Month: July 2025

Biopharma companies need more than just strong clinical data to succeed; they need a well-planned biopharma market access strategy. With pricing pressures, evolving payer expectations, and global regulatory hurdles, market access has become one of the most critical elements of a successful product launch.

 Unfortunately, many companies delay access planning until late-stage development. By then, it’s often too late to align your product’s value story with what payers need to see.

So, what does a strong biopharma market access strategy look like? And when should you start building it?

Step 1: Begin Early- Preclinical to Phase 1

The foundation of a successful biopharma market access strategy starts early in development. You may not have robust clinical data yet, but now is the time to align your product profile with what future stakeholders will care about.

Key Actions:

• Conduct current and what future landscape assessments might be to identify access barriers, competitor strategies, and payer requirements.

• Begin outlining a target product profile (TPP) that integrates access-related considerations like route of administration, distribution channels,  quality of life improvements, or caregiver burden.

• Explore pricing analogs to understand early expectations for market positioning.

An early access mindset informs smarter clinical and commercial decisions.

Step 2: Generate Evidence- Phase 2 

During Phase 2, you can start generating the data needed to support a credible and differentiated value story.

Key Actions:

• Refine your value proposition using early clinical and market insights.

• Define your HEOR (health economics and outcomes research) plan to support future payer engagement.

• Convene payer advisory boards and include provider/patient insights where possible.

• Identify any real-world evidence gaps that should be addressed before launch.

Step 3: Operationalize- Phase 3 to Pre-Launch

With pivotal data in hand, your biopharma market access strategy should evolve from planning to execution.

Key Actions:

• Build essential access tools: Global Value Dossier (GVD), budget impact model, and cost-effectiveness models.

• Finalize global pricing strategy and country-specific HTA submission timelines.

• Develop a clear payer engagement / Value Proposition plan and integrate access with your broader launch strategy.

This is when market access becomes the bridge between clinical promise and commercial reality.

Step 4: Execute and Adapt- Launch and Beyond

Market access is never one-and-done. After launching, your strategy should evolve alongside new data, changing market conditions, and competitor activity.

Key Actions:

• Track formulary decisions and real-world adoption.

• Update your value story as new evidence becomes available (e.g., post-marketing studies, label expansions).

• Continue proactive stakeholder engagement to support access and maintain formulary positioning.

• Respond quickly to policy changes, biosimilar competition, or updated payer criteria.

Ready for a conversation about market access strategy?

Danforth Advisors now offers dedicated Market Access & Value support as part of our strategic advisory services for life science companies.

Having partnered with 1,500+ life science firms, our team brings decades of experience guiding biopharma companies through every phase of the access journey, from early planning and payer insights to evidence generation, HTA submissions, and launch support. Connect with our team today.

Expert Insights from Liza Sullivan, Managing Director, Argot Partners, a Danforth Advisors company

Emerging from stealth mode is a pivotal moment for any early-stage biotech company. A biotech company launch is more than a press release and a website—it’s an opportunity to introduce your company and its mission to the world, increase awareness with a broad audience through earned and social media, and begin building lasting credibility. Here is a high-level roadmap to help you launch your biotech company the right way—strategically, confidently, and with purpose.

For more in-depth expertise, please don’t hesitate to contact our team for advice at any time.

Six Months Before Biotech Company Launch: Lay the Foundation 

When launching your biotech company, the right brand is a strategic tool that drives outcomes, helping to raise capital, recruit top-tier talent, and build partnerships. At this stage, it’s about defining your mission and brand, aligning your leadership team on messaging, and establishing your visual identity.

Run a focused messaging session

Before launching your biotech company, bring together key leaders—CEO, CSO, communications leads—to define your mission, vision, and values. This working session should answer: Why does the company exist/What problem are we solving? What benefits will we provide and to who? What’s our biotech company’s tone and personality? From this work, develop a message document and corporate narrative that will feed into all external communications tools (website, corporate deck, social media, press release etc.)

Align leadership around core messaging 

Once the messaging is established, clearly define roles: Who speaks to what in your story? For example, the CEO may focus on the business strategy, while the CSO speaks to the science. Early alignment avoids message confusion down the road.

Develop your visual identity

Start the creative process for your biotech company’s logo, color palette, typography, and brand personality. Even if you’re in stealth, these assets should be legally cleared (trademarked) and reflect who you are—not just what you do. If the company isn’t yet named or needs a new name, this is the time to initiate a process. 

Three Months Before Biotech Company Launch: Build the Assets

With messaging and brand direction in place, it’s time to create the tools that will support your biotech company launch.

Create your website

Draft website copy based on the approved key messages and work with a designer to apply the visual identity earlier defined. Make sure to apply the design elements consistently across all core assets: website, corporate deck, social media graphics and banners.

Write your news announcement

Craft a press release for your biotech company’s launch, containing your key messages that connect your company’s vision to a broader unmet need, not just your technology.  Don’t forget Q&A prep docs and FAQs to keep team messaging consistent.

Set up your digital presence

Get your LinkedIn and X (Twitter) accounts ready to go live on the launch date with branded visuals and a built-out company description. Start working on a social media content calendar that will take you from launch to three months out.

One Month Before Biotech Company Launch: Rehearse and Refine

This is when everything starts coming together, and precision becomes key.

Speaker/media training for leadership

In preparation for the news announcement and media effort, conduct a media training session with company spokespeople to prepare for tough questions, define who delivers what messages and ensure consistent and confident delivery.

Finalize all materials for launch

This includes the press release, social media content, FAQ documents, and corporate deck. Allow extra time for board and legal reviews—they often take longer than expected.

Website readiness

Have the website staging site active and ready for review and approval in order to go live on your biotech company’s launch date.

Biotech Company Launch Week: Activate and Amplify

You only get one chance to make a first impression as a startup, so use this week to go big and stay visible.

1) Distribute your press release for maximum visibility: Use a news wire service, send the press release to a friends and family list and pitch key reporters with embargoed materials in advance. Have leadership available for interviews.

2) Go live with your startup’s website and social channels: Post your launch content across all platforms and amplify media coverage with reposts, comments, and thought leadership from your leadership team.

3) Kick off investor and partner outreach: Now is the time to build momentum. Reach out to your networks and start scheduling follow-up meetings.

Post-Launch: Keep the Story Going

Brand building doesn’t stop after launch day.

1) Track Performance: Monitor media coverage, LinkedIn engagement, and web traffic to benchmark awareness.

2) Stay visible: Work with a communications partner to establish a 12-month plan that will keep your company visible through investor activities, earned and social media, and through leadership activities.

A truly distinct brand is built from the inside out, starting with a compelling story, reinforced by a cohesive visual identity, and carried forward by a leadership team that’s aligned and confident in what they’re presenting. Your biotech company’s launch is more than an announcement—it’s your first opportunity to shape perception and earn trust. Having a plan and executing based on a clear roadmap ensures you don’t miss the moment.

Looking for support with your biotech company’s launch? Connect with our expert team today.

or small biopharma companies, outsourcing clinical operations is often essential, but choosing the wrong clinical outsourcing partner can lead to delays, misalignment, and spiraling costs. 

The right clinical outsourcing partner won’t just check boxes; they’ll function as a seamless extension of your team, helping you move faster, stay lean, and execute with confidence. 

Here are three essential areas to focus on when selecting a clinical outsourcing partner: 

1. Fit and Flexibility Matter More Than Size 

It’s easy to assume that the biggest CRO or vendor is the safest choice, but for early-stage or resource-constrained teams, bigger isn’t always better. 

Instead, look for clinical outsourcing partners who: 

• Specialize in small or emerging biopharma companies 

• Offer flexible, modular engagement models 

• Can scale with your needs—from one consultant to a full clinical operations team 

A partner with the right mindset and structure will prioritize your program and adapt to your internal processes, not the other way around. 

2. Relevant Experience Is a Non-Negotiable 

Not every clinical outsourcing partner understands the nuances of your indication, trial phase, or geography. Choosing a clinical outsourcing partner with direct experience in your therapeutic area and stage of development can lead to: 

• Faster trial startup 

• Fewer protocol deviations 

• Better site relationships 

• Smoother execution overall 

Always ask for case studies, past project examples, and therapeutic area expertise specific to your goals. 

3. True Collaboration Requires Cultural Compatibility 

Even with the right technical expertise, poor communication or misaligned working styles can create bottlenecks. Look for clinical outsourcing partners who: 

• Communicate clearly and frequently 

• Embrace transparency and accountability 

• Integrate well with your internal team’s pace and preferences 

Ask about oversight models, escalation paths, and reporting cadence. The best partnerships function as strategic collaborators, not just vendors. 

Final Takeaway 

Selecting the right clinical outsourcing partner is one of the most important decisions a lean biopharma company can make. By prioritizing flexibility, relevant expertise, and cultural fit, you can accelerate development without overextending internal resources. 

Need a Partner That Scales With You? 

Danforth Advisors supports life sciences teams at all stages of clinical development—from strategic oversight to day-to-day execution. Connect with our Clinical Development experts today.