This informative webinar will provide a comprehensive examination of the development lifecycle of radionuclide conjugates and antibody-drug conjugates from initial research to clinical application.
With innovation, investment, and regulatory support accelerating radionuclide conjugate and antibody-drug conjugate research, understanding the drug development landscape is crucial to recognizing opportunities for development, anticipating challenges, and strategizing effectively. Knowledge of regulatory constructs and efficient clinical development — including study design, dose and regimen selection and optimization — is essential to navigate the complex approval process and maximize therapeutic efficacy while minimizing side effects.
In this webinar, key considerations for dose selection optimization were discussed, with a focus on how Project Optimus influences these processes to enhance dose-finding strategies as well as the design constructs of first-in-human trials. Clinical pharmacology considerations are explored, underscoring the unique pharmacokinetic and pharmacodynamic profiles of radionuclide conjugates and antibody-drug conjugates that differentiate them from traditional small molecules.
The speakers also shared operational considerations for clinical trials, including site selection and meeting patient needs, both of which are critical to the successful execution and progression of trials involving these advanced therapeutic agents. This structured approach aims to provide a clear roadmap for the integrated development and clinical implementation of radionuclide conjugates and antibody-drug conjugates, ensuring their successful transition from research to patient care.
About the Presenters
Alex MacDonald, PhD, Vice President, Model-Informed Drug Development, Allucent
Alex MacDonald is VP of Model-informed Drug Development at Allucent. He is an Engineer and Quantitative Pharmacologist by training, studying for a PhD in physiologically based pharmacokinetics and pharmacodynamics at the University of Sheffield, UK.
He has over 20 years of cross-pharma experience in modelling, clinical pharmacology and pharmacometrics and joined Allucent from AstraZeneca, where he was most recently Global Head of Respiratory and Immunology Clinical Pharmacology and Pharmacometrics. Alex is well-published across multiple therapeutic areas with different modalities including respiratory and immunology medicine, oncology and metabolic diseases.
Sugato De, MS, Vice President, Regulatory Strategy, Head of Medical Technology, Allucent
As a previous Senior Policy Advisor at the FDA, as well as a seasoned leader within the CRO industry, Sugato De has cultivated expertise in a plethora of regulatory pathways, including dossiers for combination products, expedited pathways, protocol development for medical devices and more. During his 11-year tenure with the Center for Devices and Radiological Health (CDRH) at the US FDA, Sugato developed specialized expertise in drug-device combination products, digital health technologies and critical care medicine.
Angela Brady, MHL, Senior Vice President, Global Head of Project Leadership and Client Relations, Allucent
With over 25 years of experience in global R&D clinical development and operations leadership, Angela Brady brings substantial depth and breadth of biotechnology and biopharmaceutical experience to the role of Senior Vice President and Global Head of Project Leadership and Client Relations at Allucent.
Angela has wide-ranging CRO experience, holding leadership roles in project and alliance management at many of the most acclaimed global CROs, including IQVIA, ICON and PPD, a Thermo Fisher company. Angela holds a Master’s Degree in Law from Shepard Broad College of Law, Nova Southeastern University, in Ft. Lauderdale, FL, and a Bachelor’s Degree in Chemistry from Tennessee Technological University in Cookeville, TN.
Dr. Brian Barnett, MD, Executive Medical Director, Oncology, Allucent
Prior to joining the industry, Dr. Brian Barnett, MD was a medical oncologist working in private practice. At Tulane University, he served as an Assistant Professor of Hematology and Medical Oncology, focusing on Regulatory T Cells in academic medicine. Along with Dr. Barnett’s experience in clinical practice, he has accumulated over 20 years of industry experience in translational research, medical monitoring, and regulatory meeting preparations. Dr. Barnett has held various impactful roles throughout his time in the pharmaceutical space, including Chief Medical Officer. At Allucent, Dr. Barnett provides the A-Team with expert guidance on both early- and late-stage drug and cell therapy clinical development.
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