Pharmaceutical and biotechnology manufacturing companies around the world are exploring new ways to quickly and safely develop vaccines and other drug therapies in the fight against the global COVID-19 pandemic. In the past few months, many manufacturers have announced plans to bring vaccines to market and are getting creative in their approaches. Whether exploring multiple vaccine paths, increasing batch sizes, partnering with contract development and manufacturing organizations (CDMOs), or ramping up manufacturing capabilities in order to prepare for worldwide demand, these companies are changing the way vaccines and drug therapies are developed and distributed.
Of all the factors influencing and supporting these approaches, none stands out more than an almost overwhelming need for efficiency. With the loosening of restrictions, emphasis on partnerships and collaboration, digitization of processes, and de-prioritization of non-critical initiatives, manufacturers are taking serious measures to focus efforts and increase efficiency without compromising safety, contributing to the acceleration of biologic development now and in the future.
Manufacturers and regulators are together rethinking the lengthy FDA approval process (i.e., average of 13 years for novel products) for getting a vaccine to market. The FDA already offers two main avenues for accelerating approval (fulfilling a previously unmet need and breakthrough therapy for drugs and biologics with substantial improvements over previously available therapy). But manufacturers are also looking to speed up manufacturing by conducting various development processes in parallel, standardizing facilities and leveraging already established infrastructure for quick “plug and play,” and attempting production through parallel methods (e.g., live-attenuated, adjuvanted recombinant, mRNA) potentially at risk.
Partnerships and collaborations are also playing a role in efforts to increase efficiency without compromising safety, as global and U.S. regulatory agencies have been proactive in partnering with manufacturers to establish a common path forward. Manufacturers, moreover, are partnering with CDMOs to assess and streamline time-intensive components of the development process and to prepare large-scale producers, suppliers, and other companies (e.g., research) for coordinated mobilization. And the FDA is aligning with the European Medicines Agency (EMA) to accelerate drug and biologic approval for potential COVID-19 therapies on a global scale.
The digitization of manufacturing processes and de-prioritization of non-essential initiatives are key as preparations are made to scale up for high-volume delivery while also minimizing risk to employees. Companies like Moderna, Sanofi Pasteur, and others are taking strong steps to care for their workforce by enhancing safety measures, focusing on employee wellness, and increasing investment in safety stocks to accommodate future surges in demand.
Despite these measures, manufacturers continue to face significant bottlenecks throughout the drug and biologic supply chain. For therapy development and production, manufacturers will need a stronger understanding of necessary dosages to determine available capacity, scalability of variables in clinical trials, and availability of appropriate funding. From a people perspective, manufacturers also need to secure and retain top supply chain talent and be ready to collaborate with their partners across the industry.
It is still unclear when biotech companies will have enough vaccines to support the global market and how quickly those vaccines may be available, but many believe that it will not be soon enough. Despite the estimated 1 billion doses of vaccines that are expected to be produced in 2021, a multi-pronged approach seems essential to the tackling of not only this pandemic but also future global health crises. Of note, manufacturers are repurposing existing drugs (e.g., remdesivir, chloroquine, etc.) to treat symptoms of the disease once someone is diagnosed, leveraging research conducted for previous diseases (e.g., SARS), and exploring consumer diagnostics and mobile health testing to expedite development of therapies.
In addition, while safety measures like those being taken by Moderna and Sanofi Pasteur are an imperative, they will come at a cost. Productivity will decline, operating costs will increase, service levels will change, and the overall employee and customer experience will be altered. Pharmaceutical manufacturing companies will need to innovate and adopt new ways of working to recover quickly and bring operations back to a stronger, more productive, and cost-effective state that includes the adoption of digital solutions for process, safety, and quality improvements. If a given process isn’t already digitized and low-touch, the challenge right now is keeping those employees safe and able to work while still being as efficient as possible.
All industries have been reshaped to some degree by the COVID-19 pandemic, and the microscope is clearly on the pharmaceutical industry as this situation continues to unfold. The stakes are high for pharmaceutical companies, and the immediate steps being taken to increase efficiency and safety in the effort against this virus are laying the foundation for greater awareness and preparedness in the future, forcing a vision of accelerated product lifecycles to become reality.
The companies that successfully combine innovative approaches to product development, partnerships and collaborations with companies and government organizations and agencies, and an increased focus on business continuity practices and safety measures seem poised to emerge either as new leaders in the industry or to have their existing reputations significantly bolstered. This is no small task, requiring attention to everything from business operations improvements and lab process and technology optimizations to personalized treatment regimens and customized patient support programs. West Monroe has specific focus in these areas, meaning we can help bring structure and foresight to both rapid improvements and long-term transformations.