Physician-Led · AI-Scaled

Drug Development,
led from the center.

A physician executive at the center of a closed-loop development engine — clinical judgment governs every call, AI scales the analysis, and every decision that reaches a regulator or the clinic carries a physician's signature.

Our Model Get in Touch

About N-1 Bio

Built differently, by design.

N-1 Bio, LLC is an AI-native biotech consultancy. We exist to prove that a single physician executive, armed with the right AI infrastructure, can navigate the clinical development lifecycle with the rigor and depth of a traditional organization at a fraction of the cost.

From first-in-human planning through clinical development, regulatory strategy, and commercial planning, every function is covered by a dedicated AI agent — coordinated and directed by a physician who understands the science, the patients, and the stakes.

What makes the model different is the loop. Each agent draws on a shared, growing knowledge base and adds to it at the close of every engagement, so the firm gets sharper the more it works. And the loop is governed, not autonomous — the AI accelerates the analysis, but every decision that reaches a client, a regulator, or the clinic carries a physician's signature.

Today, N-1 Bio supports clinical-stage programs across therapeutic areas — spanning clinical development, regulatory strategy, and medical affairs, from pre-IND through launch.

N-1 Bio is not a traditional biotech. It's what comes next.

Chris Galloway, MD

Chris Galloway, MD

Founder & CEO · Fractional CMO

Physician executive — fourteen years in drug development, following twelve years in emergency medicine. CMO at TractBio and Diffusion Pharmaceuticals; SVP Clinical Development & Medical Affairs at Elevar. INDs filed, NDA and BLA submissions led with Fast Track and Orphan Drug designations, and Type A/B/C meetings led with FDA and EMA.

The N-1 Framework

One physician in command.
An AI-scaled team.

N-1 Bio replaces traditional departmental structure with a closed learning loop — physician authority at the center, specialized AI agents in orbital roles, and institutional memory that compounds across every engagement.

⚕️
The Single Human Physician CEO
A central physician leader holds the ultimate decision-making authority and clinical oversight — the "1" in N-1. Agents automate the learning; the human owns every decision gate. No protocol change, endpoint, or regulatory submission moves without physician sign-off.
AI Agents
Multiple specialized AI agents perform complex tasks across scientific, regulatory, clinical, commercial, and financial domains — reporting directly to the CEO.
⚡
Virtual Biotech Operations
A lean, high-efficiency structure that replaces traditional massive departmental overhead with AI — full functional coverage at a fraction of the cost.
🔄
Closed-Loop Learning
Every engagement feeds a growing knowledge base. Each agent reads what the firm has learned before and adds to it at the close of every project — so N-1 Bio compounds expertise instead of starting cold each time.

What We Do

Hire 1 human.
You get a whole team.

N-1 Bio is a consulting firm built for lean and emerging biotech and pharma companies that need serious pharmaceutical expertise — without the cost or timeline of building a full team.

When you partner with N-1 Bio, you get a physician executive leading a fully operational virtual team: a Chief Medical Officer, Chief Scientific Officer, Chief Regulatory Officer, Head of Clinical Operations, Director of Biometrics, Head of Business Development, and more — all AI-powered, all working together collectively, all directed by a physician who has spent a career doing exactly this work.

Full Team. Fractional Cost.
C-suite-level expertise across all functions at a fraction of the cost of a single senior hire.
Compressed Timelines
AI agents work in parallel. Months of sequential handoffs now executed in weeks.
Human-Led, Always
Every deliverable directed and reviewed by a physician executive. Science and judgment stay human.
Right-Sized for Your Stage
Pre-IND to pre-launch — the model scales to your needs and your budget.

How N-1 Bio Helps

Where the model fits

Representative scenarios that show how the N-1 model maps to common inflection points. Illustrative, not client-specific.

C-Suite Gap
The C-Suite You Need, Without the Headcount
The Situation
An emerging virtual pharma company has a CEO and promising pipeline but lacks CMO, CSO, and regulatory leadership. They're heading into a Series B raise and need credible development leadership across all functions without adding FTEs before the round closes.
N-1 Bio Delivers
Embedded virtual C-suite — CMO, CSO, and CRO functional leadership available for board meetings, investor due diligence, regulatory interactions, and day-to-day development decisions. Experienced, credible, immediately available.
CMO  ·  CSO  ·  Regulatory  ·  Medical Affairs  ·  COO
Series A
Full Dev Strategy on a Startup Budget
The Situation
A Series A oncology company has $18M and a lead candidate ready to advance. The board wants a complete integrated development plan before greenlighting further spend — but they can't afford the team required to produce it.
N-1 Bio Delivers
Board-ready integrated development plan: Phase 1/2 design, adaptive trial strategy, companion diagnostic approach, TPP, regulatory milestones, and financial modeling — produced in weeks, not quarters.
CMO  ·  CSO  ·  Biometrics  ·  Regulatory  ·  CFO
Pre-IND
IND-Enabling Package
The Situation
A rare disease biotech has compelling preclinical data but no development team. Founders are scientists, not drug developers. They need a regulatory strategy, IND package, and clinical protocol — and investors are watching the clock.
N-1 Bio Delivers
Full IND-enabling package — regulatory strategy, preclinical data assessment, CMC guidance, Phase 1 protocol design, and FDA pre-IND meeting prep — on a compressed timeline, at the cost of a short consulting engagement.
CSO  ·  CMO  ·  Regulatory  ·  Clinical Ops
Business Development
Asset Package Readiness
The Situation
A clinical-stage company is preparing to out-license a promising immunology asset. They have the science, but no one to translate it into a regulatory opinion, commercial valuation, and competitive landscape that pharma BD teams expect to see.
N-1 Bio Delivers
Full BD-ready asset package: target product profile, regulatory pathway assessment, market sizing and peak sales model, competitive differentiation analysis, and deal structure guidance — ready for partnering meetings in weeks.
CSO  ·  Regulatory  ·  CCO  ·  Biz Dev

Get in Touch

Let's connect.

Whether you're looking for a strategic partner, consulting expertise, or want to learn more about the N-1 model — reach out directly.

LinkedIn linkedin.com/in/chrisgallowaymd