Life Science Leader Magazine Supplements

CMO 2015

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LIFESCIENCELEADER.COM THE CMO LEADERSHIP AWARDS 2015 12 ROUNDTABLE leaders HOW TO QUALIFY A CMO'S CAPABILITIES AND BENCHMARK ITS PERFORMANCE By E. Miseta the right CMO on board, you can start building the relationship. The principles I tend to focus on are capacity, capa- bility, compliance, communication, and creativity. We had a very good experience with a European CMO. We were working on a product with low yields and impurity issues. We had to scale up and had to move very quickly. It was a challenging project. We selected the CMO we felt was the best fit and had their chemists work alongside ours. We met the deadline with 99.6 percent purity and a five-fold increase in the yield. It was a great expe- rience, and the relationship and the communication were vital to making it a success. 6 THERE ARE CUSTOMERS WHO STILL PREFER TO WORK WITH CMOs THAT ARE A ONE-STOP SHOP. DO YOU PREFER THAT MODEL OR WORKING WITH CMOs THAT HAVE DIFFERENTIATORS TAILORED TOWARDS A SPECIFIC TYPE OF CHEMISTRY? Alonso-Caplen: That's a good question, and the answer is, it depends. For example, if I were sourcing for antibody drug con- jugates (ADCs), a toxic material, having a supply chain that is fragmented will make it more difficult, especially if the drug substance is in the U.S. and the drug product is in Europe. In that case, I would prefer to go to a one-stop shop. On the other hand, if I were sourcing for monoclonal antibodies, it really doesn't matter because we would not have the same supply chain concerns. We have CMOs and contract testing labs that are strong in that area. We have established platform methods with several companies, so it makes it much easier to source the testing to one contractor and the produc- tion to another. If a CMO were strong in one particular field, say conjugation, then by all means we would prefer to go with that CMO because they have seen a lot of these processes and we can actually learn from them. Hoffmann: I think this is another situa- tion that can be tied back to the project manager. If you have a one-stop shop that has a single project manager, that individual can follow your project all the way through the process, and there is only one person that you have to talk to at every step. That person will be responsible for managing the logistics of moving your project through the differ- ent production stages. If you have several suppliers, each performing a different stage, you will need the resources to manage the entire process. It's not impossible, but there are more logistics involved, and you have to make sure you have the manpower and resources to handle it. 7 DO YOU HAVE ANY ADVICE ON HOW TO MANAGE THE LONG CYCLE TIMES BETWEEN WHEN A CONTRACT IS SIGNED AND WHEN A PRODUCT MOVES INTO COMMERCIAL PRODUCTION? Guiles: The best way to handle that is to think ahead and ask a lot of questions during your initial discussions in the RFP phase. Ask the CMO about capacity and any possibility of having to change facilities. If moving from Phase 2b to Phase 3 means moving into another facil- ity, you would want to know that up front. Novak: That is a good point, and it's a situation that is sometimes unavoidable. Changes will occur when moving from Phase 2b to Phase 3. Suddenly, the project and the commercial capacity that the CMO signed up for have changed for the good of the owner. But for the CMO, all of a sudden there is a realization that the equipment in-house will not be sufficient to pro- duce the volume the customer is now requesting. In order to do it, there will have to be a large investment. We all know how tough it is on the CMO side to go to the board of directors and say, "Hey, by the way, I need $12 million for another fluid bed dryer." Realizing you suddenly need three times the quantity originally requested is definitely a chal- lenge, but if your relationship is a true strategic partnership, then you should be able to sit down and work things out. Hoffmann: Here again communication is a key component. There should be a collaborative process in place as your project moves through the different stages. As soon as you know there will be changes, let the CMO know. None of this happens in a vacuum. You have an idea as you move through the different phases of the clinic that your demand might be bigger, and your dose differ- ent, than what you originally thought. Always give your CMO as much advance notice as possible. Worst case scenario, if it's not possible for the CMO to accom- modate your changes, then go with a second source, which the FDA would prefer anyway. 8 HOW IMPORTANT ARE SITE VISITS? Hoffmann: Site visits are extremely impor- tant. Without them I don't think you can really get a sense of the true capabilities of a CMO. The visits allow you to see firsthand what their labs and other facili- ties look like. The visits also give you a chance to talk to the technical staff. This will help you to determine how knowl- edgeable they are and whether or not they are able to answer your questions. Go prepared with specific questions to ask. The business development peo- ple are generally very knowledgeable, but the technical staff will be able to tell you how they would approach any problems that arise.

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