The biopharmaceutical industry is changing, as many emerging biopharmaceutical companies (EBPs) are dominating the R&D industry, as in 2018, they accounted for 73% of late stage research¹. Large CROs are seeing EBPs as a growth opportunity, and they are changing their services portfolio to address EBP needs. In this interview, Chris Smyth, COO of IQVIA Biotech, will discuss how large CROs are responding to EBP targets.

Moe Alsumidaie: What are some of the unique clinical operation challenges facing EBPs, and how can they optimize their success?

Chris Smyth: When you look at EBPs, and what they are trying to do and need to do to be successful, there are a couple of trends. A recent IQVIA Institute report, Emerging Biopharma’s Contribution to Innovation noted there are three critical factors for success: the use of data and analytics, the adoption of technology, and a critical need to employ flexible business models. The challenges they face when they are developing a drug or a device are the same; it is the protocol and identifying the right sites and the right patients. The struggle for EBPs is how does a small company access the data, analytics and the technology they need to optimize their success-and that involves two things; (1), strategic outsourcing and (2), strategic partnerships.

MA: A lot of EPBs are focused on developing medical products, and do not have revenue-generating products, so they are operating with limited budgets. How is the competition in this space with regards to smaller CROs versus some of the larger ones impacting the business? Moreover, how are larger CROs starting to come into the EBP space? What offerings can bigger CROs give to those smaller companies that are better than some of the smaller niche CROs?

CS: I think the fundamental promise that an EBP company is looking for is therapeutic expertise, a focused dedication towards the smaller biotech companies, and an understanding of the unique challenges they face. Often EBPs have far fewer people supporting an EBP drug in development compared to large pharma. The challenge is, how do you support data-driven decisions? That is what some of the larger CROs can provide. They have access to vast amounts of data and the technology that can make sense of that data. They also bring domain and clinical operations expertise.

I think what IQVIA Biotech has been the first to meld that combination of the small CRO that can provide individualized, customized attention and necessary customer service support, while also providing access to critical data that helps drive better decision making. IQVIA is a human data science company, and we are integrating the study of human science with breakthroughs in data science and technology to advance our understanding of human health and make better, more insightful decisions. Hence, IQVIA is moving away from being a traditional clinical research organization and employing innovative strategies on using data to optimize clinical research.

MA: Discuss some challenges EBPs face with study design and recruitment.

CS: Some of the most basic challenges in clinical research include protocol design and ensuring the protocol is optimized and contains all the right information; specifically, not collecting redundant data, and doesn’t have unnecessary inclusion/exclusion criteria. If you can get the protocol correct out of the gate, you save a lot of time and money. The next hurdle is choosing the right site. When I was a CRA, we always assumed that 25% of the sites would never recruit a patient. What we always wanted was the ability to identify that 25% before the study starts. That is what data is providing us now-the ability to more accurately and efficiently match sites with our protocols.

We also need to know where to find the right patients. That knowledge helps us identify where to place our sites. By doing this, we can speed up our recruitment, and during the study, we can ensure that patients can be referred to sites that are taking part in the study. These data insights inform our protocol, our sites, and our patients. I think that is the foundation for a successful study.

MA: What are some of the significant R&D trends impacting big CRO services?

CS: About 80% of R&D activity is being conducted by EBPs. They conducted 65% of all clinical trials in 2018 and are now running more trials than larger companies across all phases. So, that tells you that it is an incredibly important part of the market, and it is growing. EBPs are driving innovation. They are the original patentees for 29 of the current top 100 drugs, which account for 40% of sales in the U.S. in 2018.

Another trend we are seeing is working on getting more engagement with patients through communication portals, whereby patients can become more informed about research that is being conducted. We are also looking for more engagement with site staff. That way, we're able to improve study outcomes, speed delivery, and ensure that we are not only recruiting patients but retaining them within the study.

Much technology is driving what we do, and even how we deliver clinical trials. We see more electronic patient reported outcomes were collected, increasing the use of eConsent. We are seeing wearables being incorporated into clinical trials, and that is leading us more towards, if not complete virtual trials, at least trials that allow patients to be seen in a location that is more convenient to them and makes it easier for them to participate.

MA: What do you see as the greatest motivators for outsourcing in today's market?

CS: I have been in that position where I'm outsourcing to a CRO; what I used to look for is the ability to decrease costs, manage peaks and troughs and resources. If you work in an EBP company, often this is your only trial, or it is just one of two or three trials, and you do not want to hire a large team for the trial and then have to downsize your team until the next trial begins. Outsourcing helps you manage that. What I call strategic outsourcing is the ability to access competitor information and learnings. A CRO does not breach any confidentiality in any way but certainly would never repeat a mistake it may have experienced in a previous trial. There is a considerable body of learning that a company can access when they are outsourcing.

The final point I would say is access to data and technology. These things are incredibly expensive, and it is very difficult to build up the enormous amounts of data that are needed in order to drive informed decisions. Outsourcing to a CRO is a great way to be able to have access to all these things that ordinarily would not be available.

MA: What are the keys to success for sponsor and CRO collaborations?

CS: I think everyone would love to know that, but in my mind, I would say customers are looking for a trusted partnership. They come to a CRO for customer service. So, it is incredibly important always to keep the promise that was made at the proposal stage or the bid defense meeting. Once a CRO is chosen, it is important to have shared goals, to be aligned around key performance indicators to ensure that everybody has agreed on a direction and that both parties can track progress on shared goals. It is crucial to have responsibilities clearly defined, so there is no duplication, nor does anything fall through the gaps. Finally, excellent communication is critically important for a successful relationship.

References

¹ https://www.iqvia.com/institute/reports/emerging-biopharmas-contribution-to-innovation