What will be the future of pharmaceutical outsourcing? What factors will influence the relationships between sponsor companies and contract service providers and what practical solutions are both seeking? These questions were addressed at a conference this week in Philadelphia, Bio/Pharmaceutical Manufacturing Partnerships, organized by CBI in conjunction with Pharmaceutical Technology.
Panelists described how pharmaceutical companies are using outsourcing to respond to changing fundamentals: namely, greater globalization, increasingly complex supply networks, emerging-market opportunities, and ongoing cost pressures. At the same time, pharmaceutical companies and their suppliers are tasked with how to better manage their relationships to mitigate risk, secure supply, and consistently manufacture a quality product. Sponsor companies spoke on how CMOs are an integral part of their supply networks, and as such, strategies for greater collaboration, improved information-sharing, and innovation are ever-more important. Some key take-aways from the conference are:
Increasing transparency between CMOs and sponsor companies. Dan Matlis, president of Axendia, shared results from his company’s recent research on the impact of globalization and the issues pharmaceutical executives are most concerned. An overwhelming majority of executives expect that their sales outside the US to increase and their sourcing outside the US to increase. The elongation of the supply chain, however, is accompanied by certain concerns: sourcing raw materials outside the US, increased external manufacturing, and possible implications on product quality.
To alleviate those concerns and for better management of supply networks, Matlis discussed the need to create “on-demand visibility” between CMOs and sponsor companies through better information-sharing in the form of more timely access to detailed project information, real-time information sharing, track-and-trace capabilities, and other collaborative tools. This point was further expounded by Shabbir Dahod, president and CEO of TraceLink, who explained how cloud and business collaboration tools can increase visibility across all external supply relationships, create access to accurate and timely data, and foster cross-functional and cross-company collaboration. The conference also featured perspectives from CMOs (DPT, CMIC, and Kemwell) on the value and ways to optimize communication and transparency between CMOs and sponsor companies, manage expectations, and evaluate performance.
Regulatory challenges. Marlene Swider, quality manager, FDA echoed the challenges of globalization on the pharmaceutical industry and provided an overview of the agency’s efforts in addressing globalization, including expanding FDA offices overseas, applying risk-based approaches in overseeing product quality and inspections, and collaborative efforts between regulatory and other bodies, such as the Pharmaceutical Inspection Co-operation Scheme (PIC/S).
Emerging markets. In the globalization of the pharmaceutical industry, emerging markets are increasingly important, and Thomas Salus, associate vice-president of business development of contract services for Wockhardt, examined the role of CMOs in emerging markest. A key point made was how CMOs in developing markets play a crucial role in the in-country strategy of a pharmaceutical company in accessing local markets, thereby moving certain CMOs’ value beyond just advantages of lower-cost production.
External manufacturing networks. The value and interdependence of CMOs and pharmaceutical companies in executing the manufacturing and supply strategy of a sponsor company was further discussed by Amelia Mutere, audit response manager, GMP compliance, Americas and Canada with Roche’s Genentech.
Systematic approaches to CMO selection. Jerilynn Carroll, operations manager, external manufacturing, Covidien, provided insight into the due-diligence and CMO selection-process as a means to build effective long-term partnerships by applying a systematic approach in assessing partner capabilities, defining project scope and the related expectations, and setting performance goals.
Value-based procurement. And Gregg Brandyberry, formerly vice-president, procurement, global systems and operations with GlaxoSmithKline and now senior vice-president with FedBid, an online marketplace, explained how procurement has evolved in the pharmaceutical industry to a more strategic, value-based function and how certain tools, such as online marketplace, particularly in the purchase of indirect goods and services, can be used to deliver that value.