SME + AI functional support for early-stage biotech
Fourteen functions. One small team. An expert behind every one.
Biotech Dream Builder pairs AI agents with vetted subject matter experts from the Biotech Primer network, so a lean founding team can stand up everything from target validation to commercial launch, and every regulated decision keeps a named human owner.
Built on Biotech Primer. The knowledge base and the expert network behind every function.
The problem
A biotech runs on functions a founding team can't afford to staff.
Discovery, nonclinical, CMC, quality, clinical, regulatory, commercial, and the enterprise functions that hold them together. A well-funded company hires a specialist for each. An early-stage team can't, and shouldn't have to wait for a Series B to have the expertise.
specialist hires to cover discovery, nonclinical, and core business functions before your first IND.
subscription that gives you fractional access to all of them, at a stage that matches your asset.
Meet Glim
A light for the long nights.
Behind every program on this site is a person hoping for something ordinary: a full night's sleep, a morning at the kitchen table. Glim is the firefly who keeps that hope in the room while our experts do the careful work, and who reminds every builder who they are building for.
What Glim is dreaming about
Glim shares these as it flies. Select a bubble and Glim will come over to say it.
Dream bubbles show the ordinary moments patients and families hope to get back, and Glim's words are encouragement for the people building. They show hope, never a promise, and they never imply that any treatment works.
The Build Arc
Eight phases from target to lifecycle, each with an agent and an expert.
Every phase follows the real lifecycle of a therapeutic. Agents do the first draft, the first scan, the first flag. A qualified expert owns what happens next. Select a phase to see the work, the agents, and the human sign-off.
Running in parallel
Six enterprise functions that turn functions into a company.
Corporate Finance & Fundraising
Seed through IPO, non-dilutive funding (grants, partnerships), biotech valuation, cap table basics.
Legal & Intellectual Property
Patent strategy, licensing agreements, clinical trial and vendor contracts, corporate structuring.
HR & Organizational Design
The right team and org structure at each stage of company growth.
Program & Portfolio Management
Cross-functional coordination, stage-gate governance, risk and timeline management.
Executive Leadership & Governance
Board management, investor relations, executive communication, crisis management.
Data, Digital & AI in Drug Development
AI/ML in discovery and trials, real-world data, digital biomarkers, and data governance.
The SME + AI operating model
Agents draft. Experts decide. Every decision is on the record.
One oversight framework applies to all fourteen functions. How much human review a task gets depends on how much risk it carries, and the highest-risk decisions never leave human hands.
Autonomous
The agent completes the task end to end inside defined guardrails. Your expert spot-checks a sample instead of reviewing every output.
Draft and review
The agent produces a draft, analysis, or recommendation. A named expert reviews and approves it before it moves forward.
Expert-directed
The agent provides analysis and options only. A qualified expert makes and documents the decision, with a full audit trail.
The human-data flywheel
Your program gets sharper every time an expert weighs in.
Every approval, edit, or rejection is captured as structured, validated human data specific to the function and decision context. That is how quality and speed compound over the length of an engagement.
- Agents execute the first passA protocol, a CAPA, a submission section, a launch plan.
- An expert reviews under the three-tier modelApprove, correct, or reject, with the right level of oversight for the risk.
- The correction becomes validated human dataSpecific to your function, modality, and decision context.
- The next output starts betterAgents, playbooks, and training improve for your program and every program after it.
↻ Then the loop repeats
What we never hand to an agent
These stay with a named, qualified human owner of record, every time.
- Batch release Quality
- Safety-signal adjudication Clinical
- Regulatory submission approval Regulatory
- Dosing and stopping decisions Clinical
- Deviation disposition Quality
Find your stage
Three questions to see where you'd start.
Subscriptions match the stage of your lead program. Tell us where you are and we'll show the coverage, plan level, and engagement path that usually fits, then refine it together on a discovery call.
Where the expertise comes from
The knowledge base is Biotech Primer. So is the bench.
Since 2001, Biotech Primer has taught professionals the science, business, and regulatory frameworks of biotech through expert-led courses. Dream Builder extends that foundation from learning how biotech works to building it, drawing our subject matter experts from the same network of practitioners who have done the work.
Practitioners from the Biotech Primer faculty
A selection of the instructors behind the curriculum. Full faculty on Biotech Primer's site.
Dr. Simon Tulloch
30+ years in pharma and biotech. Led drug development at Shire, including Adderall XR and Fosrenol.
Dr. Emily Burke
PhD in molecular biology, post-doctoral research at Scripps, and author of Biotech Primer One and Two.
Dr. Kevin Curran
Gene therapy consultant focused on hemophilia, muscular dystrophy, and spinal muscular atrophy. Prior cancer research at Memorial Sloan Kettering.
Jim Macemon
40+ years in medical devices, 13 patents, and led R&D at Baxter Healthcare.
Learn the language first
New to a function? Biotech Primer's on-demand courses are the fastest way to get fluent before you build.
Plans and engagement
Subscribe at your stage. Choose how you want to own the work.
Four company stages that grow with your asset, three plan levels that scale expert hours and agent capacity, and two ways to engage. Pricing is scoped to your stage and plan level and shared on your discovery call.
Company stage
Foundation
Discovery + Nonclinical
Pre-IND, from target identification through the IND-enabling package.
Development
+ CMC + Quality Systems
Process and quality buildout, through Phase 1 readiness.
Clinical
+ Clinical + Regulatory
Trials running and submissions in flight, IND/CTA through NDA/BLA.
Commercial
+ Commercialization + Lifecycle
Launch, post-marketing, and pipeline growth.
Stages are cumulative. Earlier functions stay covered, at lighter maintenance levels, as new ones become active.
Plan level
Essentials
One active program with core function coverage. Built for a lean, single-asset team.
Growth
Two to three concurrent programs, expanded expert hours and agent capacity, and priority scheduling.
Enterprise
Four or more programs or a full pipeline, a dedicated expert pod for each active function, and custom agent configurations.
Engagement model
Build-for-You
Our experts and agents operate the function on your behalf, for as long as you want. The fastest way to have capability running.
- Lower cost to start, with a one-time onboarding fee
- Best for functions you don't plan to build in-house
- Live in roughly 8 to 14 weeks depending on stage
Build-Train-Transition
We design and stand up the function, train your hires to run it, and hand over full ownership on a defined timeline. Optional advisory retainer after.
- Shadow, then co-own, then operate independently
- Fixed-fee build-out, much lower ongoing cost
- Independent in roughly 16 to 26 weeks depending on stage
Mix models by function, for example Build-for-You for Clinical and Regulatory while running Build-Train-Transition for CMC. Timelines are planning estimates, confirmed when we scope your program.
Grow your team's capability
Train the people who will run it.
Every function is taught at three levels, so your team can go from fluent to able to stand the function up from scratch. Teams practice on real artifacts, then prove it in the Builder Studio, a cohort simulation where they found and run a virtual biotech from first target to simulated launch.
In development · ask about the founding cohort