THE MISSING PIECE AT THE RIGHT TIME: How a well-timed Head of Medical Affairs hire can impact your biotech success

In today's competitive biotech landscape, a strong medical affairs (MAF) function isn't a luxury, it's a necessity. A study by the Tufts Center for the Study of Drug Development found that companies with strong medical affairs functions achieved 2.4 times higher total shareholder return than those without [1].

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But WHEN should you assemble the medical affairs team to champion your therapy to the healthcare community (HCPs) and, ultimately, patients? As CEOs, CMOs, and Heads of Clinical Development, timing this critical hire is crucial.

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Our team, at Planet Pharma, has a wealth of experience guiding early-stage biotechs through this critical process. We've successfully helped multiple companies hire the first person to build their MAF function, ensuring a strong foundation for launch success.

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Here's why building your MAF leadership early can be a game-changer:

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The Strategic Powerhouse:

Your ideal Head of Medical Affairs (HoMA) isn't just about managing MSLs. They're a strategic partner to Development. If you bring this expert on board early in the development process, they can:

• Streamline Market Access:?Ensure clinical trials capture data relevant for HCP education and payer conversations, avoiding costly post-launch scrambles [2].
• Build Long-Term Partnerships:?Building relationships and awareness with key opinion leaders (KOLs) takes time. A proactive HoMA does this early, securing crucial partners for post-launch education and real-world evidence generation [3].
• Navigate Value-Based Pricing:?The market demands therapies with real-world benefits. A good HoMA can use early data to develop a strong value proposition for payers, influencing pricing strategies before launch.

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The Right Time Formula:

So, when is "early" enough and what does this look like?

• Pre-clinical/Phase 1:?Consider bringing in an experienced consultant to assess needs and develop a strategic roadmap for your MAF function.
• Late Phase 2:?This is often considered the sweet spot for hiring your full-time Head of Medical Affairs. They can define strategy, build the core team, establish communication plans, and ensure a smooth transition from development to commercialization.

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The CRO Conundrum:

Outsourcing to external vendors is tempting, especially for early-stage companies. But, there's a hidden cost:

• Loss of Strategic Control:?Many CROs and third-party vendors excel at execution but may not have a deep understanding of your specific therapy or investment in your long-term vision. A dedicated internal hire ensures your MAF function aligns seamlessly with your overall strategy, maximizing its impact.
• Siloed Expertise: With an external vendor, medical affairs can become a separate entity and limited tribal knowledge is developed, potentially hindering seamless integration with your development team.

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The ROI Equation: “But we’re trying to conserve costs!”

We all know that early stage biotechs operate with tight budgets, and in this funding environment, now more than ever. Hiring a Head of Medical Affairs can seem like a significant investment. However, a report by Accenture found that companies with highly effective medical affairs teams achieved a 15% improvement in peak sales compared to those with average or below-average MAF functions ?[4].

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Here's how a well-timed Head of Medical Affairs hire translates into long-term financial benefits:

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• Reduced Post-Launch Rework: A HoMA ensures clinical trials capture data relevant for payer conversations and HCP education. This avoids costly time spent gathering missing information after launch, saving both time and money.
• Streamlined Market Access: Early data collection and strategic planning by your HoMA can expedite the market access process, getting your therapy to patients faster and generating revenue sooner.
• Smarter Payer Strategies: A HoMA can use early data to develop a robust value proposition for payers, potentially influencing pricing strategies and securing favorable reimbursement coverage. This translates to increased revenue potential.
• Enhanced Brand Reputation: A strong MAF function fosters positive relationships with key opinion leaders (KOLs) and healthcare professionals (HCPs). This builds trust in your therapy and can lead to wider adoption and market share growth.

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Investing in Medical Affairs early isn't just about adding another headcount cost, it's about building a strategic advantage that pays dividends throughout the lifecycle of your therapy.

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Finding Your MAF Team Captain:

The leader you hire sets the tone for your entire MAF function. Look for someone with:

• Deep Scientific Expertise:?They need to understand your therapeutic area and translate complex data into clear messaging for HCPs, to articulate the science behind your therapy.
• Strategic Vision:?They need to be able to navigate the ever-changing healthcare landscape and develop a MAF strategy where you play-to-win.
• Leadership Acumen & Culture:?They’ll inspire, motivate, and build a high-performing MAF team, developing a culture aligned with the wider organization.

The Bottom Line:

Hiring a Head of Medical Affairs “early” isn't just about adding another FTE or building a team, it's about building a strategic advantage. They'll be your captain, navigating the complexities of market access, payer engagement, and ensuring your groundbreaking therapy reaches the patients who need it most.

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At Planet Pharma, we understand the challenges of finding the right Medical Affairs leader for early-stage companies. We have a proven track record of success, having helped multiple biotechs build their MAF function from the ground up, with an average time to fill of 45 days.? Our streamlined process minimizes disruption and keeps your hiring costs predictable, allowing you to focus your resources on core development activities.

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We can guide you through the entire hiring process, ensuring you find a leader with the right blend of scientific expertise, strategic vision, and leadership acumen. Contact us today for a free consultation and leverage our knowledge!

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Sources:

[1] The Landscape and Impact of Medical Affairs Functions in Pharmaceutical Companies https://www.lek.com/insights/hea/us/ei/navigating-shifting-landscape-life-sciences-trends-and-implications

[2] DIA (Drug Information Association) - Standards of Practice for Medical Affairs https://www.diaglobal.org/en/learning-solutions/medical-affairs

[3] Nature Reviews Drug Discovery - Building a Better Bridge Between Academia and Industry [https://www.nature.com/articles/nrd4189]

[4] "The Essential Role of Medical Affairs in the New Era of Value-Based Care" https://www.accenture.com/us-en/industries/life-sciences-index