Career Summary

  • 31 years in information systems development (28 of these in healthcare, 20 of these in pharmaceutical).
  • Equally skilled at interacting with, and understanding the top management of Big Pharma and at guiding programmers and designers in their work.

Recent Career Highlights

  • ICH (International Conference on Harmonisation - standards body for pharmaceutical industry - see http://www.ich.org/)
    • Currently leading an ICH M2 project to study interoperability and compliance (with specifications) of the eCTD tools on the market. Twelve vendors have agreed to participate in the study. The results were presented at the June 2006 DIA (see http://www.etics.us/).
    • Created a technical specification for an eCTD Viewer based on a Requirements document developed by the PhRMA ERS Working Group. Directed the development of this viewer.
    • Co-authored the ICH standard for electronic submissions for the global Pharma industry known as eCTD (see http://estri.ich.org/ectd/)
  • Established the web site/service http://www.xmlpharma.org/ to provide information on XML standards for the pharmaceutical industry. Panel of experts recruited include top people in their fields from PhRMA, EFPIA, FDA, and EMEA.
  • Prepared several eCTDs for submission to the FDA. Served as the primary technical liaison to the FDA.
  • Guided a Pharma clients in the selection of SPL tools and services.
  • Provided technology, standards and regulatory guidance to a major Pharma company to prepare for electronic safety reporting in the EU in 2005.
  • Designed and co-developed software tools for electronic regulatory submissions in compliance with the evolving eCTD specification.
  • Designed and managed the development of software tools for safety reporting in compliance with the ICSR standard.
  • Guided Pharma clients in evaluating documents and records management (DMS) software products and vendors
  • Managed the implementation of the US side of a global document archive system based on Documentum for a major Japanese pharmaceutical.
  • For a major Japanese Pharma company: provided consulting services on DMS, eCTD, and validation issues.
  • For the EU subsidiary of a major Pharma (in Netherlands):
    • Provided guidance and technology in their submission of an eCTD (the first eCTD submission for a new chemical entity (NCE) in the EU).
    • Interfaced with the regulatory authority (the MEB in the Netherlands) to ensure a smooth process for receiving and reviewing the eCTD.
  • Health Canada - Ottawa (Canada’s regulatory agency)
    • Provided consulting services on e-submissions issues
    • Served as chairperson of APETI - a joint industry/regulatory advisory panel dealing with e-submissions issues.
  • MHLW - Tokyo (Ministry of Health Labor and Welfare - Japan’s regulatory agency)
  • Provided guidance and technology in their implementation of an eCTD receiving and processing strategy.
  • Established business partnership with ING Corporation, Tokyo, Japan (http://www.ing.co.jp/)
  • Other Significant Accomplishments:
    • Designed and lead the development of a document archiving tool (1994). Documents created with any of 6 different Windows applications were automatically captured and filed in a doc-base with metadata. This technology utilized Windows hooks and was written in ‘C’. The same approach is now used by popular products such as Documentum.
    • Teamed with a Tokyo based consulting firm to co-develop and implement a global, networked system for a major Japanese pharmaceutical using Internet technologies (TCP/IP, SMTP, MIME, etc.) before the Internet was in commercial use (1991-1992). The system was based on Unix servers and utilized Verity text search technology and Sybase RDB technology to provide clinical data management and reporting tools, document management tools, clinical project management tools, and communication capabilities between several geographically dispersed offices. Developed a custom module for Case Report Form indexing and viewing (eventually used by FDA).
    • Directed the development of a software product for hospital pharmacies which calculated and monitored dosage and regimen of specific drugs using pharmacokinetic formulae.
    • Directed IT facilities management services for the US office of a major Japanese pharmaceutical for 10 years. During this time it grew from 10 to 90 employees.
    • Served for 5 years as Director of Data Management and IT at a major CRO in Philadelphia.
    • Served for seven years as Director of Operations at a startup online pharmacy system company. During this time, it grew from a staff of 10 to 300.