President & CEO Biologics Consulting Group, Inc., Alexandria, VA.

• President and Chief Executive Officer of BCG responsible for the overall management of company activities including company vision, marketing & business expansion, negotiation of consulting agreements/contracts, management of consulting personnel and functions, and employee recruitment.

Director, FDA, CBER, Office of Vaccines Research and Review Rockville, MD.

• Senior regulatory official in the Office of Vaccines Research and Review with an extensive background in the regulation of vaccines and related biological products
• Excellent communication, leadership and negotiation skills, and a national and international network of collaborators in government, industry and academia.
• Responsibilities included:
  • Oversaw all facets of the clinical and product regulatory review activity, including quality assurance and oversight of review functions.
  • Planed, developed and administered CBER’s broad national and international programs and operational activities for vaccines and related products.
  • Oversaw and planed the execution of a budget of over $40 million for salaries, supplies and equipment.
  • Provided leadership and assistance in managing and directing approximately 300 personnel engaged in activities related to major national and international biological quality and safety programs encompassing planning and conducting research related to the development, manufacture, and testing of vaccines and related products.
  • Managed the Office’s programs to review investigational (IND) and biologics license applications (BLAs and sBLAs), and control tests of biological products.
  • Provided extensive briefings, training, and outreach to other federal agencies within the DHHS, Department of Defense and Veterans Affairs.
  • Provided technical guidance for Office program activities by reviewing and evaluating project proposals and plans submitted by subordinate organizations to complete operational program objectives.
  • Engaged with senior level agency/departmental officials, industry representatives, senior program managers and subject matter specialists, counterparts from other Federal, State, and local governmental agencies, and foreign government representatives to discuss and explain policies, plans and programs as they relate to operational activities involving vaccines and related products.

Deputy Director (Jan 2005 - May 2005), Associate Director for Regulatory Policy (Sep 1994 - Jan 2005). FDA, CBER, Office of Vaccines Research and Review.

• Developed standard operating criteria, procedures, policy issuances and guidelines for the regulatory review of clinical and chemistry, manufacturing and control information in the Office and Center.  Responsible for determining the adequacy of applications in conforming with appropriate biologic new drug or device regulations and laws prior to acceptance of applications for marketing, and communicating this information to the regulated industry.
• Developed FDA position in response to requests for advisory opinions from industry, governmental, and non-governmental health related organizations.
• Served as the FDA representative to the Advisory Commission on Childhood Vaccines which was created by Section 2119 of the Public Health Service Act to advise the Secretary of DHHS on the implementation of the National Childhood Vaccine Injury Act program and any research needed to execute the requirements of the National Vaccine Program.
• Served as the FDA co-representative to the National Vaccine Advisory Committee which is responsible for studying and recommending ways to encourage the availability of an adequate supply of safe and effective vaccines in the states, and establish recommendations for research priorities and other measures to enhance the safety and efficacy of vaccines.
• Served as the senior Office representative on the DHHS Pandemic Influenza Steering Committee responsible for communicating the views of the Office, Center and Agency on the decision-making management structure of the national response to pandemic influenza.
• Served as senior Office representative responsible for implementation of the FDA Modernization Act.
• Served as the chief regulatory affairs official for the Office of Vaccines Research and Review.

Deputy Director, FDA, CBER, Office of Vaccines Research and Review, Division of Vaccines and Related Products Applications, Rockville, MD.

• Assisted the division director in overseeing the scientific and regulatory work of approximately 35 doctoral level scientists and medical officers within the Division.
• Coordinated the work of the support staff, consumer safety officers and regulatory health information specialists.
• Developed procedures for reviewing licensing applications, and was responsible for training staff on how to use these procedures.
• Managed the review of new product license applications, investigational new drug applications, pertinent correspondence and related documents for scientific content, and subsequent composition of clinical correspondence.
• Interacted with the Vaccine and Related Biological Products Advisory Committee and the Allergenic Products Advisory Committee through presentations and briefing of committee members.

Regulatory Microbiologist, FDA, CBER, Office of Vaccines Research and Review, Division of Product Certification and Division of Vaccines and Related Products Applications, Rockville, MD.

• Regulatory coordinator and CMC reviewer for four new vaccines: Two Diphtheria and Tetanus Toxoids and Acellular Pertussis Vaccines, two Diphtheria and Tetanus Toxoids and Pertussis Vaccine Adsorbed combined with Haemophilus b conjugate vaccines, Varicella vaccine, and Polio virus vaccine live oral trivalent.
• Responsible for the initial administrative and regulatory review of over 50 biologics license applications and supplements, review of scientific data, and provided expertise  in cGMPs, facility design, licensing policy, and regulatory standards.
• Evaluation and review of labeling and promotion of biological products.
• Conducted inspections of vaccine manufacturing facilities.

Visiting Lecturer, Hood College, Frederick, MD.

• Responsible for teaching a graduate course in Medical Virology

Senior Research Scientist, Program Resources/DynCorp Inc., National Cancer Institute-Frederick Cancer Research and Development Center.

• Responsible for directing and coordinating a small research group: duties included designing and approving all experimental protocols, in addition to working at the laboratory bench. 
• Responsible for reviewing and analyzing data, as well as writing and editing manuscripts:  main focus of research program was in the area of retrovirology, specifically human T cell leukemia virus (HTLV-I) and human immunodeficiency virus (HIV).
• Specific areas of interest were the elucidation of cellular factors which may influence viral transcription transactivation; purification of different plant compounds for evaluation of their antiviral properties against HTLV-I and HIV; and examination of lymphokines and cytokines, such as IL-2, and TNF-alpha in virally-infected cells.

National Cancer Institute Post Doctoral Fellow, University of Virginia.

• Responsible for studying the role of the matrix protein of vesicular stomatitis virus (VSV) and influenza virus. 
• Investigated the possible regulatory role of protein phosphorylation on the ability of the matrix protein of VSV to mediate the inhibition of viral transcription in vitro.
• Research on influenza virus encompassed an investigation of the structural-functional relationships of the influenza matrix protein in the development process and transcriptional regulations of the virus. 
• Responsible for the cloning and expression of the gene coding for the influenza matrix protein. 
• Elucidated RNA-binding domains through the use of site directed mutagenesis to alter single amino acids which resulted in conformational changes in the matrix protein.

PROFESSIONAL SOCIETIES

American Society for Microbiology

American Society for Virology

SELECTED PUBLICATIONS

Baylor, NW, and Houn, F., Considerations for Licensure of Influenza Vaccines with Pandemic and Pre-pandemic Indications in Vaccines for Pandemic Influenza. Current Topics in Microbiology and Immunology, Compans, RW and Orenstein, W (eds). 2009, Volume 333, 5, 453-470, Springer-Verlag. Berlin, Heidelberg

Falk, L., Baylor, NW and Midthun, K., An Overview of U.S. Food and Drug Administration Licensure of Vaccines. New Generation Vaccines, 4^th Edition. Levine, Myron (ed). 2009 Marcel Dekker.

Baylor, NW,  The Regulation of Vaccines. Vaccines, 6^th Edition. Plotkin S, Orenstein, W, and Offit, P. (eds). In press. W.B. Saunders and Co., Philadelphia.

Baylor NW, Egan W, Richman P. Aluminum salts in vaccines – U.S. perspective. Vaccine. 2002; 20:S18-S23.

Bao-Qun Li, Tao Fu, Yiao-Dong Yan, Norman W. Baylor, Francis W. Ruscetti, and Hsiang-Fu Kung.  1993.  Inhibition of HIV infection by baicalin-A flavonoid compound purified from Chinese herbal medicine.  Cellular and Molecular Biology Research 39:119-124.

Baylor, NW, Fu, Tao and Ruscetti, FW. 1992. Inhibition of human T cell leukemia virus by the plant flavonoid baicalin (7-glucuronic acid, 5, 6-dihydroxyflavone).  J. Infectious Diseases 165:433-7.

Zhiping Ye, Norman W. Baylor, and Robert R. Wagner. 1989. Transcription-inhibition and RNA-binding domains of influenza A virus matrix protein mapped with anti-idiotype antibodies and synthetic peptides. J. Virology 63:3586-3594.

Baylor, NW, Ye, Zhiping and Wagner, RR. 1988. Molecular characterization of the structural-functional domains of the influenza A/WSN/33 matrix (M1) protein.  Virus Research Supplement 2:20.

Baylor, NW, Li, Yan Li, Ye, Zhiping and Wagner, RR.  1988. Transient expression and sequence of the matrix (M1) gene of WSN influenza A virus in a vaccinia vector.  Virology 163:618-621.

Baylor, NW, Williams, AL and Cofie, NW. 1983. Molecular characterization of ilvC specialized transducing phages of Escherichia coli K-12. Mol. Gen. Genet. 191:347-352.

Williams, AL, Baylor, NW and Ensor, M. 1981. Evidence for the site of lambda insertion in the ilv gene cluster of Escherichia coli K-12. J. Bacteriol. 147:691-693.

Page Updated: May 10, 2012