrapolating dosimetric data, ensuring that preclinical findings reliably inform human therapeutic strategies.
- Investigating a novel treatment approach in early phase clinical studies with the true theranostic pairs 61/67Cu-NU101 and 61/67Cu-NU201
- Comparing various extrapolation techniques and assessing their accuracy and applicability
- Review real-world examples where dosimetric translation informed clinical dosing, highlighting both successes and areas for improvement
- Leveraging in vivo (PET) and ex vivo biodistribution
- Dosimetry and scaling to human doses
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Outcome – Review the RWE for dosimetry informed clinical dosing – what went wrong, what could be improved and design an ideal phase zero trial.
- Evaluating isotope properties including half-life and emission type
- Assessing radiochemical behavior for stability and efficacy
- Comparing isotopes for therapeutic versus diagnostic applications
- Characterization of a novel target that expressed in several solid tumors
- Structure Activity Relationship (SAR) analysis in choosing best ligand to take into a Phase 0 clinical trial
