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Danila Medvedev

The Problem, Illustrated - 0 views

www.longevitymeme.org/...view_news_item.cfm

shared by Danila Medvedev on 15 Feb 09 - No Cached
  • 'Curing aging is not an endpoint the federal drug agency would recognize,' Dr. Westphal says dryly. Instead, both men say, they are working to ameliorate the diseases of aging." For so long as unelected government employees can declare, with no accountability and full force of law, what medicine is permitted and what is not, there will be no direct venture funded efforts to cure aging - or even to take the first steps by aiming to repair specific, identified age-related damage in order to intervene in the aging process. There is no lack of companies, research groups and billions of dollars ready to be directed to that end, as any brief survey of the biotechnology marketplace will show you - but the ignorant few who write policy continue to bury all that potential.
    • Danila Medvedev
      Danila Medvedev on 15 Feb 09
       
      Пока FDA не рассматривает старение как болезнь, для которой можно разрабатывать и утверждать лекарства (а не утверждённые доктора не смогут прописывать, они вообще запрещены), бизнес не будет финансировать разработку средств лечения старения.
Danila Medvedev

Pharmaceuticals and Aging - Interview with Dr. Larry Miller (SAGE CROSSROADS ) - 0 views

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старение бизнес фармацевтические компании FDA

shared by Danila Medvedev on 25 Apr 09 - Cached
  • Dr. Miller formerly led business operations for the global Drug Discovery Division at pharmaceutical company Glaxo Smith Kline.
  • Well one thing that I think is going to be critical is that in the past, pharmaceutical companies had treated diseases of aging as discrete entities, that is to develop something for diabetes, to develop something for osteoporosis…that is to treat each one as a separate silo if you will.
  • in the future we are going to have to look at more central regulatory pathways that are being identified now for aging.
  • ...15 more annotations...
  • I think this is quite a new concept because not until recently have we begun to understand a little bit more about the aging process and find some biochemical pathways that are at the root of aging processes.
  • Now what do you see as the greatest challenges for developing drugs that deal with aging? Would you say that it’s more regulatory and policy wise, or is this more scientific?
  • I think there is both.
  • When I was heading aging at Glaxo Smith Kline, the issues that I faced were that I was very interested in developing medications for frailty and weakness in muscle for when people get old because when people get weak they usually stop eating and then they fall and break a hip and end up in the hospital and die potentially, but the regulatory apparatus isn’t there yet.
  • Sarcopenia isn’t recognized as an official disease by the FDA, so the pathway to get drugs approved for frailty and to get more people mobile and into society is just not there, and so it’s a really difficult problem, and the pathways for osteoporosis are still very cumbersome, requiring fracture analysis.
  • There isn’t an approved, for example, like Jack Coralnick uses a scale at NIH to test people’s function. I think there is a critical need to have the FDA to recognize some battery of functional tests
  • how a reform would take place
  • Well we have a new FDA now, hopefully, but it’s going to take companies and scientists going to the FDA and to Congress to say “look the patient population is aging and currently we have a bottleneck, we can’t get these medicines through” and try to work out some new policy. Hopefully, the FDA will be a little more progressive about looking at endpoints. They are very, very conservative about what endpoints they will accept
  • You know, there is understandably some concern that people might use these drugs and abuse them for muscle building, but on the other hand, there is a critical unmet need out there in the elderly population
  • Well one thing is that it is quite difficult and expensive to develop drugs for aging per se because even to do pre-clinical models in animals is very expensive. It’s very expensive to get aged animals, and they don’t necessarily act like aged humans. So even in the pre-clinical stage, it’s a difficult area to work in.
  • find pathways to get these drugs approved
  • a lot of these companies are concerned as being seen as trying to produce “fountain of youth” drugs. I made it very clear when I was leading aging at GSK that I was not attempting simply to extend lifespan
  • I think this is a policy challenge and a perceptual challenge and if you will, a public relations challenge.
  • Potentially, I think we need to find more intelligent, creative ways to do clinical trials using biomarkers or other types of measures where we can get the trials through quickly
  • again, it goes back to the FDA policy. The FDA is going to have to be willing to accept some of these things, or we will not be able to get these drugs on the market
  • Danila Medvedev on 25 Apr 09
     
    Фармацевтика и старения (лекарства от старости)
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