Half of FDA-approved drugs underperform commercial projections in their first year. The difference between the winners and the rest isn't better science — it's better go-to-market strategy built years before launch day.
The Problem
You're building your commercial strategy too late
Most biotech companies start serious GTM planning 12 months before anticipated approval. But market access negotiations, KOL development, physician education, and payer strategy each require 18-24 months of groundwork. Starting late means compressed timelines, missed payer deadlines, underdeveloped physician relationships, and a launch that reaches a fraction of its potential market.
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 into treatment algorithms, which patient populations benefit most, what the real-world switching behavior looks like. Payers approve based on health economics and budget impact. Your clinical data is the foundation, but go-to-market strategy translates that data into the commercial language each stakeholder needs.
Market access complexity kills launches without early preparation
Formulary placement, prior authorization requirements, patient assistance programs, specialty pharmacy distribution — these decisions happen in parallel with regulatory review and determine whether patients can actually access your therapy. Companies that treat market access as a post-approval problem launch to a market that isn't ready to prescribe, fill, or reimburse their product.
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 successful biotech launches to identify timeline gaps and resource needs. Most companies discover they're 6-12 months behind where they need to be.
Strategy development builds an integrated GTM plan that synchronizes all commercial workstreams against your regulatory timeline. Market access strategy starts with payer landscape analysis and HEOR evidence planning. Medical affairs builds KOL engagement and publication strategies. Commercial operations develops field team design, targeting models, and launch sequencing. Brand strategy creates the positioning and messaging that ties everything together.
Execution is phased to match your development timeline. Pre-Phase III, we focus on market shaping — building the clinical narrative, developing payer evidence requirements, and establishing KOL relationships. During Phase III, we build operational infrastructure — field team hiring, market access negotiations, and launch materials. Post-approval, we execute the launch plan and optimize based on early market signals.
Measurement tracks both preparation milestones and commercial outcomes. Pre-launch metrics include KOL engagement depth, payer meeting completion rates, and operational readiness scores. Post-launch, we track new prescription volume, formulary access rates, time to first prescription by geography, and market share trajectory against projections.
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 24 months before. Every month you delay commercial preparation is a month of market access and physician adoption you lose at launch.
Our Methodology
Our go-to-market methodology for biotech follows a timeline-gated approach synchronized with clinical development. Phase one maps the commercial landscape — payer coverage patterns, competitive positioning, KOL networks, and market access requirements. This produces a launch readiness gap analysis that tells you exactly where you stand and what needs to happen by when.
Phase two builds the strategic framework — integrated across market access, medical affairs, commercial operations, and brand. Unlike agencies that work in silos, we connect every workstream to a unified commercial narrative. Market access evidence requirements inform clinical study design. KOL development supports both medical affairs and commercial launch. Brand positioning serves investors, physicians, and payers simultaneously.
Phase three is execution against the timeline — with quarterly milestone reviews that keep all workstreams on schedule. We adjust resource allocation as your regulatory path becomes clearer, scaling up commercial operations investment as approval probability increases.
How We Work
Go-to-market 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. We map the competitive, payer, and prescriber landscapes and develop the integrated GTM plan.
Months 3-12 build commercial infrastructure. Market access negotiations begin. Medical affairs programs scale. Field team design and hiring plans are developed. Brand and marketing materials move through development. Weekly workstream check-ins ensure all activities stay synchronized.
Months 12-24 (pre-launch through launch) are full operational execution. Field teams are hired and trained. Payer contracts are finalized. Launch materials are deployed. We manage the coordinated launch across markets, geographies, and channels.
Post-launch, we optimize based on real market data. Weekly prescription tracking, monthly market access analysis, and quarterly strategy reviews identify what's working and what needs adjustment. Most engagements transition to ongoing commercial support or hand off to a full-time commercial team we've 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 range from $30K-$80K per month depending on scope and launch complexity. Multi-indication launches or competitive therapeutic areas require more intensive preparation. Compared to the cost of a suboptimal launch — where underperformance against investor projections can reduce company valuation significantly — GTM strategy investment represents a small fraction of the value at risk.
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. Even medical affairs content and physician education programs need 12+ months of consistent effort. Starting earlier than necessary costs relatively little; starting late is extremely expensive in lost market potential.
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 capabilities. If you 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 organization, define roles, and help recruit. Weekly cross-functional meetings ensure all workstreams stay synchronized.
What makes Winston Francois different from traditional pharma launch consultancies?
Most launch consultancies specialize in one workstream — market access, or medical affairs, or commercial operations. We integrate all workstreams into a unified commercial strategy, which means your market access evidence plan aligns with your KOL strategy, which aligns with your brand positioning, which aligns with your field force design. Integrated planning prevents the workstream disconnects that cause launch underperformance.
How do you measure go-to-market success for biotech launches?
Pre-launch: KOL engagement depth, payer meeting completion, operational readiness scores, and formulary decision timelines. Post-launch: new prescription volume vs. projections, formulary access rates by payer segment, time to first prescription by geography, and market share trajectory. We establish performance benchmarks during planning and track weekly post-launch to identify optimization opportunities.
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. Ideal clients have clinical data supporting commercial potential but lack the commercial leadership or infrastructure to translate that potential into market success. If you're pre-clinical or early Phase I, it's too early for GTM — focus on brand strategy and investor positioning instead.
