- A new project from the MIT Center for Biomedical Innovation aims to align innovative pharmaceutical development with real-world patient care and public health needs.
The Learning Ecosystems for Accelerating Patient-Centered and Sustainable Innovation Project (LEAPS) within the New Drug Development Paradigms (NEWDIGS) Initiative will work to break down siloes between pharma and patient care by equipping clinical trials with a real-world evidence "learning engine."
"While pharmaceutical R&D is a global enterprise, the value of new medicines is assessed and driven locally. This has always been true in other countries, but is increasingly the case in the US," said Gigi Hirsch, MD, Executive Director of the MIT Center for Biomedical Innovation and the NEWDIGS Initiative.
"Our goal is to integrate a number of emerging but fragmented policy, process, and technology innovations into a system that works better for everyone, and especially for patients."
The initiative may help to address significant gaps in the existing precision medicine ecosystem by engineering systems that include patients, providers, and payers alongside biotechnology and pharmaceutical companies during the drug development process.
"It is critically important that we align priorities in pharmaceutical drug development with unmet public health needs," said Massachusetts Health and Human Services Secretary Marylou Sudders.
"By engaging the entire health care systems and its key stakeholders, this pilot project has the potential to serve as a model for person-centered health care and break down barriers that currently exist when linking patients with timely, essential treatments."
The first pilot will launch at the beginning of 2018, and may initially target rheumatoid arthritis, type 2 diabetes, Alzheimer's disease, or opioid addiction.
In addition to its goal of improving overall patient outcomes, the project hopes to extract additional value from existing electronic health records and other healthcare data sets, such as claims, mHealth applications, and patient registries.
Participants will use emerging technologies, including artificial intelligence, machine learning, or blockchain to generate new insights into personalized medicine while bringing hospitals and clinics into closer alignment with the pharmaceutical R&D environment.
Pharmaceutical companies GSK, Merck, and Sanofi, members of the NEWSDIGS collaborative, will provide $500,000 in start-up funding. Additional corporate and non-profit members will also contribute support and aid to the project.
"We look forward to building on the work we have done with the NEWDIGS collaborative to design and pilot a next generation biomedical innovation system in Massachusetts,” said Susan Shiff, PhD, MBA, Senior Vice President and Head of the Center for Observational and Real World Evidence (CORE) at Merck.
“Done well, we believe this effort can help transform the way new therapies are developed and delivered and serve as a model to replicate in other states, and for other diseases."