News

Wednesday, November 14, 2018
Richard Harris reports on looming costs of potential cures

Image: Katherine Streeter for NPR

November 14, 2018 • Installment plans and refunds for treatments that don't work are two options getting more attention as ultra-expensive therapies become more common. The financial strains will only grow.

Read and hear the story on NPR Morning Edition

Friday, November 2, 2018
Paying for Cures Event in DC to highlight proposed financing solutions

The FoCUS Project (Financing and reimbursement of Cures in the US) consortium, part of the NEWDIGS initiative at MIT (https://newdigs.mit.edu/), collaboratively addresses the need for new, innovative financing and reimbursement models for durable/potentially curative therapies in the US, that ensure patient access and sustainability for all stakeholders.  

This year, the consortium has begun to build on its research and analysis by proposing groundbreaking solutions in a series of research briefs and whitepapers. It will make a...

Friday, September 21, 2018
Collaboration to drive innovation across healthcare ecosystem

CAMBRIDGE, MA, 21 SEPTEMBER 2018– FasterCures, a center of the Milken Institute devoted to saving lives by speeding up and improving the medical research system, has joined the NEWDIGS initiative at theMassachusetts Institute of Technology Center for Biomedical Innovation as a strategic partner. 

NEWDIGS provides its multi-stakeholder community of members and collaborators with a safe haven, pre-competitive environment, programs, and tools to design and pilot system-level innovations that advance sustainable, patient-centered innovation.

“This partnership with NEWDIGS at MIT means FasterCures will have an even stronger potential to bring...

Tuesday, September 4, 2018

The leads of the FoCUS Research Teams, Strategic Director Mark Trusheim,  Research Advisor Casey Quinn, Director of Simulation & Policy Research Daniel Mytelka, and Director of Drug Development Pipeline Research Colin Young, were recently interviewed by Managed Health Care Connect on the challenges and the opportunities in payment models for upcoming Gene Therapies.  

Read the article Innovating Payment Models For Gene Therapy on Managed Health Care Connect here

LEAPS Project at MIT NEWDIGS
Tuesday, July 24, 2018
New initiative aims to improve decision-making across biopharmaceutical development and delivery lifecycle

CAMBRIDGE, 23 July 2018—The NEWDIGS Initiative at the Massachusetts Institute of Technology (MIT) hosted a Design Lab for its new Learning Ecosystems Accelerator for Patient-Centered, Sustainable Innovation (LEAPS) Project. LEAPS aims to support value-driven biomedical innovation by improving decision-making across the spectrum of biomedical research and healthcare delivery.

LEAPS’s initial goal is to design a pilot project in a disease area of special importance in the Commonwealth of Massachusetts, in collaboration with public leaders and private innovation organizations. To that end, participants in the Design Lab were tasked with considering disease areas offering the prospect...

Monday, July 16, 2018
Federal initiative seeks to make access to innovative therapies wider and more financially sustainable

On May 16, 2018 the US Department of Health and Human Services (HHS) published a Request for Information (RFI) to support its initiative “Blueprint to Lower Drug Prices and Reduce Out-of-Pocket Costs.” 

The RFI notes that while the United States is the global leader in pharmaceutical research and innovation, helping to bring potent therapies to billions of people, it still faces complex, system-level problems that hinder efficient, affordable patient access to new medicines. According to the RFI, “It is time to realign the system in a way that promotes the development of affordable innovations that improve health outcomes and lower both out-of-pocket cost and the total cost of...

Tuesday, May 22, 2018
Collaboration to drive innovation across health care ecosystem

WILMINGTON, N.C., May 22, 2018– Pharmaceutical Product Development, LLC (PPD), and its real-world research and market access business unit, Evidera, have joined the Massachusetts Institute of Technology Center for Biomedical Innovation’s New Drug Development Paradigms (NEWDIGS)initiative as a strategic partner. 

PPD is the first contract research organization to join NEWDIGS, expanding the group’s already large and diverse list of global collaborators, which includes biopharmaceutical manufacturers, care...

Monday, May 21, 2018
NEWDIGS leadership and thinking at recent international gatherings

Gigi Hirsch and R. John Glasspool at LIGHT 2018

The second annual LIGHT Forum (Leaders in Global Healthcare and Technology) took place at Stanford University on May 8-9, 2018, convening a broad cross-section of 200 of the most influential decision-makers in healthcare – high-ranking executives, policymakers, and experts from leading medical research institutions – to discuss the current state of healthcare and how the industry is rapidly being reshaped by technologies like artificial intelligence (AI) and machine learning. 

Learn more and see the videos at...

Wednesday, May 9, 2018
Gigi Hirsch and R. John Glasspool join other innovation leaders to explore the challenges and potential of new technologies for patient care

San Mateo, Calif., May 9, 2018 – The second annual LIGHT Forum (Leaders in Global Healthcare and Technology) took place at Stanford University on May 8-9, 2018, convening a broad cross-section of 200 of the most influential decision-makers in healthcare – high-ranking executives, policymakers, and experts from leading medical research institutions – to discuss the current state of healthcare and how the industry is rapidly being reshaped by technologies like artificial intelligence (AI) and machine learning.

NEWDIGS Director Gigi Hirsch, MD, and R. John Glasspool, Special Advisor for the FoCUS Project, appeared on panels. Dr Hirsch spoke on the panel The Cutting Edge of...

FoCUS Design Lab event report
Wednesday, April 25, 2018
Healthcare innovation stakeholders co-develop solutions to make curative therapies accessible to patients, propose new pilot project

CAMBRIDGE, MASSACHUSETTS—The NEWDrug Development ParadIGmS (NEWDIGS) initiative at the MIT Center for Biomedical Innovation (CBI) hosted a three-day Design Lab for its Financing and Reimbursement of Cures in the US (FoCUS) project, which is aimed at developing strategies to make durable and potentially curative, but high cost, therapies accessible to patients and sustainable by the healthcare system. 

The Design Lab, held April 10–12 at MIT, was the latest in a series that builds on the efforts of ongoing working groups. 62 participants provided diverse perspectives including patient advocacy; biopharmaceutical development, access and delivery; law, policy, clinical care,...

OECD (Paris) and ADAPT SMART (Budapest)
Wednesday, April 4, 2018
NEWDIGS FoCUS project leaders have appeared in three recent meetings to share emerging perspectives on financing potentially durable but expensive new therapies.

Casey Quinn and R. John Glasspool speak at the OECD Expert Panel on Pharmaceuticals and Medical Devices

The Organization for Economic Cooperation and Development (OECD) established in January of this year, the Expert Group on Pharmaceuticals and Medical Devices. This is an expert panel under the Health Committee of the OECD Council, that occurs alongside other expert groups and working parties.

At a meeting of the panel in Paris on 26-27th March, Glasspool and Quinn presented the FoCUS project, sharing the challenges facing the US and the NEWDIGS approach, and explored how it could be translated to the OECD as a whole or to individual countries. Their...

Friday, February 9, 2018
Road MAPPs to therapeutic innovation - interview with Mark Trusheim, MIT NEWDIGS

One of the original thought leaders of the concept of Adaptive Pathways was the NEWDIGS initiative of MIT’s Center for Biomedical Innovation. ADAPT SMART has had the pleasure of collaborating with NEWDIGS throughout.  ADAPT SMART interviewed NEWDIGS Strategic Director Mark Trusheim about the interactive case study he will facilitate at the ADAPT SMART closing event, as well as some of their current research.

READ THE INTERVIEW HERE

Tuesday, December 12, 2017
NEWDIGS Initiative at MIT leads multi-stakeholder collaboration to design and pilot a sustainable, patient-centered innovation ecosystem for a target disease

CAMBRIDGE, MASSACHUSETTS, 12 DECEMBER 2017— MIT’s Center for Biomedical Innovation announced today its New Drug Development Paradigms (NEWDIGS) Initiative will pilot a next generation healthcare innovation ecosystem designed to deliver more value from new medicines to patients faster, in ways that work for all parties.

The Learning Ecosystems for Accelerating Patient-Centered and Sustainable Innovation Project (LEAPS) focuses on connecting knowledge generation across the siloes of drug development (R&D) and delivery (patient care) through platform clinical trials linked with a real-world evidence “Learning Engine.” The first pilot in LEAPS will leverage Massachusetts...

Monday, October 30, 2017
Industry leaders, patient advocates, policymakers collaborate to make groundbreaking new therapies economically sustainable

CAMBRIDGE, MASSACHUSETTS—The MIT NEW Drug Development ParadIGmS (NEWDIGS) initiative, an international biomedical innovation “think and do tank” involving a range of stakeholders in the healthcare system, hosted a collaborative Design Lab to advance work on innovative financing models that could make potentially curative—but expensive—therapies accessible to patients and affordable to payers, while ensuring sustainable innovation by industry. 

The Design Lab, held October 18–20 in Kendall Square, was the third in an ongoing NEWDIGS project called Financing and Reimbursement of Cures in the US (FoCUS). 81 people, including senior leaders from a number of biotechnology and...

Thursday, October 5, 2017

Phasing Out Phase 3What if drugs were released to the public earlier, then graded on their performance in the real world?

Read the article here: http://protomag.com/articles/phasing-out-phase-3

Thursday, August 31, 2017
BLOOMBERG: Novartis’s $475,000 Cancer Breakthrough Heralds New Era of Cures

There are more than 600 gene and cell therapies in clinical trials today, according to Mark Trusheim, a strategic director at the Massachusetts Institute of Technology’s Center for Biomedical Innovation. Those that make it to approval are likely to come with similar costs, in part because of the complex manufacturing process required to make these treatments.

“Gene therapies are different because you’re treated once and then you’re done, as compared to regular drugs where you take them every month or every day,” Trusheim said. “There’s no mechanism for the developer to get paid every month, so the price points start to look pretty high.” He called Novartis’s...

Thursday, August 31, 2017
December 12–13, 2017 at MIT

Biomedical science is outpacing the system. Barriers prevent patients’ access to innovations.Are you ready to innovation how we innovate?

The Next Wave in Adaptive Biomedical Innovation:Advancing Platform Trials into End to End Rapid Learning Systems

Featuring keynote speakers Janet Woodcock, MD Robert Califf, MD Jonathan Gruber, PhD Sandy Pentland, PhD …and senior thought leaders from other innovation centers. 

Details and registration at nextwave.mit.edu

Friday, July 21, 2017
Industry leaders, patient advocates, regulators, policymakers collaborate to identify strategies for better data use in healthcare innovation

CAMBRIDGE, MASSACHUSETTS—The MIT NEW Drug Development ParadIGmS (NEWDIGS) initiative, an international biomedical innovation “think and do tank” involving a range of stakeholders in the healthcare system, hosted a collaborative Design Lab to explore the challenges and opportunities presented by Efficacy to Effectiveness (E2E) strategies for the development and delivery of new medicines. 42 people, representing pharmaceutical companies, patient advocacy groups, regulators, payers, healthcare providers, and policymakers, participated.

The Design Lab, held July 19 and 20 at the Massachusetts Institute of Technology, was part of an ongoing NEWDIGS project called WISDOM. The project is...

Friday, May 26, 2017
MIT NEWDIGS Director and advisor speak at LIGHT Forum on AI in Healthcare

CAMBRIDGE, MASSACHUSETTS—MIT NEW Drug Development ParadIGmS (NEWDIGS) director Dr Gigi Hirsch, and program advisor R. John Glasspool spoke this week at the inaugural Leaders in Global Health & Technology (LIGHT) Forum hosted by Stanford Medical School in California. NEWDIGS is an international “think and do tank” dedicated to re-engineering pharmaceutical innovation to deliver more value faster to patients, in ways that work for all stakeholders.

Hirsch and Glasspool were members of a panel entitled, “Real World Evidence: Hype or Reality?” They were joined by Hans-Georg Eichler, MD, Senior Medical Officer, European Medicines Agency; Lloyd B. Minor, MD, Dean of the Stanford...

Friday, May 12, 2017
Industry leaders, patient advocates, policymakers collaborate to lower barriers to potentially curative treatments

CAMBRIDGE, MASSACHUSETTS—The MIT NEW Drug Development ParadIGmS (NEWDIGS) initiative, an international biomedical innovation “think and do tank” involving a range of stakeholders in the healthcare system, hosted a collaborative Design Lab to explore ways to make potentially curative—but expensive—therapies available to patients as they emerge from development. 69 people, representing pharmaceutical companies, patient advocacy groups, payers, healthcare providers, and policymakers, participated.

The Design Lab, held April 11–13 at the Massachusetts Institute of Technology, was part of an ongoing NEWDIGS project called Financing and Reimbursement of Cures in the US (FoCUS). The...

Thursday, May 11, 2017

MIT NEWDIGS director Dr Gigi Hirsch and her colleague R. John Glasspool will address the LIGHT Forum on the impact of artificial intelligence and Big Data on healthcare. They will explore the evolution from an emphasis on efficacy to a focus on value, and how all healthcare stakeholders can collaborate to improve outcomes for all parties. Learn more about the Forum at http://light2017.com

Wednesday, May 10, 2017
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. Gigi Hirsch, Executive Director of...

Wednesday, February 8, 2017
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...

Friday, January 20, 2017
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 and analysis, she...

Tuesday, January 17, 2017
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...

Friday, December 16, 2016
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...

Thursday, October 27, 2016

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...

Friday, July 1, 2016
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.

“We are excited to welcome EURORDIS to the NEWDIGS community,” said Dr Gigi Hirsch, Executive Director of NEWDIGS and the MIT Center for Biomedical Innovation. “NEWDIGS is...

Sunday, January 17, 2016

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

Monday, June 8, 2015

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.

Monday, January 12, 2015
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 way that is forcing advancements in the world of health data that many believe are long overdue. These change drivers include:

Increasing pressures to accelerate access to new and better treatments for patients in need. The advancement of translational and “precision” medicine,” associated with erosion of the traditional blockbuster model of innovation toward one that targets small subpopulations and individually tailored treatments. Growing demands from reimbursement/coverage decision-makers for...
Friday, December 12, 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.

The concept of adaptive pathways foresees an early approval of a medicine for a restricted patient population based on small initial clinical studies. The first approval is followed by progressive adaptations of the marketing authorisation to expand access to the medicine to broader patient populations based on data gathered from its use and additional studies.

...

Friday, November 21, 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.

“Through NEWDIGS we’ll work with others to explore how our guidance development processes can contribute to faster and better drug development and delivery,” said Professor Sarah Garner, NICE’s associate director for R&D. “The...

CSV