Education
Undergraduate
University of Texas-Austin (1972), Pharmacy
Graduate School
University of Texas-Austin (1975), Pharmacology
Graduate School
Vanderbilt University (1981), Pharmacology

Research Interest
  • Expanded Access for Investigational Drugs and Devices, FDA-regulated research at academic health centers

Publications

Featured Publications LegendFeatured Publications

Via media: Role and responsibilities of the independent safety officer.
Holbein MEB, Hammack BN, Melvin AJ, Knox TA, J Clin Transl Sci 2019 Aug 3 4 147-151
Count me in: using a patient portal to minimize implicit bias in clinical research recruitment.
Kannan V, Wilkinson KE, Varghese M, Lynch-Medick S, Willett DL, Bosler TA, Chu L, Gates SI, Holbein MEB, Willett MM, Reimold SC, Toto RD, J Am Med Inform Assoc 2019 May
Right now, in the right way: U. S. Food and Drug Administration's expanded access program and patient rights.
Holbein MEB, Weatherwax KJ, Gravelin M, Hutchinson R, Mashour GA J Clin Transl Sci 2018 Jun 2 3 115-117
Access to Investigational Drugs: FDA Expanded Access Programs or "Right-to-Try" Legislation?
Holbein ME, Berglund JP, Weatherwax K, Gerber DE, Adamo JE Clin Transl Sci 2015 Jan
Access to Investigational Drugs: FDA Expanded Access Programs or "Right-to-Try" Legislation?
Holbein ME, Berglund JP, Weatherwax K, Gerber DE, Adamo JE. Clin Transl Sci 2015 Epub ahead of print
Recommendations From the Investigational New Drug/Investigational Device Exemption Task Force of the Clinical and Translational Science Award Consortium: Developing and Implementing a Sponsor-Investigators Training Program.
Holbein ME, Berglund JP, O'Reilly EK, Hartman K, Speicher LA, Adamo JE, O'Riordan G, Brown JS, Schuff KG J. Investig. Med. 2014 Jun 62 5 797-803
Warning letters to sponsor-investigators at academic health centres - the regulatory "canaries in a coal mine"
O'Reilly EK, Blair Holbein ME, Berglund JP, Parrish AB, Roth MT, Burnett BK. Clin Invest Med 2013 36 6 E290-6
Understanding food and drug administration regulatory requirements for an investigational device exemption for sponsor-investigators.
Holbein ME, Berglund JP J. Investig. Med. 2012 Oct 60 7 987-94
Understanding FDA regulatory requirements for investigational new drug applications for sponsor-investigators.
Holbein ME J. Investig. Med. 2009 Aug 57 6 688-94
Tumor-specific targeting by Bavituximab, a phosphatidylserine-targeting monoclonal antibody with vascular targeting and immune modulating properties, in lung cancer xenografts.
Gerber DE, Hao G, Watkins L, Stafford JH, Anderson J, Holbein B, Öz OK, Mathews D, Thorpe PE, Hassan G, Kumar A, Brekken RA, Sun X Am J Nucl Med Mol Imaging 2015 5 5 493-503

Professional Associations/Affiliations
  • American Board of Clinical Pharmacology