Life Science Leader Magazine Supplements

CMO 2016

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BEST PRACTICES outsourcing LIFESCIENCELEADER.COM THE CMO LEADERSHIP AWARDS 2016 26 By L. Garguilo 5 COMMENTS ON CHOOSING A GLOBAL CMO 5 Comments On Choosing A Global CMO L O U I S G A R G U I L O Executive Editor, Outsourced Pharma @Louis_Garguilo 'm amazed that today's biotechs and drug developers are still questioning whether they should search globally for a CMO. But, since this is a difficult business decision for many companies, I decided to compile the following (edited) excerpts from a panel discussion at last year's Outsourced Pharma West conference in San Diego, which I believe could help. The panel was moderated by Jeff Barker, principal consultant and sr. advisor, Rondaxe. The panelists were David Enloe, president/CEO, Althea; John Gregg, president/CEO, BalinBac Therapeutics; Brian Mendelsohn, leader of ADC Chemistry Group, Agensys; Nils Olsson, VP chemistry, manufac- turing and controls, Retrophin; and Nicholas Virca, president/CEO, HedgePath Pharmaceuticals, Inc. Looking Globally For CMO Support Is Inevitable COMMENT 1 First, approach outsourcing from the realization you cannot know everything. But what you can do is find some experts in the areas most vital to your project or business model. That was especially important when I joined my company because we are not married to any specific technology or disease but more driven by business development opportunities in general. It was clear to me from the beginning that I couldn't handle our CMO search or man- agement of outsourcing alone. Therefore, my initial objective — over the first year or so — was to bring in a small group of experts that I could fully rely on and that did not require any hand-holding. I was fortunate to be able to bring good people on board. Experts like this are out there for you, too. And it's no coincidence that the individuals I selected for our internal group came from the four corners of the world. They knew all the key service providers in their fields. So we felt no limitations about where to go in our search for CMOs. We now work with CMOs here in the U.S., in Europe, and Asia. In my opinion, looking globally for the best fit seems inevitable nowadays, and there are strategies to do so. Balance Your Risk/Reward COMMENT 2 I think the answer to every question regarding global outsourcing is, "It depends." There's so much risk that a company takes on with the "four-corners- of-the-world" approach, particularly depending on what your specific product is and what it requires. For example, with a biologic where the process might not be fully tried and true, yet there's a lot of expertise and knowl- edge that resides with the sponsor. It will require a ton of interaction and knowl- edge transfer to a CMO, and you'll be trying to have that across multiple time differences — and perhaps at times some language differences — if your provider is in a far off location. Small inaccuracies — a subtle miss — can lead to a failed batch in an early-stage process. It can bring a project to its knees. I think sponsors need to be balanced regarding risk/reward when considering local vs. global outsourcing. Frankly, I'm always astonished at how many people say how far and wide they looked, and then how glad they are not to have gone so far and wide. Always Be Looking For Partners COMMENT 3 Maybe our company takes a slightly dif- ferent view of this. We don't really ever start looking for CRO or CMO partners for different projects; we're basically always searching globally. Perhaps that's a luxury we have because of a constant need to find partners and because we have the headcount to do this kind of networking. But we're always talking to people, we're always looking, and we do it in Asia, North America, and Europe. We find that the global search really increases our ability to find the best and most appropriate partners for the kind of work we need done. We look at every aspect of the CRO and CMO we think is important to accomplish our due diligence. For example, our quality team attends technical audits with us to review quality systems. All of this has become just the normal way we go about outsourcing … and doing business. I

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