Business Wire07.31.18
Humacyte, an innovator in biotechnology and regenerative medicine, has appointed Jeffrey Lawson M.D., Ph.D., as president and CEO. Carrie S. Cox has assumed the role of executive chairman.
Lawson, an innovator, scientist and vascular surgeon, has been involved in the development of Humacyte’s vascular technologies, in collaboration with his career-long research partner and Humacyte founder Dr. Laura Niklason, over the past 20 years. Lawson has worked with Humacyte since its founding in 2004 to support the science, preclinical and clinical testing of Humacyte’s novel tissue engineered blood vessels, which are being developed for dialysis access and cardiovascular surgery. He was appointed chief medical officer of Humacyte in 2015 to oversee the clinical development of these vascular technologies as the company initiated Phase III clinical trials for dialysis access and expanded clinical programs in vascular repair and trauma.
Prior to joining Humacyte, Lawson served in leadership roles at Duke University Medical Center, including professor of Surgery and Pathology, vice chair for Research in Surgery, and director of Clinical Trials for the Department of Surgery. Lawson earned his medical degree and his Ph.D. in cell and molecular biology from the University of Vermont and completed his residency in general and thoracic surgery and his fellowship in vascular surgery at Duke University Medical Center. Lawson is also an American Board of Surgery-certified vascular surgeon, a Fellow of the American Surgical Association and the current president of the Vascular Access Society of the Americas.
“Under Carrie’s leadership, the organization has delivered remarkable progress in its first product candidate, catching the attention of research institutions, key opinion leaders, clinical sites, and investors all over the world,” said Lawson. “I look forward to continuing that work, along with the team at Humacyte. It will be my honor and privilege to lead the Humacyte team into the future as we continue to develop tissues to improve the lives of dialysis patients and expand our pipeline of product candidates, with the objective of helping patients in need of vascular repair and reconstruction.”
As executive chairman, Cox will serve as a senior, strategic advisor to Lawson and the executive team, helping to develop ongoing strategy for Humacyte as the company works toward regulatory approval and commercialization for the investigational Human Acellular Vessel (HAV), HUMACYL.
Since joining Humacyte as chairman and CEO in 2010, Cox has led the company through significant business, clinical, regulatory and operational milestones. She has guided the company’s clinical review process, including its ongoing pivotal Phase III clinical trials to evaluate the efficacy and safety of the bioengineered blood vessel as a conduit for hemodialysis in patients with end-stage renal disease (ESRD). Most recently, she led the negotiation of a strategic global commercialization partnership with Fresenius Medical Care to potentially make HUMACYL available to more patients worldwide following approval of the product.
“Leading Humacyte has been one the most fulfilling and rewarding experiences of my career. I’m impressed by and proud of the incredible achievements of our team, as we strive to make science a reality for patients and physicians,” said Cox. “Our work to transform vascular medicine and tissue therapy has only just begun, and under the leadership of Dr. Lawson, I’m confident we are well positioned to further advance the boundaries of regenerative medicine and vascular therapeutics. With a track record of success in our own clinical development, Dr. Lawson is uniquely positioned to lead Humacyte through our next stage of growth and pipeline development.”
Prior to serving as Humacyte’s chief medical officer, Lawson served as a consultant and advisor in the development of the investigational HAV. As an investigator in Humacyte’s Phase II clinical research program in hemodialysis, in 2013 he and Niklason, were the first to implant Humacyte’s investigational HAV for vascular access into a patient diagnosed with ESRD. “The development of Humacyte’s first-in-class therapeutics has always required a team that is committed, extremely talented, and visionary. With Jeff’s appointment to the CEO role, we are continuing our great tradition of outstanding leadership as we continue our work to develop transformative and meaningful tissues in the regenerative medicine space,” said Niklason.
Humacyte Inc., a privately held company founded by Niklason, M.D., Ph.D., in 2004, is a medical research, discovery and development company with clinical and pre-clinical stage investigational products.
Humacyte is primarily focused on developing and commercializing a proprietary novel technology based on human tissue-based products for key applications in regenerative medicine and vascular surgery. The company uses its proprietary platform technology to engineer human extracellular matrix-based tissues that can be shaped into tubes, sheets, or particulate conformations, with properties similar to native tissues. These are being developed for potential use in many specific applications, with the goal to significantly improve treatment outcomes for many patients, including those with vascular disease and those requiring hemodialysis. The company’s proprietary technologies are designed to create off-the-shelf products that, once approved, can be utilized in any patient.
Lawson, an innovator, scientist and vascular surgeon, has been involved in the development of Humacyte’s vascular technologies, in collaboration with his career-long research partner and Humacyte founder Dr. Laura Niklason, over the past 20 years. Lawson has worked with Humacyte since its founding in 2004 to support the science, preclinical and clinical testing of Humacyte’s novel tissue engineered blood vessels, which are being developed for dialysis access and cardiovascular surgery. He was appointed chief medical officer of Humacyte in 2015 to oversee the clinical development of these vascular technologies as the company initiated Phase III clinical trials for dialysis access and expanded clinical programs in vascular repair and trauma.
Prior to joining Humacyte, Lawson served in leadership roles at Duke University Medical Center, including professor of Surgery and Pathology, vice chair for Research in Surgery, and director of Clinical Trials for the Department of Surgery. Lawson earned his medical degree and his Ph.D. in cell and molecular biology from the University of Vermont and completed his residency in general and thoracic surgery and his fellowship in vascular surgery at Duke University Medical Center. Lawson is also an American Board of Surgery-certified vascular surgeon, a Fellow of the American Surgical Association and the current president of the Vascular Access Society of the Americas.
“Under Carrie’s leadership, the organization has delivered remarkable progress in its first product candidate, catching the attention of research institutions, key opinion leaders, clinical sites, and investors all over the world,” said Lawson. “I look forward to continuing that work, along with the team at Humacyte. It will be my honor and privilege to lead the Humacyte team into the future as we continue to develop tissues to improve the lives of dialysis patients and expand our pipeline of product candidates, with the objective of helping patients in need of vascular repair and reconstruction.”
As executive chairman, Cox will serve as a senior, strategic advisor to Lawson and the executive team, helping to develop ongoing strategy for Humacyte as the company works toward regulatory approval and commercialization for the investigational Human Acellular Vessel (HAV), HUMACYL.
Since joining Humacyte as chairman and CEO in 2010, Cox has led the company through significant business, clinical, regulatory and operational milestones. She has guided the company’s clinical review process, including its ongoing pivotal Phase III clinical trials to evaluate the efficacy and safety of the bioengineered blood vessel as a conduit for hemodialysis in patients with end-stage renal disease (ESRD). Most recently, she led the negotiation of a strategic global commercialization partnership with Fresenius Medical Care to potentially make HUMACYL available to more patients worldwide following approval of the product.
“Leading Humacyte has been one the most fulfilling and rewarding experiences of my career. I’m impressed by and proud of the incredible achievements of our team, as we strive to make science a reality for patients and physicians,” said Cox. “Our work to transform vascular medicine and tissue therapy has only just begun, and under the leadership of Dr. Lawson, I’m confident we are well positioned to further advance the boundaries of regenerative medicine and vascular therapeutics. With a track record of success in our own clinical development, Dr. Lawson is uniquely positioned to lead Humacyte through our next stage of growth and pipeline development.”
Prior to serving as Humacyte’s chief medical officer, Lawson served as a consultant and advisor in the development of the investigational HAV. As an investigator in Humacyte’s Phase II clinical research program in hemodialysis, in 2013 he and Niklason, were the first to implant Humacyte’s investigational HAV for vascular access into a patient diagnosed with ESRD. “The development of Humacyte’s first-in-class therapeutics has always required a team that is committed, extremely talented, and visionary. With Jeff’s appointment to the CEO role, we are continuing our great tradition of outstanding leadership as we continue our work to develop transformative and meaningful tissues in the regenerative medicine space,” said Niklason.
Humacyte Inc., a privately held company founded by Niklason, M.D., Ph.D., in 2004, is a medical research, discovery and development company with clinical and pre-clinical stage investigational products.
Humacyte is primarily focused on developing and commercializing a proprietary novel technology based on human tissue-based products for key applications in regenerative medicine and vascular surgery. The company uses its proprietary platform technology to engineer human extracellular matrix-based tissues that can be shaped into tubes, sheets, or particulate conformations, with properties similar to native tissues. These are being developed for potential use in many specific applications, with the goal to significantly improve treatment outcomes for many patients, including those with vascular disease and those requiring hemodialysis. The company’s proprietary technologies are designed to create off-the-shelf products that, once approved, can be utilized in any patient.