Advancing Inhaled & Nasal Drug Clinical Studies: Insights & Strategies

The webinar, featuring Dr. Julie Suman, Vice President of Scientific Affairs at Aptar Pharma, and Gemma Budd, Business Development Manager at Nanopharm, attracted a diverse, international audience. The range of attendees included Heads and Directors of CMC, Clinical Development, Product Development, and Analytical departments, as well as experts in Research Development, Business Development, Pharmaceutical Development, and more. The involvement of Packaging Engineers, Drug Delivery Scientists, Formulation Scientists, and others in project and innovation management highlighted the session’s broad and inclusive appeal.

One of the primary focuses of the webinar was on the challenges encountered during various development phases of OINDP. Dr. Suman and Ms. Budd provided in-depth insights into the intricate issues faced during preclinical, early, and late clinical development phases. They stressed the importance of maintaining a balance between expeditious development and risk management, emphasizing the need for strategic planning and foresight in drug development processes.

A significant part of the discussion was dedicated to understanding the regulatory expectations for OINDP. This included detailed explorations of the specific requirements of tests, target validation levels, and the different expectations of various regulatory agencies, including the FDA. The speakers aimed to equip the attendees with a comprehensive understanding of how to effectively navigate the complex regulatory landscapes, which is crucial for the successful development and approval of nasal drug delivery products.

Risk mitigation in Chemistry, Manufacturing, and Controls (CMC) studies was another critical topic discussed in the webinar. Here, the speakers delved into strategies for reducing risks in these pivotal areas of drug development. They underscored the importance of considering CMC aspects early in the development process. This proactive approach is vital for optimizing performance, avoiding redundant tasks, and ensuring the smooth progression of projects as they approach their final formulation stages.

The webinar also highlighted the crucial role of expert collaboration in the development of OINDP. Both speakers emphasized the need for a comprehensive approach, involving experts knowledgeable in drug delivery systems, the drug, the formulation, and analytical activities within the domain of combination product development. Such collaboration is key to satisfying the stringent requirements of regulatory bodies and ensuring efficient and successful clinical development from start to finish.

Additionally, the session provided a valuable opportunity for attendees to gain a deeper understanding of FDA expectations, particularly in the context of OINDP. The participants learned how to differentiate between CMC requirements for commercial products and those for clinical trials. This knowledge is essential for ensuring compliance and smooth progression in the development of nasal drug delivery systems and inhaled products.

Moreover, the webinar equipped attendees with essential information on the types of testing needed to support clinical trials for OINDP. This information is crucial for ensuring that the products are safe, effective, and meet the stringent regulatory standards set by regulatory bodies.

Another key learning objective was understanding the considerations necessary during the pre-IND (Investigational New Drug) development phases. This phase is critical in laying the groundwork for successful clinical trials and eventual product approval.

In conclusion, the “Advancing Inhaled & Nasal Drug Clinical Studies” webinar was a comprehensive and informative session that provided attendees with vital insights into the development of OINDPs. It highlighted the importance of understanding regulatory landscapes, risk mitigation strategies in CMC studies, and the value of expert collaboration in the development of nasal drug delivery systems and inhaled products. The diverse range of attendees and the depth of knowledge shared reflected the webinar’s success in contributing significantly to the ongoing discourse in the pharmaceutical industry.