Kyle Kolaja

About Kyle Kolaja

I am an experienced Pharmaceutical/Biotechnology executive Leader with a broad range of accomplishments thematically highlighted by- being an early adopter of novel models from genomics to iPSCs to AI/ML/LLMs- managing large diverse technical and scientific teams of laboratory scientists to software engineers- being a lead author on numerous successful world wide regulatory submissions and approvals- taking learning opportunities in smaller biotechnology companies departing from toxicology to be head of business development, be involved in M&A activities, and broadening the business acumenI currently am Scientific Vice President at BMS (heritage Celgene). In this role, I lead teams across the Cell Therapy Safety, the Development and Reproductive Toxicology, Genetic Toxicology, Product Quality, Investigative Toxicology and Immunotoxicology Groups. I also am responsible for all aspects of the preclinical safety for the entire BMS cell therapy portfolio. In addition, I lead the team championing the AI/LLM/ML usage within nonclinical safety including product owner of an Agile team building an architecture to automate the report and IB content generation processes and developing LLM driven Health Authority tool using all prior BMS queries and responses. Previously, I was Vice President, Business Development and Cell Therapy at Cellular Dynamics, where I established clinical and preclinical commercial applications of pluripotent stem cells and their derived tissues. Prior to CDI, I was Global Head of Predictive Toxicology Screens and Investigative Toxicology at Roche, and oversaw laboratories in US and Europe that conducted all safety screening assays, provided toxicology support to projects, and applied stem cell derived tissues to safety. Prior to joining Roche, I was Vice President at Iconix Pharmaceuticals and prior to that, was a project toxicologist and site head of investigative toxicology at Searle/Pharmacia. I am a Fellow of the Academy of Toxicological Sciences (and past President) and a Diplomate of the American Boards of Toxicology and served on the Board of Directors for both organizations. I served as President of the SOT\'s Specialty Sections for Drug Discovery Toxicology and Stem Cells and Toxicology and have over 80 peer-reviewed publications and reviews from my academic and industrial research efforts.

Experience

1. Scientific Vice President

   Bristol Myers Squibb

   Dec 2015 — Present · Summit, NJ, US

Education

• Indiana University School of Medicine

  Ph.D., toxicology

  1992 — 1996

• University of Kansas Medical Center

  post-doctoral fellowship, Toxicology

  1996 — 1998

• Michigan State University

  BS, Lyman Briggs Physiology

  1988 — 1992

• American community school - cobham

  Hs

  1987 — 1987

• Portage Central High School

  HS, na

  1984 — 1988

Skills

• Technology Transfer
• Biomarkers
• Regulatory Submissions
• In Vivo
• R
• Laboratory
• Drug Development
• Cancer
• Bioanalysis
• Biopharmaceuticals
• Cell Biology
• Clinical Trials
• Elisa
• Life Sciences
• In Vitro
• Lifesciences
• Drug Delivery
• Clinical Development
• Neuroscience
• Validation
• Oncology
• Biochemistry
• Biotechnology
• Stem Cells
• Target Identification
• Pharmaceutical Industry
• CRO
• Inflammation
• Infectious Diseases
• Flow Cytometry
• Translational Research
• Protein Chemistry
• Biomarker Discovery
• Proteomics
• Molecular Biology
• Drug Discovery
• Virology
• High Throughput Screening
• Monoclonal Antibodies
• Immunology