How a fractured training and upskilling landscape feeds continuing pharma quality and compliance issues
If you are like me, you receive a dozen or more invitations to webinars, seminars, and conferences every day. Each invitation promises to provide insight into a host of critical issues impeding success in the world of pharmaceutical/biotech development and manufacturing.
A colleague recently pointed out that despite the overwhelming number of offerings, cleaning validation 483 observations from the FDA, (these indicate practices that may compromise cleanliness or result in microbial or chemical contamination), increased almost 70% in the last ten years over the previous decade. And while we can debate the causes; this apparent performance decline is not an isolated problem.
We belong to an industry focused on the health and wellness of people. It is imperative that we challenge ourselves to get to the root cause of what is impeding our ability to execute regulations which were put in place to ensure safe and effective product manufacturing. Why has industry performance declined over the last two decades?
Regulatory Oversight and Enforcement is Not the Solution
Despite the best efforts of global regulators, over the last 110 years, the process of achieving quality compliance by enforcement action has not been successful.
The rapidly changing dynamics of our industry mirrors a revolution in the development of miraculous products in biopharmaceuticals, biosimilars, as well as cell and gene therapies. Concurrently, we face the challenges of engaging new strategic and tactical approaches such as outsourcing a significant percentage of manufacturing to third parties. These evolving strategies demand a higher level of decision-making acumen and critical thinking skills to ensure the quality of what the public receives.
The Training and Education Gap is Growing
All of us working in this industry consider ourselves to be experts; but how does our preparation compare to other groups of professionals? In the pharmaceutical industry, training remains focused on developing the individual’s ability to properly execute a discrete task. This focus is a vestige of 19th century norms and schema. We develop skills through apprenticeship – work with more experienced experts who then teach skills in return for the apprentice’s labor.
The explosive growth of biopharmaceuticals and advanced therapies has brought with it the possibility of a world changing future for personalized medicine and disease treatment. However, this same mind-blowing opportunity has also created a massive gap between existing and needed talent. Our industry may face a catastrophic shortage of workers who possess the skills needed for advanced therapy manufacturing.
Further compromising the existing training model is that these rapidly developing technologies result in a lack of skilled or experienced leaders/mentors to teach new workers. The lack of these leader/mentors is exacerbated in this space because technicians’ manipulations require not only the physical capability to execute the process but the ability to make critical decisions when issues are encountered. Any new learning and development frameworks must engage the metacognitive, kinesthetic, and academic specifics which are unique to these novel manufacturing methodologies. We must devise teaching and learning structures which deal with the short and long term needs of the industry.
The industry is responding to these needs by creating innovative, pliable, tech-forward training and education tools which include immersive simulation based, virtual and augmented reality. The best of these tools includes both education in the concepts underlying the process and the ability to practice in a risk-free environment. This shift is proving effective in training the technicians who execute the work because of the inherent, learner centered benefits of these personalized learning platforms.
Some early efforts which utilize automation and artificial intelligence are also focusing on the gap at the worker level. What remains, however, is a huge gap in the expertise of the leaders and experts who design and maintain the processes, equipment and facilities needed to meet complex global regulatory requirements. Those charged with ensuring that the products produced consistently meet the standards for safety, purity, and effectiveness.
Regulations Can Only Do So Much
The European Union has attempted to address the variability we see in the interpretation of quality compliance regulations with a legally mandated requirement for a “Qualified Person (QP)” who meet specific educational and experience requirements as defined in “Directive 2001/8/EC of the European parliament and of the council of 6 November 2001 on the community code relating to medicinal products for human use.”
This approach has its limitations in that it provides a legally required retrospective review of product performance prior to release. In the rapidly growing areas of advanced therapies and biopharmaceuticals, the QP can prevent release of compromised materials but cannot ensure consistent and sustainable performance. It requires a different skill set to take the feedback from the QP and apply it prospectively as a process improvement, risk reduction, or preemptive measure.
In the United States, the Code of Federal Regulations, Title 21, Parts 210 & 211, under part 211.25 requires “each person engaged in the manufacture, processing, packing, or holding of a drug product shall have education, training, and experience, or any combination thereof, to enable that person to perform the assigned functions.” The generalized nature of these requirements results in a dizzying array of training seminars, webinars, meetings, and certifications which each seek to provide guidance on interpretation of these regulations, there exists no organized approach or requirement for ensuring consistency from company to company or even site to site.
Without a solid educational foundation, the ability to consistently interpret and apply the intent of regulations results in varying approaches to good manufacturing practices. This “fractured” approach to training and education is manifested in continued quality deficiencies noted in regulatory inspections.
Can Pharmacy Schools Lead Needed Change?
Currently, the focus of most Colleges of Pharmacy in the United States remains preparing individuals to deliver clinical information and therapeutics to patients, primarily in retail or hospital settings. However, in a recent New York Times article by Noam Scheiber, “How Pharmacy Work Stopped Being So Great,” the author points out that cost pressures in the changing retail marketplace are driving a reduction in the number of pharmacist positions, resulting in an unhealthy working environment for many of those remaining.
As a graduate of a great pharmacy school program (Go UB Bulls!), I believe the curriculum of these pharmacy programs was and is an excellent foundation for creating strong pharmaceutical manufacturing industry leaders. Courses in chemistry, microbiology, pharmacology, pharmacokinetics, disease therapeutics, and pharmacy practice are an invaluable educational foundation for understanding and applying the regulatory, technical, and personnel related elements needed to develop and manufacture quality therapeutics utilizing good manufacturing practices.
These colleges have worked successfully over the decades to create robust, comprehensive curriculums which create capable professionals in the retail/clinical environment. I believe the faculty of these schools, with collaboration from regulatory compliance experts from government and industry, can create an elective curriculum to educate leaders in the many quality and regulatory facets of product development and manufacturing.
Courses on data integrity, statistics, study design, regulatory filing requirements, validation principles, key elements of good laboratory and manufacturing practices, and essentials of aseptic operations among others could form the core of this curriculum. These courses could comprise an elective track for those who wish to maintain the ability to practice as licensed pharmacists, as a post graduate certification for those looking to expand their career opportunities, or as an independent course of study leading to a unique degree.
Continuing education courses offered through these schools could ensure currency in a rapidly changing environment. Ultimately, the accreditation authorities for pharmacy education could establish standards to bring national consistency to these efforts.
However, there is a need in the near term to address the currently fractured landscape of training and education. A potential solution is the creation of a consortium including regulators, industry experts and educators to identify and codify the knowledge and behavioral objectives for training and then serve as a review and certification body to help attendees chose programs that deliver the needed knowledge and skills. To supplement external education, the identification of strong subject matter consultants to mentor key leaders within the organization can be an additional solution to strengthen internal capability.
Creating Industry Leadership for the 21st Century
The development of advanced therapies and rapidly changing technologies for producing these treatments requires leaders in both development and manufacturing to have the capability to interpret and apply proper controls at all phases of the product lifecycle to meet regulatory requirements. Effective and consistent application of good laboratory, clinical, and manufacturing regulations, which constitute the foundation for producing quality therapeutics, has been an elusive goal in our industry for the last century. Together with government and industry experts, educators in our nation’s Colleges of Pharmacy can provide an approach which can ultimately address the quality leadership demands of pharmaceutical development and manufacturing in the 21st century.