Maintaining a relationship, be it friendship, marriage or otherwise, requires hard work and open communication between two individuals to be successful. Personal relationships also face numerous challenges, and, at times, can be severed by both parties for a myriad of reasons.
The relationship between a client and a contract manufacturing organization (CMO) can be compared to a personal relationship, as expressed by numerous presenters at the PDA Outsourcing/Contract Manufacturing conference held in Berlin last December.
The comparisons to human relationships began immediately on the first day. Firelli Alonso-Caplen, PhD, Senior Director, Pfizer, opened the conference with her keynote presentation, “Outsourcing in the 21st Century: ‘Partnersourcing’ and Beyond,” reminding participants that you never really know a CMO until you have done at least one project with them, similar in a way to dating. Morten Munk, Senior Technology Partner, NNE Pharmaplan, then compared it to a marriage and pointed out that like a marriage, it could end in divorce or could have many anniversaries and celebrations. During the keynote, attendees learned about Pfizer’s multimillion dollar experiment where the company selected two CMOs and invested in both by giving each the same project to complete within 15 months of receiving cell bank vials; ultimately, Pfizer’s senior management selected the CMO that met the most important of their selection criteria (several dozen weighted metrics).
Following this fascinating talk, Siegfried Schmitt, PhD, Principal Consultant, Parexel, provided some different CMO/client business models while William Downey, President, High-Tech Business Decisions, offered some interesting examples of pricing options. Next, Philine Dobberthien, Senior Project Manager, Customer Business, Boehringer Ingelheim, shared some hard and soft facts (Table 1). The hard facts she listed can be considered elements important to achieving a successful relationship between a biopharma company and a CMO; the soft facts are characteristics inherent in a CMO/client relationship that lead to a higher probability of success in the endeavor, not dissimilar to the concept of “soft skills.”
| Table 1 Hard and Soft Outsourcing Facts |
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Other speakers discussed the advantages and disadvantages of micro- and macromanagement. These speakers also recommended paying attention to organizational resilience—the ability to survive adverse situations, understand the brutal reality of a situation, maintain cherished values or set new ones and be resourceful and adaptable in shaping the future.
There was also some captivating discussion about the Person in Plant (PIP). Apparently, at some sites these individuals have been referred to as “spies” who report back to their company’s headquarters without first discussing concerns with the CMO. This led to attendees discussing the nature of the PIP—a discourse still ongoing in the Management of Outsourced Operations Interest Group discussion forum of PDA ConnectSM.
Some include the PIP in the Master Services Agreement. The person has to know the process, i.e., all aspects of the project, and has to be empowered to make decisions on the spot. English is often not the primary language, so the PIP sometimes needs to give correct translations. Not every CMO allows a PIP.
Other presentations focused on specific areas of concern for external service providers, such as transitioning from phase I/II to commercial manufacturing, single-use systems, customized packaging solutions for speeding projects through CMOs with less concerns for highly potent drugs and faster access to clinical sites and refurbishing ageing equipment and cleanroom pods.
PDA will hold another Outsourcing/Contract Manufacturing conference in Copenhagen for Nov. 17–18. For more information, please visit https://europe.pda.org/outsourcing2015.
About the Author
Karen Ginsbury is President and CEO of PCI, Pharmaceutical Consulting Israel Ltd., a company which provides services to the pharmaceutical, biotech and allied industries.