Zoya Gluzman-Poltorak

Targeted and programmable DNA and RNA therapeutics

Startups advisor and mentor

Mentorship of the next generation of biotech innovators

Biotech Therapeutic Development from A to Z. Strategic, Scientific, Regulatory and Operational Planning. Cell and Gene, Genome Editing, In-vivo Viral and non-Viral Targeted Delivery. Preclinical, Regulatory, CMC, Clinical.

Led SonoThera’s Therapeutic Development, identifying and prioritizing therapeutic targets, guiding pre-clinical, manufacturing, regulatory, and clinical development in multiple target organs. - Built efficient in-house infrastructure and well-organized network of external collaborations for preclinical, manufacturing, and clinical development. - Timely initiated effective interactions with the FDA and served as a direct point of contact. - Developed IND-enabling pre-clinical programs for lead therapeutic candidates. - Guided bioanalytical development to evaluate efficacy and safety of therapeutic candidates. - Identified KOLs and potential PIs for conducting collaborative pre-clinical and clinical studies.

Pioneered ASC Therapeutics Division to develop and advance several cutting-edge AAV based genome editing, gene and cell therapies from early research toward IND submission, managing pre-clinical, regulatory, AAV manufacturing and analytical methods development: -Built Therapeutic Development team. -Prepared and conducted 3 pre-IND meetings. -Submitted and got approved 2 Orphan designations -Conducted IND-enabling pre-clinical studies in humanized liver mouse model, NHPs and mice -Authored preclinical and bioanalytical sections of ASC618 and ASC930 IND submissions, supervised and coordinated overall ASC618 IND submission -In collaboration with external experts developed a novel GMP compliant AAV manufacturing process -Developed clinical protocols and identified PIs for conducting clinical studies -Developed and qualified full spectrum of product specific AAV analytical methods to supports preclinical, clinical and manufacturing developed (on-and off-target evaluation, titer, potency, biodistribution, shedding, immunogenicity, infectivity, in-situ RNA, etc.) - Leading member in the NIST Genome Editing Consortium - Member of Bespoke Gene Therapy Consortium (BGTC)

- Helmed pre-clinical and clinical development of NM-IL-12 (HemaMax) for HSARS under the Animal Rule, including proof-of-concept, toxicology, cardiovascular and respiratory safety studies, IND filing, complete efficacy program in NHPs, dose translation, FIH, Phase II and Phase III clinical studies. - Managed several multimillion-dollar government contracts and grants with the Department of Defense (DoD), National Institutes of Health (NIH), and Biomedical Advanced Research and Development Authority (BARDA, HHS). - Steered pre-clinical and clinical development for Hematology/Oncology (CTCL, DLBCL), solid tumors (melanoma, NSCLC, glioblastoma), and surgical wound immunotherapy (SWI). - Sourced and built beneficial relationships with extensive network of contract research organizations (CROs) and analytical labs; worked closely and regularly liaised with multiple non-clinical, clinical, and analytical CROs in the U.S., Canada, and Israel. - Formulated analytical methods and managed PK/PD, biomarker, and immunogenicity testing in non-clinical and clinical studies. - Submitted and managed 3 INDs (HSARS, Hematological Malignancies, and SWI). - Secured the future of the entire program by completing an analysis for the FDA that showed how HemaMax™ was providing a significant animal survival benefit as compared to rival drug. - Completed efficacy program for HSARS with non-human primates (NHPs) in 2015. - Co-authored nine peer-reviewed articles.

Thesis: “Characterization of Neuropilin-2- a novel VEGF receptor"

Isolation and characterization of a novel vascular endothelial growth factor isoform (VEGF145)