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EXHIBIT Declaration of Rachel Clattenburg Public Citizen v. FDA et al., 16-cv-781

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  • EXHIBIT Declaration of Rachel Clattenburg

    Public Citizen v. FDA et al., 16-cv-781

  • Curriculum Vitae WILLIAM GIANNOBILE

    DATE & PLACE OF BIRTH:

    ADDRESS

    Department of Periodontics & Oral Medicine University of Michigan School of Dentistry

    1011 N. University Ave. Ann Arbor, MI 48109-1078

    EDUCATION

    D.Med.Sc. (Oral Biology) Harvard University Boston, Massachusetts Certificate (Periodontology) Harvard University Boston, Massachusetts D.D.S. (Dentistry) University of Missouri Kansas City, Missouri M.S. (Oral Biology) University of Missouri Kansas City, Missouri B.S. (Biochemistry) University of Missouri

    Rolla, Missouri POSTDOCTORAL TRAINING

    Postdoctoral Fellowship Dana-Farber Cancer Institute (Molecular Biology) & Harvard Medical School Boston, Massachusetts Research Fellowship Forsyth Institute (Periodontology) Boston, Massachusetts

    ACADEMIC APPOINTMENTS 2012-pres. Chair Dept. of Periodontics & Oral Medicine University of Michigan School of Dentistry Ann Arbor, Michigan 2007-pres. Professor University of Michigan Dept. of Biomedical Engineering Ann Arbor, Michigan College of Engineering 2004-pres. Professor of Dentistry University of Michigan Dept. of Periodontics and Oral Medicine Ann Arbor, Michigan

    Ex. 33, page 1

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  • 2004-07 Associate Professor University of Michigan Department of Biomedical Engineering Ann Arbor, Michigan College of Engineering 2003-12. Director, Michigan Center for Oral University of Michigan Health Research Ann Arbor, Michigan School of Dentistry 2003-pres. William K. & Mary Anne Najjar University of Michigan Endowed Professor Ann Arbor, Michigan School of Dentistry 2002-04 Associate Professor University of Michigan Dept. Periodontics/Prevention/Geriatrics Ann Arbor, Michigan 1998-2002 Assistant Professor University of Michigan Dept. Periodontics/Prevention/Geriatrics Ann Arbor, Michigan 1997-98 Assistant Professor Harvard University Department of Periodontology Boston, Massachusetts 1997-98 Instructor Harvard University Department of Periodontology Boston, Massachusetts 1996-97 Assistant Member of Staff Forsyth Institute Department of Periodontology Cambridge, Massachusetts 1995-98 Research Fellow Harvard Medical School and Dept. Microbiology & Molecular Genetics Dana-Farber Cancer Institute 1991-96 Research Fellow Harvard University Department of Periodontology Boston, Massachusetts ANCILLARY APPOINTMENTS HELD CONCURRENTLY 2013 Visiting Professor University College London Eastman Dental Institute London, United Kingdom 2006-07 Visiting Professor University of Genoa Biotechnology Institute for Regenerative Medical School Medicine Genoa, Italy 2006-07 Visiting Professor University of Milan Department of Maxillofacial Surgery Milan, Italy

    Ex. 33, page 2

  • 2006-07 Visiting Professor 2nd University of Naples Department of Maxillofacial Surgery Naples, Italy 1998-2001 Assistant Clinical Professor Harvard University Department of Periodontology Boston, Massachusetts 1997-2000 Assistant Clinical Investigator Forsyth Institute Department of Periodontology Cambridge, Massachusetts LICENSURE AND CERTIFICATION:

    Diplomate Board Certification, American Board of Periodontology State of Michigan - License to Practice Periodontics State of Michigan – License to Practice Dentistry Commonwealth of Massachusetts – License to Practice Dentistry Northeast Regional Dental Board

    HONORS AND AWARDS Student Clinician Alumni Dental Award (ADA/SCADA), November, . Henry D. Epstein Memorial Lecturer, Harvard School of Dental Medicine, Boston, MA. April 11, Bernard Moskow Memorial Lecturer, Columbia University, New York, NY. October 26, Jan Lindhe International Periodontology Research Award, Gothenburg, Sweden, . Distinguished Scientist Award, American Academy of Periodontology, . Fellow, International College of Dentists, Co-Recipient, American Academy of Periodontology, R. Earl Robinson Periodontal

    Regeneration Award (with co-authors Nevins, M, McGuire MK, Kao RT, Mellonig JT, Hinrichs JE, McAllister BS, Murphy KS, McClain PK, Nevins ML, Paquette DW, Han TJ, Reddy MS, Lavin PT, Genco RJ, Lynch SE), for the peer-reviewed published paper that has contributed most to the knowledge of periodontal regeneration in a given year, .

    Charles Finley Visiting Scholar, American Periodontology Foundation (Naval Dental Hospital),

    Fellow, American College of Dentists, . Co-Recipient, American Academy of Periodontology, R. Earl Robinson Periodontal

    Regeneration Award (with co-authors Q. Jin, O. Anusaksathien, S. Webb and R.B. Rutherford), for the peer-reviewed published paper that has contributed most to the knowledge of periodontal regeneration in a given year, .

    Co-Recipient, American Academy of Periodontology, Clinical Research Award (with co-authors S. Socransky, A. Haffajee, R. Levy and M. Feres), for the most outstanding scientific manuscript having direct clinical relevance and application to the practice of Periodontics in a given year, .

    Recipient, Henry Russel, Jr. Faculty Award for Excellence in Research and Teaching, University of Michigan, . (Awarded to outstanding Jr. faculty member in University of Michigan System).

    Member of Best Dentists in America,

    Ex. 33, page 3

  • Co-Recipient, American Academy of Periodontology, R. Earl Robinson Periodontal Regeneration Award (with co-authors C. Lee, M. Tomala, K. Tejeda, Z. Zhu), for the peer-reviewed published paper that has contributed most to the knowledge of periodontal regeneration in a given year. September

    Tenure, University of Michigan School of Dentistry, . Anthony Rizzo Periodontal Research Award, International Association of Dental Research, San

    Diego, California, March, Charles Finley Visiting Scholar, American Periodontology Foundation (Univ. at Stony Brook,

    New York), October . Recipient of Roger Hill Friend of the Profession Award, Michigan Dental Hygienists

    Association, October . First Prize, Research Forum, Seventh International Symposium on Periodontics and Restorative

    Dentistry, Boston, Massachusetts, June . Bud and Linda Tarrson Career Development Award, American Periodontal Foundation,

    September . Junior Investigator Travel Award, Gordon Research Conference, July Recipient, Miyahara Clinical Research Prize, Federal Dentaire International, International

    Association of Dental Research, March . James Shaw Award for Excellence in Biomedical Research, Harvard School of Dental Medicine,

    June, . Young Investigator Fellowship, American Academy of Periodontology, . First Prize, Balint Orban Memorial Program, American Academy of Periodontology, New York,

    New York, September, . Young Investigator Travel Award, International Association for Dental Research Meeting,

    Seattle, Washington, March . First Prize, American Association for Dental Research/Dentsply Research Competition,

    Acapulco, Mexico, April . Student of the Year Award, University of Missouri School of Dentistry, . Recipient, Quintessence International Award for Research Achievement, University of Missouri

    School of Dentistry, May . Recipient, Pierre Fauchard Pierre Academy Award, May, . Omicron Kappa Upsilon, Rho Chapter, University of Missouri School of Dentistry, May . Finalist, American Dental Association Student Clinician Competition, ADA Meeting, Boston,

    Massachusetts. October, . Student of the Year, University of Missouri School of Dentistry, May . Chancellor’s Research Assistantship, Department of Oral Biology, UMKC School of Dentistry,

    . Omicron Delta Kappa, Honorary Leadership Fraternity, University of Missouri, . Recipient, American Association of Dental Schools Preventive Dentistry Award, . Awardee, NIH/NIDCR Bloc Travel Grant, Dublin, Ireland, . American Association for Dental Research Fellowship, . NIH/NIDCR Predoctoral Fellow, Bone Research Branch, Bethesda, Maryland, . University of Missouri Curator’s Scholar, . STUDENT AWARDS

    Ex. 33, page 4

  • Curriculum Vitae WILLIAM GIANNOBILE

    DATE & PLACE OF BIRTH:

    ADDRESS

    Department of Periodontics & Oral Medicine University of Michigan School of Dentistry

    1011 N. University Ave. Ann Arbor, MI 48109-1078

    +1-(734-763-2105 Mobile: +1-(734) 358-8761

    E-mail: [email protected] EDUCATION 1996 D.Med.Sc. (Oral Biology) Harvard University Boston, Massachusetts 1996 Certificate (Periodontology) Harvard University Boston, Massachusetts 1991 D.D.S. (Dentistry) University of Missouri Kansas City, Missouri 1991 M.S. (Oral Biology) University of Missouri Kansas City, Missouri 1987 B.S. (Biochemistry) University of Missouri Rolla, Missouri POSTDOCTORAL TRAINING 1996-98 Postdoctoral Fellowship Dana-Farber Cancer Institute (Molecular Biology) & Harvard Medical School Boston, Massachusetts 1996-98 Research Fellowship Forsyth Institute (Periodontology) Boston, Massachusetts ACADEMIC APPOINTMENTS 2012-pres. Chair Dept. of Periodontics & Oral Medicine University of Michigan School of Dentistry Ann Arbor, Michigan 2007-pres. Professor University of Michigan Dept. of Biomedical Engineering Ann Arbor, Michigan College of Engineering 2004-pres. Professor of Dentistry University of Michigan Dept. of Periodontics and Oral Medicine Ann Arbor, Michigan

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    Ex. 33, page 5

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  • 2004-07 Associate Professor University of Michigan Department of Biomedical Engineering Ann Arbor, Michigan College of Engineering 2003-12. Director, Michigan Center for Oral University of Michigan Health Research Ann Arbor, Michigan School of Dentistry 2003-pres. William K. & Mary Anne Najjar University of Michigan Endowed Professor Ann Arbor, Michigan School of Dentistry 2002-04 Associate Professor University of Michigan Dept. Periodontics/Prevention/Geriatrics Ann Arbor, Michigan 1998-2002 Assistant Professor University of Michigan Dept. Periodontics/Prevention/Geriatrics Ann Arbor, Michigan 1997-98 Assistant Professor Harvard University Department of Periodontology Boston, Massachusetts 1997-98 Instructor Harvard University Department of Periodontology Boston, Massachusetts 1996-97 Assistant Member of Staff Forsyth Institute Department of Periodontology Cambridge, Massachusetts 1995-98 Research Fellow Harvard Medical School and Dept. Microbiology & Molecular Genetics Dana-Farber Cancer Institute 1991-96 Research Fellow Harvard University Department of Periodontology Boston, Massachusetts ANCILLARY APPOINTMENTS HELD CONCURRENTLY 2013 Visiting Professor University College London Eastman Dental Institute London, United Kingdom 2006-07 Visiting Professor University of Genoa Biotechnology Institute for Regenerative Medical School Medicine Genoa, Italy 2006-07 Visiting Professor University of Milan Department of Maxillofacial Surgery Milan, Italy

    Ex. 33, page 6

  • 2006-07 Visiting Professor 2nd University of Naples Department of Maxillofacial Surgery Naples, Italy 1998-2001 Assistant Clinical Professor Harvard University Department of Periodontology Boston, Massachusetts 1997-2000 Assistant Clinical Investigator Forsyth Institute Department of Periodontology Cambridge, Massachusetts LICENSURE AND CERTIFICATION: 1998 Diplomate Board Certification, American Board of Periodontology 1998 State of Michigan - License to Practice Periodontics 1998 State of Michigan – License to Practice Dentistry 1991 Commonwealth of Massachusetts – License to Practice Dentistry 1991 Northeast Regional Dental Board HONORS AND AWARDS Student Clinician Alumni Dental Award (ADA/SCADA), November, 2013. Henry D. Epstein Memorial Lecturer, Harvard School of Dental Medicine, Boston, MA. April 11, 2013. Bernard Moskow Memorial Lecturer, Columbia University, New York, NY. October 26, 2012. Jan Lindhe International Periodontology Research Award, Gothenburg, Sweden, 2011. Distinguished Scientist Award, American Academy of Periodontology, 2010. Fellow, International College of Dentists, 2010 Co-Recipient, American Academy of Periodontology, R. Earl Robinson Periodontal

    Regeneration Award (with co-authors Nevins, M, McGuire MK, Kao RT, Mellonig JT, Hinrichs JE, McAllister BS, Murphy KS, McClain PK, Nevins ML, Paquette DW, Han TJ, Reddy MS, Lavin PT, Genco RJ, Lynch SE), for the peer-reviewed published paper that has contributed most to the knowledge of periodontal regeneration in a given year, 2006.

    Charles Finley Visiting Scholar, American Periodontology Foundation (Naval Dental Hospital), 2005.

    Fellow, American College of Dentists, 2004. Co-Recipient, American Academy of Periodontology, R. Earl Robinson Periodontal

    Regeneration Award (with co-authors Q. Jin, O. Anusaksathien, S. Webb and R.B. Rutherford), for the peer-reviewed published paper that has contributed most to the knowledge of periodontal regeneration in a given year, 2003.

    Co-Recipient, American Academy of Periodontology, Clinical Research Award (with co-authors S. Socransky, A. Haffajee, R. Levy and M. Feres), for the most outstanding scientific manuscript having direct clinical relevance and application to the practice of Periodontics in a given year, 2003.

    Recipient, Henry Russel, Jr. Faculty Award for Excellence in Research and Teaching, University of Michigan, 2003. (Awarded to outstanding Jr. faculty member in University of Michigan System).

    Member of Best Dentists in America, 2003.

    Ex. 33, page 7

  • Co-Recipient, American Academy of Periodontology, R. Earl Robinson Periodontal Regeneration Award (with co-authors C. Lee, M. Tomala, K. Tejeda, Z. Zhu), for the peer-reviewed published paper that has contributed most to the knowledge of periodontal regeneration in a given year. September 2002.

    Tenure, University of Michigan School of Dentistry, 2002. Anthony Rizzo Periodontal Research Award, International Association of Dental Research, San

    Diego, California, March, 2002. Charles Finley Visiting Scholar, American Periodontology Foundation (Univ. at Stony Brook,

    New York), October 2001. Recipient of Roger Hill Friend of the Profession Award, Michigan Dental Hygienists

    Association, October 2001. First Prize, Research Forum, Seventh International Symposium on Periodontics and Restorative

    Dentistry, Boston, Massachusetts, June 2001. Bud and Linda Tarrson Career Development Award, American Periodontal Foundation,

    September 1998. Junior Investigator Travel Award, Gordon Research Conference, July 1997. Recipient, Miyahara Clinical Research Prize, Federal Dentaire International, International

    Association of Dental Research, March 1997. James Shaw Award for Excellence in Biomedical Research, Harvard School of Dental Medicine,

    June, 1997. Young Investigator Fellowship, American Academy of Periodontology, 1997. First Prize, Balint Orban Memorial Program, American Academy of Periodontology, New York,

    New York, September, 1995. Young Investigator Travel Award, International Association for Dental Research Meeting,

    Seattle, Washington, March 1994. First Prize, American Association for Dental Research/Dentsply Research Competition,

    Acapulco, Mexico, April 1991. Student of the Year Award, University of Missouri School of Dentistry, 1991. Recipient, Quintessence International Award for Research Achievement, University of Missouri

    School of Dentistry, May 1991. Recipient, Pierre Fauchard Pierre Academy Award, May, 1991. Omicron Kappa Upsilon, Rho Chapter, University of Missouri School of Dentistry, May 1991. Finalist, American Dental Association Student Clinician Competition, ADA Meeting, Boston,

    Massachusetts. October, 1990. Student of the Year, University of Missouri School of Dentistry, May 1990. Chancellor’s Research Assistantship, Department of Oral Biology, UMKC School of Dentistry,

    1990. Omicron Delta Kappa, Honorary Leadership Fraternity, University of Missouri, 1990. Recipient, American Association of Dental Schools Preventive Dentistry Award, 1990. Awardee, NIH/NIDCR Bloc Travel Grant, Dublin, Ireland, 1989. American Association for Dental Research Fellowship, 1989. NIH/NIDCR Predoctoral Fellow, Bone Research Branch, Bethesda, Maryland, 1988. University of Missouri Curator’s Scholar, 1983-87. STUDENT AWARDS

    Ex. 33, page 8

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  • MARJORIE K. JEFFCOAT CURRICULUM VITAE

    Received 3/3/2014

    PERSONAL INFORMATION

    Name: Marjorie K. Jeffcoat Marital Status: Home Address: Office Address: University of Pennsylvania School of Dental Medicine The Robert Schattner Center 240 S. 40th Street Philadelphia, PA 19104-6030 Tel. (215) 898-8941 Fax (215) 573-4075

    LICENSURE

    Massachusetts Connecticut, New Hampshire, New Jersey, New York, District of Columbia (1981) Alabama Pennsylvania

    EDUCATION

    Massachusetts Institute of Technology, SB, Harvard School of Dental Medicine, DMD (magna), Harvard School of Dental Medicine, Certificate, University of Pennsylvania MA (hon),

    POSTDOCTORAL TRAINING

    Research Fellow in Periodontology, Periodontology Certificate, Harvard School of Dental Medicine, 7/1975-6/1978 Medical Foundation Fellow in Radiology and Nuclear Medicine, Harvard Medical School and School of Dental Medicine, 7/1979-6/1981

    ACADEMIC APPOINTMENTS

    Instructor in Periodontology, Harvard School of Dental Medicine, 7/1978-6/1979 Assistant Professor of Periodontology, Harvard School of Dental Medicine, 7/1979-6/1985 Associate Professor of Periodontology, Harvard School of Dental Medicine, 7/1985-12/1987 Professor and Chairman, Department of Periodontics, University of Alabama at Birmingham (UAB) School of Dentistry, 1/1988-6/2003 Professor, Department of Biomedical Engineering, UAB, (Secondary Appointment) 7/1991-6/2003 James Rosen Endowed Chair of Dental Research, 7/1991-6/2003 Interim Chair, Department of Oral Biology, 7/1998-6/2000 Assistant Dean for Research, 7/1998-6/2003

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    Ex. 33, page 9

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  • Ex. 33, page 10

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  • Ex. 33, page 11

  • Ex. 33, page 12

  • EXHIBIT Declaration of Rachel Clattenburg

    Public Citizen v. FDA et al., 16-cv-781

  • Jayne S. Weiss, M.D.

    June 2014

    Curriculum Vitae

    Jayne S. Weiss, M.D. Addresses: Office: Department of Ophthalmology LSU Health Sciences Center 2020 Gravier Street, Suite B New Orleans, Louisiana 70112 Phone Number: 504-568-3156 Fax: 504-568-2385 Email Address: [email protected] Personal Information:

    Education: • B.A. (Biology) Summa cum Laude, State University of New York at Buffalo, • MD, Alpha Omega Alpha, Mt. Sinai School of Medicine, New York, NY, 1979 Residency Training: • Internal Medicine, Beth Israel Medical Center, New York, NY, • Ophthalmology, Bascom Palmer Eye Institute, University of Miami, Miami, FL, Fellowship Training: • Ocular Pathology, Howe Laboratory, Massachusetts Eye & Ear Infirmary, Harvard Medical School, Boston, MA, • Corneal & External Eye Diseases, Emory University, Atlanta, GA, Certification and Licensure: Certification: • Diplomate, American Board of Ophthalmology: Licensure: • New York, Inactive • Florida, Active • Georgia, Inactive • California, Inactive • Massachusetts, Inactive • Zimbabwe, Inactive • Michigan, Inactive • Louisiana, Active

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    Ex. 34, page 1

  • EXHIBIT Declaration of Rachel Clattenburg

    Public Citizen v. FDA et al., 16-cv-781

  • Ex. 35, page 1

  • NAME Maureen A. Finnegan, M.D., F.R.C.S.(C) ADDRESS Department of Orthopaedic Surgery

    U.T. Southwestern Medical Center 1801 Inwood Road Dallas, Texas USA 75390-8883 (214) 645-3342

    OCCUPATION Orthopaedic Surgeon _ _ _ _ _ ACADEMIC CAREER

    Undergraduate (Biochemistry), University of British Columbia

    M.D., University of British Columbia

    Rotating Intern, St. Mary's Hospital (McGill), Montreal

    R-I, Surgery, Ottawa Civic Hospital, University of Ottawa, Ontario 1976-77 R-II, Surgery, Children's Hospital Medical Center (Harvard), Boston,

    Massachusetts 1977-80 R-II to R-IV, Orthopaedic Surgery, University of Ottawa, Ontario 1980-Present F.R.C.S.(C), Orthopaedic Surgery 1980-81 Clinical Fellow, Department of Orthopaedics, Ottawa General Hospital,

    Ontario 1981-2001 License, College of Physicians and Surgeons of Ontario 1981-82 Research Fellowship, Medical Research Council of Canada (six months at

    the University of Ottawa and six months at the Swiss Research Institute, Davos, Switzerland)

    1985-Present Diplomate, American Board of Orthopaedic Surgery

    Certificate issued July 19, 1985

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    Ex. 35, page 2

  • EXHIBIT Declaration of Rachel Clattenburg

    Public Citizen v. FDA et al., 16-cv-781

  • Curriculum Vitae—Andrew J.W. Huang, M.D., M.P.H. Citizenship: Address: (Office) Department of Ophthalmology and Visual Sciences

    Washington University School of Medicine 660 South Euclid Avenue, Campus Box 8096 St. Louis, MO 63110 USA Telephone 314-362-3937 Fax 314-362-0627 E-mail [email protected]

    Present Position: Professor of Ophthalmology and Visual Sciences Director of Cornea Lab

    Washington University School of Medicine St. Louis, Missouri

    Education: Graduate

    MD, National Taiwan University School of Medicine, Taipei, Taiwan MPH, Johns Hopkins University School of Hygiene and Public Health,

    Baltimore, Maryland Postdoctoral Training

    Research Fellow, Department of Dermatology, Johns Hopkins University School of Medicine, Baltimore, Maryland

    Postdoctoral Fellow, Division of Biophysics, Johns Hopkins University School of Hygiene and Public Health, Baltimore, Maryland

    Research Fellow, Department of Ophthalmology, Harvard Medical School, Research Associate, Eye Research Institute of Retina Foundation, Boston, Massachusetts

    Research Fellow, Department of Ophthalmology, Bascom Palmer Eye Institute, University of Miami, Miami, Florida

    Resident in Ophthalmology, Bascom Palmer Eye Institute, University of Miami, Miami, Florida

    Clinical Fellow in Cornea and External Disease, Bascom Palmer Eye Institute, University of Miami, Miami, Florida

    Academic Positions/Employment: 1991-97 Assistant Professor of Ophthalmology

    Bascom Palmer Eye Institute, University of Miami, Miami, Florida 1997-00 Associate Professor of Ophthalmology

    Bascom Palmer Eye Institute, University of Miami, Miami, Florida 2000-05 Associate Professor of Ophthalmology

    University of Minnesota, Minneapolis, Minnesota 2005-07 Professor of Ophthalmology, University of Minnesota, Minneapolis,

    Minnesota

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    Ex. 36, page 1

  • Ex. 36, page 2

  • 6/30/2016 Andrew J. W. Huang, MD, MPH

    http://ophthalmology.wustl.edu/Faculty/Huang_A.aspx 1/2

    Ophthalmology & Visual Sciences

    Find a Physician

    Patient Portal

    Make a Gift

    HOME ABOUT US EDUCATION RESEARCH PATIENT CARE PHILANTHROPY FACULTY ALUMNI NEWSMAKERS

    Andrew J. W. Huang, MD, MPHProfessor,  Ophthalmology and Visual  Sciences

    Off ice Phone:   (314) 3620403 Pat ients  Seen At :   (314) 3623937

    Fax:   (314) 3623725

    Email:  HuangA@vis ion.wust l.edu

    Click  here  for Dr.  Huang  lab webs ite

    EducationMedica l  Degree: School  o f Medicine, National  Ta iwan Universi ty, Ta ipe i , Ta iwan, 1981MPH: School  o f Hygiene and Publ ic Heal th , Johns Hopkins Universi ty, Bal timore, Maryland, 1982

    TrainingResidency: Ophthalmology, Bascom Palmer Eye Insti tu te , Universi ty o f Miami , Miami , Florida, 1990Fel lowship: Cornea and External  Disease Service, Bascom Palmer Eye Insti tu te , Universi ty o f Miami , Miami , Florida, 1991

    Licensure and Board Certi且 cationOphthalmology  Certi fiedState of Florida (ME 054917), 1989State of Cal i forn ia  (A052029), 1992State of Minnesota (42658), 2000State of Missouri  (24440), 2007State of Il l ino is (036.119197), 2007

    Honors and AwardsDean’s L ist and Book Coupon Scholarsh ip , National  Ta iwan Universi ty, 197481Best In tern Award, National  Ta iwan Universi ty Hospi ta l , 1981Graduation wi th  Honors, School  o f Hygiene and Publ ic Heal th , Johns Hopkins Universi ty, Bal timore, Maryland, 1982NEIARVO Travel  Fe l lowship, 1986Pharmacia Travel  Fe l lowship, 1986Professor o f theYear, Bascom Palmer Eye Insti tu te , 1992, 2000Honor Award, American Academy of Ophthalmology, 1997Lyon Professor o f Ophthalmology, Universi ty o f Minnesota, Minneapol is, 2000Best Facul ty Teaching Award, Department o f Ophthalmology, Universi ty o f Minnesota, Minneapol is, 2001, 2007Medica l  Facul ty Award, ORBIS In ternational , New York, New York, 2004Gold Medal , Eye Advance 2006, Mumbai , Ind ia , 2006US FDA Advisory Committee Service Award, Ophthalmic Devices Panel , 2009Senior Achievement Award, American Academy of Ophthalmology, 2010

    Selected Publications1. Han YP, Sim AJ, Vora SC, Huang AJ. A un ique TGFBI prote in  in  granular corneal  dystrophy types 1 and 2. Curr Eye Res. 2012 Nov;37(11):9906.

    2. Han YP, Sim AJ, Vora SC, Huang AJ. Unique TGFBI prote in  in  la ttice corneal  dystrophy. Invest Ophthalmol  Vis Sci . 2011 Oct 28;52(11):84016.

    3. Huang AJ, Brown JS, Boyko EJ, Moore EE, Scholes D, Wal ter LC, L in  F, Vi ttinghoff E, Fihn SD. Cl in ica l  sign i ficance of postvo id  residual  vo lume ino lder ambulatory women. J Am Geria tr Soc. 2011 Aug;59(8):14528.

    4. Pate l  DA, Harocopos GJ, Chang SH, Vora SC, Lubniewski  AJ, Huang AJ. Novel  CHST6 gene mutations in  2  unre la ted cases of macular cornealdystrophy. Cornea. 2011 Jun;30(6):6649.

    5. Pate l  DA, Chang SH, Harocopos GJ, Vora SC, Thang DH, Huang AJ. Granular and la ttice deposi ts in  corneal  dystrophy caused by R124C mutationof TGFBIp. Cornea. 2010 Nov;29(11):121522.

    Ex. 36, page 3

    http://ophthalmology.wustl.edu/http://medschool.wustl.edu/http://ophthalmology.wustl.edu/PatientCarehttps://wuphysicians.followmyhealth.com/Login/Home/Index?authproviders=0&returnArea=PatientAccess#/Optionshttp://medicine.wustl.edu/giving/http://ophthalmology.wustl.edu/http://ophthalmology.wustl.edu/AboutUshttp://ophthalmology.wustl.edu/Educationhttp://vrcore.wustl.edu/http://ophthalmology.wustl.edu/PatientCarehttp://ophthalmology.wustl.edu/Philanthropyhttp://ophthalmology.wustl.edu/Facultyhttp://ophthalmology.wustl.edu/Alumnihttp://ophthalmology.wustl.edu/Newsmakersmailto:[email protected]://vrcore.wustl.edu/huang_andrew/LabHome.aspx

  • CURRICULUM VITAE

    Kuldev Singh, M.D., M.P.H. Professor of Ophthalmology Director, Glaucoma Service

    Stanford University School of Medicine Department of Ophthalmology

    2452 Watson Court Palo Alto, CA 94303

    Phone: Fax:

    E-mail:

    ______________________________________________________________ Personal Facts Birthplace: Birthdate: Citizenship: Spouse: Daughter: Education Master of Public Health, The Johns Hopkins University, School of Hygiene and Public Health, Department of Epidemiology, Baltimore, Maryland Doctor of Medicine, The Johns Hopkins University School of Medicine Baltimore, Maryland Bachelor of Science, McGill University, Montreal, Canada, Double major in Biology and Economics High School Diploma, Wheaton High School, Wheaton, Maryland

    Ex. 36, page 4

  • Postdoctoral Training: Fellow, Glaucoma Service, Bascom Palmer Eye Institute, Anne Bates Leach Eye Hospital University of Miami School of Medicine, Miami, Florida (

    Resident, Ophthalmology, Casey Eye Institute Oregon Health and Science University, Portland, Oregon ( )

    Intern, Department of Internal Medicine, Greater Baltimore Medical Center Baltimore, Maryland Eleanor Naylor Dana Charitable Trust Fellow in Preventive Ophthalmology Dana Center for Preventive Ophthalmology, Wilmer Eye Institute The Johns Hopkins University, Baltimore, Maryland ( ) Honors and Awards World Glaucoma Association Founder’s Award: one of two recipients of the 2013 award and the seventh recipient in the 10 year history of the Association Asian American Faculty Award, Stanford University: one of two recipients of university-wide award Glaucoma Speaker Award, Royal Hawaiian Eye Meeting Secretariat Award, American Academy of Ophthalmology Franklin G. Ebaugh Jr. Award for Advising Medical Students, Stanford University School of Medicine: sole recipient of medical school-wide award ( Secretariat Award, American Academy of Ophthalmology First Prize: Challenge Cup, American Society of Cataract and Refractive Surgery Annual Meeting Senior Achievement Award: American Academy of Ophthalmology Glaucoma Speaker Award, Royal Hawaiian Eye Meeting Achievement Award: American Academy of Ophthalmology Best Doctors in America Heed Ophthalmic Foundation Fellowship

    Ex. 36, page 5

  • Dana Fellowship, The Johns Hopkins University ( ) Graduation with Great Distinction, McGill University ( Faculty Scholar, McGill University ( James McGill Award, McGill University ( Professional Organizations:

    • American Academy of Ophthalmology • American Glaucoma Society • American Society of Cataract and Refractive Surgery • Association for Research in Vision and Ophthalmology • Bridgeport Glaucoma Society • International Council of Ophthalmology • Johns Hopkins Medical and Surgical Association • Pan American Glaucoma Society • Peninsula Eye Society • Unite for Sight • World Glaucoma Association

    Board Certification American Board of Ophthalmology, Initial Certification: Recertified: Recertified: Licensure California - Current: Oregon ( ) Academic Appointments Professor of Ophthalmology, Stanford University Stanford, CA (2003-present) Academic Advising Dean, Stanford University Stanford, CA (2002-2005) Associate Professor of Ophthalmology, Stanford University Stanford, CA (1998-2003)

    Ex. 36, page 6

  • Page 1 of 15

    Kuldev Singh, MDProfessor of Ophthalmology at the Stanford University Medical Center

    CLINICAL OFFICES

    • Stanford Byers Eye Institute

    2452 Watson Ct

    MC 5353

    Palo Alto, CA 94303

    Tel (650) 723-6995 Fax (650) 725-6619

    • Stanford Byers Eye Institute

    2452 Watson Ct

    MC 5353

    Palo Alto, CA 94303

    Tel (650) 723-6995 Fax

    ACADEMIC CONTACT INFORMATION

    • Personal Information

    Email [email protected]

    Tel (650) 725-5750

    Bio

    BIO

    Kuldev Singh is Professor of Ophthalmology and Director of the Glaucoma Service. He received his MD and MPH degrees from the Johns Hopkins University and

    was a Dana Foundation Fellow at the Wilmer Eye Institute, Johns Hopkins Hospital. Following residency training at the Casey Eye Institute and a Heed Foundation

    Fellowship at the Bascom Palmer Eye Institute, Dr. Singh joined the Stanford faculty in 1992. He has published over 300 papers, book chapters, monographs and

    abstracts including over 150 original peer-reviewed articles, delivered over 350 invited lectures on six continents, edited two textbooks and served on the editorial

    boards of ten ophthalmic publications. Dr. Singh’s current research interests include glaucoma and cataract surgical trials, epidemiology, genetics as well as health care

    delivery in underserved communities in the United States and overseas. He is an investigator in the National Institutes of Health funded NEI Glaucoma Human Genetics

    Collaboration. Dr. Singh's clinical practice focuses on the medical, laser and surgical management of glaucoma and cataract.

    Dr. Singh has served as President of the American Glaucoma Society and Executive Vice President, the chief executive position, of the World Glaucoma Association

    and continues to serve on the Board of Directors of both organizations. He serves on the Senior Advisory Committee of the International Society of Glaucoma Surgery.

    Dr. Singh is a member of the FDA Advisory Committee on Ophthalmic Devices and a consultant for the National Space Biomedical Research Institute for which he

    assists NASA in solving eye problems related to space travel. He received the 2015 Life Achievement Honor Award from the American Academy of Ophthalmology.

    Dr. Singh served as an Academic Advising Dean at the School of Medicine from 2002-2005 and two three year terms as an elected at-large member of the Faculty

    Senate from 2006-2012. He received the 2006 School of Medicine Franklin G. Ebaugh Jr. Award and was one of two recipients of the 2012 University-wide Asian

    American Faculty Award.

    Ex. 36, page 7

  • Kuldev Singh, MDhttp://cap.stanford.edu/profiles/Kuldev_Singh/

    Page 2 of 15

    Dr. Singh is one of seven individuals and the second American to have received the World Glaucoma Association Founder's Award, the biennially presented highest

    honor of the Association. In 2014, he was inducted into the Delta Omega Public Health Honor Society at the Johns Hopkins University Bloomberg School of Public

    Health as a distinguished alumnus. A global survey published in the April, 2014 issue of a U.K. based publication, The Ophthalmologist, ranked Dr. Singh as one of the

    100 most influential individuals in ophthalmology worldwide.

    CLINICAL FOCUS

    • Ophthalmology

    • cataract/glaucoma

    • cataract surgery

    • glaucoma surgery

    ACADEMIC APPOINTMENTS

    • Professor - Med Center Line, Ophthalmology

    • Member, Bio-X

    ADMINISTRATIVE APPOINTMENTS

    • President, American Glaucoma Society, (2013-2015)

    • Chair, Board of Directors, Glaucoma Research Foundation, (2009-2011)

    • Executive Vice President, World Glaucoma Association, (2008-2012)

    • Board of Governors, World Glaucoma Association, (2007-2017)

    • Academic Advising Dean, Stanford University School of Medicine, (2002-2005)

    • Residency Training Program Director, Department of Ophthalmology, Stanford University, (1993-1996)

    HONORS AND AWARDS

    • Life Achievement Honor Award, American Academy of Ophthalmology (2015)

    • Delta Omega Honor Society, The Johns Hopkins Bloomberg School of Public Health (2014)

    • Founder's Award, World Glaucoma Association (2013)

    • Asian American Faculty Award, Stanford University (2012)

    • First Prize, Challenge Cup, American Society of Cataract and Refractive Surgery (2006)

    • Franklin G. Ebaugh Jr. Award for Advising Medical Students, Stanford University School of Medicine (2006)

    • Senior Achievement Award, American Academy of Ophthalmology (2005)

    • Best Doctor, Best Doctors in America (1996-)

    • Heed Fellowship, The Heed Foundation (1991-92)

    • Eleanor Naylor Dana Charitable Trust Fellowship, Dana Foundation/Johns Hopkins University School of Medicine (1986-87)

    • James McGill Award, McGill University (1979)

    BOARDS, ADVISORY COMMITTEES, PROFESSIONAL ORGANIZATIONS

    • Consultant, National Space Biomedical Research Institute (2014 - present)

    • Standing Member, FDA Advisory Committee on Ophthalmic Devices (2014 - present)

    • Consultant, U.S. Food and Drug Administration (2011 - present)

    • Chair, Ethics Task Force, American Glaucoma Society (2011 - 2013)

    Ex. 36, page 8

  • Kuldev Singh, MDhttp://cap.stanford.edu/profiles/Kuldev_Singh/

    Page 3 of 15

    • Chair, Ophthalmic Technology Assessment Committee Glaucoma Panel, American Academy of Ophthalmology (2003 - 2009)

    • Associate Examiner, American Board of Ophthalmology (1998 - present)

    PROFESSIONAL EDUCATION

    • Fellowship: Johns Hopkins University (1987) MD

    • Board Certification: Ophthalmology, American Board of Ophthalmology (1992)

    • Fellowship: Bascom Palmer Eye Institute (1992) FL

    • Residency: Oregon Health Sciences Univ Hospital (1991) OR

    • Internship: Greater Baltimore Medical Ctr (1988) MD

    • Medical Education: Johns Hopkins University (1986) MD

    COMMUNITY AND INTERNATIONAL WORK

    • Adherence and Disease Severity, San Francisco General Hospital

    • Barriers to Glaucoma Care, Madurai, India

    • Antimetabolites and Glaucoma Surgery, Ghana

    Research & Scholarship

    CURRENT RESEARCH AND SCHOLARLY INTERESTS

    Glaucoma, clinical epidemiology

    Teaching

    STANFORD ADVISEES

    Postdoctoral Faculty Sponsor

    Don Nguyen

    Publications

    PUBLICATIONS

    • Effectiveness of Glaucoma Counseling on Rates of Follow-up and Glaucoma Knowledge in a South Indian Population AMERICAN JOURNAL OFOPHTHALMOLOGY

    Do, A. T., Pillai, M. R., Balakrishnan, V., Chang, R. T., Robin, A. L., Singh, K., Lee, B. W.

    2016; 163: 180-189

    • Factors Associated with Patient Press Ganey Satisfaction Scores for Ophthalmology Patients OPHTHALMOLOGYLong, C., Tsay, E. L., Jacobo, S. A., Popat, R., Singh, K., Chang, R. T.

    2016; 123 (2): 242-247

    • Special Commentary: Supporting Innovation for Safe and Effective Minimally Invasive Glaucoma Surgery: Summary of a Joint Meeting of the AmericanGlaucoma Society and the Food and Drug Administration, Washington, DC, February 26, 2014. Ophthalmology

    Caprioli, J., Kim, J. H., Friedman, D. S., Kiang, T., Moster, M. R., Parrish, R. K., Rorer, E. M., Samuelson, T., Tarver, M. E., Singh, K., Eydelman, M. B.

    2015; 122 (9): 1795-1801

    • The Effect of Phacoemulsification on Intraocular Pressure in Glaucoma Patients A Report by the American Academy ofOphthalmology OPHTHALMOLOGY

    Chen, P. P., Lin, S. C., Junk, A. K., Radhakrishnan, S., Singh, K., Chen, T. C.

    2015; 122 (7): 1294-1307

    • Self-reported Calcium Supplementation and Age-Related Macular Degeneration JAMA OPHTHALMOLOGYKakigi, C. L., Singh, K., Wang, S. Y., Enanoria, W. T., Lin, S. C.

    Ex. 36, page 9

  • EXHIBIT Declaration of Rachel Clattenburg

    Public Citizen v. FDA et al., 16-cv-781

  • Ex. 37, page 1

    rclattenburgTypewritten Text

    rclattenburgTypewritten Text

  • Specialty Certification and Licensure Diplomate in the specialty of Psychiatry - American Board of Psychiatry and Neurology -

    036811 - January 1993 Additional Qualifications in Addictions Psychiatry American Board of Psychiatry and Neurology

    – 875 -April 1996 Certification in Forensic Psychiatry American Board of Psychiatry and Neurology – 1008 - June

    1999 Maryland - License D39583 - expires 30 September 2014 Virginia - License 0101044824 - expires 30 April 2014 West Virginia - License 16049 - expires 30 June 2014 American Board of Psychiatry and Neurology Examiner – 2002 – 2003

    Career 1973 – 1977 1977-1983

    (b) (6)

    1991-1993 Chief of Addictions Medicine Services, Naval Hospital, Orlando, Florida 1992-1993 Chief of Mental Health Services, Naval Hospital, Orlando, Florida 1993-1998 On-Site Coordinator, Third Year Clerkship, Uniformed Services

    University of the Health Sciences 1993-1998 Addictions Medicine Consultant, Walter Reed Army Medical Center 1993-2007 Inpatient and Partial Hospital Attending Psychiatrist, Walter Reed Army

    Medical Center 1993-2007 Outpatient Psychiatrist, National Naval Medical Center 1998-2004 Director, National Capital Military Psychiatry Residency Program 1998-2007 Assistant Chairman (Graduate Medical Education), Department of

    Psychiatry, Uniformed Services University of the Health Sciences 2007-June 2008 Senior Scientific Advisor and Management Consultant to the Defense

    Center of Excellence for Psychological Health and Traumatic Brain Injury 2007-Present Private Practice in Forensic Psychiatry and Independent Consultant to the

    Department of Defense 2008-Present Staff Psychiatrist, Maryland Department of Health and Mental Hygiene,

    Thomas B. Finan Center, Cumberland, MD

    Operational Assignments/ Consultations: 1974 1975 1975

    (b) (6)

    2Additional Information at: http://www.griegermd.com

    Ex. 37, page 2

    http:http://www.griegermd.com

  • 1976

    1994

    1996

    1996

    (b) (6)

    1997 Peace Corps - Educational Consultant for Emergency Psychiatry in Overseas Locations – Gabarone, Botswana and San Pablo del Lago, Ecuador

    1999 Consultant to U.S Army European Command and Croatian Ministry of Defense on post-war psychiatric problems in Croatia – Zagreb and Crykvenica, Croatia, June 1999

    2001 Commanded Navy mental health assets (SPRINT) in response to the Pentagon attack (Operation Noble Eagle) Pentagon and Arlington Annex - September – October 2001

    2002 (b) (6)2003-2004 Consultant to Army G-1 Command on Psychiatric Manifestations and

    Management Following the 2001 Terrorist Attack on the Pentagon 2003-2007 Consultant to Walter Reed Psychiatry Department on Systematic Collection of

    Psychiatric and Behavioral Changes in Returning Soldiers Wounded in Combat 2007-2008 Executive consultant to the Center of Excellence for Post-Deployment

    Psychological Health and Traumatic Brain Injury, DoD Health Affairs 2013-present U.S. Food and Drug Administration Consultant for Aproval of

    Psychopharmacologic Medications

    Additional Consultations Navy Bureau of Medicine and Surgery / Surgeon General - Specialty Case Reviewer for Psychiatry - 1992 to Present Board for Correction of Naval Records - Specialty Reviewer for Psychiatry - 1992 to Present Naval Hospital, Jacksonville, FL - External Investigator for the Privileging Authority - November 1996 Naval Hospital Roosevelt Roads – External Investigator for Privileging Authority – June 2003

    Professional Societies American Psychiatric Association Member

    Distinguished Fellow 2005 - present Military District Branch (founding) President 1993 -1998 Assembly Representative 1999 - 2008 Treasurer 1998 – 2013 Nominated for election to Speaker of the Assembly 2004 Consultant on matters of detainee interrogations 2005-2006

    Alpha Omega Alpha Medical Honor Society Member

    3Additional Information at: http://www.griegermd.com

    Ex. 37, page 3

    http:http://www.griegermd.com

  • American Medical Association Member Consultant to the Council on Ethics and Judicial Affairs 2006

    American Academy of Psychiatry and the Law Member International Society of Traumatic Stress Studies Member

    Academic Appointments 1989-1993 Clinical Instructor of Psychiatry, Uniformed Services University of the

    Health Sciences 1993-1998 Assistant Professor of Psychiatry, Uniformed Services University of the

    Health Sciences 1998-2007 Associate Professor of Military and Emergency Medicine, Uniformed

    Services University of the Health Sciences 1998-2007 Associate Professor of Psychiatry, Uniformed Services University of the

    Health Sciences 2007-Present Professor of Psychiatry, Uniformed Services University of the Health

    Sciences 1993-2007 Faculty, National Capital Consortium Psychiatry Residency 2000-2007 Faculty, National Capital Consortium Forensic Psychiatry Fellowship

    Professional Honors and Recognition

    1993 (

    (b) (6)

    Navy and Marine Corps Commendation Medal - Naval Hospital Orlando 2002 Navy and Marine Corps Commendation Medal - National Naval Medical Center 1996 1990 2000 Joint Meritorious Unit Commendation - Uniformed Services University 1991 Meritorious Unit Commendation – National Naval Medical Center 1993 Meritorious Unit Commendation – Naval Hospital Orlando

    1976 2007 1998 2004 2000

    (b) (6)

    1992 2005 1996 1988 1989 1990 Bartholomew Hogan Award for Outstanding Research Paper Among Navy

    (b) (6)

    Psychiatry Residents 1991 Bartholomew Hogan Award for Outstanding Research Paper Among Navy

    Psychiatry Residents 1997 Nancy C.A. Roeske M.D., Certificate of Excellence in Medical Student

    Education, American Psychiatric Association 2001 Senior Resident Teacher of the Year and Residency Teacher of the Year 2002 LTGEN Chenault Award for Continuous Outstanding Contributions

    to Psychiatric Education and Research – with endowed cash award 2004 Senior Resident Teacher of the Year and Residency Teacher of the Year 2004 Who’s Who in Medical Sciences Education

    4Additional Information at: http://www.griegermd.com

    Ex. 37, page 4

    http:http://www.griegermd.com

  • Ex. 37, page 5

  • CURRICULUM VITAE16 September 2013

    Thomas A. Grieger, M.D., DFAPACaptain (retired), Medical Corps, United States Navy

    Professional Mailing Address PO Box 0047Falls Church, VA 22040-0047Telephone: 703.624.2496

    E-Mail: [email protected]://www.griegermd.com

    EducationB.S., School of Literature Science and the Arts, 30 April 1977The University of Michigan, Ann Arbor, Zoology, Distinction Honors

    Naval Supply Corps School – Basic Qualification Course, Athens, Georgia 1977

    Defense Logistics Agency Procurement Management Course, Fort Lee, Virginia, 1979

    M.D., F. Edward Hebert School of Medicine, Graduated 16 May 1987Uniformed Services University of the Health Sciences

    Psychiatry Categorical Internship, National Naval Medical Center, Bethesda, Maryland Graduated 30 June 1988

    Psychiatry Residency, National Naval Medical Center Graduated 30 June 1991

    Clinical Fellowship in Affective and Eating Disorders, Johns Hopkins School of Medicine October 1988 - January 1989

    Clinical Scientist Fellowship Uniformed Services University of the Health Sciences - October 1993 - October 1995

    Command and Staff Course (correspondence) Naval War College, Newport, RIFebruary 1997 - May 1998

    Additional Information at: http://www.griegermd.com1

    Ex. 37, page 6

    file:///C:/Users/griegerta/Desktop/DataFiles/Grieger_MD/[email protected]://www.griegermd.com/http://www.griegermd.com/rclattenburgTypewritten Text[Unredacted CV available online]

    rclattenburgTypewritten Text

    rclattenburgTypewritten Text

    rclattenburgTypewritten Text

  • Specialty Certification and LicensureDiplomate in the specialty of Psychiatry - American Board of Psychiatry and Neurology -

    036811 - January 1993Additional Qualifications in Addictions Psychiatry American Board of Psychiatry and Neurology

    – 875 -April 1996Certification in Forensic Psychiatry American Board of Psychiatry and Neurology – 1008 - June

    1999Maryland - License D39583 - expires 30 September 2014Virginia - License 0101044824 - expires 30 April 2014West Virginia - License 16049 - expires 30 June 2014American Board of Psychiatry and Neurology Examiner – 2002 – 2003

    Career1973 – 1977 Midshipman NROTC University of Michigan:1977-1983 Nuclear Propulsion Directorate, Naval Sea Systems Command (NAVSEA

    08) / Naval Nuclear Power Propulsion Program, United States Department of Energy (DOE) Duties: Prime Contract Manager and Subcontract Approval Officer for nuclear propulsion plant and reactor plant components; Budget Planner and Manager for nuclear fuel procurements (DOE), reactor plant components (Navy), and research and development funds (DOE and Navy) (SCN, OPN, O&MN, R&D funds); Shipbuilding Contracts Negotiator and Administrator (for nuclear propulsion plant aspects) - Los Angeles Class and Trident Class submarines and Nimitz Class aircraft carriers

    1991-1993 Chief of Addictions Medicine Services, Naval Hospital, Orlando, Florida1992-1993 Chief of Mental Health Services, Naval Hospital, Orlando, Florida1993-1998 On-Site Coordinator, Third Year Clerkship, Uniformed Services

    University of the Health Sciences1993-1998 Addictions Medicine Consultant, Walter Reed Army Medical Center1993-2007 Inpatient and Partial Hospital Attending Psychiatrist, Walter Reed Army

    Medical Center1993-2007 Outpatient Psychiatrist, National Naval Medical Center1998-2004 Director, National Capital Military Psychiatry Residency Program1998-2007 Assistant Chairman (Graduate Medical Education), Department of

    Psychiatry, Uniformed Services University of the Health Sciences2007-June 2008 Senior Scientific Advisor and Management Consultant to the Defense

    Center of Excellence for Psychological Health and Traumatic Brain Injury2007-Present Private Practice in Forensic Psychiatry and Independent Consultant to the

    Department of Defense2008-Present Staff Psychiatrist, Maryland Department of Health and Mental Hygiene,

    Thomas B. Finan Center, Cumberland, MD

    Operational Assignments/ Consultations:1974 USS Thomas C. Hart (FF1092) Guantanamo Bay, Cuba 1975 Naval Flight Indoctrination Course - Corpus Christi Texas 1975 Antisubmarine/Antiair Warfare Course - Charleston, South Carolina

    Undersea Warfare Course - Charleston, South Carolina

    Additional Information at: http://www.griegermd.com2

    Ex. 37, page 7

    http://www.griegermd.com/

  • Amphibious Warfare Operations and Small Squad Tactics Courses, Little Creek, Virginia

    1976 Polaris/Poseidon Strategic Patrol - USS George C. Marshall (SSBN 654) (Gold Crew)

    1994 On-Site Consultant to Air National Guard 171st Air Refueling Group following body recovery operations related to US Air Flight 427 crash - September 1994

    1996 Guantanamo Bay Cuba - Consultant to the Joint Task Force and Immigration and Naturalization Service regarding suitability of Cuban migrants for transport to the United States; January 1996, April 1996, and July-August 1996

    1996 Naval Medical Research Institute - Consultant to the team of divers involved in the salvage and body recovery operations after the crash of TWA Flight 800 - September 1996

    1997 Peace Corps - Educational Consultant for Emergency Psychiatry in Overseas Locations – Gabarone, Botswana and San Pablo del Lago, Ecuador

    1999 Consultant to U.S Army European Command and Croatian Ministry of Defense on post-war psychiatric problems in Croatia – Zagreb and Crykvenica, Croatia, June 1999

    2001 Commanded Navy mental health assets (SPRINT) in response to the Pentagon attack (Operation Noble Eagle) Pentagon and Arlington Annex - September – October 2001

    2002 Consultant to the South African Defense forces, Pretoria, RSA, April 20022003-2004 Consultant to Army G-1 Command on Psychiatric Manifestations and

    Management Following the 2001 Terrorist Attack on the Pentagon2003-2007 Consultant to Walter Reed Psychiatry Department on Systematic Collection of

    Psychiatric and Behavioral Changes in Returning Soldiers Wounded in Combat2007-2008 Executive consultant to the Center of Excellence for Post-Deployment

    Psychological Health and Traumatic Brain Injury, DoD Health Affairs2013-present U.S. Food and Drug Administration Consultant for Aproval of

    Psychopharmacologic Medications

    Additional ConsultationsNavy Bureau of Medicine and Surgery / Surgeon General - Specialty Case Reviewer for Psychiatry - 1992 to PresentBoard for Correction of Naval Records - Specialty Reviewer for Psychiatry - 1992 to PresentNaval Hospital, Jacksonville, FL - External Investigator for the Privileging Authority - November 1996Naval Hospital Roosevelt Roads – External Investigator for Privileging Authority – June 2003

    Professional SocietiesAmerican Psychiatric Association Member

    Distinguished Fellow 2005 - presentMilitary District Branch (founding) President 1993 -1998Assembly Representative 1999 - 2008Treasurer 1998 – 2013Nominated for election to Speaker of the Assembly 2004Consultant on matters of detainee interrogations 2005-2006

    Alpha Omega Alpha Medical Honor Society Member

    Additional Information at: http://www.griegermd.com3

    Ex. 37, page 8

    http://www.griegermd.com/

  • American Medical Association MemberConsultant to the Council on Ethics and Judicial Affairs 2006

    American Academy of Psychiatry and the Law MemberInternational Society of Traumatic Stress Studies Member

    Academic Appointments1989-1993 Clinical Instructor of Psychiatry, Uniformed Services University of the

    Health Sciences1993-1998 Assistant Professor of Psychiatry, Uniformed Services University of the

    Health Sciences1998-2007 Associate Professor of Military and Emergency Medicine, Uniformed

    Services University of the Health Sciences1998-2007 Associate Professor of Psychiatry, Uniformed Services University of the

    Health Sciences2007-Present Professor of Psychiatry, Uniformed Services University of the Health

    Sciences1993-2007 Faculty, National Capital Consortium Psychiatry Residency2000-2007 Faculty, National Capital Consortium Forensic Psychiatry Fellowship

    Professional Honors and Recognition1976 Polaris Poseidon Strategic Patrol Pin2007 Defense Superior Service Medal1998 Defense Meritorious Service Medal2004 Meritorious Service Medal2000 Joint Service Commendation Medal1993 Navy and Marine Corps Commendation Medal - Naval Hospital Orlando2002 Navy and Marine Corps Commendation Medal - National Naval Medical Center 1996 Joint Service Achievement Medal1990 Navy Achievement Medal2000 Joint Meritorious Unit Commendation - Uniformed Services University1991 Meritorious Unit Commendation – National Naval Medical Center1993 Meritorious Unit Commendation – Naval Hospital Orlando1992 National Defense Medal2005 Global War on Terrorism, Service Medal1996 Humanitarian Service Medal – JTF 160 – Guantanamo Bay Cuba1988 Marksmanship, Rifle, Expert1989 Marksmanship, Pistol, Expert1990 Bartholomew Hogan Award for Outstanding Research Paper Among Navy

    Psychiatry Residents1991 Bartholomew Hogan Award for Outstanding Research Paper Among Navy

    Psychiatry Residents1997 Nancy C.A. Roeske M.D., Certificate of Excellence in Medical Student

    Education, American Psychiatric Association2001 Senior Resident Teacher of the Year and Residency Teacher of the Year2002 LTGEN Chenault Award for Continuous Outstanding Contributions

    to Psychiatric Education and Research – with endowed cash award2004 Senior Resident Teacher of the Year and Residency Teacher of the Year2004 Who’s Who in Medical Sciences Education

    Additional Information at: http://www.griegermd.com4

    Ex. 37, page 9

    http://www.griegermd.com/

  • 2005 RADM James Sears Award for Excellence in Navy Psychiatry2005 Distinguished Fellow of the American Psychiatric Association2007 Consumers’ Research Council “Americas Top Psychiatrists”

    Editorial Review Boards2002-pres Reviewer - Psychiatry2004-pres Reviewer – Psychiatric Services2004-pres Reviewer – Annals of General Internal Medicine2005-pres Reviewer - Journal of the American Medical Association (JAMA)2005-pres Reviewer – Medical Care (Journal of the American Public Health Association)2006-pres Reviewer – American Journal of Psychiatry2006-pres Reviewer – Journal of Traumatic Stress2007-pres Reviewer – Canadian Medical Association Journal2007-pres Reviewer – Journal of Psychosomatic ResearchCommittees1991-1993 Credentials Committee Chairman, Naval Hospital, Orlando1991-1993 Executive Committee of the Medical Staff, Naval Hospital, Orlando1991-1993 Pharmacy and Therapeutics Committee, Naval Hospital, Orlando1991-1993 Committee for Officer Recruitment and Retention, Naval Hospital, Orlando1991-1993 Committee for Bioethics and the Protection of Human Subjects, Naval Hospital,

    Orlando1994-2007 Continuing Health Education Committee, Uniformed Services University of the

    Health Sciences1995 Institutional Review Board, National Naval Medical Center1996 Committee on Military Billets, Uniformed Services University of the Health

    Sciences1996-2007 Institutional Review Board Uniformed Services University of the Health Sciences

    (Vice Chair)1996-1997 Curriculum Committee Chairman, National Capital Military Psychiatry Residency

    Program1996-2007 National Capital Military Psychiatry Residency Policy Committee1997 Committee on Military Medical Professionalism, Uniformed Services University

    of the Health Sciences1997-1998 Committee on Military Unique Curriculum for Psychiatry, Uniformed Services

    University of the Health Sciences (Chairman)1997-2002 Committee on Impaired Health Care Providers, Walter Reed Army Medical

    Center1998-2000 Chief of Naval Operations Code 931 committee to establish Navy/USMC doctrine

    on management of operational stress.199 -2001 Defense Medical Readiness Training Command committee on establishment of

    joint doctrine with regard to prevention, identification, and management of operational psychiatric conditions

    2001-2007 Senior Member - Navy Health Professional Scholarship Program Selection Board Team Four

    2007-2009 Chairman, Data Safety Monitoring Committee, VA Cooperative Study #504: Risperidone Treatment for Military Service Related Chronic Post Traumatic Stress Disorder.

    Additional Information at: http://www.griegermd.com5

    Ex. 37, page 10

    http://www.griegermd.com/rclattenburgTypewritten Text

  • Ex. 37, page 11

    rclattenburgTypewritten Text

  • Ex. 37, page 12

  • Patents (Inventor) US Patent # 5,492,907 Antipsychotic Composition and Method of Treatment (Assignee: US Dept HHS; Exclusive License to Potomac Pharma, Inc) US Patent #5,663,167 Antipsychotic Composition and Method of Treatment (Assignee: US Dept of HHS; Exclusive License to Potomac Pharma, Inc)

    Society Memberships: Fellow, American College of Neuropsychopharmacology Distinguished Life Fellow, American Psychiatric Association Phi Beta Kappa Board Certifications and Licensure 1974 Diplomate, National Board of Medical Examiners 1978 Diplomate, The American Board of Psychiatry and Neurology 1985 Examiner for Oral Examination 1990 Examiner for Oral Examination Medical License: State of Maryland State of Virginia District of Columbia Selected Honors and Appointments 1981, 1984 Participant in the Exchange of Visits of World Health Organization

    Investigators in Biologic Psychiatry 1982 A.E. Bennett Clinical Science Neuropsychiatric Research Award of the

    Society of Biological Psychiatry 1982 NIMH Consultant to the United States Secret Service 1982 1st Prize, Plotzitzko Award (West Germany), for Research in “Endogenous

    Psychosis ” 1984 2nd Prize, Best Journal Paper Award, Academy of Psychosomatic Medicine,

    for "Biologic Tests in Depression"

    (b) (6)

    Ex. 37, page 13

  • CURRICULAM VITAE

    DAVID PICKAR, M.D. Current Positions and Activities

    Private Practice of Psychiatry

    Clinical Neuropharmacology and General Psychiatry

    Academic Appointments Professor (Adjunct), Psychiatry, Johns Hopkins University, Baltimore, Maryland Professor (Adjunct), Psychiatry, Uniformed Services University of the Health Sciences, Bethesda, Maryland

    Forensic Psychiatry

    Consultation and Testimony for Civil and Criminal Matters including US Federal Court, DC Superior Court, Maryland Superior Court, Virginia Superior Court, Florida Superior Court, Consultant to Special Prosecutor US Dept of Justice

    Food And Drug Administration (FDA) Member, Advisory Board for Psychopharmacologic Drugs

    Founder and President, Gabriel Sciences, LLC

    Gabriel Sciences, LLC is a biopharmaceutical company whose mission is improved treatment for psychiatric illness.

    Grants PI for R43MH67351-01 (NIH SBIR Phase I): Genetic Screen for Antipsychotic Drug Response PI for R44MH67351-02 (NIH SBIR Phase II): Genetic Screen for Antipsychotic Drug Response Project Duration: 9/25/02-12/31/06 PI R44 MH081365-01, (NIH SBIR Phase I) Triple Re-Uptake Inhibitors: Potential Antidepressants Project Duration: 9/15/07 – 9/15/08)

    Ex. 37, page 14

    rclattenburgTypewritten Text

    rclattenburgTypewritten Text

    rclattenburgTypewritten Text[Unredacted CV available online]

    rclattenburgTypewritten Text

    rclattenburgTypewritten Text

  • David Pickar, MD Curriculum Vitae Page 3 of 32

    3

    Education and Training 1969 Bachelor of Arts

    Rutgers College, New Brunswick, NJ (Phi Beta Kappa) 1973 Medical Degree

    Yale University School of Medicine, New Haven, CT 1973-1974 Intern, Internal Medicine

    University of Kentucky Medical Center, Lexington, Ky 1974-1977 Resident in Psychiatry

    Department of Psychiatry, Yale University School of Medicine, New Haven, CT

    1977-1979 Clinical Associate, Clinical Neuropharmacology Branch, Intramural Research Program, National Institute of Mental Health

    Patents (Inventor) US Patent # 5,492,907 Antipsychotic Composition and Method of Treatment (Assignee: US Dept HHS; Exclusive License to Potomac Pharma, Inc) US Patent #5,663,167 Antipsychotic Composition and Method of Treatment (Assignee: US Dept of HHS; Exclusive License to Potomac Pharma, Inc) Military Service 1972 - 1973, 1977 - 1999 Captain 0-6 (Ret.), USPHS Society Memberships: Fellow, American College of Neuropsychopharmacology Distinguished Life Fellow, American Psychiatric Association Phi Beta Kappa Board Certifications and Licensure 1974 Diplomate, National Board of Medical Examiners 1978 Diplomate, The American Board of Psychiatry and Neurology

    Ex. 37, page 15

  • Ex. 37, page 16

  • BOARD CERTIFICATIONS 2009 Diplomate, American Board of Internal Medicine – Sleep Medicine 2006 Diplomate, American Board of Internal Medicine – Critical Care Medicine 2005 Diplomate, American Board of Sleep Medicine 2004, 2014 Diplomate, American Board of Internal Medicine – Pulmonary Medicine 2001, 2011 Diplomate, American Board of Internal Medicine SPECIALTY CERTIFICATIONS • Basic Life Support – Instructor • Advanced Cardiac Life Support –Instructor

    • Advanced Trauma Life Support –Instructor • Fundamentals of Critical Care Services - Instructor

    EDITORIAL ACTIVITIES 2012 – Present Editorial Board, Journal of Dental Sleep Medicine 2010 – Present Editorial Board, Sleep and Breathing 2008 – Present Editorial Board, Pulmonary Medicine, MedScape 2005 – Present Editorial Board, Critical Care Medicine, MedScape 2006 – 2009 Editorial Board, Emergency Medicine, MedScape 2010 – Present Peer Reviewer, Sleep and Breathing 2008 – Present Peer Reviewer, Annals of Internal Medicine 2008 – Present Peer Reviewer, American Journal of Respiratory and Critical Care Medicine 2007 – Present Peer Reviewer, Sleep 2007 – Present Peer Reviewer, European Respiratory Journal 2005 – Present Peer Reviewer, Archives of Internal Medicine and JAMA 2005 – Present Peer Reviewer, Journal of Clinical Sleep Medicine 2004 – Present Peer Reviewer, Chest 2003 – 2007 Peer Reviewer, Journal of Military Medicine MILITARY TRAINING and EDUCATION

    PROFESSIONAL SOCIETIES • American College of Physicians

    o Associate, 2000-2003; Member, 2003-2008; Fellow, 2008 o Meeting Chair, 2012

    • American College of Chest Physicians o Affiliate, 2002-2006; Member, 2006-2007; Fellow, 2007 o Steering Committee Member, 2006 – 2009 o Post Graduate Course Chair, 2007, 2008

    • American Thoracic Society o Section Chair, Terrorism and Disaster Medicine, 2005 – 2008 o Post Graduate Course Chair, 2006, 2007 o Symposium Chair, 2006, 2008 o Program Committee Member, Environmental and Occupational Health, 2008 – 2009

    • American Academy of Sleep Medicine o Member, 2004-2007; Fellow, 2007

    (b) (6)

    Ex. 37, page 17

    Exhibit 33 Giannobile CV (FDA website)Giannobile CV (released)Jeffcoat CV (FDA website)Jeffcoat CV (released)Weber CV (FDA redacted high school graduation year)Emens CV (FDA redacted high school graduation year)

    Exhibit 34Weiss CV

    Exhibit 35Finnegan CV

    Exhibit 36Huang CVHuang Faculty PageSingh CVSingh Faculty Page

    Exhibit 37 Grieger CV (redacted)Grieger CV (unredacted)Pickar CV (redacted)Pickar CV (unredacted)Lettieri CV