|
Phillip Banks, Senior Vice President Biostatistics and Data Management, an M.S. statistician who has designed and analyzed numerous cancer clinical trials during his nearly 25 years in the biostatistical/clinical research field, is responsible for overseeing the activities of the Biostatistics, Information Technology, and Data Management departments. His primary responsibilities include: develop and implement adequate processes to ensure high quality biostatistical and data management deliverables, oversee the development of statistical analysis and data management plans, provide senior review on related project work, draft and administer departmental SOPs, and provide consulting services to internal staff and external clients. Mr. Banks also assures the integrity of the company�s computing environment of software, hardware, network and telecommunications systems, assures that the IT department has adequate plans for data/systems security and disaster recovery capabilities, and assures proper maintenance of the IT operating systems.
Mr. Banks� expertise includes providing strategic leadership for the design and analysis of cancer clinical trials, statistical analysis plan development, writing of clinical protocols, interpretation of clinical data for reports and publications, and senior review of technical documents. He has performed methodological research on sample size estimation, sequential testing, and appropriate use of surrogate endpoints as well as devised strategies for optimizing clinical trial designs to support acquisition of outcome and cost benefit data. Mr. Banks has also actively participated in numerous FDA and other regulatory authority meetings and teleconferences, Data Safety Monitoring Board committee meetings, and presentations at industry-sponsored meetings. Amongst Mr. Banks� many accomplishments in the oncology arena:
Was Project Statistician for NDA #50, 661 (Idarubicin in acute myelogenous leukemia)
Provided statistical guidance for design and analysis of pivotal clinical trials for Lymphoseek and RIGScan cancer interventions, performed critical analyses of disease progression and survival data in support of regulatory submissions in the areas of breast, melanoma, prostate, ovarian, gastric, and colorectal cancer;
Served as principal statistician on DSMB committees for review of cancer drugs Promycin and Campath;
Provided statistical support for Zinecard NDA (chemoprotective agent against doxorubicin induced cardiotoxicity), collaborated on the analysis and reporting of pivotal study results, established global integrated safety database, assisted in the tabulation of integrated efficacy and safety summaries, reviewed pre-clinical/clinical/statistical section of NDA for statistical competency, responded to U.S. FDA queries, and attended a pre-NDA meeting. Designed large clinical trials investigating the sparing effects of a nutraceutical on 5-Fluroucacil related toxicity in colorectal cancer patients. Provided details of study design and statistical methods for Phase III protocols enrolling cancer patients receiving bone marrow transplantation.
Other projects included Rifabutin, Epirubicin, Toremifene and other experimental anti-tumor agents.
In addition, Mr. Banks has received numerous awards including an FDA Citation at an ODAC meeting for his exemplary leadership and guidance on an NDA for AML cancer patients and was elected Fellow (F.R.S.) of the Royal Stastistical Society in London, UK. Mr. Banks is also one of the few biostatisticians who is a member of American Society of Clinical Oncology (ASCO). | 