Expert views on strategies for getting new science to patients faster, safely, and affordably

CAMBRIDGE, Mass., Nov. 9, 2016—Clinical Pharmacology & Therapeutics (CPT), a cross-disciplinary journal in experimental and clinical medicine, in collaboration with the MIT Center for Biomedical Innovation (CBI) and its New Drug Development Paradigms (NEWDIGS) initiative, published a special issue today focusing on the emerging practice of “Adaptive Biomedical Innovation (ABI).”
Featuring articles by diverse healthcare system stakeholders, this special issue embodies a key principle of ABI: working across traditionally fragmented and siloed approaches to innovation to optimize the benefit and access of new medicines for patients, while ensuring a more sustainable innovation ecosystem. Articles in the issue address emerging innovations in clinical trial designs, regulation, coverage and reimbursement, and collaboration models, and include:
Adaptive Biomedical Innovation: Evolving Our Global System to Sustainably and Safely Bring New Medicines to Patients in Need.
A Benefit–Risk Analysis Approach to Capture Regulatory Decision-Making: Non-Small Cell Lung Cancer.
Pharmaceuticals Licensing and Reimbursement in the European Union, United States, and Japan.
PIPELINEs: Creating Comparable Clinical Knowledge Efficiently by Linking Trial Platforms.
“Threshold-crossing”: A Useful Way to Establish the Counterfactual in Clinical Trials?
Leveraging Industry-Academia Collaborations in Adaptive Biomedical Innovation.
These and the issue’s other articles can be found at http://ascpt.onlinelibrary.wiley.com/hub/journal/10.1002/(ISSN)1532-6535/
The edition of CPT, which was published today, was co-edited by Dr Gigi Hirsch, Executive Director of CBI/NEWDIGS Initiative, and by Dr. Peter Honig, an Associate Editor of the journal. Dr Hirsch is a leading advocate of adaptive biomedical innovation, which focuses on evolving a more inter-dependent innovation ecosystem that optimizes new drug development for patients and sustainability alike.
“Biomedical science is evolving rapidly, but the translation of that science into medical product advances appears to be lagging,” notes Dr Honig. “This disconnect has implications for all stakeholders, and especially for patients who are eager for earlier access to long awaited treatments.”
The new approach involves bringing stakeholders together to set shared objectives, foster trust, structure decision-making and manage expectations through rapid-cycle feedback loops that maximize product knowledge and reduce uncertainty in a continuous, adaptive, and sustainable healthcare system. The articles in the journal review recent developments in these new adaptive approaches, and discuss strategies for further innovations.
John Ferguson, a Distinguished Fellow at biotechnology company Shire, expects the lessons shared in the journal will have broad impact. “The discussion about the opportunities and challenges of adaptive biomedical innovation in this issue of CPT will help stakeholders learn to work together toward solutions that minimize patient risk, ensure favorable therapeutic benefit-risk balance of—as well as optimize patient access to—new medicines, while also ensuring the sustainability of pharmaceutical innovation.”
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About MIT NEWDIGS
MIT NEW Drug Development ParadIGmS (NEWDIGS) is an international “think and do tank” dedicated to re-engineering pharmaceutical innovation to reliably and sustainably accelerate the deliver new, better, affordable therapeutics to the right patients. NEWDIGS takes a systems approach to designing, evaluating, and piloting scalable real world solutions to challenges that are too complex and cross-cutting to be addressed by a single organization or market sector. Its members include global leaders from key stakeholder communities including patient advocacy, regulation, payers, biopharmaceutical companies, and academia. For more information, visit http://newdigs.mit.edu.
About Clinical Pharmacology & Therapeutics
Clinical Pharmacology & Therapeutics (CPT) is the authoritative cross-disciplinary journal in experimental and clinical medicine devoted to publishing advances in the nature, action, efficacy, and evaluation of therapeutics. CPT publishes original Articles in the emerging areas of translational, predictive and personalized medicine; new therapeutic modalities including gene and cell therapies; pharmacogenomics, proteomics and metabolomics; bioinformation and applied systems biology complementing areas of pharmacokinetics and pharmacodynamics, human investigation and clinical trials, pharmacovigilance, pharmacoepidemiology, pharmacometrics, and population pharmacology.