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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