About five years ago, I sat on the board of a group of private medical clinics in Western Canada, one of the largest players in the anti-aging and regenerative medicine field.
Shortly after I became involved, the CEO asked me to attend a morning get-together where he was interviewing three law firms with extensive healthcare practices to gain some guidance on a matter of litigation risk prevention. I will never forget the experience.
The first two attorneys entered the meeting — a partner and an associate from a large international firm — and after some brief small talk over coffee, the CEO asked, “Tell me, how much do you know about BHRT?” Looking a bit sheepish, the partner responded, “Can you kindly help us with that acronym?” The CEO explained that is stands for Bio-identical Hormone Replacement Therapy. Looking somewhat uncomfortable, the partner explained, “I’m not sure exactly how much experience we’ve had in that area, but I can assure you that we have the largest healthcare practice in the entire country and can be up to speed in no time.” The CEO’s response… “Thanks for coming in guys.”
That lesson repeated itself, many times and in many ways throughout my consulting with many law firms, such that I continue to explain how important it is, to not just be industry-focused, but to become expert in selective micro-niches within an industry. And anti-aging, life extension, regenerative medicine, longevity — or biogerontology, the scientific name dedicated to the biology of aging — is a micro-niche in the healthcare and life sciences industries which is still “emerging,” but growing quickly.
Shocking Developments in Anti-Aging
In September, a geneticist at the University of California-Los Angeles reported in a published study how for the first time it might be possible to reverse the body’s epigenetic clock, which measures a person’s biological age. For one year, nine healthy volunteers took a cocktail of three common drugs — a growth hormone and two diabetes medications — and on average shed 2.5 years of their biological ages, measured by analyzing markers on a person’s genomes.
As an area of focus for attorneys, some $200 billion was spent in 2018 in the anti-aging industry. And that level of spend is expected to grow much, much higher. With the aging of the world’s population, novel anti-aging medicines and treatments, such as 3D printed organs, young blood parabiosis, genome sequencing, senolytic therapeutics, stem cells, and new nutraceuticals to treat age-related diseases, are gaining ground fast. Indeed, the anti-aging field is fast becoming one of the next big disruptions in the healthcare market.
One of the few law firms that has staked out a position in this niche is the California-based Cohen Healthcare Law Group, which specializes in micro-niches like anti-aging practices, biotech and nutraceutical companies, medical device companies, telemedicine ventures, and emerging healthcare technologies. The firm handles matters such as medical practice business formations, mergers and dispute resolution, e-commerce, licensing agreements, and intellectual property protection.
The anti-aging micro-niche presents numerous opportunities for those practitioners who might choose to focus on developing this kind of legal practice. Skilled corporate lawyers can help companies with securities offerings, mergers and acquisitions, IPOs, and regulatory compliance, as well as drafting the needed contracts to form strategic alliances, spread financial risk, and other contractual agreements required during a product’s lifecycle.
Clients will likely need the full range of Food & Drug Administration-related services including regulatory approval, pre- and post-approval of marketing, compliance and enforcement, clinical trials, drug and device safety, crisis management, and due diligence. And, of course there will always be a need for litigators with industry-specific experience with Hatch-Waxman litigation, consumer fraud litigation, and commercial and contract disputes.
And while traditional doctors, such as endocrinologists (who specialize in hormones) and geriatricians (who focus on the elderly) are specifically trained to treat age-related conditions such as hormone imbalances, not all anti-aging doctors have a degree or advanced expertise in what they practice. In fact, anti-aging isn’t a specialty that is yet recognized by the American Board of Medical Specialties, meaning doctors can’t officially be board-certified in it. It has its own professional society founded in 1992 — the American Academy of Anti-Aging Medicine (A4M), which boasts more than 24,000 members worldwide and offers a certificate in anti-aging medicine, available to any M.D.
Corporations Getting into the Field
Blood transfusions. Placenta stem cells. Senolytics. These are just some of the innovative ways that corporations are tackling mortality and increasing the human lifespan. Some of the interesting growth companies working in this market space include:
- AgeX Therapeutics founded in 2017 is working on various technologies along with pipeline drugs to explore pluripotent stem cells, which have the ability to produce any cell or tissue needed in the body to repair itself and replicate indefinitely, making them essentially immortal.
- One particular startup that stirred up a bit of controversy is Ambrosia, which is a private clinic where patients aged 30 to 80 can pay $8,000 to get blood plasma from younger individuals.
- Celularity has taken in around $290 million since being founded in 2016. It seeks to “make 100 years old the new 60” with stem cells taken from placentas to create drug therapeutics for fighting illnesses including cancer, Crohn’s disease, and diabetic peripheral neuropathy.
- Elevian has raised $9.3 million and is working on developing drugs that target the protein growth differentiation factor 11 (GDF11) to treat age-related diseases.
- Human Longevity Inc. uses machine learning to provide personalized health assessments including DNA sequencing and a battery of testing including whole body MRIs.
- Juvenescence AI, in a joint venture with deep-learning drug discovery company Insilico Medicine, is working on developing both pharmaceutical and nutraceutical products that target senescent cells.
- Two companies, LyGenesis and Prellis Biologics are working through the complexities in creating a human organ composed of interconnecting tissues in the hopes of achieving organ regeneration.
- ResTORbio, a 2017 spinout from Novartis, is trying to commercialize a drug platform which may prolong life, enhance immune function, ameliorate heart failure, improve memory, and delay the onset of age-related diseases.
- Unity Biotechnology targets senescent cells that cause inflammation and other age-related diseases, and has had many notable healthcare investors including ARCH Venture Partners, Mayo Clinic Ventures, WuXi Healthcare Ventures, Jeff Bezos’ Bezos Expeditions, and Peter Thiel’s Founders Fund.
With the oncoming Silver Tsunami, the process of aging and the business of helping people live longer could become the biggest and most complex legal micro-niche of the coming decade. Advances in AI, genetics, and a variety of other disciplines together with automation technology are helping to drive innovation and lend credibility to what seemed like science fiction just a few years ago.
Around the world, prominent scientists are putting it all on the line because they believe we can beat diseases such as cancer and stop the cellular ravages of time so we can age more gracefully and live longer, healthier lives.