Hilary Malone joins MIT NEWDIGS Executive Committee

Regulatory and business leader will help accelerate system-wide biomedical innovation
CAMBRIDGE, MASSACHUSETTS, 1 MARCH 2017—The MIT New Drug Development Paradigms Initiative (NEWDIGS) announced today that Hilary Malone, Chief Regulatory Officer for pharmaceutical company Sanofi, has joined the NEWDIGS Executive Committee. Sanofi is a strategic partner of NEWDIGS, which is an international, multi-stakeholder consortium to design modern systems that connect scientific discovery to patient care. In her role on the Executive Committee, Dr. Malone will help lead the initiative in its drive to advance the evolution of more adaptive approaches to biomedical innovation.

“NEWDIGS welcomes Dr. Malone to the Executive Committee,” said Dr. […]

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MIT NEWDIGS Hosts Design Lab on Clinical Trial Innovation

Biomedical Innovation Initiative Supporting New NIH-Funded Trial Innovation Center
CAMBRIDGE, MASSACHUSETTS—The MIT NEW Drug Development ParadIGmS (NEWDIGS) initiative, an international biomedical innovation “think and do tank”, co-hosted an “Efficacy to Effectiveness Clinical Trial” Design Lab in partnership with the Tufts Clinical Translational Science Institute (CTSI) and the new Johns Hopkins University (JHU) – Tufts Medical Center Trial Innovation Center (TIC), part of the CTSA Trial Innovation Network.

The JHU-Tufts TIC, recently funded through a $25 million NIH grant, provides high-quality design and operational support to investigators conducting multi-center clinical trials. The strategic goal is to create new frameworks and practices for clinical […]

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Kay Larholt joins MIT NEWDIGS as Director of Integrated Knowledge Solutions

Industry veteran will lead development of new decision support technologies
CAMBRIDGE, MASSACHUSETTS—The MIT New Drug Development Paradigms Initiative (NEWDIGS) announced today the hire of Dr. Kay M. Larholt as their Director of Integrated Knowledge Solutions. Dr. Larholt will lead a portfolio of activities focused on “Knowledge Generation and Use 2.0,” a critical component of Adaptive Biomedical Innovation.

Dr. Larholt is a seasoned statistical professional with over 25 years of experience in the Pharmaceutical, Biotechnology, and Medical Device industry. She has global experience with all phases of clinical trials and regulatory submissions. An experienced statistical collaborator providing strategic input to clinical program design […]

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OpEd: Mark Trusheim & Peter B. Bach on How the US Can Beat Hepatitis C

How the US Can Beat Hepatitis C: Don’t buy the pills, buy the company
Pharma veteran and physician advance provocative solution to overcome treatment costs
CAMBRIDGE, MASSACHUSETTS—In an article published today in Forbes, Visiting Scientist at the MIT Sloan School of Management Mark Trusheim and co-author Peter B. Bach, a physician at Memorial Sloan Kettering Cancer Center in New York, propose a startling response to the prevalence of Hepatitis C and the high cost of the leading therapy: The US government should not just pay for the pills—they should buy their maker.

The pharmaceutical company Gilead sells Hepatitis C drugs that have 80% […]

  • Clinical Pharmacology and Therapeutics Special Issue

Special Issue of Clinical Pharmacology & Therapeutics spotlights Adaptive Biomedical Innovation

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 […]


NEWDIGS convenes healthcare leaders to pioneer new pharmaceutical financing strategies

CAMBRIDGE, Mass., Oct. 27, 2016 — Patient advocates, healthcare payers, industry, and academic stakeholders gathered today at the Massachusetts Institute of Technology (MIT) to map out a new strategy for designing and piloting innovative financing and reimbursement models for promising, and possibly curative, new medicines. The project is called Financing and Reimbursement of Cures in the US (FoCUS).

FoCUS will initially target three urgent medical areas—Curative Gene Therapies, Durable Oncology Treatments, and Antibiotics for Multi-Drug Resistant Infections. Working groups will use components of a dynamic design “toolkit” to tailor innovative finance and reimbursement models that address different characteristics of curative therapy […]

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European Rare Diseases advocate EURORDIS joins as NEWDIGS member

International collaboration aims to improve healthcare for people living with a rare disease

BOSTON, PARIS, 1 JULY 2016—MIT’s NEW Drug Development ParadIGmS (NEWDIGS) program announced today that EURORDIS-Rare Diseases Europe, the European Organisation for Rare Diseases, has joined its international effort to accelerate delivery of new, better, affordable therapeutics to patients faster. NEWDIGS brings together pharmaceutical and biotech companies, regulators, insurers, patient advocacy groups, and other healthcare stakeholders to design modern systems that connect scientific discovery to patient care. […]

  • NEWDIGS podcast feature

Gigi Hirsch with Alberto Grignolo on DIA Global Forum Podcast: “An Urgent Imperative Now to Learn Quickly”

Listen to a conversation between Dr. Alberto Grignolo, Deputy Editor of DIA Global Forum, and NEWDIGS Executive Director and DIA 2016 Conference Co-Chair Dr. Gigi Hirsch discuss the challenges of healthcare system redesign in an era of groundbreaking science and new medical therapies.

Dr Hirsch is also participating in the DIA 2016 panel discussion “Europe and the US: Making Outcomes-Based Health Care Possible.

Get the podcast

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Mark Trusheim featured in Nature News Article: Financing Cures

Mark Trusheim, Director of NEWDIGS Strategic Initiatives, is quoted in the Nature News article “Promising gene therapies pose million-dollar conundrum”. He spoke at BIO on June 8th presenting on “Curative Therapies: Aligning Policy with Science to Ensure Patient Access.”

NEWDIGS will soon be launching a project on financing and reimbursement of cures in the US to focus on these issues.

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MIT’s NEWDIGS Launches New Program in Healthcare Data

The inaugural meeting of the NEWDIGS Data Program was held in January 2015, and brought together international experts from academia, government, information technology, and the healthcare sector. A series of panel discussions focused on identifying the gaps and opportunities that might be addressed through better international cooperation in data system design and use. Through discussion, participants joined in formulating a research agenda with associated pilot programs to develop the tools, methods and policies needed to leverage real world evidence for better decision-making.

The workshop referenced three important paradigm shifts currently unfolding in biomedical and healthcare innovation, which are converging in a […]

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Adaptive pathways: a future approach to bring new medicines to patients?

December 12th, 2014

Scientists argue that scientific and political changes will make adaptive pathways the preferred approach to make new treatments available. “Adaptive pathways should be the preferred approach in the near future to bring new medicines to patients.” A number of scientists, including members of the European Medicines Agency (EMA) and its scientific Committees take this position in a co-authored article published in Clinical Pharmacology and Therapeutics.

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NICE announces collaboration with NEWDIGS

November 21st, 2014

NICE (the UK National Institute for Health and Care Excellence) has joined a global group of organisations whose goal is to speed up the development and delivery of new, effective and affordable drugs to patients. The New Drug Development Paradigms (NEWDIGS) program, led by the Center for Biomedical Innovation (CBI) at the Massachusetts Institute of Technology (MIT) in Cambridge, Massachusetts brings together pharmaceutical companies, academic researchers, patient advocacy groups, government agencies involved in healthcare and other experts to collaborate on ways to reliably and sustainably deliver new, better, affordable therapeutics to the right patients faster.