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Directory of Consultants
Bay Area Biomedical Consultants Network (BABCN)
Name and Educational Degree(s) Katz, Nancy, PhD
Business Name Illyria Consulting Group, Inc.
Certifications
Education
  • Pharmaceutical Education & Research Institute (PERI):  Clinical Sciences Certificate, 2004; additional courses in Biostatistics (2005) and Oncologic Development (2005)
  • American Association of Immunologists:  Basic Introduction to Immunology, Parts I and II, June 2005
    Advanced Immunology, Parts I and II, July 2005
  • American Medical Writers Association:  Core Credential Certificates: Editing/Writing, 2002; Pharmaceuticals, 1998
  • University of California, Berkeley Extension, School of Business & Management:  Certificate in Training & Human Resource Development, with distinction, 1995
  • University of California, Berkeley: Ph.D., English, 1975; M.A., English, 1970
  • The City College of the City University of New York:  B.A., English (magna cum laude, Phi Beta Kappa, with honors in English), 1968
Business Address 2940 Tice Creek Drive
No. 4
Walnut Creek, CA 94595
USA
Contact information
Telephone:
Fax:
Mobile Number:
Email address:
Website URL:
530-426-1800
530-426-3260
510-917-1678
nrkatz@illyriaconsulting.com
http://www.illyriaconsulting.com
Specialties

Experienced biopharmaceutical writer provides writing, editing formatting, strategic planning, and management services for regulatory submissions in eCTD format (INDs, NDAs, and BLAs), journal articles, white papers, patient safety narratives, and other documents related to drug development. Subject areas include but are not limited to:

  • Cancer/Oncology:  Breast, colorectal, head and neck, liver, non-small cell and small cell lung (NSCLC and SCLC), ovarian, renal cell, pancreatic, brain metastases, other solid tumors, non‑Hodgkin lymphoma (NHL), acute myelogenous leukemia (AML), human T cell lymphotropic virus type 1‑associated adult T cell leukemia/lymphoma (HTLV‑1‑ATL), chronic lymphocytic leukemia (CLL), multiple myeloma (MM)
  • Immune‑mediated and Inflammatory Disease:  Asthma (including treatment with inhaled device), aplastic anemia, Crohn disease, type 1 diabetes, graft vs. host disease (GVHD), human T cell lymphotropic virus type‑1 associated myelopathy/tropical spastic paraparesis (HTLV‑1‑HAM-TSP), idiopathic pulmonary fibrosis (IPF), multiple sclerosis (MS), primary and secondary immune deficiency disorder, psoriasis, rheumatoid arthritis, chronic immune thrombocytopenia, ulcerative colitis
  • Cardiovascular:  Coronary artery disease, congestive heart failure
  • Ophthalmology:  Age‑related macular degeneration (AMD), autoimmune uveitis, ocular complications of Behçet disease, glaucoma, ocular hypotony, traumatic hyphema, vitreous hemorrhage
  • Central Nervous System:  Migraine (treated by inhalation device), chronic malignant pain, Parkinson disease, Duchenne muscular dystrophy
  • Anti-infectives:  Infections caused by antibiotic‑resistant Gram-negative or Gram‑positive (eg, MRSA) pathogens, including hospital‑acquired pneumonia, complicated urinary tract infections, blood stream infections, etc.)
  • Other:  Growth hormone deficiency, hypercholesterolemia; devices (inhalation devices, implanted pumps for pain medication)
Experience
  • Illyria Consulting Group, Inc.:  President & Principal Medical Writing Consultant, February 2006 to present

Medical writing and editing:  Provide writing, editing, formatting, strategic planning, and management services for regulatory submissions (INDs, NDAs, and BLAs in eCTD format). Specific documents include but are not limited to Module 2 summaries (quality, nonclinical, and clinical), clinical study reports, investigator brochures, study protocols and amendments, informed consent forms, integrated summaries of safety and efficacy (ISSs and ISEs), patient safety narratives, data safety monitoring board charters, annual reports, pharmacokinetic, toxicokinetic, pharmacodynamic, and immunology reports, assay validation reports, orphan drug applications, pre‑meeting packages, stability reports, manuscripts and journal articles

Management and infrastructure support:  Provide management and development of medical writing groups; writing of templates, SOPs, and work practice guidelines.

  • Genentech, Inc., South San Francisco, CA:  Associate Director, Development Editing, August 2005 to February 2006

Medical writing and editing:  Managed writing and editing of clinical study reports, study protocols and amendments, informed consent forms, patient safety narratives, investigator brochures, clinical overviews and summaries of safety and efficacy, annual reports, orphan drug applications, data safety monitoring board charters, pre‑meeting packages, and assay validation reports.

Management and infrastructure projects:  Supervised 10 medical editors, 1 contract medical writer/editor, and advised medical writers from CROs. Developed and managed timelines for production of clinical/regulatory documents, including electronic submissions for INDs and BLAs in eCTD format.

  • Protein Design Labs, Inc., Fremont CA:  Senior Manager, Medical Writing, September 2003 to July 2005 and Senior Medical Writer, January 2001 to August 2003

Medical writing and editing:  Wrote and edited clinical regulatory documents (protocols and amendments, investigator brochures, clinical study reports, annual reports, patient narratives) in support of therapies for autoimmune disease, prevention of rejection of organ transplant, cardiovascular disease, and cancer. Served on protocol development and global development subteams for lead drug.

Infrastructure projects:  Participated in BLA filing effort (eCTD format). Developed ICH‑compliant/eCTD templates, timelines for clinical/regulatory documents, SOPs, and work practice guidelines. Managed electronic documents; developed online library. 

Management:  Supervised 8 medical writers, 2 contractors, 1 clinical document specialist, medical writing interns, and medical writers from CROs.

  • Matrix Pharmaceutical, Inc., Fremont, CA:  Medical Writing Consultant, July to December 2000

Medical writing and editing:  Wrote clinical study reports and pharmacokinetic reports in support of NDA submission for a treatment for primary hepatocellular carcinoma, colorectal liver metastases, and other solid cancers. Participated in NDA planning strategy.

  • Covance, Inc., Walnut Creek, CA:  Senior Medical Writer, 1997 to 2000

Medical writing and editing:  Wrote clinical study reports, study protocols, investigator brochures, ISEs, ISSs, articles for publication in peer-reviewed journals. Reviewed investigator package plans; provided back-up safety reporting. Reviewed and developed case report forms. Received two Bravo! Awards (from Medical Writing group, 1998, and Human Resources Group, 1999).

Management and infrastructure projects:  Supervised 1 medical writer; mentored 4 interns. Participated in IND and NDA planning strategy. Developed and delivered client presentations, gave presentations for the Internship program. Prepared Time and Cost Estimates for medical writing. Wrote SOPs and work practice guidelines (WPGs).

  • Berlex Laboratories, Richmond, CA:  Medical Writing Consultant, 1996 to 1997

Medical writing and editing:  Wrote and edited clinical and CMC regulatory document in support of a treatment for multiple sclerosis. Coedited clinical study newsletter.

 

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