Email

grilley@bcm.edu

Positions

Professor

Pediatrics-Hem-Onc Clinical Research
Baylor College of Medicine

Director - Clinical Research and early Product Development

Center for Cell and Gene Therapy
Baylor College of Medicine

Professor

Pediatrics
Cell and Gene Therapy
Baylor College of Medicine
Houston, Texas United States

Member

Dan L Duncan Comprehensive Cancer Center
Baylor College of Medicine
Houston, Texas United States

Education

BS from University Of Texas At Austin

01/1985 - Austin, TX United States

Pharmacy

Certifications

RAC (RAPS)

CCRA (CCRP)

CCRC Certification

CIP Certification

RPh

#29048 (10/31/2014 - 10/31/2016)

Texas Board of Pharmacy

Professional Statement

Mrs. Bambi Grilley has worked in the area of Clinical Research for over 25 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 always worked in the area of oncology and, in addition to that, has worked with cell and gene therapy protocols for over 15 years.

Mrs Grilley provides indepth regulatory guidance to investigators developing projects involving translational products and assists in the regulatory submissions in support of these projects. She teaches about regulatory affairs and clinical research extensively both within BCM and internationally.
She has overseen the regulatory submissions for over 1,500 clinical research studies, almost half of which are therapeutic. She has assisted in the submission of over 70 investigator initiated INDs with over 110 studies conducted under them. She has prepared and implemented over 100 Standard Operating Procedures for clinical research and has established Quality Assurance and Quality Control programs for the protocols being conducted under her purview. She has developed Data Review Processes for internally initiated studies including the establishment of Data Safety Monitoring Boards (DSMBs) for a select group of studies.

Websites

Selected Publications

• Savoldo B, Ramos CA, Liu E, Mims MP, Keating MJ, Carrum G, Kamble RT, Bollard CM, Gee AP, Mei Z, Liu H, Grilley B, Rooney CM, Heslop HE, Brenner MK, Dotti G "CD28 costimulation improves expansion and persistence of chimeric antigen receptor-modified T cells in lymphoma patients.." J. Clin. Invest.. 2011 May 2;121(5):1822-6. Pubmed PMID: 21540550
• Grilley BJ, Trissel LA, Bluml BM "Design and implementation of an electronic investigational drug accountability system.." Am J Hosp Pharm. 1991 Dec;48(12):2616-8. Pubmed PMID: 1814202
• Grilley BJ, Gee AP "Gene transfer: regulatory issues and their impact on the clinical investigator and the good manufacturing production facility.." Cytotherapy. 2003;5(3):197-207. Pubmed PMID: 12850787
• Rousseau RF, Biagi E, Dutour A, Yvon ES, Brown MP, Lin T, Mei Z, Grilley B, Popek E, Heslop HE, Gee AP, Krance RA, Popat U, Carrum G, Margolin JF, Brenner MK "Immunotherapy of high-risk acute leukemia with a recipient (autologous) vaccine expressing transgenic human CD40L and IL-2 after chemotherapy and allogeneic stem cell transplantation.." Blood. 2006 Feb 15;107(4):1332-41. Pubmed PMID: 16249392

Memberships

Council for Certification of IRB Professionals (CCIP)

Selected Member (term starting J

Public Responsibility in Medicine and Research (PRIM&R)

Member

Drug Information Association (DIA)

Member

Society of Clinical Research Associates (SOCRA)

Member

Association of Clinical Research professionals (ACRP)

Member