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