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Directory of Consultants
Bay Area Biomedical Consultants Network (BABCN)
Name and Educational Degree(s) Gadol, Nancy, BA, MS, PhD
Business Name Nancy Gadol, PhD
Certifications
Education

PhD  Hahnemann University

MS    University of Florida

BA     Carnegie Mellon University

Business Address 301 Molton Ave.
San Carlos, CA 94070
Contact information
Telephone:
Fax:
Email address:
650-591-5370
650-595-2837
ngadol@pacbell.net
Specialties

Oncology, therapeutic monoclonal antibodies, immune-mediated inflammatory diseases, pain management, HIV, transplantation, severe primary IGF-1 deficiency (growth failure)

Experience

Background

I am a medical writer in the San Francisco Bay area with a wide range of experience in research, product development and writing. I have over 20 years experience as a scientist, initially at UCSF in two postdoctoral positions, and subsequently at a number of San Francisco Bay Area pharmaceutical, device, and biotechnology companies, working on a broad range of projects encompassing phenotypic and functional characterization of lymphocytes, oncology, cellular therapies, HIV, and cell separation and enrichment methods.

Before becoming a freelance writer in 2007, I worked as a full-time Senior Medical Writer at Protein Design Labs, Inc. and Tercica, Inc., writing everything from study reports (PK/PD, toxicology), posters, manuscripts, and protocols to Investigator Brochures, Clinical Study Reports, and INDs. I have  a solid understanding of the drug development process, FDA and ICH regulations and guidelines, and experience in various phases of drug development including research, development, preclinical and clinical testing, and regulatory writing. 

Writing Experience  (9 years)

  • CMC sections of NDA Annual Updates, synopses of clinical trials for MDs, foreign diagnostic product registrations
  • Toxicology and PK technical reports, abstracts, a pharmacology manuscript, templates, IB and IND nonclinical updates
  • CSRs, IBs, protocols, protocol amendments, clinical manuscript, FDA pre-meeting package, BLA updates, SOPs
  • Clinical Study Reports - Phase 2 and Phase 3, compilation of all tables, listings, case report forms, SAE reports, narratives, statistical analysis plan, protocol, sites list, etc.
  • IND (eCTD format) - overall summary (Section 2.3), overview (2.4), written and tabulated summaries (2.6), and study reports (4.1) 
  • BLA sections including ISS/ISE, SCS/SCE, clinical overview,   2.7.1, 2.7.2 
  • Premarket approval strategy (510k vs PMA) for an orthopedic surgical device
  • FDA regulations and guidelines for a medical device company’s clinical protocol submission
  • Templates, analytical reports, and proficiency test procedure for a diagnostic ovarian tumor test  

Employers/Clients Include:

BD Biosciences, San Jose, CA; Irwin Memorial Blood Centers, San Francisco, CA; Applied Imaging, Santa Clara, CA; Titan Pharmaceuticals, South San Francisco, CA; Protein Design Labs, Inc., Fremont, CA; Tercica, Inc., Brisbane, CA; Anesiva, Inc., South San Francisco, CA; Achaogen, Inc., South San Francisco, CA; Alexza Pharmaceuticals, Inc., Mountain View, CA; Vermillion, Inc., Mountain View, CA; Tecnologia Zerta, Guadalajara, Jalisco

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