Effective Communication: Telling the Same Story Different Ways
An interview with LyGenisis CEO Michael Hufford
By Michael Schmanske
What you say matters; how you say it matters as well. Know your audience.
Good Listening Speaks Volumes
Early-stage biotechnology companies face a dilemma: Success depends not only on great science, but also on the rare ability to navigate multiple institutional gatekeepers, craft compelling narratives and build trust across diverse stakeholders. Setting priorities, allocating resources and managing through difficult times are hallmarks of good management and required if one wants to maximize the chance of success.
Michael Hufford, PhD, has made a career of doing precisely that. His journey—spanning clinical psychology, entrepreneurship and regulatory strategy—reveals a professional uniquely suited to the complex demands of life science innovation. As co-founder and CEO of LyGenesis, a regenerative medicine company spun out of the University of Pittsburgh, Hufford exemplifies how scientific insight, regulatory know-how and team-building instincts must converge to create a successful healthcare enterprise.
I spent a casual afternoon chatting with Dr. Hufford about what sorts of skills he believed most contributed to his success. Among the experiences and skills we covered, one theme struck me as common throughout the stories he shared: an ability to communicate effectively by understanding the context and needs of his audience. Many managers fall under the mistaken assumption that a failure in communication is the fault of their audience or employees. That position does not serve them well when dealing with investors or regulators.
I was wondering where those skills may have originated; before joining LyGenesis, Hufford wore many hats (Refer to our profile piece on Dr. Hufford HERE). Personally, I believe it was his background earning a PhD in clinical psychology—including experience as an individual and group psychotherapist that furnished him with a toolset every biotech founder needs: deep human communication skills.
These skills would later prove crucial in high-stakes meetings with the FDA and investor groups alike. Helping ease anxiety and fear, whether from regulators around patient safety, or investors around putting their capital at risk, is an essential tool when taking academic discoveries and making them into commercial therapies. A manager’s communication practices should fully acknowledge the motivations and priorities of the audience in question to overcome those anxieties and build a foundation of trust.
Different practices and assets motivate audiences differently. For example, during his time as an entrepreneur in residence (EIR) at the University of Pittsburgh’s Innovation Institute, Hufford encountered Dr. Eric Lagasse, the French-born researcher whose work on ectopic organogenesis became the basis of LyGenesis, the company Hufford currently leads.
From the outset, Hufford recognized that Lagasse’s data—rescuing both small and large animals from otherwise fatal liver failure using a cell therapy engrafted into their lymph nodes—wasn’t just a marvel of biology, but also a pitch-perfect story for investors and regulators alike. In a field dominated by graphs, tables and statistical nuance, LyGenesis had pictures: fluorescent images of ectopic livers growing in lymph nodes, survival curves that stayed horizontal while controls rapidly fell to zero, and a technology platform scalable enough to turn one donated liver into treatments for up to 75 patients.
Beyond a great technical innovation it was a story he could tell to multiple audiences and they would understand. He knew he had a winner.
But compelling data isn’t enough without the right messenger. Hufford’s role as CEO was to translate that science into both actionable logic for investors and patient safety commitments for regulators. He describes his central insight this way: The same story must be told in different languages.
“The same story must be told in different languages: valuation for VCs, safety for the FDA.”
Michael Hufford, PhD
To venture capitalists, it’s about valuation inflection points and market expansion. To the FDA, it’s about being able to safely meet a critical unmet clinical need. And in both cases, the storyteller must earn trust. For government policymakers it is about consistency and process. As Hufford puts it, “Regulatory meeting minutes are the currency of the realm in life sciences,” meaning that successful FDA interaction can catapult valuation and become an investment catalyst as a key risk reduction step.
At the same time, investors require a story that speaks their language. BUT it must dovetail completely with the regulatory narrative for the FDA. This dual-track approach—developing a pitch deck for investors while simultaneously preparing the FDA briefing book—is really about building symmetry and coherence in stakeholder communication.
This symmetry isn’t just aesthetic. It’s operational.
One feeds the other. A clear, cautious first-in-human trial design impresses the FDA and validates the business plan. Investor confidence grows when they see a company executing against a known regulatory path.
I found Hufford’s success with LyGenesis to be a case study in how precision storytelling enables de-risking at both scientific and financial levels. By weaving together the technical, clinical and market narratives, he helped transform a research discovery into a funded clinical-stage program.
Communication and Team Management
Hufford’s ability to move between roles without losing cohesion and while communicating effectively was arguably his greatest asset in the growth of his career. Aspiring entrepreneurs take note: Breadth of experience can provide a valuable foundation when managing a project, but the ability to communicate effectively with experts in each field can be even more important.
For a founder that goes beyond working together effectively. A CEO’s responsibility isn’t to simply lead teams—he assembles them from disjointed parts: academic innovators, clinical advisors, regulatory experts, and investors. Each stakeholder group has different needs and different fears. A good manager’s skill lies in identifying those motivations and aligning them to a shared goal.
This isn’t just leadership—it’s orchestration.
For its part, LyGenesis is currently progressing its liver program through clinical trials and advancing potential treatments for kidney, pancreas and even thymus regeneration. Each project requires the same foundational skill: building trust through communication.
Hufford’s background in psychotherapy gave him a front-row education in human behavior. His experience at the regulatory edge taught him the value of humility and preparedness. And his leadership at LyGenesis showcases how a founder’s narrative fluency can create alignment where others see chaos.
Michael Schmanske is a 24-year Wall Street veteran with experience on trading desks and asset managers. He is the co-founder of Prognosis:Innovation as well as founder of MD.Capital.
Michael Hufford’s work experience stands as a practical guide for founders navigating the high-stakes terrain of translational science. His insights directly inform our upcoming articles on early-stage team formation, the value of entrepreneur in residence (EIR) roles and the benefits of shared resource pools in academic startups. As a co-author and consistent contributor to these pieces, Hufford doesn’t just offer anecdotes—he provides structure, vocabulary and case-based insight. For those trying to turn academic breakthroughs into clinical reality, his example isn’t aspirational—it’s instructive.
#Communication | #LifeScienceLeadership | #EarlyStageBiotech | #RegulatoryStrategy
For more on how these lessons apply across the startup landscape, check out other Prognosis:Innovation articles such as “Teams, Part 1: Executive Management.”
