
M E Blair Holbein, Ph.D.
Assistant Professor
Department Population and Data Sciences
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
- 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