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LIFESCIENCELEADER.COM THE CMO LEADERSHIP AWARDS 2015 10 ROUNDTABLE leaders HOW TO QUALIFY A CMO'S CAPABILITIES AND BENCHMARK ITS PERFORMANCE By E. Miseta 2 WHAT ARE SOME OF THE PROS AND CONS WHEN ENTERING A RELATIONSHIP THAT IS STRATEGIC VERSUS TACTICAL? Novak: I have spent 13 years in this industry leading three different CMOs. I have found that a majority of the customers I worked with will often talk strategically then act tactically. Unfortunately you don't find that out until you get to the Master Service Agreement (MSA). They initially talk to you like a partner but then include how they will hammer you with penalties if some- thing goes wrong. That is not strategic. Customers that truly want a strategic relationship will sit down with you at the start of the process and say, "Here are our expectations. How can we work together as a team to make sure we accomplish these goals?" I have always felt that if you're working with a CMO, you're in it for the long haul, unless they really mess up because the cost of getting out of a relationship can be tremendous. But it is still important to define that relationship right up front, and to be honest about it. I currently work with 23 CMOs, and I would only classify one of them as being truly strategic. Guiles: Terry makes a good point. When entering into a strategic relationship, keep asking yourself if this company is the long-term partner you had expected. Alonso-Caplen: I would define a tactical relationship as one where you need addi- tional drug product produced but have run out of available capacity. To me, a true strategic sourcing relationship has to be one where the companies are truly partners. That means you share in the risk, and you share in the success. And you don't start blaming each other when something goes wrong. 3 MANAGING THE OUTSOURCING RELATIONSHIP IS MUCH DIFFERENT FOR A SMALL COMPANY THAN A LARGE ONE. IF YOU ARE NOT A LARGE COMPANY, HOW CAN YOU MAKE SURE YOU ARE STILL GETTING THE MOST OUT OF YOUR CMO? Junning Lee, Theravance Biopharma: When I first joined Theravance, the company had only one product, but it was a difficult molecule. We had a medicinal chemist who was running all of the CMC (chemis- try, manufacturing, and controls). At that time it would have been very difficult to select a CMO. They would have needed a knowledge of chromatography and how to handle an unstable and volatile prod- uct. We also had very low yields. As we moved more product into the pipeline, we gradually built an internal CMC capability. We cre- ated several ACE (Analytical Chemist Engineer) Quality Teams that worked together to review processes and activity at various stages. They reviewed assays, ID mapping, studies of different phases, the relevant docu- ments that needed to be submitted, and what experiments had to be run to get the data we needed. We needed a good understanding of the process. The ACE QT developed the process, and eventually we were able to demon- strate it in the laboratory post-Phase 2. Only when we were able to move to late stage did we consider transferring it to a CMO. We have since produced 59 com- mercial batches without a single devia- tion and even gotten a pre-approval inspection from the FDA. So long story short I think you really need to understand your technology before you can even consider working with a CMO. We now have 13 clinical products and one commercial. Novak: I think there are a lot of smaller companies that feel they are not getting the attention they deserve from their CMO. If you are a small company, here is the best piece of advice I can give you: Develop an internal champion at your CMO, and make sure that person knows your company as well as you do. If they know your company inside and out, they will be representing you in that CMO. The good ones will do that very, very well, but they need that knowledge from you to know what your company is all about. Guiles: One of the things that has served me extremely well is former colleagues who are now located around the world, both as customers or in CMOs. These are When entering into a strategic relationship, keep asking yourself if this company is the long-term partner you had expected. J O E G U I L E S At Pfizer, we do not believe cost should be the major driver when selecting a CMO. F I R E L L I A L O N S O - C A P L E N