Every gate has one decision that is cheap to make on time and expensive to fix later.
Most programs track activities by function: a CMC timeline, a clinical timeline, a regulatory timeline. A gate-based roadmap asks a different question at each point: does everything coming together here still agree with everything else?
Milestones
- IND Filing
- IND Clearance (FDA’s 30-day review)
- First Patient In (FPI)
- Phase 2 Start
The Six Gates
- Strategy Lock (12–9 months before filing)
- Decision point: Lock the target product profile, population, route, and dose concept, and write down your global ambition.
- Cost of missing it: A Qualified Person (QP) with defined training and experience requirements
- Evidence Generation (9–6 months before filing)
- Decision point: Choose vendors on quality first. Build QP release provisions into CDMO agreements and confirm the tox material matches the clinical material.
- Cost of missing it: Reopening a signed agreement, or bridging two different products.
- Filing Readiness (6 months through submission)
- Decision point: Go/no-go to file: do the CMC, nonclinical, and clinical summaries tell one consistent story?
- Cost of missing it: A clinical hold, on FDA’s least forgiving clock.
- IND Clearance to FPIs (Months 0–3)
- Decision point: Have a post-IND execution owner in place before this gate opens, with a Phase 2 readiness plan and dated triggers.
- Cost of missing it: A planning gap that can cost 6–12 months.
- Learn and Adapt (Months 3–12)
- Decision point: Use Phase 1 data to start scale-up, place long-lead tox studies, and rebuild the Phase 2 protocol.
- Cost of missing it: Each workstream’s full duration added to your timeline.
- Phase 2 Enablement (Months 12–24)
- Decision point: Execute scale-up, complete triggered tox studies, and activate countries on schedule.
- Cost of missing it: An unplanned quarter or two before Phase 2 can start.
Design Now, Implement Later
Not every decision needs to be executed early, but every decision that will matter later needs a defined shape, owner, and trigger. Designing it costs a conversation. Discovering it was never designed costs months.
- 6 gates from strategy to Phase 2
- 24 months from IND clearance through Phase 2 Enablement
- 12–18 months to scale up for Phase 2, which is why it starts during Phase 1
How Syner-G Helps
Syner-G’s integrated CMC360 model runs the same gate discipline across your program and the ones that follow, so your second IND doesn’t start from a blank page.
Make every gate a decision, not a surprise. Connect with our team.
