Zygmund Roth, PhD

Regulatory Expert

Career Highlights

  • Managing Director, Roth Regulatory Consulting

  • IRX Therapeutics, Vice President and Senior VP, regulatory affairs and QA

    • IRX-2 (an immunostimulatory biologic containing cytokines [sterile injectable]):

      • Guided cGMP manufacture, QC testing, and validation to ensure regulatory compliance

      • Prepared IND submission to FDA; CMC, Toxicology, and Clinical sections; FDA approval obtained

      • Phase 1 clinical trials and Phase 2 clinical trials completed

      • Met with Paul Ehrlich Institute and MHRA to obtain scientific advice for CTA to EU countries

      • Obtained CTA approval for Phase 2 clinical trials in Canada, UK, Switzerland, Spain, Brazil, India

      • Obtained FDA approval to proceed with pivotal Phase 3 clinical trial

    • Represented firm’s regulatory interests in discussions with potential partners and investors

    • Set up regulatory and QA departments for a start-up biotech company developing cancer and immunostimulatory therapies

Education

  • MS and PhD: Pharmacology, Hebrew University​

  • BS, Biology: Trinity College

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