Transitioning from early- to late-stage development is a pivotal phase for any biotech startup. This journey, often laden with both opportunities and challenges, requires a keen focus on both commercial and competitive aspects.
In a recent interview, Peter Mozerov, Senior Manager of Life Science Strategy at KPMG, shared invaluable insights for biotech founders and CEOs on how to successfully manage this complex process.
Strategy and structure are the keys to success
Establishing a solid foundation early on is important. Biotech founders must design a flexible structure that not only attracts investors, but also sets the company up for future growth. Whether the goal is an acquisition or becoming a standalone organization, having this long-term perspective from the start is an important step.
”Start with the end goal in mind. Lay the right foundation early on, because the structure you build today will determine your growth tomorrow.
Peter MozerovSenior Manager Life Science Strategy at KPMG
Two success factors stand out for early-stage companies: a clear data strategy and the strength of the team. By addressing these areas early on, biotech startups can create a compelling business case for themselves and anticipate potential obstacles before they become problematic. This allows them to improve operational efficiency.
Speed and adaptability in a fast-moving field are key enablers of success
In the fast-paced biotech landscape, timing is everything. ‘Fast followers’ often emerge quickly once a breakthrough is demonstrated, underscoring the importance of conducting critical experiments promptly. While unexpected challenges in biology are inevitable, investing in the things within a company’s control—such as efficient planning and execution—can make all the difference.
Managing the transition from startup to established company
As biotech companies scale from early-stage research to commercialization, they will inevitably go through a series of ‘phase transitions.’ A company’s operational needs change significantly during this process. Early on, a lean team may suffice, but as clinical trials ramp up, companies must scale their manufacturing, build quality operations, and establish a more substantial operational footprint. Late-stage companies need even more complex structures, including smooth-running finance, HR, and IT functions to support the commercialization phase.
Companies face three common struggles: underestimating timelines, managing internal silos, and failing to fully understand global market dynamics. These factors can slow growth or derail progress if not addressed early.
Planning for the future in a dynamic sector
Looking ahead, biotech companies must brace for continued pricing pressure and reimbursement challenges. New technologies, such as cell and gene therapies, are poised to disrupt the industry, requiring companies to rethink traditional business models and invest in efficient processes.
Founders need to anticipate these changes and be prepared to pivot, when necessary, while also seeking expert help early. Biotech companies, especially startups, should not hesitate to reach out for guidance as they work through these complex transitions.
Final thoughts
In summary, successfully navigating the transition from early- to late-stage development in biotech requires a solid strategic foundation, a strong team, and adaptability to evolving market and regulatory dynamics. Early-stage companies must plan with the end in mind, ensuring that their structure, data strategy, and commercial planning can support future growth. Beyond the operational and competitive challenges, flexibility is key – biotech is an ever-changing field, and companies that remain agile in their approach will be best positioned to thrive.
For a deeper dive into these strategies, including how to manage regulatory timelines, avoid silos, and anticipate future disruptions, be sure to watch the full interview video above. There we share actionable advice that could make the difference between scaling successfully or getting stuck along the way.
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