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Bambi
Grilley, RPh, CCRC, CCRP, CIP
| Instructor
Department of Pediatrics
Section of Hematology-Oncology,
Baylor College of Medicine |
Director
Clinical Protocol Research and Regulatory Affairs
Center for Cell and Gene Therapy
Baylor College of Medicine |
Contact Information:
bjgrille@texaschildrenshospital.org
832-824-3893
Education:
BS Pharmacy, University of Texas
Research
Interests:
Ms Grilley has worked in the area of Clinical Trails for over
ten years. She has experience as an Investigational Drug Pharmacist,
IRB administrator, IRB member, Regulatory Affairs professional, and
in the conduct of clinical trials. She has been working in the area
of oncology for over 10 years and has been working in the area of gene
therapy for over 5 years.
Ms Grilley helps investigators develop clinical protocols and the related
regulatory documents. She also oversees the regulatory submissions for
the over 70 clinical trials being conducted by Center for Cell and Gene
Therapy investigators.
Selected
Publications:
Grilley BJ, Trissel LA, Bluml BM. Design and implementation
of an electronic investigational drug accountability system. American
Journal of Hospital Pharmacy 1991; 48:2616-18.
Grilley BJ, Aguilar-Cordova E, Aguilar LK: “Reporting Adverse
Events on Gene Therapy Studies”. BioDrugs 2000 Sep, Vol.14: 3(pp.141-145).
Grilley BJ: “Investigational Drugs in the Principles and Practice
of Drug Information”. Drug Information: A Guide for Pharmacists
(2nd edition), (P. Malone, Pharm.D., ed.), McGraw-Hill, 2001
Grilley BJ: “Gene Therapy Oversight” Institutional Review
Board: Management and Function. Ed. R. Amdur, L. Bankert, S. Kornetsky.
1st Edition. Jones and Bartless Publishers, 2002
Kramer M, Grilley BJ: “Gaining Access to Investigational
Drugs for Treatment: An Investigational New Drug Application Primer”.
International Journal of Pharmaceutical Compounding 2002 July/August,
Vol. 6 No. 4 (pp. 271-273).
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