Parker’s AI model learns from living skin tissue

Michael Polansky does not fit the profile of someone working at the intersection of celebrity and cutting-edge science. Sitting on a sunlit patio outside a Mill Valley bakery, about 15 miles north of San Francisco, he looks more like a friendly young professor than the founder of a stealthy biotech startup. With his glasses and dark hair streaked with gray, he speaks with the calm, measured tone of someone who has spent years quietly building something ambitious.

He is, in fact, the founder and CEO of Outer Biosciences, a company merging artificial intelligence with living human tissue research. He is also the creative and business partner of Stefani Germanotta, known globally as Lady Gaga. It is an unusual double life. One moment he is navigating the world of celebrity; the next, he is overseeing a team that has figured out how to keep human skin tissue alive outside the body for over a month, a feat the company has kept largely under wraps until now.

Polansky’s path to this point was anything but linear. Raised in Minnesota, he studied applied mathematics and computer science at Harvard, graduating in 2006. He then spent three years at Bridgewater Associates, the hedge fund, which he describes as “a very unique place” with “a really good experience,” even if it was not somewhere he would “wake up and be excited about every day.”

His move to Silicon Valley came through a stroke of hometown luck. Sean Parker’s assistant at the time had been Polansky’s childhood neighbor. At a 2007 wedding in Minnesota, she mentioned that Parker was looking for help. Polansky, already familiar with Parker’s reputation, was eager to head west. After a dinner in New York where they “hit it off immediately,” Polansky quit Bridgewater the next day and relocated to San Francisco.

He started as a principal at Founders Fund, sharing an office with Brian Singerman under the firm’s four original partners: Peter Thiel, Sean Parker, Luke Nosek, and Ken Howery. Polansky calls that period “a really, really great experience.” When Parker left to build his own family office after his Facebook windfall, Polansky went with him, running Parker’s business, investments, and philanthropy. That included helping launch the Parker Institute for Cancer Immunotherapy, where Polansky remains executive director, until COVID shifted his life in a different direction.

That shift had everything to do with Germanotta. They met in late 2019 at one of Parker’s birthday parties, thanks to the persistence of her mother, Cynthia Germanotta, president of the Born This Way Foundation. Polansky had known her through his philanthropic work. “She had said, for months and months, ‘I want to set you up with my daughter,'” he recalls. “I was like, I think you’re making fun of me.” She was not. When their mothers later met, he says laughing, “it all made perfect sense.” The two mothers are now close friends.

Their relationship is a full partnership. For Germanotta’s most recent world tour, which ran from July of last year to April, the couple managed a massive operation across three 747s, something Polansky compares to running “a 200-person startup that travels around the world every day.” He also highlights Haus Labs, the cosmetics brand Germanotta built “on her kitchen floor” rather than licensing her name. The El Segundo, California-based company, with roughly 70 employees, is reportedly thriving. Germanotta sits on the board of Outer Biosciences, and the two companies collaborate at the edges. Outer Biosciences’ chief scientist, Kyung-Jin Jang, serves on Haus Labs’ scientific advisory board, and they have run joint projects.

“People really haven’t gotten to know a certain side of her publicly,” Polansky says, beaming. “She’s such a brilliant businessperson.”

From cancer to tissue in a dish

Polansky is not a scientist, but he got into life sciences “accidentally” through more than a decade alongside Parker in cancer immunotherapy, a field that was “very fringe” when they entered it. Outer Biosciences, founded in 2022 with Polansky as CEO, grew out of a frustration that biology and chemistry innovation has never kept pace with software. The reason is simple: there is no ethical way to run experiments directly on people. The proxies scientists rely on, animal models, simplified cell cultures, and lab-grown organoids, are poor stand-ins for real human organs.

So Outer Biosciences took a different approach. Instead of engineering synthetic organs, the company sources human skin that would otherwise be discarded after surgery, mostly plastic surgery, through vetted non-profit and commercial biobanks operating under “institutional review board oversight and documented donor consent.” The primary suppliers are the National Disease Research Interchange and the Cooperative Human Tissue Network, both of which receive federal funding from the NIH and the National Cancer Institute without being federally operated.

Polansky is careful to note that no single government network qualifies buyers. He says Outer Biosciences pays fees on a cost-recovery basis rather than purchasing tissue outright. The company spent roughly two years building the pipeline and handling protocols to receive tissue “within hours” of surgery, while it is still living. Every sample arrives de-identified, stripped upstream of names and contact information. A proprietary support system feeds the tissue nutrients and removes metabolic waste, extending its viable life well past the industry norm.

That norm is a matter of days. It is enough time to test for acute toxicity, but not for slower biological processes like collagen remodeling, pigmentation change, or barrier repair, which take weeks to unfold. Dermatologists routinely tell patients to expect changes over weeks for this same reason. Outer Biosciences keeps tissue alive for up to a month, says Polansky, retaining its “day-zero architecture and preserves its day-zero epidermal, stromal and immune-associated molecular programs.” In plain terms, 30-day-old tissue cared for by the company looks a lot like day-one tissue, though not entirely indistinguishable.

Sunburn is a clear example of what that extra time buys. Polansky says researchers can induce UVB damage in living tissue, then track the stress, inflammatory, and recovery-related responses over the following weeks. The team is not “healing” the skin but watching an injury happen and observing the biology that follows.

A closed loop of discovery

Polansky is careful about how he frames the company’s achievements. The startup’s value, he says, is not any single piece but how the pieces fit together: human tissue kept alive for weeks, a diverse donor pool subject to controlled experimental conditions, and repeated molecular measurements along the way. All of it feeds into one closed, self-enforcing system. An AI model predicts which untested chemicals are likely to benefit a specific skin function. Those chemicals run through the living-tissue system. The results, whether the prediction was right or wrong, feed back into the model, improving the next round of guesses.

This is a giant improvement from where things started. Early on, the company relied on a “brute force” approach, mining scientific literature and partnering with the National Cancer Institute on natural compounds from extreme environments. That phase produced a couple of leads over about 18 months. With AI layered in, the company now generates a new candidate roughly every six weeks, with six leads currently active in its pipeline and several dozen additional “hits” logged.

What makes that pace astonishing, Polansky says, is the size of the current universe of skin-active ingredients. It is almost impossible to know the exact number, but it is small. The FDA maintains rules covering 13 categories of over-the-counter skin drugs, think sunscreen and antifungals, and across all of them, only about 120 to 130 active ingredients are approved. Add cosmetic ingredients backed by actual research, says Polansky, and that number is closer to 200.

This presents opportunities. Outer Biosciences is discovering cosmetic ingredients, not drugs, so there is no FDA approval to seek. The route runs through two steps: first, getting the ingredient a standardized industry name; then safety testing under guidelines set by the OECD, a Paris-based body whose member countries accept each other’s properly run studies.

A partner outfit then commercializes the whole thing. Rather than build its own consumer brand, Outer Biosciences plans to license or sell its finished ingredients to beauty or pharma companies that will formulate them into actual products, a serum or a cream, and bring them to market under their own brands. Already, four of the six current leads look likely to reach commercialization, Polansky says.

The company is also generating money from collaborative research partnerships, including a pharmaceutical partner studying why certain cancer drugs cause severe skin rashes, and consumer beauty brands testing whether Outer Biosciences’ data holds up against their own product-development needs.

Going public

Polansky will not say whether he is raising more money. To date, the company has raised roughly $23 million, with early backers including Calm Capital, Brighter Capital, and Polansky’s own investing firm, Hawktail. The company employs 19 people, all but Polansky based just outside Cambridge, Massachusetts.

Asked why he has chosen now to talk after years of near-total silence, he says he barely discussed the company even with close friends. It comes down to the data the team is beginning to amass and the confidence that has given them. “Trying to do this in private is hard,” he says, as wait staff start flipping chairs onto tabletops, signaling closing time. “We kind of want to start working in public now,” he adds, shrugging.

Outer Biosciences is not alone in chasing this idea, though its use of real tissue rather than synthetic is distinctive. Vivodyne, a Philadelphia-based competitor building lab-grown human organ tissue paired with predictive AI to replace animal drug testing, announced this month it has raised close to $80 million to date, including a $38 million seed round and a $40 million Series A, both led by Khosla Ventures. Other rivals are pursuing organ-on-a-chip and microphysiological systems for preclinical testing.

Polansky does not seem preoccupied with any of them, less out of arrogance than because he has his hands full. There is plenty of room for everyone. Unlike AI companies training on internet scraping, there is no “biology internet” to scrape.

Outer Biosciences has two other reasons to focus on its own work. First, the data it generates does not exist anywhere else, making its position more defensible, if slower to build, than traditional software-based AI startups. It is also cheaper to run, with modest compute demands compared with training a large language model. All of the company’s AI work currently runs on-premise, not in the cloud, because “we don’t want the data in the cloud,” Polansky says.

Whether Outer Biosciences becomes a standalone commercial-ingredients business, licenses its discoveries, or reorganizes around a single breakout compound, Polansky says he has not settled on a path, and the team does not need to. The more important goal is a predictive model accurate enough that the company can spot promising directions in skin biology without running every experiment physically first, opening up a rate of discovery in dermatology that does not currently exist.

For now, the work of turning a promising compound into a real product, the formulation, manufacturing scale-up, supply chain, and safety testing, is still done manually by the same scientists who discover the compounds. Building out a product-development team with experienced people is next on the roadmap.

“I think it’s going to be fun,” he says, “to have people know that this is what we’ve been doing.”