BioPharm International - September 2022

BioPharm International - September 2022

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www.biopharminternational.com Emerging Therapies 2022 eBook BioPharm International ® 35 their Y-axis—an $80 billion dollar a year enterprise already populated with 80,000 competitive busy staff (3, 4). The ES&I team, in conjunction with colleagues working in Business Development, has stood out for bringing genuinely creative partnership ideas and innovations into an already creative and crowded environment. "They're not just the typical corporate venture type of series A, B, or C," continues Schoen- beck from a Pharmaceutical Technology Drug Solutions podcast (5). "Increasingly, we're doing more seed in- vestments, new company formations, really trying to enable cutting-edge, emerging science areas that we see on one hand strong strategic fit to Pfizer. On the other hand, [areas] also holding a lot of potential— but really early, needing more work before you could fully implement them." A long, successful track re- cord has cleared the decks for Pfizer to go earlier than most, to uncover exciting advances as they happen, before first bloom. Wet bench assets To augment integration capabi lit y on t he Y-a x is, Pfizer brings internal expertise, capabilities, and re- sources. Discussing Pfizer's Centers for Therapeutic Innovation (CTI), for example—a collaboration model that helps translate early scientific concepts into po- tential drugs—Schoenbeck says, "We do have a num- ber of wet bench capabilities, our own labs through which we run a portfolio of about 25 or so projects, and these projects are partnered with academic or very early stage biotech companies, which focus on cutting edge new projects." Using its many f lexible partnering and collabora- tion vehicles, Pfizer has been identifying strong part- ners in both the academic world and in the biotech industry to help its scientific engine and company at large make changes it needs in the gene therapy, mRNA, and degrader spaces. The most recent and most notable example would be the multi-year part- nership Pfizer established with German biotech com- pany, BioNTech, to deliver the world's first COVID-19 vaccine in 2020. But before the pandemic arrived, the two companies had been in discussions since the early 2010s, first about the use of mRNA for oncology and later establishing an agreement for inf luenza. While COVID has been on the frontlines of the company both in headlines and scientific delivery, Schoenbeck's team has continued to plant and grow its roots in other areas. For example, in early 2022 Pfizer announced several collaborations designed to augment its leadership in mRNA. Their agreement with Beam Therapeutics will leverage Beam's base editing platform in support of potential therapies for rare diseases. A collaboration with Acuitas will allow Pfizer to explore the use of their lipid nanoparticles (LNPs) to deliver a variety of vaccines or therapeutics. Finally, a collaboration with Codex DNA will poten- tially streamline the mRNA production process by facilitating synthetic DNA assembly, another notable fruit of the team's labor to bring forth a competitive pipeline in gene therapy. Through gene therapy part- nerships, such as 2019's deal with Vivet Therapeutics to advance a treatment for Wilson disease, Pfizer now has one of the most competitive pipelines in gene therapy in the industry. Increasingly, Pfizer's focus is on a "true first-in-class mechanism, if not only in class kind of programs, that would allow us to bring real breakthroughs to pa- tients." Schoenbeck continues, "So these are by defi- nition a higher-risk approach, a higher-risk kind of bi- ology, but they hold a lot of promise and could provide a very strong fit to the Pfizer R&D organization, if we can then build a pipeline and portfolio around those areas … So, you really need to start thinking early and clearly about where do you want to focus your search? Where do you want to place your bets? And what's im- portant to us is actually that when we partner, we re- ally partner in the true sense of doing things jointly … not just to bring in the intellectual property in-house or anything like that. It's really about identifying an academic or biotech partner, that can bring something to the table that would be very complementary … al- lowing us to do something to benefit patients that nei- ther of us could do alone." How to manage risk without risking innovation Many approaches sound great on paper, or even an- ecdotally, so how does ES&I manage risk? "I think each company might take a different approach, but the way we have thought about it is that you want to have a balance in your portfolio when it comes to risk. Risk can be defined as risk in biology, risk in devel- opment, risk in therapeutic modality. If you have a mature modality, but you go for a new target, that's one level of risk. If you go for a novel target and a new therapeutic modality and invention in your de- velopment direction, then you're really multiplying your risk. Obviously, the COVID-19 vaccine was one of these examples that fortunately has been quite successful but really was a high-risk approach. You can do this where you really see the need for patients, where you really see the potential for breakthrough, but you can't do it for every single program in your pipeline obviously. Now on top of that, as I said ear- lier, you want to make sure you get a good feel for the cutting edge for anything that's emerging, really promising on the horizon. And for that we have for example this ES&I team here at Pfizer. Some of the areas that we're focusing in on include repeat expan- sion disorders, senescence, DNA damage response and nucleic acid sensing, deubiquitinase pathways, BioBusiness

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