Challenge:
Our client planning to develop and commercialize a preclinical compound for metabolic disorders. The product had a wide therapeutic potential for disorders associated with disruption of cellular energy metabolism. In order to progress the lead candidate into clinical development the client needed regulatory support in performing a gap analysis on the IND documentation and in preparation for a pre-IND meeting with the FDA.
Solution:
Alacrita conducted an in-depth gap analysis to determine what additional data had to be generated before IND submission.
This included the following items:
- Confirmation of the lead indications;
- Overall IND strategy, including feasibility of a "gating IND” that may open product / clinical development plans in more than one indication;
- Detailed pre-clinical and clinical development plan for selected indications with clinical endpoints, timing and cost;
- Staffing and hiring plan including scenarios for interim, part- or full-time basis; and support for identifying experts with relevant experience;
- Obtaining additional feedback from outside experts (KOL, payers, potentially patients) from both a clinician and payer perspective;
- Preparation of a pre-IND package for FDA submission.
Regulatory Affairs Consulting
Our group has deep preclinical, CMC and clinical regulatory experience covering a broad range of therapeutics including small molecules, biologics, and ATMPs such as cell and gene therapies. By combining our core team with the extensive capabilities of our specialized consulting network, we're able to provide regulatory support that is precisely tailored to the exact regulatory needs of your project, throughout the product development cycle.