MIT NEWDIGS and the Harvard-MIT Center for Regulatory Science announced the Dynamic Dossier in the Cloud today, a radical new platform that promises to redefine the way biopharmaceutical companies share data with stakeholders, including the Food and Drug Administration (FDA).
This initiative aligns well with priorities recently announced by FDA Commissioner Scott Gottlieb.
“We envision a world where we’re going to move toward a much more structured review process where the data will be available in a cloud-based environment,” Gottlieb said January 8th at the 37th Annual JP Morgan Healthcare Conference.
The current FDA regulatory paradigm for new product approvals is based on analysis of data submitted in discrete deliveries. Once approved, label expansions authorizing additional uses of a drug and manufacturing changes are similarly regulated by FDA analysis of discrete deliveries of data. This model has been in place for more than 50 years. According to many involved in the system, it’s expensive, inefficient, and frustrating to sponsors and regulators alike.
To address these pressing challenges, the NEWDIGS LEAPS Project, led by the MIT Center for Biomedical Innovation, introduced an initiative to usher in a new era of better data sharing for decision making. The Dynamic Dossier in the Cloud represents an innovative approach to support FDA and facilitate collaboration using artificial intelligence, machine learning, and predictive analytic techniques in a modern cloud-based architecture. It will enable streamlined approvals of new products that address unmet needs, significant operating efficiencies for sponsors and FDA, and improved patient safety.
Experts forecast that over time, the Dynamic Dossier in the Cloud will enhance decision-making and outcomes across the lifecycle of biopharmaceutical products, not only with regulators but also with other stakeholders, including payers, clinicians, and patients. For example, the integrated longitudinal tracking of clinical and patient reported outcomes data for a given product on this scalable platform could enable the implementation of performance-based contracts between sponsors and payers.
Design and implementation planning of the Dynamic Dossier in the Cloud will leverage the safe haven, pre-competitive collaboration environment, and the interactive design methods of MIT NEWDIGS, while the Harvard-MIT Center for Regulatory Science will provide domain knowledge and expertise in computational biology and medical informatics, funding, and an avenue for FDA interactions.
First year activities and deliverables will focus on analyzing stakeholder-specific functional requirements; policy, process, and technology changes needed; and a roadmap for development and implementation. Findings will be summarized in a manuscript to be submitted to a relevant peer reviewed journal.
“We believe that the Dynamic Dossier in the Cloud will be a powerful and timely enabler of patient-centered innovation,” said Gigi Hirsch, MD, Executive Director of NEWDIGS and its LEAPS Project. “We are delighted that we can provide the opportunity for collaboration across traditional stakeholder and organizational silos to advance this transformational concept toward action and impact.”
Stakeholders, including industry leaders, applauded the move.
“A large global biopharma like Sanofi with 5,000 products on the market may be required to make as many as 50,000 regulatory submissions per year,” stated Hilary Malone, Chief Regulatory Officer and Head, Global Regulatory Affairs, Sanofi, and industry champion of the project. “The current practice for submission and approval is woefully inadequate. An AI/machine learning-based, ‘green light within design space’ approach as envisioned by Dynamic Dossier in the Cloud, would be more far more effective and efficient.”
About MIT NEWDIGS:
MIT NEW Drug Development ParadIGmS (NEWDIGS) is an international “think and do tank” dedicated to delivering more value faster to patients, in ways that work for all stakeholders. NEWDIGS designs, evaluates, and initiates advancements that are too complex and cross-cutting to be addressed by a single organization or market sector. Its members include global leaders from patient advocacy, payer organizations, biopharmaceutical companies, regulatory agencies, clinical care, academic research, and investment firms. For more information, visit http://newdigs.mit.edu.
The LEAPS Project (Learning Ecosystems Accelerator for Patient-centered, Sustainable innovation) is advancing the mission of the MIT NEWDIGS consortium – to deliver more value from biomedical innovation faster to patients, in ways that work for all stakeholders – through a new collaborative systems approach to the planning, generation, and use of evidence across R&D and healthcare delivery. A model system for Rheumatoid Arthritis will be piloted in Massachusetts (2020 launch) and will inform related efforts in other diseases and geographies. Success in LEAPS targets better patient outcomes while also reducing waste and inefficiency across the system.
About Harvard-MIT Center for Regulatory Science:
Harvard, MIT, and the FDA have partnered through the Center to engage researchers, physicians, and patient advocates from across academia, industry, and government institutions to improve the process of evaluating new products. The Center promotes regulatory science through research, education, and outreach programs and unites researchers, clinicians, and regulators under the same mission: accelerating the introduction of new drugs and devices while reducing the burden of biomedical innovation. Further information can be accessed at http://hits.harvard.edu/the-program/center-for-regulatory-science/about/