BioPharm International - May 2021

BioPharm - Partnerships for Outsourcing - May 2021

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6 BioPharm International eBook May 2021 a significant driver to expand capacity and capabilities for CDMOs and CMOs today," he asserts. The M&A of companies with dif- ferent capabilities along the value chain offers the potential for a CDMO to become more vertically integrated, Grippo says. With vertical integration, CDMOs would have the ability to offer all the services along the process, pro- viding the potential for increased trans- parency between stakeholders, which ultimately should reduce risk. Yet, it is not as simple as buying a new asset and then marketing an integrated offering, Grippo explains. "The acquiring com- pany will need to work closely with the acquired company to align processes, so that the customer experience is stream- lined, otherwise to the customer, it will still feel as though it is working with multiple partners," he says. "There should be a clear vision for how the new company or technology will be incorporated into the corporate strat- egy and customer experience after the sale is closed," he adds. IMPORTANCE OF FLEXIBILITY F le x ibi l it y i n d r u g de v e lopment and manufacturing has always been important for success, but this f lexibil- ity is even more so important in today's biopharmaceutical climate. "Even when the world is not experiencing a global pandemic, the journey from f irst-in- human studies to market and beyond is often unpredictable," says Grippo. For instance, a side-effect observed in clinical trials may result in the opportunity to repurpose a drug for a new indication, or perhaps a faster uptake in the market may result in higher commercial demand than orig- inally forecast. "CDMOs need to have a collaborative mind-set when work- ing with their customers and must understand sponsor companies' evolv- ing needs, while doing their best to offer f lexibility in scale, scheduling, and technology to support a program through its entire lifecycle," he says. With uncertainty plaguing the bio/ pharmaceutical supply chain as well as the global economy in today's climate, it is important for CDMOs to have the foresight to predict issues and the flexibility to mitigate risks for their cus- tomers, Grippo states. Having f lexibil- ity includes digging deep into CDMO supply chains and establishing suff i- cient stocks and secondary suppliers. "[CDMOs] should overcommunicate when needed to ensure that sponsor companies understand the risks and the options for their program and leverage all internal expertise to find creative solutions to problems that may crop up during this unique time," he adds. FROM A CRO POINT OF VIEW On the other end of the spectrum are contract research organizations (CROs) that are pursuing potential beyond the research/pre-clinical stages. Charles River Laboratories International, for example, acquired Cognate BioServices, a cel l and gene therapy (C& GT) CDMO, in an $875-million deal that closed in late March 2021 (2). " The C& GT ma rket is rapid ly expanding, so there is a need to support not only our clients, but also the patients who are waiting for the development of critically important therapies. The team at Cognate shares Charles River's commitment to delivering treatments to patients as quickly and safely as possible. This shared value system is incredibly important," says Birgit Girshick, corpo- rate executive vice-president, Discovery and Sa fet y Assessment, Biologics Testing Solutions, and Avian Vaccine Services at Charles River. For Charles River, the acquisition of a CDMO provides it with a "one-of-a- kind portfolio" that integrates aspects of both a CRO and CDMO. Having this portfolio lends the company the ability to support projects throughout the spec- trum of drug development, from early research through to a commercialized drug product, Girshick says. "The man- ufacturing process is driven heavily by relationships and scientific quality. For our clients in this space, who have devel- oped a level of trust with their team at Charles River, the integration of Cognate will allow them to continue working with the same provider through the preclinical manufacturing stage and expect the same highly scientific approach," she adds. In searching out acquisition candi- dates, Charles River noted that, first of all, its teams and the team at Cognate share several important values: a dedica- tion to scientific excellence, a commit- ment to patients, and a high standard of client service. Second, over the past several years, Charles River has made several acquisitions in the C> space to expand its portfolio. "The team at Cognate shares our goal of being the pre- ferred single-source partner for our cli- ents' programs, and together we believe we have the most robust portfolio in the industry," Girshick asserts. "Our clients are racing against time— they are working as quickly as possible to develop safe, effective therapies for patients who critically need them," she further emphasizes. As a partner, Charles River's role is to provide strategic guid- ance and service while constantly work- ing to improve speed to market. "We've grown our portfolio to provide our clients with a comprehensive service offering and access to industry-leading technol- ogies so they can work with a single provider, with the ultimate goal being to reduce their drug development time- lines," Girshick states. Thus, the growing global market for innovative bio/pharmaceuticals will con- tinue to push for CDMO capabilities that will require f lexibility, integrated technical and scientific expertise, and reliable partners. REFERENCES 1. PricewaterhouseCoopers, Current Trends and Strategic Options in the Pharma CDMO Market, www., November 2019. 2. Charles River Laboratories International, "Charles River Laboratories Completes the Acquisition of Cognate BioServices," Press Release, March 29, 2021. BP Partnerships for Outsourcing Manufacturing

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