Dr. Furmanski has over 8 years of experience in the development of small molecule, oligonucleotide, radiopharmaceutical, and biologic therapeutics from an industrial and regulatory perspective. He has provided expert guidance on the design and interpretation of human clinical pharmacology, toxicokinetic, drug metabolism, bioanalytical and biopharmaceutical quality findings through the examination of pharmacokinetic and pharmacodynamic analyses across multiple therapeutic areas.
While at the FDA, Dr. Furmanski reviewed and provided regulatory advice on 3 NDAs, 1 BLA, 6 sNDAs, 11 sBLAs, 2 505b2s, and 1 biosimilar application. He has also reviewed over 200 INDs spanning across all phases of development (pre-IND, IND, meeting packages, breakthrough designation, pre-NDA/BLA), along with briefing packages, product labeling, and post-marketing commitment and requirement studies.
He has presented key regulatory findings at an oncology drug advisory committee meeting, scientific conferences and to other health agencies (EMA, Health Canada, PMDA, TGA and Swissmedic). His therapeutic focus areas are oncology, immuno-oncology, muscular disorders, and infectious diseases. Dr. Furmanski has been recognized for his work using model informed drug development tools for regulatory decision making and evaluation of the effect of immunogenicity on clinical efficacy and safety.