How Pharmaceutical Companies Choose A CDMO: Part 2
By Life Science Connect Editorial Staff
Pharmaceutical companies rely on CDMOs to create leading-edge therapeutics, but the CDMO field is crowded and highly competitive. How can companies choose the right partner and guarantee success? The answer involves weighing many variables to find the best fit for your product, whether working with small or large molecules or creating advanced biopharmaceuticals.
Outsourced Pharma chief editor Louis Garguilo asked Kenneth Locke, vice president of manufacturing and supply chain at Charisma Therapeutics; Jo Anne Valentino of Valentino Consulting; Marty Hughes, former Novartis executive director and senior director of technical operations for Sera Therapeutics; and Praveen Prasanna, senior director of external manufacturing at Verve Therapeutics in Which CDMO Is Best For You? Part 2 of this conversation discusses how the CDMO’s talent can make or break the selection process. To learn how these experts weigh selection, technology, and service when evaluating CDMO partners, read How Pharmaceutical Companies Choose A CDMO: Part 1.
How To Evaluate Talent
"Securing, training, and retaining talent is a challenge in the CDMO space, but the importance of project management is the most important aspect when we evaluate talent," explained Hughes. "You can have good people at the CDMO making progress on the product, but if you don't have a project manager who is communicating progress in a timely way, keeping you in the loop, you're at a disadvantage."
Locke agreed that effective project management is a critical issue in selecting a CDMO, as is establishing a productive relationship with their project managers. However, project management needs vary by company. If a company has an internal CMC who provides technical knowledge, they can be paired with a resourceful project manager on the CDMO side. But if the company also needs technical support, it needs a CDMO partner with both scientific knowledge and project management skills. Clear communication, such as shared project management documents, is crucial to effective collaboration.
"You need to get boots on the ground as part of your evaluation period," Locke explained. "Get to know the CDMO. If they come to a meeting and don't bring any of their technical people, you should start worrying. You want to meet the people who will work on your project and start building those relationships early on.”
Valentino agreed that the CDMO should bring the people who will work on the project to the initial meetings rather than only sending salespeople. She added that companies also should consider what kind of partnership they want with their CDMOs. Some companies want to be on-site with the CDMO and understand the day-to-day operations, while others want to outsource manufacturing without getting involved in the CDMO's daily operations. Another issue to consider is whether your company is looking for a long-term partner that can grow from clinical trials to commercialization or if you’re only interested in a short-term transactional relationship to produce small batches of the IP.
"Being honest with yourselves as a sponsor company and with the CDMO is critical as you go through the RFP or RFD process," Valentino elaborated. "You're looking for a company with the right technical and financial fit, and you're looking for delivery, but you're also looking for a cultural fit. While that's hard to measure, you need to consider the level of partnership you want. If you're a big pharma company, and you're coming to a tiny CMO, can they give you what you need? Or, if you're a small biotech, and you're trying to get the attention of a big, multinational CDMO, will you get what you're looking for?"
Companies should also develop an intentional strategy for creating contact points with the CDMO and letting them know how often they will meet with them and who will attend the meetings. Similarly, asking CDMOs about their attrition rate and their plans for managing staff turnover helps manage expectations. Clarity and reliability are crucial for both sides of the relationship.
Final Thoughts
Ultimately, selecting the right CDMO is a subjective process that differs for each company, depending on its size, therapeutic area, internal capabilities, and needs. The panelists agreed that creating and maintaining positive relationships with the CDMOs is just as crucial to success as selecting one based on price and capacity.
"Often, CDMOs know our processes better than we do because they're running it, especially for a commercial product that is run on a routine basis," Prasanna explained. "So, listening to them is important because they've worked in many different areas and can point us in the right direction when deviations arise. Treating them with respect as partners creates a mutually beneficial relationship."
Our panel of experts for this edition of Outsourced Pharma Live were Martin Lehr, co-founder and CEO, Context Therapeutics; Kurt Nielsen, PhD, Senior Advisor and co-founder, Longview Leader; Antiksha Joshi, Director, Urmi Quality Management Consulting Pty Ltd.; Brian James, PhD, COO, Rondaxe Pharma LLC; and Perry Calias, PhD, Pharmaceutical Development Consultant and co-founder, Educational Trainers and Consultants. To learn more, watch the Outsourced Pharma Live event here. To read about how these experts evaluate selection, technology, and service, visit How Pharmaceutical Companies Choose A CDMO: Part 1.