Life Science Leader Magazine Supplements

CMO 2016

The vision of Life Science Leader is to help facilitate connections and foster collaborations in pharma and med device development to get more life-saving and life-improving therapies to market in an efficient manner. Connect, Collaborate, Contribute

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LIFESCIENCELEADER.COM THE CMO LEADERSHIP AWARDS 2016 27 Our Experience Works for You. • Over 90% of our chemists hold PhDs • Experience with a wide variety of diffcult chemistry • Full development capability from grams to hundreds of kilos • Preclinical"Commercial • DEA licenses for controlled substance R&D and manufacturing • Full GMP analytical capability • ICH stability program Call PharmaCore today at 336-841-5250 for more info www.pharmacore.com 4180 Mendenhall Oaks Parkway • High Point, NC 27265 GMP & non-GMP Manufacturing Process Validation GMP Analytical Full Regulatory Support Process Chemistry R&D Process Engineering Support Custom Synthesis & Contract Research That's one way to get started and bring international service providers on board. Brokers or agents, though, can't replace your own due diligence. You have to visit the CMOs and kick the tires, particularly in China and India. So it is a healthy exercise first to think through whether you even want to pursue global opportunities. In the end, I agree a lot depends on your development plan for your product and overall goals for your company. It Takes Effort To Stay Connected — But It Can Work COMMENT 5 We try to be as interactive as humanly pos- sible from the investigative stage through any relationship we establish with CMOs. So, generally speaking, you can say it is a benefit to have a CMO close to your It's A Big Adventure With Potentially Big Cost Savings COMMENT 4 You'll learn that in this industry there's not one partner who can magically do everything you need. You'll most likely have to mix and match, and you'll have to learn to balance time to manage these CRO and CMO relationships. In the begin- ning, this really was a struggle for me. However, I'm convinced the extra up- front work to find the right partner and do that extra management has paid off. We feel we got the CRO that could do our formulation best and the CMO that could manufacture most reliably for us. To be clear, though, even going to India or China for starting materials can be a big adventure. But it's a big adventure for potentially big cost savings. You simply have to do your due diligence. At times we hire reputable brokers for some locations. geographic location. You can easily meet people face-to-face and go out and look at samples and processes when you like. Nonetheless, in these times of various global and instant modes of communica- tion, you can also interact quite easily with people anywhere in the world. If you take advantage of this and make the extra efforts to stay connected, you can make it work. Particularly, if you are going to search globally, the key is to establish more than communication, but a good working relationship with CMOs from the initial selection process. A fundamental ques- tion — no matter where in the world they are located — is do they have a group of individuals at the service provider that your internal resources can easily com- municate and get along with? Frankly, you should consider whether they are fun to work with. If it is going to be a struggle, why bother? L

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