C D
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`
`
`David WW. Feiggal, Jr., M.D., MM.P.H..
`
`
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`
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`Curricculumm Vitaae
`
`
`
`
`
`
`Subject
`
`
`Psychologyy
`
`Medicine
`
`Internal
`Medicine
`
`
`Epidemioloogy &
`
`Biostatisticss
`
`Epidemioloogy
`
`
`
`
`
`
`Addrresses:
`
`
`11806 Barrranca Road
`
`
`
`Santa Rossa Valley, CAA 93012
`
`
`+1 (805) 4491-3695 (Diirect)
`
`
`+1 (301) 6613 2779 (M
`obile)
`
`
`
`Feigal_daavid@msn.coom
`
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`EDUUCATIONN
`
`D
`
`
`Degree Confferred,
`
`
`TTitle or Stattus
`B.A. summa
`cum
`
`aaude
`
`MM.D.
`
`Bl
`
`DG
`
`Degree
`Granted
`1971
`
`1 1
`
`1976
`
`
`
`
`
`
`
`Inntern and RResident
`
`
`
`
`
`11983
`
`
`
`MM.P.H.
`
`
`n Clinical
`
`
`nE
`
`Epidemiologgy
`
`A.W. Mellonn Scholar
`
`Ai
`
`
`
`
`Institutioon & Locatioon
`
`
`Universitty of Minnessota
`
`Minneaapolis, MN
`
`Stanford University
`
`Palo Altto, CA
`
`
`Davis
`ento, CA
`Sacram
`
`
`
`Berkeleey, CA
`
`
`
`San Fraancisco, CA
`
`Universitty of Californnia,
`
`nia, Universitty of Californ
`
`Universitty of Californnia,
`
`
`
`
`
`
`Attended
`
`9967-71
`
` A 1
`
`
`
`19971-1976
`
`
`
`19976-1979
`
`
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`19982-1983
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`
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`19982-1984
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`Page 1
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`

`

`LICENSES, CERTIFICATIONS:
`
`1977
`1979
`
`Medical License: California (# G34473)
`Certified, American Board of Internal Medicine (# 71092)
`
`
`
`
`
`PRINCIPAL POSITIONS HELD:
`1979-80
`University of California,
`Davis
`
`1980-82
`
`1984-85
`
`University of California,
`San Francisco
`
`
`
`1986-89
`
`1989-91
`
`1992-96
`
`1996-97
`
`University of California,
`San Diego
`Food and Drug Administration,
`Center for Drug Evaluation and
`Research
`
`
`1995-97
`1997-99
`
`Food and Drug Administration,
`Center for Biologics Evaluation
`and Research
`
`1999-2004 Food and Drug Administration,
`Center for Devices and
`Radiological Health
`
`2004 -06 NDA Partners, L.L.P
`(a medical product development
`consulting group)
`
`
`Chief Resident, Medicine
`Assistant Professor, in Residence of
`Medicine
`Adjunct Assistant Professor of
`Epidemiology and International
`Health with joint appointment in
`Medicine
`Assistant Professor, in Residence of
`Medicine with joint appointment in
`Epidemiology and Biostatistics
`Associate Clinical Professor of Medicine
`
`Director, Division of Anti-Viral Drug
`Products
`Acting-Director, Division of Anti-
`Infective Drug Products
`Director, Office of Drug Evaluation-IV
`Medical Deputy Director
`
`Director
`
`Principal
`
`
`
`
`
`
`
`2
`
`Page 2
`
`

`

`2006 - 08
`
`Élan Pharmaceuticals, Inc.
`
`2008 - 10 Amgen, Inc.
`2010 -
`NDA Partners, L.L.P
`
`Senior Vice President of Global Regulatory
`Affairs and Global Safety Surveillance
`Vice President of Global Regulatory Affairs
`
`Principal
`
`
`
`
`ANCILLARY POSITIONS HELD CONCURRENTLY:
`
`
`1980-82
`
`1984-88
`
`1984-89
`1984-89
`1986-89
`
`Univ. of California, Davis
`Department of Medicine
`Univ. of California, San Francisco
`
`
`
`
`
`
`
`
`1986-89
`San Francisco General Hospital
`1985-89
`2004 – 07 Arizona State University
`
`
`2005 -
`2005 - 07 University of California, San Diego
`
`
`
`HONORS AND AWARDS:
`
`1969
`
`Phi Beta Kappa
`
`Residency Training Program Coordinator
`
`Associate Director: AW Mellon Program
`
` in Clinical Epidemiology
`Faculty, Institute for Health Policy
`Adjunct Faculty, Clinical Pharmacology
`Director, Data Center, AIDS Clinical
`Research Center
`Joint Appointment in School of Dentistry
`Chair of Quality Assurance Department
`Research Professor, Arizona Biodesign
`Institute
`Associate Faulty, School of Law
`Von Liebing Fellow in Entrepreneurship,
`School of Engineering
`
`1981
`
`1986
`
`1997
`
`1997
`
`
`
`Junior Faculty Teaching Award (selected by the medical school senior class, UC
`Davis)
``Outstanding Graduate Student Instructor' (selected by School of Public Health,
`UC Berkeley)
`FDA Award of Merit: “For providing outstanding leadership and management of
`Office of Review Management resources resulting in rapid delivery of safe,
`effective new drug products to the public.”
`CDER Excellence in Communication Award: "For exceptional team efforts in
`improving communications with Industry and within FDA to facilitate the
`review and development of safe and effective drugs in the Office of Drug
`Evaluation IV".
`
`
`
`3
`
`Page 3
`
`

`

`1998
`
`FDA Commissioner’s Special Citation: “For design and implementation of the
`Blood Action Plan to strengthen the safety of the nation’s blood supply.”
`
`
`
`
`
`HONORS AND AWARDS (Continued) :
`
`1998
`
`1998
`
`1999
`
`2002
`
`2005
`
`FDA Award of Merit: “For advancing the field of AIDS by leading the
`collaborative evaluation of HIV-RNA as an endpoint in clinical trials for anti-
`HIV drugs.”
`FDA Commendable Service Award: “ For exceptional efforts by the Guidance for
`Industry – Evaluating Clinical Studies of Antimicrobial Drug Products Team
`leading to consistency in the evaluation of anti-infective drugs.
`
`FDA Group Recognition Award: “For developing guidance for the Fast Track
`provision of FDAMA to speed availability of products to consumers suffering
`from serious and life-threatening conditions.”
`Presidential Executive Rank Award : “For Sustained Outstanding Performance.”
`
`Health and Human Service Secretary’s Award for Distinguished Service for the
`Tissue Action Plan
`
`Human Subjects Committee
`
`Educational Advisory Committee
`Physicians Advisory Committee to the Hospital Information System
`
`Third year Medicine Clerkship Committee
`Intern and Resident Selection Committee: (Chair 1980-1982)
`Residency Review Committee: (Chair)
`
`UNIVERSITY SERVICE:
`
`UC DAVIS CAMPUS WIDE:
`
`1980-82
`
`UC DAVIS SCHOOL OF MEDICINE:
`
`1980-82
`1982
`
`UC DAVIS DEPARTMENT OF MEDICINE:
`
`1979-82
`1979-82
`1981-82
`
`UC SAN FRANCISCO SYSTEM-WIDE:
`
`1985
`
`UC SAN FRANCISCO SAN FRANCISCO GENERAL HOSPITAL CAMPUS-WIDE:
`
`1985-89
`
`
`
`University-wide Task Force on AIDS: Study Section
`
`Quality Assurance Committee, (Chair)
`
`
`
`
`
`4
`
`Page 4
`
`

`

`Utilization Review Committee
`Self-Accreditation Committee, (Co-Chair)
`Product Evaluation Committee
`Joint Conference Committee
`Medical Information Steering Committee
`Ad Hoc Committee on Open Heart Surgery at SFGH
`Ad Hoc Committee on Interdepartmental Relationships and Privileges
`Ad Hoc Committee on HIV Testing
`HIV Policy Committee
`
`1985-89
`1985-89
`1985
`
`1985-89
`1985-86
`1985-86
`1987
`
`1988
`
`1989
`
`
`UC SAN FRANCISCO INSTITUTE FOR HEALTH POLICY
`1985-9
`Publications Advisory Committee
`
`UC SAN FRANCISCO, DEPARTMENT OF MEDICINE
`
`1985-6
`
`
`TEACHING ACTIVITIES: UC Davis
`
`
`SFGH Primary Care Internship Selection Committee
`
`Academic Years
`1978-82
`
`Course
`Physical Diagnosis
`
`1979-82
`
`1979-82
`
`1979-82
`
`1979-82
`
`1980-82
`
`1980-82
`
`1980-82
`
`Nature of Contribution
`Lecture: The Problem Oriented Record;
`Preceptor
`Lecture and Videotape (patient interview)
`Stress and the GI Tract
`
`Ward Attending
`
`Prepared and graded all written
`examinations
`Clinic Attending
`
`Gastroenterology: Year II
`Medical student Core
`Curriculum
`Medicine Wards
`
`Third Year Medicine
`Clerkship
`General Medicine Clinic
`
`General Medicine Consult
`
`Consult Attending
`
`Acting Internship in Medicine Course Chair
`
`Behavioral Medicine Clinic
`
`Clinic Attending
`
`Lectures at UC Davis
`
`1980 Medical Grand Rounds, "Stress and the GI Tract"
`
`Family Practice Grand Rounds, "Dementia and Delirium"
`
`Medical M&M Conference, "Fever and Abdominal Pain in an Elderly Woman"
`
`Continuing Medical Education Conference on Preoperative Evaluation,
`"Anesthetic Risk"
`Second Annual Conference on Preoperative Evaluation, "Use of Blood
`
`1981
`
`Government Service
`
`
`
`5
`
`Page 5
`
`

`

`
`
`
`
`1982
`
`1983
`
`Products"
`Internal Medicine Noon Conferences, "Dementia and Delirium"
`Medical M&M Conference, "Sudden Death in 27 Year Old Black Female with a
`Valve Replacement"
`Biostatistics Review Course for faculty and fellows (12 workshop style lectures),
`Ambulatory Case Conference, "Stress & the GI Tract"
`Medical M&M Conference, "Dementia in a 54 year old Woman"
`Third Annual Conference on Preoperative Evaluation, "Preoperative
`Assessment of the Elderly Patient"
`
`
`TEACHING ACTIVITIES: UC San Francisco / UC Berkeley
`
`
`
`Academic Years
`1982-89
`
`Course
`Ambulatory Care Clerkship
`
`Nature of Contribution
`Preceptor
`
`1982-85
`
`1982-89
`
`1982-89
`
`1983-86
`
`1984-89
`
`1984-89
`1984-89
`
`1985-86
`
`1985-1987
`
`1987-89
`
`1987
`
`1987-89
`
`
`
`A.W. Mellon Summer Student
`Research Design Workshop
`Research design Workshop
`and Advanced Epidemiology
`Seminar
`General Medicine Clinic
`
`Computer Workshop: Data
`skills for new faculty and
`fellows
`Medicine Wards
`
`Lecturer; Preceptor
`
`Lecturer; Faculty Preceptor
`
`Clinic Attending
`
`Course Director (5 week course)
`
`Ward Attending
`
`General Medicine Consult
`
`Consult Attending
`
`Section Leader
`
`Epidemiology: 1st year
`medical student core
`curriculum
`UC Berkeley BEHS 160:
`Introduction to Public health
`
`Faculty in charge of two 10 lecture modular
`sections on epidemiological methods
`Lectures on Hospital Quality Assurance
`Programs
`
`UC SF IDS 140.22:
`Responsibilities of Medical
`Practice
`Clinical Pharmacology and
`Therapeutics Elective
`UC Berkeley: Introduction to
`Epidemiology
`AIDS Epidemiology Seminar Weekly Seminar organizer
`
`Lectures on Pharmacoepidemiology
`
`Lectures on Clinical Epidemiology
`
`Government Service
`
`
`
`6
`
`Page 6
`
`

`

`Lectures at UCSF
`
`1984
`
`
`Primary Care Grand Rounds, "Isolated Systolic Hypertension"
`Family Practice Grand Rounds, "Elevated Cholesterol and your Heart: What
`have we learned from recent clinical trials?"
`Epidemiology Grand Rounds, "Pharmacoepidemiology: How we find
`adverse drug reactions"
`Conference on Practical Advances in Medicine, "Computers: How to retrieve
`medical information in a practical way"
`Clinical Pharmacology Research Seminar, "Pharmacoepidemiology", San
`Francisco, CA
`Occupational Medicine Grand Rounds, "Methodology to Detect Rare Events",
`San Francisco, CA
`Primary Care Grand Rounds, "How are adverse drug reactions detected?"
`Primary Care Grand Rounds, "Mild Hypertension: the case for
`nonpharmacologic treatment"
`Clinical Pharmacology: Topics in Therapeutics, "Pharmacoepidemiology:
`Postmarketing drug surveillance"
`Family Practice Grand Rounds, "Mild Hypertension: the case for
`nonpharmacologic treatment"
`Medicine Noon Conference, "How to read the medical literature; Part I:
`observational studies; Part II: experimental studies"
`Departments of Medicine and Anesthesia Conference: Preoperative
`Evaluation of the Surgical Patient, "Surgery and the Elderly Patient"
`SFGH Medical Grand Rounds, "Legal Aspects of Quality Medical Care"
`Comprehensive Care of the AIDS Patient: A Workshop, "Integrating Research
`into the Clinical Setting"
`Conference: Legal Aspects of Medical Practice, "The Epidemiology of
`Malpractice"
`Departments of Medicine and Anesthesia Conference: Preoperative
`Evaluation of the Surgical Patient, "Surgery and the Elderly Patient"
`Occupation Health Grand Rounds, "Application of Statistical Methods to
`Problems in Occupational Health"
`Comprehensive Care of the AIDS Patient: A Workshop, "Integrating Research
`into the Clinical Setting"
`San Francisco Department of Public Health: National AIDS Conference,
`"Care: Acute Inpatient Hospital Quality Assurance Programs"
`APEX Program for AIDS Education, "AIDS Drug Protocols”
`Conference, "Hospital Quality Assurance Programs"
`Veteran's Administration Conference on Geriatric Care: Controversies in
`Geriatric Care, "Debate: Problems in the Treatment of Isolated Systolic
`Hypertension"
`National AIDS Conference: San Francisco Department of Public Health,
`"AIDS Drug Protocols and The Testing and Approval of New Drugs"
`Conference, "Hospital Quality Assurance, Utilization Review, and Risk
`Management Programs"
`CME Course: Comprehensive Care of the AIDS Patient, "AIDS: Cost of Care”
`
`1985
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`1986
`
`
`
`
`
`
`
`
`1987
`
`
`
`
`
`
`
`
`
`
`
`1988
`
`
`
`
`
`Government Service
`
`
`
`7
`
`Page 7
`
`

`

`TEACHING ACTIVITIES: UC San Diego
`
`
`
`Academic Years
`1990-91
`
`Nature of Contribution
`Course
`Logistic Regression Workshop Course lecturer (10 week workshop)
`
`1990-91
`
`1990-91
`
`1990-91
`
`1990-91
`
`
`
`
`General Internal Medicine /
`Geriatrics Journal Club
`General Medicine Clinic
`
`Medicine Wards
`
`Coordinator
`
`Clinic Attending
`
`Ward Attending
`
`General Medicine Consult
`
`Consult Attending
`
`Lectures at UC San Diego
`
`1989
`
`
`
`1990
`
`
`
`Physicians for AIDS Care: Update on the prevention and management of
`PCP, "PCP Prophylaxis", San Diego, CA
`University of California, San Diego Infectious Disease Conference, "Oral
`Manifestations of HIV Infection", San Diego, CA
`Medical Grand Rounds, "Prophylaxis and treatment of Pneumocystis carinii
`with aerosolized pentamidine", San Diego, CA
`Annual Conference on the Evaluation of the Preoperative Patient, "The
`Political Economy of Surgery"
`
`
`TEACHING ACTIVITIES: Arizona State University
`
`
`Academic Years
`2005 - 2010
`
`Course
`Food and Drug Law
`
`Nature of Contribution
`Course Director (15 week, 3 Credit, Fall
`Semester Law School course). Responsible
`for about two- thirds of the lectures.
`
`
`PREDOCTORAL STUDENTS SUPERVISED:
`
`
`1983 Chris Cox
`1985 Tamara Barr, R.N.
`1986 Constance Rainer
`1986 David Kirn
`
`1987 Tom Tieri
`
`1988 Deborah Kato
`1988 Paul Cusick
`
`
`(Medical Student, UCSF)
`(MPH Candidate, UC Berkeley)
`(Medical Student, University of Minnesota)
`(Medical Student, UCSF)
`(Medical Student, UCSF)
`(Medical Student, Cornell)
`(Medical Student, University of Massachusetts)
`
`
`
`
`
`
`
`
`
`Government Service
`
`
`
`8
`
`Page 8
`
`

`

`1989 Eckart V. Hirschhausen
`
`(Medical Student, University of Heidelberg,
` Germany)
`
`
`POSTDOCTORAL FELLOWS PRECEPTED:
`
`1983-85
`1984-85
`1987-89
`1989
`
`1991
`
`2005-6
`
`Susan Cummins, M.D.
`Richard Glaser, M.D.
`Robin Edison, M.D.
`
`David Glidden
`
`Fernando Rubenstein
`Christine Meis McAuliffe
`
`(Epidemiology Fellow)
`(Epidemiology Fellow)
`(Preventive Medicine Resident)
`(University of Washington, Biostatistics Ph.D. Student)
`(Primary Care Fellow)
`(Law School Doctoral Dissertation Committee)
`
`
`
`GOVERNMENT SERVICE:
`WORLD HELATH ORGANZATION:
`Global Program on AIDS:
`
`
`1993-96
`1993
`
`1993
`
`1993-97
`
`1994
`
`1994
`
`
`
`Steering Committee on Drug Clinical Trials: Member
`Second Meeting on the Development of Drugs and Vaccines for AIDS:
`Speaker and FDA representative: Harmonization of Regulatory
`Requirements for AIDS Drugs, "Accelerated Approval", Geneva,
`Switzerland
`Workshop on the Development of Agents to Prevent Heterosexual
`transmission of HIV: “Topical Microbicides, "Regulatory
`Requirements for Vaginal Microbicides to Prevent HIV Infection",
`Geneva, Switzerland
`International Working Group on Vaginal Microbicides: chair and
`founding member
`Global program on AIDS Consensus Panel on Prevention of perinatal
`transmission of HIV: Speaker and panelist
`Workshop on Harmonization of Regulatory Requirements for AIDS
`Drug Development: Invited participant
`
`Government Service
`
`
`
`9
`
`Page 9
`
`

`

`INTERNATIONAL CONFERENCE ON HARMONIZATION
`
`
`1995-96
`1995
`
`
`1995-96
`1997- 99
`1998
`
`Efficacy Lead: Center for Drug Evaluation and research, FDA
`3rd ICH Delegate
`3rd International Conference on Harmonization, "General
`Considerations for Clinical Trials", Yokohama, Japan, 1995
`CDER Topic Lead E8: “General Considerations”
`CBER Topic Lead: M4 “Common Technical Document, Efficacy”
`ICH Update, "The ICH Common Technical Document", Bethesda, MD
`
`
`GLOBAL HARMONIZATION TASK FORCE
`
`
`2000 – 04
`2000
`
`2002
`
`GHTF Steering Committee Member: Lead US Regulatory Delegation
`8th Global Harmonization Task Force Meeting, "DEHP Plasticizers in
`Medical Devices", Quebec, Canada, 2000
`9th Global Harmonization Task Force Meeting, "Total Product Life Cycle:
`Postmarket Surveillance and Vigilance", and "New and Emerging
`Technologies: Consumer Protection that Fosters Innovation", Singapore,
`2002
`
`
`EUROPEAN MEDICINES EVALUATION AGENCY (EMEA)
`
`
`1996
`
`Invited Presentation: Surrogate markers, combination nucleosides and
`protease inhibitors
`
`
`NATIONAL ACADEMIES OF SCIENCE
`
`Institute of Medicine
` Combination HIV Therapies: Considerations for Policy and Research, "Preclinical
`Data Requirements", Washington, DC, 1992
` Changing Demographics of the AIDS Epidemic: Implications for Clinical Research,
`"Enhancing Diversity in Drug Development, An FDA Perspective", Washington,
`DC, 1993
`IOM Panel to Review FIAU, "The FIAU Experience", Washington, DC, 1994
`Roundtable for the Development of Drugs and Vaccines Against AIDS:
`Collaboration between Government and Industry, "Challenges and
`Opportunities for HIV Drug and Vaccine Development", Washington, DC, 1994
`IOM Conference on Therapeutics of Children, "Special Considerations for Evaluating
`Medical Devices in Infants and Children", Washington, DC, 1999
`IOM Workshop: Innovation and Invention in Medical Devices, "Innovation and
`
`
`
`
`
`
`
`
`Government Service
`
`
`
`10
`
`Page 10
`
`

`

`Invention in Medical Devices", Washington, DC, 2000
` New Approaches to Early Detection and Diagnosis of Breast Cancer: Accelerating
`the Flow from Concept to Clinic, "Challenges in assessing the safety and efficacy
`of cancer detection devices", Washington, DC, 2003
`IOM Committee on Post-marketing Surveillance of Pediatric Medical Devices.”
`Device Post-Market Surveillance in Children.” Consultant to the Committee 2004
`-2005
`IOM Workshop on Modifications to the 510(k) Clearance Process. Invited Paper. 2010
`
`
`
`
`
`
`
`
`National Academy of Engineering
`Bioengineering, Materials (BEMA) Roundtable, "FDA Perspective on Medical Device
`Development", Washington, DC, 2000
` National Academy's Biomedical Materials Roundtable Meeting, "Developing
`Biomaterials: An FDA Perspective", Washington, DC, 2002
`BEMA – “Science-Based Assessment: Accelerating Product Development of
`Combination Medical Devices”, Washington, DC, 2003
` AIMBE Symposium: Imaging and Bioengineering, Partners for the Future, “Public
`Policy Issues Related to Imaging”, Washington, D.C. 2004
`BEMA – “Examining the Regulatory Path for Emerging Biomaterials Technologies” ,
`Woods Hole, MA, 2004
`
`
`
`
`National Research Council, Board on Mathematical Sciences
` National Research Council, Board on Mathematical Sciences: Science and Technology
`Symposium, "Surrogate Markers", Washington, DC, 1992
`
`
`
`
`U.S. DEPARTMENT OF HEALTH AND HUMAN SERVICES
`
`Secretary's Advisory Committees
`
`1996 - 98
`2000 - 02
`
`
`HHS Panel on Clinical Practices for Treatment of HIV Infection
`Secretary's Advisory Committee on Genetic Testing,
` Presentation: "FDA‘s Role in the Transition of In Vitro Diagnostic
`Devices from Research to Routine Testing", Washington, DC, 2000
`Women's Health Dialogue, Washington, DC, 2001
`Secretary's Advisory Committee on Regulatory Reform, "FDA and CMS
`Collaboration", Minneapolis, MN
`Secretary's Advisory Committee on Genetics Health and Society, FDA
`Liaison Representative
` Presentation: "FDA's Regulation of Genetic Tests, Washington, DC,
`2003
`
`2001
`2002
`
`2003 - 04
`
`
`
`Government Service
`
`
`
`11
`
`Page 11
`
`

`

`
`
`HHS Workshops
`
` National AIDS Task Force on Drug Development, "Surrogate Markers: FDA
`proposal for and integrated approach", Washington, DC, 1994
`Public Health Service Disability Awareness Conference, "Opening Remarks ",
`Rockville, MD, 1996
` Office of AIDS Policy Workshop, "Clinical Practice of HIV Treatment", Washington,
`DC, 1997
` HHS Consumer Roundtable, "Medical Devices and Radiological Health",
`Washington, DC, 2000
` White House Conference on Alternative Medicine, "Medical Devices and Alternative
`Medicine", Washington, DC, 2000
` CMS - Medicare Medical Directors Workgroup, "New Technology in Medicine",
`Baltimore, MD, 2001
`
`
`NATIONAL INSTITUTES OF HEALTH
`
`
`1992 - 96
`1992 - 97
`1992 - 96
`
`AIDS Clinical Drug Development Committee
`Faculty: IDSA AIDS Fellowship Program
`Executive Committee: AIDS Clinical Trials Group
`
`
`
`
`
`
`
`
`
`PHS Consensus Conferences
`
`US Public Health Service Consensus Panel on Prophylaxis against PC in HIV
`infected Patients, "Evaluation of the trimethoprim-sulfamethoxazole", Bethesda,
`MD, 1987
`Steroid Use in Pneumocystis carinii pneumonia, "Acute mortality of PCP
`pneumonia: A case series of the first 500 cases at San Francisco General Hospital
`1981 - 1986", San Diego, CA, 1990
`Consensus Conference on Steroids and PCP, "Predictors of early mortality upon
`hospital admission for PCP", San Diego, CA, 1990
`NIH Workshop on the Placebo, "Use of placebos in clinical trials to test procedural
`interventions", Bethesda, MD, 2000
`
`
`
`NIH Workshops and Conferences
`NCI
`National Cancer Institute: Third National Forum on Biomedical Imaging
`in Oncology, "Cancer Imaging Products: Drug, Biologicals, and Devices",
`Arlington, VA, 2002
`Fourth National Forum on Biomedical Imaging in Oncology, "Regulatory
`Update", Bethesda, MD, 2003
`Fifth National Forum on Biomedical Imaging in Oncology, "Current Issues
`in Imaging Device Regulation", Bethesda, MD, 2004
`BIROW II: Biomedical Imaging Research Opportunities II, “Developing
`
`
`
`
`
`Government Service
`
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`Page 12
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`

`

`NIAID
`
`
`
`
`
`
`
`NIDCR
`
`NIHCHD
`
`Clinical
` Center
` Rounds
`Other NIH
`Workshops
`
`New Imaging Technology: An FDA Perspective”, Bethesda, 2004
`ACTG Annual Meeting, "Women and special populations in HIV Drug
`Trials", Washington, DC, 1993
`12th meeting of the acquired Immunodeficiency Syndrome Program
`Advisory Committee (APAC), "Accelerated Approval", Bethesda, MD,
`1993
`CPCRA: Annual Meeting, "Data collection requirements and monitoring
`clinical trials", Alexandria, VA, 1993
`NIAID-UNAIDS Satellite Symposium on Topical Microbicides, "Topical
`Microbicides", Vancouver, BC, 1996
`National Institutes of Health: NIDCR - Dental, Oral & Craniofacial
`Forum, "FDA and Medical product Consumer Protection",
`Washington, DC, 2001
`Contraceptive Technology Workshop, "Development of Vaginal
`Microbicides to Prevent HIV transmission", Bethesda, MD, 1994
`NIH Clinical Center: Critical Care Medicine Department Conference,
`"Evidence based Medicine and Device Regulation: How to Foster
`Innovation", Bethesda, MD, 2002
`Cost Effective Strategies for the Diagnosis of Pulmonary Complications:
`Calculations of 'Cost Effectiveness', "NIH Workshop on the Pulmonary
`Complications of AIDS", San Francisco, CA, 1987
`NIH - FDA Symposium on AIDS Clinical Trials, "AIDS Clinical Trials:
`Non traditional study designs", Rockville, MD, 1990
`Fogarty Center, NIH: US-Japan Cooperative Medical Science Program:
`Sixth Joint Scientific Meeting of the AIDS Panels, "Scientific Research
`Opportunities in the Pacific: FDA Perspectives", Palm Springs, CA,
`1994
`Gene Therapy Conference, "Surrogate Markers NIH,", Bethesda, MD,
`1997
`Research Needs for the Design and Analysis of Surrogate Endpoints in
`Clinical Trials, "Clinical Perspectives on Surrogate Markers", Potomac,
`MD, 1998
`Prenatal Gene Therapy Workshop, "Clinical Endpoints and
`Measurement Outcome", Bethesda, MD, 1999
`FDA/NIH Workshop on Non-Clinical Toxicological Study Design Issues
`for Development of AAV-Based Gene Therapies: A Platform Studies
`Approach, "Role of Platform Studies in Drug Evaluation", Bethesda,
`MD, 1999
`NIH Technology Assessment Conference on Improving Medical
`Implant Performance Through Retrieval Information: Opportunities
`and Challenges, "National Implant Data Retrieval and Analysis",
`Bethesda, MD, 2000
`Foundation for NIH: Imaging Database Resources Initiative, “Importance
`of FDA-NIH-Industry Collaboration”, Bethesda, MD 2004
`
`
`
`
`
`
`
`
`
`
`
`
`
`
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`
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`Government Service
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`13
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`Page 13
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`

`

`
`
`INVITED PAPERS, LECTURES AND PRESENTATIONS
`Academic Institutions
`
`
`Applied Sciences
`International Seminar on Harmonization of Standards (Honoring
`University,
`the Retirement of Professor Horst Frankenberger), "Global
`Lubeck
`Harmonization of Medical Devices", Lubeck, Germany, 2003
`Germany
`Arizona State
`University
`
`
`Personalized Medicine and Molecular Diagnostics, Legal
`Regulatory and Ethical Perspectives, “Regulatory Issues for
`Personalized Medicine”, 2007
`Materials Science Seminar Series, "Medical Devices", Pittsburgh, PA,
`2001
`FDA Workshop: Community based clinical trials, "The San
`Francisco Community based trials of PCP prophylaxis", New
`York, NY, 1989
`Symposium on Quality of Life, "Drugs, Drug Companies and
`Quality of Life Issues: Quality of Life Measures: An FDA
`Perspective", New York, NY, 1993
`The American Institute of Life-Threatening Illness and Loss:
`Regulatory Issues, Pharmacoeconomics and Quality of life Issues
`in the Evaluation of Therapeutic Agents: Oncologic,
`Cardiovascular, and other Drugs as Models, "Assessment of Drug
`Therapies Using Quality of Life Measures", New York, NY, 1997
`Device and Drug 3D1 Symposium, "Clinical Development and
`Commercialization: Differences: United States and
`Europe/United Kingdom", Woodstock, VT, 2003
`Seminar:, "Role of Clinician Inventor/Entrepreneur in Pre-Clinical
`and Clinical Development of a new Medical Device", Lebanon,
`NH, 2003
`Medical Grand Rounds, “Innovation and Consumer Protection –
`FDA and New Technology”, Lebanon, NH, 2004
`Device and Drug 3D3 Symposium, "Conflict of Interest: Medical
`Device Development", Woodstock, VT, 2005
`Device and Drug 3D4 Symposium, "International Harmonization of
`Regulatory Standards, Is it worth the trouble?", Woodstock, VT,
`2006
`Device Drug Eluting Stents Conference, "The Shrinking Total
`Product Life Cycle: Regulatory Processes and Innovation",
`Washington, DC, 2002
`Clinical Research Institute Roundtable, "New Technology Review",
`Tyson's Corner, VA, 2002
`Clinical Research Institute: Genetics and Cardiovascular Disease II,
`"", Pentagon City, VA, 2003
`Clinical Research Institute: Device Evaluation Think Tank, "",
`Rockville, MD, 2003
`
`Carnegie Mellon
`University
`Columbia
`University
`
`
`
`
`
`Dartmouth
`Medical School
`
`
`
`
`
`Duke University
`
`
`
`
`
`
`
`Presentations
`
`
`
`14
`
`Page 14
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`

`

`
`Georgetown
`University
`
`
`
`
`
`
`
`
`
`
`
`
`
`Georgia Tech
`
`
`
`Golden Gate
`University
`
`
`
`Harvard
`University
`
`
`
`
`
`Howard
`University
`
`Johns Hopkins
`University
`Memorial Sloan
`Kettering
`
`Georgetown Clinical Pharmacology Conference, "Rapid Drug
`Development: The Protease Inhibitors", Washington, DC, 1997
`Center for Drug Development Science Course: Modeling and
`Simulation of Clinical Trials in Drug Development and
`Regulation, "PK/PD Modeling in Regulatory Decisions for
`Effectiveness", Herndon, VA, 1997
`Center for Drug Development Study Conference,
`"Pharmacogenomics", Washington, DC, 1999
`Center for Drug Development Study Conference: Protein
`Pharmacology, "Protein PK/PD: A Regulatory Perspective",
`Annapolis, MD, 1999
`Center for Drug Development Studies, Georgetown University:
`Confirmatory Evidence (to Support a Single Clinical Trail (SCT):
`An Exploratory Workshop, "The Nature and Source of Evidence
`for Effectiveness", Washington, DC, 2002
`Center for Drug Development Study Conference: Clinical
`Development of Oncologic Agents: Challenging the Tradition,
`"Predictive diagnostics, biomarkers/surrogate endpoints and how
`they can be used in drug development", Washington, DC, 2003
`The International Life Science Summit East, "Drug and Device
`Development: The Challenge of Turning Research into Reality",
`Washington, DC, 2003
`Biomedical Engineering Seminar, "One Hundred Years of
`Consumer Protection", Atlanta, GA, 2001
`Medical Technology Leadership Forum Summit - Defining a
`Regulatory Process for Combination Product: The emergence of
`Tissue Engineering, "Regulatory Approaches to Tissue
`Engineering", Atlanta, GA, 2002
`Conference, "Hospital Quality Assurance Programs", San Francisco,
`CA, 1987
`Conference, "Hospital Quality Assurance, Utilization Review, and
`Risk Management Programs", San Francisco, CA, 1988
`Contemporary Issues in Clinical Trials Harvard School of Public
`Health, Department of Biostatistics, "Current and Future FDA
`Criteria for the Evaluation of Anti-HIV Drugs by the FDA, Boston,
`MA", Boston, MA, 1997
`Medical School Seminar-The Clinical Investigator Training
`Program, "Endpoints in Clinical Trials", Boston, MA, 1999
`Center for Innovation in Medical Technology - Harvard Medical
`School - Stanford Conflict of Interest Forum, "", Boston, MA, 2002
`Deadly Diseases & People of Color: Are Clinical Trials an Option?,
`"New Therapies for Diseases Affecting People of Color: AIDS",
`Washington, DC, 1996
`Medical School Symposium, "Prophylaxis with Aerosolized
`Pentamidine for PCP", Baltimore, MD, 1989
`Pulmonary Grand Rounds, "Prophylaxis against P carinii
`pneumonia", New York, NY, 1990
`
`Presentations
`
`
`
`15
`
`Page 15
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`

`
`New Jersey
`University of
`Medicine and
`Dentistry
`San Diego State
`University
`
`
`
`Scripps Clinic
`
`
`
`
`
`Shanghai Institute
`of Mental
`Health
`
`Stanford
`University Law
`School
`Stanford
`University
`School of
`Engineering
`Suffolk University
`School of Law
`
`Tufts University
`
`
`
`
`
`Uniformed
`Services
`University of
`Health Sciences
`
`
`University of
`Arizona
`
`University of
`California,
`Berkeley
`
`Presentations
`
`Infectious Disease Rounds, "New agents in the treatment and
`prevention of PCP", Newark, NJ, 1990
`
`Regulatory Affairs Student Seminar, "Consumer Protection and
`Medical Devices", Rockville, MD, 2001
`Student FDA Field Visit, "Consumer Protection: Devices and
`Radiological Products", Rockville, MD, 2002
`Scripps Clinic Symposium: The Changing World of International
`Product Development, "Pharmacogenomics: A Regulatory
`Perspective", La Jolla, CA, 1999
`Symposium, "Drug Delivery: Problems and Possibilities", La Jolla,
`CA, 2001
`5th Bio Symposium, "Perspectives on the Future FDA", La Jolla, CA,
`2003
`"Quality Assurance in Acute Care Hospitals, Peer Review of
`Medical Staff, Accreditation and Licensing American Hospitals,
`Use of Small Computers in Medical Departments (A day long
`seminar for Hospital Administrators)", Shanghai, China, 1988
`Program in Law Science and Technology Conference, "Genetic in
`vitro Diagnostics", Stanford, CA, 2000
`
`Bioengineering Class: Innovation and Technology, “Innovation and
`the FDA – 100 years of Consumer Protection” 2005
`
`FDA Regulation of Medical Technologies, “Defining a Medical
`Device”, “Device Classification”, “An Inside Look at the FDA
`Approval Process”; Boston, MA 2004
`PRIM&R (Public Responsibility in Medicine and Research): AIDS
`Clinical Research and Care: Meeting the Challenges of an
`Epidemic in Flux, "An Overview of the Status of AIDS Research in
`the '90s", Boston, MA, 1992
`Accelerated Approval of New Drugs, "Constructing a Framework
`for Surrogate Endpoint Selection", Boston, MA, 1994
`New Technologies, Challenges and Opportunities for the Medical
`Device Industry: A Collaborative Workshop Sponsored by the
`Tufts University Schools of Engineering & Medicine. “Innovation
`and Regulation.”, Boston 2004
`Clinical Pharmacology Seminar, "Surrogate Markers in Drug
`Development", Bethesda, MD, 1994
`
`The Promise of Stem Cells: Tissue Engineering And Regenerative
`Medicine, “Regulation of Stem Cells: Role of FDA, States and
`Others”, Tucson, AZ 2006
`Haas School of Business: New Economic Forum, "Biotechnology
`and Medical Devices", Portola Valley, VA, 2003
`
`
`
`16
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`Page 16
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`

`

`Conference on Practical Advances in Medicine, "Computers: How
`to retrieve medical information in a practical way", Sacramento,
`CA, 1985
`University of California Davis Conference, "The Political Economy
`of Surgery: Surgical practice in a changing environment", Carmel,
`CA, 1989
`Annual Conference on the Evaluation of the Preoperative Patient,
`"The Political Economy of Surgery", Carmel, CA, 1990
`Annual Conference on the Evaluation of the Preoperative Patient,
`"The Political Economy of Surgery", Carmel, CA, 1990
`von Liebig Forum Lecturer, the Jacobs School of Engineering,
`“Innovation and Consumer Protection – FDA and New
`Technology”, San Diego, CA 2004
`Department of Epidemiology and Biostatistics: Clinical Trials
`Workshop, "Interacting with the FDA", San Francisco, CA, 1995
`
`
`University of
`California,
`Davis
`
`
`
`
`
`
`
`University of
`California, San
`Diego
`University of
`California, San
`Francisco
`
`
`
`
`
`
`
`
`
`
`
`School of Dentistry, "Rapid Development of AIDS Drugs", San
`Francisco, CA, 1995
`San Francisco County Health Department, "Update on AIDS Drug
`Development", San Francisco, CA, 1996
`UCSF Department of Epidemiology and Biostatistics: Clinical Trials
`Workshop, "Interacting with the FDA", San Francisco, CA, 1996
`UCSF Department of Epidemiology and Biostatistics: Clinical Trials
`Workshop, "Placebo vs. Active Controlled Clinical Trials", San
`Francisco, CA, 1996
`8th Symposium on Clinical Trials: Design Methods and
`Controversies, "FDA Perspect