Edit: This article was updated on Jan 25th, 2017, after an exploratory conference call with the Ambrosia, LLC, Founder. -KH
So, do you wanna live forever?
When I began writing my number one non-selling book, “Surrogate Threats,” I was motivated by the idea that advancements in medical science had put us near the cusp of consumer-accessible life extension. Even back in 2015, a growing number of very smart people were predicting near immortality within ten years. My contemplation of that possibility spawned the creation of a fictional antagonist named Ryk Marius who, obsessed with the desire to become immortal and unwilling to be constrained by regulatory brakes or cumbersome morality, developed a plausible plan for life extension using today’s (and, okay, a little bit of tomorrow’s) medical technology. As an entrepreneur, I had such great fun hashing out my antagonist’s business model and innovating through his logistics challenges, I ultimately put his company, Marius Technologies, online at Rejuvi.me.
I’d be lying if I didn’t admit to spending part of 2015 caught up in recurring fantasies about extracting the (mostly) legal aspects of Marius Technologies to create and fund an actual bio-tech venture. If I’d known then what I know now, I might just have done it!
The Tantalizing Business of Life Extension
My sticking points in 2015, other than a chickenshit reticence toward funding legally gray, outlandish, futurist ventures, were (1) that I didn’t think I’d be able collect quite enough funding to get my life-extension venture off the ground; and (2) that I’d have to move out of the country to get around the United States’ oppressive regulatory environment when it came to building businesses out of experimental bio-tech. Put another way, I’d pretty much have to become a full blown Bond villain to develop this world-changing therapy into a profitable business. So I was stymied.
What made it more frustrating was that I was pretty sure someone could actually pull my plan off, if those meddling kids (and, you know, the rest of the world) would just leave them (and me, and my imaginary investors) alone to do it!
I needed a way to advance the vision that the rest of the world wouldn’t consider insane, ethically dangerous, and/or shudderingly creepy. Aye, therein lay the rub!
I was stuck.
Then, a week ago, I was stunned to learn I could have worked within the current US regulatory system to offer experimental age rejuvenation services while collecting substantial revenues — even if the process ultimately didn’t work! After all, while Winston Churchill once said,
“Success is stumbling from failure to failure with no loss of enthusiasm,”
Kevin Higgins adds, “…and, even better, with no loss of your own money!”
There WAS a way!
The inciting element in this week’s narrative was a blog post on the site Singularity Hub by Peter Diamandis titled, “Stem Cells Are Poised to Change Health and Medicine Forever.”
Buried about three-quarters of the way into that article, in a section about the four main areas of stem cell therapies to watch, was a section on parabiosis. (For those not into linking away while reading, parabiosis was the term originally coined in the 1860’s (!) for linking the circulatory systems of two creatures, one young and one aged. The resulting blood sharing was found to literally, significantly, reverse the age of virtually all bodily tissues in the older creature. More recently, parabiosis is a term used to describe a process where blood (or plasma) from young donors is provided to elder recipients. The most energetic studies of parabiosis potential today in the US are being done at Stanford, where the treatments are being explored for their potential to stop (or reverse!) the progression of Alzheimer’s. Similar studies are being pursued at many other universities and research clinics elsewhere in the world.)
It’s really not science fiction that hordes of our most advanced researchers are beginning to view aging as a disease that can be cured.
It may turn out that Ponce de Leon’s long-sought “Fountain of Youth” was circulating through the arteries of the Utes* around him all the time!
This is the part where your inner mad scientist says, “Well, wait. If learned and aggressive clinical research doctors are securing valuable (and always scarce) funding to explore whether parabiosis rejuvenates aging, Alzheimer’s-riddled brains …and a full century of parabiotic experimentation with animals has created reams of peer-reviewed findings documenting the reversal of cellular age in virtually all bodily tissues …then maybe parabiosis has a strong chance of becoming at least one part of a multi-faceted strategy to cure people of aging!”
And your inner entrepreneur says, “Holy crap — that’s one of the Holy Grails of bio-tech!” (the other, of course, is to resolve once and for all whether a European Swallow might carry a coconut)(sorry, that was obligatory after a Holy Grail reference, but I digress)
Meet Dr. Jesse Karmazin, MD, Founder of Ambrosia, LLC, and your Conductor on this Entrepreneurial Train to Sci-Fi Town. Because what Dr. Karmazin has figured out, which I missed back in 2015, is (1) how to offer old (and perhaps wealthy, or desperate, or both) people access to the blood of youths via transfusions of plasma (a modern day, lower-risk take on actual parabiosis), while (2) operating under FDA regulations in the US, AND (3) get the applicants to pay the cost of the clinical trial! Genius!
Karmazin realized that as part of the Federal Drug Administration Amendments Act of 2007 (one of many regulatory evolutions that opened up and increased transparency around clinical trials), establishing a clinical trial has become much more accessible (read: cheaper). He also pieced together two additional key allowances that made Ambrosia’s study viable: (1) (some) patient-funded clinical trials now fall under less scrutiny than they used to, and (2) the FDA doesn’t require approval for processes that are well-established, standard treatments. As you might expect, common blood transfusions (and, especially, even less-risky plasma transfusions) fall under this category!
One valuable type is genius is the ability to solve Gordian Knots of bureaucratic red tape with Alexander-like clarity.
Having found a way through the regulatory maze that I thought would require going offshore, Karmazin next had to develop a capitalization scheme — never an easy prospect when your core enabling technology (blood or plasma transfusions) isn’t protectable via patent. Because without developing a barrier to competition, finding Angel Investors, let alone Venture Capital, is a low-probability moon shot!
Still, the financial prospects were persuasive: 600 participants at $8000 USD per enrollee …comes to a cool $4.8MM in potential revenue for this study! …if you can find that many applicants.
Advancing science while making money? That’s enough to make the Pet Shop Boys sit up and take notice!
And the costs? Here’s my personal speculative back of the napkin work: The wholesale prices for getting blood tested and bio-markers reported can be found for less than a couple hundred dollars (depending on the various markers being evaluated and the accuracy desired). [Update: this may cost significantly more, given the vast number of biomarkers being tracked in this study.] You’ll need that done at least twice. And the cost of an actual unit blood plasma? Only about $61, on average. (Maybe one might pay a little more for the special order, primo stuff — like the plasma of Utes). [Update: this article’s initial calculations were based on erroneous information found online. Dr. Karmazin’s study is for an initial infusion of seven (7) units of Ute plasma, not the ~3 units originally reported.] Add in some consumables here and there and that creates estimated testing and plasma variable costs of about $1000 for each study enrollee. But, then it gets harder; you have to have a place for the participants to go for initial testing and qualifications, to receive the transfusions, and for subsequent blood draws and foll0w-up. That requires staff and office space. And, as every entrepreneur knows, fixed costs can be a bitch for a small venture (it’s why we so often start them in a garage).
[Update: At about an hour per unit of infused plasma, the seven (7) hours of clinic “seat time,” which is spread over a two-day period, will have to be factored into the variable costs.]
Enter young Dr. Karmazin’s savvy choice of business partner, Dr. Craig Wright, a longtime luminary in the field, a board-certified physician with over 30 years experience in seeing patients and working in the biopharmaceutical industry, an innovator (he holds over 15 patents), and a man with one additional important contribution: He’s already come out of retirement to open and operate an infusion clinic in Monterey, CA! With one brilliant partnership, that smashes our fixed costs flat and flattens out many of the other logistical hurdles — opening and managing clinical office space, tapping into an existent business for insurance and regulatory compliance, hiring technicians, etc. And it’s a win for Dr. Wright — his clinic is (presumably) already operating in the black; this is yet another source of (high-margin) revenue that doesn’t increase his existing fixed costs.
Work your way through the creation of a clinical trial and register it on the FDA’s clinicaltrials.gov web site, pay the requisite fee, and Voila! You’re in business!
[Update: And there’s an additional business model strength. The shortness of the clinical trial (one month) introduces opportunities for participants to come back for multiple transfusions, enabling this clinical trial to perform financially more like a therapy. That’s beautiful. As an entrepreneur, being able to sell deeper into your market, tapping satisfied customers, is usually a more profitable course than having to acquire new customers for additional revenues (assuming your therapy works).]
So, who wants a chance to feel (and perhaps actually become) younger? As a bonus, you may help advance the science of longevity, of anti-aging.
Step right up. You pays yer money and you takes yer chances.
* “Utes” – Youths