A growing share of newly approved drugs miss their first-year sales projections, and it is rarely the science that falls short. It's payer access, physician awareness, and field infrastructure that weren't ready on day one. The difference between the winners and the rest is go-to-market work that starts years before launch, not weeks after approval.
The Problem
You're building your commercial strategy too late
Most biotech companies start serious GTM planning about 12 months before anticipated approval. Market access negotiations, KOL development, physician education, and payer strategy each need 18-24 months of groundwork to land. Starting late means compressed timelines, missed payer contracting windows, thin physician relationships, and a launch that reaches a fraction of its addressable market in year one.
Clinical endpoints don't translate directly into commercial messaging
Your Phase III data proves efficacy. But physicians prescribe based on clinical context: how your therapy fits existing treatment algorithms, which patient subgroups benefit most, what realistic switching behavior looks like from the current standard of care. Payers approve based on health economics and budget impact, not efficacy alone. GTM strategy is the translation layer between your clinical data and the commercial language each stakeholder actually responds to.
Market access complexity kills launches without early preparation
Formulary placement, prior authorization criteria, patient assistance programs, and specialty pharmacy distribution all get decided in parallel with regulatory review, and they determine whether patients can actually fill a prescription. Companies that treat market access as a post-approval task launch into a market that isn't set up to prescribe, dispense, or reimburse their product, and that gap shows up directly in quarter-one revenue.
How We Help
Our initial assessment evaluates launch readiness across five workstreams: market access, medical affairs, commercial operations, brand strategy, and competitive preparedness. We benchmark your current state against comparable biotech launches to identify timeline gaps and resource needs. Most companies we assess are 6-12 months behind where they need to be for the approval date they're targeting.
Strategy development builds one integrated GTM plan that synchronizes every commercial workstream against your regulatory timeline, rather than letting each function plan in isolation. Market access strategy starts with payer landscape analysis and HEOR evidence planning. Medical affairs builds KOL engagement and publication strategy. Commercial operations designs field team structure, territory targeting, and launch sequencing. Brand strategy ties it into positioning and messaging that holds up with investors, physicians, and payers at once.
Execution is phased against your development timeline. Pre-Phase III, we focus on market shaping: building the clinical narrative, scoping payer evidence requirements, and opening KOL relationships. During Phase III, we build operational infrastructure: field team hiring, market access negotiations, and launch materials. Post-approval, we run the launch plan and adjust weekly based on early prescribing signals.
Measurement tracks both preparation milestones and commercial outcomes, not just activity. Pre-launch metrics include KOL engagement depth, payer meeting completion rate, and operational readiness scores by workstream. Post-launch, we track new-prescription volume, formulary access rates by payer segment, time to first prescription by geography, and market share trajectory against the plan we set during strategy development.
What we deliver
- Integrated GTM plan – synchronized workstreams mapped to your regulatory timeline
- Market access strategy – payer targeting, HEOR evidence plan, and formulary negotiation approach
- Launch sequencing – geographic and account prioritization based on access and opportunity
- Commercial operations design – field team structure, targeting models, and KPI frameworks
The biotech companies that launch successfully don't start go-to-market planning at approval. They start 18-24 months before. Every month you delay commercial preparation is a month of payer access and physician adoption you don't get back at launch.
Our Methodology
Our go-to-market methodology for biotech follows a timeline-gated approach synchronized with clinical development, not a generic launch playbook. Phase one maps the commercial landscape: payer coverage patterns, competitive positioning, KOL networks, and market access requirements specific to your therapeutic area. That produces a launch readiness gap analysis showing exactly where you stand and what needs to happen by when.
Phase two builds the strategic framework across market access, medical affairs, commercial operations, and brand. Unlike consultancies that work in silos, we connect every workstream to one commercial narrative: market access evidence requirements inform clinical study design, KOL development supports both medical affairs and commercial launch, and brand positioning serves investors, physicians, and payers simultaneously instead of three separate messages.
Phase three is execution against the timeline, with quarterly milestone reviews that keep every workstream on schedule. We reallocate resources as your regulatory path clarifies, scaling commercial operations investment up as approval probability increases and pulling back on speculative spend if a trial readout pushes the timeline.
How We Work
GTM engagements for biotech typically begin 18-24 months before anticipated approval and run through the first 6-12 months post-launch. The first 60 days focus on landscape analysis and strategic framework development: mapping the competitive, payer, and prescriber landscapes and producing the integrated GTM plan.
Months 3-12 build commercial infrastructure. Market access negotiations begin, medical affairs programs scale, and field team design and hiring plans get built out. Brand and marketing materials move through the internal review that biotech and pharma require. Weekly workstream check-ins keep market access, medical affairs, and commercial ops on the same timeline instead of drifting apart.
Months 12-24, from pre-launch through launch, is full operational execution: field teams hired and trained, payer contracts finalized, launch materials deployed, and a coordinated launch managed across markets and channels rather than left to each function to sequence on its own.
Post-launch, we optimize against real market data: weekly prescription tracking, monthly market access analysis, and quarterly strategy reviews to identify what's working and what needs to shift. Most engagements transition to ongoing commercial support or hand off to the full-time commercial team we helped build.
- Launch readiness – all commercial workstreams synchronized before approval
- Market access – formulary coverage and payer contracts secured pre-launch
- Adoption velocity – physician awareness and prescribing intent built before launch day
If your biotech & pharma company needs go-to-market leadership, we should talk.
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Frequently asked questions
How much does go-to-market strategy cost for biotech companies?
GTM strategy engagements typically run $30K-$80K per month depending on scope and launch complexity, with multi-indication launches or crowded therapeutic areas requiring more intensive preparation. Compared to the revenue and valuation impact of a launch that misses its projections, GTM strategy investment is a small fraction of the value actually at risk. Cost also scales down for narrower indications with a smaller prescriber base to reach.
When should a biotech company start go-to-market planning?
Ideally 18-24 months before anticipated approval. Market access strategy needs at least 18 months for payer evidence development and negotiation, KOL programs need 12-18 months to mature, and even medical affairs content and physician education need 12-plus months of consistent effort to land. Starting earlier than strictly necessary costs relatively little; starting late is expensive in lost market potential you can't recover in year one.
How does your GTM team integrate with our existing commercial and medical affairs staff?
We work as an extension of your leadership team, filling gaps rather than replacing existing capability. If you already have medical affairs leadership, we coordinate market access and commercial strategy alongside them. If you're building the commercial team from scratch, we design the org, define roles, and help recruit into it. Weekly cross-functional meetings keep every workstream synchronized against the same launch date.
What makes Winston Francois different from a traditional pharma launch consultancy?
Most launch consultancies specialize in one workstream: market access, or medical affairs, or commercial operations. We integrate all of them into one commercial strategy, so your market access evidence plan lines up with your KOL strategy, which lines up with your brand positioning, which lines up with your field force design. That integration is what prevents the workstream disconnects that quietly erode launch performance.
How do you measure go-to-market success for biotech launches?
Pre-launch, we track KOL engagement depth, payer meeting completion, operational readiness scores, and formulary decision timelines. Post-launch, we track new prescription volume against projections, formulary access rates by payer segment, time to first prescription by geography, and market share trajectory. We set the benchmarks during planning, then track weekly post-launch so we can catch and correct underperformance early instead of discovering it in a quarterly review.
What type of biotech company is the right fit for GTM strategy services?
Companies with assets in Phase II or later that need to build commercial readiness infrastructure ahead of approval. The best fit has clinical data supporting real commercial potential but lacks the in-house commercial leadership or infrastructure to translate that potential into a market launch. If you're pre-clinical or early Phase I, GTM is premature; brand strategy and investor positioning are the more useful starting points.
