(M-012) Considerations for Industry—Preparing for the FDA Model-Informed Drug Development (MIDD) Paired Meeting Program

Gerald Galluppi, n/a – n/a, Sumitomo Pharma America, Marlborough, Massachusetts, USA; Malidi Ahamadi, n/a – n/a, Sanofi US, Bridgewater, New Jersey, USA; Nageshwar Budha, n/a – n/a, BeiGene USA Inc., San Mateo, California, USA; Ferdous Gheyas, n/a – n/a, Merck & Co., Inc, Rahway, New Jersey, USA; Chi-Chung Li, n/a – n/a, Genentech Inc, South San Francisco, California, USA; Yuan Chen, n/a – n/a, Genentech Inc, South San Francisco, California, USA; Anne-Gaëlle Dosne, n/a – n/a, The Janssen Pharmaceutical Companies of Johnson & Johnson, Beerse, Belgium; Niels Rode Kristensen, n/a – n/a, Novo Nordisk A/S, Bagsvaerd, Denmark; Mindy Magee, n/a – n/a, GSK, Collegeville, Pennsylvania, USA; Mahesh Samtani, n/a – n/a, Janssen Research and Development, Raritan, New Jersey, USA; Vikram Sinha, n/a – n/a, Novartis Institute of Biomedical Research, Berwyn, Pennsylvania, USA; Kunal Taskar, n/a – n/a, GSK, Stevenage, UK; Vijay Upreti, n/a – n/a, Amgen Inc, South San Francisco, California, USA; Jianning Yang, n/a – n/a, Astellas Pharma Inc., Northbrook, Illinois, USA; Jack Cook, n/a – n/a, A2-Ai LLC, Ann Arbor, Michigan, USA

Objectives: The FDA recently announced the continuation of the MIDD Paired Meeting Program as part of the Prescription Drug User Fee Act VII. Here we aim to highlight the key take home message from recent publication [1] prepared by sponsors that are members of The International Consortium for Innovation and Quality in Pharmaceutical Development with the objective of providing relevant information that will optimize the value of the MIDD Program. The primary objective of the MIDD Paired Meeting Program is to support good decision-making in drug development. Secondary objectives can include the added benefits of substantial time saving and development costs.

Methods: The report [1] describes a set of practices based on the collective experiences of industry participants involved in the MIDD Program to date, including all aspects of the process from meeting request submission to follow-up actions. The report elaborated on aspects involved in the MIDD paired meeting program including the choice of meeting topic, sponsor planning and internal involvement, meeting request, meeting information package (including the model credibility assessment) and planning for the second (Paired) Meeting.

Results: With limitations on the number of meeting request that can be accepted by FDA as part of the MIDD Paired Meeting Program, the choice of topic is critical to ensure a high likelihood of being selected by FDA as part of the MIDD paired meeting program. The report [1] provided details on the eligibility criteria established by FDA and includes points to consider for selecting a qualified MIDD topic. The report discussed strategies for internal alignment and discussion before submitting a MIDD meeting request which provides a pathway for the necessary cross-functional alignment on model-based strategies and prioritization of potential MIDD topics. Several points to consider while framing MIDD strategy and questions to be included during a meeting request were discussed. Once the meeting request is approved, the section on the meeting information package provides explanation on how to prepare a successful package that includes the right amount of information allowing to perform appropriate model credibility assessments to make the best use of the allotted time. Finally, the report talks about the possibility for a follow-up meeting as part of the overall process for planning, discussing, and defining post-meeting actions.

Conclusions: The FDA’s MIDD Paired Meeting Program has shown tangible benefits for industry participants. To facilitate optimal benefits for future participants, the co-authors have provided the guidance based on their collective experience with the program. Continued participation in the program is highly recommended for sponsors applying MIDD.

Citations: [1] “Considerations for Industry—Preparing for the FDA Model-Informed Drug Development (MIDD) Paired Meeting Program”, Galluppi, G.R., Ahamadi, M., Bhattacharya, S., Budha, N., Gheyas, F., Li, C.-C., Chen, Y., Dosne, A.-G., Kristensen, N.R., Magee, M., Samtani, M.N., Sinha, V., Taskar, K., Upreti, V.V., Yang, J. and Cook, J. (2024), Clin Pharmacol Ther. https://doi.org/10.1002/cpt.3245 (available free through Open Access)