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GTM Strategy for Biotech & Pharma

by Jason Shafton

Most GTM frameworks assume you control your launch date. In biotech and pharma, the FDA does. We build go-to-market strategy that sequences around clinical milestones, approval timing, and payer readiness, so your commercial team isn't starting from zero the week you get a green light.

The Problem

GTM plans built like a SaaS launch, not a drug launch

Most GTM consultants apply the same funnel-and-channel framework to a biologic that they'd apply to a project management tool. That framework has no place for a PDUFA date, a formulary review cycle, or a Phase 3 readout that shifts your launch window by two quarters. When the plan doesn't account for regulatory sequencing, commercial teams end up rebuilding it mid-cycle.

Market access work starts after approval instead of before it

By the time a company starts talking to payers, HEOR isn't built and formulary conversations haven't started. Payer and PBM review cycles run in parallel with FDA review, not after it. Companies that wait for approval before starting market access work lose months of reimbursement runway they can't get back.

Medical, market access, and commercial don't talk to each other

Medical affairs is building the clinical narrative, market access is building the value dossier, and commercial is building physician messaging, often with three different sets of assumptions about launch timing and positioning. Nobody owns the handoff. The result is a launch where the sales team is pitching a story the payer team hasn't cleared yet.

HCP messaging that ignores the prior authorization wall

A physician can be convinced your therapy is right for their patient and still not prescribe it if prior authorization requirements make it a two-week fight with the payer. GTM strategy that only targets physician awareness, without addressing what happens at the pharmacy counter or the PA form, generates interest that doesn't convert to scripts.

How We Help

We start with an assessment, not a deck template. Over the first two weeks we map your current stage against your regulatory timeline: where you are in the approval process, what your payer and formulary exposure looks like, whether your HEOR data supports the value story your commercial team wants to tell, and whether medical, market access, and commercial are working from the same launch calendar. Most engagements surface at least one place where the commercial plan and the regulatory plan are running on different clocks.

From there we build the strategy layer: a launch sequencing plan that ties specific GTM activities to specific regulatory and clinical milestones, a market access and payer messaging framework built around your actual reimbursement pathway (formulary tier strategy, prior authorization mitigation, payer segmentation by coverage policy), and an HCP go-to-market model that distinguishes physician-facing education from patient-direct awareness where both apply.

Execution is where most GTM engagements stop being useful and ours keeps going. We don't hand you a strategy document and leave. We embed with your team, fractional but hands-on, to build the actual assets: HCP segmentation and targeting models, payer value dossiers, sales enablement material that reflects real formulary status by region, and a launch playbook your commercial and medical teams can both operate from without a translator.

Measurement in biotech GTM isn't pipeline velocity and CAC the way it is in SaaS. We track the metrics that actually indicate launch health: time from approval to first prescription, payer coverage decisions by plan, prior authorization approval rates, and physician awareness-to-prescribing conversion by segment. We build the dashboard once and hand over ownership so your team isn't dependent on us to read it.

What makes this different from a traditional life sciences consultancy is the model. We're not a team of slide-deck strategists who show up for a quarterly review. We're operators who sit inside your commercial function for the length of the engagement, make the calls a VP Marketing or Chief Commercial Officer would make, and leave your team with a system they can run without us. Fractional doesn't mean part-time attention. It means senior GTM operators at the table without the twelve-month ramp of a full-time hire.

We also don't pretend every biotech company needs the same GTM motion. A pre-commercial company two years from approval needs investor narrative discipline and early payer relationship building. A commercial-stage company facing a formulary decision next quarter needs competitive positioning and sales enablement now. We build the plan for where you actually are, not a generic template with your logo on it.

By the end of the engagement you have a launch sequencing plan mapped to your regulatory timeline, a market access strategy your payer team can execute, HCP and patient-direct messaging that reflects reimbursement reality, and a measurement system that tells you whether the launch is working before your quarterly board update does.

What we deliver

A launch plan that starts the day after FDA approval is already three quarters late on payer strategy.

Our Methodology

We run every engagement as a 90-day sprint, not an open-ended retainer. Days 1-30 are assessment: we map your regulatory timeline against your current commercial readiness, audit whatever market access and HCP strategy already exists, and identify the gap between what your medical, market access, and commercial teams each believe the launch plan is. This phase ends with a single shared timeline, not three competing ones.

Days 31-60 are strategy build: launch sequencing, payer messaging framework, HCP and patient-direct segmentation, and competitive positioning against whatever incumbent therapy your prescribers currently default to. We build these as working documents your team will actually use in sales enablement and payer conversations, not as a strategy binder that gets read once.

Days 61-90 are execution and handoff: we build the first wave of commercial assets alongside your team, stand up the measurement dashboard, and train whoever owns GTM internally to run the system without us. The difference from traditional consulting is that we're still in the room for execution, not gone the moment the strategy deck is approved. Traditional consultancies bill for the recommendation. We stay accountable for whether the recommendation actually launches on time.

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How We Work

The first 30 days are diagnostic: we sit with your medical affairs, market access, and commercial leads separately before we sit with them together, because the gaps between those teams are usually the real problem, not the messaging itself. You'll get a single-page launch timeline that reconciles regulatory milestones with commercial activity, something most companies don't have when we start.

Days 31-60 is where the strategy gets built and stress-tested against your actual payer mix and competitive set. We work in weekly working sessions, not monthly check-ins, because GTM decisions in a live regulatory window can't wait a month for the next meeting. Your team sees drafts early and often; nothing shows up finished with no chance to redirect it.

The team is a fractional GTM lead plus specialists as the work requires: someone who has built payer and market access strategy before, someone who understands HCP marketing in a regulated category, and someone who can build the measurement layer. You're not getting a single generalist consultant stretched across a launch that has multiple distinct workstreams running at once.

By day 90, ownership transfers. You get the launch plan, the messaging frameworks, the enablement assets, and the dashboard, plus a trained internal owner who can run it. If your biotech or pharma company needs GTM strategy that actually accounts for your regulatory reality, we should talk.

If your biotech & pharma company needs gtm strategy leadership, we should talk.

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Frequently asked questions

How early before FDA approval should we start GTM strategy work?

Ideally 12-18 months out, while you still have time to build payer relationships and HEOR data before formulary reviews begin. Payer and PBM review cycles often run in parallel with FDA review, not after it, so waiting for approval to start market access work means losing months you can't recover.

What is the difference between pre-commercial and commercial-stage GTM for biotech?

Pre-commercial GTM is largely investor-facing and pipeline-facing: building the narrative that supports funding rounds and partnership conversations while laying groundwork with payers years before launch. Commercial-stage GTM is payer-facing and provider-facing: executing formulary strategy, HCP targeting, and sales enablement against a competitive set that's already prescribing something else.

Do you build payer and market access strategy, or just physician-facing marketing?

Both, and we treat them as one connected system rather than two separate workstreams. Physician-facing messaging that ignores prior authorization and formulary tier status generates interest that doesn't convert to scripts.

How does Winston Francois structure market access and HEOR messaging?

We start from your existing HEOR data and clinical evidence, then build a value proposition framework tailored to how specific payer segments make coverage decisions, whether that's cost-offset arguments for a payer focused on total cost of care or comparative efficacy positioning against an incumbent therapy. We don't generate new HEOR studies.

Can you help us compete against an incumbent therapy at launch?

Yes, this is one of the more common reasons companies bring us in. We build competitive positioning that accounts for why physicians currently default to the incumbent, what would actually change a prescribing habit, and where the incumbent is vulnerable on cost, side-effect profile, or dosing convenience.

Why use a fractional GTM team instead of hiring in-house or a traditional agency?

Hiring a VP-level GTM lead in-house takes months you may not have before an approval date, and a traditional consultancy typically hands you a strategy deck and leaves execution to your team. We embed as operators for a defined 90-day sprint, build the actual commercial assets alongside your team, and transfer ownership with a system already running, not a set of recommendations someone still has to build.


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