The New Requirements and Priorities for a Changing Pharmaceutical Industry
Mehdi Yazdi Senior Technical Consultant Seqens CDMO NA
One silver lining of the pandemic is that it has illuminated the vital role of pharmaceutical innovation and generated a newfound respect for the power of science. Yet, amidst a backdrop of supply chain disruption and staff shortages, it also has resulted in accelerated de- mand for the services of Contract Development & Manufacturing Organizations (CDMOs).
In fact, according to a McKinsey survey (link to survey: https://mck. co/3611plI) of senior executives at global pharma firms, the majority of respondents feel that pharma companies will outsource more components of the value chain in order to focus on their core capabilities. While pandemic-related R&D and manufacturing has been the hot topic, the fact is, chronic diseases and ailments have not gone away because of COVID-19. Creation of new drug products, medical devices and treatments to treat a myriad of issues require utmost attention now more than ever.
Two years into the pandemic, CDMOs are confronting a drastically changing landscape in terms of sponsor expectations, filled with pent-up demand, reduced capacity, accelerated timelines and the need for continuous innovation. Today’s CDMO needs to be faster than ever before. The CDMO role is considered one of the major links in the global supply chain, and any delay can significantly impact the rest of the delivery process.
Therefore, what’s required of today’s CDMO in order to meet changing demands and ensure product readiness? Consider the following five attributes:
1. Increased digital and analytic capabilities. The need to produce more, with fewer staff and under unprecedented timelines is putting digitalization to the forefront of pharma development and manufacturing. Advanced project and workflow management systems are enabling CDMOs to operate more efficiently with consistent processes and oversight. And, data driven analytics is enabling CDMOs to anticipate and plan for future outcomes as well as make decisions faster. Analytics also will increasingly play a role in quality processes, helping CDMOs identify and reduce manufacturing deviations as well as inconsistencies in Standard Operating Procedures (SOPs).
2. Growing reliance on remote collaboration. The key to reducing API development time as complexity grows, budgets shrink, and optimal efficiency is expected will require a “right team” approach to ensure effective collaboration of the best experts for the job, wherever they may be located. This can be challenging when teams and centers of excellence are spread out across the world. A collaborative, global approach requires smart technologies, as well as access to real-time shared data and resources that enable them to, in essence, share virtual labs.
3. A Right-First-Time (RFT) approach. Given the uncertain climate, CDMOs will need to manage risk like never before. Every Active Pharmaceutical Ingredient (API) requires never-before attempted chemistry, with all the complexity and pitfalls that entails. To manage this, CDMOs should adopt a Right-First-Time-approach when performing GMP manufacturing of a complex molecule and choose the synthetic route that most likely succeeds in early- and late-phase development. This approach requires a critical balance between quality and availability of key raw materials, chemical yield, process impurities, cycle times, number of chemical steps, and number of energy-consuming operations.
4. Agility across the project spectrum. Prior to the pandemic, the key challenges were managing costs while meeting ever more complex regulatory mandates. Today’s challenge is developing a commercial process for a drug candidate more efficiently and within a much shorter timeframe while adhering to requlatory guidelines. These new mandates require an agile approach – a term used quite frequently in other industries but now gaining traction in the pharma industry. An agile CDMO is one with core processes and capabilities that are highly flexible for rapid response to change. It requires extra attention to key performance indicators (KPIs) along the various project phases, as well as greater delegation of responsibilities and decision-making.
5. The rise of employee experience. R&D projects are long and intensive and can take upwards of ten years to reach commercialization. Employee Experience (EX), a term which has become central in many industries, is taking on a greater role in pharma development, in recognition of the need to keep teams motivated and professionally fulfilled. While meeting KPIs is important, the emphasis will be on keeping teams energized to ensure continuous innovation.
We will emerge from the pandemic against a drastically changing landscape, filled with new priorities and bringing new ways of collaboratively working and innovating. It’s also requiring a whole new set of strategies and commitments from CDMOs – requiring that they adapt or perish.
About the Author
Mehdi Yazdi, Senior Technical Consultant, Seqens CDMO NA, holds a Ph.D. in Analytical Chemistry in the areas of chromatography and spectroscopy. Dr. Yazdi has over thirty years of experience in pharmaceutical industries including bulk pharmaceutical manufacturer, a CDMO, Specialty Pharmaceutical Companies, API manufacturer, and finished dose pharmaceutical manufacturer. He began his career at Ciba-Geigy a large specialty/pharmaceutical company.