For CMC leaders
Built for the people accountable for the portfolio.
Summit is for Heads of CMC, Program Leads, and CMC PMOs running multiple biopharma development programs at once — where risk, capacity, and sequencing are the actual job.
What we hear
The four things that quietly cost the most.
Portfolio collisions you only see in hindsight
Two programs hit the same fill line in the same week. The third needs the formulator who's already on the first. Summit makes the collision visible before the schedule locks.
Risk that lives in tribal knowledge
Your most senior people carry the real picture in their heads. When they're out, the org is blind. Summit captures the trade-offs as part of the work, not in side conversations.
Reviews that defend the past
By the time the steerco deck is built, reality has moved on. Summit gives leaders a live, defensible portfolio view — so the meeting is about decisions, not data reconciliation.
Lessons that never travel
A program closes. The team moves on. The hard-won knowledge — what worked, what failed, what you'd do differently — gets buried in a folder no one opens. Summit's Knowledge Base keeps those lessons in circulation, tagged and searchable for the next team that needs them.
What changes
Outcomes, not features.
You'll feel Summit in the meetings you don't have to chase, the surprises you saw coming, and the decisions you made on time.
- Walk into portfolio review with the same picture as your team.
- See sequencing collisions weeks before they become escalations.
- Test re-allocation before committing it.
- Onboard new program leads against a shared model, not a folder of decks.
- Give the exec team a defensible answer to "what changed and why?"
Who it's for
Three roles. One shared picture.
Head of CMC
You're accountable for the portfolio. You need a view that doesn't depend on every program lead being available on Tuesday at 3.
Program Lead
You know your program. You need the rest of the portfolio to stop surprising you with resource pulls and dropped commitments.
CMC PMO
You assemble the picture today. Summit assembles it with you, so you spend more time on what the picture means and less on building it.
The Plan of Attack
The briefing book is the game plan.
Summit assembles each program into a chapter-based POA — overview, product, timeline, team, risks, load, budget. One shared artefact your team plans against and your steerco signs off on.
Plan of Attack · ASC-204
The shared game plan for delivering the program — every chapter, one source of truth.
Chapter 01
ASC-204 · Phase 2 oncology mAb · Tier 1
Lead asset toward a 2027 BLA. CDMO partner confirmed. Program intent signed by the steering committee on Feb 12.
Risk, before it's a fire drill
See the next risk early — and the way around it.
Summit watches the portfolio for sequencing, supply, and capacity threats and surfaces them with modelled pivots. The team walks into the room with options, not just bad news.
Upcoming risk · ASC-204
Resin-A single source — 5-week window before PPQ lock
Summit detected that the only qualified vendor for the capture resin has a confirmed 12-week lead-time extension. Without action, this slips PPQ start by ~4 weeks and pushes first regulatory submission into the next fiscal year.
Pivots Summit modeled
Three ways to manoeuvre around it.
Each option is scored against schedule, cost, and residual risk — so the trade-off is explicit before the steerco call.
Selected pivot
Qualify second-source resin
Open a parallel qualification stream with Vendor B. Removes the single-supplier cliff before PPQ.
If this sounds like your week — let's talk.
If you've rebuilt the same risk assessment three times this year, Summit was built for you. We're onboarding a small group of CMC leaders as design partners. Early access is personal, hands-on, and directly shapes the roadmap.
Request early access