“Science leads where courage and care walk beside.”

Dr. Thomas B. Leemhuis stands as a distinguished figure in the field of cellular therapy and biotechnology, having forged a path defined by technical innovation, regulatory precision, and compassionate leadership over the course of a 30-year career. His professional journey, which bridges academic research and clinical manufacturing, exemplifies a rare fusion of scientific rigor and visionary foresight. From cleanroom design to FDA regulatory submissions, Dr. Leemhuis has consistently translated cutting-edge science into tangible solutions that have enhanced patient outcomes and advanced the capabilities of cell-based treatments.

His passion for cellular therapies began in the late 1980s, when he worked as a Research Associate in Indianapolis. It was during this time that his dedication to the life sciences took root, leading him to pursue advanced degrees in immunology and experimental hematology.  After earning his Ph.D. from the Indiana University School of Medicine, Dr. Leemhuis swiftly ascended through a variety of roles that would cement his reputation as a pioneer in cell processing and translational medicine.

In the 1990s, he held leadership roles at SyStemix, Inc., where he managed GMP cell processing and technical operations for one of the earliest biotech firms exploring hematopoietic stem cell manipulation. His work during this era contributed to foundational advancements in cell sorting and purification technologies, as well as process development strategies still emulated today. He later took on the role of Scientific Director at the Bone Marrow Transplant Laboratory at Stanford Hospital, a move that further reinforced his deep commitment to clinical application and operational excellence.

In 2001, Dr. Leemhuis began what would become a transformative tenure at the University of Cincinnati’s Hoxworth Blood Center. For more than two decades, he directed the Cellular Therapies Laboratory, providing both technical and administrative leadership for a team responsible for producing cellular therapy products used for standard of care therapies and investigational use in clinical trials.  Under his guidance, the lab supported over 250 hematopoietic stem cell transplants annually across five health care institutions. His influence extended far beyond technical oversight—he fostered a culture of both quality and innovation.

Beyond his administrative achievements, Dr. Leemhuis held a concurrent academic role as an Associate Professor.  He designed and taught coursework on cellular therapy principles and practices and mentored several graduate students, leaving a lasting imprint on the next generation of scientists and clinicians. His commitment to education reflects his belief in science as a collective endeavor—one that grows stronger when shared and cultivated through mentorship.

A respected voice in regulatory affairs, Dr. Leemhuis contributed to multiple Investigator-Sponsored IND applications and collaborated on FDA submissions that enabled early-phase clinical trials for cell and gene therapies. His expertise was not limited to documentation—he also played a pivotal role in cleanroom facility design and environmental compliance, setting the standard for GMP-compliant operations. As an inspector and accreditation committee member for the Foundation for the Accreditation of Cellular Therapy (FACT) for over two decades, he has helped shape policies and accreditation protocols that continue to influence laboratory practices worldwide.

Throughout his career, Dr. Leemhuis has also remained active in clinical research, publishing over 40 peer-reviewed journal articles and contributing to key reference texts in cellular therapy. His work on virus-specific T-cell therapies has garnered attention for its clinical efficacy, especially in immunocompromised patients undergoing stem cell transplantation. These contributions underscore his ability to innovate at the intersection of clinical need and scientific opportunity.

Dr. Leemhuis’s career is also defined by his role as a connector—linking academia, industry, and regulatory frameworks to accelerate therapeutic development. His leadership has enabled seamless technology transfer, robust quality systems, and collaborative partnerships with both public and private entities. Whether overseeing investigational pharmacy services or coordinating cross-institutional manufacturing efforts, he brings strategic clarity and operational discipline to every initiative.

Now, as he transitions into advisory and board roles, Dr. Leemhuis is eager to lend his experience to companies aiming to develop, commercialize, and scale next-generation cell therapies. He is particularly interested in working with organizations in the biotechnology and pharmaceutical sectors and is open to opportunities that involve travel and cross-disciplinary collaboration. With decades of insight, a strong publication record, and a grounded understanding of both scientific and operational dynamics, he offers immediate value to any boardroom or executive team.

At his core, Dr. Leemhuis is guided by a deep respect for science and an unwavering commitment to patient care. His professional motto—“Science leads where courage and care walk beside”—captures the essence of his approach: bold in vision, meticulous in execution, and always rooted in the ethical imperative to heal.

Character:
Dr. Leemhuis exemplifies humility and professionalism, consistently putting team success and patient outcomes above personal accolades. His long-standing roles in leadership and mentorship reflect his deep integrity and commitment to service.

Knowledge:
With a Ph.D. in Experimental Hematology and decades of hands-on experience in cellular therapy manufacturing, Dr. Leemhuis possesses an encyclopedic understanding of his field. His ability to translate complex science into regulatory and operational frameworks sets him apart as a thought leader.

Strategic:
Dr. Leemhuis’s career has been marked by the foresight to align clinical needs with scalable biotech solutions, often ahead of industry trends. He navigates complex environments with clarity, balancing scientific advancement with business objectives and compliance demands.

Communication:
An accomplished educator and author, Dr. Leemhuis articulates his ideas with clarity and conviction. Whether mentoring students, engaging regulators, or collaborating with peers, his communication fosters trust, alignment, and actionable outcomes.