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GLOBAL BUSINESS UPDATE insights Snapshot analyses of selected companies developing new life sciences products and... DRUG DEVELOPMENT outsourcing LIFESCIENCELEADER.COM THE CMO LEADERSHIP AWARDS 2015 44 By L. Garguilo "PHASE-APPROPRIATE" DRUG DEVELOPMENT THE NEW "TIME AND PLACE" your own business and management strategy when selecting a CMO. "You need to pick a CDMO appropriate to your company philosophy," he says. "Do you want a potential commercial process put in place right at Phase I, or are you just looking for a quick Phase I acceptable process? These are definitely different. It's a conscious decision for your management team. Based on that you should select a CMO that aligns with that direction." Last and certainly not least on our panel is James Henshilwood, senior director, API process development and manufac- turing for biotech InterMune, now a whol- ly owned subsidiary of Roche. InterMune is focused on therapies in pulmonology and orphan fibrotic diseases. Henshilwood is a veteran of the industry since the 1980s and has seen a number of drugs make it from discovery to com- mercial. He touches on a topic often left out of discussions on provider-sponsor approaches — the provider's pitch. "Generally, it should be recognized there's an opportunity cost for a CDMO to accept your business," he says. "What are the chances of the molecule you're working on actually making it to the next stage of the market? I've always gone into a CDMO understanding what phase of the project we are in, and with the atti- tude that I need to pitch my company, to explain why I think it's wise for them to work with us." We can discern another axiom from all these comments: Know thyself (and thy project). It's incumbent upon the bio- pharma to understand its own preferred course of advancement, methodology, goals, and overall strategy. And then go out to the outsourcing industry to find a good fit and learn more. The OPW discussion brought into the open perhaps the biggest tension point between CDMO and project owner: the question of batch size. TIME, PHASE … AND (BATCH) SIZE "CMOs tell you their clients think the biggest waste of time is what can be an elaborate discussion during scale up regarding batch size," is how one OPW participant phrased it. "The sponsor says, 'You just made 10 grams, so now make this next one a 10-kilo batch.'" If only scaling up chemistry or biology were so easy; in most cases it just is not. A small "demonstration batch" for a newly transferred project to show process robustness and control — as well as pro- vide material — rarely becomes a strong enough jumping board to spring to a suc- cessful multikilo run at a CDMO (or any- where). At this juncture, there are still risks and potential unknowns; even should a multikilo batch pass this (one) time, you may miss gathering crucial insight about how the process behaves, starting materi- als, and what might be the most appropri- ate equipment for production. "We'll say, 'Maybe we should make a couple more batches in between,'" explains a representative of a CDMO. "But try discussing with a customer at this stage that we should only scale up to a one-kilo run. All the customer hears is we're somehow trying to get more money to do more batches, and we're wasting time. It's really a back-and-forth, and from this side of the business, hard to negotiate." Moreover, should a larger scale-up encounter issues, who takes the blame and financial hit? That negotiation is even less pleasant. On the other side, sponsors (big phar- ma and virtual biotech alike) may indeed have a well-developed, robust process born from thorough internal investiga- tion (and investment of additional time and money). They naturally look askance upon the need – or logic – in additional "development work," which is what these scale-ups can amount to. "If your internal folks are capable and competent," says one of the experienced attendees, going back to the point above about in-house expertise, "wherever you're transferring a process should be a reasonable fit in the first place because you made the appro- priate selection of CDMO. "To be clear," he continues, "what you want out of this initial scale-up phase is confidence that the process is going to work in the CDMO's hands. You don't want some sideshow where the CDMO is telling you how this or that in-house tech- nology is applicable to your project. You really don't want your process drifting during a tech transfer. I've seen that happen, and it becomes an arm wrestling contest. You really want to avoid that. If you feel confident that what you're bringing in is robust enough, and is a good enough fit, you're going to question additional work or change." That's quite an admonition of some CDMOs. Perhaps it's not stretching a metaphor to say if the sponsor-provider relationship hasn't "scaled up" to a point of mutual trust, there could be difficulties at this and potentially each new phase that comes along. Our experts say that to a degree it can be expected some further development will enhance a process, and that is a good thing. But more importantly, the appropriate technical counterparts should be talking and helping manage- ment map out a realistic strategy for getting to a higher degree of confidence on both sides that the scaling up will work and the best path to the ultimate endpoint is taken. Generally, it should be recognized there's an opportunity cost for a CDMO to accept your business. J A M E S H E N S H I L W O O D Senior director, API process development and manufacturing, InterMune