Mike Romanko

About Mike Romanko

Experienced Biotechnology Leader who develops translational and commercialization strategies (i.e. regenerative medicine, tissue engineering, gene & cellular therapies, etc.) to address a broad number of medical indications. This experience has encompassed many levels of breadth of the product development process from early discovery to product launch and post market surveillance. I gather competitive intelligence, conduct landscape analysis, and lead technology search and evaluation efforts for investment and acquisition targets. I also mentor and advise small companies with their research and product development strategies to achieve their commercialization goals. This work is further enhanced by professional training I have received in Artificial Intelligence (AI), Finance, and Drug, Medical Device, & Combination Product Development.Selected Achievements:• Led search and evaluation (S&E) of early development and mature product portfolios, overseeing NPD/R&D pipelines and large research consortia across academia, biotech, medtech, pharma, and government partners.• Built and executed market and product landscape analyses to identify and prioritize targets for acquisition, collaboration, and strategic partnerships across medical device & pharmaceutical industries, non-profit & government sectors (DoD).• Advised and mentored companies (including FDA Breakthrough-designated assets and competitively funded programs) on early portfolio strategy, governance, and management to enhance value and readiness for partnership or investment.• Directed R&D portfolio activities, including an international product launch that consistently generated one-third of sports medicine revenue before, during, and after COVID disruptions.• Served as sole MSL Lead (U.S. & Canada) for a biologics portfolio with three successful international launches in spine, orthopedics, and trauma; strategically positioned second-generation assets to avoid cannibalization and expand sales into new territories.• Enabled a successful IND for a first-in-class stem cell therapy by orchestrating preclinical strategy (discovery, external collaborations, characterization, CMC, DMPK, toxicology, safety, and scale-up) and leveraged this framework to de-risk additional combination product INDs (e.g, iPSC programs, novel regulatory designation for hyaluronic acid).

Experience

1. Seta

   ECS

   Nov 2025 — Present · Washington, DC, US

   Supporting the Advanced Research Projects Agency for Health, ARPA-H, https://arpa-h.gov/ • Senior SME and strategic advisor in regenerative medicine, biologics, and cell & gene therapies supporting the ARPA-H NITRO (Novel Innovations for Tissue Regeneration in Osteoarthritis) Program.• Provide technical, commercialization, and portfolio advisory support for 16 novel multifaceted combination products leveraging drugs/biologics, CRISPR and AAV gene therapies, cellular therapies (ASCs, iPSC, immune cells), tissue engineering/bioprinting, 3D printing, and prosthetics.• Support development across three therapeutic areas: TA1 Injectable/Non-invasive Bone Regeneration, TA2 Injectable/Non-invasive Cartilage Regeneration, and TA3 Replacement Joints Built from Human Cells.• Advise across the full product lifecycle—from early R&D through IND-enabling studies, scale-up manufacturing, op-co formation, regulatory strategy, clinical trial execution, and commercialization/market landscape analysis— with a focus on patient access and affordability for underserved populations

Education

• King's College

  Bachelor of Science - BS, Biology, General - Molecular Biology Certification - Liberal Arts Honors Program

• MIT xPRO

  Graduate Certificate: Drug and Medical Device Development: A Strategic Approach

• Johns Hopkins Whiting School of Engineering

  Graduate Certificate, Artificial Intelligence (AI) for Healthcare

• Harvard Business School Online

  Graduate Certificate: Leading with Finance

• University of Pennsylvania School of Medicine

  Postdoc, Gene & Cellular Therapy - Traumatic Brain Injury and Lysosomal Storage Disorders

• Penn State College of Medicine

  Doctor of Philosophy - PhD, Integrated Biosciences: Molecular Medicine

• Rhode Island School of Design

  Continuing Education

  2018 — 2019

Skills

• CRO
• Cell Therapy Products
• Adipose Stem Cells
• Fda
• Glp
• Medical Devices
• Bone and Cartilage Regeneration
• Molecular Biology
• Medical Device Development
• Tissue Culture
• Ind
• Scale Up
• Early Stage Discovery/ Efficacy
• Pharmacology
• Regenerative Medicine
• Drug Development
• In Vitro
• Embryonic Stem Cells
• Biotechnology
• Stem Cells
• Vascular Regeneration
• Biodistribution
• In Vitro Characterization
• Neuroregeneration (Cns/ Pns)
• Life Sciences
• Composite Tissue Transplantation
• Animal Models
• Microscopy
• Animal Models (Large/Small)
• R&D Product Portfolio Management
• Ind Requirements
• Cell Biology
• Technology Transfer
• Bioimaging
• Muscle Regeneration
• Good Laboratory Practice (Glp)
• Cross-Functional Team Leadership
• Cell Therapy
• Neuroscience
• CRO Management