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18 BioPharm International May 2022 eBook www.biopharminternational.com Balancing Internal Focus Against External Capabilities Demand for outsourced services of technical R&D activities is increasing. I n pharmaceutical science, several divergent paths typ- ically exhibit clear validity. Decisions often boil down to embracing instead of eschewing risk, to accelerate as the only priority, or to trust a partner rather than emphasize self-reliance. Each molecule, each company or research group possessing that molecule, has an assortment of strengths and weakness to guard against or to leverage. Multiple factors weigh in the balance when deciding how best to move forward, and increasingly the route chosen is to outsource research, development, and manufacturing. The global contract development and manufacturing organization (CDMO) industry, averaging across several market research firm estimates, is currently valued around $100 billion (1). In part, this growth is shaped through direct regulatory inf luences suggesting, if not demanding, that a drug have multiple sites of manufacture to spread the risk for supply chain planning. Above regulations, companies also seek to reduce the complexity of their operations internally, and to reallocate internal resources most effectively. RISING DEMANDS According to Hanns-Christian Mahler, CEO and board member of ten23 health—a new CDMO that offers devel- opment, manufacturing, and testing services for inject- ables—there are a variety of reasons as to why demand for outsourced services of technical R&D activities is increas- ing. "[Reasons] include a potential lack of internal asset(s) for a given technology and/or specif ic requirement," he says. "For example, the building and operating costs of a sterile fill/finish facility are significant. If a pharma com- pany would not have sufficient molecules in a portfolio that would benefit from being manufactured in that facility, the costs could be quite prohibitive, and outsourcing is surely much more cost efficient." CHRIS SPIVEY Partnerships for Outsourcing Development m.mphoto - STOCK.ADOBE.COM