Young scientists, partnerships and resources among the focus of final 21st Century Cures Initiative roundtable

September 16, 2014

Investing in the next generation of scientists, incentivizing partnerships, exploring new approaches to clinical trials, and ensuring stable funding for research were among issues top of mind for nearly two dozen members of Congress at an Energy and Commerce Committee roundtable last week. Led by Chairman Fred Upton and Representative Diana Degette, the roundtable caps a four-month effort to gather solutions designed to accelerate the path to cures, the focus of the Committee’s 21st Century Cures Initiative.

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All Star Lineup Joins FasterCures Sept. 23 Benefit-Risk Boot Camp

August 27, 2014

Novel opportunities are emerging for patient perspectives to shape decision-making in R&D, clinical care and coverage. Join topic experts like U.S. Food and Drug Administration’s Janet Woodcock and Jeff Shuren, Patient Centered Outcomes Research Initiative’s Joseph Selby, Parent Project Muscular Dystrophy’s Holly Peay, and more September 23rd in Washington, D.C. for this one-day event designed specifically for patient organization research and engagement staff members, patient advocates, policy makers, and other stakeholders to help build capacity for expanded participation in the new benefit-risk landscape.

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5 Takeaways from the 21st Century Cures Initiative - Thus Far

August 19, 2014

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The U.S. House of Representatives Energy and Commerce Committee has engaged in a flurry of activity since the May launch of the 21st Century Cures initiative that aims to accelerate the pace of cures and medical breakthroughs in the United States. The committee has held three roundtables and six Congressional hearings on various topics affecting the full arc of the drug development process – from discovery to development to delivery – as well as published four white papers.

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10 Days Left to Apply for a Presentation Slot at Partnering for Cures

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The call for applications to serve as an innovator presenter at Partnering for Cures is open through August 22.

Each 25-minute presentation will provide an opportunity to engage potential investors, partners, and/or collaborators in moving your existing initiative forward or amplifying the impact of your approach.

We are particularly, although not exclusively, interested in hearing from partnerships that focus on one or more of the following categories:

  1. Translation/commercialization of basic scientific discoveries
  2. Data sharing
  3. Clinical trial innovation/infrastructure
  4. Creation of broadly-used tools and resources
  5. Innovative financing models

Would you take a drug that could KILL you?

July 30, 2014

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“Would you take a drug that could kill you? We ask questions like this all the time,” noted Dr. Bennett Levitan of Janssen Research & Development during a July 29 FasterCures webinar about understanding the benefit-risk assessment in new pharmaceutical products. “Do I let the wind blow through my hair or do I wear a helmet for safety?  Do I text while driving or wait until I pull over?”  It is no different for medicine, he noted.  Once an individual decides that the benefits exceed the risks for a certain treatment, they want it approved and they want to be able to use it. And that does not always occur because the patient perspective has limited voice right now in the regulatory approval process.

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Aled Edwards: Carrying Out Open-Access Research in Structural and Chemical Biology

August 4, 2014

This is the eighth in a series of profiles of people driving some of the most promising consortia in medical research. It is part of FasterCures’ Consortia-pedia project – which dissects the research-by-collaboration model and aims to establish a framework that can be applied broadly.

        

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PDUFA V: Enhancing Benefit/Risk Analysis at the FDA

July 18, 2014

REBLOG - The Campaign for Modern Medicines

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With the fifth reauthorization of the Prescription Drug User Fee Agreement (PDUFA V) one and half years underway, we welcome Dr. Rob Metcalf back to the CMM platform for a second blog in our series exploring how PDUFA V accelerates patient access to medicines. Dr. Metcalf is Vice President of Global Regulatory Affairs at Eli Lilly and Company and a member of the FasterCures Benefit Risk Advisory Council, which provides recommendations to expand patient input in shaping new medicine development and influencing regulatory decisions.

As I’ve written previously for the Campaign for Modern Medicines, PDUFA has helped the FDA streamline the new medicine approval process — bringing new treatments to patients faster. The fifth reauthorization of PDUFA helped stimulate widespread patient advocacy engagement in FDA’s regulatory processes in ways that haven’t been seen over the past two decades. This is best demonstrated through two related key initiatives included in PDUFA V: the Patient-Focused Drug Development Initiative and Benefit-Risk Assessment. Both these efforts have emerged as promising and important initiatives for patients and developers of new medicines.

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R&D Leaders to Capitol Hill: Consortia are Necessary to Accelerate Medical Progress

July 28, 2014

 

Leaders from across sectors in medical research and development delivered a strong message to Capitol Hill last week: to accelerate medical progress, we need to encourage and incentivize public-private partnerships that advance shared goals.

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Walter Capone: Identifying New Potential Standards of Care in Multiple Myeloma

This is the seventh in a series of profiles of people driving some of the most promising consortia in medical research. It is part of FasterCures’ Consortia-pedia project – which dissects the research-by-collaboration model and aims to establish a framework that can be applied broadly.

        

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