Life Science Leader Magazine Supplements

CMO 2015

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Page 27 of 83

By L. Garguilo LIFESCIENCELEADER.COM THE CMO LEADERSHIP AWARDS 2015 28 PHARMA MANUFACTURING quality INNOVATION IN BAYER HEALTHCARE'S QUALITY MANAGEMENT led to the first submission to FDA and European regulatory agencies utilizing this approach. It was an exciting journey because we got to be innovative for the growing biotech industry." Not surprisingly, she sees Amgen also leading this quality philosophy. "Judging from conferences I attend, they con- sistently embody this way of thinking about quality management. I also hear from many other quality managers at pharmaceutical companies who are pas- sionate about these concepts." "So, on a company and industrywide basis, this thinking of quality manage- ment as an innovative key to enabling better patient and business outcomes is becoming pervasive. It's been gratifying for me to engage in this level of thought leadership," she concludes. L to be applying the same interpreta- tion. "I was recently on a panel with an associate director at CDER [Center for Drug Evaluation and Research] who is involved with product quality," says Lin. "He shared the same thoughts that I had on this new direction." That new direction, according to Lin, is determining whether a company under- stands why it put together particular controls for analytics, particular specifi- cations, but perhaps most important of all, how everything adds up to a strategic and quality manufacturing process. The emphasis is squarely on understanding process and control strategies critical to ensuring product quality. This dif- fers from a more traditional regulatory focus on whether a registered product is following individual procedures for manufacturing and testing. Drug companies must now demon- strate their forward-looking flexibility and a process to improve as knowledge is gained from more production runs and post-launch market data. "The FDA is looking for integrated thinking regarding how you design your product, as well as the final product itself," she says. "You need this to effectively imple- ment and understand the impact of changes throughout the entire develop- ment process. This integrated thinking requires that quality professionals are part of the scientific and business design for drugs and heavily involved with any improvement efforts, issues, and change management." BAYER (AND OTHERS) GET IT Lin says the entire Bayer organization benefits from this innovative qual- ity direction. I ask her if she sees signs that other pharmaceutical companies are practicing this quality approach. "Yes, I think many are, and it is becom- ing the natural way of thinking. And it didn't just start. I remember Genentech started early with a continuous monitor- ing program, an important element of ICHQ10," she says. "We also worked on quality-by-design when I was there that had melted, or the clinic cold room was not adequately controlled. Product, and thus potentially trials, could be at risk." Lin threw out the traditional quality approach with the melting ice. "Instead of the usual way of looking at each inci- dence and rendering a yes or no deci- sion, which would take up vast resources and be ineffective, we sat with experts from different functions, including product stability and shipping valida- tion. Quality management drove a differ- ent and more robust solution." According to Lin, they implemented a process to review all the data, define a time and temperature range for the product, and then build that into the dis- tribution system. The resultant solution reduced inquiries (e.g., those received from shippers, storage facilities, and/or clinical trial managers regarding wheth- er the drug still met specifications and could be used in the clinical trial) and lost product. "It may not seem like a big scientific invention," she says, "but it introduced me to how you can directly apply creative, quality ideas to solve a costly business problem." "And what is the definition of innova- tion anyways?" she asks. "It's about find- ing new ways to do old things. I believe as a result of this applied approach, I was labeled an innovative quality leader. I've had the opportunity to do quality management in a divergent way ever since." REGULATORS AGREE WITH INNOVATION ICHQ10, updated guidelines for qual- ity systems issued by the FDA in 2009, reinforced Lin's approach and thinking. In the pharmaceutical quality realm, this was the FDA's official attempt to insert the type of innovation in which Lin believed. The guidelines provided a stimulus for a more holistic thought process for implementing systems for pharmaceutical products. " When the guidelines were issued, people said, 'This makes sense, but how do we actually do it?'" recalls Lin. Today, regulators and industry seem Quality management is designing manufacturing processes and controlling strategies to arrive at product quality. D R . C L A U D I A L I N Director of Quality Assurance for Biologic Product Development at Bayer HealthCare

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