Bayer and the Massachusetts Biotechnology Council (MassBio) are this week opening a regulatory best practice center for startup biotech and digital health companies. Their goal? Get new drug developers to start thinking about regulatory requirements earlier.
“Getting some kind of regulatory insights much earlier in the decision-making process can help startups in terms of formulating a path to get to the patient market more quickly. We thought that we should do this right now, especially as the entire regulatory landscape is changing,” Chandra Ramanathan, Bayer global head of R&D open innovation, said.
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John Hallinan, chief business officer of Cambridge-based MassBio, called the initiative groundbreaking, adding that “many early-stage startups and academics have a limited understanding of regulatory science, which can become a major roadblock in the drug development process. The Center for Regulatory Excellence will infuse startups with critical information at an early stage of development.”
The initiative has two main parts—regulatory education through the existing MassConnect mentorship program and quarterly seminars that will be open to all biotech and digital health startups. The session topics will evolve over the year, but each session will include lectures, open dialogue and networking opportunities.
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What Bayer and MassBio are doing is important in making regulatory thinking and insights a systematic part of the process, Ramanathan said. While there are many informative standalone regulatory seminars, the center takes a more integrated and continuous approach.
“The ability for startups to tap into this unparalleled knowledge base (of Bayer) is so critical. You can look at the attrition rate in biopharma development of a drug reaching patients is about 90%. Allowing these very early-stage companies, who are very much focused on the discovery aspects, and bringing that regulatory focus in is going to make a difference for a lot of these companies,” Hallinan said.