From Isotope to Injection: Managing Risk and Compliance in Radiopharmaceutical Development

Radiopharmaceutical manufacturers face a complex landscape. This webinar will explore how strategic choices can help radiopharmaceutical developers overcome these hurdles and maintain compliance without compromising efficiency.

Register Free: https://www.pharmtech.com/pt_w/isotope

Event Overview:

Radiopharmaceutical manufacturers face a complex landscape of regulatory, operational, and technical challenges. From managing radiation safety and contamination risks to navigating short shelf-lives and accelerated release protocols, every step in the development process demands precision and compliance. The need to balance sterility, speed-to-market, and evolving GMP expectations—especially under the lens of Annex 1 revisions—places added pressure on teams working with highly sensitive isotopes.
As companies scale from early development to commercial readiness, ensuring robust contamination control, aseptic processing, and reliable quality systems becomes critical. This webinar will explore how strategic choices in equipment, materials, processes, and packaging can help radiopharmaceutical developers overcome these hurdles and maintain compliance without compromising efficiency.

Key Learning Objectives:

• Understand the unique contamination and sterility risks in radiopharmaceutical environments
• Learn how to balance speed-to-market with regulatory compliance
• Discover how to build scalable, risk-resilient systems that proactively manage extractables, particulates, and container closure integrity

Who Should Attend:

• Regulatory affairs personnel
• Technical operations, CMC, and manufacturing personnel
• Next most relevant audience job positions

Speakers:

Aubrey Jeter
Senior Specialist, Technical Customer Support
West Pharmaceutical Services

Aubrey Jeter is a member of the North American technical customer support team at West Pharmaceutical Services. She joined the West Pharmaceutical team in November 2021. In this role, Jeter addresses technical questions and concerns regarding West and Daikyo products and processes, provides sound technical advice, and provides product recommendations to ensure quality, efficiency, and safety of the injectable product. Jeter supports multinational customers in numerous spaces, including cell/gene therapy, generics, and pharma. Jeter graduated from Pennsylvania State University with a bachelor’s degree in animal sciences.

Lake Wooten, PhD
Project Manager
Orchestra Life Sciences

Lake Wooten, PhD, is an expert in medical isotopes and GMP manufacturing of radiopharmaceuticals. With 12 years of experience, Wooten has worked on projects for several important therapeutic isotopes. He has helped establish 3 new radioligand therapy manufacturing facilities and has led high-impact projects as a site director and as a senior scientific project manager. His leadership has encompassed isotope production, radiochemistry, GMP manufacturing/QC, technology transfer, project management, and radiation safety. Wooten has been a radiation safety officer and an authorized user on US Nuclear Regulatory Commission licenses. He has authored 17 publications and has earned 5 engineering degrees, including a PhD in biomedical engineering. A dedicated advocate for radiopharmaceuticals, Wooten is an ambassador for Oncidium Foundation and affiliate faculty at the Purdue University College of Pharmacy.;

Jason Mercer, PhD
Strategic Program Champion
Facet Life Sciences

Jason Mercer, PhD, strategic program champion with Facet Life Sciences, has more than 16 years of regulatory affairs experience guiding small and midsized pharma and biotech companies through the complexities of drug and biologic development. He is known for designing innovative, efficient strategies that help sponsors overcome regulatory challenges and accelerate timelines while maintaining compliance. With broad experience spanning CMC, clinical, and nonclinical regulatory support across diverse therapeutic areas and product types, Mercer helps development teams achieve successful outcomes from early development through approval.

Register Free: https://www.pharmtech.com/pt_w/isotope