The goal of regulatory science is to make innovations that get to patients better, faster and cheaper.

There is broad agreement that our current system is broken. Today approximately 70% of the cost of drug development can be attributed to past failures.  Only 10-15% is used to produce effective therapies.

A critical aspect of the unique HiTS mandate is to create a safe-harbor in which academe, industry and the FDA can jointly pursue new approaches to the evaluation and administration of drugs.

This aspect of our mission is a naturally corollary to our modeling work at the Laboratory of Systems Pharmacology (LSP). When we advance our understanding of beneficial and adverse responses to therapeutic molecules, devices and cells, we can then take the critical next step and look at how those advances might be integrated into our regulatory system.

New computational and measurement technologies could dramatically improve the practical business of developing and evaluating drugs, including toxicology clinical trial design and evaluation.

What if we could design a regulatory framework from the ground up?

One opportunity involves areas of research and drug development where FDA procedures and regulations are not yet formulated. These include some new combination therapies, stem cells, engineered proteins, and devices that incorporate biological materials. If we can measure these therapies against specific predictive models we should be able to make go or no go decisions much, much sooner, before we waste time and money on trials that will ultimately fail.

Using the HiTS safe harbor to explore critical questions

HiTS investigators are working on a broad range of projects that have profound implications for the future of drug development.  The list below highlights some areas that are an early focus for our team:

  • Systems Toxicology
  • Linking preclinical and clinical science through multi-scale modeling
  • Failure Analysis
  • Qualification and evaluation of biomarkers
  • Evaluation and approval of novel therapeutic and combination therapies
  • Risk surveillance and assessment of adverse events
  • Adaptive and biomarker driven clinical trials and post-market surveillance
  • Ethical Analysis
  • Legal and Policy Analysis


Harvard-MIT Center for Regulatory Science Annual Symposium – May 8, 2018

Harvard-MIT Center for Regulatory Science Annual Symposium – March 7, 2017

Discovery and Validation of Biomarkers – April 3, 2017