Keywords
Last Name

Lindsay A McNair, MD, MPH

TitleAdjunct Assistant Professor
InstitutionBoston University School of Public Health
DepartmentEpidemiology
Phone(617) 782-3698
 Research Expertise & Professional Interests
Dr. McNair is Principal Consultant at Equipoise Consulting, LLC. As a consultant to pharmaceutical and biotechnology companies, Dr. McNair provides medical guidance on clinical development strategies and study design for new drugs, medical oversight all phases of clinical trials, and medical review of marketing and educational materials. She was formerly the Senior Medical Director for Clinical Development and Medical Affairs at Vertex Pharmaceuticals.

She is an adjunct Assistant Professor at Boston University and teaches in the Master’s of Clinical Investigation graduate programs on the scientific design of clinical research studies. Her areas of interest include the ethical issues of pharmaceutical drug development and marketing, and interactions between research review boards and the pharmaceutical industry.

Dr. McNair graduated from the University of Connecticut School of Medicine and trained in general surgery at Boston University Medical Center. She completed her Master’s in Public Health at Boston University, concentrating in Biostatistics/Epidemiology. She was a member of the Institutional Review Board at Boston University Medical Center for several years, and founded and chaired the Human Subject Protection Committee at Vertex Pharmaceuticals. She is an active member of PRIM&R and was a Site Visitor for the Association for the Accreditation of Human Research Protection Programs (AAHRPP).

Lindsay McNair, MD, MPH, MSBioethics is the Chief Medical Officer for the WIRB-Copernicus Group (WCG). Dr. McNair has extensive experience in the pharmaceutical industry working in clinical research and drug development. Prior to joining WCG, she was a consultant to pharmaceutical and biotechnology companies, providing medical guidance on clinical development strategies and study designs for new drug studies, and medical oversight of all phases of clinical trials. Dr. McNair is adjunct faculty at Boston University and teaches graduate-level courses on the scientific design of clinical research studies, research ethics and the responsible conduct of research, and the development of clinical study protocols. She now oversees the physician team within the WCG IRBs, and provides consultation to institutions and pharma/biotech companies on a wide range of issues related to protocol design, regulatory compliance, human subject protection, and ethical policy development (compassionate use, etc).

Dr. McNair graduated from the University of Connecticut School of Medicine and trained in general surgery at Boston University Medical Center. She completed her Master’s in Public Health at Boston University concentrating in Biostatistics/Epidemiology, and her Master’s of Science in Bioethics at Union Graduate College concentrating in research ethics. She was a member of the Institutional Review Board at Boston University Medical Center, and founded and chaired the Human Subject Protection Committee at Vertex Pharmaceuticals. She was a site visitor for the Association of the Accreditation of Human Research Protection Programs (AAHRPP). Dr. McNair serves on committees including the Multi-Regional Clinical Trials Center at Harvard, and is an associate editor of the Journal of Empirical Research on Human Research Ethics.

 Publications
Publications listed below are automatically derived from MEDLINE/PubMed and other sources, which might result in incorrect or missing publications. Faculty can login to make corrections and additions.
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  1. Li RH, Wacholtz MC, Barnes M, Boggs L, Callery-D'Amico S, Davis A, Digilova A, Forster D, Heffernan K, Luthin M, Lynch HF, McNair L, Miller JE, Murphy J, Van Campen L, Wilenzick M, Wolf D, Woolston C, Aldinger C, Bierer BE. Incorporating ethical principles into clinical research protocols: a tool for protocol writers and ethics committees. J Med Ethics. 2016 Apr; 42(4):229-34. PMID: 26811365.
    View in: PubMed
  2. Cooper JA, McNair L. Sham Surgery Research. J Empir Res Hum Res Ethics. 2015 Dec; 10(5):496-8. PMID: 26564946.
    View in: PubMed
  3. McNair LA, Biffl WL. Assessing Awareness and Implementation of a Recommendation for Surgical Innovation Committees: A Survey of Academic Institutions. Ann Surg. 2015 Dec; 262(6):941-8. PMID: 25373465.
    View in: PubMed
  4. Cooper JA, McNair L. How to distinguish research from quality improvement. J Empir Res Hum Res Ethics. 2015 Apr; 10(2):209-10. PMID: 25819760.
    View in: PubMed
  5. Cooper JA, McNair L. Simplifying the complexity of confidentiality in research. J Empir Res Hum Res Ethics. 2015 Feb; 10(1):100-2. PMID: 25742671.
    View in: PubMed
  6. Cooper JA, McNair L. What Is the Role of a Statistician on the IRB? J Empir Res Hum Res Ethics. 2014 Dec; 9(5):89-90. PMID: 25747693.
    View in: PubMed
  7. Cooper JA, McNair L. IRB Authority. J Empir Res Hum Res Ethics. 2014 Oct; 9(4):86-7. PMID: 25747299.
    View in: PubMed
  8. Curry MP, Forns X, Chung RT, Terrault NA, Brown R, Fenkel JM, Gordon F, O'Leary J, Kuo A, Schiano T, Everson G, Schiff E, Befeler A, Gane E, Saab S, McHutchison JG, Subramanian GM, Symonds WT, Denning J, McNair L, Arterburn S, Svarovskaia E, Moonka D, Afdhal N. Sofosbuvir and ribavirin prevent recurrence of HCV infection after liver transplantation: an open-label study. Gastroenterology. 2015 Jan; 148(1):100-107.e1. PMID: 25261839.
    View in: PubMed
  9. Cooper JA, McNair L. Scientific review by the ethics committee. J Empir Res Hum Res Ethics. 2014 Jul; 9(3):93-4. PMID: 25746791.
    View in: PubMed
  10. Garg V, Chandorkar G, Yang Y, Adda N, McNair L, Alves K, Smith F, van Heeswijk RP. The effect of CYP3A inhibitors and inducers on the pharmacokinetics of telaprevir in healthy volunteers. Br J Clin Pharmacol. 2013 Feb; 75(2):431-9. PMID: 22642697.
    View in: PubMed
  11. Glickman SW, Galhenage S, McNair L, Barber Z, Patel K, Schulman KA, McHutchison JG. The potential influence of Internet-based social networking on the conduct of clinical research studies. J Empir Res Hum Res Ethics. 2012 Feb; 7(1):71-80. PMID: 22378136.
    View in: PubMed
  12. Kablinger AS, Lindner MA, Casso S, Hefti F, DeMuth G, Fox BS, McNair LA, McCarthy BG, Goeders NE. Effects of the combination of metyrapone and oxazepam on cocaine craving and cocaine taking: a double-blind, randomized, placebo-controlled pilot study. J Psychopharmacol. 2012 Jul; 26(7):973-81. PMID: 22236504.
    View in: PubMed
  13. Rustgi VK, Lee WM, Lawitz E, Gordon SC, Afdhal N, Poordad F, Bonkovsky HL, Bengtsson L, Chandorkar G, Harding M, McNair L, Aalyson M, Alam J, Kauffman R, Gharakhanian S, McHutchison JG. Merimepodib, pegylated interferon, and ribavirin in genotype 1 chronic hepatitis C pegylated interferon and ribavirin nonresponders. Hepatology. 2009 Dec; 50(6):1719-26. PMID: 19852040.
    View in: PubMed
  14. McHutchison JG, Everson GT, Gordon SC, Jacobson IM, Sulkowski M, Kauffman R, McNair L, Alam J, Muir AJ. Telaprevir with peginterferon and ribavirin for chronic HCV genotype 1 infection. N Engl J Med. 2009 Apr 30; 360(18):1827-38. PMID: 19403902.
    View in: PubMed
  15. Hézode C, Forestier N, Dusheiko G, Ferenci P, Pol S, Goeser T, Bronowicki JP, Bourlière M, Gharakhanian S, Bengtsson L, McNair L, George S, Kieffer T, Kwong A, Kauffman RS, Alam J, Pawlotsky JM, Zeuzem S. Telaprevir and peginterferon with or without ribavirin for chronic HCV infection. N Engl J Med. 2009 Apr 30; 360(18):1839-50. PMID: 19403903.
    View in: PubMed
  16. Kwong AD, McNair L, Jacobson I, George S. Recent progress in the development of selected hepatitis C virus NS3.4A protease and NS5B polymerase inhibitors. Curr Opin Pharmacol. 2008 Oct; 8(5):522-31. PMID: 18835365.
    View in: PubMed
  17. Lawitz E, Rodriguez-Torres M, Muir AJ, Kieffer TL, McNair L, Khunvichai A, McHutchison JG. Antiviral effects and safety of telaprevir, peginterferon alfa-2a, and ribavirin for 28 days in hepatitis C patients. J Hepatol. 2008 Aug; 49(2):163-9. PMID: 18486984.
    View in: PubMed
  18. Gelderblom HC, Zeuzem S, Weegink CJ, Forestier N, Mcnair L, Purdy S, Dijkgraaf MG, Jansen PL, Reesink HW. Inflammatory markers neopterin and alanine aminotransferase in HCV patients treated with HCV NS3.4A protease inhibitor telaprevir (VX-950) and/or peginterferon alfa-2a. Scand J Gastroenterol. 2008; 43(9):1122-7. PMID: 18609142.
    View in: PubMed
  19. Forestier N, Reesink HW, Weegink CJ, McNair L, Kieffer TL, Chu HM, Purdy S, Jansen PL, Zeuzem S. Antiviral activity of telaprevir (VX-950) and peginterferon alfa-2a in patients with hepatitis C. Hepatology. 2007 Sep; 46(3):640-8. PMID: 17879366.
    View in: PubMed
  20. Marcellin P, Horsmans Y, Nevens F, Grange JD, Bronowicki JP, Vetter D, Purdy S, Garg V, Bengtsson L, McNair L, Alam J. Phase 2 study of the combination of merimepodib with peginterferon-alpha2b, and ribavirin in nonresponders to previous therapy for chronic hepatitis C. J Hepatol. 2007 Oct; 47(4):476-83. PMID: 17629590.
    View in: PubMed
  21. Reesink HW, Zeuzem S, Weegink CJ, Forestier N, van Vliet A, van de Wetering de Rooij J, McNair L, Purdy S, Kauffman R, Alam J, Jansen PL. Rapid decline of viral RNA in hepatitis C patients treated with VX-950: a phase Ib, placebo-controlled, randomized study. Gastroenterology. 2006 Oct; 131(4):997-1002. PMID: 17030169.
    View in: PubMed
  22. McHutchison JG, Shiffman ML, Cheung RC, Gordon SC, Wright TL, Pottage JC, McNair L, Ette E, Moseley S, Alam J. A randomized, double-blind, placebo-controlled dose-escalation trial of merimepodib (VX-497) and interferon-alpha in previously untreated patients with chronic hepatitis C. Antivir Ther. 2005; 10(5):635-43. PMID: 16152757.
    View in: PubMed
  23. Beaulac SM, McNair LA, Scott TE, LaMorte WW, Kavanah MT. Lymphedema and quality of life in survivors of early-stage breast cancer. Arch Surg. 2002 Nov; 137(11):1253-7. PMID: 12413312.
    View in: PubMed
  24. Nagler-Anderson C, McNair LA, Cradock A. Self-reactive, T cell receptor-gamma delta+, lymphocytes from the intestinal epithelium of weanling mice. J Immunol. 1992 Oct 1; 149(7):2315-22. PMID: 1382095.
    View in: PubMed
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