Life Science Leader Magazine Supplements

CMO 2017

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LIFESCIENCELEADER.COM THE CMO LEADERSHIP AWARDS 2017 27 I'd advise creating the entire list of activities — as far as you can identify them — from in vitro testing and solubility profil- ing to canine/primate repeat dosing, even nationalization of patents. Since many or all of these activities are outsourced, the complete landscape can allow for coordinating, scheduling, and budgeting more efficiently. Particularly, (1) create each study, or er you can get to first-in-human experience, the better. However, this requires spending a great deal of that preclinical cash very rapidly, generally in a six-to-10-month time frame. A balance needs to be struck between an exhaustive comprehensive study and one that is more minimalistic, or even skeletal. Finally, there is "good." In the biopharmaceutical industry, good is of course not optional, but it does have varying degrees. So how do we define good? While a vague term in general, it can be parsed into several components and addressed individually. I'll describe them here briefly as safety, manufactur- ing controls (quality), and clinical (and projected commercial) efficacy. Safety of course is nonnegotiable. In vitro and in vivo profiling are required by the FDA and other regulatory agencies. The holis- tic design of IND-enabling trials, with alternative plans for using feedback from early in-life experience, will gener- ally save money and be faster overall than walking through the menu of initial stud- ies sequentially. cGMPs, while they may vary by product, process, and aspect of supply chain, have sufficient components in common as to be understandable to even the nonexpert receiving adequate training in standard operating procedures. However, qual- ity — the result of cGMP implementation and controls — can elevate what might appear to be a straightforward produc- tion of a relatively inexpensive mate- rial into an unexpectedly costly budget section. The third component, clinical efficacy, may be indicated by preclinical studies, but is really definitively proven in Phase 3 trials. The end result is very difficult to anticipate or accommodate in almost any environment, let alone the resource-limited one we are focusing on. DIVIDE (TASKS) AND CONQUER? Henry Ford famously said that nothing is particularly hard if you divide it into small jobs. Investors and senior manage- ment at startups might agree, and they will add that they like to see a sense of urgency to get projects moving. However, I know from experience that a holistic plan will better assist both the opera- tional and administrative stakeholders. We have come together to support all your development needs. We have combined the expertise of Penn Pharma, Biotec Services International, AndersonBrecon and Packaging Coordinators to create PCI, an integrated pharmaceuticals provider positioned to support your drug needs from molecule to market. With drug manufacturing expertise, global clinical trial services, and commercial services for manufacturing and packaging, PCI supports over 50 product launches per year and medicines destined to over 100 countries around the world. We invite you to learn more about how partnering with PCI can ensure the success of your next product launch. Commercial Services Clinical Services Manufacturing | Packaging & Labeling | Global Storage & Distribution Manufacturing | Packaging | Serialization Introducing PCI, a market leader for integrated drug development and commercialization Introducing © Copyright 2015 Packaging Coordinators, Inc. All Rights Reserved

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