I first met Angie Green at the 2013 WTG Global Pharma Manufacturing Summit in Boston. She had recently left The Medicines Company as head of commercial outsourced manufacturing. Angie gave a presentation on the steps sponsors should follow when selecting CMO partners. She had a remarkable understanding of the sponsor/CMO relationship, and it was one of the most informative sessions I attended. Angie was kind enough to offer additional insight for an article on Outsourced Pharma.
The CMO selection steps Angie reviewed are echoed in many of the conference sessions for Outsourced Pharma West—topics chosen by Life Science Leader readers. Green was clearly right on the mark with her suggestions. Take a look at her recommendations and the corresponding OPW sessions below:
1. Set An Outsource Manufacturing Strategy
Relationship Models: Fee For Service to Shared Opportunity
Many companies make the mistake of undertaking the process of identifying an outsourcing partner without any preparation. Angie states, "Every company should discuss and produce a supplier selection strategy. Assigning the task to a project team with an urgent, immediate deadline will basically leave the selection process to chance. This is one of the biggest mistakes I see companies make. CMOs will differ in many ways, including culture, size, capacity, equipment, and expertise. If you do not come up with a plan that outlines which strategic and tactical qualities are important to your firm, the odds of you getting them by chance are slim."
2. Selecting The Right CMO
Matching A Vendor To Your Stage Of Development
CMO selection should be conducted via a designated team including stakeholders with business, technical, and supply chain expertise. "Diversity on that team will strengthen the buy-in for the final selection," says Green. "This group will manage the RFP process and conduct the onsite visits with the final candidates. Be sure to give quality assurance a significant voice on this team, since they will play an important role in reviewing the compliance risk management aspects of the final CMO candidates."
3. Negotiating The Contract
Establishing A Balanced Quality Agreement - Who Controls What?
Price may no longer be top dog when it comes to negotiating the contract. "If pricing is approached as the top priority, with a win\lose mentality, then your company has already lost," she says. “It is always best to negotiate a balanced agreement that is operationally feasible. Be sure to keep asking yourself what kind of customer you will be, because your CMO partner will be asking itself that same question."
4. Properly Managing Your CMO
Managing The Quality Agreement - Best Practices, Benchmarking Your CDMOs Performance
Once the commercial agreements are signed, the next step is managing the relationship with a supplier management structure. Green recommends holding three to four face-to-face meetings per year for each major CMO, especially for overseas partners. Face-to-face meetings strengthen commitment to the product, resolve miscommunication issues, and align priorities.
As Green points out, "No one person can fully understand all of the nuances of a CMO relationship.” More knowledge of these nuances from team members will increase the chance of smoothly executing an outsourcing partnership. We hope the contract outsourcing experts at Outsourced Pharma West will help you to build better and stronger relationships going forward.
Get more information on Outsourced Pharma West Conference And Exhibition