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Program Director/Principal lnvestigator(Last, First, Middle): Goland, Robin S.
`
`BIOGRAPHICAL SKETCH
`Provide the following information for the Senior/key personnel and other significant contributors in the order listed on Form Page 2.
`Follow this format for each person. DO NOT EXCEED FOUR PAGES.
`
`NAME
`
`POSITION TITLE
`
`eRA COMMONS USER NAME (credential, e.g., agency login)
`
`Co-Director, Naomi Berrie Diabetes Center
`
`EDUCATION/TRAINING (Begin with baccalaureate or other initial professional education, such as nursing, include postdoctoral training and
`residency training if applicable.)
`
`INSTITUTION AND LOCATION
`
`Harvard University
`Columbia University
`
`DEGREE
`(if applicable)
`BA
`MD
`
`MM/YY
`
`06/76
`06/80
`
`FIELD OF STUDY
`
`Hi~tory
`Medicine
`
`A. Personal Statement
`Dr. Robin Goland is J. Merrill Eastman Professor of Clinical Diabetes in Medicine and Pediatrics at
`Columbia University and founder and Co-Director of the Naomi Berrie Diabetes Center. She is an
`experienced clinical investigator and principal investigator in diabetes trials.
`
`B. Positions and Honors
`Positions and Employment
`1980-84 Medical Residency, Internal Medicine, NewYork-Presbyterian/Columbia University, NY
`1984-87 Research Fellow in Endocrinology, Columbia University P&S
`1987-89 Assistant Professor of Clinical Medicine, Columbia University P&S
`1987-
`Chief, Diabetes Clinic, NewYork-Presbyterian Hospital/Columbia University, NY
`1990-96 Assistant Professor of Medicine, Columbia University P&S
`1997-08 Florence Irving Associate Professor of Medicine, Columbia University P&S
`1997-
`Founder and Co-Director, Naomi Berrie Diabetes Center at Columbia University
`2008-
`Professor of Clinical Medicine, Columbia University P&S
`2010-
`Professor of Clinical Medicine and Clinical Pediatrics, Columbia University P&S
`2011-
`J. Merrill Eastman Professor of Clinical Diabetes, Columbia University P&S
`
`Other Experience and Professional Memberships
`1984-
`Member, The Endocrine Society
`1984-
`Member, American Diabetes Association
`1994-00 Editorial Board, Journal of Clinical Endocrinology and Metabolism
`1998-11 Member, Medical Advisory Board, Juvenile Diabetes Foundation, NY Chapter
`2001-12 Member, Pharmacy and Therapeutics Committee, Merck Health Solutions
`2006-
`Member, Medical Advisory Board, NY Stem Cell Foundation
`
`Honors
`1979
`1983-84
`1996-99
`
`Alpha Omega Alpha, Columbia University College of P&S
`Chief Resident in Internal Medicine, New York Presbyterian Hospital/Columbia University
`Irving Scholar Award for Clinical Investigation, Columbia University
`
`PHS 39812590 (Rev. 06/09)
`
`Page
`
`Biographical Sketch Format Page
`
`Sanofi Exhibit 2112.001
`Mylan v. Sanofi
`IPR2018-01676
`
`

`

`Program Director/Principal Investigator (Last, First, Middle): Goland, Robin S.
`C. Selected Peer-reviewed Publications
`1.
`loacara S, Flanagan S, Frohlich-Reiterer E, Goland R, Fica S. First case of neonatal diabetes
`with KCNJ11 Q52R mutation successfully switched from insulin to sulphonylurea treatment. J
`Diabetes lnvestig. 2017 Jan 13. doi: 10.1111/jdi.12620. PMID: 28083968
`2. Arslanian S, El Ghormli L, Bacha F, Caprio S, Goland R, Haymond MW, Levitsky L, Nadeau
`KJ, White NH, Willi SM; TODAY Study Group. Adiponectin, Insulin Sensitivity, ~-Cell Function,
`and Racial/Ethnic Disparity in Treatment Failure Rates in TODAY. Diabetes Care. 2017
`Jan;40(1):85-93. doi: 10.2337/dc16-0455. Epub 2016 Nov 1. PMID: 27803118
`3. Do C, Lang CF, Lin J, Darbary H, Krupska I, Gaba A, Petukhova L, Vonsattel JP, Gallagher
`MP, Goland RS, Clynes RA, Dwork A, Kral JG, Monk C, Christiano AM, Tycko B. Mechanisms
`and Disease Associations of Haplotype-Dependent Allele-Specific DNA Methylation. Am J
`Hum Genet. 2016 May 5;98(5):934-55. doi: 10.1016/j.ajhg.2016.03.027. PMID: 27153397
`4. Weinstock RS, DuBose SN, Bergenstal RM, Chaytor NS, Peterson C, Olson BA, Munshi MN,
`Perrin AJ, Miller KM, Beck RW, Liljenquist DR, Aleppo G, Buse JB, Kruger D, Bhargava A,
`Goland RS, Edelen RC, Pratley RE, Peters AL, Rodriguez H, Ahmann AJ, Lock JP, Garg SK,
`Rickels MR, Hirsch 18; T1 D Exchange Severe Hypoglycemia in Older Adults With Type 1
`Diabetes Study Group. Risk Factors Associated With Severe Hypoglycemia in Older Adults
`With Type 1 Diabetes. Diabetes Care. 2016 Apr;39(4):603-10. doi: 10.2337/dc15-1426. Epub
`2015 Dec 17. PMID: 26681721
`5. Freeby MJ, Kringas P, Goland RS, Leibel RL, Maffei A, Divgi C, lchise M, Harris PE. Cross(cid:173)
`sectional and Test-Retest Characterization of PET with [(18)F]FP-(+)-DTBZ for~ Cell Mass
`Estimates in Diabetes. Mo! Imaging Biol. 2016 Apr;18(2):292-301. doi: 10.1007/s11307-015-
`0888-7. Epub 2015 Sep 14. PMID: 26370678
`6. Klingensmith GJ, Pyle L, Nadeau KJ, Barbour LA, Goland RS, Willi SM, Linder B, White NH;
`TODAY Study Group. Pregnancy Outcomes in Youth With Type 2 Diabetes: The TODAY
`Study Experience. Diabetes Care. 2016 Jan;39(1):122-9. doi: 10.2337/dc15-1206. Epub 2015
`Dec 1. PMID: 26628417
`7. Gandica RG, Chung WK, Deng L, Goland R, Gallagher MP. Identifying monogenic
`diabetes in a pediatric cohort with presumed type 1 diabetes. Pediatr Diabetes. 2015
`May;16(3):227-33. doi: 10.1111/pedi.12150. Epub 2014 Aug 1. PMID: 25082184
`8. Weinstock RS, Trief PM, El Ghormli L, Goland R, McKay S, Milaszewski K, Preske J, Willi S,
`Yasuda PM. Parental Characteristics Associated With Outcomes in Youth With Type 2
`Diabetes: Results From the TODAY Clinical Trial. Diabetes Care. 2015 May;38(5):784-92. doi :
`10.2337/dc14-2393. Epub 2015 Mar 17. PMID: 25784663
`9. Wang L, Meece K, Williams DJ, Lo KA, Zimmer M, Heinrich G, Martin Carli J, Leduc CA, Sun
`L, Zeltser LM, Freeby M, Goland R, Tsang SH, Wardlaw SL, Egli D, Leibel RL. Differentiation
`of hypothalamic-like neurons from human pluripotent stem cells. J Clin Invest. 2015
`Feb;125(2):796-808. doi: 10.1172/JCl79220. Epub 2015 Jan 2. PMID: 25555215
`10. Davis AK, Du Bose SN, Haller MJ, Miller KM, Di Meglio LA, Beth in KE, Goland RS, Greenberg
`EM, Liljenquist DR, Ahmann AJ, Marcovina SM, Peters AL, Beck RW, Greenbaum CJ; T1 D
`Exchange Clinic Network. Prevalence of detectable C-Peptide according to age at diagnosis
`and duration of type 1 diabetes. Diabetes Care. 2015 Mar;38(3):476-81. doi: 10.2337/dc14-
`1952. Epub 2014 Dec 17. PMID: 25519448
`11. Goland R, Egli D. Stem Cell-Derived Beta Cells for Treatment of Type 1 Diabetes?
`EBioMedicine. 2014 Oct 29;1(2-3):93-4. doi: 10.1016/j.ebiom.2014.10.018. eCollection 2014
`Dec. No abstract available. PMID: 26137512
`12. Yamada M, Johannesson B, Sagi I, Burnett LC, Kort DH, Prosser RW, Paull D, Nestor
`MW, Freeby M, Greenberg E, Goland RS, Leibel RL, Solomon SL, Benvenisty N,
`Sauer MV, Egli D. Human oocytes reprogram adult somatic nuclei of a type 1 diabetfc
`to diploid pluripotent stem cells. Nature. 2014 Jun 26;510(7506):533-6. PMID:
`PHS 398/2590 (Rev . 06/09)
`Page 2
`Continuation Format Page
`
`Sanofi Exhibit 2112.002
`Mylan v. Sanofi
`IPR2018-01676
`
`

`

`Program Director/Principal Investigator (Last, First, Middle): Goland, Robin S.
`24776804. doi: 10.1038/nature13287. Epub 2014 Apr 28. PMID: 24776804
`13.Shang L, Hua H, Foo K, Martinez H, Watanabe K, Zimmer M, Kahler DJ, Freeby M, Chung W,
`LeDuc C, Goland R, Leibel RL, Egli D. ~-cell dysfunction due to increased ER stress in a stem
`cell model of Wolfram syndrome Diabetes. 2014 Mar;63(3):923-33. doi: 10.2337/db13-0717.
`Epub 2013 Nov 13. PMID: 24227685
`14. Pescovitz MD, Greenbaum CJ, Bundy 8, Becker DJ, Gitelman SE, Goland R, Gottlieb
`PA, Marks JB, Moran A, Raskin P, Rodriguez H, Schatz DA, Wherrett DK, Wilson OM,
`Krischer JP, Skyler JS; Type 1 Diabetes TrialNet Anti-CD20 Study Group. 8-
`lymphocyte depletion with rituximab and beta-cell function: two-year results. Diabetes
`Care. 2014 Feb;37(2):453-9. PMCID:PMC3898764
`15. Orban T, Bundy 8, Becker DJ, Dimeglio LA, Gitelman SE, Goland R, Gottlieb PA,
`Greenbaum CJ, Marks JB, Monzavi R, Moran A, Peakman M, Raskin P, Russell WE,
`Schatz D, Wherrett DK, Wilson OM, Krischer JP, Skyler JS; Type 1 Diabetes TrialNet
`Abatacept Study Group. Costimulation modulation with abatacept in patients with
`recent-onset type 1 diabetes: follow-up 1 year after cessation of treatment. Diabetes
`Care. 2014 Apr;37(4):1069-75. PMCID: PMC3964491. doi: 10.2337/dc13-0604. Epub
`2013 Dec 2. PMID: 24296850
`16.Bergenstal RM, Ahmann AJ, Bailey T, Beck RW, Bissen J, Buckingham 8, Deeb L, Dolin
`RH, Garg SK, Goland R, Hirsch 18, Klonoff DC, Kruger OF, Matfin G, Mazze RS, Olson BA,
`Parkin C, Peters A, Powers MA, Rodriguez H, Southerland P, Strock ES, Tamborlane W,
`Wesley DM. Recommendations for standardizing glucose reporting and analysis to optimize
`clinical decision making in diabetes Diabetes Technol Ther. 15(3):198-211, 2013
`PMID:23448694
`17. Trief PM, Izquierdo R, Eimicke JP, Teresi JA, Goland R, Palmas W, Shea S, Weinstock RS
`Adherence to diabetes self care for white, African-American and Hispanic American
`telemedicine participants: 5 year results from IDEATel project.Ethn Health. 18(1):83-96;
`2013 PMID: 22762449
`18. Paull D, Emmanuele V, Weiss KA, Treff N, Stewart L, Hua H, Zimmer M, Kahler DJ, Goland
`RS, Noggle SA, Prosser R, Hirano M, Sauer MV, Egli D. Nuclear genome transfer in human
`oocytes eliminates mitochondrial DNA variants. Nature. 31;493(7434):632-7, 2013
`PMID:23254936
`19. Hua H, Shang L, Martinez H, Freeby M, Gallagher MP, Ludwig T, Deng L, Greenberg
`E, Leduc C, Chung WK, Goland R, Leibel RL, Egli D. iPSC-derived ~ cells model
`diabetes due to glucokinase deficiency. J Clin Invest. 2013. PMCID:PMC 3696557
`20. Simmons JH, Chen V, Miller KM, McGill JB, Bergenstal RM, Goland RS, Harlan OM,
`Largay JF, Massaro EM, Beck RW; T1 D Exchange Clinic Network. Differences in the
`management of type 1 diabetes among adults under excellent control compared with
`those under poor control in the T1 D Exchange Clinic Registry. Diabetes Care. 2013
`Nov;36(11 ):3573-7 PMC3816911. PMCID:PMC3816911
`21. TODAY Study Group: Results of a randomized clinical trial of 3 treatments to maintain
`glycemic control in a large multi-ethnic cohort of adolescents diagnosed with type 2 diabetes.
`New Eng J Med 2012 PMCID: PMC3661790
`22. Kalscheuer H, Danzl N, Onoe N, Faust T, Winchester R, Goland R, Greenberg E, Spitzer T,
`Savage D, Tahara H, Yang Y-G, and Sykes M: A model for immune rejuvenation and
`individualized in vivo analysis of immune responsiveness of adult humans. Science
`Trans Med; 14; 4(125), 2012 PMCID: PMC3697150
`
`Active Research Support
`Dates: 9/1/01-5/30/19
`Sponsor: NIH NIDDK DE14260 (Greenbaum)
`Title: Type 1 Diabetes TrialNet Major Affiliate Center at Columbia University
`Page 3
`PHS 398/2590 (Rev. 06/09)
`
`Continuation Format Page
`
`Sanofi Exhibit 2112.003
`Mylan v. Sanofi
`IPR2018-01676
`
`

`

`Program Director/Principal Investigator (Last, First, Middle): Goland, Robin S.
`Role: Pl, Columbia site Description: Consortium of centers for prevention, treatment trials in T1 D
`
`Dates: 1/1/13-7/31/21
`Sponsor: NIH/NIDDK U01-DK098246 (Nathan)
`Title: GL YCEMIA REDUCTION APPROACHES IN DIABETES: (GRADE)
`Role: Pl, Columbia site Description: Multi-center trial to understand the relative effectiveness of
`different medications in combination with metformin in maintaining glycemic goals over time.
`
`Sponsor: Juvenile Diabetes Research Foundation Dates: 3/1 /16-2/31 /19
`Title: TUDCA in New Onset Type 1 Diabetes
`Role: Co-Pl Description: study of use of TUDCA, an agent to reduce ER stress, to preserve insulin
`secretion in new onset type 1 diabetes
`
`Sponsor: Helmsley Charitable Trust Dates: 11/1/10-10/31/21
`Type 1 Diabetes Exchange
`Role: Pl, Columbia site Description: Multi-center type 1 diabetes registry, biobank, and patient
`portal
`
`PHS 398/2590 (Rev. 06/09)
`
`Page 4
`
`Continuation Format Page
`
`Sanofi Exhibit 2112.004
`Mylan v. Sanofi
`IPR2018-01676
`
`

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