The vision of Life Science Leader is to help facilitate connections and foster collaborations in pharma and med device development to get more life-saving and life-improving therapies to market in an efficient manner. Connect, Collaborate, Contribute
Issue link: https://lifescienceleadermag.epubxp.com/i/183480
Contract Manufacturing Roundtable James Bruno Llew Keltner David Casebier Heidi Kempinski Michael O'Brien Operational Excellence — The Solution To Rising Recalls A ccording to Frost & Sullivan's global pharmaceutical contract manufacturing market research, large pharmaceutical companies increasingly consider outsourcing manufacturing to CMOs because of the uncomplicated, timely, and cost-effective services these companies provide. And while the debate rages as to how big the market will grow over the next three to five years, one thing is certain — life sciences companies don't select a CMO in the hopes of increasing the number of products they can have recalled. This past August, the Medicines and Healthcare Products Regulatory Agency (MHRA) recalled 16 drugs by one manufacturer after finding deficiencies at one of the company's factories in India. This was the second setback for Wockhardt, which had previously received an FDA-imposed import ban on products from one of its factories, which could result in lost revenues of approximately $100 million this fiscal year. This is not an isolated incident. For the first half of 2013, FDA recalls were higher for both pharmaceuticals (348, up 158 percent) and medical devices (726, up 40 percent) when compared to the same period in 2012. An increasing number of recalls occurring in the world's largest pharmaceutical market indicates the need for companies to take a closer look at their manufacturing operations, perhaps through the implementation of an operational excellence (OPEX) initiative. As a consequence, Life Science Leader magazine assembled a group of pharmaceutical industry veterans and posed a series of questions to gain their insights on OPEX in pharma/bio manufacturing. The group includes James Bruno, director, Chemical and Pharmaceutical (CAP) Solutions and past president of Drug, Chemical and Associated 10 By Rob Wright The CMO Leadership Awards 2013 Technologies (DCAT); David Casebier, Ph.D. VP of chemistry, manufacturing and controls (CMC), Navidea Biopharmaceuticals; Llew Keltner, M.D., Ph.D., CEO and founder of EPISTAT and former CEO of Light Sciences Oncology; Heidi Kempinski, VP of pharmaceutical development and manufacturing operations, Tesaro; and Michael O'Brien, Ph.D., head of the pharmaceutical sciences & technology & innovation group and member of the pharmaceutical sciences executive leadership team, Pfizer. WHAT ARE THE KEY COMPONENTS TO ACHIEVING OPEX IN BIO AND PHARMA MANUFACTURING? James Bruno, CAP Solutions: We need to be looking at innovative ways to increase efficiencies and to reduce time and cost, as we are beyond the days of just handing projects over. This is a group effort which includes the sponsor as well as the CMO. It starts with understanding the problem, having clear goals and tactics as guidance, followed by an understanding of our capabilities and what is really critical in this area tied to well-defined outcomes and metrics. Start looking at incremental step improvements. Instead of a 20 percent or 30 percent increase in yield, perhaps look at 5 percent, followed by 5 percent more and so on. This will eventually net better growth and improvement. Heidi Kempinski, Tesaro: OPEX involves achieving a level of quality beyond that required through compliance standards alone. A corporate-wide shift in thinking is necessary so quality becomes an imbedded part of the organization's culture. Fundamental components include gaining a deeper understanding of manufacturing processes, assuming risk-based approaches, and pursuing of continuous process improvement. As a result, one expects to see improvements in quality and safety, increased productivity in yields and cycle times, improved plant utilization and capacity, efficiency in compliance approaches, and lower utility and waste costs. Michael O'Brien, Pfizer: The first step toward achieving supplier OPEX should occur at the vendor selection stage. There are a number of elements that collectively enable a robust assessment of the ability of an organization to provide sustained OPEX, including but not limited to, onsite due diligence visits, review of regulatory inspection, performance and financial records, and a "quality culture assessment." Through these mechanisms, we look for consistent reliability, demonstrated efficiency gains, reducing or holding down prices over time, structured efficiency programs (e.g. Lean, 6-Sigma, demonstrated quality by design [QbD] programs), and very importantly, senior leadership accountability.