Charles A. Knirsch, MD, MPH

Vice President, Clinical Research and Development
Professional Address
Pfizer Vaccines Clinical Research

Education
1995 - M.P.H. Columbia University, New York, New York
1985 - M.D. McGill University, Montreal, Quebec, Canada
1981 - B.Sc. McGill University, Montreal, Quebec, Canada,

TRAINING

Research Fellow, 1990-1991, Division of Infectious Diseases, College of Physicians and Surgeons, Columbia University, New York, N.Y.

Clinical Fellow, 1989-1990, Division of Infectious Diseases, College of Physicians and Surgeons, Columbia University, New York, N.Y.

Diploma in Tropical Medicine and Hygiene, London University, London, England, 1989.

Intern and Resident, Department of Medicine, Columbia-Presbyterian Medical Center, New York, NY1985-1988.

Columbia University Academic Appointments/Date

The Presbyterian Hospital Appointments/Date

Pfizer Career Summary Brief

Program Lead, Therapeutic Vaccines, Clinical Research and Development, January 2014 - present

Clinical leadership of early development portfolio of pre-clinical to Phase 2 vaccines in atherosclerosis, allergy, smoking cessation, oncology and prevention of hospital acquired infections (C. difficile).

Global Head, Clinical Development, Specialty Therapeutics, January 2009 - December 2013

Managed ~ 200 FTE’s for Clinical, Statistics and Clinical Pharmacology at 7 Global Development sites across multiple disease areas in Specialty Therapeutics BU including: Inflammation, Rare Diseases, Vaccines, Infectious Diseases and Psychiatry.

New York Site Head, Clinical Research and Development, PGRD, October 2005-December 2008

Line leadership including statistical, PK-PD and clinical group (134 scientists).

Conduct of phase 1- 4 trials in all Pfizer therapeutic areas.

Service on several Pfizer Leadership Teams including Clinical Leadership Team, Informatics Governance, Global Medical Affairs, Clinical Quantitative and Innovative Medicine Leadership, Clinical Trial Policy Group and Multilateral Organisation Working Group.

Therapeutic Head, Anti-infectives, WW Development, May 2003 – October 2005

Led worldwide medical and clinical activities for antibacterials, antifungals, and antiviral medicines.

Director and Senior Medical Director, Pfizer Anti-infectives, July 1997-April 2003

Academic Leadership Positions

July 1990 – July 1997

· Physician in Charge, Washington Heights Tuberculosis Clinic, New York City Department of Health. Transformation of city clinic into a leading center of epidemiology and TB treatment during the resurgence of TB in New York City in the early 1990’s.

· Assistant Hospital Epidemiologist, Columbia Presbyterian Medical Center. Led integration of epidemiology with innovative medical informatics research, molecular epidemiology into applied disease management. In addition, public relations and media interaction were managed around sensitive hospital outbreaks including Legionella infections that received national attention in the hospital heart transplant program.

· AIDS Clinical Trials Group, Columbia University. Conducted phase 2/3 trials for anti-retroviral agents including initial protease inhibitor trials and combination therapy trials. Community advisory board in neighborhood with diverse ethnic backgrounds and vulnerable populations at risk of disease.

· Co-Director, Parasitic Diseases Course, Columbia University. Also, co-author of Parasitic Diseases, a widely used introductory text for clinicians and medical students.

Board Certification

Professional Societies and Committee Membership

Editorial Journal Reviewer

Federal Funded Research

Investigator-National Institutes of Allergy and Infectious Diseases - AIDS Clinical Trials Group (Columbia University site)-1993-1995.

Co-Principal Investigator—US Department of Commerce TIIAP 36-40-94065 "Applied Informatics," October 1994 to April 1996

Investigator for Columbia University subcontract (Carol Friedman overall PI)—National Library of Medicine R01 LM06274 "Unlocking data from medical records with text processing," July 1997 to June 2000

Principal Investigator- National Institutes of Allergy and Infectious Diseases- (Pfizer Inc- Collaborative Grant to Study Azithromycin Drug Combinations in Malaria)- October 2001NIH Grant recipient (# UC 1 A149500-01): Azithromycin combinations for the treatment of P. falciparum malaria.

NIH Study Section Service

Peer Reviewed Publications

1. Jain NL, Knirsch CA, Friedman C, Hripcsak G. Identification of suspected tuberculosis patients based on natural language processing of chest radiograph reports. J Am Med InformaticsAssoc 1996;3 (Suppl.)542

2. Pablos-Mendez A, Knirsch CA, Barr RG, Lerner BH, Frieden TR. Noncompliance with antituberculosis treatment: Predictors and consequences in New York City. Am J Med 1997;102:164-170.

3. Pablos-Mendez A, Blustein J, Knirsch CA. The role of diabetes mellitus in the higher prevalence of tuberculosis among Hispanics. Am J Public Health 1997; 87:574-579.

4. Hripcsak G, Knirsch CA, Jain NL, Pablos-Mendez A. Automated tuberculosis detection. J Am Med Informatics Assoc 1997;4:376-381.

5. Knirsch CA, Jain NL, Pablos-Mendez A, Friedman C, Hripcsak G. Tuberculosis Detection and Monitoring by an Automated Clinical Decision Support System. Infect Control Hosp Epidemiol 1998;19 (2) 94-100.

6. Hripcsak G, Knirsch CA, Jain N, Stazesky RC, Pablos-Mendez A, Fulmer T. A health information network for managing inner-city Tuberculosis: Bridging clinical care, public health, and home care. Computers and Biomedical Research 1999 Feb;32 (1):67-76.

7. Neu N, Saiman L, San Gabriel P, Whittier S, Knirsch CA, Ruzal-Shapiro C, Della-Latta P. Diagnosis of Pediatric Tuberculosis in the modern era. PIDJ 1999;18 (2):122-126.

8. Friedman C, Knirsch CA, Shagina L, Hripcsak G. Automating a severity score guideline for community-acquired pneumonia employing medical language processing of discharge summaries. Proc AMIA Symp 1999;:256-60

9. Knirsch CA, Jakob KA, Schoonmaker D, Kiehlbauch J, Wong S, Della-Latta P, Whittier S, Layton M, Scully B. Legionella micdadei pneumonia in transplant patients: Molecular Epidemiology and Control. Am J Med 2000; 108: 290-295.

10. Plouffe J, Schwartz DB, Kolokathis A, Sherman BW, Gezon JA, Suh B, Anzuetto A, Greenberg RN, Niederman M, Paladino JA, Ramirez, JA Inverso J, Knirsch CA. Clinical Efficacy of Intravenous Followed by Oral Azithromycin Monotherapy in Hospitalized Patients with Community-Acquired Pneumonia. Antimicrobial Agents and Chemotherapy 2000:Jul;44(7):1796-802.

11. Currier JS,Williams PL, Koletar SL, Cohn SE, Murphy RL, Heald AE, Hafner R,Bassily EL,Lederman HM, Knirsch CA, Benson CA, Valdez H, Aberg A, McCutchan JA for the ACTG 362 study team. Discontinuation of MAC prophylaxis for subjects with antiretroviral therapy induced CD4 increases: a randomized double-blind placebo controlled trial. Ann Intern Med. 2000 Oct 3;133(7):493-503.

12. Barr RG, Diez-Roux AV, Knirsch CA, Pablos-Méndez A. Neighborhood poverty and the resurgence of Tuberculosis in New York City, 1984 to 1992. Am J Public Health 2001 Sep;91(9):1487-93.

13. Luchsinger JA, Pablos-Mendez A, Knirsch CA, Rabinowitz D, Shea S. Antibiotic use and risk of ischemic stroke in the general population. Am J Med 2001 Oct 1;111 (5) :361-6.

14. Luchsinger JA, Pablos-Mendez A, Knirsch CA, Rabinowitz D, Shea S. Antibiotic use and risk of myocardial infarction in the general population. Am J Cardiol 2002 Jan 1;89 (1):18-21

15. Saiman L, Chen Y, San Gabriel P, Knirsch CA. Synergistic activity of macrolide antibiotics against Pseudomonas aeruginosa, Burkholderia cepacia, Stenotrophomonas maltophilia and Alcaligenes xylosoxidans isolated from patients with cystic fibrosis. Antimicrob Agents and Chemother 2002 Apr;46(4):1105-7.

16. Ohrt C, Willingmyre GD, Lee P, Knirsch CA, Milhous W. Assessment of Azithromycin Drug-Combinations against Plasmodium falciparum in vitro. Antimicrob Agents and Chemother 2002 Aug;46(8):2518-24.

17. Batt SL, Charalambous BM, Solomon AW, Knirsch CA, Massae PA, Safari S, Sam NE, Everett D, Mabey D, Gillespie SH. Impact of azithromycin administration for trachoma control on the carriage of antibiotic resistant Streptococcus pneumoniae. Antimicrob Agents Chemother 2003 Sep;47(9):2765-9.

18. Adachi JA, Ericsson CD, Jiang ZD, DuPont MW, Martinez-Sandoval F, Knirsch C, DuPont HL. Azithromycin found to be comparable to levofloxacin for the treatment of US travelers with acute diarrhea acquired in Mexico. Clin Infect Dis. 2003 Nov 1;37(9):1165-71.

19. Mecaskey JW, Knirsch CA, Kumaresan JA, Cook JA. The possibility of eliminating blinding trachoma. Lancet Infect Dis. 2003 Nov;3(11):728-34.

20. Plouffe JF, Breiman RF, Fields BS, Herbert M, Inverso J, Knirsch C, Kolokathis A, Marie TJ, Nicolle L, Schwartz DB. Azithromycin in the treatment of Legionella pneumonia requiring hospitalization. Clin Infect Dis. 2003 Dec 1;37(11):1475-80.

21. Frenck RW Jr, Mansour A, Nakhla I, Sultan Y, Putnam S, Wierzba T, Morsy M, Knirsch C. Short-course azithromycin for the treatment of uncomplicated typhoid fever in children and adolescents. Clin Infect Dis. 2004 Apr 1;38(7):951-7.

22. Jacobs RF, Maples HD, Aranda JV, Espinoza GM, Knirsch C, Chandra R, Fisher JM, Kearns GL. Pharmacokinetics of intravenously administered azithromycin in pediatric patients. Pediatr Infect Dis J. 2005 Jan;24(1):34-9.

23. Weigelt J, Itani K, Stevens D, Lau W, Dryden M, Knirsch CA. Linezolid Versus Vancomycin in the Treatment of Complicated Skin and Soft Tissue Infections. Antimicrob Agents Chemother 2005 Jun;49(6):2260-6.

24. Grayston JT, Kronmal RA, Jackson LA, Parisi AF, Muhlestein JB, Cohen JD, Rogers WJ, Crouse JR, Borrowdale SL, Schron E, Knirsch CA. Antibiotic Treatment for Secondary Prevention of Coronary Events: Results of the Azithromycin and Coronary Events Study (ACES). The New England Journal of Medicine2005 Apr 21;352(16):1637-45

25. Miller RS, Wongsrichanalai C, Buathong N, McDaniel P, Walsh DS, Knirsch C, Ohrt C. Azithromycin-quinine combination therapy is effective for the treatment of uncomplicated falciparum malaria: a randomized, dose-ranging study. American Journal of Tropical Medicine and Hygiene 2006 Mar;74(3):401-6.

26. Noedl H, Krudsood S, Chalermratana K, Silachamroon U, Leowattana W, Tangpukdee N, Looareesuwan S, Miller RS, Fukuda M, Jongsakul K, Sriwichai S, Rowan J, Bhattacharyya H, Ohrt C, Knirsch C. Azithromycin combination therapy with artesunate or quinine for the treatment of uncomplicated Plasmodium falciparum malaria in adults: a randomized, phase 2 clinical trial in Thailand. Clin Infect Dis. 2006 Nov 15;43(10):1264-71.

27. Noedl H, Krudsood S, Leowattana W, Tangpukdee N, Thanachartwet W, Looareesuwan S, Miller RS, Fukuda M, Jongsakul K, Yingyuen K, Sriwichai S, Ohrt C, Knirsch C. In vitro antimalarial activity of azithromycin, artesunate, and quinine in combination and correlation with clinical outcome. Antimicrob Agents Chemother. 2007 Feb;51(2):651-6.

28. Hripcsak G, Knirsch C, Zhou L, Wilcox A, Melton GB. Using discordance to improve classification in narrative clinical databases: an application to community-acquired pneumonia. Comput Biol Med. 2007 Mar;37(3):296-304.

29. Amsden GW, Gregory TB, Michalak CA, Glue P, Knirsch CA. Pharmacokinetics of azithromycin and the combination of ivermectin and albendazole when administered alone and concurrently in healthy volunteers.
Am J Trop Med Hyg. 2007 Jun;76(6):1153-7.

30. El-Tahtawy A, Glue P, Andrews EN, Mardekian J, Amsden GW, Knirsch CA. The Effect of Azithromycin on Ivermectin Pharmacokinetics – A Population Pharmacokinetic Model Analysis. PLoS Negl Trop Dis. 2008 May 14;2(5):e236.

31. Wilcox MH, Tack KJ, Bouza E, Herr DH, Ruf, BR, Ijzerman MM, Croos-Dabrera RV, Kunkel MJ, Knirsch CA. Complicated Skin/Skin Structure Infections and Catheter-Related Bloodstream Infections: Non-inferiority of Linezolid in a Phase III Study. Clin Infec Dis, 2009 Jan 15;48(2):203-12

32. Alemayehu D, Andrews EN, Glue P, Knirsch CA. Considerations for the design and conduct of a pharmacovigilance study involving mass drug administration in a resource constrained setting. PLoS Negl Trop Dis. 2010 Jan 26;4(1):e564.

33. Hripcsak G, Knirsch C, Zhou L, Wilcox A, Melton G. Bias associated with mining electronic health records. J Biomed Discov Collab. 2011 Jun 6;6:48-52

34. Alemayehu D, Quinn J, Cook J, Kunkel M, Knirsch CA. A paradigm shift in drug development for treatment of rare multidrug-resistant gram-negative pathogens. Clin Infect Dis. 2012 Aug;55(4):562-7

35. Rex JH, Eisenstein BI, Alder J, Goldberger M, Meyer R, Dane A, Friedland I, Knirsch C, Sanhai WR, Tomayko J, Lancaster C, Jackson J. A comprehensive regulatory framework to address the unmet need for new antibacterial treatments. Lancet Infect Dis. 2013 Mar;13(3):269-75.

36. van der Ryst E, Heera J, Demarest J, Knirsch C. Development of maraviroc, a CCR5 antagonist for treatment of HIV, using a novel tropism assay. Ann N Y Acad Sci. 2015 Jun;1346(1):7-17.

37. Knirsch C, Alemayehu D, Botgros R, Comic-Savic S, Friedland D, Holland T, Merchant K, Noel GJ, Pelfrene E, Reith C, Santiago J, Tiernan R, Tenearts P, Goldsack JC, Fowler VG. Improving Conduct and Feasibility of Clinical Trials to Evaluate Antibacterial Drugs to Treat Hospital Acquired Bacterial Pneumonia (HABP) and Ventilator Associated Bacterial Pneumonia (VABP): Recommendations of the CTTI Antibacterial Drug Development (ABDD) Working Group. Clin Infect Dis. 2016 Aug 15;63 Suppl 2:S29-36.

38. Donnelly H, Alemayehu D, Botgros R, Comic-Savic S, Eisenstein B, Lorenz B, Merchant K, Pelfrene E, Reith C, Santiago J, Tiernan R, Wunderink R, Tenaerts P Knirsch C. Streamlining Safety Data Collection in Hospital-Acquired Bacterial Pneumonia (HABP) and Ventilator-Associated Bacterial Pneumonia (VABP) Trials: Recommendations of the CTTI Antibacterial Drug Development (ABDD) Working Group. Clin Infect Dis. 2016 Aug 15;63 Suppl S39-45.

Review Articles/Textbooks/Supplements

1. Knirsch CA. Travel medicine and health issues in university student travelers. Physicians and Surgeons Med Review. 1997; 4 (2): 3-11.

2. Knirsch CA. Travel medicine and health issues for families traveling with children. Advances in Pediatric Infectious Diseases 1999;14 (8): 163-189.

3. Parasitic Diseases, Fourth Edition. Authors: Despommier DD, Gwadz R, Hotez P, Knirsch CA. Apple Trees Productions LLC, New York, 2000.

4. Rosen H, Muhlestein JB, Bartlett J, Chen S, Chikami G, Corson M, Shah PK, Gurfinkel E, Handsfield H, Jackson L, Knirsch C, Kronmal R, McCutchan JA, Shea S. Collaborative Multidisciplinary Workshop Report: Clinical Antimicrobial Trials for Primary and Secondary Prevention of Atherosclerotic Cardiovascular Disease. J Infect Dis 2000 Jun;181(Suppl 3):S582-S584

5. Knirsch CA, Mecaskey J, Chami-Khazraji Y, Kilima P, West S, Cook J. Trachoma Elimination and a Public Private Partnership: The International Trachoma Initiative (ITI). Proceeding 12th International Chlamydia Conference. Ed; Schachter J et al 2002.

6. Knirsch CA, Cook J. Trachoma: Progress and Promise. Preface, Centennial Meeting of the American Society of Tropical Medicine and Hygiene, 2003. Am J Trop Med Hyg, 69 (suppl 5), 2003, pp 1-35.

7. Parasitic Diseases, Fifth Edition. Authors: Despommier DD, Gwadz R, Hotez P, Knirsch CA. Apple Trees Productions LLC, New York, 2005.

8. Proceedings of the Eleventh International Symposium on Human Chlamydial Infections. Ed: Chernesky M, Caldwell H, Christiansen G, Clarke I, Kaltenboeck, B, Knirsch C, Kuo CC, Mahony J, Rank, R, Saikku P, Schachter J, Stamm W, Stephens R, Summersgill J, Timms, P, Wyrick P. International Chlamydial Symposium, San Francisco, 2006.

9. Knirsch C. Trachoma: ancient scourge, disease elimination, and future research.
Curr Infect Dis Rep. 2007 Jan;9(1):21-8.

10. Knirsch CA, Chandra R. Azithromycin and the risk of cardiovascular death. N Engl J Med. 2012 Aug 23;367(8):772-3

11. Alemayehu D, Utt E, Knirsch C. Vaccines: A review of immune-based interventions to prevent and treat disease. J Clin Pharm. 2015 55(S3) S93-S102.

7/1/90 - 6/30/91	Assistant in Clinical Medicine
7/1/91 - 1/31/93	Instructor in Clinical Medicine
2/1/94- 6/31/97	Assistant Clinical Professor of Medicine
7/1/97-present	Adjunct Assistant Professor of Medicine

7/1/90 - 6/30/91	Clinical Assistant Physician
7/1/91 - 1/31/93	Assistant Physician
6/1/95 - 6/30/97	Assistant Hospital Epidemiologist
2/1/94 – 6/30/97	Assistant Attending Physician

Charles A. Knirsch, MD, MPH