Editor’s note: This story is part of our 2022 PharmaVoice 100 feature.
Our honoree: Dr. Laura Niklason
Title: CEO, president, founder Humacyte
The company’s focus: Humacyte’s human acellular vessel technology allows for the creation of off-the-shelf, universally implantable tissue that becomes the patient’s own living tissue.
Niklason’s biggest wins: A photo of the first U.S. implantation of Humacyte’s human acellular vessel (HAV) in an operating room at Duke University holds a place of prominence in Niklason’s office — and for good reason. This marked a breakthrough in making regenerative medicine a reality.
Niklason founded Humacyte in 2004 based on her invention of the HAV, which at the time seemed more like science fiction than a scientific reality. Fast forward 18 years and as president and CEO, she has the clinical-stage biotechnology platform company on the right path — Humacyte went public in August 2021 with a “valuation of more than $1 billion,” a nominator notes.
As a scientist, entrepreneur and executive, Niklason is one of the “rare people in biotechnology who is creating an entirely new category of products to reshape medical practice,” one of her nominators says. “She is a living example of the biotechnology industry’s need for diversity and female leaders — succeeding as a top-tier research scientist, entrepreneur and CEO of a company that just went public.”
Her impact: The inspiration for her HAV technology goes back to Niklason’s days as a resident at Mass General in the operating room. Watching a surgical team “look for a suitable vein in a patient to use to perform a heart bypass procedure,” her nominator says, was the spark that has inspired Niklason’s work for the past 30 years.
Niklason’s decision to “create a better way — a bioengineered, regenerative, off-the-shelf tissue capable of being implanted in anyone,” coincided with regenerative medicines start as a field of medical research.
“Many doubted the ability for a true regenerative medicine product to overcome extreme hurdles, such as immunogenicity, to produce viable bioengineered human tissues,” a colleague says. But Niklason, ever-determined, pressed on, “creating the first prototype engineered blood vessel in 1997” while establishing the scientific foundation in laboratories at MIT and then Duke University.
"In order for science to change medicine, moving ideas from the academy into industry is indispensable."
Dr. Laura Niklason
CEO, president, founder, Humacyte
Niklason went on to co-found Humacyte in 2004 with Dr. Juliana Blum and Dr. Shannon Dahl — her postdoc and graduate student colleagues, respectively.
“This all-women team of founders was unique then, and unfortunately, is still a rarity today,” says her nominator. “Funding was hard to come by for an entirely new category of product, not to mention for female entrepreneurs, and the team relied on grants and family investment for the first decade of its existence. In 2013, the first U.S. human surgical implant of the HAV took place at Duke. Less than a year later, Humacyte’s lead product, the 6mm HAV received FDA fast track designation for vascular access in hemodialysis. In 2017, the HAV was the first product to receive the regenerative medicine advanced therapy designation from FDA, further underscoring the unique and transformative potential of this product.”
Additionally, the U.S. Secretary of Defense granted the company priority designation for the treatment of vascular trauma, and Humacyte “inked a $150 million equity investment with Fresenius Medical Care, a leader in hemodialysis, which brought the total raised to approximately $480 million as a private company.”
In 2020, Niklason formally assumed the role of CEO, “and in quick succession, led the company’s transition to the public markets via a SPAC, which raised $245 million and valued the resulting public company at ~$1.1 billion to fuel its continued progress making science fiction into fact with its HAV and platform technology,” a nominator says.
Humacyte is currently working in six indications and expects to have a commercial product in the next two to three years. Her nominator says based on clinical studies, “the HAVs have demonstrated the potential to realize their promise — exhibiting durable long-term use and ongoing clinical function, with data on more than 500 patients and 1,000-plus patient-years of exposure. The potential for the technology is almost limitless. Beyond engineering vascular constructs, the technology could create other complex tissue and organ system constructs, including a biovascular pancreas for the treatment of Type 1 diabetes.”
Niklason and her team have also overcome a major barrier — manufacturing — to making HAVs available at scale.
“Humacyte’s 83,000-square-foot manufacturing facility has the capacity to make about 40,000 HAVs per year and is readily scalable to support future growth,” a colleague notes.
Why she’s inspiring: Some who know her best say Niklason’s entrepreneurial and inspirational spirit extends beyond medicine.
“She’s leveraged her platform to become a driving force for gender parity and inclusivity in the workplace, inspiring a generation of women — inside and outside of Humacyte — to take their much-deserved position in a male-dominated industry,” a colleague says.
Today, more than half of the workforce at Humacyte is comprised of women, including 50% of the leadership team.
“Niklason is an innovator in every sense of the word, blazing new trails in regenerative medicine and for women and underrepresented groups in academia and industry,” a nominator says. “Her grit has helped forge a potential new category of medicine out of nothing but an idea.”
In her own words: “My lifelong passion has been the combination of medicine and science,” she says. “In order for science to change medicine, however, moving ideas from the academy into industry is indispensable. I am in industry so that I can bring ideas, in the form of new therapeutics, to patients.”
Editor’s note: We caught up with Niklason last year to hear about her entrepreneurial and scientific journey in an installment of our Woman of the Week podcast series. Click here to hear the episode and listen to her story.