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By L. Garguilo SOME STRAIGHT TALK TO CMOs ACHAOGEN Leaders LIFESCIENCELEADER.COM THE CMO LEADERSHIP AWARDS 2017 10 was used to previously," she explains. "I bet a decade from now, we'll visit today's small molecule facilities, and perhaps with the help of professionals from cell- based therapy companies and others, they'll be the ones driving innovation and the next generation of transformative technology. Small molecule manufac- turing has the potential to be so much more elegant, because the chemistry is so well characterized com- pared to biologics. Manufacturers have just lacked the business drivers to modernize. I can see this changing." But there's also a twist in her narrative, because she feels that the biologics facilities are starting to seem dated; it won't be long before we are talking about how old these plants are. So where to look next? "The new kids on the block are smaller organizations using, for example, technologies for single-use solutions, enabling more potent, niche, and cell-based therapies," she replies. "To enable new antibiotics, we need both small molecule and biologics manufacturers that are cost-effective, but most importantly, focused on speed to market." But more on the business needs of speed to market later. First, let's quickly review the drug development and manufacturing environment where that speed must take place. depending On DisrupTion? A lack of innovation speaks directly to institutionalized industry barriers. They include an elongated product- development cycle for new drugs, extended on-the- market timelines, and regulatory roadblocks. This list provides a partial answer to Larson's question above of motivation: Both sponsors and service providers (per- haps particularly on the small molecule side) can, to a degree, get away without innovating and still achieve relative success. A most obvious challenge to innovation lies with the filing of an NDA (new drug application) or BLA (biologic license application), setting off what's become a regula- tory process with immense impact on markets for drug owners. Says Larson, "The global nature of managing a supply chain and making postmarket or even premar- ket changes is so daunting and expensive you need an incredibly good reason to implement any innovations to process or manufacturing technologies." She notes that most plants are still designed to run drug substance and product processes without variation, and often for decades. Furthermore, when the next develop- ment drug is introduced into a facility — external or internal — the temptation is to try to fit even that poten- A large sTep back, A small sTep forward At Achaogen, Larson is working on the global push for a repioneering of the antibiotics space. "By 2050," she says, "antimicrobial resistance is projected to kill more people than cancer unless we do something. Our indus- try needs to revitalize its ability to bring novel antibiot- ics to market. And we need to do it now." She's got her challenges. "Although I went from driv- ing innovation in biologics manufacturing facilities to this cutting-edge work on next-generation antibiot- ics, still for me it's like a journey back in time a few decades," says Larson. That journey requires recali- brating herself to older, small molecule manufacturing facilities, after spending a career inside their younger biologic cousins. "I've recently seen technologies like something out of the early 1980s, for example in chro- matography steps, which should be more in common to both facilities," she says. "Biologics plants are just not that old." Nonetheless, Larson says it's instructive to have this "back-in-time experience," and enjoys the challenge of partnering with CMOs in her new space. "Engaging a small molecule service provider feels different from engaging a biologics CMO," she explains. "I have to admit, my first questions were: 'What motivation do small molecule CMOs have to modernize? Is this seg- ment of our industry actually interested in moderniz- ing drug manufacturing?'" Larson isn't impugning past models or motiva- tions. Rather, she's encouraged that with the renewed, worldwide, and urgent focus on antibiotics today, posi- tive change is on the way. In fact, her experience, and that of others like her, may be just the medicine needed for advancement. "I can see our future within those biologics plants I I've had great experiences collaborating on process analytical technology [PAT] via cross-industry groups.