“Right to try” laws are awesome in theory. But the Federal Government (FDA) preempts States from governing in the drug regulation space, so I’m trying to figure out how “right to try” laws are Constitutional.On Wednesday, December 31, 2014, Liz Parrish wrote:
Good question and something we have been working on. We have been searching host countries for “right to try” use scenarios. I have traveled to a number of potential host countries. Some frown upon experimental therapies that involve the patient paying for the therapy but offer no financial assistance otherwise. Some have no infrastructure for gene therapy but are marginally set up for stem cell therapies. Some have socialized medicine and cannot afford to bring a new therapy to their people at large even if it proves viable. It would be great if we could get allocation on USA soil but a lot of “right to try” seems targeted at small molecule approaches and not gene therapy, indicative of a new market with few results outside phase three trials. That being said, we have a lot to learn and could use guidance.
One of the biggest problems is that the therapies we are working on are very expensive to build at GMP, so cost to the patient right now might be out of most persons grasp. BioViva is seeking investment to bring those costs down significantly. By building therapies with a small team without 5 paper pushers behind each scientist we can achieve marked results, then to work on a couple news ways of increased therapy production.
We can use gene therapies with safety/efficacy and re-use/re-allocate them to test for longevity based purposes. We can also expedite large animal studies on therapies that show promise for cognitive enhancement, age reversal and other benefits that need further testing to become life saving biotechnologies. There are over 164 gene therapies in trials around the world, we sit and gather their data. We look at the data in a very different way than the 1 therapy for 1 disease model. In the mean time we have enough data to start, but funding is the big issue.
I believe we will build the fastest pipeline to results, ethics and medicine have been badly interwoven. To me it is unethical to let people die without trying a treatment that could save their life and improve the lives of millions.
Liz,L.Parrish – Skype
On Dec 30, 2014, at 11:49 PM, steve hill wrote:
Could the number of states initiating “right to try” programs for the Terminally ill be an avenue towards faster Human trials?
There are a number of promising methods out there but nothing will happen unless testing in-vivo is tried. The recent use of young blood introduced to an aging system has shown reversal of some aging so perhaps this could be combined with Telomere restoration as a combined therapy?
From: Liz Parrish To: Gerontology Research Group Sent: Wednesday, 31 December 2014, 5:00Subject: Re: [GRG] Cnio telomere therapy
Sierra Science has done a lot of work in this field and I appreciate and support Bill Andrews’ expertise in this area. He is the authority on the matter of telomerase. Werner syndrome and Progeria are both accelerated aging diseases and are marked by short telomeres.
BioViva will not take telomere lengthening therapies off our top-ten anti-aging list until therapies have been tried in-vivo at the level needed to lengthen the telomeres to full length and the data collected. Animals studies point to no and even reduced risk of cancer. I believe this follow through method needs to be instated with all potential therapies before they are moved aside. We can not move forward on hypothetical reasoning. Human data is greatly needed. Best,Elizabeth Parrish
Liz,L.Parrish – Skype
On Dec 30, 2014, at 12:51 PM, email@example.com wrote:The earlier Mouse study paper is here:http://ift.tt/1tlyzwY increasing telomere length is not the only aspect of aging but it’s certainly a key factor and short telomeres lead to a host of problems. I understand from the vector they used applying this to humans would not be difficult.Another consideration is that mice are not the best model as they are not as focused on telomere attrition as we are and have longer telomeres. It could be possible that any benefits may be considerably increased in a Human.There has been considerable debate that it causes cancer though from my research recently it appears that telomeres of optimal length protect against it, whereas short telomeres encourage it. I’m not an expert of course but it does seem telomere rejuvenation is a worthwhile avenue.