EDUCATION:

Director, Cell and Gene Therapy, Biologics Consulting Group, Inc.

• Provide consultation for the development of regulatory strategies to facilitate rapid development of cell and gene based therapies using a science based approach.
  
• Support for CMC submission, interpretation of FDA and NIH/RAC guidelines, pre-IND and IND preparation, phase I, II and III product development strategies and assessment of cGMP, cGTP and quality system compliance
  

• Expert knowledge of CBER regulations, recommendations and scientific principles relevant to somatic cell and gene therapies and cytokine product areas.  Responsible for development of policy guidance for of cellular and gene therapy and related products.  Represented CBER to the public and other government agencies as invited speaker at internationally and nationally sponsored scientific meetings and symposia.  Responsible for review of pre-IND, IND and BLA materials with regard to completeness and consistency of the manufacturing process, characterization and safety testing of the product and scientific rationale.
• Proposed research questions, carried out analyses to improve current RCR recommendations for product testing and patient follow-up and authored new Guidance to Industry which was published in Nov. 1999.  This included organizing and co-chairing two symposia at national gene therapy meetings and co-authoring article in gene therapy journal to discuss current data and propose recommendations.
• As agency representative to the RAC (alternate) , presented FDA perspectives at quarterly RAC meetings and works with the Director of the Office of Biotechnology Activities (OBA) as an advisor and to coordinate activities in Gene Therapy area.  In this regard, responsible for coordination of CBERs Appendix M activities in 1996 and for deletion of requirement for appendix M submission to CBER in 1997.  Instituted a formal agreement between CBER and OBA, for disclosure of information to NIH pertaining to gene therapy INDs based on FDA regulation.  Actively involved in administration and coordination of adverse event reporting between the agencies.
• Served as CBER lead for developing policy on disclosure of gene therapy and xenotransplantation information.

• As a member of the Unit on Developmental Biology my research focused on  the study of genes involved in specification of body pattern during the early stages of development in Xenopus laevis.  Isolated and sequenced two cDNAs containing homeobox or forkhead domains.  The expression patterns of these genes during development were determined and specific functions of these genes in the developmental process were preliminarily characterized by microinjection of synthetic RNA into developing embryos.

• Using a transgenic mouse model, studied the effect of cytokines and mitogens on the activation of immunoglobulin gene enhancer and promoter elements.  By following the level of expression of the reporter gene CAT whose expression was driven by the immunoglobulin regulatory elements, observed an increase in CAT expression after treatment with interleukin 6, LPS and Conconavalin A only when both the Ig enhancer and promoter were present.  This work was submitted as a dissertation to the George Washington University.

• Participated in the study of regulation of gene expression of JC virus; a human papovavirus, to explain the mechanism of viral infection at the molecular level.  A continuous tissue culture line of human fetal astroglial cells (SVG) was established using an origin deficient mutant of SV40.  Using the technique of southern blot, determined the integration pattern of SV40 in the SVG genome.  
• Also supervised and instructed one research technician in techniques of molecular genetics.

• Participated in NIH funded research of the regulation of eukaryotic gene transcription using a Drosophila melanogaster system.  
• Responsible for the characterization of newly accessioned cultures and maintenance of 125 existing bacterial host strains and plasmid vectors for company's recombinant DNA collection.

• Assisted in organization of company's Recombinant DNA Propagation and Purification Service.  Marketed this service to researchers.  
• Responsible for all phases of recombinant DNA and protein A reagents developed in lab including supervision of production, fielding technical questions from customers and cost analysis.  
• Supervised two research assistants.  
• Prepared advertisements for national scientific magazines, organized direct mailings and made many customer contacts to market company's biotech products.  
• Technical experience included work with fermentation, DNA and protein purification, restriction and modifying enzymes, phage and plasmid vector systems, electrophoresis, column chromatography.