Senior Clinical Consultant, Biologics Consulting Group, Inc.
Bethesda, MD.

• Provides wide range of regulatory (strategic, CMC and clinical) advice to various clients in the drug industry, focusing primarily on vaccines and other biological products.
  
• Specialties include regulatory strategy, product development strategy, clinical protocol design, submission preparation and review, and FDA and Advisory Committee meeting preparation.
  

Corporate Head and Vice President, World-wide Regulatory Affairs and Pharmacovigilance, MedImmune, Inc., Gaithersburg, MD.

• Member of key strategic and operations committees, including Executive Management, Commercial Operations, Product Development, Product Safety, Labeling and Corporate Compliance Committees.
  
• Strategic, operational and compliance responsibility for 5 licensed and 18 investigational products, including vaccines, monoclonal antibodies, plasma derivatives and small molecules.
• Also provided regulatory support to 5 commercial manufacturing sites and 2 pilot plants. Department handled ~1000 regulatory submissions annually (US and foreign).
  
• Built Department from a staff of 12 members to 45. Expanded each of three therapeutic areas (ID/Immunology, Oncology and Vaccines)
• Created a Regulatory Operations Division (including submission publishing and electronic submissions capability)
• Increased post-marketing drug safety surveillance capability (including installation of a new global safety database)
• Established risk management and regulatory intelligence functions.
  
• Maintained "hands on" skills by taking primary responsibility for writing and coordinating key submissions (including MedImmune's first IMPD and CTD) and participating (typically as lead) in all interactions with the FDA, including sponsor and Advisory Committee meetings, telecons and pharmacovigilance and BIOMO inspections
• Provided support to QA for GMP inspections, including PAIs and biannual (Team Biologics) inspections.
  
• Served as regulatory lead for all mergers, acquisitions, in-licensing, out-licensing and other due diligence activities.
  

Deputy Director (1995-1997), Acting Director (1997) and Director (1997-2001), Division of Viral Products, Office of Vaccines Research and Review, CBER, FDA, Bethesda, MD.

• Managed full-time staff of ~100 employees, including 60 senior scientists involved in basic and applied laboratory-based research in HIV and other retroviruses, hepatitis, arboviruses, herpesviruses, poxviruses, enteroviruses and respiratory viruses.
  
• Directed Division activities related to the medical, public health, and regulatory aspects of viral vaccines, including licensed and investigational products.
  
• Review portfolio consists of hundreds of active INDs and BLA supplements, Master Files, and 6 original BLA applications.
  
• Responsible for secondary and tertiary review; quality and consistency of CMC and clinical reviews performed by subordinate staff; and primary review for selected INDs and BLAs.
  
• Integral participant in licensing committee deliberations and senior management oversight and approval decisions.
  
• Interacted extensively with industry during all phases of product development, including Advisory Committee Meetings, face-to-face meetings, and teleconferences and ad hoc consultations.
  
• Participated in Guidance Document development and review, including ICH-related, combination vaccines, toxicology, reproductive toxicology, surrogate endpoints, and internal clinical review practices.
  
• Chair of working group concerned with the development and regulation of novel cell substrates for the production of viral vaccines.
  
• Chair of government-wide working group on influenza pandemic preparedness in the U.S., with primary focus on rapid development and deployment of vaccines and antiviral agents.
  
• Member of the Poliomyelitis Eradication Certification Commission for the Western Pacific Region , World Health Organization (1996-2001).
  
• FDA liaison representative to the American Academy of Pediatrics Committee on Infectious Diseases ("Redbook Committee")
  

FDA Coordinator for the National Institute of Biologicals Project, India, CBER, FDA, Office of Medical and International Affairs, Office of the Director, Bethesda, MD.

• In collaboration with other scientists within CBER and architects and engineers at the NIH, developed scientific, regulatory and laboratory training programs for the National Institute of Biologicals (NIB) Project, India, a $100+ million project sponsored by the U.S. and Japanese Governments.
  
• The NIB is an independent agency established within the Ministry of Health and Family Welfare, New Delhi, that was responsible for quality control testing of all biological products.
  
• Participated in optimal facility design, testing algorithms, and tech transfer of key in vitro and in vivo assays from the U.S. FDA.
  
• Performed product and clinical reviews of selected biologics applications as assigned.

Associate Director for Vaccine Research, National Vaccine Program Office, DHHS, Office of the Assistant Secretary for Health, Rockville, MD.

• Coordinated vaccine-related research activities (domestic and international) carried out by Federal Agencies
  
• Coordinated activities related to vaccine safety; coordinated Federal roles in the distribution and use of vaccines in the U.S. and the interface between public and private entities responsible for vaccine development and immunization programs.
  
• NVPO reorganized during my tenure and I was reassigned to the FDA.
  

Various positions (with progression of responsibility), Centers for Disease Control and Prevention (primarily the National Immunization Program and the Division of Viral and Rickettsial Diseases, NCID), Atlanta, GA (1980 - 1993)

• Served as Epidemic Intelligence Service (EIS) Officer and Supervisory Medical Epidemiologist assigned to various outbreak investigations and special field studies, primarily related to influenza and other vaccine-preventable diseases.
  
• Principal investigator or Project Director for several large-scale, controlled field trials and observational research studies of licensed and investigational vaccines, including influenza, polio, pertussis, and measles.
  
• Established poliomyelitis eradication activity at CDC to provide WHO and WHO Regional Offices (esp. Americas and Western Pacific) with funding, technical support and training.
  
• Architect of flaccid paralysis surveillance system used in the Americas and performance indicators (later adapted by other Regions).
  
• Wrote the National Plan of Action for the Eradication of Poliomyelitis in China (target achieved within 2 years).