Nora E. B. Email & Phone Number

Oversee and lead Clinical QA, Quality Systems, and Electronic Trial Master File (eTMF) Operations Teams

*Responsible for overseeing quality operations and risk management of Geron’s clinical programs.

San Francisco, Ca, Us

*Quality Assurance, Quality Systems, Quality Compliance*GxP Quality Management System (QMS).*Establish QA Dept*Implement eQMS System

Waltham, Ma, Us

*Quality Assurance, Quality Control, Quality Systems*Designed and maintained GCP, GLP, GMP, & GVP (GxP) Quality Management System (QMS).*Managed QA/QC activities.* XACDURO®- (approved June 2023) FDA-approved treatment used to fight against HABP/VABP infections caused by isolates of Acinetobacter baumannii-calcoaceticus complex, which can include those resistant to carbapenems (CRAB).

*Quality Assurance & Compliance: Audit/Inspection Readiness, Clinical Operations, Clinical QA, GMP QA, GLP/GCLP, GxP SOPs, Quality Agreements, Regulatory Compliance, Vendor Oversight/Management *Medical Writing: MW Support (Editor), Technical Writer, GxP Services, Document QC (Annual Reports/BB/BLA/Clinical Protocols/CSRs/IB/IND/Informed Consent Forms/NDA/Patient Safety Narratives)*GxP Auditing (US, Canada, & China)* Establish QMS, support eQMS implementation and/or migration activities*Assign, deliver, and manage Global Training Plans, Group, or Individual Training

Newton, Ma, Us

Quality Assurance*Assigned global training plans for all staff. *Oversaw Audit Master Plan and ensured GCP audits were executed per risk-based assessments.*Followed up on CRO CAP/CAPA to ensure site observations were properly remediated and closed.*Reviewed clinical documents to ensure Regulatory Compliance (ICF, Clinical Study Protocols).*Managed lifecycles and executed global change controls for all controlled documents.

Cambridge, Massachusetts, Us

Medical Writing*Established Document QC process for MW deliverables intended to support global regulatory filings (Annual Reports, CSR, IB).

Cambridge, Ma, Us

Clinical Pharmacology & Pharmacometrics (CPP)/Early Clinical Development/Regulatory Affairs-CMC*Established & led Quality Function within CPP*Developed QMS to manage training, lead internal & external audits (CRO), inspection readiness, SOPs*Managed the QC workload to support Phase 1-3 study reports, NDA, BLA, Drug Label Expansion, Investigator’s Brochures, and Annual Reports (TECFIDERA®, ELOCTATE®, ALPROLIX® ).*Authored Pre-Clinical Summary Section of BLA filing (SPINRAZA®).*One yr work shadow CMC Regulatory Affairs (2015)*Created database to track global CMC agency inquiries

Kalamazoo, Mi, Us

Pre-Clinical Development*Established off-site lab to support bioanalytical PK/PD testing *Lead role in performing biochemical and molecular assays to support in vivo studies*MSD (Meso Scale Discovery) ELISA System using electrochemiluminescence*Thesis: The Qualitative Preliminary Assessment of BMP-7 Mediated Signal Transduction Events In Vivo

Kalamazoo, Mi, Us

BioAssay Development*Developed, qualified, and validated ELISA based assays used for (PK/PD/NAb) Pre-Clinical and Clinical testing (Phase I-IV/PMCs) GCLP*Managed sample testing workload for 3 RAs*Lead QC review of Qualification and Validation of equipment, laboratory test, and transfer methods*Managed SOP updates and document control for GCLP laboratory. *Trained new staff “on-the-job training”*Archived Lab notebooks, Logbooks, and other data

Kalamazoo, Mi, Us

Analytical Development/Analytical Services*Designed assays using DOE techniques*Optimized Cell-based assays for QC use in support of potency/release testing (OP-1 Implant [BMP-7])*Authored SOPs and technical reports to document assay qualifications and validations, working under cGMPs.

Us

*Processed human blood specimens for testing in ELISA, Coagulation assays, Lymphocyte isolation, DNA Purification, PCR, Gel Electrophoresis, Andrology, and Flow Cytometry in support of miscarriage diagnosis.*Prepared hormones for use in Embryology Testing; Pregnant Mare Serum (PMS) and Human Chorionic Gonadotropin (hCG) to promote superovulation in mice. *Harvested embryos from mouse oviducts, and froze using cryologic freeze unit.CLIA, CAP, GCLP, GLP

Graduate Certificate, Regulatory Affairs

Master Of Science (M.S.), Biotechnology

Bachelor Of Science (B.S.), Biology, General