
Zygmund Roth, PhD
Regulatory Expert
Career Highlights
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Managing Director, Roth Regulatory Consulting
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IRX Therapeutics, Vice President and Senior VP, regulatory affairs and QA
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IRX-2 (an immunostimulatory biologic containing cytokines [sterile injectable]):
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Guided cGMP manufacture, QC testing, and validation to ensure regulatory compliance
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Prepared IND submission to FDA; CMC, Toxicology, and Clinical sections; FDA approval obtained
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Phase 1 clinical trials and Phase 2 clinical trials completed
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Met with Paul Ehrlich Institute and MHRA to obtain scientific advice for CTA to EU countries
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Obtained CTA approval for Phase 2 clinical trials in Canada, UK, Switzerland, Spain, Brazil, India
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Obtained FDA approval to proceed with pivotal Phase 3 clinical trial
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Represented firm’s regulatory interests in discussions with potential partners and investors
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Set up regulatory and QA departments for a start-up biotech company developing cancer and immunostimulatory therapies
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Education
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MS and PhD: Pharmacology, Hebrew University
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BS, Biology: Trinity College