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Susan Haigney is managing editor of BioPharm International, firstname.lastname@example.org.
The COVID-19 pandemic has created a rise in demand for R&D and a shift in focus for some contract organizations.
The first half of 2020 will be remembered for the rapid spread of the SARS-CoV-2 novel coronavirus. As the bio/pharmaceutical industry raced to develop vaccines and treatments, drug companies looked for ways to balance the demands for pandemic-related research and development, while maintaining ongoing development projects for diseases and conditions.
The urgency of new research programs, combined with altered work environments due to social distancing requirements, made contract service providers a viable option for many bio/pharma companies. These contract research organizations (CROs), contract development and manufacturing organizations (CDMOs), and contract manufacturing organizations (CMOs) also faced the challenge of managing existing workloads, changing needs of clients, as well as rapid turnaround to address pandemic concerns. Impacts of the pandemic on the contract services industry-as well as the response-has been varied.
While the long-term impact of the pandemic is too early to understand or predict, says Cindy Reiss-Clark, senior vice president, commercial marketing and customer solutions at West Pharmaceutical Services, some trends have been observed, including delays in clinical trials themselves, development pipeline reprioritization, and finding new ways to connect to patients.
Wilbert Frieling, corporate senior vice president, global discovery services at Charles River, has seen the shift in focus to COVID-19 treatments push work to contract research organizations. “This boost of directly COVID-related work has been absorbed by the flexibility and capacity inherent to CROs. As volume in the market fluctuates, CROs are able [to] easily accommodate increases of work in a short time frame. Also, of course, during this time, other work hasn’t stopped. So, we’ve made a concerted effort to accommodate new projects while maintaining existing programs for other indications,” says Frieling.
Some non-essential clinical study visits stopped or were delayed during the pandemic because of patient reluctance to travel and local restrictions, says Michael Brooks, president, Covance Clinical Development and Commercialization Solutions. “The business has experienced customer-initiated trial delays, limitations and access to certain trial sites, and interruptions to the supply chain,” says Brooks.
But Brooks also sees a healthy biopharma drug development market. “In fact, COVID-19 is likely to strengthen the fundamentals of drug development operations to enable more effective use of data insights, digital solutions, and better patient engagement,” Brooks states. “As countries and regions begin to reopen, we expect impacted non-COVID-19 clinical trials to resume, potentially with more focus on decentralized trial solutions, which can include digital capabilities and mobile nurses/phlebotomists. These trials reduce the need for patients to travel, which for many is a burden to trial participation.”
Contract manufacturers are also seeing an impact. CDMO Recipharm has seen an increase in demand for the production of antibiotics to treat secondary infections in COVID-19 patients, says Erik Haeffler, vice-president, manufacturing services and head of sustainability. “To meet this demand, we are working hard to ensure our facilities can continue to operate while at the same time protecting the safety of our employees,” he says. The company is manufacturing antibiotics in four facilities, taking steps to increase the safety stock of API and raw materials, evaluating shift patterns for existing team members, and recruiting more personnel where needed. “Our safety protocols have also undergone enhancement, with additional risk assessment undertaken and the introduction of workflow adjustments to maximize social distancing,” says Haeffler.
He expects the demand has reached its peak, however, and hasn’t seen an impact on the company’s normal operations because their manufacturing of beta-lactams and cephalosporins occurs in dedicated plants. “While there have been necessary changes to how our business is operating in terms of safety and distancing, our broader business plans continue as normal,” he says.
Inhalation specialist, Vectura, has seen an increase in formulation and analytical services during the pandemic, according to Mark Bridgewater, chief commercial officer, Vectura, including an increase in demand for dry powder inhaler and pressurized metered-dose inhaler expertise and technology platforms, he says.
The pandemic’s impact on the company’s overall business has not been as great as anticipated, however, Bridgewater explains. “Recruitment to clinical trials was initially impacted, but we are seeing a move back towards normality. Priorities have, of course, changed to meet the immediate needs of patients, but it is amazing how robust our society has proven in dealing with the COVID-19 impact. The industry’s resilience has been truly outstanding.”
Catalent, which has facilities in China, Italy, and other areas affected by the pandemic, took steps to track the pandemic and interpret how it may affect the company’s business by setting up a dedicated management team. “We have also had to respond quickly, innovating and adjusting our processes and ways of working to help vaccine innovators around the world to move their COVID-19 projects forward with greater speed, enabling the ingenuity, technology, and manufacturing expertise and passion of our people to come through,” says Elliott Berger, vice president and chief marketing officer, Catalent. Proactive investments made by the company have helped to mitigate the impact of the pandemic on their customers’ products. “For example, well before the COVID-19 outbreak, Catalent announced that it was to spend $200 million to expand capacity for biologics drug substance in Madison, WI, and fill/finish capabilities in Bloomington, IN. Such investments are now helping to accelerate availability of manufacturing capacity,” he says.
The pandemic has changed the way many companies in the pharmaceutical industry conduct business. Contract organizations and suppliers have been adjusting their practices as they also protect their employees, with many implementing remote processes.
“We have been impacted in our ability to support our customers with traditional face-to-face meetings, so we have embraced technology to stay connected virtually. Because West is a global organization, our manufacturing operations and supply chain efforts are aligned with local government guidelines,” says Reiss-Clark. “We continue to work closely with our customers to mitigate any impacts to our ability to deliver goods and services. To date, we have had minimal disruption due to the pandemic.”
Catalent has restricted visitor access to the company’s facilities, limited employee travel, and implemented remote working. “But the pandemic has proven again that ‘necessity is the mother of invention’, and we are trying new things every day,” says Berger. “For example, we have rolled out new wearable camera technology to over 30 facilities in just weeks, enabling our customers to do virtual plant visits and audits, collaborating with us in a very innovative, secure, and interactive manner, as well as allowing our sites to bring together expertise and support from the global network.”
Charles River has moved to a virtual model when working with clients. “Before the pandemic, there was still a lot of personal contact, in-person project discussions, and on-site audits. Now, we are leveraging all types of virtual connections for meetings, as well as virtual site audits. By these means, we have stayed close to our clients and continued to fulfill their needs,” says Frieling. The company is also examining their processes for working with suppliers. “Our procurement team has been monitoring any changes very closely and helped significantly in sourcing the required supplies to keep the business going. This combination of staying close to our clients and managing our supplies allowed us to continue to deliver for our clients,” he says.
Recipharm is also using a virtual model, providing virtual access to its facilities so customers can audit and inspect their services. “This initiative will allow our customers to virtually experience our facilities and capabilities, while simultaneously satisfying their need to review the robustness of our processes. While we are continuously monitoring the impact of COVID-19 on all our worldwide operations, we are also working hard to maintain our number one priority, which is to uphold our responsibilities to all our customers,” says Haeffler.
“Clearly, there has been no physical interaction,” says Bridgewater. “Due diligence and audits have been virtual or paper based. There has been a level of innovative resilience that people and companies have adopted to continue to drive business forward.”
With the health crisis creating an all-hands-on-deck situation, a collaborative approach between health authorities, regulators, pharmaceutical companies, and contractors will be necessary to develop and manufacture effective and safe treatments. “I believe it will take strong partnerships and a holistic approach to expertise and resources in order to develop, manufacture, and fill the vaccines for distribution around the globe,” says Reiss-Clark. “Planning is key. We have to think about the total supply chain and capacity to make the doses required for herd immunity. Everyone will be needed.”
According to Brooks, the pandemic has created a stronger relationship for Covance and its clients, finding common ground with the goals of patient safety and data integrity. “This has also been true of regulators, and we have seen remarkably productive collaborations,” he says. “In addition, we are collaborating with sites on critical patient safety considerations, evaluating the use of Covance and third-party technology to help research sites more effectively manage trial activities, and have deployed enhanced solutions for clinical trials and research sites to lessen the burden on patients, investigational sites, and healthcare providers.”
Frieling believes that outsourcing companies can play a key role in battling the pandemic. “By beginning to outsource research programs, the industry reduces their necessity for constant on-site support, and places that requirement on outsourcing partners, who are equipped and capable to carry out those activities anyway, with expertise across drug development. An increased reliance on outsourcing with a geographic spread will allow the biopharma industry to better continue research under extreme circumstances like we’ve experienced with COVID-19,” he says.
“We think the industry has now realized that we have to realistically assess capabilities and gaps and work closely together to move projects forward,” says Berger. “Catalent has gone to the extent of risking starting work before contracts were finalized and signed, we have repurposed capacity and equipment between programs, we moved to purchase equipment available on the secondary market for the new programs outside the usual budgeting and procurement cycle. We have also created innovate contracting models to account for those ‘at risk’, and if approved, we will need millions of doses in a few months. This flexibility and willingness to work in new and collaborative ways makes a big difference,” he says.
Catalent is helping pharma and biopharma partners prepare for anticipated demand by offering outsourced capacity to complement in-house capabilities, Berger says. “To illustrate this, we are currently helping a customer to prepare for large-scale commercial manufacturing of a vaccine candidate for COVID-19 in Bloomington, and we are partnering with a leading clinical-stage messenger RNA (mRNA) medicines and vaccines company in Madison to support the expected manufacture of an mRNA vaccine candidate against the SARS-CoV-2 coronavirus,” Berger says.
The pandemic will drive an increase in the outsourcing of biologics development, at least in the short-term, says Haeffler, noting that “as vaccine production increases, considerable manufacturing capacity is going to be required to meet the ambitious annual capacity targets for 2021 that are in the region of 1 billion doses.”
Short-term growth created by the pandemic will increase as the development, testing, and manufacturing of these products ramps up, Haeffler says. He also believes there will be a future impact to the industry. “Spurred by the current crisis, the bio/pharmaceutical industry is also likely to see long-term adjustments that will result in increased measures being put in place to handle the threat of future pandemics,” he explains. “I would expect to see greater focus on the development of more collaborative relationships, as well as an increase in pharmaceutical companies looking for partners that can offer the rapid and flexible end-to-end development and production processes necessary to speed products to market in crisis situations."
Vol. 33, No. 7
When referring to this article, please cite it as S. Haigney, “Contractors Balance Increased Demand During COVID-19,” BioPharm International 33 (7) 2020.