Successful outsourcing offers solutions to increased demand across the biopharmaceutical industry

newsMar 1, 2021 | Phorum : Development Group | News

As demand increases across the biopharmaceutical industry, the need for streamlined approaches increases in turn. This has been particularly evident during the pandemic.

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.

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Daniel Milano, Associate Director, Antibody Drug Conjugate Development and Manufacturing Outsourcing from ImmunoGen explained, “For our company, the decision to go to an outsourced model was a significant one but it was consistent with what has been seen in the industry, with many companies moving in this direction in the last several years. We have learned quite a bit from participation in the workstream, and I believe other companies who are establishing an outsourced model can get a good sense of what it takes and what the benefits and trade-offs of outsourcing are from the survey and paper.”
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Andrew Kim, Associate Director, Downstream MSAT at Samsung Biologics added, “We want to properly manage common risks. For an organization who has less experience, what is common may not be so obvious. So hopefully this paper can help make those common risks more visible. One aspect that stands out for me is hidden costs. It is easy to focus on the upfront costs, especially for those who are less initiated, but then there are also hidden costs that a client or sponsor may not be aware of.”

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.”
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Firelli Alonso, Senior Director, External Supply at Pfizer added, “For Pfizer, this will validate our strategies that we use in our outsourcing group. For others, especially small biotech companies, they can definitely learn from the findings of this work.”

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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