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Pharma Manufacturing product portfolio and supply chain model will reduce complexity and enable optimal capacity utilization. A responsive manufacturing process that avoids the risk of inventory pileups and obsolescence can be achieved by adopting a flexible manufacturing model in which it is easy to switch between a batch process and a continuous process according to the fulfillment model identified based on the product portfolio. With the recent trend of moving to a continuous manufacturing process, the looming question is: Does adopting one or the other process for all product types and supply chain models yield desirable results? Defining pharmaceutical manufacturing that extends well beyond production cost and labor arbitrage and that generates value from supply chain fulfillment and product portfolio encompasses the following key elements, at minimum: ¥ a segmented manufacturing approach such as a Ójob-shop factoryÓ for low-volume, highly-differentiated MTO products, and a dedicated production line for high-volume, lowmix, MTS-based products ¥ a sophisticated modeling tool to simulate various plant configurations to enable testing various plant configurations for varying fulfillment models and product portfolios ¥ a postponement capability to enable packaging, labeling, and just-in-time delivery of products in a location-specific manner ¥ standardized business processes to optimize trade-offs among performance, yield, and price ¥ Engaging manufacturing business units or CMOs from the very product portfolio definition stage. GUIDELINES FOR EXCELLENCE Plant efficiency and ideal full capacity utilization cannot be achieved without tight integration of supply chain processes and a product portfolio assessment, of which new product introduction (NPI) is a key part. Regardless of the supply chain model and manufacturing processes, a visionary manufacturing organization will have shorter cycle time, pull-based API consumption, capacity planning that is closely aligned with NPI planning, tighter finished inventory for goods, order tracing, shipment tracing, integrated quality, and transparency. These are just a few examples of levers to elevate manufacturing execution to a more strategic role. In addition, the product portfolio should be continually renewed with a focus on shorter time-to-market, maximized forecast accuracy, and end-to-end efficiency to ensure responsiveness and efficiency of producing and fulfilling orders. Cycle time and customer experience are key metrics to track for improving responsiveness, and customer experience is a key consideration for genetics or products that are in a steady 58 The CMO Leadership Awards 2013 state. In addition, assessing of inventory levels on an ongoing basis is imperative for cost reduction and efficiency management. Regardless of the products, place, and manufacturing model, the following are some of the best practice recommendations that can save money and improve margins: ¥ With increasing costs and lower return on investments, pharmaceutical manufacturing under a one-size-fits-all umbrella is no longer sustainable. ¥ A portfolio approach that starts with a product portfolio assessment to match manufacturing strategies with the supply chain and fulfillment model will not only decrease inefficiencies and cost but also improve timeto-market in a sustainable way. ¥ With demand-based pull strategies and a supply-based push model, pharmaceutical manufacturing can become more responsive with clear visibility into the quality of products. External collaboration with suppliers and customers and internal collaboration with product development teams, supply chain operations, sales and marketing will help build tighter links along the value chain to strengthen manufacturing. Above all, integrated manufacturing planning must carefully consider risks, such as increasing demand uncertainty, exploding product proliferation and complexities, and global uncertainties. CONCLUSION The proposed approach is not without challenges. For example, it is not clear how a continuous manufacturing process characterized by economies of scale can be adopted for a pull strategy. Similarly, Lean, Six-Sigma concepts that are well adopted for a continuous manufacturing process with high-volume, low-mix and repetitive operations lines pose challenges when adopted to biologics-based therapeutics agents. But with cross-pollination from other industriesÕ improvements in technology and changing market conditions, pharmaceutical manufacturing can address these challenges and deliver on its parent companyÕs business and strategic objectives of being responsive and efficient to meet customer needs. About the Author Booma Yandava works for KPMG. She received her MBA from Babson - Olin Graduate School of Business and is a certified global business professional with several years of experience with manufacturing and supply chain in the pharmaceutical industry.