PDA Letter Article

Strategic Alliances: A Preview of the PDA Workshop on Choosing the Right CDMO Partner

by Maria Amaya, Roche

Selecting a contract development and manufacturing organization (CDMO) for biopharmaceutical development requires prioritizing expertise, technical capabilities, capacity, and a skilled workforce covering the full project spectrum. Leading CDMOs, acting as innovators, provide novel manufacturing solutions and possess specialized skills for successful development within industry timelines. Their extensive experience in diverse molecule types and regulatory submissions, coupled with continuous involvement in regulatory audits, ensures a profound understanding and adaptation to evolving requirements, guaranteeing timely project completion for clients.

The 2024 PDA CDMO Partnership Workshop offers a fantastic opportunity for industry professionals to gain practical solutions that will aid them in optimizing crucial partnerships. Participants will explore strategies for enhancing communication, elevating project oversight, navigating regulatory complexities, and managing costs effectively. This event provides attendees with the opportunity to uncover best practices for supplier selection and risk mitigation, imparting the knowledge necessary for successful collaboration and achieving positive project outcomes.

The workshop also is designed to provide a comprehensive understanding of the sponsor-CDMO journey, encompassing decisions related to outsourcing, relationship management, and regulatory considerations. It kicks off with a session dedicated to exploring strategies for making informed choices between insourcing and outsourcing. Steven Oh, PhD, Deputy Office Director for the Office of Therapeutic Products under the Center for Biologics Evaluation and Research, will share valuable insights into the regulatory landscape of CDMO relationships, offering participants a unique perspective from the U.S. FDA. The workshop also addresses intricacies of CDMO selection, covering criteria, metrics, and best practices.

Moreover, participants will engage in a hands-on experience through a project case study, extending discussions to technology transfer, emphasizing its importance, and addressing pitfalls and regulatory aspects with case studies. The workshop highlights the art of crafting quality agreements and underscores transparent relationships with CDMOs. In addition, an interactive discussion on transparency, using a case study, will shed light on managing deviations and implementing corrective actions. Moreover, sessions will delve into fostering a robust relationship between a CDMO and a sponsor company, recognizing individual strengths and aspiring to a collaborative, mutually beneficial outcome.

In conclusion, the 2024 PDA CDMO Partnership Workshop is a premier platform for industry professionals to gain unparalleled insights into optimizing vital partnerships. This event will offer a rich exploration of strategies for effective communication, enhanced project oversight, regulatory navigation, and cost management. In addition, this event equips participants with invaluable knowledge for successful collaboration and positive project outcomes.