MassBio, Bayer Launch Center for Startups in the Biotech Space

MassBio and Bayer recently announced the Center for Regulatory Excellence, a first-of-its-kind forum that will be open to all startups and academia in the biotech and digital health space to learn from regulatory experts.

The nonprofit and pharmaceutical company voiced that the Center will provide formal mentorship and regular seminar to ensure early identification and alleviation of regulatory issues and enhance overall success.

“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 and reinforces Bayer’s exceptional commitment to MassBio’s MassCONNECT program and open innovation,” John Hallinan, chief business officer at MassBio, said in the announcement. “The Center will help entrepreneurs define a pathway and formulate a plan that will save countless amounts of time and money and provide earlier access for patients.”

The Center for Regulatory excellence will be open for MassCONNECT graduates. Each startup and biotech session will focus on certain areas of interest linked with the regulatory process and will entail lectures, open dialogue, and networking.

“The already complex regulatory landscape is becoming increasingly challenging with the evolving regulatory frameworks for new technologies in the overall digitalization of regulatory operations, “said Max Wegner, head of regulatory affairs at Bayer. “The launch of the Center for Regulatory Excellence provides great opportunity to support talent development by sharing our experience. We hope this knowledge-sharing activity will help these companies developing innovative products so eventually, the products can reach patients.”

Currently, Bayer has hundreds of drugs approved and is currently present in 90 countries. The regulatory approvals include both small molecule and biological products covering various therapeutic areas such as cardiovascular, oncology, ophthalmology, hemophilia, and hormonal contraceptives, and announcement highlighted.

“The future success of the biopharma industry is dependent on a strong startup community, and with a constantly shifting regulatory landscape it becomes increasingly challenging for entrepreneurs to have the resources and expertise to commercialize their idea so it eventually reaches patients in need,” said Chandra Ramanathan, global head of R&D open innovation at Bayer. “Bayer and MassBio have recognized a greater need for regulatory guidance for entrepreneurs and Bayer is committed to providing that expertise as part of our long-standing commitment to fostering innovation in Massachusetts and beyond.”

The US pharmaceutical industry will continue to be one of the most heavily regulated sectors in the American economy and growing regulatory burdens have pharmaceutical companies searching for technology solutions.

In the past year, 25 cities and countries have filed cases against various companies in the drug supply chain, according to a recent blogpost. These companies included some of the biggest names in the industry.

The growing regulatory and litigation puts significant pressure on corporate executive teams to manage electronic data effectively. Companies will be called upon to conduct e-discovery and produce responsive evidence.

“Savvy pharma executives are managing this surge in electronic data management pressure by leveraging software that helps them deal with huge amounts of data and extracts relevant information,” the blogpost stated.

As government regulations of the drug result in a more drawn-out and expensive product development process, the Center for Regulatory Excellence is vital to reduce any roadblocks and formulate a definite pathway for drug development.

The Center will also reduce added stress and pressures for companies affected by the regulatory burden that is so prevalent in the US.