Consultant, Biologics Consulting Group, Inc.
Alexandria, VA

• Expertise in publishing and submission of electric documents to FDA
• Familiar with legacy IND format (following form 1571) and CTD format
• Familiar with clinical study report and dataset requirements from FDA epublishing perspective
• Provides regular support to US Agent clients with regard to IND and BLA maintenance (amendments)

Information Technology Specialist, FDA, Center for Biologics Evaluation and Research, Office of Information Management, Rockville, MD

• Technical lead for the CBER electronic submissions program.
  
• System administrator of the Electronic Document Room (EDR) and secure e-mail infrastructure.
  
• Involved in the joint CBER/CDER development of a processing and review system (EVS) for eCTD submissions.
  
• Quality control and loading of eIND, eBLA and eCTD submissions into the EDR and EVS.
  
• Made panel presentations regarding the CBER electronic submissions program at DIA conferences.
  
• Provided daily support and periodic training to CBER staff regarding electronic submissions review.
  
• Technical editing of electronic submissions guidance documents.
• Comprehensive review of demonstration eIND and eBLA applications submitted by industry.
  
• Assisted industry in establishing secure encrypted e-mail communications with CBER through the use of SMIME certificates or SPN connections.
  
• Provided technical solutions to CBER staff and industry regarding problems with electronic submissions.

Biologist, FDA, Center for Biologics Evaluation and Research, Division of Viral Products, Bethesda, MD

• Chaired and served on review committees for numerous PLA, ELA, BLA and IND submissions.
  
• Performed hemagglutination inhibition (HI) serological tests in support of yearly influenza vaccine strain selections.
  
• Made presentations of serology results at FDA Advisory committee meetings.
  
• Responsible for strain identity, potency (SRID) and inactivation tests of influenza vaccine.
  
• Produced high yield reassortant influenza viruses for use in vaccine manufacture.
  
• Implemented an automated data collection and calculation system for SRID testing.
  

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