Making it through pivotal trials with positive data is a monumental milestone for any biotech. The air is thick with anticipation, the long-held dream of bringing a new medicine to patients is finally within reach. It's a moment to celebrate, undoubtedly. But it’s also the starting gun for a profound transformation, a shift from a company laser-focused on clinical development to one ready to launch a product and engage with the complexities of the real-world market.
This leap isn't just an extension of previous work; it’s a fundamental change in strategic focus, operational demands, and internal capabilities. Many biotechs, high on clinical success, underestimate this metamorphosis and can stumble badly in the transition. Successfully navigating this requires a deliberate pivot, with your Medical Affairs function stepping into a leading strategic role, all guided by the continuous thread of a dynamic Integrated Evidence Plan (IEP).
The Great Pivot: From "Does it Work?" to "How Does it Work in the Real World (and Why Should Anyone Care)?"
Throughout its clinical development phase, your biotech has been laser-focused on a core set of questions, primarily for regulators: Is our drug safe? Does it demonstrate efficacy in a controlled trial setting? Essentially, can it work? The environment is one of carefully selected patients, meticulously monitored protocols, and data generated to meet the exacting standards of regulatory approval.
But as you approach launch, and certainly post-launch, the nature and sheer volume of questions explode. The focus broadens significantly:
- How will our drug perform in diverse, everyday patient populations, often with multiple comorbidities and concomitant medications the kind of patients not typically enrolled in pristine clinical trials?
- How does its effectiveness and safety profile compare to existing standards of care when used in routine clinical practice, not just against a placebo or an idealised comparator in a trial?
- What is its tangible value, clinical, economic, and humanistic to patients, to the physicians treating them, to payers footing the bill, and to entire healthcare systems?
- How do we best educate the wider medical community about this new therapeutic, its appropriate use, and its place in the treatment landscape?
Answering these questions effectively, consistently, and credibly becomes the new strategic imperative. This is precisely where a fully empowered Medical Affairs function transitions from a supportive role in R&D to become a central, strategic pillar of the product-launching biotech.
Medical Affairs: Stepping Up as the Strategic Linchpin
In the pre-launch and post-launch phases, Medical Affairs is no longer just about responding to medical information requests or managing publications. It becomes the crucial interface between your company’s science and the medical world, a key driver of your product's success. The remit expands dramatically to include:
- Leading Scientific Exchange: Serving as the primary, credible scientific voice of the company to healthcare professionals, researchers, and patient organisations.
- Driving Post-Approval Evidence Strategy: Taking the lead in planning and executing studies (Phase IV, registries, RWE analyses) that address remaining uncertainties, confirm real-world effectiveness and safety, and explore new areas of value.
- Communicating the Evolving Value Story: Articulating not just the clinical trial data, but the continuously accumulating evidence of the product's real-world impact and benefits.
- Identifying and Addressing Educational Needs: Ensuring the medical community has the accurate, balanced information they need to use your product appropriately and optimally.
- Gathering Real-World Insights: Acting as a critical conduit, bringing back insights and observations from clinical practice to inform lifecycle management, identify new research questions, and understand competitive dynamics.
For many biotechs, this represents a significant step-change, requiring deliberate investment in Medical Affairs capabilities, leadership, and its strategic influence across the organisation.
The Integrated Evidence Plan (IEP): Your Bridge Across the Chasm
So, how do you ensure a smooth transition and a strategically aligned approach as you pivot towards launch? The Integrated Evidence Plan (IEP) is the critical bridge. Your IEP shouldn't be a static document that gathers dust after your regulatory submission. As we’ve discussed in "How an IEP is critical when resources are tight" and essential for "Integrated evidence plans: A key tool for regulatory success", a dynamic IEP is a living strategy that must evolve to meet new challenges and opportunities.
As you transition to a product-launching company, Medical Affairs becomes a key custodian and driver of this evolving IEP, ensuring it now robustly addresses post-approval evidence needs:
- Real-World Effectiveness and Safety: The IEP must now outline plans for understanding how your drug performs in the crucible of real-world clinical practice. This often involves designing and implementing Phase IV commitment studies, patient registries, or pragmatic RWE studies to monitor effectiveness in broader, more diverse populations and to continue to build the long-term safety profile. The quality of this RWE is paramount, demanding the rigour we explored in "What exactly is regulatory-grade RWE?”.
- Health Economics and Outcomes Research (HEOR): Demonstrating clinical efficacy is only part of the battle. The IEP must now prioritise generating robust HEOR data to articulate your product's economic value to payers, formulary committees, and health technology assessment (HTA) bodies. This evidence underpins market access and reimbursement.
- Comparative Effectiveness Research (CER): Clinicians and payers will inevitably ask: how does your new drug stack up against what we’re already using? The IEP should proactively plan for studies, often leveraging RWE, to provide credible comparative effectiveness information, especially as regulators themselves are increasingly interested in this aspect, which we touched on in "How to use RWE to support regulatory strategy".
- Addressing Unmet Needs in Specific Subgroups & Exploring Future Opportunities: The post-launch IEP should also look to the future, identifying evidence gaps for particular patient subgroups who might benefit, exploring new therapeutic hypotheses, or gathering data that could support future label expansions or lifecycle management initiatives.
Critically, the evolving IEP remains the central tool for cross-functional alignment. It ensures that late-stage Clinical Development, Medical Affairs, and any emerging Commercial or Market Access teams are working from the same playbook, with shared priorities for evidence generation, clear timelines, and consistent messaging. It prevents the development of operational silos and ensures that finite resources are deployed to answer the most pressing post-approval questions.
Practical Steps for a Smoother Transition
- Empower Medical Affairs Early and Meaningfully: Don't treat Medical Affairs as an afterthought brought in just before launch. Integrate them deeply into late-stage clinical development discussions and give them a leading role in evolving the IEP well in advance of anticipated approval.
- Invest in Building a Strong Medical Affairs Capability: This means hiring experienced Medical Affairs professionals, providing them with the necessary tools and platforms (especially for RWE generation and scientific communication), and allocating a budget that reflects their strategic importance. This isn't just an operational cost; it's an investment in your product’s long-term success.
- Evolve Your IEP for True Lifecycle Management: Your evidence strategy doesn't end at launch. The IEP should be a dynamic, forward-looking plan that anticipates evidence needs one, three, and five years post-launch to support continued market access, address competitive challenges, and explore the full potential of your asset.
- Develop a Proactive Post-Launch RWE Strategy: Beyond any regulatory commitments, a robust RWE strategy is essential for continuously understanding how your product is being used in the real world, its long-term effectiveness and safety, and for identifying new opportunities or potential risks early.
- Foster Seamless Internal Communication and Collaboration: The transition to a product-launching company requires breaking down any remaining silos between R&D functions and the newly critical Medical Affairs and commercial teams. Open communication and shared objectives are vital.
From Clinical Success to Market Impact
The journey from a clinical-stage biotech to a company launching its first product is one of the most demanding and transformative in the industry. It's a shift from proving a concept in controlled settings to demonstrating sustained value in the complex, multifaceted real world.
Success in this new chapter hinges on a deliberate strategic pivot, with a fully empowered and strategically focused Medical Affairs function leading the charge on post-approval evidence generation and scientific engagement. And the thread that binds this entire transition together, ensuring continuity, alignment, and a relentless focus on what matters most, is your dynamic Integrated Evidence Plan. It’s this commitment to ongoing, strategic evidence generation that will ultimately maximise your product's value to patients, to healthcare systems, and to your company.