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Contract Manufacturing How The Experts Assess CMO Attributes By Rob Wright The global CMO market was valued at $26 billion in 2010 — growing from 2008 at a CAGR of 10.7%. The main factor driving this market is the increase in sourcing of biologics and generics. Forecasts antici- pate the market reaching revenues around $60 billion by 2018 – CAGR of 11%. The trend of pharmaceuti- cal and biotech companies outsourcing their prod- uct manufacturing has no end in sight, even though many recent and very public recalls have involved CMOs. As this trend continues, so too must the trend of both parties to be vigilant during the process of developing strategic partnerships. In a recent article, Jeffrey Baker, Ph.D., deputy director, office of biotechnol- ogy products at the FDA's Center for Drug Evaluation and Research (CDER), stressed the importance of differentiating between outsourcing and strategic partnerships saying, "In strategic partnering, there is shared pain and shared gain. You can contract out activities, but you cannot contract out responsibilities." With this in mind, Life Science Leader mag- azine posed a series of questions to indus- try experts in order to gain their insights on how they assess CMO attributes, as well as to uncover potential growth opportunities in the CMO space. Firelli Alonso-Caplen, Ph.D., is the senior director of Pfizer's biotherapeutics and vaccines outsourcing group within the BioTherapeutics Pharmaceutical Sciences organization of worldwide R&D.; Dr. Alonso-Caplen has 27+ years of combined experience in research, development, and cGMP production of biological products and vaccines, with more than 7 years spe- cific to outsourcing, project/contract man- 10 The CMO Leadership Awards 2012 agement, and technology transfer to quali- fied third parties. Barry Rosenblatt, Ph.D., is a subject matter expert in chemistry and manufacturing controls (CMC) of biothera- putics. Dr. Rosenblatt is the president of SME Biotech Consulting. He has 27+ years of experience in the biopharmaceutical and contracting industry, which include previ- ously held positions with Centocor, J&J;, and Charles River Laboratories. RANK THE FOLLOWING CMO ATTRIBUTES: INNOVATION, PRO- DUCTIVITY, QUALITY, REGULA- TORY, AND RELIABILITY Firelli Alonso-Caplen of Pfizer: Quality is always number one, followed by regula- tory, reliability, productivity, and innova- tion. For my group — biotherapeutics and vaccines outsourcing — quality refers to the quality of the deliverables (e.g. clinical trial materials) made in compliance with cGMP (regulatory), ahead or on sched- ule (reliability), at reasonable costs and meeting success criteria (productivity). Innovation is important when generating better or more effective processes, prod- ucts, or services, as in an R&D; environ- ment. Barry Rosenblatt of SME Biotech Consulting: In my estimation, reliability should be ranked the highest because in order for a CMO to be reliable, it must have elements of all of the other attri- butes. A CMO that is not productive has questionable quality, does not maintain adherence to the regulatory requirements, cannot demonstrate innovation when required, and cannot be reliable. Solid quality and quality systems would be next on my list, especially in light of the cur- rent emphasis by both the FDA and EMA (European Medicines Agency) on CMO