The upcoming Pre-Filled Syringes East Coast Conference in Boston will feature a comprehensive examination of drug-device combination product development, with industry leaders addressing critical challenges and innovations in the field.
Susan Neadle, head of the Combination Products Center of Excellence at Janssen, will deliver a keynote presentation focusing on the intricate challenges facing drug-device combination product development. Her address will explore how the integration of drugs with medical devices can optimize treatment outcomes while minimizing adverse events and enhancing user experience.
Key Development and Regulatory Considerations
The presentation will delve into the complexities of combining drug and device development processes, emphasizing the importance of integrated approaches. Neadle will specifically address risk management strategies crucial for combination products and navigate the dynamic regulatory landscape that governs these innovative therapeutic solutions.
Manufacturing Excellence and Technical Innovation
The conference program extends beyond regulatory considerations to include critical manufacturing aspects. Representatives from GSK will share insights on the challenges and solutions in syringe filling of high-concentration monoclonal antibody formulations. Additionally, ZEON will provide technical updates on Cyclic Olefin Polymer (COP) developments, highlighting advances in materials science for pre-filled syringe applications.
Advanced Workshop Sessions
Preceding the main conference, specialized workshops on April 10th will offer hands-on learning opportunities. Battelle will lead a session on design considerations for real-world applications outside clinical settings, while Cambridge Consultants Ltd will conduct a workshop focusing on human factors in connected drug delivery systems.
The two-day conference, scheduled for April 11-12 at the Sheraton Boston Hotel, brings together industry leaders, including major pharmaceutical companies and device manufacturers. The event is supported by prominent industry players such as Aptar Pharma, BD, Mitsubishi Gas Chemical, and Nemera, among others, demonstrating the collaborative nature of advancement in drug delivery technology.
