ELIZABETH LAUREN ALEXANDER

I am a physician scientist with a broad background in infectious diseases, allergy/immunology and oncology spanning 10+ years in the biotech and pharmaceutical industry. My experience ranges from first-in-human to phase IV trials, including IND submission, EUA submission, NDA/MAA submission and BLA preparation for both small molecules and biologics. These efforts resulted in regulatory approval and launch of 5 therapeutic agents (Sotrovimab, Lefamulin, Meropenem-Vaborbactam, Minocycline (EU) and Oritavancin). I am passionate about developing talent, building teams and leveraging innovative clinical development strategies to bring forward new scientific discoveries and address unmet medical needs.

• Clinical and Translational Science Center Program in Clinical Investigation (K30), Weill Cornell Graduate School of Medical Sciences, 09/01/08, 05/31/14, Master of Science
• Fellow, Division of Infectious Diseases, Weill Cornell Medical College/New York and Presbyterian Hospital, 07/01/07, 06/30/10
• Resident, Internal Medicine, The Mount Sinai Hospital, 07/01/04, 06/30/07

• 2019, Elected to Fellow, Infectious Diseases Society of America
• 2019, Recertification, ABIM, Infectious Diseases
• 2013, President’s Council of Cornell Women (PCCW) Affinito-Stewart Award
• 2013, National Institutes of Health, Loan Repayment Program Award
• 2011, American Society for Microbiology Young Investigator Award, ASM
• 2010, IDSA Program Committee Choice Award
• 2010, 8th Annual Department of Medicine Fellows Research Award Winner
• 2009, Diplomate, ABIM; Infectious Diseases
• 2007, Diplomate, ABIM; Internal Medicine
• 2006, New York State License #239476
• 2006, Advancing Clinical Excellence in Medicine Training Grant Mount Sinai School of Medicine
• 2004, B.H. Kean Class of 1964 Fellowship, Cornell University Medical College
• 1999, Psi Chi Honor Society, Stanford University

• 2021-present, Member, Clinical Trials Transformation Initiative (CTTI) Steering Committee.
• 2016-2017, Member, Clinical Trials Transformation Initiative (CTTI) HABP/VABP Studies Team.
• 2015-2017, Member, FNIH HABP/VABP Project Team
• 2019-present, Member, American College of Physicians
• 2014-present, Member, European Society for Clinical Microbiology and Infectious Diseases.
• 2007-present, Member, Infectious Disease Society of America., Advanced to Fellow 2018
• 2009-present, Member, American Society for Microbiology.
• 2011-present, Member, New York Academy of Sciences.

• Clinical failure of vancomycin in a dialysis patient with methicillin-susceptible vancomycin-heteroresistant S.aureus, Fusco D., Alexander E., Weisenberg S., Mediavilla J., Kreiswirth B., Schuetz A., Jenkins S., and K.Y. Rhee., Diagn Microbiol Infect Dis, 2009, 65, 2, 180-183
• Endemic Acinetobacter baumanii in a New York Hospital, Weisenberg SA, Schuetz AN, Alexander EL, Eiss B, Behta M, Laiman L, Larone DH, Jenkins SG and K.Y. Rhee, PLoS One, 2011, 6, 12, e28566, 2011-12-13
• Prevalence, persistence and microbiology of Staphylococcus aureus nasal carriage among hemodialysis outpatients at a major New York Hospital, Alexander EL, Morgan DJ, Kesh S, Weisenberg SA, Zaleskas JM, Kaltsas A, Chevalier J, Silbersweig J, Barron Y, Mediavilla JR, Kreiswirth BK and K. Y. Rhee, Diagn Microbiol Infect Dis, 2011, 70, 1, 37-44
• Extended Spectrum Beta-Lactamase-producing Enterobacteriaceae in International Travelers and Non-Travelers in New York City, Weisenberg S, Chen, Alexander E, Kreiswirth B, PLoS One, 2012, 7, 9, e45141, 2012-09-20
• Translational research in infectious disease: current paradigms and challenges ahead, Fontana J, Alexander EL, Salvatore M, Translational Research, 2012, 159, 6, 430-53, 2012-01-15
• Candida Osteomyelitis: Analysis of 207 Pediatric and Adult Cases (1970-2011), Gamaletsou MN, Kontoyiannis DP, Sipsas NV, Moriyama B, Alexander E, Brause B and TJ Walsh, Clin Infect Dis, 2013, 55, 10, 1338-51
• Worldwide challenges of multidrug-resistant bacteria in patients with hematologic malignancies, Alexander EL, Satlin MJ, Gamaletsou MN, Sipsas NV and TJ Walsh, Int J Hematol Onco, 2013, 2, 5, 377-390
• Intermediate-type vancomycin resistance (VISA) of Staphylococcus aureus is linked to specific alterations of intermediary metabolism, Alexander EL, Gardete SJ, Bar HY, Wells MT, Tomasz A and KY Rhee, PLoS One, 2014, 9, 5, e97137, 2014-05-09
• Heirarchical expression of the Bacillus subtilis CodY regulon, Brinsmeade SR, Alexander EL, Livny J, Stettner AI, Segre D, Rhee KY and AL Sonnenshein, Proceedings of the National Academy of Sciences USA, 2014, 111, 22, 8827-32, 2014-06-03
• In vitro Interactions between Farnesol and Fluconazole, Amphotericin B or Micafungin against Candida albicans Biofilms, Katragkou A, McCarthy M, Alexander EL, Antachopoulos C, Meletiadis J, Jabra-Risk MA, Petraitis V, Roilides E and TJ Walsh, Journal Antimicrobial Chemotherapy, 2015, 70, 2, 470-478
• Effects of fluconazole on the metabolomics profile of Candida albicans, Katragkou A, Alexander EL, Eoh H, Raheem SK, Rolides E and TJ Walsh, Journal Antimicrobial Chemotherapy, 2016, 71, 3, 635-40
• Carbapenem-resistant Enterobacteriaceae: Results from a retrospective series and implications for the design of prospective clinical trials, Alexander EL, Loutit J, Tumbarello M, Wunderink R, Felton T, Daikos G, Fusaro K, White D, Zhang S and MN Dudley, Open Forum Infectious Disease, 2017, 4, 2, oxf063, 2017-06-01
• Effect of Meropenem-Vaborbactam vs Piperacillin-Tazobactam on Clinical Cure or Improvement and Microbial Eradication in Complicated Urinary Tract Infection: The TANGO I Randomized Clinical Trial, Kaye K, Bhowmick T, Metallidis S, Bleasdale S, Sagan OS, Stus V, Vazquez J, Ziatsev V, Bidair M, Chorvat E, Dragoescu PO, Fedosiuk E, Horcajada JP, Murta C, Sarychev Y, Stoev V, Morgan E, Fusaro K, Griffith D, Lomovskaya O, Alexander EL, Loutit J, Dudley MN and EJ Giamarellos-Bourboulis, JAMA, 2018, 319, 8, 788-799, 2018-02-27
• Ex vivo characterisation of effects of renal replacement therapy modalities and settings on pharmacokinetics of meropenem and vaborbactam., Sime FB, Pandey S, Karamujic N, Parker S, Alexander E, Loutit J, Durso S, Griffith D, Lipman J, Wallis SC, Roberts JA., Antimicrob Agents Chemother, 2018, 2018-08-06
• Effect and Safety of Meropenem-Vaborbactam versus Best Available Therapy in Patients with Carbapenem-Resistant Enterobacteriaceae Infections: The TANGO II Randomized Clinical Trial, Wunderink RG, Giamarellos-Bourboulis EJ, Rahav G, Mathers AJ, Bassetti M, Vazquez J, Cornely OA, Solomkin J, Bhowmick T, Bishara J, Daikos GL, Felton T, Furst MJL, Kwak EJ, Menichetti F, Oren I, Alexander EL, Griffith D, Lomovskaya O, Loutit J, Zhang S, Dudley MN, Kaye KS., Infect Dis Ther, 2018, 7, 4, 439-455, 2018-12-07
• Oral Lefamulin vs Moxifloxacin for Early Clinical Response Among Adults With Community-Acquired Bacterial Pneumonia: The LEAP Randomized Clinical Trial, Alexander E, Goldberg L, Das AF, Moran GJ, Sandrock C, Gasink LB, Spera P, Sweeney C, Paukner S, Wicha WW, Gelone SP, and J Schranz, JAMA, 2019, 2019-09-27
• Post Hoc Assessment of Time to Clinical Response Among Adults Hospitalized with Community-Acquired Bacterial Pneumonia Who Received Either Lefamulin or Moxifloxain in Two Phase III Randomized, Double-Blind, Double-Dummy Clinical Trials, Lodise T, Colman S, Stein D, Fitts D, Goldberg L, Alexander E, Scoble P and Schranz J, Open Forum Inf Dis, 2020, 7, 5, 145-149
• Health-related quality of life as measured by the 12-item short-form survey among adults with community-acquired bacterial pneumonia who received either lefamulin or moxifloxacin in two phase III randomized, double-blind, double-dummy clinical trials, Lodise T, Colman S, Alexander E, Stein D, Fitts D, Goldberg L and J Schranz, Open Forum Inf Dis, 2020, Accepted, 05/26/20
• Impact of pathogen identification and guideline concordant therapy on hospitalized US patients with community-acquired pneumonia, Alexander E, Tabak Y, Gupta V, Yu K, Zilberberg M and A Shorr, Annals ATS, 2020, Accepted, 06/21/20
• Reply to “Lefamulin for treating community-acquired bacterial pneumonia in adult patients age
• Lefamulin efficacy and safety in a pooled phase 3 clinical trial population with community acquired bacterial pneumonia and common clinical comorbidities, File T, Alexander E, Goldberg L, Das A, Sandrock C, Paukner S and GJ Moran, BMC Pulmonary Med, 2021, 05/08/21
• Oral 5-Day Lefamulin for Outpatient Management of Community-Acquired Bacterial Pneumonia: Post-Hoc Analysis of the Lefamulin Evaluation Against Pneumonia (LEAP) 2 Trial, LoVecchio F, Schranz J, Alexander E, Mariano D, Meads A, Sandrock C, Moran G and P. Giordano, J Emerg Med, 2021, 06/01/21
• Early Treatment for COVID-19 with SARS-CoV-2 Neutralizing Antibody Sotrovimab., Gupta A, Gonzalez-Rojas Y, Juarez E, Crespo Casal M, Moya J, Falci DR, Sarkis E, Solis J, Zheng H, Scott N, Cathcart AL, Hebner CM, Sager J, Mogalian E, Tipple C, Peppercorn A, Alexander E, Pang PS, Free A, Brinson C, Aldinger M, Shapiro AE; COMET-ICE Investigators., New Engl J Med, 2021, 11/18/21, 385, 21, 1941-1950
• Pooled Microbiological Findings and Efficacy Outcomes by Pathogen in Adults With Community-Acquired Bacterial Pneumonia from the Lefamulin Evaluation Against Pneumonia (LEAP) 1 and LEAP 2 Phase 3 Trials of Lefamulin Versus Moxifloxacin, Paukner, S., Goldberg L, Alexander E, Das A, Heinrich S, Patel P, Moran G, Sandrock C, File TM, Vidal J, Waites K, Gelone S and J. Schranz, J. Glob. Antimicrob. Resist., 2022, 06/01/22, 29, 434-443
• Effect of sotrovimab on hospitalization or death among high-risk patients with mild to moderate COVID19: a randomized clinical trial., Gupta A, Gonzalez-Rojas Y, Juarez E, Crespo Casal M, Moya J, Rodrigues Falci D, Sarkis E, Solis J, Zheng H, Scott N, Cathcart AL, Parra S, Sager JE, Austin D, Peppercorn A, Alexander E, Yeh WW, Brinson C, Aldinger M, Shapiro AE; COMET-ICE Investigators., JAMA, 2022, 327, 13, 1236-1246, 10.1001/jama.2022.2832
• Efficacy and safety of two neutralising monoclonal antibody therapies, sotrovimab and BRII-196 plus BRII-198, for adults hospitalised with COVID-19 (TICO): a randomised controlled trial., ACTIV-3/Therapeutics for Inpatients with COVID-19 (TICO) Study Group, Lancet Inf Dis, 2022, 22, 5, 622-635
• Antibody therapy reverses biological signatures of COVID-19 progression., Maher, MC, Soriaga LB, Gupta A, Chen YP, di Iulio J, Ledoux S, Smithey MJ, Cathcart AL, McKusick K, Sun D, Aldinger M, Alexander E, Purcell L, Ding X, Peppercorn A, Austin D, Mogalian E, Yeh WW, Shapiro AE, Corti D, Virgin HW, Pang PS, Telenti A., Cell Rep Med., 2022, 3, 8, 100721
• Intramuscular Versus Intravenous SARS-CoV-2 Neutralising Antibody Sotrovimab for Treatment of COVID-19 (COMET-TAIL): A Randomised Non-inferiority Clinical Trial, Shapiro AE, Sarkis E, Acloque J, Free A, Gonzalez-Rojas Y, Hussain R, Juarez E, Moya J, Parikh N, Inman D, Cebrik D, Nader A, Moormohamed N, Wang Q, Skingsley A, Austin D, Peppercorn A, Parra S, Chow S, Mogalian E, Pang PS, Hong D, Sager J, Yeh WW, Alexander E, Gaffney L and A. Kohli, Lancet Preprints, 2023, 07/14/23
• The Association of Baseline Plasma SARS-CoV-2 Nucleocapsid Antigen Level and Outcomes in Patients Hospitalized With COVID-19, ACTIV-3/TICO Study Group., Ann Intern Med, 2022, 175, 10, 1401-1410, 10/01/22
• Population pharmacokinetics and exposure-response analysis of a single dose of sotrovimab in the early treatment of patients with mild to moderate COVID-19., Sager JE, El-Zailik A, Passarell J, Roepcke S, Li X, Aldinger M, Nader A, Skingsley A, Alexander EL, Yeh WW, Mogalian E, Garner C, Peppercorn A, Shapiro AE, Reyes M., CPT Pharmacometrics Syst Pharmacol., 2023, 12, 6, 853-864, 06/01/23
• Assessment of symptoms in COMET-ICE, a phase 2/3 study of sotrovimab for early treatment of non-hospitalized patients with COVID-19., Shapiro AE, Sarkis E, Acloque J, Free A, Gonzalez-Rojas Y, Hussain R, Juarez E, Moya J, Parikh N, Inman D, Cebrik D, Nader A, Noormohamed N, Wang Q, Skingsley A, Austin D, Peppercorn A, Agostini ML, Parra S, Chow S, Mogalian E, Pang PS, Hong DK, Sager JE, Yeh WW, Alexander EL, Gaffney LA, Kohli A., J Patient Rep Outcomes., 2023, 7, 1, 92, 09/13/23
• Pharmacokinetics, Safety and Tolerability of Anti-SRAS-CoV-2 Monoclonal Antibody, Sotrovimab, Delivered Intravenously or Intramuscularly in Japanese and Caucasian Healthy Volunteers., Nader A, Alexander E, Brintziki D et al, Clin Pharmacokinet., 2024, 63, 1, 57-63, 01/01/24
• Viral and Host Factors Are Associated with Mortality in Hospitalized patients with COVID-19, Aggarwal N, Nordwal J, Braun D et al, Clin Infect Dis, 2024, 02/20/24
• Effect of Neutralizing Monoclonal Antibody Treatment on Early Trajectories of Virologic and Immunologic Biomarkers in Patients Hospitalized with COVID-19, Jensen T, Grandits G, Jain M et al, J Infect Dis, 2024, 03/14/24

• Assistant Professor of Medicine, Weill Cornell Medical College, Division of Infectious Diseases, Department of Medicine, 09/01/12, 06/30/14
• Instructor in Medicine, Weill Cornell Medical College, Division of Infectious Diseases, Department of Medicine, 09/01/10, 06/30/12