As demand increases across the biopharmaceutical industry, the need for streamlined approaches increases in turn. This has been particularly evident during the pandemic. To overcome challenges associated with this change in demand, companies have increasingly sought to outsource chemistry, manufacturing, and controls (CMC) development services. In doing so, companies have realized that building these successful collaborations can deliver many benefits including reducing the time to market, enhancing knowledge, increasing access to new techniques and technology, improving capacity, and conserving sponsor resources.
The trend in outsourcing has been increasing over the past decade; however, the BioPhorum Development Group realized that many companies approach outsourcing differently. To gain a better understanding of best practices for decision making, governance and management, the group developed a self-survey for outsourcing approaches for both sponsor and contract (development) and manufacturing organization [C(D)MO] member companies. The results of the survey were published in a paper entitled Trends in outsourcing of CMC development services for biologics. The group had also developed a Balanced Scorecard tool from the sponsor’s point of view that is available on the BioPhorum website to aid in the evaluation process when forming a strategic partnership with a C(D)MO.
Insights benefit a wide spectrum of companies
The results presented in the paper will benefit companies across the industry, from sponsors and C(D)MOs, to both large and small companies. According to Kim, “The paper offers a complementary perspective of two different viewpoints from the sponsor and the contract manufacturer. That is something you don’t see very often in the literature. That to me is something that stands out and differentiates it from other papers. Hopefully, this prompts new thinking that the readership will not have considered.”
Participation drives benefits
Companies who participated in the collaboration saw several benefits arise from their participation and many realized that the challenges they faced were similar to those faced by other companies. Vincent Turula, Director, External Supply at Pfizer, explained, “I am a big proponent of participation in these phorums with industry colleagues and peers. Benchmarking is important. Some of the struggles we hear, including those within established companies, are similar to ours.” According to Milano, sharing knowledge through the BioPhorum Development Group and development of the paper offered insights that their company may not have considered previously, and also improved their outsourcing processes. “As a whole, participation in this group has helped guide our approach and speed up implementation of our new model. There is value in learning from what others have done, where they have been successful, or where and what challenges they have encountered. And for larger companies with a well-established outsourced network, I believe the output of this work provides a useful benchmark to see how they compare and where they might see additional benefit or find new ideas,” explained Milano.
The workstream will formally close in February 2021; however, the members have the option to continue sharing their knowledge and continuing the progress they have made through the BioPhorum collaboration tool.
“It is critical to have broad input and the diversity that BioPhorum offers and was successfully captured within the survey. BioPhorum gives you the opportunity to engage a network of consultants at once, including sponsors and C(D)MOs, big and small pharma, biotech companies, all in one place. BioPhorum provides access to a bigger and broader pool to gather this data and feedback,” said Milano.
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