The FDA & NIH Building “Critical Bridge” to Treatments

Today, the LA TimesBloomberg both reported on a recent development at both the National Institutes of Health and the Food and Drug Administration.

The NIH and the FDA are collaborating to build a “critical bridge” between biomedical research and new medical products. This collaboration will promote the development of testing and other tools that FDA regulators need in order to assess drugs and other products coming from fields such as genomics, nanotechnology and stem cell therapy. This news should be of interest to people who care about rare diseases for which there are no established testing protocols and should be monitored for its progress.

The NIH-FDA collaboration includes the formation of a six-member council of top scientists from both agencies to make sure that the latest science is incorporated into the regulatory review process.  The NIH and FDA also will make at total of $6.75 million in grants for regulatory science research over a three-year period.

As we learn more about this collaboration we’ll inform you about what this means for research for all diseases.

Original Press Release: NIH and FDA Announce Collaborative Initiative to Fast-track Innovations to the Public: Partnership Combines Strengths to Speed New Treatments to Patients

Original Blog Post at Myelin Repair Foundation Blog.

PatientsLikeMe Co-Founder Interviews Scott Johnson

The Value of Openness: PatientsLikeMe co-founder James Heywood interviews Scott Johnson on why WhereAreTheCures.org was created. Says Scott Johnson: ”I believe the single most rate-limiting factor (slowing the process) is the failure to move promising scientific discoveries made in academic laboratories into the commercial development pipeline.” Read more here.

Your voices are being heard… the conversation starts here

Thank you to all those who have signed the Manifesto. Your voices and your frustrations are being heard.

For those who have taken the time to comment and read the comments of others, there are some ideas here that might be explored further. Among them is the notion that certain parties in the system have a vested interest in slowing the process.

As a long-time MS patient myself, I can appreciate where those comments are coming from. However, over the last seven years I have gotten to know hundreds, if not thousands, of individuals involved with MS research in one capacity or another including scientists, physicians and managers in academia, the pharmaceutical industry, government agencies and institutes, clinics, and non-profits. I can tell you that virtually all have devoted their lives to increasing scientific knowledge and striving to get treatments to patients.

The problem is not lack of interest, motivation or dedication.  The problem is that there is currently no mechanism for moving breakthrough discoveries across the Valley of Death so that industry can develop treatments.

What has been missing is an entity to get involved with each of the many complex steps in the continuum of drug development. Continue reading Your voices are being heard… the conversation starts here