As Omicron cases continue to decline and hopes for a return to normalcy rise once again, it's tempting to let your guard down. However, Robert Kramer, CEO of Emergent BioSolutions, cautioned that now is the time to plan and prepare for the next public health threat. "We cannot assume the next pandemic, or even the next phase of this one, will be the same. We need to take an expansive view of potential public health threats and create the capabilities to respond. That work should begin now, before the next crisis takes shape, and Emergent stands ready to do so" Kramer said.
As a contract development and manufacturing organization (CDMO), Emergent has been working for more than two decades to develop, manufacture and deliver protections against public health threats and deliver vaccines and therapeutic products for clients. In its work with biopharma and biotechnology businesses, as well as government and nongovernment organizations, Emergent provides the technology, expertise and talent to help quickly and efficiently ramp up manufacturing and development for its clients' products. During COVID-19, Emergent deployed new processes, and technologies to manufacture novel coronavirus vaccine and therapeutic candidates for CDMO clients. That experience has doubled as a learning opportunity for the future. Below, Emergent team members reflect on lessons learned through COVID-19 and share four considerations to help prepare for the next public health threat.
1. Establish relationships with outside partners, such as CDMOs, early
Well before a crisis strikes, you need an action plan and partners in place. Jon Lenihan, Emergent's head of sales and business development, CDMO business, said that it can take considerable time and effort to find the right CDMO partner. You need an organization with technical competence, relevant experience — including experience operating in a pandemic environment — and available capacity, that is also a good cultural fit. "The more time you have to thoroughly evaluate these criteria, the fewer compromises you may have to make," Lenihan said. "There tend to be far more options available to companies that begin their search early."
When staring down the next public health threat, Lenihan said, a well-vetted team could be the key to making a lasting impact. "Securing the necessary expertise, capacity and materials can mean the difference between a promising product making it to the patients that need it and an equally promising product that never makes it to production," he said. "Good science alone doesn't guarantee that a product will be successful. It takes a network of suppliers, manufacturers and other partners whose activities are closely coordinated."
2. Establish strong partnerships with regulators, and understand the CDMO's regulatory offerings
It's important that biopharma businesses know the regulatory landscape — including which global regulators they'll be working with — but also understand that in a time of crisis, that landscape can shift. "We saw during the COVID-19 pandemic that guidance and orders were issued and updated on a regular cadence across the globe; monitoring and seeking to understand this in real time is important to ensure your assumptions are correct and remain true," said Karolyn Gale, Emergent's senior director, regulatory affairs. Gale added that when developing and/or manufacturing potential vaccines or therapeutics, it's important to seek feedback and engage early with regulatory agencies, because written policies may not include all considerations necessary to satisfy the statutory and regulatory requirements for licensure.
For organizations working with a CDMO, Gale said, it's important to inquire about how both parties will work together and understand their respective roles with global regulators. Regulatory offerings may include areas such as inspection readiness, hosting inspections, source document creation, document review, document provision and/or filing support. Biopharma businesses should also discuss specific deliverables and timelines with CDMOs when it comes to filings so there are no surprises. "A true partnership between both the CDMO and the sponsor is needed," she said.
3. Know and understand your supply chain
COVID-19 laid bare the vulnerability of supply chains. Looking ahead, businesses must prioritize building strong partnerships with suppliers and establishing supply chains that are agile and robust enough to rapidly respond to an organization's growth, said Stephanie Malone, director, supply chain, with Emergent. Malone said a successful supply chain must be adaptable, scalable and redundant to respond in a timely manner to the needs of their stakeholders. "Failure to adapt can result in a loss of confidence in the organization and the inability to support any new unplanned demand. Continuity of operations is dependent upon supply chains' holistic approach to their planning activities," Malone said. By understanding the supply chain from end to end, a biopharma business can identify pain points and make adjustments and contingency plans early on so they're not caught off guard in a crisis.
4. Stay up to date on technology
To hit the ground running, it's imperative to have the latest tech and tools at the ready. Lenihan said that many biopharma businesses opt to work with CDMOs for that very reason: Emergent, for example, offers its partners diverse technology platforms to help build customizable solutions at scale. "Experienced CDMOs tend to see a broad cross section of technologies and processes and can offer valuable insights that might not be apparent to innovators who only have experience with a single process or technology," he said. "An experienced CDMO may be able to identify failure modes more proactively or identify gaps in critical process parameters because they have worked on similar projects or with similar production technologies in the past."
Over the last two years, we've all seen the world change with barely a moment's notice. This certainly isn't the first time we've navigated a public health threat, and it won't be the last. By aligning with the right partners today, we can best prepare our scientific, manufacturing and logistical capabilities, so they're ready when needed.