Collaborative Investigation of Adaptive Licensing Highlighted in Reference Paper Authored by MIT NEWDIGS Initiative

CAMBRIDGE, Mass., (February 13, 2012)—A collaborative, multi-disciplinary research team led by Massachusetts Institute of Technology ’s (MIT) Center for Biomedical Innovation (CBI) is investigating the evolution of drug development and licensing systems. Through a systems-based research approach, MIT NEWDIGS (NEW Drug Development ParadIGmS) aims to understand, inform and catalyze the evolution of global regulatory systems to improve the management of safety and efficacy of drugs in use, reduce risk to patients and produce better therapeutic outcomes.

MIT NEWDIGS is a collaborative, action-research community led by MIT’s Center for Biomedical Innovation – based in the MIT Engineering Systems Division – comprised of representatives from regulatory, payor, patient, industry and other influential elements of the healthcare system. This diverse group is collaborating to actively model a range of elements central to the advancement of drug evaluation and approval systems such as research and data analysis methodologies; stakeholder interactions, information sharing and decision-making processes; and legal, policy and financial implications for each player in the system.

The initial focus of the MIT NEWDIGS collaborators is on Adaptive Licensing, an emerging regulatory paradigm which has potential benefits to patients and public health if critical elements are aligned to support its effective implementation. A recent paper “Adaptive Licensing, Taking the Next Step in the Evolution of Drug Approval,” to be published in the March edition of Nature Clinical Pharmacology & Therapeutics by MIT NEWDIGS collaborators explores this paradigm and reviews eight related programs from across the globe. Each program aims to better understand acceptable levels of risk to benefit for patients, improve public communication on drug safety and efficacy, and advance learning throughout the lifecycle of new products.

“The systems-approach to research allows MIT NEWDIGS to bring together a collaborative community to design, evaluate and interpret elements that we hope will progressively evolve the global regulatory system and improve patient access to important new therapeutics,” said Gigi Hirsch, M.D., Executive Director of MIT’s Center for Biomedical Innovation and MIT NEWDIGS. “Our first research module is examining the concept of Adaptive Licensing to identify how to reduce patient risk while continuously enhancing our knowledge about the safety, efficacy and effectiveness of drugs in real-world conditions.”

The MIT NEWDIGS Adaptive Licensing program aims to maximize the public health benefit of new drugs by balancing timely access to drugs for patients who need them most, with the need to continuously improve our understanding of how to use the product to optimize clinical benefit to patients. Adaptive Licensing would allow for controlled and closely monitored post market access to drugs, with a structure to expand, contract or refine patient access based on emerging information from the drug’s use under real-world conditions.

The impetus for MIT NEWDIGS research in Adaptive Licensing is a desire to reduce the excessive levels of risk that patients are exposed to once a drug is approved under current licensing systems. In addition, research on Adaptive Licensing has the potential to improve the way regulatory systems understand and accommodate scientific and clinical advancements. Regulatory systems often require lengthy periods before developing and implementing guidance to validate emerging science. MIT NEWDIGS collaborators hope to find ways of reducing this time period to more fully and expeditiously leverage scientific breakthroughs to benefit patients.

“The lack of structure to obtain ongoing knowledge about the effectiveness of drugs, once they are approved, puts patients at greater risk,” added Dr. Kenneth Oye, faculty of MIT’s Department of Political Science and Engineering Systems Division and member of the MIT NEWDIGS research team. “MIT NEWDIGS and our diverse network of collaborators are asking targeted questions and conducting extensive research to ensure that however the regulatory process evolves, it does so with the highest degree of knowledge and understanding to ensure safety and efficacy for patients.”

MIT NEWDIGS hopes to evolve one of its Adaptive Licensing studies into a real-world collaborative demonstration project within 2012. The goal is to design an optimized model system that enables greater efficiency in the delivery of a safe and effective product to patients suffering from an important unmet medical need.

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About MIT NEWDIGS
MIT’s NEWDIGS (NEW Drug Development ParadIGmS) program, led by the MIT Center for Biomedical Innovation (CBI), is a unique collaborative learning environment focused on enhancing the value of innovation for all global healthcare stakeholders. Building on the world-class expertise of MIT in systems approaches to science, engineering and management, MIT NEWDIGS catalyzes the intelligent evolution of the complex interdependent processes, technologies, policies and people required for sustainable change.

About MIT’s Center for Biomedical Innovation
CBI’s mission is to improve global health by overcoming obstacles to the development and implementation of biomedical innovation. CBI provides an open and transparent environment for collaborative research among industry, academia and government, and draws on the expertise of MIT’s schools of engineering, science and management. Residing within the MIT Engineering Systems Division, CBI catalyzes research by targeting areas where breakthroughs would have important and immediate impact on healthcare innovation, productivity, regulation and practice. Learn more at: web.mit.edu/cbi/.

Press Release

Media Contact:
Stefanie Koperniak
Communications Director
MIT Engineering Systems Division
617-324-3806
skoperni@MIT.EDU

MIT-led Program Drives Systems Approaches to Improving Global Regulatory Systems

NEWDIGS Press release 2.13.2012