Challenge:
Our client was developing a highly novel and versatile intracellular delivery vehicle which could readily penetrate cells without compromising membrane integrity or inducing cytotoxicity. The product offered the potential to transport both small and large-molecular cargos into the cytoplasm, including oligonucleotides, peptides, proteins and genetic materials. Given the novel nature of the product, the company sought early consultation with the FDA to gain agreement on the correct regulatory classification and suitability of the proposed data package. Alacrita was engaged to provide support for a Type C meeting with the FDA to clarify these matters.
Solution:
Regulatory classification of this type of product and the studies required to get to the clinical phase of development are dependent on its intended use. Not all regulatory classifications require the same regulatory pathway or supporting data, offer the same marketing/data exclusivity protection, or allow for the same commercial positioning options. We led a strategic planning session to help the client consider these factors in the context of different potential regulatory classifications. This included business development, commercial and IP input from Alacrita subject matter experts. We evaluated the available data on the product and advised on additional non-clinical safety data that would be required in consideration of current FDA guidance. We advised on appropriate discussion items for an early informal FDA consultation, and lead the preparation of a pre-meeting information package. Alacrita served as the FDA point of contact for requesting and scheduling the Type C meeting, lead the preparation for and attended the meeting, and prepared the sponsor meeting minutes afterwards.
Our Regulatory Affairs Expertise
Our regulatory affairs consultants can help you devise effective regulatory strategies to place you on the best path torward regulatory approval, helping you avoid regulatory delays and overcome critical regulatory hurdles. We also provide hands-on support, including assistance with regulatory applications and eCTD publishing. Our experts can work alongside and supplement your internal regulatory teams to solve bandwidth challenges. We can also provide interim regulatory affairs leadership during periods of transition. Additionally, our team conducts regulatory due diligence both for internal purposes as well as for external parties engaged in licensing, investment, and M&A activities.