Public Call for Expert in MIDD - Deadline 5 September
August 18, 2023
Background and Rationale
In 2019 IQ formed the MIDD Working Group-1 with a primary mission to capture and summarize quantitative and qualitative benefits received by companies who had participated in the newly formed FDA MIDD Paired Meeting Pilot Program. The work culminated in a manuscript published in Clinical Pharmacology and Therapeutics, which was well-received as a top-downloaded paper in 2021 according to Wiley Publishing. As a follow-up, IQ formed MIDD Working Group-2 to help sponsor companies prepare for and conduct effective MIDD discussions with regulatory authorities.
Project Details
MIDD Working Group-2 is preparing a manuscript entitled: Considerations for Industry – Preparing for the FDA Model-Informed Drug Development (MIDD) Paired Meeting Program. The main objectives of the WG are to promote the use of modeling and simulation to support decision-making in drug development and to encourage participation in the paired meeting program by helping sponsors choose topics and write effective meeting requests to the Agency. Recognized experts in applying M&S in drug development and past participants in the MIDD Paired Meeting Program are needed to help the WG meet its objectives.
Qualifications (all are necessary)
Note: Qualifications below must be based upon specific scientific or technical expertise.
- Recognized expert in applying modeling and simulation in drug discovery and development
- Deep understanding of FDA requirements for application of M&S in drug development
- Experience in leading science-based working teams to improve effectiveness of drug R&D
Objectives and Boundary of Engagement
The ideal candidate will be responsible for coordinating actions of MIDD WG-2, manuscript preparation, and interfacing with the journal editor.
Respondents, please note this is a volunteer role.
When this project is completed, membership in this IQ working group ends.
Interested parties must submit a current CV to the IQ Secretariat by 5 September 2023. A selection committee will be formed within the working group to evaluate the candidates and make the final recommendation for membership.