A recent survey by the Economist Intelligence Unit questioned biopharma industry leaders about their plans and concerns for the future. Along with excitement over expanding into novel therapies and emerging markets, they expressed serious concerns about risk mitigation. To combat risk, they raised the potentially contradictory options of building internal capacity and using outside experts. We spoke with Sebastien Ribault – Director of the brand-name BioDevelopment Center – to get his take on this duality and how it’s changing the nature of partnership.
brand-name's Provantage® End-to-End service offering supports biopharmaceutical companies throughout their development journey from initial molecule through to commercialization. These end-to-end services encompass the support and expertise biopharmas need to accelerate clinical drug development, scale their process and implement local production facilities, globally. Provantage® End-to-End services can be accessed by biopharmas at their own sites or via the brand-name Biodevelpment Center in Martillac, France, which is cGMP audited and ISO® 14001 certified.
On the Economist Intelligence Unit survey, when asked about how they intend to manage development risks, respondents chose “working with outside experts” and “building internal capabilities” as their top strategies. Are those contradictory answers?
When I think about risk management—there’s a recent case that shows how it works. A customer was trying to make a decision regarding single-use manufacturing, and they came to us. Why? Specifically because we are external experts. We provided them with a business case for single-use, and then they could look at this with the knowledge and history they have. We were complementing their internal team. We were not only bringing our expertise, but also a different point of view. And by putting the internal and the external team together, they mitigated the risk in such a decision.
With that in mind, how exactly do companies utilize outsourcing today? Is the definition of it changing?
I see two different needs with outsourcing. The first one is for the emerging biotech companies. You’re a virtual company, and you need someone to do everything – someone to take the lead on the clinical and manufacturing sides, someone who provides a full package. So you’re just looking for a turnkey solution. You don’t want to interact with three competing firms. You want one project manager, one contact, one entity, one company.
And the other need?
It’s been kind of a surprise to me that large companies are also very interested in the Provantage® End-to-End offering. When we started offering these services, we thought it would be mostly small biotechs. But actually, we realized by starting discussions with much larger companies – and I'm talking about the big ones – that there was a need as well. We met with one such company – they have everything internally. They have the engineering, they have the process development, they work in each and every area of biopharma. Vaccines, monoclonal antibodies, microbial... everything. But the reason they came to us was really about risk mitigation. Can I do it with my internal team? Yes, probably, if you are fully mobilized and working exclusively on that project. You know, no conflict with other internal activities, no change of priorities. In this case, the desire to look outside came down to mitigating internal risks that the project might slip or be late or even be a failure, because their own teams might not be fully devoted to that project.
There are also companies who say, “You know what? We’re building internally, but we need to reach out to experts.” They need someone to help them build a culture and guide them on the right path. And we are those experts.
It sounds like expertise is a key factor pushing the definition of “outsourcing.”
Why do you reach out to experts? Either you need something very specific, or you're seeking something that is hard to find. If you just need an engineering design, it's fairly simple. You're just going to contact an engineering firm, you give them the input, they give you the output. End of the story.
You’re talking about the type of expertise that’s less transactional and a little more open-ended?
In this business you need to be flexible and agile, able to revamp the site quickly to address new technical needs. But you also need to be regulatory compliant, and the regulations are different in Asia, Europe, and the U.S. You need to meet a number of quality standards that are moving constantly. And you’re facing competition.
This is really a multifactorial discussion. For example, when discussing how to build a facility, the engineers are going to bring you an engineering answer. But what you want to know is how to run the facility, which is a mix of engineering and operations. So you actually need the head of operations and the head of engineering. You don’t need one expert, you need two or more to give multiple points of view on a complex problem.
So when you put together these multiple capabilities, could you say that, the Provantage® End-to-End program is actually a way to reduce outsourcing?
Absolutely. We're bringing our customers the expertise, so in the future they can do it themselves. But that's a choice. If at the end, if they want us to transfer everything we build to a CMO, for example, we can do that. So we give them the opportunity to choose between outsourcing and insourcing.
That speaks to the EIU’s briefing paper. There, they spoke with an analyst who said companies might be insourcing more was to have more control over their product.
That makes sense. But to control more, you need to be skilled, and that's where we come into the picture. For example, often as we’re developing a process and a facility, we’re also helping a customer with recruiting. We're not headhunters per se. But we do screen CVs from the perspective of, 'If you want to develop biotech facilities in the future, these are profiles that you will need.' This is how far we push our collaboration with customers. Having in mind that, in the future, they will insource the activity, and setting them up to do that.
If I understand, you’re saying that Provantage® End-to-End services combine two needs. They bring together the services that might typically fall under the outsourcing you'd get with a CMO, but also provide that more open-ended expertise.
Yes, that’s right. With the End-to-End team, we can provide everything to a customer who has a budget and a need, but they don’t know where to reach out to make it happen. With other companies, you can outsource an analytical package, the manufacturing, recruitment, or other parts of the process. We’re the only company that brings all those pieces together. If you want to do that anywhere else, you have to contract separately with at least two companies, if not three.
Imagine going to a company, and you say, “I want to develop a process, and I want a facility. Call me when it’s done – and done means my people will be trained, it will be GMP compliant, regulatory accepted, and the molecule is ready to go to commercial.” Imagine: you just sign the check, and then you come for the inauguration and you cut the ribbon. That’s pretty much what we offer.