CURRICULUM VITAE
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`FRED DAVID LUBLIN, M.D.
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`September 28, 1946; Philadelphia, Pa.
`Barbara H. Swartz, June 11, 1969
`Children: Alex L.
`(Aug. 6, 1972)
` Derek M. (May 5, 1976)
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`U.S.A.
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`Corinne Goldsmith Dickinson Center
` for Multiple Sclerosis
`Department of Neurology
`Icahn School of Medicine at Mount Sinai
`5 East 98th Street; Box 1138
`New York, NY 10029-6574
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`(212) 241-6854
`(212) 423-0440
`fred.lublin@mssm.edu
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`40 East 94th Street; #4L
`New York, NY 10128
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`A.B. - June 1968, Temple University, Phila., Pa.
`M.D. - June 1972, Jefferson Medical College, Phila., Pa.
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`Internal Medicine, Bronx Municipal Hospital -
`Albert Einstein Medical Center, Bronx, N.Y.
`July 1, 1972 - June 30, 1973
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`Neurology, New York Hospital -
`Cornell Medical Center, N.Y., N.Y.
`July 1, 1973 - June 30, 1976
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`National Hospital for Nervous Diseases,
`Queen Square, London. April 10, 1972-
`May 29, 1972.
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`Born:
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`Citizenship:
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`Address:
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`FAX
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`Home
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`Education:
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`Professional Training:
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`Apotex v. Novartis
`IPR2017-00854
`NOVARTIS 2004
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`Academic Appointments:
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`Fred D. Lublin, M.D.
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`Instructor in Neurology,
`Cornell Medical College
`July 1, 1975 - June 30, 1976
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`Instructor in Neurology,
`Jefferson Medical College
`July 1, 1976 - June 30, 1978
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`Research Associate in Biochemistry
`(Immunology) Jefferson Medical College
`July 1, 1976 - June 30, 1978
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`Assistant Professor of Neurology,
`Jefferson Medical College of Thomas Jefferson University
`July 1, 1978 - June 30, 1982
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`Assistant Professor of Biochemistry,
`Jefferson Medical College of Thomas Jefferson University
`July 1, 1978 - June 30, 1983
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`Associate Professor of Neurology,
`Jefferson Medical College of Thomas Jefferson University
`July 1, 1982 - June 30, 1986
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`Associate Professor of Biochemistry & Molecular Biology
`Jefferson Medical College of Thomas Jefferson University
`July 1, 1983 - October 31, 1996
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`Professor of Neurology, Jefferson Medical
`College of Thomas Jefferson University
`July 1, 1986 - October 31, 1996
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`Director, Division of Neuroimmunology,
`Department of Neurology, Jefferson Medical College
`of Thomas Jefferson University
`January 1, 1987 (inception) - October 31, 1996
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`Vice-Chairman, Department of Neurology
`Jefferson Medical College of Thomas Jefferson University
`June 1, 1987 - June 30, 1995
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`Member, The Jefferson Cancer Center of the
`Jefferson Cancer Institute, Jan. 1994 - October 31, 1996
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`

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`Fred D. Lublin, M.D.
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`Acting Chairman, Department of Neurology
`Jefferson Medical College of Thomas Jefferson
`University, July 1, 1995- June 30, 1996
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`Professor of Neurology, MCP Hahnemann University
`(formerly Allegheny University of the Health
`Sciences), November 1, 1996 – April 30, 2000
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`Vice-Chairman for Clinical Affairs, Neurology
`MCP Hahnemann University (formerly Allegheny
`University of the Health Sciences), November 1, 1996
`- April 30, 2000
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`Director, Multiple Sclerosis Center at MCP
`Hahnemann University (formerly Allegheny
`University of the Health Sciences), November 1, 1996
`(inception) - April 30, 2000
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`Director, Neurological Clinical Trials Center of
`MCP Hahnemann University (formerly Allegheny
`University of the Health Sciences)
`November 1, 1996 (inception) - April 30, 2000
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`Member, Center for NeuroVirology and
`NeuroOncology, MCP Hahnemann University
`(formerly Allegheny University of the Health Sciences)
`November 1, 1996 – September 30, 1999
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`Professor of Neurology, Mount Sinai School of
`Medicine, April, 2000 – Present
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`Director, Corinne Goldsmith Dickinson Center
`For Multiple Sclerosis, Mount Sinai School of
`Medicine, April 1, 2000 – Present
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`Saunders Family Professor of Neurology, Mount Sinai
`School of Medicine, September 2004 - Present
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`Assistant Neurologist - New York Hospital
`July 1, 1973 - June 30, 1975
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`Neurologist - New York Hospital
`July 1, 1975 - June 30, 1976
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`Hospital Appointments:
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`Fred D. Lublin, M.D.
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`Attending Neurologist - Thomas Jefferson
`University Hospital, July 1, 1976 - October 31, 1996
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`Co-Director, Multiple Sclerosis Comprehensive
`Clinical Center, Thomas Jefferson University Hospital,
`November, 1984 (inception) - October 31, 1996
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`of
`Attending Neurologist, Medical College
`Pennsylvania Hospital; Hahnemann University
`Hospital (formerly Allegheny University Hospitals),
`November 1, 1996 – April 30, 2000
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`Neurology Chief of Service, Medical College of
`Pennsylvania Hospital (formerly Allegheny University
`Hospitals-MCP), November 1, 1996 - April 30, 2000
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`Attending Neurologist, Mount Sinai Medical
`Center, April, 2000 - Present
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`New York, 1973:
`Pennsylvania, 1976:
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`M.D. 116580
`M.D. 17745E
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`Diplomat, American Board of Medical Examiners, 1973
`Certified in Neurology - American Board of
`Psychiatry and Neurology, October 1977
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`Phi Eta Sigma National Honor Fraternity, 1965
`President's Scholar, 1968
`Magna Cum Laude, 1968
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`Lange Medical Publications Prize, 1969, 1970, 1971
`Roche Award, 1970
`Alpha Omega Alpha, 1971 (President)
`Henry M. Phillips Prize, 1972
`William Potter Memorial Prize, 1972
`Alumni Prize, 1972
`Summa Cum Laude, 1972
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`Teacher-Investigator Development Award-
`National Institute of Neurological and
`Communicative Disorders and Stroke.
`July 1, 1978.
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`Medical Licensure:
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`Certification:
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`Awards and Honors:
`Temple University:
`Honors
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`Jefferson Medical
`College Honors:
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`Professional Honors:
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`Page 5
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`Fred D. Lublin, M.D.
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`Established Investigator - National Multiple
`Sclerosis Society, June 1987.
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`Who's Who in Frontiers of Science and Technology
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`The Best Doctors in America: 1994-2016;
`Neurology: Infectious and Demyelinating Diseases
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`President, Philadelphia Neurological Society, 1991-92
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`Sally Harrington Goldwater Lecturer and Visiting
`Professor: Barrow Neurological Institute, Phoenix, AZ;
`March 1993
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`Chairman, Advisory Committee on Clinical Trials of
`New Drugs in Multiple Sclerosis; National Multiple
`Sclerosis Society, Jan. 1994- December 1999
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`Advisor, National Institute of Allergy and Infectious
`Diseases/NIH Advisory Council, Sept. 1994
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`Chairman, Professional/Clinical Advisory Committee,
`Delaware Valley Chapter, National Multiple Sclerosis
`Society, July 1995 – October 1999.
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`Milestone Award, National Multiple Sclerosis Society,
`Delaware Valley Chapter, November 1996
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`Hope Award, National Multiple Sclerosis Society,
`Delaware Valley Chapter, November 1, 1999
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`McEwan Visiting Professorship & Lecture in
`Neurology, Univ. of Toronto, November 11-12, 1999
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`Chairman, Research Programs Advisory Committee,
`National Multiple Sclerosis Society, Jan. 2000 – Jan.
`2004
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`Best Doctors: New York Magazine, 2000, 2001, 2002,
`2003, 2004, 2005, 2006, 2007, 2008, 2015
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`Attending of the Year Award, Mount Sinai Medical
`Center Neurology Residents, June 2001
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`Fred D. Lublin, M.D.
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`Teacher of the Year Award, Mount Sinai Medical Center
`Department of Neurology, June 2003
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`National Multiple Sclerosis Society Volunteer Hall of
`Fame, Nov. 2003
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`Fellow, American Academy of Neurology, July, 2004
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`Saunders Family Professor of Neurology, invested
`September, 2004
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`John N. Whitaker Lecture in MS- University of Alabama,
`Birmingham. April 3, 2007
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`MS Charcot Lecture, Embassy of France, Washington,
`DC. May 22, 2007
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`Chairman, Clinical Advisory Committee- New York City
`Chapter, National Multiple Sclerosis Society
`June 2008 – Dec 2014
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`Award of Appreciation for Outstanding Teaching, Mount
`Sinai Medical Center; Neurology Residents, June 2008
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`George A. Schumacher Lectureship (Inaugural) in
`Neurology, University of Vermont College of Medicine
`November 13, 2008
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`William S. Fields Lecturer, University of Texas Health
`Sciences Center at Houston, December 14, 2012
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`Award of Appreciation for Outstanding Academic
`Teaching, Mount Sinai Medical Center
`Neurology Residents, June 2013
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`American Neurological Association (Fellow, 2013)
`American Academy of Neurology (Fellow, July 2004)
`Assoc. for Research in Nervous and Mental Diseases
`Alpers Society for Clinical Neurology
`Research Group on Neuroimmunology of the
` World Federation of Neurology
`International Brain Research Organization
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`Page 6
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`Professional Organizations
` and Societies:
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`Page 7
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`Fred D. Lublin, M.D.
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`International Society of Neuroimmunology
`(charter member)
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`Philadelphia Neurological Society
` Second Vice-President, 1989 -1990
` First Vice-President, 1990 -1991
` President, 1991-1992
` Councillor, 1992-1995
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`Member, Medical Advisory Board,
`Myasthenia Gravis Foundation,
`Delaware Valley Chapter, 1982-1990
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`Member, Professional/Clinical Advisory Committee,
`Greater Delaware Valley Chapter,
`National Multiple Sclerosis Society, 1985-2000
`Vice-Chairman, 1/93 - 6/95
`Chairman, 7/95-10/99
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`Member, Committee on Drug Development,
`National Multiple Sclerosis Society, 1983-Present
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`Member, Advisory Committee on Clinical Trials of New
`Drugs in Multiple Sclerosis; National
`Multiple Sclerosis Society, 1987-Present;
`Chairman, Jan. 1994-December 1999
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`Chairman, Computer Database Committee,
`National Multiple Sclerosis Society, 1986-1997
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`Member, Advisory Committee on Health Care
`Delivery and Policy, National Multiple Sclerosis
`Society, 1992-1995; 1998-2001
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`Member, Medical Advisory Board, National Multiple
`Sclerosis Society, 1988-1991; 1993-2014
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`Member, Executive Committee of the Medical Advisory
`Board, National Multiple Sclerosis Society, 1988-
`2007, 2009 – Sep 2012
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`Member, International Medical Advisory Board,
`International Federation of Multiple Sclerosis Societies,
` (MSIF) 1988-Present
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`Page 8
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`Fred D. Lublin, M.D.
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`Member, Commission of European Communities
`Concerted Action in Multiple Sclerosis;
`European Charcot Foundation
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`Member, Working Group for American Academy of
`Neurology Quality Standards Subcommittee Guideline
`Project on Multiple Sclerosis, 1993 - 1996
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`Member, Research Programs Advisory Committee,
`National Multiple Sclerosis Society, Jan 1998- Jan. 2004
`Chairman Jan. 1, 2000 – Jan. 2004
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`Member, Multiple Sclerosis Council for Clinical Practice
`Guidelines, 1997- 2003
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`Member, U.S. Linomide MS Study Group Executive
`Committee, 1994-1998
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`Member, Berlex Laboratories Secondary Progressive
`MS Study Steering Committee, 1995-1996
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`Member, Teva Marion Partners Copaxone in Primary
`Progressive MS Study Advisory Committee,
`1997 - 2003
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`Coordinating Investigator, A Safety Trial of
`Adding COPAXONE (glatiramer acetate)
`Injections to Patients with Relapsing-Remitting
`Multiple Sclerosis (MS) receiving AVONEX
`(interferon beta-1a), (CombiRx) 1998-2002
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`Member, International MS Data Center Oversight
`Committee of
`the Sylvia Lawry Center
`for MS
`Research;
`International Federation of Multiple
`Sclerosis Societies; Vice-Chair Clinical Trials Working
`Group; 1999 – 2005
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`Member, Advisory Committee, Oral Copaxone in MS
`Clinical Trial. Teva, August 1999- 2003
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`Member, Board of Trustees, Greater Delaware Valley
`Chapter of the National MS Society
`November 1999- October 2002
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`Fred D. Lublin, M.D.
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`Member, IGIV-C in MS International Steering Committee
`Bayer, Nov. 2000 – 2007
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`Member, Clinical Advisory Committee- New York City
`Chapter, National Multiple Sclerosis Society
`July 2002 – Present.
`Chairman- June 2008 – Dec 2014
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`Deputy Medical Officer, National Multiple Sclerosis
`Society, July 2003 – Present
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`Member, National Board of Directors,
`National Multiple Sclerosis Society,
`Jan 2004 – July 2015
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`Executive Committee- MS-Core, 2004-2010
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`Chair, American Academy of Neurology Dystel Award
`Subcommittee, April 2005 – April 2009
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`Member, MSSM General Clinical Research Center
`Advisory Committee, October 2006 – Present
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`Member, Executive Committee of the Multiple
`Sclerosis
`International Federation
`International
`Medical & Scientific Board, 2007- 2013
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`Councilor, American Academy of Neurology MS
`Section Executive Committee, 2013 – 2016
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`Member, Board of Directors, MS Hope for a Cure
`Feb 2007 - present
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`Member, Board of Directors, New York City/Southern
`NY Chapter, NMSS, 2008-2014
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`Member, Neurological Disorders Program Project B
`Committee, National Institute of Neurological
`Disorders and Stroke, NIH, July 1, 1990 -June 30,
`1994
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`Member, Advisory Committee on Health Care
`Delivery and Policy, National Multiple Sclerosis
`Society, 1992-1995; 1998-2001
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`Page 9
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`Scientific Review Activities:
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`Fred D. Lublin, M.D.
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`Advisor, National Institute of Allergy and Infectious
`Diseases/NIH Advisory Council, Sept., 1995
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`Ad Hoc Reviewer for NIH, NSF, Veterans
`Administration, National Multiple Sclerosis Society,
`Canadian MS Society, Italian MS Society.
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`Chair, Mount Sinai School of Medicine Clinical Research
`Center Scientific Advisory Committee
`March 2010 – March 2015
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`Co-Chair, NINDS MS Common Data Elements Working
`Group, Sept 2010- Present
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`Member, NINDS Common Data Elements Steering
`Committee, 2010- present
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`World health Organization (WHO) Advisory Group for
`the Revision of ICD-10 Diseases of the Nervous System-
`Demyelinating Diseases Working Group, 2010
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`Chairman, Proof of Concept Clinical Trial Strategies
`Working Group of the International Progressive MS
`Collaborative Working Group; Jan 2012 - present
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`Multiple Sclerosis (inception 1995 - Aug 2011)
`Neurology (2004-2007)
`MS Update
`Neurology News
`Neura: Perspectives on CNS Disease Management
`Mount Sinai Journal of Medicine- 2007- 2013
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`Co-Chief Editor, Multiple Sclerosis and Related
`Disorders, Elsevier, 2011 (inception) - Present
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`Annals of Neurology, Neurology, Science, Brain,
`Laboratory Investigation, Journal of Neuroimmunology,
`Annals of Internal Medicine, Pediatrics, Journal of the
`Neurological Sciences, Clinical Therapeutics. Journal of
`NeuroVirology, Archives of Neurology, BioDrugs,
`Acta Neurologica Scandinavica
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`Examiner in Neurology, The American Board of
`Psychiatry and Neurology - 1986; 1993
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`Page 10
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`Editorial Boards:
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`Journal and Manuscript Review:
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`Professional Review:
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`Page 11
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`Research Grants:
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`Fred D. Lublin, M.D.
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`Pennsylvania Carrier Advisory Committee- PA Blue
`Shield Medicare; Neurology Representative, 1992-95
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`Dystel Award Subcommittee, American Academy of
`Neurology, May 2001 – April, 2009
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`Chair, Data Safety & Monitoring Board, Biogen-Idec
`Antegren Phase III Trials
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`Member, Data Safety & Monitoring Board, Novartis
`FTY720 Phase II trial
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`Member, Data Safety & Monitoring Board, Pfizer
`Ponezumab (PF-04360365), Phase I & II
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`Basic Research Support Grant- National
`Institutes of Health; Small Grants Program.
`F.D. Lublin, Principal Investigator.
`Investigation of Immunologic Reactivity of
`Lymphocytes Isolated from the Central
`Nervous System and Its Environs. November1,
`1976 - October 31, 1977
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`National Institute of Neurological and
`Communicative Disorders and Stroke (NINCDS):
`Teacher Investigator Development Award - F.D. Lublin.
`Studies of Cellular Immune Responses Within
`the CNS. July 1, 1978 - June 30, 1983
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`National Multiple Sclerosis Society Research
`Grant - F.D. Lublin, Principal Investigator.
`Studies of Delayed, Relapsing Experimental
`Allergic Encephalomyelitis in Mice.
`April 1, 1981 - January 31, 1985
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`National Multiple Sclerosis Society Research
`Grant - F.D. Lublin, Principal Investigator.
`NMSS-Industry Drug Screening Program.
`September 1, 1983 - September 30, 1993
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`National Multiple Sclerosis Society Research
`Grant - F.D. Lublin, Principal Investigator.
`Study of Brain Transplants in Genetic
`Analysis of EAE. July 1, 1985 - March 30, 1989
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`Page 12
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`Fred D. Lublin, M.D.
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`Triton Biosciences Inc. Research Study-
`F.D. Lublin, Co-Investigator. Double Blind
`Placebo Controlled Phase I Study to Evaluate
`the Safety of IFN-BSER Given Subcutaneously
`in Patients with Relapsing-Remitting
`Multiple Sclerosis. April, 1986 -March, 1993
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`National Multiple Sclerosis Society Research
`Grant - F.D. Lublin, Principal Investigator.
`Maintenance of a Colony of Recombinant Inbred
`Strains of Mice. October1, 1987 - September 30, 1988
`National Institutes of Health-NINCDS
`Research Grant - NS 23081. F.D. Lublin,
`Principal Investigator. Study of Brain
`Transplants in Genetic Analysis of EAE.
`July 1, 1986 - June 30, 1990
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`Triton Biosciences Inc/ Berlex Labs. Research Study-
`F.D. Lublin, Co-Investigator. Double Blind
`Placebo Controlled Phase III Study to
`Evaluate the Efficacy of IFN-BSER Given
`Subcutaneously in Patients with Relapsing-
`Remitting Multiple Sclerosis.
`July, 1988 - Dec, 1993
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`National Multiple Sclerosis Society Research
`Grant - F.D. Lublin, Principal Investigator.
`Study of Brain Transplants in Genetic
`Analysis of EAE. April 1, 1989 -
`September 30, 1992
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`National Multiple Sclerosis Society Grant -
`F.D. Lublin, Principal Investigator. Establishment
`of an MS COSTAR Computer Support Center.
`July 1, 1990 – Sep 30,1999
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`Athena Neurosciences/Bio-Pharm Clinical Services -
`F.D. Lublin, Principal Investigator.
`A Multi-Center, Double Blind, Randomized, Placebo
`Controlled Study
`to Assess
`the Efficacy and
`Tolerability of Tizanidine Tablets in Patients Suffering
`from Spasticity due to Multiple Sclerosis.
`Feb 1, 1992 - Jan 31, 1993
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`Page 13
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`Fred D. Lublin, M.D.
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`National Multiple Sclerosis Society Research Grant
`F.D. Lublin, Principal Investigator.
`Superantigen Modulation of the T Cell Response in
`EAE. April 1, 1992-Sep 30, 1993
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`Commonwealth of Pennsylvania- Legislative Initiative
`Grant- F.D. Lublin, Principal Investigator. Role of the
`Blood-Brain Barrier in Autoimmune Disease of the
`Brain. July 1, 1992 - June 30, 1993
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`Athena Neurosciences/Bio-Pharm Clinical Services -
`F.D. Lublin, Principal Investigator.
`A Multi-Center, Open-Label, Long Term Study to
`Evaluate the Safety of Tizanidine Tablets in Patients
`Suffering from Spasticity due to Multiple Sclerosis.
`Sep 1, 1992- Aug 31, 1996
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`National Multiple Sclerosis Society Research Grant
`F.D. Lublin, Principal Investigator.
`Cellular Localization of Genetic Susceptibility to EAE.
`April 1, 1993 - March 31, 1996
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`National Multiple Sclerosis Society
`Aaron Miller, Principal Investigator
`F.D. Lublin, Co-Investigator
`A Double-Blind, Randomized, Placebo-Controlled
`Trial of Influenza Immunization in Multiple Sclerosis.
`Sep. 23, 1993 - Sep. 22, 1994
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`National Multiple Sclerosis Society Research
`Grant - F.D. Lublin, Principal Investigator.
`Effects of Bee Venom on EAE.
`Nov. 1, 1994 – Sep. 30, 1999
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`Vespa Laboratories
`F.D. Lublin, Principal Investigator.
`Effects of Bee Venom on EAE.
`Nov. 1, 1994 – Sep. 30, 1999
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`Berlex Laboratories
`F.D. Lublin, Principal Investigator
`Phase II, Open Label, Randomized Study to Evaluate
`Masking Techniques in Patients with Multiple Sclerosis
`Receiving Betaseron Therapy.
`Jul. 14, 1994 - Jul. 13, 1995
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`Page 14
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`Fred D. Lublin, M.D.
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`Berlex Laboratories
`F.D. Lublin, Principal Investigator
`Betaseron Outcome Study- Six Month Analysis
`May 5, 1995 - May 4, 1999
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`The R.W. Johnson Pharmaceutical Research Institute
`F.D. Lublin, Co-Investigator
`Leustatin (Cladribine) Clinical Trial in Chronic, Non-
`Remitting, Progressive Multiple Sclerosis (Phase III)
`August 1994 - January 2001
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`Berlex Laboratories
`F.D. Lublin, Co-Investigator,
`Steering Committee Member
`Phase III, Double-Masked, Placebo-Controlled Study
`To Evaluate the Safety and Efficacy of Two Doses of
`Betaseron in Patients with Secondary Progressive
`Multiple Sclerosis. August 1995 - Oct. 1996
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`Pharmacia-Upjohn
`F.D. Lublin, Principal Investigator and Steering
`Committee Member.
`A Randomized, Double-Blind, Placebo-Controlled,
`Phase III Study of Roquinimex (Linomide) in Relapsing-
`Remitting and Secondary Progressive Multiple Sclerosis
`December 1995 - December 1998
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`Neurocrine Biosciences
`F.D. Lublin, Principal Investigator
`Double-Blind, Randomized, Placebo-Controlled
`Evaluation of the Safety, Tolerability, and
`Pharmacokinetics of NBI-5788 in Patients with Multiple
`Sclerosis. August 1996 - May 1999
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`NIH/NINDS
`Program Project: Viral Model for Tumor Pathogenesis
`In Brain. K. Khalili, Principal Investigator
`Project 3. Immunobiology of Viral-Induced Tumors in
`Experimental Animals
`F.D. Lublin, Project Leader
`September 30, 1996 - June 30, 1999
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`Fred D. Lublin, M.D.
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`ICOS Corporation
`F.D. Lublin, Principal Investigator (for all sites)
`Phase II Study of HU23F2G in Acute Exacerbations of
`Multiple Sclerosis
`November 1996 - January 1999
`
`Athena Neurosciences
`F.D. Lublin, Principal Investigator
`An Open-Label Study to Assess the Long-Term Safety
`of Zanaflex (Tizanidine HCL) in Patients Treated
`With 28 to 36 Mg/Day.
`Nov. 1997 - Mar. 1999
`
`Biogen, Inc.
`F.D. Lublin, Principal Investigator
`A randomized, Double-Blind, Placebo-Controlled Study
`To Evaluate the Efficacy of Avonex in the Treatment of
`Secondary Progressive Multiple Sclerosis (MS).
`March 1998- March 2001
`
`Biogen, Inc. & Teva Marion Partners
`F.D. Lublin, National Coordinator
`A Safety Trial of Adding Copaxone (Glatiramer
`Acetate)
`Injections
`to Patients with Relapsing-
`Remitting Multiple Sclerosis Receiving Avonex
`(Interferon β-1a) Therapy (CombiRx)
`January 1, 1999 – December 2000
`
`Teva Marion Partners
`F.D. Lublin, P.I.
`A Multi-National, Multi-Center, Double-Blind, Placebo
`Controlled Study to Evaluate the Efficacy, Tolerability
`and Safety of Glatiramer Acetate for Injection In Primary
`Progressive Multiple Sclerosis Patients.
`March 16, 1999 – December 31, 2002
`
`Teva Marion Partners
`F.D. Lublin, P.I
`in Treatment-Naïve and
`Copaxone Responsivity
`Interferon Non-Responders in MS.
`December 1, 2000 – July 2002
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`Page 16
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`Fred D. Lublin, M.D.
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`NIH/NINDS R21 NS41986
`F.D. Lublin, P.I.
`Combination Therapy in Multiple Sclerosis
`Clinical Trial Planning Grant
`July 1, 2001 – June 30, 2002
`
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`Pfizer
`A 12 Week, Multicenter, Randomized, Double-Blind,
`Placebo-Controlled Evaluation of the Efficacy and
`Safety of Donepezil Hydrochloride (E2020-A001-405)
`in the Treatment of Cognitive Impairment in Patients
`with Multiple Sclerosis
`F.D. Lublin, P.I.
`March 2001-March 2002
`
`Immunex/Amgen
`Registry to Evaluate Novantrone Effects in Worsening
`MS (RENEW): Prospective, Open-Label Tolerability
`and Safety Monitoring Study of Novantrone in a
`selected cohort of Multiple Sclerosis Patients
`F.D. Lublin, P.I.
`March 2001- 2005
`
`Biogen
`A Multicenter, Phase IV, Randomized, Open-Label
`Study to Compare the Efficacy of Two Therapies
`(Acetaminophen and Prednisone) in the Management
`of Flu-Like Symptoms Associated with AVONEX®
`(Interferon beta-1a) Treatment
`in Patients with
`Relapsing Multiple Sclerosis
`F.D. Lublin, P.I.
`May 2001-August 2002
`
`Wyeth-Ayerst
`Placebo-Controlled,
`Randomized, Double-Blind,
`Multiple Ascending Dose Safety, Tolerability, and
`Magnetic Resonance Imaging Study of J695 in
`Patients with Multiple Sclerosis
`F.D. Lublin, P.I. June 2001—July 2002
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`Page 17
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`Fred D. Lublin, M.D.
`
`Bristol Myers Squibb
`A Phase II, Randomized, Double-Blind, Placebo
`Controlled Study to Evaluate the Preliminary Efficacy,
`Pharmacokinetics and
`Immunogenicity of BMS-1
`88667 Administered to Subjects with Relapsing-
`Remitting Multiple Sclerosis
`F.D. Lublin, P.I.
`Sept 2001-Nov. 2003
`
`Immunex/Amgen
`An Open Label Study of the Safety and Efficacy of
`Combination Therapy with Mitoxantrone (Novantrone)
`and Either Interferon-b1a (Avonex) or Glatiramer
`Acetate
`F.D. Lublin, P.I.
`Sept 2001- 2005
`
`Serono
`A Randomized Multicenter, Parallel Group, Open-
`label Study Comparing
`the Tolerability of Rebif
`Injection with and without the use of Rebiject Mini in
`Relapsing-Remitting Multiple Sclerosis
`F.D. Lublin, P.I.
`November 2001- July 2002
`
`National Multiple Sclerosis Society
`Oral Megadose Corticosteroid Therapy of Acute
`Exacerbations in MS (OMEGA)
`F.D. Lublin, P.I.
`October 2002 – July, 2013
`
`Bayer
`Randomized, Double-blind, Placebo-Controlled Study
`to Compare the Effects of Different Dose Regimens of
`IGIV-Chromatography (IGIV-C), 10% Treatment on
`Relapses
`in Patients with Relapsing-Remitting
`Multiple Sclerosis
`F.D. Lublin, P.I.
`September 2002 – 2008
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`Page 18
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`Fred D. Lublin, M.D.
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`Acorda Therapeutics
`Double-Blind, Placebo-Controlled, 20-Week, Parallel
`Group Study to Evaluate Safety, Tolerability and
`Activity of Oral Fampridine-SR in Subjects with
`Multiple Sclerosis
`F.D. Lublin, P.I.
`November 2002 – 2008
`
`TEVA Neuroscience
`A Multi-Centered, Randomized, Two-Arm, Open
`Label Study to Evaluate the Safety, Tolerability, and
`Efficacy of Induction Treatment with Mitoxantrone
`(Novantrone®) Preceding Treatment with Glatiramer
`Acetate (Copaxone®) versus Chronic Treatment with
`Glatiramer Acetate Alone in Relapsing Forms of
`Multiple Sclerosis NC-100; 9/01/2002- 2007
`
`NIH/NINDS U01 NS045719
`Fred D. Lublin, PI
`Combination Therapy in Multiple Sclerosis
`Sep. 30, 2003 – Nov 30, 2008
`
`to
`
`Acorda Therapeutics
`MSF203 EXT- Open-Label Extension Study
`Evaluate the Safety, Tolerability and Activity of Oral
`Fampridine-SR in Subjects with Multiple Sclerosis
`who Participated in the MS-F203 Trial
`F.D. Lublin, P.I.
`09/01/2005-2009
`
`Acorda Therapeutics
`MSF204 - Double-Blind, Placebo-Controlled, 21-
`Week, Parallel Group Study to Evaluate Safety and
`Efficacy of Oral Fampridine-SR in Subjects with
`Multiple Sclerosis
`F.D. Lublin, P.I.
`3/01/2007-2009
`
`Acorda Therapeutics
`MSF204 EXT- Open-Label Extension Study
`Evaluate the Safety, Tolerability and Activity of Oral
`Fampridine-SR in Subjects with Multiple Sclerosis
`who Participated in the MS-F204 Trial
`F.D. Lublin, P.I.
`7/01/2007-2009
`
`to
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`

`

`Fred D. Lublin, M.D.
`
` Sanofi-Aventis
`An international, multi-center, randomized, double-
`blind, placebo-controlled, parallel-group study
`to
`evaluate the efficacy and safety of two-year treatment
`with teriflunomide 7 mg once daily and 14 mg once
`daily versus placebo in patients with a first clinical
`episode suggestive of multiple sclerosis. TOPIC
`Fred D. Lublin, Principal Investigator
`Feb, 2007 – Sep 2012
`
`New York State MS Consortium
`The Establishment of a Patient Registry and initiation
`of related projects of The New York State Multiple
`Sclerosis Consortium (NYSMSC)
`Fred D. Lublin, Principal Investigator
`Feb, 2006 –Dec, 2012
`
`NIH/NINDS U02 NS045719 (Lublin)
`Continuation of Combination Therapy in Multiple
`Sclerosis (CombiRx-Phase III)
`Fred D. Lublin, Principal Investigator
`12/01/2008-11/30/2014
`
`PDA-001
`Celgene Cellular Therapeutics
` A Phase 1B, Randomized, Placebo Controlled,
`Multiple Dose Study
`to Evaluate the Safety of
`Intravenous
`Infusion of Human Placenta-Derived
`Cells (PDA001) for the Treatment of Adults with
`Multiple Sclerosis
`Fred D. Lublin, Principal Investigator (Study & Site)
`Jan, 2011 – Sep, 2013
`
`NMSS
`Maintaining and Further Developing the CombiRx
`Participant Cohort at Study Sites
`Fred D. Lublin, Principal Investigator
`April 2012- June, 1014
`
`Teva Pharmaceuticals
`Laquinimod Disease Progression Planning Project
`Fred D. Lublin, Principal Investigator
`July, 2013 – June 2014
`
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`Page 20
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`Fred D. Lublin, M.D.
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`NMSS RG 5120A3/1 (Co-PI; Inglese)
`Multimodal Longitudinal Imaging in Progressive MS
`April 2014 - present
`
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`NMSS
`Institutional Clinician Training Award
`Fred D. Lublin, Principal Investigator
`July 2014 – Present
`
`Teva Neuroscience(Co-PI; Inglese, PI)
`Structural, Metabolic and Functional Characterization
`of Progressive MS at High and Ultra-high Field MRI
`January 2015 - Present
`
`International Progressive MS Alliance- NMSS
`Collaborative Network Award Planning Grant
`Fred D. Lublin, Principal Investigator
`October 2015 – October 2016
`Prospectively Defining Secondary Progressive MS
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`Page 21
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`
` BIBLIOGRAPHY
`
`Fred D. Lublin, M.D.
`
`
`ORIGINAL ARTICLES
`
`1.
`
`Duckett, S., Cracco, J., Lublin, F. and Scott, T. Electron Microscopical Diagnosis of
`Lipidosis with the Use of Rectal Biopsy. American Journal of Diseases of Children
`127:704-705, 1974.
`
`
`2.
`
`
`3.
`
`
`4.
`
`
`5.
`
`
`6.
`
`
`7.
`
`
`8.
`
`
`9.
`
`
`10.
`
`Lublin, F.D., Tsairis, P., Streletz, L.J., Chambers, R.A., Riker, W.F., Van Poznak, A. and
`Duckett, S.W. Myokymia and Impaired Muscular Relaxation With Continuous Motor
`Unit Activity. Journal of Neurology, Neurosurgery and Psychiatry 42:557-562, 1979.
`
`Lublin, F.D., and Maurer, P.H. Separation and Properties of Lymphocytes Obtained
`from the Central Nervous System. Journal of Clinical and Laboratory Immunology
`4:195-198, 1980.
`
`Lublin, F.D., Maurer, P.H., Berry R.G., and Tippett, D. Delayed, Relapsing
`Experimental Allergic Encephalomyelitis in Mice. Journal of Immunology 126:819-822,
`1981.
`
` Syringoencephalomyelia
`Berry, R.G., Chambers, R.A., and Lublin, F.D.
`(Syringocephalus). Journal of Neuropathology and Experimental Neurology 40:633-
`644, 1981.
`
`Lublin, F.D. Delayed Relapsing Experimental Allergic Encephalomyelitis in Mice, Role
`of Adjuvants and Pertussis Vaccine. Journal of the Neurological Sciences 57:105-110,
`1982.
`
`Check, J.H., Lublin, F.D., Mandel, M.D. Clomiphene as an Anticonvulsant Drug.
`Archives of Neurology 29:784, 1982.
`
`Bakri, Y.N., Lee, J.H., Lewis, G.C., Lublin, F.D., and Danoff, B. Meningeal
`Carcinomatosis Complicating Gynecologic Malignancies: A Literature Review and
`Report of a Case. Obstetrical and Gynecological Survey 37:10-16, 1982.
`
`Lublin, F.D., Tippett, D.L., and Maurer, P.H. Central Nervous System and Blood
`Lymphocytes in Experimental Allergic Encephalomyelitis. Journal of Clinical and
`Laboratory Immunology 10:139-142, 1983.
`
`Lublin, F.D. Role of Myelin Antigens in Murine Relapsing Experimental Allergic
`Encephalomyelitis. Journal of Clinical and Laboratory Immunology 13:179-182, 1984.
`
`
`11. Stoll, D.B., Lublin, F.D., Brodovsky, H., Laucius, J.F., Patchefsky, A., and Cooper, H.
`Association of Subacute Motor Neuronopathy with Thymoma. Cancer 54:770-772,
`1984.
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`

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`Page 22
`
`Fred D. Lublin, M.D.
`
`Lublin, F.D. Immunomodulation of Relapsing Experimental Allergic Encephalomyelitis.
`Neurology 34:1615-1617, 1984.
`
`Lublin, F.D. Adoptive Transfer of Murine Relapsing Experimental Allergic
`Encephalomyelitis. Annals of Neurology 17:188-190, 1985.
`
`
`
`
`
`Lublin, F.D. Relapsing Experimental Allergic Encephalomyelitis: An Autoimmune
`Model of Multiple Sclerosis. Springer Seminars in Immunopathology 8:197-208, 1985.
`
`
`
`12.
`
`
`13.
`
`
`14.
`
`
`15. Kim, S., Tuck, L.-L. Ho., Capagnoni, A., Barbarese, E., Knobler, R., Lublin, F.D.,
`Chanderkar, L., and Paik, W. Myelin basic protein-specific methylase 1 activity in
`shiverer mutant mouse brain. Journal of Neuroscience Research 16:357-365, 1986.
`
`
`16.
`
`Jabourian, Z., Lublin, F.D., Adler, A., Gonzales, C., Northrup, B., and Zwillenberg, D.
`Hydrocephalus in Kartagener's Syndrome. Ear, Nose, and Throat Journal 65:468-472,
`1986.
`
`
`17. Korngold, R., Feldman, A., Rorke, L., Lublin, F.D., and Doherty, P.C. Acute
`Experimental Allergic Encephalomyelitis in Radiation Bone Marrow Chimeras Between
`High and Low Susceptible Strains of Mice. Immunogenetics 24:309-315, 1986.
`
`
`18.
`
`Lublin, F.D., Knobler, R.L., Doherty, P.C., and Korngold, R. Relapsing Experimental
`Allergic Encephalomyelitis in Radiation Bone Marrow Chimeras Between High and Low
`Susceptible Strains of Mice. Clinical and Experimental Immunology 66:491-496, 1986.
`
`
`19. Goldowitz, D., Lublin, F.D., and Knobler, R.L. Brain Transplantation in the Study of Host
`Regulation of Susceptibility to Experimental Allergic Encephalomyelitis. Annals of the
`New York Academy of Sciences 495:707-7