Case study

The story

Dr Joey Studts, Director Late Stage Downstream Development at Boehringer Ingelheim explains the benefits that he has enjoyed while being involved in the Phorum, and talks about the impact that it can have on the industry as a whole. “In the development phase of a new drug, the key is information exchange. Being part of the BioPhorum Development Group has had a big impact on our strategy and how we bring a drug to the market – from very detailed process-related topics, all the way through to regulatory strategies. And it goes deep, from the very in-depth discussions on novel formulation strategies concerning new excipients, to how we identify critical process parameters and how we, as an industry, should weigh the criticality in a standard process versus an accelerated process. Being part of BioPhorum is a valuable way to exchange ideas and put forward topics for discussion. It’s a unique opportunity to work together as we usually don’t. We’re competitors in the market, but BioPhorum allows us to work together to benefit the whole industry and impact and collaborate with the regulatory agencies. Everyone wants to get effective drugs onto the market and BioPhorum allows us to collaborate while connecting to agencies.

The outcomes

The FDA and the EMA are giving the pharmaceutical companies new paths to bring novel drugs quickly through clinical trials to impact patients’ lives. With that, they very astutely say that they’re not going to accept any additional CMC risk – manufacturing or development. Therefore, our industry must be faster and more efficient. It’s very difficult with the relatively small dataset that each company has to make proper decisions on where to invest resources for these very impactful accelerated drugs. The discussions we have within BioPhorum allow us to set those risks and priorities. Then, as an industry, we can talk about how we structure ourselves with the knowledge that we have, and then we can interact effectively with regulatory agencies, so they can also make quicker and more impactful decisions. Without BioPhorum, that wouldn’t be possible. Another aspect of BioPhorum – the online Q&A platform ‘AskBioPhorum’ – also provides a constant exchange of information, which generates a lot of value for our company. People ask real-world, real-time questions and it shows that everyone is facing the same questions. Being part of this collaboration is not a leak of confidential information; this is a value-generating machine.”