By Bernhard Paul
As you are reading this, the Life Science Leader CMO Leadership Awards have been presented for the ninth time. This is always an exciting event for the industry. Sponsors get to see how their partners are performing and CMOs find out whether their continuous improvement efforts have resulted in increased customer satisfaction.
What’s unique about the CMO Leadership Awards is that all responses come from individuals who have done work with these CMOs within the last 18 months. In an industry that changes rapidly and has been through a lot of consolidation and employee turnover, this is important. The company that you worked with five or 10 years ago might be a completely different organization today, so it’s important not to let prior impressions influence today’s assessments.
Having said that, if you look at who has been honored over the last few years, there’s a clear trend of companies that are near the top every year. Despite all the changes, some companies deliver outstanding service year after year.
TAKING THE NEXT STEPS
For any upcoming project that requires a CMO, looking at the list of awardees in the various categories is an excellent start, as these organizations have been rated highly by actual customers. But just as when you select a hotel, a contractor, or a tax professional in your private life, reviews aren’t where the selection journey ends. Recognitions such as the CMO Leadership Awards allow you to narrow your initial selection to a smaller group, or they provide an extra data point when comparing one supplier against the other.
Before taking the next steps, it is important to carefully consider the requirements of your particular project and company. While there are, of course, many such considerations, I have highlighted two specific ones that come up frequently in outsourcing discussions.
HANDS-OFF OR HANDS-ON?
One item of importance when considering a new outsourcing relationship is your preference when it comes to ways of working. Some customers are hands-off and are merely interested in the outcome (e.g., the material deliverable). If that fits your way of working, you should consider what strengths you need within an organization so they can deliver a project autonomously. Do they have the know-how, systems, and procedures to operate independently?
I remember a project where our customer was a tiny company led by Jim, an individual without any chemistry background. Jim was the CEO and COO, and he also led BD and strategy. Given his background and multiple roles, he had no interest in detailed project updates or in-depth discussions about reaction conditions or analytical data. Jim just needed the material to be ready by a certain point, and he required a company that could handle all of that independently and deliver the product on time.
Or, are you someone who wants to be involved in the decision-making, look at raw data, and be actively engaged in the project execution? In that case, you should discuss this with your potential CMO up front to make sure that your outsourcing provider is not only comfortable with such an approach, but also has the project management skills to provide you with information in real time and make you an active part of the project team. You might also plan to spend considerable time in their plant while operations are being conducted. I have worked with several industry veterans who routinely spend weeks at their manufacturing partners’ facilities during validation campaigns. Some CMOs readily accept this, while others are unwilling to host customers at their site for extended periods of time, so it’s essential to discuss this up front.
"Before you enter into any outsourcing relationship it’s important to consider how likely it is that your plan or timelines might change significantly."
HOW LIKELY ARE THINGS GOING TO CHANGE?
Early in development, processes and requirements constantly change. Synthesis and dosage form are still being developed, and little is known about the drug and its properties. As a result, there are often multiple changes in terms of requirements, and the timelines change constantly. For example, the amounts of drug substance and drug product required might change dramatically, or certain deliverables suddenly need to be expedited. As projects move toward the later phases of development, things typically settle down somewhat and become more predictable. However, it is not always just the phase of development that impacts project plans. For certain projects, a customer might consider multiple clinical designs or pursue several indications in parallel, which might lead to changing requirements even in the later phases.
Before you enter into any outsourcing relationship it’s important to consider how likely it is that your plan or timelines might change significantly. Some CMOs are excellent when it comes to steadily executing a static and well-defined plan and, in such an environment, they provide high-quality products that are delivered on time. But that same company might struggle to accomplish a project where requirements change multiple times.
I remember a project with a CMO where the goal was to produce an intermediate on several hundred-kilogram scale. The material was needed for inventory and was not used immediately, so there was plenty of time available. Our CMO partner had very thorough new product introduction processes that included a regimented scale-up approach. The scale-up took a long time, but the company produced excellent quality material. As a result of the positive experience on this project, the sponsor wanted to go back to them for a second project that had a very aggressive timeline. Unfortunately, that second project didn’t go so well. The same robust procedures that proved so valuable on the first project proved to be a hurdle when speed was the critical parameter. And the plant that was very efficient at producing multiple batches in a row required lengthy process changeover procedures between steps that impacted the overall timeline. While the material was eventually synthesized just in time, this CMO struggled to deliver in a setting where speed was the most important factor.
On the other hand, some companies excel in terms of speed and flexibility, but they might lag in other areas. It all comes down to what’s most important to you. And remember the old saying: “Price, quality, and speed — you can pick two.”
FACTORS TO CONSIDER
There are many considerations when it comes to selecting a partner. Cost is always a major factor, but it’s important to also consider some of the other project requirements and how well they match the skills of any particular CMO. Also, we’ve enjoyed a lengthy period of strong market conditions with a continued influx of funding for biopharmas. As a result, many new biopharmas have emerged, and existing company pipelines are full. As a result, many CMOs are very busy — and plants can be full for months and even years — so plant availability can become a critical decision factor as well.
When it comes to creating successful outsourcing relationships, selecting the right partner in the beginning is the critical first step. The CMO Leadership Awards represent a unique opportunity to recognize industry leaders, and beginning your search for your next partner with these companies is a great start. Build on this by considering your preferences and requirements, and you’ll be in a great position to set up your next project for success.
Finally, use your network in the industry to find out what experiences others have had with a particular company. As with hotels and contractors, nothing beats a personal reference from someone you know and trust.
BERNHARD PAUL, PH.D., is the founder and principal consultant at Carinth Consulting, a chemistry, manufacturing, and controls (CMC) consulting firm based in the Boston area.