Pro sports’ COVID protocols led to real-world data impacts for pharma
When Christina Mack was a junior in high school, she took an advanced placement computer science class because she was “just into it.” The only problem? It wasn’t offered at her all girls-school, so she had to make a daily trek to the all-boys school in her town. That was the early 1990s.
“Obviously, I was the only girl in the class, and they didn’t even offer it at my all-girls high school,” she said. “That kind of tells you where I’ve been.”
The class helped spark Mack’s love for “all things technical,” but it wasn’t until her first job out of college — she graduated with an engineering degree from the University of Notre Dame — in information technology as part of Johnson & Johnson’s leadership program that she realized data could “change the world.”
“It was like a fire was lit when I discovered you can apply the deep technology to healthcare and really make a difference for patients,” she said.
Now, after over two decades pioneering the use of technology and data science to revolutionize epidemiology — including through work with major league sports during the COVID-19 pandemic — Mack is hoping to push the field toward deeper patient insights as chief scientific officer for IQVIA’s real-world solutions business.
The role is perfectly suited for Mack, whose career has closely aligned with the rise of tech in the life sciences, often putting her at the forefront of major industry changes.
“It’s funny because when I decided to go get my Ph.D. in epidemiology, at that time, it was about 2008, people were like ‘Oh, you’re having a career change. You’re an engineer, you’re in technology, and now you’re going into healthcare” she said. “Now, those disciplines are not separate at all.”
And after years of timid acceptance, she believes the time is finally ripe for greater adoption of a major focus of her work: real-world data (RWD) across the life sciences industry.
“The data is richer than it was 10 years ago because we have people that have wearables, have people that are interacting with the healthcare system, and that information is going into the electronic health records,” Mack, who took over the IQVIA role from her longtime mentor and PharmaVoice 100 honoree Dr. Nancy Dreyer in June, said. “We now have the ability to put clinical outcome assessments to patients and understand from the patient’s perspective what matters to them.”
A data revolution
Mack partially credits her career success to having the right skillset at the right time.
She entered the life sciences industry at the dawn of the new millennium when Y2K fears were real, computer programmers were highly in-demand and pharma companies were figuring out how to electronically submit clinical trial documents to the FDA.
While she acknowledges it wasn’t the most glamourous job, creating the encryption codes for those electronic records enthralled Mack.
“I was just sold on working in healthcare from then on and I ended up moving to Africa and doing global health work. I did a whole lot of HIV (and) AIDS research and collecting information for healthcare in resource-constrained settings,” she said.
Eventually, that led her in 2007 to a first-of-its-kind project aimed at creating a global registry of avian flu cases. The research group she worked with, which also counted Dreyer among its ranks, collected and streamlined data from over 12 countries with outbreaks of the virus, each with different infrastructures for reporting cases, symptoms and outcomes.
“What happened with COVID, and especially in the sport setting, is that we were forced to do real public health in a way that we really hadn’t been forced to do in a long time.”
Christina Mack
Chief scientific officer, real-world solutions, IQVIA
“All of the techniques and frameworks we have for harmonizing data were either in their infancy or just didn’t exist,” Mack said. “And so, the processes that we had to put in place to get those cases and that data, and then understand the impact to patients, and whether that indication worked for that product, was just a really different model.”
Ultimately, the reporting system and agile analytics model they developed laid the groundwork that allowed scientists to understand the COVID-19 virus more quickly a decade later — a feat Mack also played a significant role in. In fact, her real-world research with both the National Football League (NFL) and National Basketball Association (NBA) led to pivotal discoveries about COVID-19 transmission, mitigation and vaccine effectiveness.
For instance, early in the pandemic a study conducted with the NFL led to a revised understanding of what constituted a high-risk exposure to the virus based on masking and length of contact. Later, in 2021, insights from the NBA transmission data revealed that initial vaccine booster shots were effective in protecting against incident infection.
Because professional sports teams continued to play throughout the pandemic, they proved to be perfect test pools to draw high-quality longitudinal data for research into the virus. Data collected in these studies also emphasized how RWD — collected from patient health records, mobile devices and elsewhere — could be utilized to supplement traditional trial data.
“What happened with COVID, and especially in the sport setting, is that we were forced to do real public health in a way that we really hadn’t been forced to do in a long time,” Mack said. “Because the sports organizations invested so much into the testing, and the genomic sequencing, and the clinical management of the cases and the recording of that data, we had follow-up on the patients.”
Moving forward, she believes lessons learned and structures developed from those studies could further transform future epidemiology research.
“When I look forward into the future, and at what we’ve done in the past few years, what gets me really excited is that we have data out there on the population, and we have data out there about our patients, and we can understand them really well,” Mack said.
RWD’s potential
In a recent report, McKinsey and Co. estimated that between now and 2027, the top 20 pharmaceutical companies could pocket over $300 million a year by adopting RWD tactics. This, in addition to an increased variety of data sources and improved analysis technology could make this the ideal moment for RWD, and Mack argues the industry needs to be ready to fully embrace it.
“There is no doubt that real-world evidence has a critical role in telling us how to make populations and patients healthier and serve patients better,” Mack said. “What we need to figure out is: How do we harness these data in a way that furthers our knowledge?”
One of the areas she sees the greatest potential for use of RWD is in rare disease trials, with small patient populations often scattered across the globe.
“We are on the cusp of being able to break through and learn in a more relevant way than we (have) before.”
Christina Mack
Chief scientific officer, real-world solutions, IQVIA
“We cannot put all of those patients through clinical trials to learn everything that we need to learn about them,” Mack notes, arguing that collecting health record data from these patients could provide an easier, and potentially more cost-effective way to supplement trials.
It also could be used to better understand older patients with comorbidities, who are often excluded from clinical trial data, she said. And her team at IQVIA is also looking into better ways of using electronic clinical outcome assessments — reports directly from patients, physicians or caregivers — to collect information on the patient experience.
“I think of it as giving the patient a microphone in a way that you’re not going to get from a trial endpoint,” Mack said. “It’s a place where we can give a lot of value to patients that we haven’t seen before.”
As these possibilities presented by RWD blossom, she credits the growth of new research tactics to the convergence of fields that, not too long ago, people thought were considered disconnected. No longer the only girl in her computer science class, but now one of the only woman in the locker room, Mack is excited about the road ahead in healthcare technology.
“We are on the cusp of being able to break through and learn in a more relevant way than we (have) before,” she said. “The recognition is there, the technology is there, and the data is there. And what’s exciting right now is that it really is moving forward.”
Source link
#Pro #sports #COVID #protocols #led #realworld #data #impacts #pharma