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

Publisher: Wiley Country of Publication: United States NLM ID: 0372741 Publication Model: Print-Electronic Cited Medium: Internet ISSN: 1532-6535 (Electronic) Linking ISSN: 00099236 NLM ISO Abbreviation: Clin Pharmacol Ther Subsets: MEDLINE

Publication: 2015- : Hoboken, NJ : Wiley
Original Publication: St. Louis : C.V. Mosby

United States Food and Drug Administration* ; Drug Development*/legislation & jurisprudence ; Drug Development*/methods ; Drug Industry*/legislation & jurisprudence; United States ; Humans ; Pilot Projects ; Drug Approval

A recent industry perspective published in this journal describes the benefits received by drug companies from participation in the MIDD Pilot Program. Along with the primary objectives of supporting good decision-making in drug development, there were substantial savings in time and development costs. Furthermore, many sponsors reported qualitative benefits such as new learnings and clarity on MIDD strategies and methodology that could be applied to other development programs. Based on the success of the Pilot Program, the FDA recently announced the continuation of the MIDD Paired Meeting Program as part of the Prescription Drug User Fee Act (PDUFA VII). In this report, we describe the collective experiences of industry participants in the MIDD Program to date, including all aspects of the process from meeting request submission to follow-up actions. The purpose is to provide future participants with information to optimize the value of the MIDD Program.
(© 2024 The Authors. Clinical Pharmacology & Therapeutics published by Wiley Periodicals LLC on behalf of American Society for Clinical Pharmacology and Therapeutics.)

Venkatakrishnan, K. & van der Graaf, P.H. Model‐informed drug development: connecting the dots with a totality of evidence mindset to advance therapeutics. Clin. Pharmacol. Ther. 110, 1147–1154 (2021).
Madabushi, R., Seo, P., Zhao, L., Tegenge, M. & Zhu, H. Review: role of model‐informed drug development approaches in the lifecycle of drug development and regulatory decision‐making. Pharm. Res. 39, 1669–1680 (2022).
Madabushi, R. et al. The US Food and Drug Administration's model‐informed drug development paired meeting pilot program: early experience and impact. Clin. Pharmacol. Ther. 106, 74–78 (2019).
Wang, Y., Zhu, H., Madabushi, R., Liu, Q., Huang, S.M. & Zineh, I. Model‐informed drug development: current US regulatory practice and future considerations. Clin. Pharmacol. Ther. 105, 899–911 (2019).
Jain, L., Mehrotra, N., Wenning, L. & Sinha, V. PDUFA VI: it is time to unleash the full potential of model‐informed drug development. CPT Pharmacometrics Syst. Pharmacol. 8, 5–8 (2019).
Marshall, S. et al. Model‐informed drug discovery and development: current industry good practice and regulatory expectations and future perspectives. CPT Pharmacometrics Syst. Pharmacol. 8, 87–96 (2019).
Krishnaswami, S. et al. MID3: Mission impossible or model‐informed drug discovery and development? Point‐counterpoint discussions on key challenges. Clin. Pharmacol. Ther. 107, 762–772 (2020).
Chan, J.R. et al. Current practices for QSP model assessment: an IQ consortium survey. J. Pharmacokinet. Pharmacodyn. 11, 1–13 (2022).
United States, Food and Drug Administration. Pilot meetings program for model informed drug development. 83 FR 16868 (2018). https://www.federalregister.gov/documents/2018/04/17/2018‐08010/pilot‐meetings‐program‐for‐model‐informed‐drug‐development‐approaches.
Lesko, L.J. Perspective on model‐informed drug development. CPT Pharmacometrics Syst. Pharmacol. 10, 1127–1129 (2021).
Madabushi, R., Benjamin, J., Zhu, H. & Zineh, I. 2024. The US Food and Drug Administration's model‐informed drug development meeting program: from pilot to pathway. Clin. Pharmacol. Ther. 116, 278–281 (2024).
Galluppi, G.R. et al. Industrial perspective on the benefits realized from the FDA's model‐informed drug development paired meeting pilot program. Clin. Pharmacol. Ther. 110, 1172–1175 (2021).
United States, Food and Drug Administration. Prescription Drug User Fee Act of 2023 VII meetings program for model informed drug development approaches. 88 FR 1597 (2023). https://www.federalregister.gov/documents/2023/01/11/2023‐00389/prescription‐drug‐user‐fee‐act‐of‐2023‐vii‐meetings‐program‐for‐model‐informed‐drug‐development.
FDA model‐informed drug development paired meeting program. (Accessed December 5, 2023).
United States Food and Drug Administration. Guidance for industry: interacting with the FDA on complex innovative trial designs for drugs and biological products. https://www.fda.gov/media/130897/download (Accessed December 20, 2020).
Anziano, R.J. & Milligan, P.A. Model informed drug development: collaboration through a common framework. Clin. Pharmacol. Ther. 110, 1165–1167 (2021).
Model‐informed drug development paired meeting program. (Accessed February 12, 2024).
American Society of Mechanical Engineers. Assessing credibility of computational modeling through verification and validation: application to medical devices (2018). ASME Standard, V&V 40–2018 p. 60. (Accessed February 12, 2024).
Kuemmel, C. et al. Consideration of a credibility assessment framework in model‐informed drug development: potential application to physiologically‐based pharmacokinetic modeling and simulation. CPT Pharmacometrics Syst. Pharmacol. 9, 21–28 (2020).
Nijsen, M.J.M.A. et al. Preclinical QSP modeling in the pharmaceutical industry: an IQ consortium survey examining the current landscape. CPT Pharmacometrics Syst. Pharmacol. 7, 135–146 (2018).

IQ consortium

Date Created: 20240323 Date Completed: 20240716 Latest Revision: 20240716

20240716

10.1002/cpt.3245

38519861