Keynote Speakers

CDER/CBER Perspectives in the Use of Study Data for Regulatory Reviews

Do you ever wonder what pharmacology/toxicology, clinical, or statistical reviewers are looking for during the regulatory review process at the FDA? Seven speakers from CDER (Center for Drug Evaluation and Research) and CBER (Center for Biologics Evaluation and Research) present their perspectives in the use of study data and analytics for drug and biologics reviews. The topics of this presentation include (1) Technical Rejection Criteria (TRC) for study data; (2) the use of standardized SEND study data in nonclinical regulatory review in CDER; (3) the use of standardized study data and analytical tools for clinical safety evaluation in CDER; (4) study data traceability, transformation, mapping, consistency, and challenges for clinical reviews in CDER; and (5) study data considerations from a CBER perspective.

Alan Shapiro, MD, PhD, FAAP, is a Pediatrician Infectious Diseases Specialist working in the Office of Computational Science (OCS) at the Center for Drug Evaluation and Research (CDER) at the FDA. He received his PhD in Biochemistry (1993) and his MD (1994) from the University of California, San Francisco. Dr. Shapiro is certified by the American Board of Pediatrics in general pediatrics and pediatric infectious diseases. He is also certified by the American Board of Preventive Medicine in clinical informatics. Dr. Shapiro has been a medical officer at the Center for Drug Evaluation and Research (CDER) of the FDA since 2003. He joined the OCS in November 2015 and is clinical lead for the JumpStart service, the CISST-Assist Service, the JReview Standard Analysis Catalog and for MedDRA Adverse Event Detection (MAED) teams. Dr. Shapiro is also a member of the Office of New Drugs Safety Review Working Group.

 

 

Andrew O’Carroll is a pharmacology/toxicology reviewer in CBER’s Office of Vaccine Research and Review, where he reviews nonclinical studies conducted for the safety assessment of vaccines indicated for the prevention or treatment of infectious diseases, as well as a variety of other biologics including but not limited to allergenics, probiotics and phage-based products among others. He also provides subject matter expertise to CBER’s Data Standards staff, as well as to external stakeholders, to establish differences in data expectations, as pertained to the standardized exchange of nonclinical data (SEND). Andrew holds a DVM from the Virginia-Maryland College of Veterinary Medicine and a BA in Biology from McDaniel College. He has been with the FDA since 2014.

 

Lilliam Rosario is the Director of the Office of Computational Science (OCS) in the Office of Translational Sciences, Center for Drug Evaluation and Research. The OCS leads and directly supports the modernization of CDER’s scientific review capabilities. The OCS innovates tools, technologies, and services specifically for drug product review and then provides these to reviewers at the right time, backed up with training and support. Acknowledging that successful review starts with good data, the OCS continues to support efforts to regularly achieve high-quality data. The OCS continues to innovate and service reviewers, as Dr. Rosario has led to the OCS, to make real its motto: Better Data, Better Tools, Better Decisions.

 

Ethan Chen provides overall leadership to CDER in streamlining electronic and traditional submissions and delivering solutions to enable rapid adoption of emerging electronic data standards. Since joining the FDA in 2012, Ethan has led several critical initiatives as the CDER Informatics Architect, including data management and business intelligence programs. Ethan has over 20 years’ experience in data management, enterprise architecture, solution development and system integration.

 

Darcie Everett, MD, MPH, is a clinical reviewer for CBER’s Office of Vaccine Research and Review. Her duties include review of the protocols and results of all phases of clinical trials for investigational vaccines and other biologics, including review of clinical trials supportive of licensure. Her professional interests include maternal immunization and tools designed to support the review process. Dr. Everett is board-certified in Internal Medicine, Pediatrics, and Preventive Medicine. She received her medical degree and a Master of Public Health in International Health and Development from Tulane University in New Orleans. Dr. Everett completed residencies at the Mount Sinai School of Medicine in New York (combined Internal Medicine and Pediatrics), where she also worked as a hospitalist, and at Emory University in Atlanta (Preventive Medicine).

 

Matilde Kam is Associate Director of Analytics and Informatics in the Office of Biostatistics (OB) at CDER. She has strategic and oversight responsibility for matters pertaining to analytics and informatics, including data standards, data integrity/data quality, scientific computing and statistical programming activities in the OB. Prior to joining the FDA, Dr. Kam had significant experience in building and overseeing highly effective statistics and analytics groups in the pharmaceutical industry. She is actively involved in various scientific working groups sponsored by the Biopharmaceutical Section of the American Statistical Association (ASA). Dr. Kam is a Fellow of the ASA and has served in various leadership roles for the association. She received her PhD in Statistics from Pennsylvania State University.

 

Matthew Whittaker is a Nonclinical Reviewer in the CDER Office of New Drugs (OND), Division of Pulmonary, Allergy & Rheumatology Products (DPARP). He has been involved in SEND-related initiatives at the FDA since 2013 and currently is Co-Chair of the Janus Nonclinical Advisory Group. This group of nonclinical reviewers provides development requirements and tests the functionality of Janus Nonclinical, the SEND data analysis and visualization application that is being developed by the Office of Computational Science (OCS) at the FDA. Matthew holds a PhD in Biomedical Pharmacology from Boston University School of Medicine and a BA in Biology from the College of the Holy Cross. He has been with the FDA since 2011.

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