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Contract Manufacturing and deliverables. A CMO that has a project management group separate from its science and technology lines reflects a CMO that is well experienced in contract work. The project manager oversees the daily coordination and execution of all activities, as well as the key performance indicators for each project. Monitoring and tracking functions are crucial for keeping projects on time, within budget, and meeting the highest qual- ity standards. Those functions also offer the opportunity to WHERE DO YOU SEE GROWTH OPPORTUNITIES FOR THE CMO MARKET? Alonso-Caplen: More CMOs that can offer "soup-to-nuts" capa- bilities (i.e. an integrated service model) for various technologies are areas for growth opportunities. A CMO that can produce drug substance and drug product, and be able to perform release and stability testing of antibody-drug conjugates, is a specific example of a desired CMO. This simplifies the supply chain and reduces "A CMO that can produce drug substance and drug product, and be able to perform release and stability testing of antibody-drug conjugates, is a specific example of a desired CMO." Firelli Alonso-Caplen, Ph.D., Pfizer routinely evaluate risks or identify gaps. Rosenblatt: Reliability of a CMO can be measured in its consis- tency of on-time delivery of the promised amount of product with a minimum of deviations. Warning signs of less reliability include a large number of deviations, unusually long lead times, and a lack of milestones presented in project plans. WHAT IS A COMMONLY USED CMO ASSESSMENT TOOL THAT BRINGS LITTLE OR NO VALUE TO THE SELECTION PROCESS, AND WHY DOES IT CONTINUE TO BE UTILIZED? Alonso-Caplen: All the tools we currently use for the assessment of a CMO are currently utilized, otherwise these would be elimi- nated. However, the selection criteria are weighted, and CMOs are scored and ranked on predetermined weighted criteria based on their responses to RFPs and after their successful completion of a technical evaluation, a quality/compliance audit, and an envi- ronmental health and safety audit. Cost competitiveness is not a weighted criterion. However, it can become the tiebreaker when faced with choosing between CMOs that are equal in all other weighted criteria. Rosenblatt: Many sponsors place a great deal of emphasis on the experience of the senior most staff, without assessing the experi- ence of the technical staff. Since quality in any organization should come from all segments of the organization, not just from the top, this tends to overestimate the quality of the CMO. It is commonly utilized as a selling point for the CMO, embedded in their sales presentations. 14 The CMO Leadership Awards 2012 the occurrence of a technology transfer with oversight by a single team. Rosenblatt: There are several potential growth areas for CMOs in the current economy. • Service offerings: With Big Pharma often reducing or shutting down its research and early-stage development groups, CMOs with the ability to develop early-stage pro- duction and purification processes, as well as GMP pro- duction, will likely see an uptick in business as these com- panies increase outsourcing. In addition, many pharmas are looking for "one-stop-shops" to meet their outsourcing needs. Partnering or implementing CRO offerings, espe- cially as package deals, will shift some business away from stand-alone CROs. • Cost of goods reduction: CMOs partnering with technol- ogy companies (disposables, high-throughput purification systems, etc.) to reduce the cost of goods will be attractive to both the innovator companies and biosimilar companies. • International markets: As markets grow in areas outside of the U.S. and Europe, and as pressures increase to reduce costs, expansion into "developing" areas will be attractive for the next few years. WHAT TOOLS DO YOU USE TO ASSESS A CMO IN THE AREA OF REGULATORY COMPLIANCE? Alonso-Caplen: We typically ask a CMO to fill out a technical site previsit information questionnaire a couple of weeks prior to a scheduled technical evaluation. This template includes questions on regulatory submissions history, if any. Depending on the phase of the project to be outsourced, lack of experience with preap-