How Pharmaceutical Companies Choose A CDMO: Part 1
By Life Science Connect Editorial Staff
How do pharmaceutical companies find the right CDMO partner? 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 1 of this conversation details how these experts weigh selection, technology, and service when evaluating CDMO partners. To learn how the CDMO’s talent can make or break the selection process, read How Pharmaceutical Companies Choose A CDMO: Part 2.
How To Begin The Selection Process
Locke shared that looking for a CDMO begins with an internal assessment. For example, a small company with only a few employees will need help with both development and project management while larger companies may only need to outsource manufacturing. When creating IP for a clinical trial, companies ask themselves questions such as, are we looking for a U.S.-based trial or operating global trials? Is this a first-in-human investigational product? Are we looking for commercial manufacturing or only interested in a company that can create enough IP for Phase 1 clinical trials? He notes that specialty manufacturers, such as those that make gene therapy plasmas, are harder to find. Hughes added that smaller companies who lack the bandwidth to find the perfect CDMO could benefit from turning to a consultant to help them choose the right partner.
"The first question I ask is, ‘How much development is needed?’" offered Hughes. "Do you need to engage an operation with a robust development process, or do you have a mature project, and you're looking to tech transfer and continue manufacturing based on the development you've already completed? These questions help narrow your choice of vendors."
Valentino pointed out that the CDMO is not there to make decisions for the sponsor or do their CMD selection, and even if a sponsor delegates responsibility to the CDMO, ultimately the sponsor is responsible for the outcome. However, if the sponsor is a small company that needs more guidance and help from the CDMO, they should be honest about that upfront to ensure that the CDMO can help them. Likewise, it's important to remember that CDMOs are manufacturing experts with experience in multiple therapeutics, and sponsors should consider their recommendations. Having mutual respect and listening to their advice about equipment, research, or other aspects of the manufacturing process can help companies avoid mistakes.
To determine if a CDMO is trustworthy, Prasanna advises companies to rely on data. For example, if one CDMO promises to complete the work in six months, but everyone else says it will take 18 months, then the six-month quote is likely unobtainable. Similarly, a CDMO that offers significantly lower prices than their competitors may not be providing realistic information, or they don't fully understand the project's specifics. For example, if a company's RFP is not as thorough as it should be, a CDMO’s projections can be faulty, too. The panel also agreed that establishing transparency from the beginning creates a mutually beneficial partnership.
"That relationship is a two-way street, and honesty pays dividends throughout the process," stated Locke. "And people will change. I may change my role or bring in someone else, and it's the same on the CDMO side. How well a handoff goes depends on the relationship we've developed."
How To Weigh Technology And Service
“The ‘C’ in GCMP means ‘current,’ so I look for companies that are adopting new or next-generation technology versus proven historical practice,” explained Hughes. “Much of my experience has been in the parenteral space, and aseptic processing is key. Regulators rigorously review this process, pushing the industry to adopt full isolator fill finish operations. And so, it's not enough for a company to have a historically good record with regulators; they need to be up to date, too."
Prasanna agreed that a CDMO's technological expertise is a "must-have" in drug development. Locke added that his company wants their resources at the manufacturing site in the cell therapy space, where every patient is a batch. However, problems can arise with internal or external manufacturing systems, and companies need mitigation plans to handle them.
Finding a CDMO that can meet your company's expectations also involves setting clear expectations from the outset and asking for realistic timelines. For example, Locke explained that Charisma Therapeutics' autologous cell therapies prioritize rigid turnaround times for the sake of their patients. Having firm deadlines for the drug product, batch record reviews, and quality reviews is essential to providing reliable patient care. CMOs must be realistic with project management milestones and fulfil their promises to maintain good relationships with pharmaceutical companies.
However, Locke acknowledged that pricing can be challenging for CMOs working in the cell and gene space because they may not know the final costs until they fully understand the company's process and final product. Therefore, having regular, transparent communication from both sides is essential to establishing and maintaining a positive working relationship and working through potential problems or areas of disagreement.
“I go into my relationships with CMOs with the idea that I don’t want to be their least favorite customer,” Locke elaborated. “If you’re their most painful customer, hyper-aggressive and always finding fault with them, the boots-on-the-ground people will not want to work with you. Remember that sometimes you will need them more than they need you, so show appreciation for the folks doing the work, whether they’re in manufacturing operations or QA doing behind-the-scenes tasks. Every role is critical."
Hughes added that building a partnership with CDMOs is also a matter of choosing the right-sized operation for your company. Smaller companies may worry that their vendors prioritize their commitments to larger companies. However, if you're looking for a long-term commercial manufacturing partner, that will also affect your relationship with the CDMO. Prasanna emphasized the importance of first assessing your organization's internal capabilities to determine what exactly you need from a CDMO, such as manufacturing or end-to-end service, to set realistic expectations.
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 2.