Patient-Focused Drug Development at FDA: An Update

April 16, 2014

by Kim McCleary, Director of Strategic Initiatives, FasterCures

The FDA’s Patient-Focused Drug Development Initiative (PFDDI) has attracted considerable attention within the patient community and industry since the first public meeting held in October 2012. FasterCures hosted a February 19, 2014 webinar with FDA and the National Health Council to describe this initiative and new activities at FDA that will bring greater structure to the assessment of benefits and risks of new pharmaceutical products being reviewed by the agency.

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You Don’t Have to Be a Billionaire to Influence Science

April 14, 2104

by Melissa Stevens, Deputy Executive Director, FasterCures

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The New York Times recently reported on the emerging trend of the ultra-wealthy financing American science.

What’s “so hot”? Philanthropists taking up the fight against deadly and debilitating diseases.

What’s “so not”? Anyone making gifts without proper due diligence and formulation of a research plan.

Donors don’t have to make a 9-figure pledge to steer science or improve research progress, but they should assess the needs of field, find trusted partners, and articulate key milestones before making gifts of any size. Although science philanthropy appears to be growing overall, philanthropic investment represents only about two percent of the total medical R&D funding in the U.S., making it a scarce resource. Philanthropy can have an outsized impact because of its high risk tolerance, flexibility, and ability to align incentives across multiple sectors, but it needs to be carefully stewarded.

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10 Things You Need to Know About the FDA

April 11, 2014

by Shawn Sullivan, Associate, Executive Administrator & Policy Analyst

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Chances are, by the time you’re into the first hour of your morning, you will have touched an average of 10 products that are regulated by the U.S. Food and Drug Administration. Coffee, bagels, toothpaste, soaps, makeup and daily medications are just a sampling of the products that the FDA is responsible for.

It is one of the oldest agencies of the federal government and can trace its roots back to before the American Civil War. Its modern role in American life started when President Teddy Roosevelt championed the Pure Food and Drug Act at the infancy of the 20th century. You might remember this, because you probably read Upton Sinclair’s famous novel The Jungle in high school and strongly considered becoming a vegetarian (I know I did).  Still, over one hundred years later, the FDA remains an essential agency – protecting and promoting your health.

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Crowdsourcing data challenges to speed the search for cures

April 3, 2014

by Kristin Schneeman, Program Director, FasterCures

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“The way biomedical research is carried out is changing fundamentally,” Sage Bionetworks President Stephen Friend declared at the beginning of a webinar about the crowdsourced computational challenges Sage is facilitating in partnership with the DREAM (Dialogue for Reverse Engineering Assessment and Methods) project that originated at IBM. Friend laid out five opportunities he believes are giving rise to new ways to generate, analyze, and support new research models:

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Let’s Allow Young Scientists to Try it Their Way

March 31, 2014

by Kathi E. Hanna, FasterCures Senior Fellow

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In fall 2013, we interviewed a dozen leaders in academic medical research to gather their perspectives on a variety of issues, including educating and training the workforce of the future, particularly translational scientists. We wanted to know if there is a more proactive and strategic approach to training this new breed of researcher, rather than relying on opportunistic evolution of the field. This issue is particularly concerning for three reasons.

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Innovation via H@cking

March 24, 2014

by Mark Lim, Associate Director, Medical Research Innovation

If “hacking” conjures up images of pizza-fueled students coding algorithms in a stuffy room for indeterminate purposes, you’re not alone. Until last week I was one of you. But then I attended Healthcare’s Grand H@ckfest, hosted by MIT’s Hacking Medicine Program and the Ewing Marion Kauffman Foundation, and was blown away by the problem-solving potential of these self-declared nerd-fests.

Hacking itself pre-dates the computer age and is all about pulling apart a problem with fresh eyes in hopes of creating a solution. There will always be hackathons focused on developing code (don’t expect pizza at all of them), but there are also ways to hack personal productivity, get kids excited about STEM, and increase patient enrollment in clinical trials. Who knew?

So there I was in the awe-inspiring studios of MIT’s Media Lab with 450 strangers, each more brilliant and energetic than the next. The creativity and openness was palpable; and I could see for the first time how the brainstorm-to-action approach is applicable to biomedical R&D.

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Centering the diagnosis around the patient

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By Mark Lim  

Drugs emerging from the biopharmaceutical industry are increasingly more powerful. Rather than going for as wide a net as possible, many developers are using tools such as genomics to find groups of patients within a disease population who have a higher chance of being cured. We rarely hear the word “blockbuster” these days; instead, strategies to develop “personalized” or “targeted” therapies are in the spotlight. As one of many examples, breast cancer is rarely treated as a single disease and often considered a group of individual diseases, with some groups (known as subtypes) individually treatable

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Innovator Spotlight: Professor Michel Goldman, Innovative Medicines Initiative (IMI)

March 17, 2014

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This is the second 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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BRAIN Initiative, meet Human Genome Project

March 13, 2014

by Robert Cook-Deegan, FasterCures Senior Fellow

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The excitement surrounding the BRAIN Initiative is real, and has invited many comparisons to the Human Genome Project (HGP) circa 1985. In those days, the HGP was a budding idea wobbling towards definition and consensus. It was also an exciting, somewhat controversial idea. Well, to paraphrase a political quip, “I knew the Human Genome Project. BRAIN Initiative, you’re no HGP.”

This is not a putdown of the initiative, but a recognition that the world has changed over three decades. Here are six reasons why.

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Q&A with Nancy Brown, CEO of American Heart Association

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In this month’s TRAIN Innovator Spotlight, Nancy Brown, CEO of the American Heart Association, talks about the association’s belief that when you fund bright, creative minds and give them the flexibility to pursue their ideas, great discoveries ensue. This spotlight is part of a series that catalyzes the innovative activities of disease research organizations that participate in The Research Acceleration and Innovation Network (TRAIN). 

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