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CURRICULUM VITAE SUMMARY
PERFORMANCE
• Medical Team Leader responsible for managing the activities of a team of 3 Medical Officers who evaluate the safety and efficacy of drugs for investigational use (IND) and for commercial marketing (NDA), O-6 billet • Team of Medical Officers completed 1 NDA review, 24 IND reviews, 44 End-of-Phase 2, Pre-NDA, and Pre- IND submissions, and 5 consultations in the last year • Personally completed 24 NDA and NDA supplement reviews, 28 IND reviews, 86 End-of-Phase 2, Pre- NDA, and Pre-IND submissions, and 55 consultations while serving at FDA, 1999-present • USPHS Outstanding Service Medal, 2006 • USPHS Commendation Medal: 2004, 2005, 2007 • Navy and Marine Corps Achievement Medal: 2002 • USPHS Outstanding Unit Citation, 2006 • USPHS Unit Commendation: 2003, 2004, 2005 • Navy and Marine Corps Meritorious Unit Commendation: 2003, 2004 EDUCATION, TRAINING, AND PROFESSIONAL DEVELOPMENT
Education
• Allergy Fellowship, Wilford Hall USAF Medical Center, TX, July 1989–June 1991 • Flight Surgeon, USAF School of Aerospace Medicine, Brooks AFB, TX, March 1990–April 1990 • Residency and Internship in Pediatrics, University of Maryland Hospital, Baltimore, MD, July 1980–June • M.D., University of Maryland School of Medicine, Baltimore, MD, August 1976–May 1980 • B.S., Microbiology, University of Maryland, College Park, August 1972–May 1976 Medical Licensure
• State
Certification
• American Board of Allergy & Immunology [year redacted], Recertified [year redacted] • American Board of Pediatrics [year redacted], time unlimited CAREER PROGRESSION AND POTENTIAL
• Medical Team Leader, FDA: Center for Drug Evaluation and Research, Division of [name redacted] Drug Products, Silver Spring, MD, 2006-present • Medical Officer, FDA: Center for Drug Evaluation and Research, Division of Pulmonary and Allergy Drug Products, Rockville and Silver Spring, MD, 1999-2006 • Pediatrician, Allergist-Immunologist, A. I. duPont Institute: Georgetown, DE, 1994-1997 • Staff Physician, Allergy & Immunology, USAF: Travis AFB, CA, 1991-1994 • Pediatrician and Chief, Newborn Nursery, USAF: K. I. Sawyer AFB, MI, 1987-1989 • Pediatrician, Private Practice: Salisbury, MD, 1987 • Pediatrician, USPHS National Health Service Corps: DE and PA, 1983-1986 PROFESSIONAL CONTRIBUTIONS TO THE PHS COMMISSIONED CORPS (OFFICERSHIP)
• Staff Physician, National Naval Medical Center, Bethesda, MD, 2001-present • Peer reviewer for the journal Military Medicine, 2002-present • Member COA, AMSUS, ROA, 2001-present READINESS
• OFRD readiness status basic, assigned to Tier 1 Asset, Emergency Management Group Alpha • Deployed to Baton Rouge, LA in August 2005 in support of Hurricane Katrina relief efforts. One of the 37 PHS officers deployed with CAPT Charles McGarvey in the initial PHS response to Hurricane Katrina. • Completed all required and optional OFRD training modules, four FEMA Emergency Management Institute courses, Medical Effects of Ionizing Radiation Course, and Homeland Security Medical Executive Course CURRICULUM VITAE
PRECEPT 1: PERFORMANCE
CURRENT POSITION
Medical Team Leader Division of Pulmonary and Allergy Products Center for Drug Evaluation and Research, FDA Address November 2006-present • Serves as Medical Team Leader (O-6 billet) in the Division of [name redacted]
Products (redacted), Center for Drug Evaluation and Research (CDER) • Principal advisor to Division Director and other center managers on issues on
• Responsible for planning, coordinating, and evaluating medical programs and activities of a team of three medical officers within DPAP
• Advises, counsels and instructs team members on significant concepts of medical science, procedures, guidelines, and policies Evaluation of the safety and efficacy of drugs for investigational use (IND) and for
commercial marketing (NDA) that are to be used by millions of Americans, including
antihistamines such as Allegra and Claritin, allergy nasal inhalers, and asthma
inhaler medications
Providing guidance to industry on the design of their development programs for
these drugs
Reviewing proposed labeling and labeling changes to determine if claims are
truthful and if they provide appropriate directions for use and warnings against
misuse
Serving as a consultant to other medical specialists and scientists within the FDA and other government agencies • Promoted to Medical Team Leader position
• Managed and provided leadership, scientific guidance, and secondary review for
Team accomplishments in the last year: - Completed 1 NDA review leading to an “Approvable” action for an antitussive
drug. Review identified increased systemic exposure to the antitussive when it
was administered with food; a potential safety problem. Increase in systemic
exposure precluded approval of the application.
Provided critical guidance to sponsors on trial design and drug development in
44 Pre-IND, End-of-Phase 2, Pre-NDA, and advice meetings
Completed 24 IND reviews, insuring studies met their objectives and safety of subjects was maintained Reviewed 4 Special Protocol Assessments (SPA), assessing whether the protocols were adequate to meet regulatory and scientific requirements. SPAs are considered to be binding on the review division. Completed 5 consultations, providing analysis and recommendations for other Center for Drug Evaluation and Research (CDER) Divisions • Personal accomplishments in the last year: Completed review and clinical lead for 1 NDA, leading to "Approval" action for
a new allergy drug and 1 NDA labeling supplement adding a boxed warning and
important safety information to the label of the drug (name redacted)
Provided critical guidance to sponsors on trial design and drug development in
5 Pre-IND and advice meetings
Completed 4 IND reviews, insuring studies met their objectives and safety of subjects was maintained Completed 1 SPA review, assessing whether the protocol was adequate to meet the regulatory and scientific requirements identified by the sponsor Composed 1 Written Request for pediatric studies, requesting the sponsor to
conduct clinical studies to provide needed information on the use of an
intranasal allergy drug in children
Completed 3 consultations, providing analysis and recommendations for other Center for Drug Evaluation and Research (CDER) Divisions Clinical lead for Regulatory Briefing on anaphylaxis adverse events for CDER
Senior Management Staff
Co-authored scientific publication on anaphylaxis associated with the drug
(name redacted)
DPAP co-representative for Combined Nonpresciption Drug Advisory
Committee and Pediatric Advisory Committee Meeting on the safety of cough
and cold medications in children
Awarded PHS Commendation Medal for analysis of anaphylaxis reports and
development of labeling to ensure the safe use of the drug (name redacted)
Awarded Outstanding Unit Citation for participation in medical response to Hurricane Katrina while deployed to Baton Rouge, LA Awarded Special Assignment Award for support activity as member of PHS Music Ensemble Awarded the Crisis Response Service Award for medical response to the Gulf Coast Hurricanes, 2005 • Selected as 2007-2008 Council for Excellence in Government Fellow, a program to
develop talented leaders and to improve the performance of government and government’s place in the lives and esteem of American citizens • Selected for and completed FDA Formula for Achieving Managerial Excellence
Leadership Skills Training
• Exceptional COER while serving at the O-5 grade in an O-6 billet
Accomplishments since coming to the FDA: • Completed reviews and clinical lead for 24 NDA and NDA supplements, assisting the Division in approval, approvable, and not approvable actions, including approvals of
(drug name redacted) for over-the-counter (OTC) marketing, boxed warning and
important safety information on the use of the drug (drug name redacted), and
pediatric-friendly formulations of the antihistamine (drug name redacted), among others
• Completed reviews and clinical lead for 28 IND applications allowing investigational
studies to proceed or resulting in clinical holds or withdrawal of applications that included studies that were not safe to proceed • Completed reviews and clinical lead for 86 End-of-Phase 2, Pre-NDA, Pre-IND, and
other submissions and participated in the subsequent meetings providing scientific guidance for the sponsors • Completed 55 consultations and Division lead providing assistance to other CDER
Divisions, Office of Compliance, CDER Executive Operations Staff, and CDRH • Drafted 4 Written Requests for Pediatric Studies for the drugs (drug name redacted) (2 Written Requests), (drug name redacted) Nasal Spray, and a currently unapproved
antihistamine nasal spray, requesting the sponsors to perform studies to provide
needed information on use of these drugs in the pediatric population
• Completed 3 SPAs for allergy and asthma drugs, assessing whether the protocol was adequate to meet the regulatory and scientific requirements identified by the sponsor • Provided testimony at deposition and trial as expert witness for FDA in case against
Pharmakon, Inc., a manufacturer of unapproved and illegal drug products. The
testimony was instrumental in U.S. District Court Judge Richard A. Lazzara’s order for a
permanent injunction against the company, which shut down operations at the firm and
resulted in the destruction of 160,000 lbs. of illegal drug products.
• Prepared and presented a briefing for the Pediatric Implementation Team regarding
an applicant’s decision to decline to a Written Request for Pediatric studies for an antihistamine used for the treatment of allergic rhinitis and pediatric studies for an inhaled corticosteroid for treatment of asthma • Prepared a review and delivered a presentation for the Pulmonary/Allergy Drugs
Advisory Committee, January 2002, regarding an indication for the inhaled drug
Flovent for the treatment of chronic obstructive pulmonary disease
• Prepared the background summary on the OTC indication for (drug name redacted)
for the Nonprescription Drugs and Pulmonary/Allergy Drugs Advisory Committee
and participated in the Advisory Committee meeting, April 2002
• Selected for and completed FDA Formula for Achieving Managerial Excellence Supervisory Potential Workshop
• Division of [redacted] Drug Products Pediatric Exclusivity Working Group, 1999-present
• Lead for CDER Guidance for Allergic Rhinitis Drug Development Programs, 2004-
• CDER Prescription Studies Working Group Member, 2000-present ─ Completed 549 interpretations of drug proprietary names • CDER Pediatric Committee, Division of Pulmonary and Allergy Drug Products co-
representative, 1999-2004
• CDER OTC Antihistamine Switch Review Team, 2000
• CDER Sedating Prescription Drugs Working Group Member, 2002-2003
• Division of Pulmonary and Allergy Drug Products Epidemiology Coordinator, 1999-2005
PHS PROMOTION
• Commander, temporary, 2004 • Lieutenant Commander, temporary, 2001 • Lieutenant Commander, permanent, 2001 AWARDS AND HONORS
Uniformed Services Awards, in order of precedence
─ Critical expert scientific and regulatory input in the trial of U.S. v Pharmakon ─ Performance of outstanding service as Staff Allergist/Immunologist, Allergy and Immunology Clinic, David Grant USAF Medical Center, Travis AFB, CA, 1994 ─ Analysis of anaphylaxis reaction reports and development of labeling to ensure safe ─ Continuous outstanding scientific and regulatory contributions to the U.S. Food and Drug Administration in the completion of medical officer consultations, 2005 ─ Exceptional and sustained scientific contributions to the U.S. Food and Drug Administration in the performance of scientific consultations in the field of Allergy and Immunology, 2004 ─ Meritorious service as Pediatrician, K. I. Sawyer AFB, MI, 1989 ─ Superior performance and achievement in duties at the Allergy and Immunology Clinic, National Naval Medical Center, Bethesda, MD, 2002 • Navy and Marine Corps Achievement Medal ─ Professional achievement, performance, and leadership as Staff Physician in the Allergy and Immunology Clinic, National Naval Medical Center, Bethesda, MD, 2002 ─ Protecting the public health of the citizens of Louisiana, Texas, Florida, and Mississippi after Hurricanes Katrina, Rita, and Wilma, 2007 ─ David Grant USAF Medical Center, Travis AFB, CA, 1994 ─ Dedication and diligence to promote the Commissioned Corps through the real and ─ Contributing to the creation of a risk management program to assure the safe use of ─ Exceptional communication and coordination of the review and approval of NDA supplements for the OTC switch of Claritin brand (loratadine) drug products, 2003 • Navy and Marine Corps Meritorious Unit Commendation: 2004 ─ Service in support of Operations ENDURING FREEDOM and IRAQI FREEDOM over the period of 15 December 2002 to 15 September 2003, 5/2004 • Navy and Marine Corps Meritorious Unit Commendation: 2003 ─For provision of uninterrupted medical care and services by the National Naval Medical Center staff while supporting the Office of the Attending Physician to Congress in response to anthrax attacks • USPHS Special Assignment Award: 2007 ─ Completion of 30 non-consecutive days of administrative, performance/rehearsal, and/or support activity with the PHS Ensemble • USPHS Crisis Response Service Award: 2006 ─ Response to Gulf Coast Hurricanes (Katrina, Rita, Wilma) in Mississippi, Louisiana, • National Defense Service Medal, USAF: 1991 • USPHS Regular Corps Ribbon: 2006 • Commissioned Corps Training Ribbon: 2002 • Air Force Training Ribbon, USAF: 1987 • Field Medical Readiness Badge: 2007 ─ Demonstration through training, physical fitness, and other requirements necessary • Air Force Flight Surgeon, USAF: 1989 Other Awards and Honors
• AMA Physician’s Recognition Award for Continuing Medical Education, 2007 • Letter of Thanks from RADM Wyatt, NIH representative to the Office of the Surgeon General, for participation in NIH Commissioned Corps Officer Promotion Ceremony, July 2007 • Letter of Thanks from RADM Williams, Chief of Staff Office of the Surgeon General, for participation in Commissioned Corps Wind Ensemble at Memorial Service for RADM Knouss, July 2007 • Surgeon General’s Certificate of Appreciation from RADM Moritsugu for outstanding service and musical contributions to the Office of Surgeon General while serving in the USPHS Commissioned Corps Music Ensemble, December 2006 • Letter of Appreciation from Surgeon General, VADM Richard Carmona, for support at the Inauguration of President George W. Bush, January 2005 • Letter of Thanks from CAPT Murphy, Chief Commissioned Corps Operations Staff, for participation in Commissioned Corps Wind Ensemble at HRSA Commissioned Corps Promotion Ceremony, August 2004 • Letter of Appreciation from RADM Haffner, FDA Representative to Surgeon General’s Policy Advisory Council, for participation in Commissioned Corps Wind Ensemble at Promotion Ceremony of RADM Steven Galson, March 2004
Other Awards and Honors, continued
• Letter of Appreciation from CAPT Hamilton Brown, Executive Director, Anchor and
Caduceus Society, for participation with the Commissioned Corps Ensemble at the annual meeting and luncheon, January 2004 • AMA Physician’s Recognition Award for Continuing Medical Education, 2002 • Letter of Appreciation from RADM Haffner, FDA Representative to Surgeon General’s Policy Advisory Council for participation in Commissioned Corps Wind Ensemble at FDA Commissioned Corps Promotion Ceremony, July 2002 • CDER Team Excellence Award as a member of a working group that reviewed the safety databases for three prescription antihistamines proposed for a possible switch to over-the-counter marketing status, May 2002 • CDER Center Director’s Special Citation for reviewing and interpreting drug proprietary names in its effort to reduce medication errors, November 2001 • FDA On-the-Spot Award for review of a prostate cancer drug associated with • One of four of Delaware’s Top Allergists, Delaware Today Magazine, 1998 • Second place award for abstract by a Fellow in Training, Southwest Allergy Forum, San • Alpha Omega Alpha, 1979 • Phi Beta Kappa, 1976 • Phi Kappa Phi, 1975 • Sigma Alpha Omicron, Microbiology Honor Society, 1975 PRECEPT 2: EDUCATION, TRAINING, AND PROFESSIONAL DEVELOPMENT
EDUCATION
University of Maryland School of Medicine Baltimore, MD MD, 1980 University of Maryland College Park, MD BS, Microbiology, 1976 TRAINING
Allergy–Immunology Service Wilford Hall USAF Medical Center Lackland AFB, TX Fellow, July 1989–June 1991 USAF School of Aerospace Medicine Brooks AFB, TX Aerospace Medicine Primary Course (Flight Surgeon) Honor Graduate (First in class) April 1989 TRAINING, continued
University of Maryland Hospital
Baltimore, MD
Resident, Pediatrics
July 1981–June 1983
University of Maryland Hospital Baltimore, MD Intern, Pediatrics July 1980–June 1981
MEDICAL LICENSES
State, active status State, inactive status State, inactive status PROFESSIONAL SOCIETY MEMBERSHIPS
American Academy of Allergy and Immunology, Fellow, 2006-present, Member, 1989-2006 American College of Allergy and Immunology, Fellow, 1992-present American Academy of Pediatrics, Fellow, 1986-present American Academy of Pediatrics Section on Allergy and Immunology, Member, 1992-present Commissioned Officers Association of the U.S. Public Health Service, Member, 2001-present Association of Military Surgeons of the U.S., Member, 2001-Present Reserve Officers Association, Member, 2001-Present CERTIFICATIONS
Medical Specialty
Board-certified in Allergy and Immunology and Pediatrics • American Board of Allergy and Immunology 1991, Recertified 2001 • American Board of Pediatrics, 1985
Other Current Certifications
Basic Life Support, 2007
Previous Certifications
Pediatric Advanced Life Support, 1997
Advanced Cardiac Life Support, 1993
Advanced Trauma Life Support, 1988
Combat Care Casualty Course (C4), 1988
INSERVICE TRAINING AND WORKSHOPS
Title Sponsor
Fellow, Council for Excellence in Government Homeland Security Medical Executive Course Continuous Marketing Applications Training Tools for Pre-Approval Drug Safety Workshop Title Sponsor
The Label and Beyond--Risk Communication Economic Assessment in Controlled Clinical Review for the ABAI Recertification Exam PRECEPT 3: CAREER PROGRESSION AND POTENTIAL
PREVIOUS PROFESSIONAL EXPERIENCE
Medical Officer, UPSHS Commissioned Corps Division of [name redacted] Products Center for Drug Evaluation and Research, FDA Address October 2005-November 2006 Address July 2001-September 2005 • Served as Medical Officer (O-6 billet) in the Division of [name redacted] Drug Products, Center for Drug Evaluation and Research (CDER) • Responsible for evaluation of the safety and efficacy of drugs for investigational use
(IND) and for commercial marketing (NDA) that are to be used by millions of Americans, including antihistamines such as Allegra and Claritin, allergy nasal inhalers, and asthma inhaler medications • Provided guidance to applicants on the design of their development programs for
• Reviewed proposed labeling and labeling changes to determine if claims are truthful
and if they provide appropriate directions for use and warnings against misuse • Served as a consultant to other medical specialists and scientists within the FDA
Medical Officer, civilian appointment Division of [name redacted] Drug Products HFD-[redacted], Center for Drug Evaluation and Research, FDA Address June 1999–July 2001 • Responsibilities and accomplishments as noted above in “PREVIOUS Sussex Allergy, Asthma, & Immunology Address August 1995–May 1999 • Provided allergy and immunology specialty care for adults and children
• Supervised and trained office nurses, receptionists, and office manager
• Performed accounting and bookkeeping
• Established the only board-certified allergy practice in Sussex County, Delaware
• Chosen as one of four of Delaware’s Top Allergists by peers for Delaware Today
• President of the Asthma & Allergy Society of Delaware, 1998
PREVIOUS PROFESSIONAL EXPERIENCE, continued
Pediatrician
A. I. duPont Institute Children’s Clinics
15 Georgetown Plaza Shopping Center
Georgetown, DE 19947
August 1994–May 1997
• Provided primary care pediatrics, inpatient and nursery hospital care
• Provided outpatient allergy and immunology specialty care
• Supervised nurse practitioner, office nurses, and receptionists
• Was the first primary care pediatrics practice dedicated to providing care to the
health-underserved population in Sussex County, Delaware for the A. I. duPont Institute
Staff Allergist, Allergy–Immunology Service David Grant USAF Medical Center Travis AFB, CA 94535-5300 July 1991–July 1994 • Provided outpatient and inpatient allergy, asthma, and immunology specialty care
• Served active duty, dependents, and retirees in the Northern California area
• Supervised allergy evaluations performed by other providers at Western US and
• Supervised and trained residents and primary care physicians in allergy
• Supervised allergy and immunization technicians
Pediatrician and Chief, Newborn Nursery 410th Strategic Hospital K. I. Sawyer AFB, MI 49843 August 1987–June 1989 • Provided primary care general pediatrics, including inpatient hospital and nursery care
• Served active duty, dependents, and retirees in Northern Michigan
• Supervised and trained pediatrics and nursery nurses and technicians
• Trained and supervised family practice residents
Dr. James J. Peipon and Associates 207-A Maryland Avenue Salisbury, Maryland 21801 July 1986–July 1987 • Provided primary care general pediatrics, including inpatient hospital and nursery
• Co-supervised and trained pediatrics nurses and nursery nurses and technicians
Pediatrician, National Health Service Corps, USPHS Broad Top Area Medical Center Box 127 Broad Top, Pennsylvania 16621 July 1985–July 1986 • Provided primary care general pediatrics at a public clinic in a health-underserved area
• PHS National Health Service Corps service under the Private Practice Option
PREVIOUS PROFESSIONAL EXPERIENCE, continued
Pediatrician, National Health Service Corps, USPHS Dickinson Medical Group, P.A. 800 North DuPont Highway Milford, Delaware 19963 July 1983–April 1985 • Provided primary care general pediatrics including inpatient and outpatient pediatrics
and nursery care in a health-underserved area
• Trained and supervised an office nurse
• PHS National Health Service Corps service under the Private Practice Option
ASSIMILATION
Appointed to Regular Corps
September 11, 2006
PRIOR MILITARY SERVICE
United States Air Force
Allergist-Immunologist, Pediatrician, Flight Surgeon
July 1987–July 1994, Honorable Discharge
Highest rank held: Lieutenant Colonel (O-5)
PRECEPT 4: PROFESSIONAL CONTRIBUTIONS TO THE PHS COMMISSIONED
CORPS (OFFICERSHIP)
• Commissioned Corps Wind Ensemble, 2002-present ─ Participated in biweekly rehearsals and 62 performances, including support at
ceremonies for the Secretary and Assistant Secretaries of HHS, Surgeon General and Deputy Surgeon General and attended by Surgeons General of the Army and Air Force; awarded Special Assignment Award, Unit Commendation, and Surgeon General’s Certificate of Appreciation for my participation • PHS Commissioned Corps lead and coordinator for an amendment to the citations for
two Navy and Marine Corps Meritorious Unit Commendations at NNMC. As a result of
this action, 98 PHS officers with duties at NNMC were awarded these decorations.
• Staff Physician, Allergy & Immunology, National Naval Medical Center, Bethesda, MD, as a professional development activity and to maintain clinical currency, 2001-present • Provided guidance and encouragement resulting in the recruitment of 1 PHS officer and • Peer reviewer for Military Medicine, 2002-present ─ Reviewed 10 manuscripts for scientific articles and provided editorial comment
• Member COA, AMSUS, ROA, 2001-present • BOTC and IOTC completed, 2002 • Daily proud wear of uniform since 11 September 2001 PRECEPT 5: READINESS
• Basic level of OFRD readiness maintained since September 2003
• Assigned to Tier 1 asset, Emergency Management Group Team A
• Deployment role: Primary Care Physician
• Deployed to Baton Rouge, LA from August 28 through September 9, 2005 in support of
Hurricane Katrina relief efforts. One of the 37 PHS officers deployed with CAPT Charles
McGarvey in the initial PHS response to Hurricane Katrina. Served as
Administrative Operations Officer at the field hospital established at the Pete
Maravich Assembly Center and Lead Medical Officer for 200-bed special needs facility
during this deployment.
• Deployed in support of Presidential Inauguration, January 2005 • Completed all OFRD deployment readiness training modules required for the Intermediate and Advanced levels of deployment readiness • Awarded Field Medical Readiness Badge, March 2007
• Completed four required FEMA Emergency Management Institute training courses
• Completed advanced readiness training:
• Homeland Security Medical Executive Course, June 2006 • Medical Effects of Ionizing Radiation Course, August 2004 • Medical History and Physical Examination current • Participating in the President’s Challenge fitness program, achieving 3 Presidential Champions Bronze Awards, 3 Presidential Champions Silver Awards, and 3
Presidential Champions Gold Awards; 95th percentile among the 4974 USPHS
participants
• Height and weight meet PHS standards
• Passed CCRF Annual Fitness Test at Level 2, 2006 and 2007
PUBLICATIONS, ABSTRACTS, PRESENTATIONS
PUBLICATIONS
Redacted.
Journal of Allergy and Clinical Immunology December 2007

Redacted.
Annals of Allergy November 1992
Redacted. Journal of Allergy and Clinical Immunology 89(5):1010-1020, May 1992. Redacted. Molecular and General Genetics 1980.
ABSTRACTS
Redacted. Journal of Allergy and Clinical Immunology 1991.
Redacted. Journal of Allergy and Clinical Immunology 1991. Redacted. Journal of Allergy and Clinical Immunology 1990. PRESENTATIONS
Briefing for Pediatric Implementation Team regarding an applicant’s Written Request for
Pediatric studies for an inhaled bronchodilator for treatment of asthma, December 2007
Anaphylaxis associated with (drug name redacted)
Participated in briefing to CDER Director and CDER Senior Management Staff, Regulatory
Briefing, January 2007
Briefing for Pediatric Implementation Team regarding an applicant’s Written Request for
Pediatric studies for an inhaled corticosteroid for treatment of asthma, January 2006
Briefing for Pediatric Implementation Team regarding an applicant’s decision to decline a
Written Request for Pediatric studies for an antihistamine used for the treatment of allergic
rhinitis, August 2005
Testimony at deposition and trial as expert witness for FDA in case against Pharmakon,
Inc., June 2005
Anaphylaxis in a new drug for the treatment of prostate cancer
Presentation to CDER Director and CDER Senior Management Staff, Regulatory Briefing,
July 2003
Response to second Written Request for Pediatric Studies for (drug name redacted)
Presentation to Director, Office of New Drugs and Pediatric Exclusivity Board, January 2003
Over-the-counter indication for the treatment of hives for (drug name redacted)
Presentation for CDER Director of Medical Policy and ODE II Director, June 2002
Chronic obstructive pulmonary disease indication for (drug name redacted)
Presentation to Pulmonary-Allergy Drug Products Advisory Committee, January 2002
Response to first Written Request for Pediatric Studies for (drug name redacted)
Presentation to Pediatric Exclusivity Board, August 2000
Response to Written Request for Pediatric Studies for (drug name redacted)
Presentation to Director, Office of New Drugs and Pediatric Exclusivity Board, Regulatory
Briefing, November 1999
Anaphylaxis in a new drug for the treatment of prostate cancer
Presentation to CDER Director and CDER Senior Management Staff, Pre-decisional
Meeting, May 2001

Why is my asthma patient not getting better?
Fourth Annual David Grant USAF Medical Center Pediatric Update, Travis AFB, California,
May 1992.
Interleukin–6 is released in the cutaneous response to antigen challenge.
Annual Scientific Session of the Association of Military Allergists, Fitzsimons Army Medical Center, Aurora, Colorado, February 1992. Interleukin–6 is released in the cutaneous response to antigen challenge. Southwest Allergy
Forum, San Antonio, TX, April 1991.
Second place award for abstract by a Fellow in Training.
Interleukin–6 is released in the cutaneous response to antigen challenge.
Poster presentation at the 47th Annual Meeting of the American Academy of Allergy and
Immunology, San Francisco, California, March 1991.
Identification of peanut and true nut allergens.
Poster presentation at the 46th Annual Meeting of the American Academy of Allergy and
Immunology, Baltimore, Maryland, March 1990.
Identification of peanut and true nut allergens.
Annual Scientific Session of the Association of Military Allergists, Fitzsimons Army Medical
Center, Aurora, Colorado, February 1990.
Nucleoside transport in Rickettsia typhi.
Department of Microbiology, University of Maryland School of Medicine, Baltimore,
Maryland, October 1977.
NEW DRUG APPLICATION REVIEWS—FDA APPROVAL ACTIONS ONLY
(APPROVABLE AND NOT APPROVABLE ACTIONS NOT LISTED)
Redacted.

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