Outer Biosciences AI Models Living Skin for Innovation
In a significant stride for biotechnology, Outer Biosciences, an innovative startup co-founded by Michael Polansky, is leveraging artificial intelligence to train models on living human skin, a move poised to revolutionize cosmetic and pharmaceutical ingredient discovery. The company has developed a proprietary system capable of keeping human tissue alive for over a month outside the body, a breakthrough that substantially expands the scope of biological experimentation.
Polansky, also known for his creative, business, and romantic partnership with superstar Lady Gaga (Stefani Germanotta), leads Outer Biosciences as CEO. His journey into this specialized field began unexpectedly, rooted in over a decade spent alongside tech titan Sean Parker in cancer immunotherapy research. This experience, he noted, highlighted a persistent frustration: the pace of innovation in biology and chemistry has historically lagged behind software, largely due to ethical constraints on direct human experimentation and the limitations of existing proxy models.
From Hedge Funds to High-Tech Biology
By Decode Today News
Michael Polansky's career trajectory is as unique as his current venture. A Harvard graduate from 2006 with degrees in applied mathematics and computer science, he began his professional life at the hedge fund Bridgewater Associates. Describing it as a "very unique place" and a "really good experience," he acknowledged it wasn't a long-term passion.
His pivot to Silicon Valley was serendipitous. A chance encounter at a wedding in 2007 led him to connect with Sean Parker, who was seeking an assistant. Polansky "hit it off immediately" with Parker, leading him to leave Bridgewater and move to San Francisco. He initially joined Founders Fund as a principal, working alongside original partners Peter Thiel, Sean Parker, Luke Nosek, and Ken Howery.
When Parker departed Founders Fund, Polansky followed, helping to establish and run Parker's family office. Here, he managed Parker's business, investment, and philanthropic endeavors, including playing a pivotal role in standing up the Parker Institute for Cancer Immunotherapy, where Polansky remains an executive director. His life "moved in a different direction" with the onset of COVID-19, significantly influenced by his relationship with Stefani Germanotta, whom he met in late 2019.
Their professional partnership extends to Germanotta's involvement with Outer Biosciences, where she sits on the board, and collaborations with her cosmetics brand, Haus Labs. Kyung-Jin Jang, Outer Biosciences' chief scientist, serves on Haus Labs' scientific advisory board, highlighting the synergistic potential between the two entities, particularly in understanding skin biology.
The Breakthrough: Sustaining Living Human Tissue
Founded in 2022, Outer Biosciences emerged from a critical need to bridge the gap between biological research and rapid innovation. The company's core innovation addresses the challenge of ethical experimentation by utilizing human skin that would otherwise be discarded after surgical procedures, primarily plastic surgery.
This tissue is sourced through vetted non-profit and commercial biobanks and brokers, operating under strict institutional review board (IRB) oversight and documented donor consent. Key partners include the National Disease Research Interchange and the Cooperative Human Tissue Network, both recipients of federal funding from the NIH and the National Cancer Institute. Polansky emphasized that these fees are on a cost-recovery basis, not outright purchase, and all samples arrive de-identified to ensure donor privacy.
The company invested approximately two years in establishing this pipeline and refining protocols to receive the living tissue "within hours" of surgery. Once acquired, a proprietary support system developed by Outer Biosciences' team feeds the tissue essential nutrients and removes metabolic waste. This advanced system has extended the viable life of human tissue to **over a month**, a dramatic improvement over the industry norm of just a few days. The company reports that 30-day-old tissue, under their care, largely retains its "day-zero architecture and preserves its day-zero epidermal, stromal and immune-associated molecular programs," appearing remarkably similar to freshly collected tissue.
This extended viability enables scientists to study slower biological processes, such as collagen remodeling, pigmentation changes, or barrier repair, which take weeks to unfold. For example, researchers can induce UVB damage in the living tissue and track the subsequent stress, inflammatory, and recovery responses over several weeks, providing invaluable data on skin biology.
Understanding the Mechanics of AI-Driven Discovery
The true power of Outer Biosciences' approach lies in its integration of an advanced AI model. This model serves as the engine for accelerating the discovery of novel compounds with beneficial effects on skin function, a significant leap from traditional research methodologies.
The company's approach is characterized by a closed, self-enforcing system:
- Prediction: An AI model predicts which untested chemicals are likely to yield a beneficial effect on a specific skin function.
- Experimentation: These predicted chemicals are then tested on the living human tissue system.
- Feedback Loop: The experimental results, whether confirming or refuting the prediction, are fed back into the AI model. This continuous learning process refines and improves the model's predictive accuracy for subsequent rounds of guesses.
This systematic integration represents a "giant improvement" from earlier, more laborious methods. Initially, Outer Biosciences relied on a "brute force" approach, involving extensive mining of scientific literature and collaborations with the National Cancer Institute to identify natural compounds from extreme environments. This method yielded only a couple of leads over an 18-month period.
With the AI model layered into the process, the pace of discovery has accelerated dramatically. The company is now generating a new candidate compound roughly every **six weeks**, with six leads currently active in its pipeline and several dozen additional "hits" logged. This rapid advancement in the R&D pipeline demonstrates significant improvements in
Navigating the Cosmetics Market and Commercialization Strategy
The current universe of FDA-approved active ingredients for over-the-counter skin drugs is remarkably small, totaling only about **120 to 130** compounds across 13 categories. Including cosmetic ingredients backed by actual research, this number rises slightly to around **200**. This limited landscape presents a significant opportunity for Outer Biosciences' novel discovery platform.
The company is primarily focused on discovering cosmetic ingredients, which avoids the lengthy and expensive FDA approval process required for drugs. Their commercialization route is streamlined:
- Standardized Naming: Obtaining a standardized industry name for the new ingredient.
- Safety Testing: Conducting safety testing under guidelines set by the OECD (Organisation for Economic Co-operation and Development), an international body whose member countries mutually accept properly conducted studies. This ensures broad international market access and
compliance security .
Rather than developing its own consumer brand, Outer Biosciences plans to license or sell its finished ingredients to established beauty or pharmaceutical companies. These partners will then formulate the ingredients into products, such as serums or creams, and bring them to market under their own brands, addressing direct
Beyond ingredient discovery, the company is generating revenue through collaborative research partnerships. These include a pharmaceutical partner investigating why certain cancer drugs cause severe skin rashes, and consumer beauty brands validating Outer Biosciences' data against their own product development and marketing needs.
Funding and Competitive Landscape
To date, Outer Biosciences has raised approximately $23 million from early backers including Calm Capital, Brighter Capital, and Polansky's own investing firm, Hawktail. The company employs **19 people**, with the majority based outside Cambridge, Massachusetts, reflecting a strategic location for biotech talent.
Polansky chose to break the company's long-standing silence now due to the growing body of data and the confidence it has instilled in the team. "We kind of want to start working in public now," he stated, signaling a readiness to engage with the broader scientific and commercial communities.
While Outer Biosciences is not alone in pursuing advanced biological testing, its distinctive use of **real human tissue**, as opposed to synthetic alternatives, sets it apart. Competitors such as Philadelphia-based Vivodyne are also making significant strides, building lab-grown human organ tissue paired with predictive AI for drug testing. Vivodyne recently announced raising nearly $80 million, including a $38 million seed round and a $40 million Series A, both led by Khosla Ventures. Other rivals are exploring various forms of "organ-on-a-chip" and microphysiological systems for preclinical testing, highlighting a rapidly evolving and competitive market focused on next-generation biological
