Getting quality medicines out to market can be a difficult balancing act. Companies want to release products quickly to create treatment options for their patients, and of course, try to generate revenue for their investors. However, pushing something out to the public too quickly, without proper vetting, can lead to disastrous results.
Michael Brooks is the executive VP of product registration for PRA Health Sciences, which works with pharmaceutical companies to oversee conduct of their clinical drug trials. Brooks is closely involved in the drug-development process by ensuring his customers’ trials are executed properly, upholding patient rights and well-being as a top priority, enforcing proper training for all of PRA’s employees, and maintaining a balanced workload—all while meeting his customers’ needs.
Here, Brooks shares some keys to helping clients go to market, common hiccups in the process, and details about PRA’s new technology platform that can predict those hiccups before they happen.
How does PRA help its clients get their products to market? How has your experience helped the company do so?
Michael Brooks: We have to ensure our therapeutic and operational leaders of PRA are able to apply real world experiences and data to help our clients develop the best strategy for product development and trial conduct. We work in an evolving, highly competitive landscape and have to make sure our teams are operating with the “end of mind,” which means taking into account the clients’ development strategies, their protocol end points, understanding what the patient experience is going to be like, and what the patients’ motivations are for consenting and remaining in a clinical trial. Ultimately, we have to understand how to help our clients leverage technology for real time safety monitoring and reporting.
I’ve been fortunate in my career to work with industry leaders and drug development operations and they provided me opportunities to work on complex trials, patient populations and customers. Through my experience, my approach has been shaped by—no pun intended—trial and error. I have learned how to lead teams, support clients, and how to drive innovation within a highly regulated environment—one that tends to reject change.
Speaking of complex patient populations, you’ve worked in oncology units. How has that experience helped you in your current job?
Brooks: That was a life and career-changing experience for me. There’s a saying for those in oncology that oncology is different. Intellectually I understood that, but once I worked and was immersed in the oncology environment, I really began to understand why oncology is different. It has to do with the patient population and the end points; they are very unique in how we look to support patients and their experience in fighting cancer. Also, the way you work with regulators to determine how to best bring products to market and the finish line is very different. I believe more than any other therapeutic care, it hits home for those that work in this space because everyone has a family member or friend, if not themselves, who has faced the fight against cancer. It’s personal.
We tell all of our product teams when you’re working in oncology drug development, every day their trial is delayed could mean there’s a delay of a day or more for patients to receive access to that therapy. Someone could lose their life because they don’t have access to that therapy.
Working in oncology generated a passion for me that what we are doing isn’t just a business; it’s about the patients.
What are some of the best practices for ensuring a client’s product goes to market?
Brooks: Steering toward more of my lessons learned, companies like PRA have an interesting perspective to observe the decision making of a large number of biopharmaceutical companies—big, small, conservative, and innovative, based in the US, Europe, Asia, Latin America, Japan—successful and not so successful. Those drug developers that are successful, more often than not, tend to have the [same] characteristics. I think PRA’s culture.
represents these characteristics —we certainly strive to demonstrate them internally and with our clients. From my experience in this industry, this is a key distinction between PRA and other competitors.
What are some hurdles you’ve experienced in getting a product to market? How do you overcome them?
Brooks: Probably the biggest challenges we are facing are aged-out methodologies in drug development. At least up until recently, drug development today was very much your drug development of the early 1990s. This represented a more conservative approach to protocol design—in working with physicians, conducting the trials, and engaging the patient.
PRA overcomes this historical approach by pushing a twenty-first-century mindset of how to use data and powerful intelligence tools to inform and shape the protocol designs and to ensure there is more of a real-time intervention. It’s a bit cliché, but the only constant is change. We have to prepare our teams to always be on the lookout for the unknown, identify the risks very quickly, get to the root cause, and correct that issue or adjust to it as best they can.
What exactly is PRA’s Predictivv Platform? How does it work?
Brooks: Predictivv is an integrated, global platform that will create greater consistencies and efficiencies in the clinical development process. It provides transparency into all processes and their statuses through a proprietary analytics engine. Predictivv enables project teams to more proactively identify process and protocol deviations enabling course corrections before risks occur. Essentially, Predictivv more effectively combines process, oversight controls, data, and expertise.
Who will benefit most from the Predictivv Platform?
Brooks: Ultimately, PRA believes all participants in a clinical trial will benefit: patients, investigators, our customers, our internal project teams, our third-party vendors. Our vision is to provide better predictability in the outcome of the product development strategy, better visibility to the deliverables of individuals trials—timelines, endpoints, cost—and better visibility to risks and issues within the conduct of the trial. And with improved visibility, much earlier intervention and resolution.
And, most importantly, [we want to] provide our PRA project teams and sponsors the ability to model out scenarios, the pros and cons of each, to select the best approach for their trial and their risk-tolerance level.
Ideally what would constitute as a “win” for PRA by using this platform?
Brooks: Within the current system environment, we want to ensure we’re delivering to our customers’ expectations. From a business perspective, it is infinitely easier to maintain a customer than build a new one, so through the use of Predictivv PRA grows its current customer base. Furthermore, the Predictivv platform enables PRA to penetrate other customer segments. AHL