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Speed to Clinic initiative launches: learning from the COVID-19 pandemic

Spurred on by lessons learned from the COVID-19 pandemic, as well as the ever-pressing need to streamline development and get needed medicines into clinics faster, BioPhorum has initiated a Speed to Clinic pathfinder in its Development Group Phorum. This freshly launched initiative has been met with much enthusiasm from members and is a priority topic for the industry.

Accelerating the drug development process, however, is not a novel concept. “This is not just a response to the COVID-19 pandemic,” noted Richard Alldread, Senior Director, Recombinant Product Development at CSL Behring. “For most of my career in the industry, speed to clinic has always been a big theme of anything that we’ve done, whether that was creating a new development pathway, introducing new technology, and so forth.” As anyone who works in the biopharmaceutical industry knows, “we operate on very long development timelines,” said Alldread. “Some of that is absolutely necessary of course, because we have to ensure the safety of what we do. But we do have very long timelines of development before we get a drug to a patient in the first clinical trial and that’s something we would all like to reduce.” Shortening the process would confer significant financial benefits, but more importantly, “What the COVID experience has done is really crystallize for people how important responding to new threats can be.” Reducing time to clinic, to get treatments to patients sooner, is everyone’s ultimate goal.

The Speed to Clinic pathfinder work has strong ties to BioPhorum’s already established Accelerated Development workstream, as well as the virtual Development Group meeting that will be held at the end of 2021. The meeting focuses on mining learnings from the COVID-19 pandemic, as well as other non-related COVID-19 experiences, with the hope of applying them to normal development timelines. “What we’ve been going through was, and still is, a really big deal,” noted Nick Abu-Absi, Director, Cell Culture Development at AbbVie. “However, we’ve seen what can happen when we come together to solve problems, as evidenced by sequencing of coronavirus and the subsequent development and distribution of vaccines and therapeutics in record times. Ultimately, I think this is what 2020 will really be remembered for, all the good things that happened and were enabled by science and technology, whether it be remote work in school, staying connected with family, or the treatments and vaccines that are getting us through the pandemic. It only makes sense to learn from these efforts collectively and continue these practices.”

Kartik Subramanian, Vice President, Science & Technology Biologics at AbbVie, also reflected on the transformations that sprang from the pandemic. “In many aspects of our lives, we’ve really been licensed to innovate to enable us to overcome the many challenges that we have been faced with,” he said.  “What we are doing now is initiating conversations related to how our normal workflows were disrupted, the needs that were demanded of the industry, and how we leveraged science and technology to invent new ways of working to ultimately allow us to maintain the same level of confidence in our products with new benchmarks for speed.”

“Bringing a novel molecule to the clinic safely is an incredibly complex scientific and logistical problem,” noted Abu-Absi. “Speed with rigor is the key to doing this effectively. We’ve learned over the last year and a half what can be accomplished when we work together to solve these challenging problems. What we’re trying to do now is understand how each of us approaches these problems and different strategies that are used to solve them. Part of this involves benchmarking and sharing strategies that were used to bring potential COVID-19 treatments to the clinic. We can then apply these to establish best practices for bridging the gap between development and discovery of molecules to clinical studies.”

Harnessing scientific and technological advancements to streamline the development process while maintaining confidence in the safety of products is a key theme being explored by the pathfinder.  “Technologies such as in silico modeling are going to be hugely important if we’re going to shorten development timelines, so that we can still develop processes with acceptable risk levels,” said Alldread.  “We don’t want to take shortcuts in terms of safety, but there are certain new ways we can approach development in order to speed up the process of getting that drug to a patient.”

Looking ahead, next steps include learning from colleagues through case studies “and then potentially taking a deep dive into a benchmarking exercise to collect current practices and identify key technical themes of future focus for us as a CMC community, to continue to develop and improve upon in the near future collectively,” said Subramanian. “It would be nice to work together to collectively deliver a white paper on how we approach CMC activities to accelerate the process of bringing medicines to patients, integrating all of the recent learning in the space,” he added. “This is something we can do by ourselves, but it wouldn’t be nearly as impactful or meaningful as it would if you do this collectively as an industry.”

While the pathfinder is in its earliest stages, engaging with regulators is a vital objective. “Pandemic responses do tend to concentrate people’s minds, and in particular bring the industry and the regulators together,” noted Alldread. “It gives the regulators a good impetus for looking at how they will accept a shortened timeline…I think one of the most valuable things we can do as part of the pathfinder is to start those discussions with regulators, to maybe agree on a number of areas where we can take a different approach to how we do things now, in terms of development of cell lines and the whole development pathway—what can be delayed until later on in the process…bringing together all those interested parties is really the key value that we can develop.”

The power of collaboration is certain to bolster the pathfinder’s efforts. “Working together on a topic such as this would automatically grant much more authority and wider acceptance than if any one of us were to attempt to create this work on our own,” said Abu-Absi. “Getting more molecules into the clinic on faster timeframes is good for everyone. Most importantly, for the patients we serve.”

Tony Gill, BioPhorum Development Group Lead added, “This emerging topic is exciting for our membership community and the industry as a whole.  I look forward to seeing how this develops and the benefits that this work might bring.  On a personal level, wouldn’t it be great to work together to see some real tangible changes for the benefit of all?”

For more information, contact Tony.Gill@BioPhorum.com

 

 

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