Lisa Brooks, BA, UNC Chapel Hill (Click here to see Lisa’s resume)
Lisa has worked in drug development for over 20 years and began providing consulting services as Iris Statistical Computing to biotechnology and pharmaceutical companies in January 2007. She is a statistical programmer by trade and is a SAS Certified professional. Her consulting focuses on supporting CDISC data submissions for licensing applications. In 2007, Lisa was hired to be the biometrics project manager on one of the earliest New Drug Applications to attempt a data submission in CDISC format. That submission was accepted for review by FDA in 2009. Along with that submission work came the task of sponsor infrastructure remediation including team building, outsourcing, inspection readiness, training matrices, SOPs, and computer system validation (SAS server and electronic document management system). Since then, Lisa and a collection of subcontractors have been extensively involved in 12 licensing applications with CDISC data submissions. She has interacted directly with FDA reviewers and staff in the Office of Computational Science and eData regarding sample submissions, data standard strategies, and responses to information requests.
Lisa has stayed on top of regulation, technology, and standards through constant industry experience, networking, and volunteerism. Lisa is very active in the Bay Area CDISC Network and the Pharmaceutical Users Software Exchange (PhUSE). Lisa is a co-lead for the PhUSE Working Group Optimizing the Use of Data Standards. In addition, she is a member of two PhUSE project teams: Study Data Standardization Plan and Legacy Data Conversion Plan and Report. In her work with PhUSE, Lisa collaborates with FDA personnel from eData and the Office of Computational Science at CDER and CBER.
Michael Lock, PhD in Biostatistics, UC Berkeley
Mike has supported the development of diagnostics, vaccines, and drugs for over 20 years. Since 2008 he has worked as an independent consultant on nonclinical, preclinical, and Phase 1-3 vaccine and drug trials. He has proven experience in all aspects of the development lifecycle: from planning, through execution, reporting, and manuscript preparation. As the lead sponsor statistician on New Drug Application and Biologic License Agreement filings he communicates extensively with FDA.
Indication Experience: Vaccines, neurology, biomarkers, endocrinology, cardiology and HIV.
Statistical Expertise: Linear and mixed models, sample size estimation, multiple hypothesis testing, interim analyses, non-inferiority testing and writing. Specialization in modern nonparametric methods and graphical displays. Mike programs in R and SAS.
Ann Shiba, BS, UC Davis
Ann has over 20 years’ experience in medical affairs and clinical operations for diagnostic and drug development companies. This experience plus her writing skill has proven her ability at contributing to standard operating procedures, protocols, informed consents, and clinical study reports. She has consulted independently since 2008 and in 2017 became well versed in the development process for eCTD Module 5 documents, including Clinical Study Data Reviewer’s Guide, the Analysis Data Reviewer’s Guide and define.xml. Ann comes with an arsenal of management experience including strategy development, leading departments, and executing global clinical studies.