Professional Experience

e-Submissions, San Diego, CA (a California corporation)

October 2000 to present.  Founder, Principal

Independent consultancy advising life sciences companies on solutions for regulatory publishing and document management.  Offering consulting services in the following areas:

  • Submission publishing services:
    • Pfizer Corporation (Kalamazoo, MI, and Ann Arbor, MI) – staff augmentation to publish hybrid eNDA/CTD and MAAs using CoreDossier and Documentum.
    • Baxter Corporation, Westlake Village, CA – published eBLA using CoreDossier, Documentum, PCDocs, and ISI Toolbox.
    • GD Searle (now Pfizer), Skokie, IL
      • Produced first electronic NDA with CoreDossier and Documentum.
      • Producing first hybrid eNDA/CTD with CoreDossier and Documentum.
      • Validated CoreDossier upgrade.
      • Staff augmentation for publishing other submissions.
    • Takeda Pharmaceuticals, Lincolnshire, IL – facilitated development of submission publishing strategy, assessed current system and staff skills, supported production of first NDA using CoreDossier and Documentum, QC of electronic submissions prior to delivery to FDA.
    • ALZA Corporation, Mountain View, CA – developed, documented and validated submission publishing process using Ezsubs, Documentum, and ISI Toolbox.  Staff augmentation to publish hybrid eNDA/CTD.
    • Elan Pharmaceuticals, San Diego and South San Francisco, CA – published case report forms (CRFs) and case report tabulations (CRTs) using CoreDossier, validated upgrade of CoreDossier integrated with shared file system and Documentum.
    • Microbia, Cambridge, MA – published first IND and developed and trained users in process of submission publishing using ISI Toolbox and shared file server.
    • DeCODE genetics, Woodridge, IL – electronic publishing first in-house developed IND, and developed and trained users in process of submission publishing using ISI Toolbox and shared file server.
  • Technical support services:
    • Amylin & Quintiles, San Diego, CA – technical support during production of first eNDA using CoreDossier
    • Chugai Pharmaceuticals, San Diego – staff augmentation for ongoing administration and technical support of their Documentum and CoreDossier systems.
  • Electronic submission & EDMS strategy and corporate standards:
    • Arena Pharmaceuticals, San Diego – developed MS Word templates, developed IND publishing process using ISI Toolbox and shared file system, developed standards for electronic case report forms (CRFs) and case report tabulations (CRTs) for their CROs.
    • CancerVax, Carlsbad, CA – developed and implemented electronic submission publishing and EDMS strategy using shared file system.
    • Eos Pharmaceuticals, South San Francisco, CA (now Protein Design Labs) – facilitated selection and implementation of FileNET EDMS; developed process and lead team to use ISI Toolbox to produce their first IND.
    • 3M Corporation, St. Paul, MN – facilitated installation & validation of new hardware, new version of CoreDossier, migration of CoreDossier database, and user acceptance testing of upgraded system integrated with Documentum.
    • Telik, Inc., Palo Alto, CA – developed EDMS and submission publishing strategy.
    • CorCept Therapeutics, Inc., Menlo Park, CA – developed EDMS and submission publishing strategy.
    • Watson Pharmaceuticals, Corona, CA, Salt Lake City, UT, and Morristown, NJ – developed requirements for EDMS and submission publishing, developed MS Word templates. 
    • Myogen, Inc., Westminster, CO – developed and implemented strategies for EDMS and submission publishing.
    • Structural GenomiX, San Diego, CA – developed EDMS and submission publishing strategies.
July 1997 to October 2000.  Director, West Coast Operations, Liquent, Inc. (formerly ESPS, Inc.)

Expert in CoreDossier, kPublisher, kPortal products applied within pharmaceutical, biotechology, and medical device companies to produce BLAs, NDAs, MAAs, PMAs, and INDs in paper and electronic formats.

  • Prepared customer pre-eBLA and pre-eNDA demonstrations and attended meetings with FDA.
  • Developed solutions using Liquent products integrated with the customer’s EDMS – including Documentum, FileNet, OpenText, PC DOCS, and Lotus Notes/Domino.
  • Partnered with systems integrators to build total solutions.
  • Initiated partnerships with printing services bureaus for paper submission production.

CSC Consulting & System Integration, Berwyn, PA

October 1994 to July 1997.  Senior Consultant, Life Sciences Unit

Implemented document management and publishing systems for pharmaceutical and biotechnology companies in North American and Western Europe.

  • Technical architect for the integration of publishing and EDMS.
  • Developed Documentum virtual document architectures to support publishing requirements. 
  • Deployed Xerox XDA and Documentum worldwide for leading pharmaceutical company.
  • Led a customer team in the evaluation of publishing solutions which resulted in the first commercial installation of CoreDossier 2.0.
  • Produced first MAA published with XDA for leading European pharmaceutical company.
  • Produced NDAs with Xerox XDA and CoreDossier for North American and European pharmaceutical companies.

Azevedo & Associates, San Francisco, CA

January 1993 to October 1994.  Principal
  • Market analyst - SGML Applications for Interconsult, Inc., Cambridge, MA.  Researched and wrote industry report on SGML solutions and market sizing.
  • Independent consultant on document management and publishing systems for aerospace, defense, pharmaceutical, and other industries.
  • Independent consultant advising computer systems vendors on strategic alliances & technical feasibility of advanced technologies for document management and publishing, including SGML, PDF, and dataglyphs.

Sun Microsystems, Inc., Palo Alto, CA

March 1992 to January 1993.  Corporate Marketing Manager for Document Management, Imaging, Executive Information Systems & Decision Support Systems
  • Responsible for managing corporate partnerships with SAS Institute, Documentum,Verity, Fulcrum, Information Resources (now part of Oracle), Cognos, Business Objects, Pilot, and others.
  • Trade show organization & execution in support of marketing partner announcements and launches. 
  • Integration of partners with Sun announcements, corporate marketing, corporate demonstration center. 
  • Liaison between partners and Sun companies for technical support and advanced development.

Xerox Corporation, Palo Alto, CA, and San Diego, CA

December 1986 – March 1992.  Marketing Manager for Publishing Systems.

Marketing manager for SGML and structured document publishing systems.

  • Integrated publishing solutions into Xerox Docutech worldwide launch program.
  • Trained sales force worldwide in features and functions, sales process, customer prospecting for newly-developed publishing systems in life sciences and other industries.
  • Managed team which provided presales technical support and which performed post-sales implementation worldwide.

Azevedo & Associates, Oakland, CA, and Mountain View, CA

July 1984 to December 1986. Independent Consultant

Technical/marketing consultant responsible for requirements definition, competitive analysis, product positioning for publishing systems.  Clients included largest offices systems vendors in the world.

Atex Systems, South San Francisco, CA

June 1983 to July 1984.  Systems Engineer

Responsible for implementation of complex systems for newspaper publishing – news, classified ads, and accounting.

Mergenthaler Linotype, Hayward, CA

June 1981 to June 1983.  Systems Consultant

Responsible for implementation of computer typesetting systems for newspaper, magazine, and industry applications in advertising, aerospace, pharmaceutical, defense, computer software and hardware, and telecommunications.

Various companies, San Francisco, CA Bay Area

1975 to June 1981.  Typographer and book designer

Designed and developed book, magazine, corporate communication, and technical publishing projects, resulting in the production of camera-ready output for printing and distribution.