Profile: Michael Hufford, PhD

LyGenisis Co-Founder and CEO Michael Hufford, PhD

From academia to biotech leadership in Pittsburgh, Hufford currently drives the future of next-generation organ replacement therapy.

Academic Foundations and Early Career

Michael Hufford, PhD, has built a career at the intersection of academia and industry, establishing himself as a leader in drug development and biotech entrepreneurship. He earned his undergraduate degree with distinction from Purdue University followed by early research focused on substance use disorders leading to a master’s and PhD in Clinical Psychology from the University of Pittsburgh (Pitt).  

While holding a Research and Clinical Fellowship in psychiatry at Harvard Medical School, his work increasingly intersected with questions of drug efficacy, treatment design and public health strategy. During this period Hufford became frustrated by the limitations and lack of efficiency in translating discoveries from academic research into tangible patient outcomes—a realization that began to pull him toward industry. The pace and impact of pharmaceutical development, coupled with exposure to translational science, convinced him that moving beyond the lab bench was necessary to effect meaningful change.

By the early 2000s, Hufford had transitioned from academia to pharma, bringing a rigorous scientific mindset to roles at public biotech companies like Amylin Pharmaceuticals and Cypress Bioscience. At Cypress, he helped shepherd a new treatment for fibromyalgia through FDA approval while gaining firsthand experience in regulatory strategy, clinical trial design and public market pressures. But despite the scale and visibility of these successes, Hufford found himself increasingly drawn to smaller, earlier-stage ventures—places where scientific agility, entrepreneurial risk and direct impact on patient care were tightly interwoven.

Serial Entrepreneur and Life Sciences Executive

His first foray into this world in the early 2000s was quite the leap, leaving a tenured academic post to join a Pitt spinout capturing real-time patient-reported outcome data for pharmaceutical companies. The experience set the tone for a career built on calculated risks. Along the way, he emerged as a serial entrepreneur, co-founding multiple companies across diverse healthcare sectors.

By 2015, Hufford was recognized as a seasoned executive in the field and was recruited as vice president for regulatory affairs, behavioral science and innovation at Pinney Associates, a consulting firm known for expertise in public health and pharmaceuticals​, with an expertise in prescription to over-the-counter switches as well as tobacco harm reduction.

While at Pinney Associates, he leveraged his broad experience (spanning orphan metabolic diseases to psychiatry and oncology) to advise on drug development programs​—a blend of scientific insight and business acumen which has been a through-line in Hufford’s career.  

His experience there led him to co-found with John Pinney Harm Reduction Therapeutics, a 501(c)(3) nonprofit pharmaceutical company dedicated to making a low cost over-the-counter naloxone nasal spray available across the United States.  Having returned to Pittsburgh to work at Pinney Associates, Hufford reconnected with the university as an entrepreneur in residence (EIR) at Pitt’s Innovation Institute. In his role as a two-time Pitt alumnus and former EIR at the Innovation Institute, he became involved with his current company, LyGenisis, after working with founder Dr. Eric Lagasse; Hufford was instrumental in spinning out LyGenesis as a private company​. The company was even named Pittsburgh’s “Startup of the Year” in 2022 by the local entrepreneurial community, highlighting it as a poster child for how academic discoveries can fuel regional growth.

LyGenesis: Pioneering Organ Regeneration in Pittsburgh

LyGenesis, Inc., which Hufford co-founded in 2017, was born from decades of academic research at the University of Pittsburgh’s McGowan Institute for Regenerative Medicine. ​ The Pittsburgh-based startup has developed a cell therapy platform that injects donor liver hepatocyte cells into a patient’s lymph nodes, which then serve as in-body bioreactors to grow new mini-organs. 

The potential is paradigm-shifting: One donated organ could treat dozens of patients, with an outpatient procedure instead of major surgery​. [See mirm-pitt.net and blog.innovation.pitt.edu ]

Pittsburgh possesses a vibrant research ecosystem garnering more than $7B in government-supported blue-sky research funding between 2014–2024 and regularly ranks in the top five of healthcare research regions nationally.  However, despite these successful efforts to drive fundamental innovation, the region also has a relatively poor record converting Intellectual Property into successful startups. This was something Hufford was specifically focused on changing as the EIR at Pitt.

For its part under Hufford’s guidance, LyGenesis broke that trend and advanced from preclinical studies to human trials—securing FDA clearance to launch a Phase 2a trial for patients with end-stage liver disease and raising more than $37 million in funding to date​. Notably, by successfully attracting investment from major longevity and tech investors (Juvenescence Ltd. and Prime Movers Lab), he illustrated how one Pittsburgh spinout overcame regional or small-market biases to galvanize global support behind a solid team and strong narrative.

Hufford’s decision to build LyGenesis in Pittsburgh was a natural outgrowth of the deep scientific and medical expertise at the University of Pittsburgh as well as at UPMC (University of Pittsburgh Medical Center). It also speaks to his support of the region’s innovation ecosystem. That goal has been championed by organizations like the Pittsburgh Technology Council (PTC), which supports regional entrepreneurs and encourages the founding of new companies. “Our universities are fueling growth and innovation in the Pittsburgh region,” ​Hufford states as a guest on a PTC web call; the PTC seeks to foster the growth of innovation based startups with educational resources and local events and support.

Hufford appreciates that community support and mandate to develop the regional ecosystem: Last year he moved LyGenesis into a new headquarters in Pittsburgh’s Squirrel Hill neighborhood, positioning the company for “incredible growth, right here in Pittsburgh.” In an ecosystem still emerging on the national biotech stage, Hufford’s work is both a testament to Pittsburgh’s potential and a blueprint for how to leverage its regional strengths: world-class research and a collaborative spirit.

Reviving Lives through Harm Reduction

As he pushes the frontiers of regenerative medicine with LyGenisis, Hufford has also applied his leadership to more immediate public health challenges. He is co-founder and CEO of Harm Reduction Therapeutics (HRT), a 501(c)(3) nonprofit pharmaceutical company launched to combat the opioid overdose crisis.

HRT’s mission under Hufford has been to develop a low-cost, over-the-counter naloxone nasal spray—an opioid antidote—and make it widely accessible. In 2023, that mission achieved a pivotal milestone when the FDA approved HRT’s naloxone spray, named RiVive, for over-the-counter use. Hufford’s nonprofit secured this approval as the second-ever OTC naloxone in the United States, with a plan to distribute it at no profit.

The spray costs only about $34 per twin-pack to produce, a price that “allows us to give 10% of our inventory away free,”​ Hufford says.

By working with charitable partners and leveraging donor support, he aims to drive the cost down further and donate even more doses. It’s an entrepreneurial endeavor, to be sure (requiring FDA navigation and fundraising, including support from Purdue Pharma’s bankruptcy settlement funds), but one firmly rooted in social impact rather than profit​.

A Leadership Journey Bridging Bench and Bedside

From laboratory research to life-saving nasal sprays, Michael Hufford’s trajectory crosses a wide breadth in biomedical leadership. He has navigated a range of life sciences ventures: academic research and teaching, executive management in biotech and pharma, serial entrepreneurship with multiple exits and even philanthropy-driven drug development. 

Equal parts scientist and CEO, Hufford is known for thoughtful communication techniques when marrying technical knowledge with operational savvy—raising capital, forging partnerships and clearing regulatory hurdles to bring new therapies to patients​. His work in Pittsburgh’s burgeoning biotech scene has drawn national attention to the region’s capacity for innovation and impact. As one of the city’s prominent repeat founders​, he both benefits from and contributes to the growing momentum of Pittsburgh’s life sciences ecosystem.  

Join us in welcoming Michael Hufford as he shares his expertise as a partner and contributor leveraging scientific expertise, entrepreneurial grit and community ethos to help early-stage healthcare founders fight for their startups’ successes.

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