The roles of Contract Manufacturing Organizations (CMOs) and Contract Research Organizations (CROs) are growing at light speed as pharma, life sciences and biotech firms of all shapes and sizes discover the benefit of outsourcing key functions in the race to get products to commercialization faster and more efficiently. But unlike the traditional model, in which a company conducts R&D, as well as manufacturing and commercialization in-house, this new services-based model requires a new way of thinking. So what does it take to ensure a good working relationship between a sponsoring organization and the CMO/CRO?
Perhaps the utmost requirement is trust. Both the sponsor and CMO/CRO must trust each other, while ensuring that the lines of communication remain open to ensure that there are no surprises – in terms of timetables, cost overages or in expectations. When a problem arises – whether the information is positive or negative, most people are grateful to know the true story in a timely fashion; yet it’s the delivery that also counts. When hearing of a problem, no one likes to feel like it’s being dumped in his or her lap. Rather, it’s important for the deliverer to explain it, while also providing some solutions – and there are always solutions.
Below are other prerequisites for an effective partnership:
Transparency. Pharmaceutical development is a messy thing and it’s not easy. Historically, there’s a hierarchy with the sponsors, of course, wielding the most power. But even the best intentioned sponsor can have internal problems and difficulty with communication and collaboration. For this reason, transparency is key, and when you don’t have it, things can start to spiral unnecessarily. The CMO has to appreciate that it doesn’t understand what’s going on behind-the-scenes at the sponsor organization. It’s not uncommon to work several months with a sponsor, only to learn that the sponsor has to shut down the project – despite having already invested $1 million; we’ve seen sponsors who, due to budget restraints that may have nothing to do with the project we’re working on, temporarily shut down a project until the next fiscal year’s budget came through – even though shutting down and starting back up added significant delays and costs to the project. By being transparent and letting the CMO/CRO know about possible concerns early in the game, both sponsor and CMO can avoid unnecessary costs to restart the program. It’s important to act like true partners, which can be a challenge internally, externally and financially.
Technology Transfer. Sponsors consistently work with many service providers on different phases of the development lifecycle, so it’s imperative that critical information be shared each step of the way. Aside from legally required disclosures, it’s important that each provider understands the challenges of the others and how they can impact the eventual product. While technology transfer is critical, it’s also important to disclose events/activities that can seem unrelated to the product delivery timetable.
Addressing Mistakes. There are many people involved in a project – from the sponsor’s staff to its consultant and its CROs/CMOs – who can be helpful or detrimental to a project. And because of the people role, human mistakes can happen. Many sponsors, who work closely with their consultants can be quick to blame the CRO/CMO, but it can always be many factors involved in a situation, and no one side always holds the blame. The CMO should be your main consultant. And all parties must understand that mistakes happen, but they need to be looked at realistically. Some mistakes can be minor without affecting the outcome, yet, because of them everything else is often called into question by the sponsor, which delays the entire project. Sponsors must remember that the CMO/CRO will get the work done, at one-third to one-quarter of the time and cost it would take to develop it in-house, building the infrastructure and hiring the staff.
Let’s face it, the market for CMO and CRO service providers is only getting bigger and more competitive. There are many highly qualified firms, filled with expert scientists, chemists and other professionals, but what can be a clear differentiator is the ability to work together with mutual respect and understanding. In an ironic twist, in light of all the scientific advances available today, the most important factor in a successful outcome is the human relationship.
Ed Price is President of PCI Synthesis (www.pcisynthesis.com), a 15-year-old custom chemical manufacturer of new chemical entities (NCEs), generic active pharmaceutical ingredients (APIs), and other specialty chemical products.