Michael Polansky is remarkably unassuming for someone operating in a corner of the world known for outsize egos.

Seated at a leafy patio outside a popular bakery in Mill Valley, an affluent town about 15 miles north of San Francisco, Polansky — bespectacled, his fresh face framed by dark hair shot through with gray — has the look and the friendly demeanor of a young professor.

He is, in fact, both the co-founder of a buzzy AI and biology startup called Outer Biosciences and the creative, business, and romantic partner to Stefani Germanotta — better known as Lady Gaga. It’s an unlikely double life. On the one hand, the couple invariably moves in the world that comes with celebrity; on the other, he’s running an outfit that has spent years figuring out how to keep living human tissue alive outside the body — for over a month, so far — without anyone outside the company knowing.

He didn’t see any of it coming. Polansky grew up in Minnesota and went on to Harvard, where he studied applied mathematics and computer science, graduating in 2006. Afterward, he logged three years at the hedge fund Bridgewater Associates — “a very unique place,” Polansky says over coffee, and one where he had “a really good experience,” even if it wasn’t a place he was going to “wake up and be excited about . . .every day.”

His pilgrimage from Bridgewater to Silicon Valley ran through Minnesota. By coincidence, Sean Parker’s assistant at the time had been Polansky’s neighbor growing up. At a 2009 wedding in their home state, she mentioned that Parker was looking for someone to work with him. Polansky already knew who Parker was and was looking to move west. The two had dinner in New York, “hit it off immediately,” and, as Polansky tells it, he quit Bridgewater the next day and moved to San Francisco.

He first landed a role as a principal at Founders Fund when the firm was run by its four original partners — Peter Thiel, Sean Parker, Luke Nosek and Ken Howery – with Polansky and another young principal at the time, Brian Singerman, sharing an office. “It was a really, really great experience,” Polansky says.

When Parker left Founders Fund after becoming liquid in his Facebook stock and wanted to build out his own family office, he brought Polansky with him. Polansky ran that office — handling Parker’s business, investment, and philanthropic interests, including helping stand up the Parker Institute for Cancer Immunotherapy (where Polansky remains executive director) until COVID, when his life “moved in a different direction.”

That change had a lot to do with Germanotta. Polansky met her in late 2019 at one of Parker’s birthday parties. Charmingly, the meeting came at the urging of her mother, Cynthia Germanotta, president of the Born This Way Foundation, whom Polansky had come to know through his philanthropic work.

“She had said, you know, for months and months, ‘I want to set you up with my daughter,’” Polansky recalls. “I was like, I think you’re making fun of me.” She wasn’t. When their own mothers later met, he says, laughing, “it all made perfect sense.” (His mother and Germanotta’s mother are now close friends.)

Their relationship is a full partnership, professionally and personally. Notably, for Gaga’s most recent world tour, which began in July of last year and ended in 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.”

It also includes Haus Labs, the cosmetics brand Germanotta initially built “on her kitchen floor,” Polansky says, instead of simply licensing her name to an existing company. That business, based in El Segundo, California, an operation with roughly 70 employees, is reportedly thriving.

Germanotta also sits on the board of Outer Biosciences, and the two companies collaborate at the margins. For example, Outer Biosciences’ chief scientist, Kyung-Jin Jang, sits on Haus Labs’ scientific advisory board, and the companies have run some joint projects.

Says Polansky, beaming as he talks about her from our sun-dappled table: “People really haven’t gotten to know a certain side of her publicly … She’s such a brilliant businessperson.”

From cancer to tissue in a dish

While Polansky is also a businessperson, he’s not a scientist. He got into life sciences “accidentally,” he says, through more than a decade spent alongside Parker in cancer immunotherapy, a field that was “very fringe” when they entered it.

Outer Biosciences, co-founded in 2022 by Polansky (CEO), Jang, Chris Hinojosa (CTO), and Stanley King (chief business officer), grew out of frustration that the pace of innovation in biology and chemistry has never matched software, in large part because there’s no ethical way to run experiments directly on people. Meanwhile, the proxies scientists rely on instead — animal models, simplified cell cultures, lab-grown organoids — are poor stand-ins for how a real human organ behaves.

So Outer Biosciences took a different approach. Instead of engineering a synthetic organ, the company sources human skin that would otherwise be discarded after surgery – mostly plastic surgery – through what it describes as vetted non-profit and commercial biobanks and brokers operating under “institutional review board oversight and documented donor consent,” principally the National Disease Research Interchange and the Cooperative Human Tissue Network. (Both outfits receive federal funding from the NIH and the National Cancer Institute without being federally operated.)

Polansky is careful to note that there is no single government tissue network that qualifies buyers. He says Outer Biosciences pays fees to these suppliers on a cost-recovery basis rather than purchasing tissue outright. He also says the company spent roughly two years on building that pipeline and handling the protocols required to receive that tissue “within hours” of surgery, while it’s still living.

Asked about the donors’ privacy, he says that every sample arrives already de-identified — stripped upstream by the supplying organizations of names, contact information and other direct identifiers. A proprietary support system developed by his team then feeds the tissue nutrients and removes metabolic waste, extending its viable life well past the industry norm.

That norm, by the way, is a matter of days. That’s enough time to test for acute toxicity, but not for slower biological processes like collagen remodeling, pigmentation change, or barrier repair that take weeks to unfold. (Dermatologists routinely tell patients to expect changes over a matter of weeks for this same reason.)

Outer Biosciences’ system meanwhile keeps tissue alive for up to a month, says Polansky, who says it retains its “day-zero architecture and preserves its day-zero epidermal, stromal and immune-associated molecular programs.” In plainer English, that means that 30-day-old tissue cared for by the company looks a lot like day-one tissue, but it isn’t fully indistinguishable from it.

Sunburn is one of the clearer examples of what that extra time buys Outer Biosciences. Polansky says that its researchers can induce UVB damage in living tissue, then track the stress, inflammatory, and recovery-related responses that follow over the following weeks as an information-gathering exercise. He says the team isn’t “healing” the skin but rather watching an injury happen and then watching the biology that follows it over time.

Perhaps anticipating pushback from the scientific community, Polansky is careful about how he frames the company’s achievements when this reporter asks questions about rival technologies. The startup’s value, he says, isn’t any one piece of what it’s doing but how the pieces fit together: human tissue that can be kept alive for weeks, a diverse donor pool that Outer Biosciences’ team can subject to controlled experimental conditions, and repeated molecular measurements taken along the way.

And it’s all fed into one, closed self-enforcing system. An AI model predicts which untested chemicals are likely to have a beneficial effect on a specific skin function. Those chemicals get run through the living-tissue system. Then the results, whether the prediction was right or wrong, get fed back into the model, improving the next round of guesses.

It’s a giant improvement from where things started, says Polansky. 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, but with AI layered in, the company is now generating 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 truly astonishing, Polansky says as the crowd around us thins out, is the size of the current universe of skin-active ingredients.

It’s almost impossible to know the exact number, but it’s small. “Active ingredient” means something different informally than it does formally. While the FDA maintains rules covering 13 categories of over-the-counter skin drugs (think sunscreen, antifungals), 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, of course, presents opportunities.

Outer Biosciences is discovering cosmetic ingredients, not drugs, so there’s no FDA approval to seek out. Instead, 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 international body whose member countries agree to accept each other’s properly run studies — meaning a study done correctly in one participating country is accepted in the other 40-plus.

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

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

If Polansky is raising more money for the company currently, he won’t say. To date, the company has raised roughly $23 million, with early backers including Wing Ventures, Initialized, and Polansky’s own investing firm, Hawktail, among others. The company employs 19 people, with all but Polansky based just outside Cambridge, Massachusetts.

Asked why he’s chosen now to talk about the company after years of near-total silence — he says he barely discussed it even with close friends — Polansky points 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 the wait staff start flipping chairs onto tabletops, signaling it’s closing time at the bakery. “We kind of want to start working in public now,” he adds, shrugging.

Outer Biosciences is not the only company chasing this idea, even if its use of real tissue, rather than synthetic, is distinctive.

Vivodyne — a Philadelphia-based competitor building lab-grown human organ tissue — just this month announced 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 various flavors of organ-on-a-chip and microphysiological systems for preclinical testing.

Polansky doesn’t seem especially preoccupied with any of them — less, it seems, out of arrogance than because he seems to have his hands full. Besides, there’s plenty of room for everyone in this moment. Unlike AI companies training on scraping the internet, there is no “biology internet” to scrape.

And Outer Biosciences has two other reasons to focus on its own knitting. First, the data it generates doesn’t exist anywhere else, which, conceivably, makes the company’s position more defensible, if a lot slower, to build than “traditional” software-based AI startups. It’s also cheaper to run, with modest compute demands compared with training a large language model. In fact, 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 over time, Outer Biosciences becomes a standalone commercial-ingredients business, licenses its discoveries, or eventually reorganizes around a single breakout compound, Polansky says he hasn’t settled on – and the team doesn’t need to. The more important goal, he says, is a predictive model that’s accurate enough that the company can spot promising directions in skin biology without having to run every experiment physically first, opening up a rate of discovery in dermatology that doesn’t currently exist.

For now, instead, the work of turning a promising compound into a real product — the formulation, the manufacturing scale-up, the supply chain, the safety testing — is still done manually by the same scientists who discover the compounds in the first place. Building out a product-development team, with people who’ve done this kind of work before, 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.”