Thursday, August 20, 2015

The Potential Impact of the 21st Century Cures Act on Healthcare Translation

As we wind down the day on Wednesday, a panel discussion with Anthony Atala (Wake Forest University), John Trojanowski (Professor of Geriatric Medicine and Gerontology, Perelman School of Medicine, University of Pennsylvania) and David DiGiusto, (Executive Director, Laboratory for Cell and Gene Medicine, Stanford Health Care), moderated by David Brindley, Research Fellow, University of Oxford/Center for the Advancement of Sustainable Medical Innovation.

With the introduction of the 21st Century Cures Act, one goal is promoting the development and speeding approval of new drugs and devices, and to persuade the FDA to consider nontraditional study designs. The Act does numerous things, including making exploration joint efforts less demanding; elevating treatments like biomarkers to upgrade customized medication medicines, focused at people and not only extensively at illnesses; transforming and streamlining clinical trials and making it less difficult and extravagant for organizations to offer medications for sale to the public; making motivators for creating medications for unprecedented yet lethal sicknesses; making an Innovation Fund to urge youthful researchers to do way breaking research; and putting more cash into both the National Institutes of Health and the Food and Drug Administration to make these developments work.

Of course, we all know this act still has to become a law before Approximately $1.9B is to be allocated for funding complex research in medicine.

Many challenges remain, though, despite the potential influx of funds. The regulatory process is still long and costly, with an average of 15 years and $1B to bring to market. Additionally, novel treatments and devices never before seen, means the FDA has to re-evaluate their current approval processes. To add insult to injury, DiGiusto notes bias from funding organizations towards newer, younger researchers,  without a proven track record, hence losing the funding opportunities they need to move forward to next steps.

Trojanowski points out that at least 50% of people age 80 and older will develop Alzheimer's Disease. Considering the fact that we are living longer than ever, the drain on the global economy this would have is huge. By developing treatments or prevention strategies for this and other disease of age, we would essentially help save our economy at the same time.

Of those who have walked the "Valley of Death" (the time between research and commercialization when many do not receive adequate funding to commercialize), it is clear that a new business model should be considered. For example, a type of annuity payment, where companies would get paid as long as the treatment/medication worked, no payment for failed treatments. Of course, public-private partnerships are another popular funding model. Clearly, collaboration and common sense amongst regulatory bodies and researchers will be crucial to the success of commercializing life saving treatments. 

No comments:

Post a Comment