Best Practices for Successful Execution of Radiopharmaceutical Clinical Trials

Life Sciences, Clinical Trials,
  • Monday, February 24, 2025 | 11am EST (NA) / 4pm GMT (UK) / 5pm CET (EU-Central)
  • 60 min

This webinar will provide an overview of evolving field of radiopharmaceuticals in the treatment of cancer, the complexities of radiopharmaceutical trials, and the considerations that are needed to successfully execute them.

Some of these considerations include drug manufacturing and distribution logistics, site feasibility, patient recruitment, operations management and regulatory considerations. The expert speakers will review these key areas and provide advice on how to manage them successfully.

The demand to treat patients with radioligand therapy (RLT) is anticipated to grow, in order to treat aggressive cancers to help improve survival and quality of life.

Register for this webinar to explore the complexities of radiopharmaceutical trials from drug manufacturing and distribution logistics to site feasibility, patient recruitment and regulatory considerations.

Speakers

Dr. Binh Nguyen, Thermo Fisher Scientific

Binh Nguyen, MD-PhD, VP, Medical Science and Strategy, Clinical Research, Thermo Fisher Scientific

Dr. Binh Nguyen is Vice President, Medical Science and Strategy – Oncology, with 30 years of experience in oncology clinical development in the pharmaceutical/biotech industry. He provides medical and strategic guidance to the oncology product development strategy team and clinical trial design as well as regulatory guidance to clients.

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Prior to joining PPD in 2015, Dr. Nguyen was VP, Clinical Development at Endocyte, Chief Medical Officer at Tigris Pharmaceutical and Executive Medical Director at Eli Lilly and Co. He also was a Medical Fellow at the Investigational Drug Branch, Cancer Treatment Evaluation Program, NCI, NIH, and Medical Reviewer for INDs and NDAs at the US Food and Drug Administration prior to joining the industry.

Dr. Nguyen holds an MD from the University of Maryland School of Medicine and a PhD in Organic Chemistry from Georgetown University in Washington, DC. He completed an oncology fellowship at the NCI, NIH.

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Message Presenter

Justin Martin, Project Oversight Director Strategy, Clinical Research, Thermo Fisher Scientific

Bio coming soon

Message Presenter
Erin Schaller, Thermo Fisher Scientific

Erin Schaller, Clinical Supplies Client and Portfolio Associate Director, Clinical Research, Thermo Fisher Scientific

Bio coming soon

Message Presenter
Anne Gold, Thermo Fisher Scientific

Anne Gold, Project Oversight Director, Clinical Research, Thermo Fisher Scientific

Bio coming soon

Message Presenter
Heather Horne, Thermo Fisher Scientific

Heather Horne, Project Mgr Director, Clinical Research, Thermo Fisher Scientific

Heather Horne is a seasoned Project Leader with a deep commitment to addressing unmet medical needs through the development of new medicines. With a solid foundation in Clinical Research and Nuclear Medicine, she brings over 25 years of extensive experience in drug development.

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This includes more than two decades on the sponsor side and over five years in a Contract Research Organization (CRO), managing projects from First-In-Human Phase I through to global Phase III and post-marketing Phase IV studies.

Their expertise is particularly pronounced in hematology/oncology, where they have worked with radiolabeled compounds, immunotherapy, antibody-drug conjugates (ADCs) and medical imaging studies. Additionally, they have experience in autoimmune disorders and imaging studies. Notably, they played a pivotal role in the development and approval of the first ADC for triple-negative breast cancer, demonstrating their capacity to lead critical projects from initial human trials to full regulatory approval.

As a leader, she is hands-on and driven, known for her excellent communication skills and high integrity. She excels in taking full ownership of studies, effectively motivating and mentoring teams to deliver projects on time and within budget. This background makes them an invaluable leader in the field of clinical research, particularly within drug development for oncology and complex therapeutic areas.

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Message Presenter
David Rhein ,Thermo Fisher Scientific

David Rhein, Associate Director, Regulatory Affairs, Thermo Fisher Scientific

Bio coming soon

Message Presenter

Who Should Attend?

This webinar will appeal to those with the following job titles or in the following fields:

  • Biotech researchers
  • Biopharma researchers
  • Clinical operations

What You Will Learn

Attendees will learn about:

  • The evolving field of radiopharmaceuticals in cancer treatment
  • Key challenges and complexities of radiopharmaceutical trials
  • Regulatory considerations needed to manage radiopharmaceutical trials
  • Key considerations of drug manufacturing and distribution logistics
  • Patient recruitment and site feasibility strategies

Xtalks Partner

The PPD clinical research business of Thermo Fisher Scientific Inc

The PPD clinical research business of Thermo Fisher Scientific Inc., the world leader in serving science, enables customers to accelerate innovation and increase drug development productivity. Utilizing patient-centered strategies and data analytics, their capabilities cover multiple therapeutic areas and include early development, all phases of clinical development, peri- and post-approval, novel approaches to patient recruitment and investigator sites, and comprehensive laboratory services. Recognized as a global industry leader in accelerating promising medicines from early development through regulatory approval and market access, they serve pharma, biotech, medical device and government organizations with custom-tailored solutions, including full-service partnerships and functional service partnerships. As a strategic partner in clinical development and analytical services, they apply cutting edge technologies, therapeutic expertise and a firm commitment to quality to help customers deliver life-changing therapies.

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