BioViva’s CEO Liz Parrish on de-risking regulatory systems and creating evidence-based medicine from medical tourism.

Liz Parrish is the CEO of Seattle-based biotech BioViva, a company working to lengthen healthy human lifespans with gene therapy which includes both adeno-associated virus (AAV) and cytomegalovirus vector (CMV) approaches.

Longevity.Technology: Parrish is passionate about reducing the suffering and death caused by cellular aging and its associated diseases. So much so, in fact, that she traveled to Colombia to test BioViva’s tech on herself in personalized N=1 research.

We sat down with Liz Parrish to find out her thoughts on patient advocacy, BioViva’s research into telomerase reverse transcriptase gene therapy and longevity medical tourism.

Liz Parrish on…

Advocating for advocacy

It’s my humanitarian effort to get involved in every way possible and make sure that I’m not only helping to develop better drugs for the future of treating biological aging, but that we’re getting people access to those drugs and that we’re creating new pre-regulatory routes to even expedite that access for those who need it – which are more than 41 million people this year.

Testing telomerase

In the next 12 months, we’re going to be releasing a paper on what happens when people take telomerase reverse transcriptase gene therapy – data has been collected for over five years on that. Earlier this year, we released the data on 10 patients, the 20th percentile shortest telomeres and the changes in those, but the paper should be more expansive than that. Although people can get early access to technology in a variety of locations throughout the world, you can’t do the same tests in every location in the world. You have to have tests that they can do locally so that they can do follow-up because without the follow-up data from the exact same test, we would be of out of luck. So, on 10 patients, we were lucky enough to get the shortest 20th percentile of telomeres, but you’ll also see many more patients in their average or median length telomeres coming up.

From clinic to clinical trial

I’ve been pushing hard on a pre-regulatory route in several countries, and some of those will be going online in the next year. That will create a legal route for people in need to get access to things like gene therapy. Right now, we work with what’s called investigator-led studies – other companies and other medical doctors lead investigator-led studies, and BioViva picks up the data and the patenting rights when we can, so that we can move those towards clinical trials and towards a bigger audience.

Clinicians treat, and they have been historically responsible for a lot of excellent data in patients who couldn’t get access in other regulatory systems, helping millions of people. Medical tourism is a huge market, but binding it with research and creating mandated protocols in which so much data is required pre-treatment and post-treatment isn’t actually their specialty – and so that’s where we come in to bridge that gap. What’s important is if people are traveling abroad, and taking a risk on new technologies, that we create evidence-based medicine out of that use.

Destination: longevity?

BioViva is a US company, so we can’t do clinical trials offshore unless they’re FDA approved – our goal is to get those onshore to the US. We have applied for our pre-IND and we’re sorting out now how much money we have to raise to get into Phase 1 for dementia.

I think that a lot of people have misperceptions of medical tourism; an investigator-led study is a legally run study and can actually sometimes be safer than a clinical trial in a regulatory body just because of the massive amount of oversight.

But I want medical tourism to be open to everyone, forever. While that might give BioViva’s investors pause, they will still have the biggest market being open to a regulatory system in the US and the EU. So, there’s a lot of incentivization to get drugs to everyone and make money.

But what I like about medical tourism is it forces the price down; the cheapest gene therapy that’s approved in the United States is $425,000 to treat one eye – and they just go up from there. If your child is born with spinal muscular atrophy and would die otherwise in a few weeks, then it’s between $2 and $5 million for the gene therapy. They are the most expensive drugs on the planet, but if you go offshore, those are a fraction of the price.

A $2-$3 million gene therapy is between $200,000 and $300,000 – that’s still too expensive, but as more people are using those routes, the price will come down and down because while gene therapy is expensive, it’s less expensive by scale.