MDMI

Medicines Development Modernization Initiative

About

The Medicines Development Modernization Initiative (MDMI) is a multi-stakeholder and interdisciplinary initiative that brings together leaders and experts in the medicines development space who have a common interest in developing strategies and solutions that can optimize the medicines development process and, ultimately, bring medicines to patients more efficiently.

Mission

MDMI is focused on making the medicines development process more efficient and less resource intensive by achieving the full potential of medicine development tools (MDTs).

MDMI Stakeholders

MDMI brings together a wide array of stakeholders, including, but not limited to, the following:

  • Biopharmaceutical sector
  • Patient Advocates
  • FDA, NIH, and other public stakeholders
  • Payers
  • Providers
  • Academics
  • Technology Developers
  • Innovative CROs
  • Global Representatives
  • Other Consortia and Thought Leaders

Why is Modernization Needed?

Rapid scientific advances are enabling a greater understanding of diseases at the molecular level; but at the same time, increasing clinical trial complexity and economic pressures have made the medicines development process more difficult. Novel medicine development tools (MDTs), such as real-world evidence (RWE), Bayesian statistical methods, and emerging digital technologies, can unlock systemic changes in medicines development and reverse these trends, but these MDTs have not been widely integrated into drug development programs and the clinical trial process because stakeholders throughout the ecosystem have not developed comfort and confidence in them. MDMI is executing a strategic process to bring stakeholders together to systematically develop that comfort and confidence and speed the development of medicines patients need.

MDMI Biostatistics Innovation Team White Paper

The Biostatistics Innovation Team’s white paper on Bayesian methodology has been published in Nature Reviews Drug Discovery. The white paper explains the importance and value of leveraging Bayesian methodology in drug development clinical trials to bring down the time and cost of drug development. To read the white paper, follow this link

Data science and digital health in clinical development and operations: impact, challenges, and calls to action for the drug development system

In April 2023, the Data Sciences Innovation Team released a white paper on how three medicines development tools (MDTs) –  artificial intelligence and machine learning algorithms, digital health tools, and augmentation of randomized controlled trial data with real-world data – can be applied to transform clinical development. The white paper specifically highlights the impact these MDTs can have and outlines the outstanding challenges to realize the full potential of MDTs and the considerable opportunity that exists to modernize medicines development further. Click here to read the white paper and learn more.

June 2022 Virtual Event: Official Unveiling MDMI

On June 28, 2022, MDMI representatives publicly launched the Initiative during a virtual event, titled “A Systematic Approach to Modernizing Drug Development.” During the event, webinar attendees heard from a variety of thought leaders, including Michael Leavitt, former HHS Secretary and Utah Governor, Dr. Andrew von Eschenbach, former FDA Commissioner and former Director of the National Cancer Institute, and others, on various topics, including why modernization in the medicines development ecosystem is needed.