Life Science Leader Magazine Supplements

CMO 2017

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Page 27 of 81

By D. Casebier TIMELINE AND DEVELOPMENTAL ACTIVITIES WHEN RESOURCES ARE LIMITED DRUG DEVELOPMENT Outsourcing LIFESCIENCELEADER.COM THE CMO LEADERSHIP AWARDS 2017 26 cially true for smaller companies. In other words, the intersection of fast and cheap precludes a good prod- uct. Obtaining a high-quality product on a reasonable budget is generally time-consuming, but for a resource- limited company, time is money. On the other hand, creating a quality product quickly generally requires, shall we say, pallets of cash. First, here are a couple of comments on "cheap." With limited resources (e.g., money and headcount), trying to advance as inexpensively as possible is a given. The life sciences industry is far from cheap, but there are activities that are at least flexible. The best descrip- tor of this might be the concept of phase-appropriate development, and spending only as the program pro- gresses, throttling immediate spend, but achieving milestones that trigger subsequent funding. Second, let's look at "fast." Time is money, especially in the sense that a small company generally has fixed costs that mount on a month-by-month basis; the fast- oday, with translational/personalized/bio- marker-driven medicine, we are in a much different environment. Nowadays, typi- cal funding and investments are made in tranches and based on milestone events, so small bio- pharmaceuticals, with nominal funding for proof of concept and less chance of asset monetization (e.g., IPO, acquisition, large pharma partnership/licensing), find themselves with minimal budgets to get to IND (inves- tigational new drug)-enabling studies or IND filing and possibly beyond a Phase 1 clinical trial. At the same time, given the pressures to be first to market, time is more a factor than ever in the making of critical decisions. Outsourcing partners play an increasingly key role, but biotechs and other small companies may only have the resources to assign one or two people to work with the CDMO or manage the CDMO. Many of the activities that must be outsourced are nonnegotiable, meaning required for compound development, yet the imple- mentation and administration can vary widely. Below I'd like to offer some reminders and a bit of advice to startups — or any drug developer — about what to expect and how to plan for what's not expected in the process of advancing new drugs. LIMITED RESOURCES IN A DEMANDING BUSINESS We'll start with the often-used saying of "fast, cheap, or good: you can only pick two." Perhaps this is espe- T It is increasingly rare that early-stage compounds or platform technologies are acquired without demonstration of clinical effect. Many years ago you could get funding for an idea, a piece of data, or a novel platform. With little exaggeration, funding could be generally raised as long as there was promise and the ability to tell a story, or until the concept was fully disproven. A new enzyme-based target, or even a quasi-crystalline idea, was sufficient for seed funding, and Phase 1 compounds were thought to be solid investments or acquisition targets. Timeline And Developmental Activities When Resources Are Limited D A V E C A S E B I E R The life sciences industry is far from cheap, but there are activities that are at least flexible.

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