A lesson for R&D: slowing down can help you speed up

Tim Garnett of Eli Lilly and Company explores how sometimes slowing down can help us to get ahead and puts this into the context of drug research and development at Lilly.

In recent years, prominent professional cyclists have argued that it's impossible to be competitive in their sport without cheating. U.S. velodrome cyclist Sky Christopherson disagreed. Doping may be the most expedient way for a cyclist to improve performance, but Sky opted for a smarter, slower approach.

First, he gathered data on the various factors that impacted his race: exercise, sleep, diet, mood, and even his chromosomal make up. Then, Sky made it his mission to optimize his performance in each area. The gains he made with each minor adjustment may have been small on their own, but they added up to make a significant difference. In fact, after a little over a year of quantified training, he broke a world sprint-cycling record.

In other words, Sky proved that sometimes the best way to speed up is to slow down.

I tell this story because at Lilly, we're taking a very similar approach to streamlining drug development. Right now, our molecular development cycle exceeds the industry's 12-year average by nearly six months, which means to stay competitive we have to find a way to get drugs to market faster.

To accomplish this, we're working to squeeze every drop of efficiency out of our development process, meaning we must approach clinical trials in much the same way that Sky approached his training. For us, the smarter, slower approach is taking the time to understand the various factors that impact molecular development. We know there isn't a silver bullet to cut down our development time, but we believe that identifying a dozen or so smaller opportunities could ultimately add up to something significant.

For instance, we've learned that one of the best ways to avoid getting bogged down in Phase 3 clinical trials is to slow down and invest more time and resources in Phase 2 studies. While that may sound counter-intuitive on its face, applying more data-driven and iterative dosing studies in Phase 2 can help make the transition into Phase 3 more seamless – and, at the same time, help us anticipate challenges to overcome in late-stage regulatory review.

As for the studies themselves, patient participation can make or break Phase 3 work. So we've made it a point to step back and examine the process from our patients' perspectives. The fact is patients who participate in clinical trials aren't eager to repeat the experience -- only about two percent of these patients complete a second study.

This is a big problem for chronic illnesses like diabetes, osteoporosis or cardiovascular disease. To give you an idea of the scope, Lilly could be running as many as five studies for diabetes treatments over the next several years, requiring as many as 60,000 participants. And of course, we're not the only company performing research in this area.

Lilly has therefore refocused on making it easier for patients to find and participate in clinical trials, and making the experience one they'll consider signing up for again. We are putting ourselves in the mind of patients – and investigators – as we design clinical research studies. And we're also developing mobile and web-based tools for patients to increase awareness of – and access to – clinical trials in their geographic locations.

These efforts are showing progress, and our goal is to refine and build upon our progress to shave five years off our clinical development timeline by 2020. While we're optimistic, we also recognize that our industry needs to move forward together to maximize efficiencies in an evolving clinical environment. There are some great examples of what this kind of collaboration looks like. TransCelerate BioPharma is a joint venture founded by 10 biopharmaceutical companies to support each other's mutual interest in the course of research and development for innovative medicines.

Prior to such initiatives, for example, investigators conducting clinical trials for more than one company would often have to sit through hours of redundant training sessions with each sponsor. Now, we're cross-referencing these certifications and allowing investigators to spend more time focusing on their research. It's a simple adjustment, but one that saves hours of valuable study time and has a significant impact on investigator perceptions of clinical research.

This point illustrates how slowing down to work together as an industry can help us make the sort of progress in drug development that no company could muster on its own – and that's critical for the patients at the center of our work. The process may seem counterintuitive or even tedious, but as companies and as an industry, taking the time to go slow now could ensure we're able to speed up when it counts.

About the author:

Dr. Timothy Garnett, FRCOG, MFFP, FFPM, is Chief Medical Officer, Senior Vice-President and Co-Leader of the Development Center of Excellence managing Medical Affairs, Global Health Outcomes, Regulatory, Safety and Translational Medicine/Pharmacogenomics for Eli Lilly and Company. During his 14 years at Lilly, Dr. Garnett has served as Vice President for Global Patient Safety; Global Brand Development Leader and Group Medical Director responsible for the development of Duloxetine for incontinence, pain and depression; Medical Director – Duloxetine SUI Team; and European Clinical Research Physician for EVISTA.

Prior to joining Lilly, Dr. Garnett had acquired 7 years of experience, holding a variety of positions in the pharmaceutical industry in Europe with Organon Laboratories.

He qualified in Medicine at St. George's Hospital in London. He practiced Obstetrics and Gynecology for eight years prior to joining the pharmaceutical industry and conducted clinical research into menopause, pre-menstrual tension and post menopausal osteoporosis.

Dr. Garnett is a Fellow of the Royal College of Obstetricians and Gynecologists in the United Kingdom. He is also an active board member for the following: Centre for Innovation in Regulatory Science; Personalized Medicine Coalition; Indiana Health Industry Forum; and Eiteljorg Museum of American Indians and Western Art.

Closing thought: Is slowing down sometimes the best way to speed up?