One Person Bio
The one-person biotech

Toward the one-person biotech.

A one-person biotech has one founder who owns the science and the decisions. AI does the information work: reading the literature, tracking the field, drafting the documents. Fractional experts hold the seats the company needs for a few days a month, and CROs and CDMOs do the lab work, the manufacturing and the trials. Every piece of it exists today.

This page follows the trend, describes the practice, and reports how the functions actually get covered.

01

Why now

Ask why a biotech with one asset employs sixty people. Most of the org chart exists to move information: find it, read it, reconcile it, and turn it into a decision. For twenty years, every new question became a new hire, a new vendor, or a consultancy.

Biotech outsourced the physical work decades ago, to CDMOs, CROs and sites. The information work is the part that just changed its price. Headcount was the price of information. Agents just changed the price.

What the public record shows
  1. Small companies already start most of the trials.

    Emerging biopharma companies accounted for 68 percent of all clinical trial starts in 2025, up from 56 percent in 2019.

    Source: IQVIA Institute, Global R&D Trends 2026, May 2026
  2. The regulator uses AI for its own information work.

    In June 2025 the FDA launched Elsa, a generative AI tool its staff use for clinical protocol reviews, scientific evaluations and choosing inspection targets. In December 2025 it deployed agentic AI to all employees, for tasks that include pre-market reviews and post-market surveillance.

    Sources: FDA, June 2, 2025 · FDA, December 1, 2025
  3. AI companies now build for life sciences.

    In October 2025 Anthropic launched Claude for Life Sciences, with connectors to Benchling, PubMed, 10x Genomics and other research platforms, for work from early discovery through to commercialization.

    Source: Anthropic, October 20, 2025
  4. Drugs found with AI are in randomized trials.

    In 2025 Nature Medicine published a randomized, placebo-controlled phase 2a trial of rentosertib in idiopathic pulmonary fibrosis. Both its target and the molecule were found with generative AI.

    Source: Xu et al., Nature Medicine, 2025 · PubMed
  5. The early signal shows up in small companies first.

    IQVIA reported early evidence of stronger success rates for AI-enabled programs at emerging biopharma companies, and cautioned that the improvement is not yet visible across the whole industry.

    Source: IQVIA Institute, May 14, 2026

From my own work: a competitive landscape that used to take a consulting team a quarter now takes about a week, and it stays current after the slide is made. Daniel Branco

02

The shape

People for context and judgment. Agents for information. Partners for the physical work. This is how each function of a biotech can be covered when the company is one founder.

Owned
The founder holds it and answers for it.
AI
Agents and assistants do the work. The founder checks it.
Fractional
A senior expert for a few hours or days a month.
Outsourced
A CRO, CDMO, site or service provider.

Filled marks the main way a function is covered. Outlined marks support.

Strategy and decisions
The founder decides what the company is for and signs every decision. AI informs it: the landscape, the numbers and the options.
OwnedAI
Science and program design
The founder owns the hypothesis. AI reads the literature. Advisors stress-test the design.
OwnedAIFractional
Competitive intelligence
Agents track registries, publications, filings and congress abstracts. The founder checks what matters.
AIOwned
Business development
The agent builds the target list and the diligence pack. The founder keeps the negotiation and the trust.
OwnedAI
Medical affairs
The agent builds the KOL map. A person keeps the scientific relationships.
AIOwnedFractional
Regulatory strategy
The agent finds the precedent. A regulatory expert and the founder hold the conversation with the agency.
FractionalAIOwned
Medical accountability and safety
A physician accountable for safety decisions, on a fractional basis or through the CRO.
FractionalOutsourced
Clinical operations
A CRO and the sites run the trial. AI does much of the analytical work. The founder keeps direct contact with the investigators.
OutsourcedAIOwned
Lab and preclinical work
Contract research organizations run the studies. The founder designs them and reads the data.
OutsourcedOwned
Manufacturing
A CDMO makes the drug. A fractional CMC expert oversees the work.
OutsourcedFractional
Quality and compliance
A fractional quality lead, with documents and training records kept in a quality system.
FractionalOutsourced
Finance and fundraising
The founder raises the money. AI builds the model, tracks the budget and keeps the investor pipeline current. A fractional finance lead and an accounting firm keep the books.
OwnedAIFractionalOutsourced
Conferences
The agent triages the abstracts and writes the who-to-meet list. The founder has the conversations.
AIOwned

Agents fail quietly, so the design has to plan for it: read the primary source, check every load-bearing claim before a person sees it, and label what is sourced and what is inferred.

Three things agents do not supply: context, meaning which question matters this week; judgment, meaning someone accountable signs every decision; and aspiration, meaning what the company actually wants to become. Those stay with the founder.

03

The practice

OnePersonBio runs the information functions of a biotech for founders who won't hire a department. One seat, agents built on BioAlma, a workspace of your own, and a channel to the agents where you already work.

The practice
04

Case reports

One company, one function, how it was covered, what happened. From the practice's own engagements, published with each company's written OK and described without a name until then.

05

Who runs this page

Daniel Branco
Daniel Branco, MD, PhD, MBA, neurologist, founder of BioAlma.

He writes the CoCreating.Bio newsletter on AI and biotech, and keeps this page as a public record of the one-person biotech as it forms.

Disclosure: Daniel founded BioAlma, an AI intelligence platform for biotech. It is the platform behind OnePersonBio.