032: Theratome Bio | Regenerative Breakthroughs with Michael Coleman and Karen Momper
Release Date: 04/30/2019
The Obesity Drug Race: From Breakthrough Science to Global Scale
The Life Science Effect
In this solo episode, Steve Vinson explores the rapidly evolving obesity drug market, highlighting insights from a recent Fierce Biotech power rankings article. He breaks down why Lilly and Novo Nordisk currently dominate, while examining the growing competitive field and what may determine the next wave of winners. The discussion focuses on the shift from breakthrough science to scalable execution and commercialization. Episode Overview The obesity drug market has transformed dramatically over the past decade, driven by the success of GLP-1 therapies like Ozempic, Wegovy, and Zepbound. In...
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Global Biopharma Manufacturing: Beyond Tariffs and Toward Resilience
The Life Science Effect
In this episode, Steve Vinson examines the sustained wave of biopharma manufacturing investment in North America and challenges the idea that tariffs were the primary driver. He explores the deeper forces reshaping the industry, including supply chain resilience, demand for complex biologics, and global uncertainty. The discussion focuses on what is actually being built, why it matters, and what to expect over the next one to three years. Episode Overview Steve Vinson steps back to assess the current state of global biopharma manufacturing, with a practical focus on North America. While...
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Why Prescription Drug Pricing Feels Broken: Cost, Complexity, and Trust in the U.S. System
The Life Science Effect
In this solo episode, Steve Vinson explores the confusing and often frustrating reality of prescription drug pricing in the United States. Through a personal story, he unpacks how the same medication can cost dramatically different amounts depending on how and where it is accessed. The episode highlights a deeper issue beyond cost—lack of transparency—and what that means for trust in the healthcare system. Episode Overview This episode starts with a real-world example that many listeners can relate to: discovering that the exact same prescription can vary widely in price across pharmacies,...
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Infrastructure as Innovation: How Ossium Health is Redefining Bone Marrow Access
The Life Science Effect
In this episode, Steve Vinson reflects on a recent Indianapolis Business Journal article about Ossium Health and its approach to bone marrow banking. He explores how innovation in life sciences often comes not from new discoveries, but from improving systems, logistics, and execution. The discussion highlights why infrastructure and operational excellence are becoming critical to the future of medicine—and why Indiana is uniquely positioned to lead. Episode Overview This episode examines Ossium Health’s effort to build a scalable bone marrow banking system using donations from deceased...
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AI Validating AI: The Future of Compliance in Life Sciences
The Life Science Effect
Artificial intelligence is moving fast—but in regulated life science environments, speed without trust is a non‑starter. In this episode of The Life Science Effect, host Steven Vinson reacts to a recent EY article on AI validation in pharmaceutical and biotech settings and explores a fascinating question: Can AI actually be used to validate other AI systems? Steven walks through how regulators are beginning to rethink traditional validation models to accommodate AI’s non‑deterministic nature, where the same input can produce different, but still acceptable, outputs. Drawing parallels...
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How Modular Biotech is Changing Everything - Even in Orbit
The Life Science Effect
In this episode, host Steve Vinson dives into one of the most futuristic — yet rapidly emerging — trends in life sciences: transportable and point‑of‑care pharmaceutical manufacturing. After discovering a compelling ISPE article, Steve explores how modular clean rooms, distributed manufacturing models, and space‑ready production units are reshaping the future of medicine. From personalized tablet production to on‑demand therapies in extreme environments, these technologies could redefine how and where healthcare happens. Drawing on his 30+ years in manufacturing, Steve connects...
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Global Biotech - Is America Falling Behind?
The Life Science Effect
In this episode, Steve Vinson dives into a provocative article by US Senator Todd Young, exploring the shifting landscape of global biotech innovation. With China’s rapid advances—highlighted by a breakthrough lung cancer drug—Steve analyzes the factors behind America’s waning leadership, from fragmented policy and regulatory uncertainty to funding challenges and talent migration. Drawing on his own industry experience, Steve discusses the impact of immigration crackdowns, supply chain vulnerabilities, and the long-term effects of reshoring manufacturing. Listeners will gain insight...
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Pharma 4.0: AI, Validation, and the Future of Life Sciences
The Life Science Effect
Step into the future of pharmaceutical and medical device innovation with Steve on The Life Science Effect. In this episode, Steve explores the transformative power of Pharma 4.0 and Validation 4.0, drawing insights from two thought-provoking blog posts by Robert Perks of Performance Validation. Discover how digital-first strategies, artificial intelligence, and continuous monitoring are reshaping compliance, quality assurance, and operational efficiency in life sciences. Steve breaks down the shift from paper-based systems to predictive analytics, highlighting the importance of aligning...
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The End of Solo Leadership: How Industry 4.0 is Changing the Game
The Life Science Effect
In this thought-provoking Active Ingredient episode, host Steve Vinson tackles a leadership paradigm that's challenging everything he thought he knew about accountability. Inspired by on breaking people silos, Steve dives deep into the tension between traditional "one person accountable" thinking and the emerging concept of shared accountability across teams. Drawing from his real-world experience designing process lane diagrams that keep spanning across departments, Steve explores why Industry 4.0 might be demanding a complete rethink of how we structure organizations. He examines the...
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Raul Zavaleta's Journey from UCLA to Life Science Legend
The Life Science Effect
Meet Raul Zavaleta, the visionary engineer whose innovations fundamentally transformed how clinical trials collect and process data. In this captivating conversation, Raul shares the incredible journey from UCLA graduate to co-founder of what became Covance - one of the world's largest clinical research organizations. Discover how a simple frustration with keypunch cards led to revolutionary solutions that reduced clinical trial data error rates from 39% to under 2% and compressed data cleaning timelines from six months to 48 hours. Raul reveals the story behind the Zavacor system, the...
info_outlineWhat if a cutting edge technology saved your life? And then what if you got to be part of a startup company that is working on similar technology to save others' lives? Karen Momper, of Theratome Bio is living that story.
This week, Micheal Coleman, PhD, and Karen tell the story of Theratorm Bio and the exciting platform they are working on. Learn about how Theratome Bio is developing a portfolio of products derived from adult stem cell secretions. The future includes exciting potential therapies like stroke treatment and organ preservation during transport.
Learn Michael's and Karen's inspiring stories.
Resources in this episode:
Indiana Center for Biomedical Innovation
About Michael Coleman, PhD:
Michael brings a wealth of research and new drug development experience to Theratome Bio. He directed multidisciplinary teams at GeneMedicine and Valentis in Houston, Texas, prior to accepting a role with Centelion (a subsidiary of Sanofi-Aventis) as Vice President of R&D. He there led a team of scientists in discovery, process & clinical development, and regulatory affairs. Most recently, Michael was President and CEO of InGeneron, a medical device firm committed to driving personal regenerative medicine therapies. During his tenure InGeneron attained several regulatory approvals in Europe and initiated clinical trials in the US under FDA approval.
Michael has dedicated his career to developing new therapies, ushering these innovations through regulatory paths, and ultimately seeing new therapies transitioned into the clinic. He has also continued to publish research in peer-reviewed journals and maintain a close relationship with leading researchers and clinicians in academia.
He earned his BS and MS degrees from Texas A&M, his PhD from Penn State, and completed post-doctoral work at the Baylor College of Medicine.
Michael has a passion for the regenerative medicine space. He’s long thought that a cell-free option is where the future of regenerative therapy is headed, and believes that TheratomeTM technology provides the key attributes of product consistency and ease of handling and administration necessary to achieve widespread clinical application. In his own words, “TheratomeTM technology solves the key issues limiting clinical application of stem cell based therapies. I am excited for the opportunity to be part of developing this technology that will provide life changing benefits patients and disrupt the field of regenerative medicine.”
Karen earned a B.A. in Chemistry with a minor in Marketing from the University of Dayton. She completed an Undergraduate Thesis while there, worked for the Office of Admission leading campus tours, and was hired as a new grad to work as a Traveling Student Recruiter.
Karen began her career with the Bristol-Myers Squibb Company shortly thereafter. During her ten years of employment, she served Primary Care and Hospital Sales roles, sold in multiple outpatient and inpatient therapeutic areas, negotiated formulary contracts, earned district, region, and national recognition for sales, and was selected to serve in leadership roles within her district.
Since then, Karen has taken on several non-profit initiatives whereby she has initiated a group, raised funding, and marketed and maintained a leadership role in organizations. She has also used her public speaking abilities to fund-raise. In one such effort, she contributed to the establishment of an in-house Therapeutic Massage Therapy Program to treat Oncology Patients at Oregon Health and Science University (OHSU) Hospital in Portland, Oregon, a cause that was previously only filled by intermittent volunteers.
Karen is happily married, and proud mother to two sons. In addition to multiple volunteer roles at her Parish and children’s schools, Karen reads live broadcasts for IRIS Radio, a free service that provides audio news and literature for the visually impaired. Karen is also the survivor of a stem cell transplant (2009), and an autologous stem cell procedure to her hip to reduce the likelihood for need of replacement. These experiences fuel her unique passion for furthering regenerative medicine innovation.