By Louis Garguilo, Chief Editor, Outsourced Pharma
“Innovation” and “pharmaceutical quality management” inhabit the same sentence more often these days. Bayer HealthCare’s Director of Quality Assurance for Biologic Product Development in Berkeley, Dr. Claudia Lin, takes pride in that.
She’s an avowed “innovative research scientist,” so what’s she doing in quality management? “Now more than ever, quality management requires innovative thinking that comes from the ability to interpret regulations; creatively solve scientific, technical, and business problems; and challenge the status quo. These types of professionals are in demand. I believe this is the onset of a transition, a positive movement in the pharmaceutical quality world.”
Lin also believes that if any tenured quality managers haven’t already noticed the need for change, their bosses will. “If the top quality leaders in biopharmaceutical companies today don’t have these qualities, they should learn from somebody who does. Otherwise, CEOs will realize, ‘We are behind the eight ball on this,’ and look for options.”
Prior to Bayer HealthCare, Lin worked at a number of pharmaceutical and biotechnology companies. She has a Ph.D. from UC Berkeley in cell and molecular biology, two post-docs from UCLA and UC Berkeley, and an undergraduate degree from Fudan University (Shanghai). I met her at the Outsourced Pharma West 2014 conference in San Francisco.
She defines her adopted profession this way: “Quality management is designing manufacturing processes and controlling strategies to arrive at product quality. It’s also about continuously improving product quality so that not only do you better serve patients, but also you derive more rewards from your R&D investments.”
QUALITY MANAGEMENT AS A CRITICAL BUSINESS FUNCTION
Lin says her desire to further innovation in the quality management field has been growing for years. Personal experience led her to believe there is a major component of innovation in quality, equally as vital as in all other areas of drug research, development, and manufacturing. Moreover, she has a keen view of quality management as a critical business function and as a tool to help drive and solve business solutions.
Her first position, though, was in her first field of study. “As a research scientist specializing in cancer, I always wanted to go into industry to help develop drugs,” she says. Throughout her career she became known as a go-to person for difficult projects. She cites an example from a time at a previous company. A leader was needed to identify and implement biomarkers for a new cancer therapy. “This was more than 10 years ago when people just started talking about biomarkers; nobody really knew how to proceed. They looked to me for help. It was all innovation, and very gratifying.”
Her next step, she jokes, was when Genentech lured her “to the dark side,” and a job in quality. “At the beginning, I thought there was a dichotomy between innovation and quality management,” she says. She struggled to find how an innovative scientist could become a valuable quality person, and she even worried she might be on the wrong path. That personal struggle ended up placing her on a career-long path of leadership and advocacy for a new quality management approach.
She says a breakthrough occurred for her when she gained quality management responsibility for a large anti-cancer drug. “At first it was a basic quality job, focused primarily on lot release. I could see why some people think quality is not necessarily innovative,” she says. “Granted, in quality you have essential tasks that are repetitive and require methodical checking of details, but I soon realized that is a small portion of what quality management should be doing.”
The initial challenge was planning the launch of clinical trials in over 20 countries. While it was tedious strategizing applications and approvals, she says she thought, “Nobody can actually direct us in how to do this. We had to create a way for the first global trial of what became a famous drug.”
A smaller victory within that project proved just as educational to Lin. “We had discussed cold chain management. The drug had to be transported through various countries, climates, clinics, and system regulations. It seemed every other day we would get a call saying a package was in customs for five days, or the dry ice 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 incidence and rendering a yes or no decision, which would take up vast resources and be ineffective, we sat with experts from different functions, including product stability and shipping validation. Quality management drove a different 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 distribution system. The resultant solution reduced inquiries (e.g., those received from shippers, storage facilities, and/or clinical trial managers regarding whether 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 innovation anyways?” she asks. “It’s about finding 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 quality 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 to be applying the same interpretation. “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 understands why it put together particular controls for analytics, particular specifications, 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 differs from a more traditional regulatory focus on whether a registered product is following individual procedures for manufacturing and testing.
Drug companies must now demonstrate 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 implement and understand the impact of changes throughout the entire development 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.”
"Quality management is designing manufacturing processes and controlling strategies to arrive at product quality."
Dr. Claudia Lin
Director of Quality Assurance for Biologic Product Development at Bayer HealthCare
BAYER (AND OTHERS) GET IT
Lin says the entire Bayer organization benefits from this innovative quality 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 becoming the natural way of thinking. And it didn’t just start. I remember Genentech started early with a continuous monitoring program, an important element of ICHQ10,” she says. “We also worked on quality-by-design when I was there that 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 consistently embody this way of thinking about quality management. I also hear from many other quality managers at pharmaceutical companies who are passionate about these concepts.”
“So, on a company and industry-wide basis, this thinking of quality management 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.