Dr. Stephen Harrison’s pioneering work in liver research has left an indelible mark on the medical community. Over a 30-year career, he not only advanced the understanding of metabolic dysfunction-associated steatohepatitis (MASH) and metabolic dysfunction-associated steatotic liver disease (MASLD) but also played a critical role in the development of the first FDA-approved drug for these conditions.
CEO and Co-Founder
Summit Clinical Research
Today, his vision lives on through Summit Clinical Research, a company that continues to transform clinical trials and enhance patient outcomes in the MASH space.
In this Xtalks Spotlight edition, Gail Hinkson, CEO and Co-Founder of Summit Clinical Research, discusses how Summit continues to celebrate Dr. Harrison’s legacy.
She emphasizes their commitment to achieving his vision of improving the execution of clinical trials for the industry’s future.
From Vision to Reality: The Early Days of Summit Clinical Research
Hinkson recalls the early collaboration with Dr. Harrison that laid the foundation for their groundbreaking work. Their partnership began over 16 years ago when Dr. Harrison was a military researcher at Brooke Army Medical Center, and Hinkson was involved with a 501(c)(3) dedicated to research and education with the military.
“We had always envisioned building a research center that was dedicated to fatty liver disease,” she explains, and in 2015, they brought that vision to life with the launch of Pinnacle Clinical Research. That venture quickly demonstrated its effectiveness by identifying patients that were suitable for the trials and helping sponsors effectively enroll their studies.
In 2018, leveraging their initial success, they expanded their efforts by founding Summit Clinical Research to extend these strategies to additional research sites.
Pioneering a Model of Excellence in MASH Clinical Research
Summit Clinical Research has built its reputation on a model that prioritizes operational excellence and scientific insight.
“Our first trial that we did was with 15 sites enrolling 175 patients. And our objective was to do that in under a year, and we actually exceeded that,” Hinkson notes. “So, we knew that the method that we had built was viable. In fact, we’ve replicated it across all of the programs…”
This achievement set the stage for expanding their focus not only on MASH research but also on related disease states. They saw firsthand how these metabolic conditions overlap, so Summit leveraged their expertise to address the broader spectrum of metabolic disorders.
Expanding Horizons: Integrating New Therapeutic Areas
Hinkson explains their seamless expansion into related MASH areas, including hyperlipidemia, obesity and cardiovascular disease. “Our sites have access to that patient population since it is part of that connected penumbra of MASH disease states.”
By leveraging established site networks and patient recruitment strategies, Summit can efficiently launch studies across various metabolic disorders.
Moreover, Dr. Harrison’s legacy is not confined solely to liver research. As Hinkson notes, “Dr. Harrison had also found a synergy between MASH research and Alzheimer’s research, both having some metabolic association,” prompting Summit to broaden its scope. Building on this insight, Summit Clinical Research is actively exploring Alzheimer’s disease trials, aiming to apply its proven metabolic expertise to neurodegenerative conditions.
In addition, Hinkson describes that one of their objectives for long-term growth is “bringing our scientific insights and our operational insights into building a medical education and medical communications division within Summit.” This initiative will help ensure that stakeholders can benefit from the company’s collective experience and uphold the high standards set by Dr. Harrison.
Navigating Change and Leadership Transitions
The passing of Dr. Harrison marked a substantial moment for Summit Clinical Research. The company was prepared for this transition, though it never expected to enact the plans so quickly.
“In 2022, we had brought in Dr. Mazen Noureddin as our Chief Scientific Officer and someday successor for Dr. Harrison,” Hinkson explains, underscoring their foresight in ensuring continuity of scientific leadership.
Following Dr. Harrison’s passing, Dr. Noureddin “has stepped into that role more fulfilled the scientific and clinical insights related to the disease states that we’re working in,” she adds, highlighting his seamless integration into Summit’s leadership.
Alongside him, Hinkson notes, “We’ve also brought in Dr. Naim Alkhouri as our Chief Academic Officer to drive that scientific insight, that medical communication element that we’re building within Summit.”
With these strategic appointments — and an expanded bench of KOLs and thought leaders across Alzheimer’s, obesity and cardiovascular research — Summit Clinical Research is poised to maintain the momentum of innovation and excellence that Dr. Harrison championed. The core engine of Summit continues to advance this collective vision.
Honoring a Shared Legacy and Looking to the Future
At its core, Summit Clinical Research is driven by a shared vision — a vision that was shaped during 16 years of collaboration between Dr. Harrison and Hinkson.
The company’s commitment to transforming clinical trials remains steadfast. By continuing to evolve and embrace disruptive ideas, Summit Clinical Research is dedicated to advancing MASH research and exploring new therapeutic frontiers.
Their ongoing efforts serve not only as a tribute to Dr. Harrison’s legacy but also as a promise to patients and sponsors alike: the pursuit of better research, more effective clinical trials and ultimately, improved patient care.
This article was created in collaboration with the sponsoring company and the Xtalks editorial team.
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