When you take that pill or get that injection in your arm, how often do you think about what it took to get that medication to you?
Ask Jennifer Byrne, and she can give you a pretty exact answer.
As CEO and co-founder of Javara, an integrated research organization improving access to clinical research, and a career-long professional in the clinical trials industry, Byrne has spent over 30 years exploring how new medical treatments go from a research concept untested in humans to a fully-approved product available to the masses.
There are a million jobs that fit under the umbrella of science, technology, engineering, and math (STEM) careers. Some are the heavy-hitters that you normally think of, like doctors and engineers, but there are many others that you may not even know exist. Byrne has spent her career in one of those lesser-known–but also vitally important–jobs, helping physicians administer clinical research.
From enrolling patients in clinical trials to leading an established clinical research organization to venturing out to start her own companies, Byrne has had the gamut of clinical trials experience, developing a deep expertise in the field. What makes her innovative isn’t that she’s an entrepreneur or a CEO or even a woman in a male-dominated arena; Byrne is innovative because she’s not afraid to crack the mold.
Sometimes, innovation is less about groundbreaking discovery and more about knowing when it’s time to tip the scales, to break with tradition and create a new way of providing a service–like when improving access to clinical trials means taking a broader, more strategic approach to the problem.
But let’s not get ahead of ourselves. This story starts a little earlier–and while the job is unusual, Byrne’s path to it is less so.
We start with phlebotomy.
How does someone even get into clinical trials in the first place?
When Jennifer Byrne was a child, she wanted to be a doctor, maybe a teacher. In high school and college, she worked some of the usual jobs–waiting tables, babysitting, working retail–but she also spent some time doing something a little different than the average teenager: she was a phlebotomist. As a phlebotomist, Byrne drew blood for a hospital lab, which gave her an introduction to patient care in areas like the emergency room, intensive care unit, and labor and delivery.
“All of these jobs helped prepare me for a career in research,” Byrne says. “They center on anticipating people’s needs and providing exceptional service.”
In the hospital, she was exposed to pharmaceutical representatives and the world of drug development and clinical research.
From there, Byrne’s story is not dissimilar to many others. After she finished college, she took a job–not one that she dreamed of, but it ticked some of the boxes around her interests in healthcare. Byrne became a clinical research coordinator.
“Clinical research was not ever anything that I had dreams of growing up to do,” Byrne says. “It is a very specific subset across healthcare and life sciences. In a short period of time, however, I knew I had found my life’s work.”
Clinical research coordinators are the boots on the ground, the frontlines of clinical trials: they recruit and screen potential participants, work with the oversight of physicians, run the day-to-day details of studies, and collect data to substantiate (or not) the safety and effectiveness of a new therapy.
For many, it’s a transition into another career path, such as pharmaceutical sales or R&D, medical school or other advanced professional careers. But for Byrne, the coordinator position was more than that–she interacted face-to-face with patients, worked alongside physicians and other medical professionals, and supported research that she learned was vitally important–and she realized that she was there to stay.
Byrne became keen at identifying and solving problems she encountered, and soon enough she was growing in position and responsibility, not just knowledge and experience. Like many young professionals, she was climbing the ladder, but for Byrne it wasn’t titles that drove her but passion and curiosity. Little did she know that one day her position and her passion wouldn’t quite align, and she would have to pull on all her experiences to blaze a trail that could change the clinical trials industry.
Why are clinical trials so important?
Clinical trials undergird a lot of the trust that we put into healthcare treatments. Whenever we or our loved ones need treatment for a health issue–whether it’s a medication to treat a heart issue or a simple vaccine to prevent disease–we trust our healthcare providers to prescribe effective treatment, and they trust the research process that informs their recommendations.
“In those moments, you are vulnerable and you have a need, and it’s a tremendous public service that–generally speaking–we can put trust in those recommendations because there have been years of research and, in some cases, the experiences of thousands of people who have been part of answering questions about the validity of these treatments,” Byrne says.
Those people Byrne references include the researchers behind the scientific discoveries, as well as the non-medical professionals who move the clinical research process forward (like Byrne) and the thousands of individuals who volunteer to test the treatment before it is approved for general use.
Nearly everyone will reap the benefits of clinical research not just once or twice, but dozens–if not hundreds–of times across their lifetime. More specifically, participants in clinical trials are the first to experience groundbreaking treatments.
As important as clinical research is, it is equally complex. It can take many years, thousands of clinical trial participants, and billions of dollars to bring a treatment to market. It also takes a lot of expertise and hard work to orchestrate clinical trials. However, the people working in the industry get to be on the frontlines of seeing how treatments benefit patients–or not–and that can be rewarding.
“You’re a big part of a patient’s healthcare journey,” Byrne says, an aspect that helped hook her on clinical trials research.
After her first job in research in Texas, Byrne relocated to North Carolina for a position with PMG Research (now known as Accellacare), a clinical research organization that was once based out of Winston-Salem. PMG’s role in the clinical research ecosystem is to help pharmaceutical companies coordinate the large clinical trials within a group of healthcare facilities in the Southeast and, eventually, in the Midwest. She moved up from role to role within the company, garnering extensive knowledge of the clinical trials industry, until she ultimately became CEO, a position she held for almost ten years.
Put yourself in Byrne’s shoes: she’s a woman at the top of her (largely) male-dominated industry. She’s an expert in the prime of her career. You might expect her to ride that wave as long as possible, to stay with the job she held for so many years.
Not Byrne. She could see that her industry had a problem and she knew it was time to take a leap. As chance would have it, PMG was sold in 2015 and, after helping the company through the transition, Byrne felt the time was right to make a change and she stepped down as CEO in 2017.
She spent about a year running Greater Gift, a non-profit she started while she was still at PMG, (that’s a story all in itself, and you can read about some of it here), and speaking to as many leaders of health systems across the nation as possible before a new solution materialized. That solution required building a company from the ground up, a company she called Javara.
“My journey has never been about being a business owner or a CEO. It’s always been about the next iteration or the next door that opens to solve a problem,” Byrne says. “Both Greater Gift and Javara are pieces of a solution, tools for the broader ecosystem of clinical trials.”
Javara, which is headquartered in the Innovation Quarter, became the tangible output of Byrne stepping down as CEO of PMG and was her new approach to one of the big picture problems within clinical research: how to find the right people to participate in clinical trials.
What’s so difficult about finding clinical trial participants?
Let’s back up a step. In clinical trials, the name of the game is usually enrolling as many patients as you can, but there are major problems that complicate that effort.
First, the requirements for patients are rigorous–there are a million inclusions and exclusions that weed people out of the pool of potential participants.
Second, finding those people with all the correct characteristics and conditions is laborious and expensive.
“For pharmaceutical companies, just finding these needles in haystacks is the most expensive part of running a clinical trial,” Byrne says. “It can add years to an already long drug development process.”
Additionally, for most trials, pharmaceutical companies work with a doctor or a department within a health system. If an ideal candidate for the trial isn’t connected to one of these doctors, they may never hear about the trial or be able to participate. The smaller the pool of participants is, the less likely you are to get a diverse group, which, in turn, weakens the results of the study.
The goal is to work across multiple health systems to find your pool of participants. One problem:
“Typically, health systems are not well-equipped to run clinical research and they don’t have the resources to provide clinical trials across all of the patient populations they serve,” Byrne says.
From her decades of experience and her year of research on-the-road, Byrne knew that health systems often lack the resources and the expertise needed to efficiently and effectively run clinical trials. Because trials require staff with training, management of complex technology, and a maze of regulatory and legal complexity to ensure compliance and patient safety, most clinical trials end up costing a health system money.
“When you lose money, you simply cannot prioritize research, even if it’s part of your organization’s core mission,” Byrne says.
As a result, pharmaceutical companies tend to turn to the same network of smaller, independent research organizations to run clinical trials over and over again—easing the burden of execution but limiting the patient pool. Limiting the pool equals less diversity and less access.
“But there’s a cost to not running clinical trials, as well. When health systems don’t prioritize clinical research, the people in that community may have little to no access to research–and its potential benefits,” Byrne says.
Byrne was seeing that impact firsthand. There was a growing disconnect between the companies doing the research (usually pharmaceutical companies) and the smaller community health systems. The industry had changed from when she first found her calling, and healthcare systems (and the people who use them) like the ones she had worked with in her own city, Winston-Salem, NC, were being cut out of the equation.
What do you do when faced with a problem no one has tackled before?
What could be done to help health systems–both in the region and the nation as a whole–connect better with pharmaceutical companies? How could clinical trials access larger patient populations across more systems to find candidates?
Byrne and the other co-founders of Javara were asking these questions, but there was no blueprint for addressing them because few in the clinical trials ecosystem had really broken from the traditional model of how partnerships are facilitated in clinical research.
When that moment came, Byrne and her colleagues chose the latter option. Reaching into all of those past experiences, they founded Javara, an integrated research organization–a new category of research organization–with the goal of improving the connections between all the players in the clinical trials ecosystem: pharmaceutical companies, health systems, and clinical trial participants.
The big idea was to create an organization that sits in the middle, or better yet, becomes the connective tissue between pharmaceutical companies and health systems.
On the health system side, Javara provides a clinical trials dream team that provides the infrastructure and personnel needed for a trial that can plug into healthcare organizations. On the pharmaceutical side, Javara can access the patient pools of their health system partners and help them match patients to the thousands of new therapies in the drug development pipeline. By doing this, they can identify more clinical trials candidates more quickly.
If you’re not familiar with the business this may not hit you as revolutionary, but here’s how Javara helps everyone in the clinical trial equation win:
Pharmaceutical companies (and others) can come to Javara to locate clinical trials candidates, Javara can look for participants out of tens of thousands or even millions of patients across the country, as opposed to relying on single physicians or smaller, independent groups, who serve smaller patient populations.
Health systems don’t have to maintain costly clinical trials departments in-house, yet they are still able to participate in valuable clinical research.
And finally, the best part of the equation for Byrne, Javara can help more diverse groups of people–diverse in every sense of the word–access clinical trials. The more people who have access to clinical research, the more diverse participants become, and the stronger the research becomes because it’s more representative of the broader population.
When Byrne left PMG, she saw an industry that was contracting on itself. Now she and her team are blazing a trail that will help push the boundaries back out by rejuvenating the ecosystem—whether that means tipping the scales to broaden the reach of clinical trials or elevating the expectations of how the industry does business.
What does it mean to elevate expectations for the clinical trials industry?
Byrne knew if she was going to build a company from the ground up her product wasn’t the only thing that needed a refresh. She understood that if access to clinical trials was going to expand, access to the industry as a profession would also need to expand.
Within her companies, Byrne strives to create a culture that values diverse perspectives, something she learned in part from being a woman in STEM. She helps provide opportunities for people of all walks of life to find on-ramps into clinical research careers. She views it as part of her responsibility as a leader in the world of clinical trials.
“Clinical research has a workforce issue,” Byrne says. “You can’t wave a magic wand and hire a perfectly diverse staff in one go, but you can be part of building toward a balanced and inclusive workforce and use your voice to remind your peers that they have the same responsibility.”
For Byrne, the pay-off of having diverse perspectives at the table is building trust–trust with patients and trust in the process to produce medical solutions that care for all people.
“To me, the goal for Javara is to be well-rounded as a company, because what we want is to build trustworthiness,” Byrne says. “We are trying to build bridges between pharmaceutical companies and health systems and between the clinical trials industry and the general public. Having a variety of voices in the room is what builds that trust.”
When there’s a problem, Byrne isn’t afraid to take a risk to solve it–whether it’s changing the way clinical trials are conducted or advocating for a more inclusive workforces.
By being a trailblazer, she opens a path for others to follow, but not just in clinical trials–because every industry needs people with deep expertise who can take a look at the big picture and know when it’s time to break with tradition, to make the moves that change how things are done for the better.
