Skip to content

Latest commit

 

History

History
223 lines (176 loc) · 23 KB

index.md

File metadata and controls

223 lines (176 loc) · 23 KB
layout title
cv
Ishir Bhan's CV

Ishir Bhan, MD MPH

ishirbhan@gmail.com https://www.linkedin.com/in/ishirbhan/

Summary

  • Harvard Medical School trained physician, completing residency in internal medicine and fellowship in nephrology with previously board certification in both; 8 years as academic staff physician at Massachusetts General Hospital
  • NIH-funded independent clinical research career with numerous publications and presentations at international conferences
  • Over 7 years of industry experience spanning drug safety and clinical development involving siRNA, ASOs, and gene therapy
  • Clinical lead for Phase 1-3 studies across multiple assets
  • Multiple regulatory engagements involving FDA, EMA, MHRA, PDMA and others including face-to-face meetings, teleconferences, briefing document authoring, successful IND and sNDA submissions, and RTQs

Employment

Pharmaceutical Industry

Alnylam Pharmaceuticals, Cambridge, MA

Date Description
2019-2022 Director, Clinical Research
2022- Senior Director, Clinical Research

Clinical lead for Phase 2 Study of Zilebesiran (siRNA targeting angiotensinogen for hypertension)

  • led clinical protocol development, coordinating cross-functinoal team and leading governance meeting presentations
  • coordinated input from partner pharmaceutical company, establishing alignment prior to cross-company governance
  • established study steering committtee to provide expert input on study design and execution
  • identified key metrics for site identification and selection
  • activated first site ahead of schedule

Clinical lead for ILLUMINATE C (Phase 3 trial of Lumasiran for patients with primary hyperoxaluria in advanced kidney disease)

  • led cross-functional clinical development subteam
  • successfully completed enrollment and led presentation of top-line data for company meetings, online presentations, and abstracts/publications
  • authored summary of clinical efficacy and clinical study report
  • filed successful sNDA with FDA, leading to updated indication
  • in coordination with KOLs, developed and established validation strategy for novel scales of systemic oxalosis

Clinical lead for ALN-XDH (siRNA for treatment of gout)

  • designed and led authoring of Phase 1/2 protocol for efficient evaluation of safety/efficacy using novel paradigm later adopted by other programs; led governance presentations
  • led advisory board and 1:1 calls with KOLs to incorporate expert feedback
  • led authoring of investigator brochure
  • successfully filed CTA and IND with MHRA and FDA
  • led cross-functional team to rapidly assess therapeutic viability while minimizing time, cost, and subject exposure
  • completed enrollment and analysis of SAD study in healthy volunteers

Clinical lead for cemdisiran (siRNA for suppression of C5 complement component)

  • led phase 2 trial in IgA nephropathy, amending protocol to enable successful completion of enrollment despite challenges from COVID-19 pandemic
  • led interpretation and presentation of positive top-line results, including internal presentations, international conferences, and manuscripts
  • worked with cross-functional team and external consultants to establish viability of phase 3 program
  • led authoring and design of phase 3 protocol including leading advisory boards and multiple KOL meetings to incorporate feedback
  • led successful end of phase 2 interactions with FDA (teleconference), EMA, and PMDA including development of briefing books and response to questions
  • worked with collaborator Regeneron to enable development and execution of phase 2 and 3 studies of cemdisiran/pozelimab combination in myasthenia gravis and paroxysmal nocturnal hemoglobinuria

Clinical lead for pre-clinical complement assets

  • led clinical assessment of potential indications for novel agents directed against complement cascade, incorporating commercial assessments and pre-clinical data
  • worked with collaborator to assess viability of combination therapeutic approaches, presenting to leadership at both companies

Biogen, Cambridge, MA

Date Description
2016-2018 Associate Medical Director, Drug Safety
2018-2019 Medical Director, Drug Safety

Global Safety Officer

  • led medical safety activities for SPINRAZA and several developmental assets
  • provided clinical oversight and authored relevant section for SPINRAZA PSUR and DSUR
  • maintained relevant sections of Investigator Brochures, Core Data Sheet, Patient Safety Information, Expected Term Lists, and Informed Consent Forms
  • Provided clinical oversight for analysis and characterization of clinical trial and postmarketing adverse events
  • Represented safety issues in cross-function teams (including clinical study, program, communications, and publications teams) and governance committee presentations
  • Supported successful registration of SPINRAZA in 13 regions including EU, Canada, Japan, Australia, and others
  • Authored and edited responses to regulatory inquiries for both registration-related and postmarket settings
  • Provided input and editing for revision to package inserts including USPI, SmPC, and other regional labels

Development and Diligence

  • Assessed safety risks for potential asset acquisitions
  • Reviewed and assessed pre-clinical and clinical trial data in context of competitive landscape
  • Contributed to study design for gene therapy assets under development
  • Worked on cross-functional team to develop strategy for accelerating development through innovative approaches including hybrid virtual trials and wearables for data collection

Academic Medicine

Massachusetts General Hospital, Boston, MA

Date Description
2014-2016 Associate Physician, Department of Medicine Served as attending nephrologist. Covered the inpatient Nephrology consultation, dialysis, and intensive care unit services. Taught and supervised fellows, residents, and students.
2014-2016 Director of Nephrology Informatics, Department of Medicine, Division of Nephrology Oversaw all information-technology based initiatives within the Division of Nephrology, including research activities, clinical activities, and administrative initiatives. Provided informatics support for research ventures.
2013-2016 Director of Collaborative Informatics, Department of Medicine, Laboratory of Computer Science Designed, planned, and managed development of web and smartphone-based clinical task management, electronic documentation, and collaboration software used at four Boston-area hospitals.
2012-2016 Subspecialty Core Educator, Department of Medicine Oversaw outpatient and inpatient nephrology rotations for medical residents. Developed educational program. Coordinated clinical experiences.
2012-2016 Associate Program Director, Nephrology Fellowship Program Oversaw nephrology fellowship activities at Massachusetts General Hospital including clinical rotations and research education.
2006-2014 Assistant in Medicine, Department of Medicine

Academic Appointments

Harvard Medical School, Boston, MA

Date Description
2014-2016 Assistant Professor in Medicine
2008-2014 Instructor in Medicine

Education and Training

Degrees

Date Description
1996 AB, Harvard College
Cambridge, MA Biology, Magna Cum Laude
2001 MD, Harvard Medical School
Boston, MA
2008 MPH, Harvard School of Public Health
Boston, MA Clinical Effectiveness

Post-Graduate Training

Date Description
2001-2004 Internship and Residency, Massachusetts General Hospital
Boston, MA Internal Medicine
2004-2008 Clinical and Research Fellowship, Massachusetts General Hospital/Brigham and Women's Hospital
Boston, MA Nephrology
2005-2008 Research Fellowship, Massachusetts General Hospital Laboratory of Computer Science
Boston, MA Informatics

Awards and Honors

Date Description
2015 Physician of the Year, Massachusetts General Hospital Given in recognition of a physician who exemplifies dedication to nephrology education, patient care, and collegiality.
2005-2006 Partners in Excellence Award, Partners Healthcare Given in recognition of informatics contributions.
2005-2006 Chief Resident in Medicine, Massachusetts General Hospital, Department of Medicine Developed curriculum for internal medicine residency program. Oversaw educational programs and clinical rotations. Introduced web-based platform for program activities. Launched program providing all residents with internet-connected smartphones and developed clinical software for these devices.

Grants

Date Description
2016-2017 Fanconi Syndrome, Multiple Sclerosis, and Chronic Kidney Disease
BiogenIdec - Principal Investigator
The goal of this project is to characterize urinary and renal function changes associated with multiple sclerosis.
2014-2015 Dialysis Extending Longevity With Intensive Vitamin Ergocalciferol Replacement
Massachusetts General Hospital Interim Support Fund - Principal Investigator
The goal of this project is to define the relationship between survival and ergocalciferol replacement in hemodialysis patients.
2014-2015 Multiple Sclerosis and Chronic Kidney Disease
BiogenIdec - Principal Investigator
The goal of this project is to identify the association between chronic kidney disease and Fanconi syndrome in multiple sclerosis.
2009-2014 Role of hCAP18/LL37 and Vitamin D in Dialysis Mortality
NIDDK/5K23DK081677 - Principal Investigator
The goal of this project was to study the effects of vitamin D on the antimicrobial peptide hCAP18/LL37.
2007-2008 Human Cathelicidin (hCAP18) in Chronic Kidney Disease
National Kidney Foundation Research Fellowship - Principal Investigator
The goal of this project was to study inflammatory predictors of mortality in individuals with end-stage renal disease.

Publications

Selected from over 50 publications.

  1. Berg AH, Bhan I, Powe C, Karumanchi SA, Xu D, Thadhani RI. Acute Homeostatic Changes Following Vitamin D2 Supplementation. J Endocr Soc. 2017;1(9):1135-1149.
  2. Darras BT, Farrar MA, Mercuri E, Finkel RS, Foster R, Hughes SG, Bhan I, Farwell W, Gheuens S. An Integrated Safety Analysis of Infants and Children with Symptomatic Spinal Muscular Atrophy (SMA) Treated with Nusinersen in Seven Clinical Trials. CNS Drugs. 2019;33(9):919-932.
  3. Rhee CM, Bhan I, Alexander EK, Brunelli SM. Association between iodinated contrast media exposure and incident hyperthyroidism and hypothyroidism. Arch Intern Med. 2012;172(2):153-159.
  4. Corapi KM, McMahon GM, Wenger JB, Seifter JL, Bhan I. Association of loop diuretic use with higher parathyroid hormone levels in patients with normal renal function. JAMA Intern Med. 2015;175(1):137-138.
  5. Bhan I, Powe CE, Berg AH, Ankers E, Wenger JB, Karumanchi SA, Thadhani RI. Bioavailable vitamin D is more tightly linked to mineral metabolism than total vitamin D in incident hemodialysis patients. Kidney Int. 2012;82(1):84-89.
  6. Corapi KM, Wenger JB, Bhan I. Blood pressure and serum parathyroid hormone level--reply. JAMA Intern Med. 2015;175(6):1069-1070.
  7. Bhan I. Breaking down the vitamin D-GFR relationship. Am J Kidney Dis. 2014;64(2):168-170.
  8. Nigwekar SU, Negri AL, Bajpai D, Allegretti A, Kalim S, Seethapathy H, Bhan I, Murthy K, Ayus JC. Chronic prolonged hyponatremia and risk of hip fracture in elderly patients with chronic kidney disease. Bone. 2019;127:556-562.
  9. Bhan I, Camargo CAJ, Wenger J, Ricciardi C, Ye J, Borregaard N, Thadhani R. Circulating levels of 25-hydroxyvitamin D and human cathelicidin in healthy adults. J Allergy Clin Immunol. 2011;127(5):1302-1304.e1.
  10. Pippins JR, Gandhi TK, Hamann C, Ndumele CD, Labonville SA, Diedrichsen EK, Carty MG, Karson AS, Bhan I, Coley CM, Liang CL, Turchin A, McCarthy PC, Schnipper JL. Classifying and predicting errors of inpatient medication reconciliation. J Gen Intern Med. 2008;23(9):1414-1422.
  11. Bhan I, Burnett-Bowie SAM, Ye J, Tonelli M, Thadhani R. Clinical measures identify vitamin D deficiency in dialysis. Clin J Am Soc Nephrol. 2010;5(3):460-467.
  12. Viscidi E, Juneja M, Wang J, Wang N, Li L, Farwell W, Bhan I, Makepeace C, Laird K, Kupelian V, Eaton S, Dilley A, Hall S. Comparative All-Cause Mortality Among a Large Population of Patients with Spinal Muscular Atrophy Versus Matched Controls. Neurol Ther. 2022;11(1):449-457.
  13. Allegretti AS, Steele DJR, David-Kasdan JA, Bajwa E, Niles JL, Bhan I. Continuous renal replacement therapy outcomes in acute kidney injury and end-stage renal disease: a cohort study. Crit Care. 2013;17(3):R109.
  14. Berg AH, Tavasoli M, Lo AS, Burnett-Bowie SAM, Bhan I, Karumanchi SA, Kalim S, Zhang D, Zhao S, Thadhani RI. Development and analytical validation of a novel bioavailable 25-hydroxyvitamin D assay. PLoS One. 2021;16(7):e0254158.
  15. Bhan I, Dubey A, Wolf M. Diagnosis and management of mineral metabolism in CKD. J Gen Intern Med. 2010;25(7):710-716.
  16. Bhan I, Hewison M, Thadhani R. Dietary vitamin D intake in advanced CKD/ESRD. Semin Dial. 2010;23(4):407-410.
  17. Leaf DE, Waikar SS, Wolf M, Cremers S, Bhan I, Stern L. Dysregulated mineral metabolism in patients with acute kidney injury and risk of adverse outcomes. Clin Endocrinol (Oxf). 2013;79(4):491-498.
  18. Schnipper JL, Hamann C, Ndumele CD, Liang CL, Carty MG, Karson AS, Bhan I, Coley CM, Poon E, Turchin A, Labonville SA, Diedrichsen EK, Lipsitz S, Broverman CA, McCarthy P, Gandhi TK. Effect of an electronic medication reconciliation application and process redesign on potential adverse drug events: a cluster-randomized trial. Arch Intern Med. 2009;169(8):771-780.
  19. Quraishi SA, De Pascale G, Needleman JS, Nakazawa H, Kaneki M, Bajwa EK, Camargo CAJ, Bhan I. Effect of Cholecalciferol Supplementation on Vitamin D Status and Cathelicidin Levels in Sepsis: A Randomized, Placebo-Controlled Trial. Crit Care Med. 2015;43(9):1928-1937.
  20. Baron JM, Cheng XS, Bazari H, Bhan I, Lofgren C, Jaromin RT, Lewandrowski KB, Dighe AS. Enhanced creatinine and estimated glomerular filtration rate reporting to facilitate detection of acute kidney injury. Am J Clin Pathol. 2015;143(1):42-49.
  21. Nigwekar SU, Bhan I, Thadhani R. Ergocalciferol and cholecalciferol in CKD. Am J Kidney Dis. 2012;60(1):139-156.
  22. Bhan I, Thadhani R. Fibroblast growth factor-23 and outcomes: new answers, new questions. J Am Soc Nephrol. 2013;24(4):523-525.
  23. Powe CE, Seely EW, Rana S, Bhan I, Ecker J, Karumanchi SA, Thadhani R. First trimester vitamin D, vitamin D binding protein, and subsequent preeclampsia. Hypertension. 2010;56(4):758-763.
  24. Kanji Z, Powe CE, Wenger JB, Huang C, Ankers E, Sullivan DA, Collerone G, Powe NR, Tonelli M, Bhan I, Bernhardy AJ, Dibartolo S, Friedman D, Genovese G, Pollak MR, Thadhani R. Genetic variation in APOL1 associates with younger age at hemodialysis initiation. J Am Soc Nephrol. 2011;22(11):2091-2097.
  25. Gordon WJ, Bhan I. Graphical timeline software for inpatient medication review. Health Informatics J. 2019;25(1):62-70.
  26. Nigwekar SU, Wenger J, Thadhani R, Bhan I. Hyponatremia, mineral metabolism, and mortality in incident maintenance hemodialysis patients: a cohort study. Am J Kidney Dis. 2013;62(4):755-762.
  27. Rhee CM, Alexander EK, Bhan I, Brunelli SM. Hypothyroidism and mortality among dialysis patients. Clin J Am Soc Nephrol. 2013;8(4):593-601.
  28. Bhan I, Tamez H, Thadhani R. Impact of new vitamin D data on future studies and treatment. Curr Opin Nephrol Hypertens. 2013;22(4):377-382.
  29. Friedman DJ, Afkarian M, Tamez H, Bhan I, Isakova T, Wolf M, Ankers E, Ye J, Tonelli M, Zoccali C, Kuro-o M, Moe O, Karumanchi SA, Thadhani R. Klotho variants and chronic hemodialysis mortality. J Bone Miner Res. 2009;24(11):1847-1855.
  30. Gombart AF, Bhan I, Borregaard N, Tamez H, Camargo CAJ, Koeffler HP, Thadhani R. Low plasma level of cathelicidin antimicrobial peptide (hCAP18) predicts increased infectious disease mortality in patients undergoing hemodialysis. Clin Infect Dis. 2009;48(4):418-424.
  31. Michael M, Groothoff JW, Shasha-Lavsky H, Lieske JC, Frishberg Y, Simkova E, Sellier-Leclerc AL, Devresse A, Guebre-Egziabher F, Bakkaloglu SA, Mourani C, Saqan R, Singer R, Willey R, Habtemariam B, Gansner JM, Bhan I, McGregor T, Magen D. Lumasiran for Advanced Primary Hyperoxaluria Type 1: Phase 3 ILLUMINATE-C Trial. Am J Kidney Dis. Published online July 14, 2022:S0272-6386(22)00771-5.
  32. Gutierrez OM, Tamez H, Bhan I, Zazra J, Tonelli M, Wolf M, Januzzi JL, Chang Y, Thadhani R. N-terminal pro-B-type natriuretic peptide (NT-proBNP) concentrations in hemodialysis patients: prognostic value of baseline and follow-up measurements. Clin Chem. 2008;54(8):1339-1348.
  33. Darras BT, Chiriboga CA, Iannaccone ST, Swoboda KJ, Montes J, Mignon L, Xia S, Bennett CF, Bishop KM, Shefner JM, Green AM, Sun P, Bhan I, Gheuens S, Schneider E, Farwell W, De Vivo DC. Nusinersen in later-onset spinal muscular atrophy: Long-term results from the phase 1/2 studies. Neurology. 2019;92(21):e2492-e2506.
  34. De Vivo DC, Bertini E, Swoboda KJ, Hwu WL, Crawford TO, Finkel RS, Kirschner J, Kuntz NL, Parsons JA, Ryan MM, Butterfield RJ, Topaloglu H, Ben-Omran T, Sansone VA, Jong YJ, Shu F, Staropoli JF, Kerr D, Sandrock AW, Stebbins C, Petrillo M, Braley G, Johnson K, Foster R, Gheuens S, Bhan I, Reyna SP, Fradette S, Farwell W. Nusinersen initiated in infants during the presymptomatic stage of spinal muscular atrophy: Interim efficacy and safety results from the Phase 2 NURTURE study. Neuromuscul Disord. 2019;29(11):842-856.
  35. Nigwekar SU, Bhan I, Thadhani R. Nutritional vitamin D in dialysis patients: what to D-iscern? Nephrol Dial Transplant. 2011;26(3):764-766.
  36. Bhan I, Dobens D, Tamez H, Deferio JJ, Li YC, Warren HS, Ankers E, Wenger J, Tucker JK, Trottier C, Pathan F, Kalim S, Nigwekar SU, Thadhani R. Nutritional vitamin D supplementation in dialysis: a randomized trial. Clin J Am Soc Nephrol. 2015;10(4):611-619.
  37. Allegretti AS, Hundemer G, Chorghade R, Cosgrove K, Bajwa E, Bhan I. Perspectives of continuous renal replacement therapy in the intensive care unit: a paired survey study of patient, physician, and nurse views. BMC Nephrol. 2015;16:105.
  38. Bhan I. Phosphate management in chronic kidney disease. Curr Opin Nephrol Hypertens. 2014;23(2):174-179.
  39. Lee PS, Sampath K, Karumanchi SA, Tamez H, Bhan I, Isakova T, Gutierrez OM, Wolf M, Chang Y, Stossel TP, Thadhani R. Plasma gelsolin and circulating actin correlate with hemodialysis mortality. J Am Soc Nephrol. 2009;20(5):1140-1148.
  40. Bhan I, Shah A, Holmes J, Isakova T, Gutierrez O, Burnett SM, Juppner H, Wolf M. Post-transplant hypophosphatemia: Tertiary “Hyper-Phosphatoninism”? Kidney Int. 2006;70(8):1486-1494.
  41. Quraishi SA, Bittner EA, Blum L, McCarthy CM, Bhan I, Camargo CAJ. Prospective study of vitamin D status at initiation of care in critically ill surgical patients and risk of 90-day mortality. Crit Care Med. 2014;42(6):1365-1371.
  42. Nigwekar SU, Bhan I, Turchin A, Skentzos SC, Hajhosseiny R, Steele D, Nazarian RM, Wenger J, Parikh S, Karumanchi A, Thadhani R. Statin use and calcific uremic arteriolopathy: a matched case-control study. Am J Nephrol. 2013;37(4):325-332.
  43. Rhee CM, Curhan GC, Alexander EK, Bhan I, Brunelli SM. Subclinical hypothyroidism and survival: the effects of heart failure and race. J Clin Endocrinol Metab. 2013;98(6):2326-2336.
  44. Viscidi E, Wang N, Juneja M, Bhan I, Prada C, James D, Lallier S, Makepeace C, Laird K, Eaton S, Dilley A, Hall S. The incidence of hydrocephalus among patients with and without spinal muscular atrophy (SMA): Results from a US electronic health records study. Orphanet J Rare Dis. 2021;16(1):207.
  45. Lee PS, Bhan I, Thadhani R. The potential role of plasma gelsolin in dialysis-related protein-energy wasting. Blood Purif. 2010;29(2):99-101.
  46. Kong J, Kim GH, Wei M, Sun T, Li G, Liu SQ, Li X, Bhan I, Zhao Q, Thadhani R, Li YC. Therapeutic effects of vitamin D analogs on cardiac hypertrophy in spontaneously hypertensive rats. Am J Pathol. 2010;177(2):622-631.
  47. Bhan I, Thadhani R. Vascular calcification and ESRD: a hard target. Clin J Am Soc Nephrol. 2009;4 Suppl 1:S102-105.
  48. Kong J, Zhu X, Shi Y, Liu T, Chen Y, Bhan I, Zhao Q, Thadhani R, Li YC. VDR attenuates acute lung injury by blocking Ang-2-Tie-2 pathway and renin-angiotensin system. Mol Endocrinol. 2013;27(12):2116-2125.
  49. Bhan I. Vitamin d binding protein and bone health. Int J Endocrinol. 2014;2014:561214.
  50. Thadhani R, Appelbaum E, Chang Y, Pritchett Y, Bhan I, Agarwal R, Zoccali C, Wanner C, Lloyd-Jones D, Cannata J, Thompson T, Audhya P, Andress D, Zhang W, Ye J, Packham D, Singh B, Zehnder D, Manning WJ, Pachika A, Solomon SD. Vitamin D receptor activation and left ventricular hypertrophy in advanced kidney disease. Am J Nephrol. 2011;33(2):139-149.
  51. Tamez H, Zoccali C, Packham D, Wenger J, Bhan I, Appelbaum E, Pritchett Y, Chang Y, Agarwal R, Wanner C, Lloyd-Jones D, Cannata J, Thompson BT, Andress D, Zhang W, Singh B, Zehnder D, Pachika A, Manning WJ, Shah A, Solomon SD, Thadhani R. Vitamin D reduces left atrial volume in patients with left ventricular hypertrophy and chronic kidney disease. Am Heart J. 2012;164(6):902-909.e2.
  52. Quraishi SA, Bhan I, Matthay MA, Thompson BT, Camargo CAJ, Bajwa EK. Vitamin D Status and Clinical Outcomes in Acute Respiratory Distress Syndrome: A Secondary Analysis From the Assessment of Low Tidal Volume and Elevated End-Expiratory Volume to Obviate Lung Injury (ALVEOLI) Trial. J Intensive Care Med. 2022;37(6):793-802.
  53. Thadhani R, Appelbaum E, Pritchett Y, Chang Y, Wenger J, Tamez H, Bhan I, Agarwal R, Zoccali C, Wanner C, Lloyd-Jones D, Cannata J, Thompson BT, Andress D, Zhang W, Packham D, Singh B, Zehnder D, Shah A, Pachika A, Manning WJ, Solomon SD. Vitamin D therapy and cardiac structure and function in patients with chronic kidney disease: the PRIMO randomized controlled trial. JAMA. 2012;307(7):674-684.
  54. Bhan I, Thadhani R. Vitamin D therapy for chronic kidney disease. Semin Nephrol. 2009;29(1):85-93.
  55. Powe CE, Evans MK, Wenger J, Zonderman AB, Berg AH, Nalls M, Tamez H, Zhang D, Bhan I, Karumanchi SA, Powe NR, Thadhani R. Vitamin D-binding protein and vitamin D status of black Americans and white Americans. N Engl J Med. 2013;369(21):1991-2000.
  56. Denburg MR, Bhan I. Vitamin D-Binding Protein in Health and Chronic Kidney Disease. Semin Dial. 2015;28(6):636-644.
  57. Powe CE, Ricciardi C, Berg AH, Erdenesanaa D, Collerone G, Ankers E, Wenger J, Karumanchi SA, Thadhani R, Bhan I. Vitamin D-binding protein modifies the vitamin D-bone mineral density relationship. J Bone Miner Res. 2011;26(7):1609-1616.