Life Science Leader is read by more than 25,000 pharmaceutical executives. It is a prominent print and online media outlet and as such regularly surveys its audience. The surveys show that the pharma industry regularly struggles to efficiently vet potential CMO partners. To address this issue, the media outlet developed the CMO Leadership Awards. Respondents vote only for the CMOs they have outsourced projects to in the past 18 months.
Year after year, including this year, SEQENS North America (N.A.) – formerly PCI Synthesis – has been privileged to win awards in each of the six leadership and six attribute awards categories. Practically speaking, what does that mean for sponsors?
This article will discuss the ramifications of one of this year’s attribute award, Accessible Senior Management, in which SEQENS N.A. was named among just a handful of Top Performers.
A sponsor’s size doesn’t matter: all sponsors have the same concern when outsourcing to a CMO. Whether big or small, whether a single molecule startup or a multinational with a deep drug development pipeline, all drug developers want their project to be a priority. Meeting timelines is critically important, as it impacts costs and initiation of planned clinical trials. With novel drugs, there’s a first-to-market race too.
Underpinning this concern is the question, “Am I going to get as much attention as another company’s product?”
Rest assured, at SEQENS N.A. the answer is “Yes.” And that’s one of the reasons we received the Access to Senior Management award.
Just about everyone appreciates that CMOs are complicated, with >100 people working if they manufacture APIs, functional foods and other GMP materials as we do. Unlike a commodity business that spits out plastic corks, ours is a messy business. Things don’t always go according to plan when it involves new chemistry. As well there are always several groups working and a problem can arise at any time during a project.
Difficult decisions need to be made. Go or no-go. Or the need to add budget to overcome an unanticipated challenge with the chemistry of a promising drug candidate. Or the need to fast-track the project to meet timelines.
In such circumstances, knowing you have access to senior management during these critical times is reassuring. At SEQENS N.A., your project will get attention when it’s needed. You are working with a CMO where every sponsor is equal. With their vote, our customers acknowledged that they know they will not be shortchanged. All our customers are aware we’re not saving our resources for someone else, pushing them aside for a larger company or for someone paying more. Many of the votes we received came from Big Pharma sponsors, whose teams choose to work with us because of the access and rapid problem solving that keeps projects on track. We owe much of this to our superbly experienced Project Managers and involved, experienced management team.
I’ll share an observation with you as to why we give everyone equal access to top management, and why we don’t take the approach of “Oh, it’s Big Brand Name Pharmaceutical Company, let’s push their project ahead of others.”
Big Pharma is often price driven. We’ve seen in our industry that they will drop a CMO at a moment’s notice if they think they can get something done cheaper elsewhere. Yes, they’re under great pressure to reduce the cost of drug development, but this is a business where you truly get what you pay for, where experience and know-how ultimately saves money.
That’s why we’ve never treated large multinationals any differently from smaller companies. Our experience has been that the best relationships, the most collaborative and the most productive have been with companies that appreciate what we’re doing for them, who realize the role and importance of what we do.
Management gets involved when there’s a problem that can’t be resolved. These tend to fall into three categories:
Usually it’s a money issue. Perhaps a company has spent a good amount of money for R&D and analytics. The project is slated for six to eight weeks in the manufacturing suite. However, in the GMP plant, despite precautions such as kilo lab scaleup, a process impurity crops up.
Many sponsors understand these things happen. Because it can involve the need for additional expenditures, this is a problem where top management can step in to resolve the issues with the project and create value.
Another major issue is timelines. People come to me when they’re up against the wall and it is truly critical for them to get a sample by a certain date. They ask for our help. Fact is, at SEQENS NA, you can go to senior management and request that we prioritize the project —and we will make every effort to help and accommodate, assuming another project can wait with no negative consequences.
We also will do what is humanly possible to get things done. Work late. Add another person to the project. Get it done, no matter what it takes. That’s our culture.
When management needs to step in, the first thing we do of course is assess the situation. We go through our decision tree, understanding as best we can why a problem occurred. One of the first questions we ask is, “Did we make a mistake?” If we did, which does happen in rare circumstances, we take full responsibility for it and cover the cost.
At our shop, senior management is always active. Sponsors don’t see the daily huddles that go on talking about their project, or the weekly production meeting where we dive into how the project is proceeding and don’t leave the room until decisions are made and people assigned. We believe such extensive senior management involvement is atypical in the CMO world.
The involvement of top management when problems arise is, however, less effective if the CEO and senior managers don’t have contract manufacturing expertise. When choosing a CMO, look at the bios of top managers. Look at their experience. Do they have a manufacturing or drug development background? If not, if they’re accountants or related to the owner in some way, they likely won’t be helpful in decision-making when the chips are down. If I’m a small molecule company and top managers all have biology backgrounds, I’d be concerned. One company I worked for had five CEOs in four years. They didn’t know the first thing about running the business. In those circumstances the results are always the same – poor performance. The more competent and knowledgeable senior management is, the faster decisions are made.
Big problems and small problems are daily occurrences at a CMO. We continue to win this award because our senior managers are hands on. They get involved. It’s nice to have the recognition, but most importantly, it truly is a culture that has served us and our sponsors well over many years.