The CRO market has seen tremendous growth in the last 10 years, undergoing significant changes in terms of remote trials, smaller patient populations, as well as the more recent pandemic pressures.
The drug pipeline is also now larger than ever and CROs have increased their strategic importance to innovators – particularly smaller and virtual biotechs. What these innovators need is a CRO that will partner and provide the knowledge of trial design and implementation that will enable them to take a promising target through towards commercial success. Yet one of the dualities of the industry is that many of these smaller innovators might initially turn to the big five CROs, when in fact their needs are more likely better served by a mid-sized CRO that can combine that much needed knowledge and global outlook with flexibility. In fact, choice of CRO is now a mission critical step to many of these projects’ ultimate success or failure. Picking the wrong CRO is likely to have huge ramifications in terms of timelines but even the ability to make key milestones.
We spoke with Nilay Shah, VP, Global Head of Strategic Alliances and Business Development at Emmes to discuss his views on the CRO market and how Emmes has been particularly successful in building long term partnerships. The CRO originally concentrated on helping government and academic partners with trials but has more recently specialised in empowering biotechs, where these 40+ years of research partnerships are providing invaluable support. Founded in Maryland during the late 70s, Emmes has conducted over 2,000 clinical studies for clients in over 75 countries. One widely acknowledged strengths of the company is their strong partnerships not only with clients but with academic centers and clinical sites.
Q) What does a strategic collaborative partnership mean to you?
Nilay Shah: A collaborative partnership to me means that we can always be open and honest with each other, and we actively look to share the work – looking together at the big picture about how we can achieve the trial’s goals.
Q) How do transactional relationships and strategic collaborative partnerships differ?
Nilay Shah: It means a true partnering approach. For example, we try to collaborate in a way where the client sees our clinical managers as part of their in-house team. So this means understanding what the mission of the study is as someone from the inside and this enables much more open communication. If there is something that we don’t agree upon, we want the client to be willing to take on board the news – positive or negative – knowing that we are all working towards the same common goal.
Q) From the biotech’s perspective, how can they nurture a collaborative partnership?
Nilay Shah: One of the most important things a biotech can do is have a CRO involved from the beginning and create a consulting agreement with the CRO to make sure it has the same vision for running the clinical study and is willing to collaborate in ways that suite them. This consulting agreement can be for regulatory work, protocol writing, and/or development strategy. For newer biotech companies who may not have experience of working with CROs, they should know that having a team that is available and that really understands how to run clinical trials is important. Try out the CRO first. A full study contract can come next. Start small together.
Q) What should prospective partners watch out for when choosing bigger CROs?
Nilay Shah: A very common situation is that you get intentional underbidding by a CRO – just to get the biotech through the door. And then once you have an agreement with a CRO, it’s very hard to change, because they will have already started building data systems and capital has been invested. The nightmare scenario for the biotech is after six-months a change order comes in and the goal posts have been moved. So that is why it’s so important to be able to trust the CRO and have a partner that explains what you need, not just what you want to hear.
That said, not all change orders are inherently bad or unavoidable. If the scope of work changes from what you bid on, then a change order is a must. But really what I am pointing to here are those situations where a CRO came in much cheaper and then you know there is a high probability of a problem within a few months. My advice is to keep asking questions about scope and timelines so they really have costed out and planned for all eventualities.
Q) Do you see any differences between working with small to mid-sized partners?
Nilay Shah: From a CRO perspective yes there is, as there is often a much greater singular focus at the biotechs, and this is extremely exciting for us as these people bring a great deal of entrepreneurship, energy, and drive. If they believe you’re the right partner, that drive and entrepreneurship is shared with you and the team to make it a collaborative approach.
In a different way, academia also brings a lot of wealth to the table as well, and these relationships can be incredibly valuable to CROs – it’s often the key to unlocking resources in biotech trials. For example, a lot of the US rural areas are supported by academic centers, and that’s where most of the clinical trials are run. Having that relationship with academic centers, which we’ve developed through our public partnerships, is extremely important.
Q) When is the ideal time to start working with partners?
Nilay Shah: Ideally, at the preclinical stages, when the biotech company is thinking about the phase one study. It’s extremely important that we get our statisticians involved early enough to make sure that they’re thinking about what an appropriate designed protocol will look like. Putting that extra thought and consideration in early will pay huge dividends later.
Q) Have you seen any changes in the CRO biotech model in the last few years?
Nilay Shah: Things are changing and there’s a lot more Venture Capital and angel money coming in as people are investing in innovation again. Consequently, the positive is, that people are coming to CROs much earlier to get an estimate for clinical trials. They approach us to get a ballpark estimate and this could be the first step in building a strong relationship. But here is when you can again really standout as a CRO and try to put in some assumptions around the trial so that they are already better prepared. Moving forward, I see an even stronger relationship occurring between the CRO and the biotech world. We are such natural partners, especially mid-sized CROs, where we can be that bit more flexible and nimble and try and match their entrepreneurial outlook.
Q) What advice do you have for building a successful partnership?
Nilay Shah: The single biggest tip I can give, is simply speaking the truth. Telling your partners honestly what it will take and what we can do together to make the biggest impact on public health.
It’s not an everyday occurrence, but occasionally, we will suggest another partner – if we feel that the science is not something that we or someone within our company can support to the degree they need, or perhaps we might suggest working with us and alongside another partner to bring in all the resources needed. We would rather do the very best clinical job rather than take the maximum revenue.
Q) Do you try to build your clinical team around the customer, how do you do that?
Nilay Shah: Absolutely, and I think it’s one of the most underestimated keys to a successful partnership. We look to see if we have an experienced individual for that therapeutic area, but after that it’s all about cultural fit. For example, if you have someone who is looking for the collaborative approach, you don’t want to put a shy person on that project; you want to put someone who is going to be a part of the team on a regular basis. And one thing we really try not to do is switch personnel post proposals. If we put someone in our proposal, that person is going to be on the team leading the study.
Q) Is it fair to say that Emmes puts more time into picking the initial team than other people?
Nilay Shah: I think so, there’s a lot of thought that goes into who’s going to be part of the team because it’s not only the project manager that is client facing. For example, the main person who is site facing is our clinical research associates (CRA), and CRAs in general are a hot commodity in the market. Recognising this, we work very hard to keep our CRAs happy and here, as they play such a key part of the study. So that could be another area to look at for the biotech – to ask prospective CROs how long their CRAs have been with the company, because industry-wide there has been a lot of turnover.
Q) How is technology changing CRO models and partnering?
Nilay Shah: What’s going to happen over the next few years is technology is going to make a big impact. Artificial intelligence will be put into the CRO market to consolidate a lot of the work that’s being done by humans. It may allow you to run a lot more statistical models in advance of the clinical trial project and this may give a better insight into how long they will take to complete. There are already companies doing this that give you a projection and almost a full timeline video of what your whole clinical trial is going to look like. The other thing is decentralised clinical trials, which are something huge. Every CRO is going to have to play a part in this because people just don’t want to go too far away sites to participate in clinical trials.
So, in theory, this could help the industry become more efficient, with the ability to recruit patients a lot faster in a hybrid or decentralised setting. But it has to be done correctly by ensuring that there’s procedures in place of monitoring the data correctly, and making sure that the real patients are being recruited.
So again, it won’t be a panacea and undoubtedly you are going to need the CRO to have the skills to oversee everything and ensure your data packages are truly robust and ready for regulatory scrutiny further down the line.