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Issue link: https://lifescienceleadermag.epubxp.com/i/183480
Contract Manufacturing Roundtable WHAT'S THE BIGGEST CHALLENGE FACING PHARMA AND BIO MANUFACTURERS, AND WHAT SHOULD A CMO BE DOING TO ADDRESS/MANAGE IT? Casebier: Cost containment and time management. Accurate estimation of supply costs as well as the ability to schedule and project product availability are critical aspects for a virtual company like ours. While the adage that time is money may apply, I would rather have an accurate timeline for deliverables to plan with than an optimistic timeline that could potentially cause program issues when it is late. Keltner: I believe the biggest challenge is changing regulations. There are many sources of change in regulations which can affect manufacturing process and flow — all geographic political jurisdictions as well as federal agencies like FDA, EPA, OSHA, and HHS. The CMO needs to have an internal or external resource to warn of upcoming changes which could affect processes in any way. This is hard to do on the local scale, but absolutely necessary. I once witnessed a change in a city's smoking ordinance shut down a critical commercial finished product facility for almost two months, putting the drug in very short supply and causing years of reputation problems for the seller. Kempinski: Flexible access to capacity and technology is one of the biggest challenges facing pharma now. Important trends in the industry are: 1) continued needs to build Lean organizations, leading to increased dependence on outsourcing, 2) a desire to work with fewer, quality partners, putting pressure on CMOs to offer more capabilities across the entire development life-cycle versus a focus on early-stage or late-stage, and 3) a transition to lower volume, specialty products. CMOs must be thinking and acting strategically with their clients to understand how needs are evolving and where focus is needed over the long-term. DO YOU THINK MANUFACTURING INITIATIVES ARE CRITICAL TO ACHIEVING OPEX, AND IF SO, WHICH ONES? Bruno: I think that QbD (quality by design), if properly implemented and designed, will be a major help for achieving OPEX. Truly understanding the space that we work in and the risk that we face in these areas is critical. It should give a true picture of what we need to do and if not with a bias, give us areas of improvements which will lead to OPEX and, more importantly, lower cost. Casebier: QbD is something that makes sense in light of the philosophy that quality cannot be tested into a product. This means understanding the process and having sufficient knowledge of manufacturing plant abilities and limitations such that both the sponsor and the CMO know the critical parameters of the process as they apply in that particular manufacturing environment. 18 The CMO Leadership Awards 2013 Keltner: No. A good CMO can logically plan and determine best methods to get a campaign done. Outsourcers are well aware — if they are any good — of the best methods for optimization and efficiency. Lean and other "initiatives" are just rigid codifications of logical campaign planning and should never be needed if the right people and methods have been put in place and common sense is being exercised on a constant basis. Kempinski: OPEX cannot be achieved without a systematic, corporatewide approach. Initiatives such as Lean or Six Sigma can be instrumental in building a foundation of methods and training to support continuous improvement, but more scientific initiatives such as QbD are critical to afford further progress. QbD facilitates a closer collaboration between development and manufacturing earlier in the product life-cycle, and affords better long-term results through continuous monitoring and improvement goals. The FDA has embraced QbD as a means of assuring product quality. O'Brien: We are committed to the application of QbD principles and Lean in both development and manufacturing. We have demonstrated the value of these programs in quality, cost and efficiency metrics and consequently have reduced our business risks. When problems arise, this science-based approach better positions us to more quickly understand causative factors and develop corrective action or risk mitigation strategies. WHAT ROLE DO SUSTAINABILITY INITIATIVES PLAY IN ACHIEVING OPEX, AND WHAT SHOULD YOUR CMO BE DOING AND WHY? Bruno: Today, technology is changing more rapidly than in the past. If you do not take advantage of these constant improvements, you cannot sustain and grow your business. You cannot sustain growth simply by cutting costs. You need to make improvements and operational improvements can go a very long way to improve overall profitability and reduce cost. If you look at the CMO market today and our competition with lower cost countries like China and India, we can only maintain our businesses by constant improvements and by innovation. Increased yields, lower energy and waste costs, as well has higher throughputs, can negate the low labor rates of these regions. Casebier: I believe that these are orthogonal issues, not necessarily inclusive or exclusive. The most important aspects of any drug are the safety, quality, and efficacy of the agent. Imposing sustainability initiatives in principal onto a process without understanding the precise impact is not a good idea — especially if done at the outset of the program, because one is implicitly endorsing the potential compromise of quality for an orthogonal property. If the process is well understood and the