The True Disruptors In Clinical Trials: Insights From Agile, Merck, BI, And EMD Serono

By Ed Miseta, Chief Editor, Clinical Leader

Innovation is shaking up the world of clinical trials. Advancements in technology are rapidly changing the landscape of data collection and analysis, while patients and patient advocacy groups do their best to get their voices heard in the process of planning and executing trials. But while we often hear references to disruptions in clinical trials, it can often be difficult to identify exactly what is disrupting the clinical trials process. An executive panel at the CROWN Congress in Philadelphia earlier this year attempted to answer that question.

Participants in the panel, moderated by Elizabeth Mascherino, Advisor, Clinical Innovation at Eli Lilly, included:

• Al Altomari, President and CEO, Agile Therapeutics
• Andy Lawton, Global Head, Clinical data management at Boehringer Ingelheim
• Paulo Moreira, VP of Global Clinical Operations  - External Innovation at EMD Serono
• Mark Travers, Global Head of Monitoring Excellence and Interim Head of North America Clinical Operations, Merck

In this article the panel shares their thoughts on the technologies driving innovation, and how these technologies should be pitched to executives within Big Pharma companies.

Certainly one change happening in the clinical space is the sudden convergence of devices, information, and people, all connecting in new ways to bring about needed solutions. But when looking at that mix, which of the three (technology, information, or people) is the most disruptive agent?

Although all three are intertwined, Moreira believes new technologies are the true drivers of innovation. “The information is vital, and people are necessary to generate the information,” he says. “But it is the technology that helps to collect and assemble information in a manner that makes sense, which is vital to the clinical trial process. I define innovation as developing something that people did not know they need, but which they later find they cannot live without. This is happening in clinical trials like it is elsewhere. People are discovering new technologies and putting them to better and greater use. Coping with the symptoms of a disease is a burden. So if technology can help people to better connect and collect data, and then help us to better analyze and understand it, we can make real progress in making trials better and more efficient. With technology the sky is the limit as far as what we can do for patients and trials.”

Lawton agrees new technologies will be game-changing, but notes it cannot solve problems on its own. He notes real change can only come about when all three parts come together. Unfortunately, he doesn’t believe a lot of the change needed in the industry is happening fast enough. He believes pharma in some quality aspects is around 40 years behind many other industries. Still, he feels changes coming about via ICH (the International Council on Harmonisation) will have a major impact on processes, technology, and quality in the pharma industry.

Travers also felt tempted to say all three. “I believe risk-based monitoring is a good example of that,” he says. “People, information, and technology all have to come together to make processes better. Having worked on the RBM TransCelerate work stream, I know how effective the combination can be in transforming companies. Merck is in the process of implementing RBM, and I can tell you it is a very difficult task to accomplish in a global organization. There are many departments that have a say or a touch in the final solution, and if you do not have all three of those pieces working together in an efficient manner, you will not attain the results you might anticipate.”   

Get To The Right Person

Lawton notes technology is one of the most disruptive aspects of his job. He believes one of the primary challenges we face in this industry regarding the adoption of innovative technologies is how to get them introduced into global organizations. He notes part of the problem has to do with technology companies making contacts within pharma companies at an inappropriate level. He often sees them making their pitch at the C-suite level. If those folks get a call or email about saving time, increasing efficiency, or improving quality, it will definitely get their attention. But eventually all of those messages will make their way to him. 

“It disrupts my life because I am interested in anything that will improve the performance of our global clinical operations,” he says. “But at the same time I will then be responsible for having to manage expectations within the company, from those above me and from within my own group. So my recommendation to the technology companies is to spend a little time thinking about who you need to influence, select the right entry point within pharma, and get all of your facts in order.”

Those companies should also avoid leading with a cost argument. For most companies, Lawton believes saving money is not at the top of the list in terms of factors hindering adoption. “Quality and timeliness are much more important,” he states. “If pitching a pharma company, you also need to make sure you understand the operating systems within the company and how your product or platform can fit into it. It has to fit in every country we operate in, and it also has to satisfy legal, finance, our vendor management team, and senior managers. So understand that I will not sign off on anything at our first meeting. It will take months of negotiation and discussion for us to come to an agreement.”

As a CEO, Altomari notes he looks at the problem from a business, rather than a technical perspective.  He believes many of the issues pharma deals with regarding technology adoption are symptoms of a much bigger problem, and that is communication. He believes the whole industry needs to learn how to communicate differently.

“Technology is changing quickly, and it will have an impact on how we communicate with each other,” he says. “This is especially true in the clinic. How you communicate with a 70-year old person with congestive heart failure will be very different from how you communicate with a 17-year old taking part in a contraceptive trial. But in many cases we are using the exact same tools, and it is simply not working. As an industry, if we simply keep buying the next generation of toys without dealing with the underlying issues, then we’re going to have problems.”

Altomari notes the pharma industry is to the point where it has a glut of data, and new means of capturing data, but with no clear vision of what to do with it. He works closely with physicians, who he notes are equally impacted by this data and communication issue.

“Our challenge is to understand how we need to communicate with our new customers,” he says. “This latest generation has gone through rapid changes and we are going to struggle with how to communicate with them. But this is also a great opportunity for us to learn how to communicate better.”

In part two of this article, the panel will discuss empowered patients and how they are disrupting the clinical trial process.