Advancing Precision Oncology: Radionuclide Conjugate and Antibody-Drug Conjugate (ADC) Development Strategies

Life Sciences, Clinical Trials, Pharmaceutical Regulation, Pharmaceutical,
  • Thursday, September 05, 2024

Webinar Preview

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.

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In this webinar, key considerations for dose selection optimization will be 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 will be explored, underscoring the unique pharmacokinetic and pharmacodynamic profiles of radionuclide conjugates and antibody-drug conjugates that differentiate them from traditional small molecules.

Finally, the speakers will share 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.

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Register for this webinar today to gain a deeper understanding of the transformative potential of antibody-drug conjugates and radionuclide conjugates and learn why they are pivotal in the advancement of precision medicine and significantly improving patient outcomes in oncology.

Speakers

Alex MacDonald, Allucent

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.

Message Presenter
Sugato De, Allucent

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.

Message Presenter
Angela Brady, Allucent

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.

Message Presenter
Dr. Brian Barnett, Allucent

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.

Message Presenter

Who Should Attend?

This webinar will appeal to Executives, VPs, Directors, Managers, Department Heads and operational staff from biotech and pharma companies working within:

  • Clinical research
  • Clinical operations
  • Project management
  • Regulatory affairs
  • Medical affairs
  • Medical writing
  • Research and development
  • Outsourcing and procurement
  • Clinical Pharmacology
  • Pharmacokinetics

What You Will Learn

Attendees will gain insights into:

  • The current landscape of antibody-drug conjugates and radionuclide conjugates
  • Regulatory constructs, submission readiness, dose structuring and optimization
  • Project Optimus implications
  • First-in-human design considerations and constructs
  • Clinical pharmacology considerations
  • Operational insights for clinical trials

Xtalks Partner

Allucent

Allucent is on a mission to help bring new therapies to light by solving the distinct challenges of small and mid-sized biotech companies. The company is purpose-built through the convergence of leading providers to address this unmet need. Today, Allucent is a global provider of comprehensive drug development solutions, including consulting, clinical operations, biometrics, and clinical pharmacology across a variety of therapeutic areas. With more than 30 years of experience in over 60 countries, Allucent’s individualized partnership approach provides experience-driven insights and expertise to assist its clients in successfully navigating the complexities of delivering novel treatments to patients.

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