`
`Daniel Richard Wynn, MD, FACN, FAASM
`
`Consultants in Neurology, Ltd.
`1535 Lake Cook Road
`Suite 601
`
`Northbrook, Illinois 60062
`Phone: 847/509-0270
`Fax: 847/509-0273
`Cellular : 847-744-1545
`
`Email: dwynnmcl@gmail.com
`
`Academic Degrees/Graduate Education
`
`Attended lngtjtgtion & Location
`
`Degree or Title
`
`Field Study
`
`1988
`
`1987
`
`Mayo Graduate School of Medicine
`Rochester, Minnesota
`
`Mayo Graduate School of Medicine
`Rochester. Minnesota
`
`Fellow
`
`Fellow
`
`Sleep Disorders/
`Polysomnography
`
`EEG
`
`I984-1987
`
`Mayo Graduate School of Medicine
`Rochester, Minnesota
`
`Rosidcnt/Fellow
`
`Neurology
`
`I983-I984
`
`Mayo Graduate School of Medicine
`Rochester, Minnesota
`
`Resident/Fellow
`
`Internal Medicine
`
`1979-1983
`
`I973-1977
`
`The Chicago Medical School
`North Chicago, Illinois
`
`Reed College
`Portland, Oregon
`
`M.D.
`
`B.A.
`
`Medicine
`
`Biology
`
`Certifications
`
`American Board of Psychiatry and Neurology, Board Certified in Neurology, 10/88, #31061
`American Board of Psychiatry and Neurology, Board Certified with Special Competence in Clinical
`Neurophysiology, 3/92, certificate # 222; recertified May 2003
`American Board of Clinical Neurophysiology, Fellow, Board Certified, Clinical Neurophysiology, FACN
`American Board of Electrodiagnostic Medicine, Fellow, Board Certified, EMG and Neuromuscular Disease, 9/90,
`#1434
`
`American Board of Sleep Disorders, Medicine, Fellow, Board Certified Accredited Clinical Polysomnographer,
`April 1989, FAASM
`American College of Fomnsic Examiners, Board Certified. 8/97
`National Board of Medical Examiners. Diplomats, Certificate #274967
`Atomic Energy Commission, #OP-3519, Docket #55-4714 —Nuclear Reactor Operator, 1974
`
`Page 1 of 29
`
`Biogen Exhibit 2047
`Coalition v. Biogen
`IPR2015—01993
`
`
`
`Licensure
`
`Primary MD -— 036-XXXXXX, Illinois
`State Controlled Substance - 336-XXXXXX, Illinois
`DEA licensure — active Class II-V
`Atomic Energy Commission, #OP-3159, Docket #55-4714 -— Nuclear Reactor Operator License
`(inactive)
`
`Hospital A fflliations
`
`Highland Park Hospital, NorthShorc University Healthsystern, Highland Park, Illinois
`Evanston Hospital, Northshore University Healthsystem, Evanston, Illinois
`Glenbrook Hospital, Northshore University Healthsystem, Glenvicw, Illinois
`Skokie Hospital, Northshore University HealthSystem, Skokie, Illinois
`Advocate Illinois Masonic Medical Center, Chicago, Illinois
`
`Professional Societies
`
`Alpha Omega Alpha Honor Medical Society
`American Academy of Clinical Neurophysiology
`American Academy of Neurology
`American Association of Neuromuscular and Electrodiagnostic Medicine
`American College of Forensic Examiners
`American Electroencephalographic Society
`American Epilepsy Society
`American Medical Association
`
`American Pain Society
`Chicago Medical Society
`Illinois State Medical Society
`Midwest Pain Society
`National Multiple Sclerosis Society
`
`Page 2 of 29
`
`
`
`Honors, Awards and Research
`
`Director, Clinical Research, Consultants in Neurology, Ltd.
`Director, Consultants in Neurology Multiple Sclerosis Center
`Member, Clinical Advisory Committee, National Multiple Sclerosis Society.
`Chicago—Orenter Illinois Chapter
`Board Member, National Multiple Sclerosis Society
`Member, Illinois Medical Advisory Board, Illinois Secretary of State, State of Illinois
`Director, Consultants in Neurology Sleep Disorders Laboratories
`Ad Hoc Reviewer: l-leadaclte, Journal Neuroscience, Ncurokehabilitation and Neural
`Repair
`
`Volunteer of the Year, National Multiple Sclerosis Society. Greater Illinois Chapter.
`
`Medical Director, The Chicago Wolves Professional Hockey Team
`
`Valedictorian, Multiple Sclerosis Leadership Award, Deloitte and Touche LLP and
`National Multiple Sclerosis Society, Greater Illinois Chapter, September 14, 2000
`Member, Electronic Media Committee, American Academy of Neurology
`Member, Electronic Media Committee, American Association of Elcctmdiagnostic
`Medicine
`
`Neurology Consultant, Ann Kiley Developmental Center, Waukegan, Illinois
`
`Committee Member, Physical Medicine and Rehabilitation Committee, Highland Park
`Hospital
`
`Medical Director, Lake Forest Hospital Sleep Disorders Center, Lake Forest, Illinois
`
`Medical Director, Headache Treatment Center, Pain Treatment Center, Lake Forest
`Hospital, Lake Forest, Illinois
`
`Immunology and Neuroepidemiology Research in Multiple Sclerosis, Departments of
`Neurology, Epidemiology and Laboratory Medicine. Mayo Clinic, Mayo Graduate
`School of Medicine, Rochester, Minnesota
`
`Class Salutatorian; class rank 2/135, graduating class of 1983. The Chicago Medical
`School, North Chicago, Illinois
`
`Alpha Omega Alpha Honor Medical Society
`Awarded Junior Year. The Chicago Medical School, North Chicago, Illinois
`
`Melvyn Leichtling Annual Oncology Research Award
`Scholarship for Immunology/Oncology Research, The University ofthe Health
`Sciences, The Chicago Medical School, Department of Obstetrics
`and Gynecology, Cook County Hospital, Chicago, Illinois
`
`Nuclear Reactor Operator, TRIGA Research Nuclear Reactor, Reed College,
`Portland, Oregon
`
`National Science Foundation Scholar, Toxicology,
`National Science Foundation Student Science 'lYaining Program, Luther College,
`Decorah, Iowa
`
`Present
`
`2006
`
`l 993 -2006
`
`2000
`
`1990-1995
`
`1988-1994
`
`I988-1990
`
`1983-1988
`
`1983
`
`1982
`
`1980
`
`I 974
`
`I971
`
`Page 3 of 29
`
`
`
`Selected Publications and Presentations
`
`1. Laflanke C, Wynn, D, McCague K, Barbato LM, I-lashmonay R, No Effect On Incidence Of Infection
`Afler Therapy Switch To Fingolimod, submitted this for The 27th Annual Meeting of the CMSC and the
`5 I11 Cooperative Meeting of the CMSC-ACTRIMS (CMSC) Meeting, Orland, Florida, May 2013 (in press).
`
`2.
`
`3.
`
`4.
`
`Schapiro R, Wynn D, Lissin D, AL—Sabbagh A, Jones E, Pike J, The burden of multiple sclerosis-related
`spasticity on indirect costs and requirement for nomprofessional care: results ofa crosS—sectional study in
`the USA. Presented at the 65"’ Annual Meeting of the American Academy of Neurology, San Diego, CA,
`March 2013, (in press).
`
`Schapiro R, Wynn D, Lissin D, AL-Sabbagh A, Jones E, PikeJ, Impact of spasticity on heallhcare resource
`utilisation: results of a cross-sectional study in the USA. Presented at the 65"‘ Annual Meeting of the
`American Academy of Neurology, San Diego, CA, March 20 I 3, (in press).
`
`Polman C, Bowen JD, Barl(hofF, Bates D, Wynn D, Sanders E, Wolf C, Morris DL, Vandendriossche A,
`Dudal’, WeinkaufB, Lynn F, Bennett B, CDP32322 manuscript (NCTYJ0484536): Randomized, Double-
`blind, Placebo-Controlled Phase 2 Trial of CDP323 in Multiple Sclerosis. PLOS ONE. In press
`
`5 . Wynn D, Cascione M, Agashivala N, Mcctage K, Pestrich L, Schofield L, Barbato L, Kim B, Reasons for
`switching first-line disease modifying therapies in multiple sclerosis. Baseline data from the trial to
`Evaluate Patient 0utComes, safety and tolerability of fingolimod (EPOC). Presented at the 28"‘ European
`Committee on the Treatment and Research in Multiple Sclerosis (ECTRJMS), Lyon, France, 2012.
`Multiple Sclerosis Journal 2012; 18: (54) 55-277.
`
`6. Cascione M, Wynn D, Agashivala N, McCage K, Pestrich L, Sehofield L, Kim B, Barbato’L. Sumlnry
`scores for patient-reported outcome measures in multiple sclerosis. Baseline data from the trial to Evaluate
`Patient OutComes, safety and tolerability of fmgolimod (EPOC). Presented at the 28"‘ European
`Committee on the Treatment and Research in Multiple Sclerosis (ECTRIMS), Lyon, France, 2012.
`Multiple Sclerosis Journal 2012; 18: (S4) 55-277.
`
`7. Wynn D, Shapiro R, Lissin D, AL-Sabbagh A, Jones E, Pike J, Onset of multiple sclerosis-related
`spasticity and its impact on health-related quality of life as measured by EQ-SD and HAQUAMS,
`Presented at the 28“ European Committee on the Treatment and Research in Multiple Sclerosis
`(ECTRIMS), Lyon, France, 2012. Multiple Sclerosis Joumal 2012; 18: (84) 55-277.
`
`8.
`
`9.
`
`Sehapiro R, Wynn D. Lissin D, AL-Sabbagh A, Jones E, Pike J, The burden of multiple sc|el'osis—related
`spastieity on indirect costs and requirement for non-professional care: results of a cross-sectional study in
`the USA, Presented at the 28"‘ European Committee on the Treatment and Research in Multiple Sclerosis
`(BCTRIMS), Lyon, France, 2012. Multiple Sclerosis Journal 2012; is: (s4) 55-277.
`
`Sehapiro R, Wynn D. Lissin D, AL-Sabbagh A, Jones E, Pike J, Impact of Spastieity on Healthcare
`Resource Utilization: Results of a Cross-Sectional Study in the USA, Presented at the 28"‘ European
`Committee on the Treatment and Research in Multiple Sclerosis (ECTRIMS), Lyon, France, 2012.
`Multiple Sclerosis Journal 2012; 18: (s4) 55-277
`
`10. Wynn D. McMillan S, Corslno A, Hepner A, Pseudobulbar Affect In MS: Evaluation of Baseline Patterns
`in a Double—Blind, Placebo-Controlled Study. Presented at The 6"‘ World Congress on Controversies in
`Neurology, Vienna, Austria, March ll, 2012
`
`Page 4 of 29
`
`
`
`Selected Publications and Presentations
`
`ll.
`
`I2.
`
`13.
`
`l5.
`
`17.
`
`18.
`
`20.
`
`Wynn D, McMillan S, Corsino A, Hepner A, Pseudobulbar Affect in MS: Baseline Intenelations in a
`Study CohorL Presented at the Forth Cooperative Meeting of the Consortium of Multiple Sclerosis Centers
`(CMSC) and Americas Committee for Treatment and Research in Multiple Sclerosis Meeting, San Diego,
`California, 2012
`
`M011 RW, McAuley E, Wynn D, SandroffB, Suh Y. Physical activity. self-efficacy, and health-related
`quality of life in persons with multiple sclerosis: analysis of associations between indivldua|—level changes
`over one year. Quality of life research: an international journal of quality of life aspects of treatment, care
`and rehabilitation 20] 2.
`
`Fox E, Wynn D. Cohan S, Rill D, McGuire D, Markowitz C. A randomized clinical trial of autologous T-
`cell therapy in multiple sclerosis: subset analysis and implications for trial design. Mult Scler 2012;18:843-
`852.
`
`Vollmer TL, Wynn DR, Alam MS, Valdes J. A phase 2, 24-week, randomized, placebo-controlled, double-
`blind study examining the efficacy and safety of an anti-interleukin-12 and -23 monoclonal antibody in
`patients with relapsing-remitting or secondary progressive multiple sclerosis. Mull Scler 20] l',l7: 181-191 .
`
`Motl RW, McAuley E, Wynn D, Vollmer T. Lifestyle physical activity and walking impainnent over time
`in relapsing-remitting multiple sclerosis: results from a panel study. Am J Phys Med Rehabil 201l;90:372
`
`Motl RW, McAu1ey E, Wynn D, Suh Y, Weikert M. Effects of change in fatigue and depression on
`physical activity over time in relapsing-remitting multiple sclerosis. Psychol Health Med 201 1:16: 1-1 1.
`
`Comi G, Cohen JA, Arnold DL, Wynn D, Filippi M. Phase III dose-comparison study of glatiramer acetate
`for multiple sclerosis. Ann Neunol 201 l;69:75—82.
`
`Colcs A], Fox E, Vladic A, Wynn D, et al. Alemtuzumab versus interferon beta—1a in early relapsing~
`remitting multiple sclerosis: post-hoc and subset analyses of clinical efiicacy outcomes. Lancet ‘Neurol
`201 l;lO:338~348.
`
`Wynn DR, Emerging Treatments for Pseudobulbar Affect, presented at the 4"‘ World Congress on
`Controversies in Neurology (CONy), Barcelona, Spain, October, 2010
`
`Kaye R, Hepner A, Wynn DR, Dextromethorphan/Quinidine for Pseudobulbar Affect: Bfficacy
`Evaluation in Patients Using Concomitant SSRIS, presented at the 4"‘ World Congress on Controversies in
`Neurology (CONy), Barcelona, Spain, October, 2010
`
`Wynn, D on behalf of the CAMMS223 Study Group, Disability-Free Efficacy. Presented at the 26"‘
`European Committee on the Treatment and Research in Multiple Sclerosis (ECTRIMS)/15'” Annual
`Conference of Rehabilitation in Multiple Sclerosis (RIMS), Gothenburg, Sweden, October, 2010
`
`Herbert, J, Wynn, D on behalf of the CAMMS223 Study Group. Alemtuzumab's efficacy in the
`CAMMS223 Trial as assessed with the multiple sclerosis severity score. Presented at the 26"‘ European
`Committee on the Treatment and Research in Multiple Sclerosis (ECTRIMS)/15"‘ Annual Conference of
`Rehabilitation in Multiple Sclerosis (RIMS), Gothenburg, Sweden, October, 2010
`
`Page 5 of 29
`
`
`
`Selected Publications and Presentations
`
`23.
`
`24.
`
`25.
`
`26.
`
`2'7.
`
`28.
`
`29.
`
`30.
`
`3!.
`
`32.
`
`33.
`
`Filippi M, Rocca MA, Perego E, Agosto F, Meani A, Bajenaru O, Carra. A, Elovaara l, Fazekas F, Hattung
`HP, Hillert J, King J, Komoly S, Lubetzki C, Montalban X. Myhr KM, Ravnborg M, Rieckmann P, Wynn
`D, Young C, Comi G, for the PreClSe study group. Benefit of early treatment with glatiramer acetate: MRI
`results from the 5-year prospectively planned follow up in patients with clinically isolated syndrome
`enrolled in the PreCISe study. Presented at the Late Breaking News, 26"‘ European Committee on the
`Treatment and Research in Multiple Sclerosis (ECTRJMS)/15"‘ Annual Conference of Rehabilitation in
`Multiple Sclerosis (RIMS), Gothenburg, Sweden, October l6, 2010
`
`Comi G, Martinelll , Rodegher M, Moiola L, Bajcnaru 0, Cam; A, Elovaara I, Fazekas F, Hartung HP,
`Hillert J, King I, Komoly S, Lubctzki C, Montalban X, Myht KM, Ravnborg M, Rieckmann P, Wynn D,
`Young C, Filippl M. for the PreClSe study group. Benefit of early treatment with glatiramer acetate
`(COPAXONE): Results from the 5-War prospectively planned follow up in patients with clinically isolated
`syndrome ii-om the PreCISe study. Presented at ECTRIMS, October, 2010
`
`Motl RW, McAuley E, Wynn I), Vollmcr T. Lifestyle physical activity and walking impairment over time
`in relapsing-remitting multiple sclerosis: results from a panel study. American journal of physical medicine
`& rehabilitation I Association ofAcadcmic Physiatrists 2011;90:372-379.
`
`Mot] RW, McAuley E, Wynn D, Suh Y, Weikert M. Effects of change in fatigue and depression on
`physical activity over time in relapsing-remitting multiple sclerosis. Psychology, health & medicine
`20] l;l6:l-I l.
`
`Volmer TL, Wynn DR, Alam S, Valdes J, A Phase 2, 24-Week, Randomized, Placebo-Controlled, Double-
`Blind Study Examining the Efficacy and Safety of an Anti-Interleukin-12 and -23 Monoclonal Antibody in
`Patients With Relapsing-Remitting or Secondary-Progressive Multiple Sclerosis. April, 2010
`
`Pioro E. Brooks B, Cummings J. Schiffer R, Wynn D, I-Iepncr A, Kaye R, on Behalf of the STAR Trial
`Investigators, Safety and Tolerability of Dextromethorphun/Quinidlne for Pseudobulbar Affect in a ]2—
`Week, Open—Label Extension Study. Presented at the American Academy of Neurology Meeting, Toronto,
`ON, Canada, April, 2010
`
`McGuire D, Fox E, Markowltz C, Cohen S, Wynn D, Rill D, Riser M, lnman 8, Safety and Efficacy of
`Autologous T-Cell Immunolherapy (Tovaxin) in Patients with Active Relapsing—Remitting Multiple
`Sclerosis. Presented at the American Acdemy of Neurology Meeting, Toronto, ON, Canada, April, 2010
`
`Polman C, Bowen J, Barkhof F, Bates D, Wynn D, Sanders E, Wolf C, Mon‘is T, Dudu P, Weinkauf'B,
`Lynn F, Bennett B, Double-Blind, Placebo-Controlled, Randomized Phase 11 Serial MRI, Safety and
`Tolerabillty Study ofTwo Doses of CDP323 in Subjects with Relapsing Fonns of Multiple Sclerosis over
`24 Weeks, Presented at the American Academy of Neurology Meeting, Toronto, ON, Canada, April, 2010
`
`Weikert M, RW, Suh Y, McAulcy E, Wynn D, Accelemmetiy in persons with multiple sclerosis:
`Measurement ofphysical activity or walking mobility, J Neurol Sci 20lO:290:6—l1
`
`Motl RW, McAuley E, Wynn D, Suh Y, Weikert M, Dlugonski D, Symptoms and Physical Activity
`Among Adults With Relapsing—Remitting Multiple Sclerosis, J Nerv Ment Dis 2010; 1 98: 213-219
`
`Giovannoni G, Comi G, Cook S, Rammohan K, Rieckmann P, Soelberg Sorensen P, Vermersch P, Chang
`P, I-lamlett A, Musch B, Grecnbcrg SJ; CLARITY Study Group, A placebo—controlled trial of oral
`cladribinc for relapsing multiple sclerosis. N Engl J Med. 2010 Feb 4;362(5):4l6-26. Epub 2010 Jan 20
`
`Page 6 of 29
`
`
`
`Selected Publications and Presentations
`
`34.
`
`35.
`
`36.
`
`Wynn D, Kaufman M, Montalban X, Vollmer 1'‘, Simon J, Elkins J, O'Neill G, Neyer L, Sheridan 1, Wang
`C, Fong A, Rose JW; CHOICE investigators. Daclizumab in active relapsing multiple sclerosis (CHOICE
`study): a phase 2, randomized, double-blind. placebo-controlled, add-on trial with interferon beta. Lancet
`Nourol. 2010 Apr;9(4):38 I-90. Epub 2010 Feb 15
`
`Weikert M, Suh Y, McAuley E, Wynn DR, Motl R, Measurement of Physical Activity Using
`Accelerometry in Multiple Sclerosis: Evidence of a Conundrum. Presented at the Consortium of MS
`Centers Meeting, Atlanta, Georgia, May 2009
`
`Motl RW, McAuleyE, Wynn D, Su11Y, Weikert M, Do Specific Symptoms Account for the Association
`Bewteen global Symptoms and Physical Activity in Relapsing-Remitting Multiple Sclerosis, Presented at
`the Consortium at‘MS Centers Meeting, Atlanta, Georgia, May 2009.
`
`Motl RW, McAuley E, Wynn D, Physical Activity Predicts Progression of Mobility Impairments in
`Multiple Sclerosis, Presented at the Consortium of MS Centers Meeting, Atlanta, Georgia, May 2009.
`
`Motl RW, McAuloy E, Wynn D, Suh Y, Weikcrtlvl, Fatigue and Depression are Independent Predictors of
`Naturally Occurring Changes in Physical Activity in Relapsing-Remitting Multiple Sclerosis, presented at
`the American Psychiatric Association Meeting, New Orleans, May, 2010.
`
`Weikert M, Motl RW, Suh Y, McAuley E, Wynn D. Aocelerometry in persons with multiple sclerosis:
`measurement of physical activity or walking mobility? J Neurol Sci 20l0;290:6-I l.
`
`Radue B-W, Stuart WH, Calabresi PA, Confavreux C, Galetta SL, Rudick RA, Lublin FD, Woinstoclc-
`Gunman B, Wynn DR, Fisher E, Papadopoulou A, Lynn F, Panzera MA, Sandrock AW, for the SENTINEL
`Investigators. Natalizumab plus interferon beta~la reduces lesion formation in relapsing multiple sclerosis.
`J Neurol Sci. 2010 May lS;292(l-2):28-35. Epub 2010 Mar 16
`
`37.
`
`38.
`
`39.
`
`40.
`
`41.
`
`42.
`
`43.
`
`Pioro EP, Brooks BR, Cummings J, Wynn D, et al. Dextromethorphan plus ultra low-dose quinidine
`reduces pseudobulbar affect. Ann Neurol 20 103581693-702.
`
`Brooks BR, Cumming J, Pioro E, Schiffer R, Wynn D, Hepner A, for the STAR Trial investigators, STAR
`Trial: Sub-Analysis of an Intomational, Multi-Center, Placebo-Controlled Study of AVP-923. Presented at
`the lntornatlonal Symposium on ALS/MND, Berlin, 2009
`
`Comi G, Martinelli V, Rodegher M, Moiola L, Bajenaru O, Carra A, Elovaara I, Fazekas F, I-lartung I-lP,
`Hlllert J, King J, Komoly S, Lubetzki C, Montalban X, Myhr KM, Ravnborg M, Rieckmann P, Wynn D,
`Young C, Filippi M; PreCISe study group, Effect of glatiramer acetate on conversion to clinically definite
`multiple sclerosis in patients with clinically isolated syndrome (PreCISe study): a randomized, double-
`bllnd, placebo—controlled trial. Lancet. 2009 Oct 3 l;3‘74(9700): l503—l 1. Epub 2009 Oct 6
`
`44.
`
`45.
`
`Wynn D, Bandari D, Miller T, Wray S, Bennett R, AL-Sabbagh A, Dangond F (on behalf of the RcbiQoL
`Study Group. Rebit‘ Quality of Life (RnbiQoL) Study: 12-Week Results in Patients with Relapsing Multiple
`Sclerosis. Presented at the 3" World Congress on Controversies in Neurology (CONy) Meeting, Prague,
`Czech Republic, October‘ 8-11, 2009.
`
`Brooks BR, Cummings l, Pioro E, Schiffer R, Wynn D, Kaye R, Hepner A, on behalf of the STAR Trial
`Investigators. Double—B1ind Placebo Controlled Study of AVP-923 for Pseudobulbar Afiect. Presented at
`the American Neurological Association Meeting, Baltimore, Maryland, October l 1-] 3, 2009.
`
`Page 7 of 29
`
`
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`Selected Publications and Presentations
`
`46.
`
`47.
`
`48.
`
`49.
`
`50.
`
`51.
`
`52.
`
`Wynn D, Schiffer R, Brooks BR, Picro E, Cummings J, I-lepner A, Kaye R on behalf of the STAR Trial
`Investigators. Double-Blind, Placebo-Controlled, Multinational Study of AVP-923 for Pseudobulbar Affect
`in MS. Presented at the 3"‘ World Congress on Controversies in Neurology (CONy) Meeting, Prague,
`Czech Republic, October 8-1 1, 2009.
`
`Wynn D on behalf of the CAMMS223 Study Group, Alemtuzumab Increases the Likelihood of Sustained
`Reduction in Disability, Independent of Baseline Demographic or Disease Characteristics, presented at
`European Conference on the Treatment and Research in Multiple Sclerosis (ECTRIMS), Dusseldorf,
`Germany, September 10-12, 2009.
`
`Hutchinson M, Kappos L, Calabresi PA, Confavreux C, Giovannoni G. Galena SL, Havrdova E, Lublin
`FD, Miller DH, O'Connor PW, Phillips JT, Polman CH, Rnduc EW, Rudick RA, Stuart WH, Wajgt A,
`Wynn DR, Lynn F, Panzara MA; AFFIRM and SENTJNEL Investigators. The efficacy of natalizumab in
`patients with relapsing multiple sclerosis: subgroup analyses of AFFLRM and SENTINEL. J Neurol. 2009
`Mar;256(3).'40S-15. Epub 2009 Mar is
`
`Apostol, G, Wynn D ct al, Safety and Tolerability of Divalproex Sodium Extended-Release in the
`Prophylaxis of Migraine Headaches: Results of an Open-Label Extension Trial in Adolescents, Headache.
`49(l):36-44, January 2009.
`
`Sosnoff J, Moll RW, Snook EM, Wynn D. Effect of a 4-week period of unloaded leg cycling exercise on
`spasticity in multiple sclerosis. Neurokehabilitaticn 2009;24:327-331.
`
`Motl RW, McAuley E, Wynn D, Suh Y, Weikert M, Dlugonskl D, Symptoms and Physical Activity among
`Adults with Relapsing-Rcmitting Multiple Sclerosis. J New Mom Dis. 2008 Jun;l96(6):492—5
`
`Coles AJ, Compston DA, Sclmaj KW, Lake SL, Moran S, Margolin DH, Norris K, Tanclon PK for the
`CAMMS223 Trial Investigators, Alcmtuzumab vs. interferon beta: I a in early multiple sclerosis. N Engl J
`Med. 2008 Oct 23;359(l 7):l786-801
`
`Mikcl DD, Bcrkhof F, Chang P, Coyle PK, Jeffery DR, Schwld SR, Stubinski B, Uitdehaag BM; REGARD
`study group. Comparison of subcutaneous interferon lJcta~la with glatiramer acetate in patients with
`relapsing multiple sclerosis (the Rebif vs. Glatiramer Acetate in Relapsing MS Disease [REGARD] study):
`a multicentre, randomised, parallel, open-label trial. Lancet Neurol. 2008 Oct;7(l0):903—14. Epub 2008
`Sepll.
`
`Giovannoni G, Wynn DR, et al., Safety and immunogenicity of a new formulation of interferon B-la
`(Rebiflll) New Formulation), Mult Scler.2009; 15: 219-228.
`
`Fox EJ, Cohan S, Murkowitz C, Wynn D, Rill D, Riser M, , Williams JC. TERMS Trial T-Cell
`Vaccination Secondary Analysis of Clinical and Immunologic Outcomes in Relapsing Remitting Multiple
`Sclerosis. American Academy of Neurology (AAN). Presentation P06.l32, 2009
`
`Wynn D, Kaye R, Hepner A, Amold R, Impact of Pseudobu lbar Affect on Health and Quality of Life.
`Presented at the American Neurological Academy Meeting, Chicago, 2008
`
`Wynn D, Kaye R, Hepner A, Arnold R, Impact of Pseudobulbar Affect on Caregivers. Presented at the
`American Neurological Academy Meeting, Chicago, 2008
`
`Jeffery D, Wynn D, Bennett R, AL-Sabbagh A, Bandari D, Bcnefit—Risk Evaluation of Mitoxantrone and
`Natalizumab in Multiple Sclerosis. Presented at the European Conference on the Treatment and Research in
`Multiple Sclerosis (ECTRJMS), Montreal, Canada, September 2008
`
`56.
`
`57.
`
`58.
`
`Page 8 of 29
`
`
`
`Selected Publications and Presentations
`
`59.
`
`60.
`
`62.
`
`Motl RW, Shook EM, Wynn DR, Vollmer T. Physical activity correlates with neurological impairment
`and disability in multiple sclerosis. J Nerv Ment Dis 2008; l96:492-495.
`
`Fox BI, Cohan S, Markowitz C. Wynn D, Inman S, Riser M, Rill D, Newsom B, Games P, Williams JC.
`TERMS (Tovaxin° for Early Relapsing MS) phase 2!: placebo-controlled trial of autologous T-cell
`Vaccination in patients with clinically isolated syndrome or relapsing remitting multiple sclerosis. World
`Congress on Treatment and Research in Multiple Sclerosis (WC TRJMS). Presentation 56, 2008
`
`Eggenberger E, Calabresi PA, Confavreux C, Galetta SL, Giovannoni G, Havrdova E, Hutchinson M,
`Kappos L, Lublin F, Miller DH, O’Connor PW, Phillips JT, Polman CH, Radue E-W, Rudiclt RA,
`Weinstock-Gunman R, Wynn DR, Pace A, Hyde R, Kim R, Panzera MA, Complete Clinical and MR1
`Response in Multiple Sclerosis: Effects of Natalizumab. Presented at the Consortium of MS Centers
`Meeting, Denver, Colorado, May 28-31, 2008
`
`Wynn DR, Bennett R, Glanzman R, AL-Sabbagh A, Using the Principles of Evidence-Based Medicine for
`Determining Optimal Pharmacotherapy Options for an Individual Patient with Relapsing—Remitxing
`Multiple Sclerosis. Presented at the Consortium ofMS Centers Meeting, Denver, Colorado, May 28-3 1,
`2008.
`
`Miller E, Ruddick R, Calabnesi PA, Confavreux C, Giovannoni G, Havrdova E, Hutchinson M, Kappos L,
`Lublin F, O'Connor PW, Phillips JT, Polman CH, Radue E-W, Stuart WH, Wajgt A, Weinstock—Guttman
`B, Wynn DR, Pace A, Hyde R, Kim R, Panzer-a MA, Relationship Between Pain and Clinical Outcomes in
`Multiple Sclerosis: Effects of Natalizumab. Presented at the Consortium of MS Centers Meeting, Denver,
`Colorado, May 28-31, 2008.
`
`Fox El, Markowitz CE, Cohan S, Wynn DR, Riser M, Rill D, Garces P, Williams JC and the TERMS
`study group, TERMS Trial T-Cell Vaccination Secondary Analysis of Clinical and Immunologic Outcomes
`in Relapsing Remitting Multiple Sclerosis Patients. Poster presentation American Academy of Neurology,
`April, Chicago, 2008.
`
`Fox EI, Marltowitz CE, Wynn DR, Cohan S, Inman S, Riser M, Rill D, Garces P, Newsom B, Williams JC
`and the TERMS study group, TERMS (Tovaxin for Early Relapsing Remitting MS) Phase 2b Placebo-
`Controlled Trial of Autologous T-cell Vaccination in Patients with CIS or RRMS. Poster presentation
`American Academy of Neurology, April, Chicago, 2008
`
`Motl R, Sosnoff J, Snook EM, Fliclcinger J, Meyers J, Wynn D, Managing Spasticity with Chronic
`Exercise in Multiple Sclerosis, Poster presentation American Academy of Neurology, April, Chicago,
`2008.
`
`Miller B, Ruddiclt R, Calabrcsi PA. Confavreux C, Galetta SL, Gicvannoni G, Havrdova E, Hutchinson M,
`Kappos L, Lublin F, Miller DH, O'Connor PW, Phillips JT, Polman CH, Radue E-W, Stuan WH, Wajgt A,
`Weinstock-Gunman B, Wynn DR, Pace A, Hyde R, Kim R, Panzera MA, Pain in Patients With Multiple
`Sclerosis‘. Effects of Natalizumab. Poster presentation American Academy ofNeurology, April, Chicago,
`2008.
`
`l-lerbelt J, Kappos L, Calabnesi PA, Confavneux C, Galetta SL, Giovannoni G, Havrdova E, Hutchinson M,
`Lublin F, Miller E, O'Connor PW, Phillips JT, Polman Cl-I, Radue E-W, Ruddick R, Stuart WI-I, Wajgt A,
`Weinstoclc-Guttman B, Wynn DR, Bacon J, Kister I, Pace A, Panzera MA, Natalizumab Reduces Multiple
`Sclerosis Severity: Analysis of Patients From the AFFIRM and SENTINEL Studies Using the Multiple
`Sclerosis Severity Scale. Poster presentation American Academy of Neurology, April 12-19, Chicago,
`2008.
`
`64.
`
`65.
`
`66.
`
`67.
`
`68.
`
`Page 9 of 29
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`
`
`Selected Publications and Presentations
`
`Galetta SL, Calabresi PA, Confavreux C, Giovannoni 0, Havrdova E, Hutchinson M, Kappos L, Lublin F,
`Miller E, O'Connor PW, Phillips IT, Polman CH, Radue E-W, Ruddick R, Stuart WI-l, Wajgt A,
`Weinstock-Gunman B, Wynn DR, Pace A, Hyde R, Kim R, Panzera MA, Natalizumab Increases the
`Proportion of Patients Who Are Disease-Free Based on MRI Criteria in Relapsing Multiple Sclerosis.
`Poster presentation American Academy of Neurology, April 12-19, Chicago, 2008
`
`Rudick RA, Pace A, Panzera M, Rani S, Schmck J, Calabresi P, Confavreux C, Galetta SL, Lublin FD,
`Radue EW, Stuart W, Weinstock-Guttman B, Wynn DR, Effects of statins on intramuscular interferon
`beta-la for relapsing remitting multiple sclerosis. Poster presentation American Academy of Neurology,
`April, Chicago, 2008
`
`Calabresi PA, Giovannoni G, Confavreux C, Galetta SL, Havrdova E, Hutchinson M, Kappos L, Miller
`DH, O'Connor PW, Phillips IT, Polman CI-l, Radue EW, Rudick RA, Stuart WH, Lublin FD, Wajgt A,
`Weinstock-Gunman B, Wynn DR, Lynn F, Panzera MA; AFFIRM and SENTINEL Investigators, The
`incidence and significance of anti-natalizumab antibodies: results tbom AFFIRM and SENTINEL,
`Neurology. 2007 Oct 2;69(14): 1391-403. Epub 2007 Aug 29
`
`Bandari D, Bennett R, Chang P, Glyman S, Miller T, Singer B, wray S, Wynn D, Divan V, AL-Sabbagh
`A, The RebiQoL Study: Rationale, Design, Baseline, and Demographic Data for n Quality-of—Life Study in
`Patients Receiving Subcutaneous New Formulation Interferon Beta-Ia for the Treatment of Relapsing
`Multiple Sclerosis. Presented at the Em-opean Conference for Treatment and Research in Multiple
`Sclerosis, Prague, Czech Republic, October ll-14, 2007
`
`Rudick RA, Pace A, Hyde R, Panzera M, Ransohoffk, Rani S, Schmck J, Calabresi PA, Confavreux C,
`Galetta 8, Giovanni G, Lublin F, Radue EW, Stuart W, Weinstock-Guttman B, Wynn D, Statins Do Not
`Interfere With Intramuscular Interferon Beta-la in Relapsing-Remitting Multiple Sclerosis. Presented at
`the European Conference for Treatment and Research in Multiple Sclerosis, Prague, Czech Republic,
`October ll-14, 2007
`
`69.
`
`70.
`
`7].
`
`72.
`
`73.
`
`74.
`
`75.
`
`Rudick RA, Miller D, 1-[ass S, Wynn D, et al. Health-related quality of life in multiple sclerosis: effects of
`natalizumab. Ann Neurol 2007;62:335-346.
`
`Rudick R, Miller D, Hutchinson M, Calabresi P, Confavreux C, Galetta S, Giovanni Cr, i-Iavrdova E,
`Kappos L, Lublin F, Miller D, O'Connor PW, Phillip JT, Polman C, Radue EW, Stuart W, Wajgt A,
`Weinslock-Guttman B, Wynn D, Lynn F, Panzcra M for the AFFIRM and SENTINEL Investigators,
`Health Related Quality of Life in Multiple Sclerosis: Effects of Natalizumab. Neurology 2007 Mar 20:63
`(Supplement 1) Poster Presentation, P05.089, American Academy of Neurology, Boston, 2007
`
`76.
`
`77.
`
`78.
`
`Wynn DR, Smith R, Pope LE, Arnold RA. Long Tenn Safety of AVP—923 (Dextromethorphan/Quinidine)
`in the Treatment of [nvoluntury Emotional Expression Disorder (IEED). Neurology 2007 Mar 20;68
`(Supplement 1), Poster Presentation, P0l.0l 5, American Academy of Neurology, Boston, 2007
`
`Biederman J, Melmed R, Patel A, McBumett K, Konow J, Lyne A, Slat C, Schercr N, Wynn D, A
`Randomized, Double~BIind, Placebo-Controlled Study of Guanfacine Extended Release in Children and
`Adolescents With Attention-Deficit/Hyperactivity Disorder for the SPDS03 Study Group, Pediatrics, 12:1
`January 2008, pp. e73-e84 (doi: I 0.1 S42/pcds.2006-3695)
`
`Motl RW, Snook EM, Wynn DR, Physical Activity Behavior in Individuals With Secondary Progressive
`Multiple Sclerosis, Int J MS Care. 2007;9:139—142
`
`Page 10 of 29
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`Selected Publications and Presentations
`
`'79.
`
`80.
`
`Calabresi PA, Giovannoni G, Confavreux C, Wynn D, et al. The incidence and significance of anti-
`natalizumab antibodies: results fi'om AFFIRM and SBNTINEL. Neurology 2007;659:1391-1403.
`
`Balccr LI, Galetta SL, Calabresi PA, Confavreux C. Giovannoni G, Havrdova E, Hutchinson M, Kappos L,
`Lublin FD, Miller DH, O'Connor PW, Phillips JT, Polman CH, Radue E-W, Rudick RA, Smart WH, Wqjgt
`A, Weinstock—Guttman B, Wynn DR, Lynn F, and Panzera MA, for the AFFIRM and SENTINEL
`Investigators, Natalizumab reduces visual loss in patients with relapsing multiple sclerosis. Neurology
`2007;68: 1299-1304.
`
`82.
`
`84.
`
`85.
`
`86.
`
`87.
`
`Cohen JA, Rovaris M, Goodman AD, Ladkani D, Wynn D, 1'-‘ilippi M; 9006 Study Group. Randomized,
`double-blind, dose—comparison study of glatiramer acetate in relapsing-remitting MS. Neurology
`2007;68:939-944.
`
`Panitch HS, Thisted RA, Smith RA, Wynn DR, Wymer JP, Achiron A, Vollmcr TL, Mandler RN, Dietrich
`DW, Fletcher M, Pope L, Berg J, Miller A, Randomized, controlled trial of dextromethorphan/quinidine for
`pseudobulbar affect in multiple sclerosis. Ann Neurol 2006;59:780-787.
`
`Wynn DR, Management of Physical Symptoms, in Multiple Sclerosis: Symptom and Side Effect
`Management, International Journal of MS Care, Februry 2006 (supplement)
`
`Ross AP, Wynn DR, Management of Treatment Side Effects, in Multiple Sclerosis: Symptom and Side
`Efibct Management, International Ioumal of MS Care, February 2006 (supplement)
`
`Kim M, O'Connor PW, Havrdova E, Hutchinson M, Kappos L, Miller DH, Phillips JT, Polman CH, Stuart
`WI-l, Calabnesi PA, Confavreux C, Galettu LS, Radue EW, Rudick RA, Lublin FD, Giovannoni G, Wajgt
`A, Weinstock—Guttman B, Wynn DR, Lynn F, Panzera MA, Sandroclc AW, for the AFFIRM and
`SENTINEL Investigators. Natalizumab improves health-related quality of like in patients with relapsing
`multiple sclerosis. (Presented at the Academy of Managed Care Pharmacy Educational Conference,
`Chicago, 2006.)
`
`Weinstock-Guttman B, O‘Cormor PW, Havrdova E, Hutchinson M, Kappos L, Miller DH, Phillips JT,
`Polman CH, Stuart WH, Calabresi PA, Confavreux C. Galetta. SL, Radue EW, Rudick RA. Lublin FD,
`Giovannoni G, Wajgt A, Wynn DR, Lynn F‘, Pnnzera MA, Sandrock AW, for the AFFIRM and
`SENTINEL Investigators. Natallzumab reduces corticosteroid use and hospitalizations, and increases the
`proportion of disease-free multiple sclerosis patients. (Presented at the Academy of Managed Care
`Pharmacy Educational Conference, Chicago, 2006.)
`
`Balcer L, Galena S, O’Connor P, Havrdova E, Hutchinson M, Kappos L, Miller D, Phillips J, Polman C,
`Stuart W, Calabresi P, Confavreux C, Radue W, Rudick R, Lnblin F, Giovannoni G, Wajgt A, Wci'nstock-
`Guttman B, Wynn DR, Lynn F, Panzera M, Sandrock A for the AFFIRM and SENTINEL Investigators,
`Natalizumab Reduces Loss of Visual Function in Patients with Relapsing Multiple Sclerosis. (Presentation
`at the American Academy of Neurology meeting, San Diego 2006)
`
`Rudick R, Hutchinson M, O'Connor