Value-focused Model-informed Drug Discovery and Development (MID3) Strategies Key to Future Health Policy
Model-informed Drug Discovery and Development (MID3) integrates computational modeling and simulation with drug development expertise and real-world data. Dr. Farrell will present how MID3 is being applied at every stage of drug development from preclinical and clinical research through to market access strategy and post-marketing activities.
He will show how MID3 increases certainty at every step from identifying the best new drug candidate through to negotiating its value with payers and health authorities and how it provides quantitative assessments for key go/no-go decisions and informs comparative effectiveness, an important metric in value-based pricing.
MID3 is already accepted by all major health authorities, including Japan’s Pharmaceuticals and Medical Devices Agency (PMDA), the US Food and Drug Administration (FDA), Australian Therapeutic Goods Administration, European Medicines Agency, and China National Drug Administration. Indeed, in the past three years MID3 data has been used in 90% of all novel drugs approved by the US FDA. This innovative approach has stimulated new regulatory precedents and policies worldwide. MID3 is also being used to provide a quantitative framework to develop and deploy cost-effective drugs at the optimal dose to targeted patient populations.
The adoption of MID3 methodologies:
-Enable precision drug development and dosing to treat Japan’s ageing population
-Allow the creation of novel frameworks for delivering cost-effective healthcare and enable it to take a global leadership role in managing ageing populations
-Optimize planning and deployment of medical countermeasures (MCM) to treat infectious diseases and pandemic planning and readiness
-Inform new regulatory science pathways for developing drugs for special populations, including elderly and pediatric patients and those with chronic or rare diseases.
Dr. Farrell will show how MID3 is a game changer and a leading-edge development combining the power of modeling, simulation and data analytics.
If you are in the healthcare industry, this is one event you will not want to miss.
ACCJ Healthcare Committee
ACCJ Digital Health Subcommittee
ACCJ Medical Devices and Diagnostics Subcommittee
ACCJ Pharmaceuticals Subcommittee
ACCJ Regenerative Medicine and Bioscience Subcommittee
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