Leonardo Mirandola

Founder and Principal Consultant

Elemental Bio Advisors, LLC · Houston, Texas, United States

Feb 2026 – Present(3 mos)

Technical Consultant

Vision BioSciences · Fort Worth, Texas, United States

Dec 2025 – Present(5 mos)

Strategic and technical advisor supporting the development of regenerative therapies for maculopathies, with a focus on translating early scientific concepts into IND-ready programs.

Fractional CSO & Scientific Advisor

Self-employed · Houston, Texas, United States

Apr 2025 – Present(1 yr 1 mo)

I work independently as a senior scientific and strategic advisor to early-stage biotechnology companies, helping founders and small teams translate innovative ideas into clear, actionable development plans. Drawing from my experience leading R&D programs, building cell-therapy platforms, and guiding companies through preclinical and early clinical planning, I help early teams make the right technical and strategic decisions from day one. My contributions typically include: • Defining scientific strategy and early product concepts • Designing preclinical PoC experiments that validate the core biology • Translating complex science into investor-ready narratives • Identifying feasibility risks and developing mitigation paths • Guiding founders on platform differentiation and competitive positioning • Outlining development roadmaps suitable for seed or seed-plus financing • Advising on early regulatory considerations and IND-enabling expectations • Providing input on IP strategy, FTO boundaries, and scientific defensibility • Supporting early decisions on cell engineering approaches, guide selection, donor DNA strategy, and functional readouts • Helping founders structure data packages, value inflection points, and early partnership opportunities I work with startups developing cell and gene therapies, non-viral gene-editing systems, dendritic-cell immunotherapies, and early gene-therapy concepts. In each case, my goal is the same: to help early founders sharpen their strategy, avoid costly missteps, and build a scientifically credible, capital-efficient path from concept to proof-of-principle. I focus specifically on the earliest stages of company creation and platform development, where experienced scientific direction can materially accelerate progress and increase the likelihood of successful fundraising and validation.

Network member

GLG

Jan 2023 – Present(3 yrs 4 mos)

As a GLG Network Member, I bring over 15 years’ of experience in the biotech industry to help clients solve some of their toughest business challenges around product development and preclinical research. GLG is the world’s insight network. It connects decision makers to the right experts so they can act with the confidence that comes from true clarity and have what it takes to get ahead. Its network of experts is the world’s largest and most varied source of first-hand expertise.

Scientific Development Advisor and Execution Lead

SOHM, Inc. · Chino Hills, California, United States

May 2025 – Present(1 yr)

Providing executive technical leadership for preclinical development programs leveraging SOHM's proprietary gene editing platform for next-generation therapeutics. I translate strategic R&D objectives into actionable experimental plans with defined milestones and timelines, ensuring alignment with regulatory requirements and commercial goals. Key responsibilities include: Leading laboratory teams and coordinating CDMO/CRO partnerships to maintain quality standards and advance development programs Designing preclinical strategies that reduce regulatory complexity and optimize development pathways for advanced therapy products Serving concurrently on the Scientific Advisory Board, advising leadership on preclinical/clinical program design, GMP manufacturing strategy, and regulatory preparedness for IND submissions

Interim Chief Operations Officer

Kiromic Biopharma, Inc. · Houston, Texas, United States

May 2023 – Mar 2025(1 yr 11 mos)

Chief Scientific Officer

Kiromic Biopharma, Inc. · Houston, Texas, United States

Jul 2022 – Mar 2025(2 yrs 9 mos)

Vice President of Research and Development

Kiromic Biopharma, Inc.

Sep 2021 – Jul 2022(11 mos)

Independent Biotechnology, Pharmaceutical, Life Sciences Consultant

Self-employed · Dallas/Fort Worth Area

Jul 2019 – Sep 2021(2 yrs 3 mos)

Director Of Clinical Operations

Kiromic, Inc. · Houston, Texas

Aug 2018 – Jul 2019(1 yr)

I was responsible for delivering assistance in the development of clinical operations quality systems, including SOPs, document management, clinical operations personnel training, and quality control process to maintain seamless flow work. My job was to direct cGMP manufacturing process of the Company’s dendric cells-based therapy in accordance with SOP and FDA regulatory guidelines. My task was to prepare and share clinical studies progress reports with executive-level management.  Conducted training sessions to enhance understanding of site personnel regarding handling and administration of anti-tumor dendritic cell vaccine.  Followed all protocol specifications, FDA regulations, and chain of custody documentation while managing delivery of product to patients.

Executive Director

Kiromic, Inc. · Greater Houston

May 2016 – Jul 2019(3 yrs 3 mos)

My task was to support Company’s R&D activities to accomplish clinical product development in fast and cost effective manner. I performed in vitro, ex vivo, and in vivo validation of new cancer immunological targets by devising new experimental methodologies. I was responsible for acquiring partial funding for the development of single-step manufacturing process while working in close collaboration with MD Anderson Cancer Center, as Principal Investigator and Kiromic’s leader.  Involved in discovery and validation of new tumor-specific targets for anti-CD19 CAR T cell-resistant B-ALL, DLBCL, ovarian cancer, and mesothelioma by developing a novel bioinformatic prediction and wet-lab validation process.  Assisted in the production of dendritic cells for cancer immunotherapy by developing and executing cGMP protocol.  Ensured 50% cost and time reduction by improving dendritic cell manufacturing protocol.  Utilized a cost-effective single-step manufacturing process to make an orally delivered, M-cell targeting microparticle vaccine.  Played an important role in identifying a new adeno-associated virus vector to deliver anti-inflammatory gene therapy and treat arteriosclerosis.  Wrote five patents covering all aspects of the new technologies and methodologies in collaboration with the Company’s IP lawyers to expand company IP portfolio.

Executive Director

Kiromic, Inc. · Greater Houston

Mar 2016 – Feb 2018(2 yrs)

My job was to coordinate with Chief Scientific Officer to lead R&D department in accordance with the Company's objectives. I was responsible for contributing to developing new cellular immunology and molecular immunology techniques. I provided assistance to the Medical Officer in the successful implementation of standard operating procedures for the manufacturing of clinical-grade products.

Post-Doctoral Researcher

Texas Tech University Health Sciences Center

Sep 2013 – Mar 2016(2 yrs 7 mos)

I was involved in authorizing new Cancer/Testis Antigens in NSCLC as vaccine targets as well as a novel panel of Cancer/Testis Antigens in Triple-Negative Breast Cancer. My job was to study non-invasive imaging of ovarian cancer by designing new SP17-targeted, near-infrared and quantum dot-based system.  Performed research on new ovarian cancer oral vaccine efficacy in murine models. Conducted study on ovarian cancer detection by executing and new serological test.

Postdoc research associate

University of Milan, Dep. of Medicine, Surgery and Dentistry, Molecular Pathology Lab · Milan, Lombardy, Italy

Feb 2010 – Sep 2013(3 yrs 8 mos)

My research project is focused on unrevealing the molecular mechanisms of Notch-mediated signals affecting the response to chemokines in hematological malignancies, namely acute leukemias and multiple myeloma. We have shown that Notch-1 is required for T-cell acute leukemia survival and metastatic spread, both in cell lines and in patients’ primary tumor cells as well. The research on multiple myeloma has been performed in collaboration with Dr M. Chiriva-Internati (Director of the Translational Research Project, Division of Hematology and Oncology, Texas Tech University Health Sciences Center, Lubbock, Texas, U.S.A.). In vitro and in vivo experiments based on xenograft murine models of the disease clearly indicated that inhibition of Notch receptors significantly reduced plasma cell survival, bone marrow infiltration and bone disruption by affecting the expression of the chemokine receptor CXCR4 and of its ligand SDF-1. We have shown that the Notch-CXCR4-SDF1 axis is a novel and very promising druggable target to treat advanced multiple myeloma, reducing the risk of resistance to chemotherapy and the infiltration of the bone marrow by plasma cells. Results were published in Leukemia (Mirandola L et al., 2013).

Postdoc

University of Milan, Dep. of Medicine, Surgery and Dentistry, Molecular Pathology Lab

2009 – 2013(4 yrs)

Teaching assistant

University of Milan, Dep. of Medicine, Surgery and Dentistry, Molecular Pathology Lab · Milan, Lombardy, Italy

Jan 2008 – May 2010(2 yrs 5 mos)

Teaching activity/board of examiners in the course “Neoplastic Cell”.

Teaching assistant

University of Milan, Dep. of Medicine, Surgery and Dentistry, Molecular Pathology Lab · Milan, Lombardy, Italy

Jan 2008 – Jan 2010(2 yrs 1 mo)

Teaching activity in the degree course “Laboratory Practice”.

PhD

University of Milan, Dep. of Medicine, Surgery and Dentistry, Molecular Pathology Lab

Nov 2006 – Dec 2009(3 yrs 2 mos)

Teaching assistant

University of Milan, Dep. of Medicine, Surgery and Dentistry, Molecular Pathology Lab · Milan, Lombardy, Italy

Oct 2007 – Oct 2009(2 yrs 1 mo)

Teaching activity in the course “General Pathology”.