The Changing Needs of Mid-sized Sponsors

Article

Applied Clinical Trials

Becky Carpenter, Head of North America/Euro Operations at WuXi Clinical, a newly formed CRO, discusses the evolution of the mid-sized pharma and CRO space-and the level of support now needed for some of the smaller and more nimble customers.

Becky Carpenter, Head of North America/Euro Operations at WuXi Clinical, recently answered questions from Applied Clinical Trials about the evolution of the mid-sized pharma and CRO space. WuXi Clinical is a new mid-sized CRO resulting from the merger of Research Point Global and WuXi Clinical Development Services (CDS.) The rebranding is being launched at this week’s DIA 2019 in San Diego. The newly combined company employs about 1,000 clinical research specialists across 20 global locations with two main hubs in the US and China.

ACT: What are some of the most significant changes in the mid-tier pharma market you’ve observed over the last five years and how is that translating to impacts on CROs?

BC: One major difference is that the mid-to-larger CROs are all now realizing the huge potential of small to mid-size sponsor companies-it’s a natural evolution of how the pipeline is changing, with many discoveries coming from small and more diverse companies. So even the larger CROs are now attempting to create operating units designed to serve the smaller client. The crucial point of course, is that not everyone is really capable of understanding their unique needs and expectations. The level of support needed for some of the smaller and more nimble customers, the big CROs are not set up to service.

Becky Carpenter

Understandably, that means a big opportunity for companies like ourselves operating just below the traditional big six or seven CROs.

ACT: How do you anticipate the CRO market will look like in five years’ time? What role will WuXi Clinical play?

BC: The good news is, the market is booming, everyone is busy. The volume of products reaching clinical phase, especially in the oncology space, is unprecedented. Across all sectors, there are more than 300,000 trials and more than 100,000 in the US.What we are also seeing in the last few years is that China has established itself as a leader in discovery, as a result of the number of life science professionals and the abundance of capital available for innovators. CROs that are poised to serve this market will undoubtedly grow in the coming years. So in five years’ time we will be looking at a market still with huge number of products emerging into trials from the US, but also, a significantly large number from China.

ACT: Can you describe what typical mid-sized customers need from their CRO partners? What challenges do they face?

BC: It is one thing to set up bespoke divisions for smaller customers, but quite another to be providing them with the specialist services they need. With our clients, it’s very much a partnership and we bring in senior trial expertise to oversee work, as we understand that, unlike in big pharma, much of this experience is coming from our team. The other aspect is that these customers are far nimbler in their operations and they need us to be able to have the same level of flexibility, and, crucially, responsiveness. For the smaller companies, the limited number of products they have in development are quite often critical to the company’s overall survival and success. It’s not one of a portfolio, but their number one priority. That is what a good CRO partner recognizes and we try to act as a natural extension of in-house teams, working cross-functionally. We work together to reach milestones. On a more practical level, a larger CRO might not have the incentive to prioritize a smaller client’s needs and instead will seek to give preferential access to larger partners. The CRO partner chosen needs to be able to fight in their client’s corner-for instance, site access can often be very competitive.

ACT: How will the company balance any future expansion (remaining in the mid-size space, i.e., not too big, but also continuing to extend service offerings, etc.)?

BC: It is a good question, but undoubtedly, our biggest asset is and will continue to be our people, and we retain our best talent with the core founders still within the business. It’s also a matter of company culture, and we have been very clear in that we aim to be the best-not the biggest. What we intend to do from here is supplement what we have been doing well for more than 20 years-flexible client-centric services-with the new capabilities we can offer. We have hundreds of repeat customers, and we can now help them through the wider WuXi Group to achieve full development of their products, and without having to change providers. There are also obvious synergies for many of our clients in the new opportunities in China. In everything we do, we look for how we can better enable our clients; we really see them as our partners, and we will look to grow together.

ACT: How do the needs of US customers differ from the needs of those in China?

BC: In terms of markets, the US customer, understandably, looks first at incorporating the US markets and then Europe and increasingly Asia. But in China, the focus will either be domestic first or increasingly US and China in parallel. For our US customers, what they value most is our expertise and the quality of the trial put in place. It has been something of great pride that this year we improved “enrollment goal completion” ahead of time to 92 percent. This also resonates very positively in China, as clients here are very aggressive in the timelines they set, and they value CROs that are able help them complete ahead of their competitors.

ACT: How important is flexibility? It is often cited as a key element for biotechs and medium-sized pharma.

BC: It is probably the single-most important factor for them, along with expertise. Biotechs and mid-sized pharma need a partner they can trust to be there when they need them, and be flexible in delivery-from changing timelines to recruiting complex subject populations. It very much what sets a great CRO apart from a merely good one. Can they deliver to changing needs, for example, the ability to train staff very quickly to monitor for even the most complicated indications?

 

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1https://clinicaltrials.gov/ct2/resources/trends

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