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Embracing a Functional Service Partnership Model for Rapidly Growing Biotechs



Biotechnology companies are passionately focused on speeding new medicines to patients who need them. Usually with nothing on the market, they must look externally for funding. When topline trial results are positive and the next phase is imminent, young biotech companies face accelerated – sometimes explosive – growth, which creates an urgent need for the right resources. With a proven scientific rationale for the mechanism of action, multiple propositions for additional indications, an expanding pipeline, and sufficient financial resources, a major bottleneck for necessary organisational growth is the ability to quickly recruit employees with the right expertise, especially in the current competitive marketplace. Then, should there be any significant delays due to scientific, regulatory, or manufacturing issues, biotechs that have ramped-up by hiring scores of people now have a lot of people on their payrolls with little work to do while timelines stretch out to the horizon. Massive hiring, whether doubling a team from four to eight people, or tripling an organisation from 50 to 150, is the ‘make’ in the ‘make vs buy’ decision-making process.

On the ‘buy’ side, an outsourcing model designed to provide dedicated staffing within particular functions offers biotechs the bandwidth, breadth of services, and geographic reach they need, while de-risking heavy payroll expenses, as well as the co-employment risks that come with depending on contractors. By breadth of services, we highlight pre-approval functional services including data management, statistics, medical, supplies, contracts and payments, regulatory, medical writing, quality assurance, monitoring and programme management, as well as postapproval lifecycle management, real-world evidence generation, publications support, medical communications, and on and on. It’s important to note that even within the 'make vs buy' discussion, there is no one-size-fits-all solution. There are many considerations that biotechs face when they choose, or have no choice but to go down the ‘buy’ path.

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Timothy King, PhD, is an executive director for PPD FSP. In global medical research since 1990, Dr King has built and led operational departments in a variety of therapeutic areas, including infectious diseases, haematology/oncology, cardiopulmonary, and internal medicine. He also has worked on pharmacotherapies and medical devices, in both full-service and FSP models.

Jan Maarten Kroodsma, MD, is a senior director at PPD FSP. Since becoming a clinical investigator in 1993, Dr Kroodsma has held a variety of clinical management roles with pharma and CRO before joining PPD, where he has led a wide variety of FSP programmes. These programmes have ranged from small to large, single-service to cross-functional, and unitised to FTE-based, both for pharma and biotech.
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