Who We Are
MEET OUR OFFICERS
The objective of the Section on Medical Devices and Diagnostics is to serve Association members with special interests in the application and appropriate use of statistics to the design, development, evaluation, quality control and use of medical devices and diagnostic tests in humans and animals, where a simple definition of a medical device is any medical product that does not work solely by chemical or biological means.
Any members of the American Statistical Association who are interested in medical devices and diagnostics can join this section.
Elected officers organize events, initiatives, communications, and focus the energies of MDD's members toward advancing our common causes. Meet the MDD officers below.
"Dr. Gene A. Pennello is a Team Leader and Mathematical Statistician at the FDA Center for Devices and Radiological Health, Division of Biostatistics, Diagnostics Devices Branch. He has been with the Agency since 1998. Before joining FDA, Dr. Pennello was a postdoctoral training fellow at the National Cancer Institute, Division of Cancer Epidemiology and Genetics. He has a Ph.D. in Statistics from Oregon State University (1993), a Master’s degree in Statistics from the University of California at Davis, and two Bachelor of Science degrees also from Davis, in Statistics and in Computer Science and Mathematics. Dr. Pennello has experience in the FDA review of in vitro diagnostic tests, including those that measure biomarkers for prognostic or predictive claims. He also has experience in the review of diagnostic imaging devices. Some of his statistical interests include Bayesian analysis, multiple comparisons, and missing data.
I have been a member of the FDA’s Medical Devices Advisory Committee for 10 years. I have been the lead statistician on numerous device trials and diagnostic studies and have been a member of several Data Monitoring Committees overseeing device trials. I have a Visiting Professor Appointment in Japan where I teach clinical trials (focused on devices) at the National Cerebral and Cardiovascular Center in Osaka. Recent work includes lead authorship on an upcoming manuscript describing the results of the first study conducted by a new clinical trial research network (the Antibiotic Resistance Leadership Group), entitled “Informing Antibiotic Treatment Decisions: Evaluating Rapid Molecular Diagnostics to Discriminate Susceptibility vs. Resistance in Escherichia coli and Klebsiella pneumonia infection”. I am familiar with the ASA processes having been the Chair of two ASA Sections and an ASA Committee, the President of the Boston Chapter, and the Executive Editor of an ASA journal.
My primary role will be to develop ideas for session topics and speakers at JSM and possibly other meetings /events. I plan to solicit ideas from a number of sources including the preceding program chair (Gene Penello) as well as other academic and industry colleagues. I will also talk with FDA personnel at the FDASA year-end event and solicit input from membership via email. My ideas for topics include: benefit:risk in devices and diagnostics, issues in companion diagnostics and personalized medicine, drug-device (possibly contributed in in tandem with the biopharmaceutical section), and lessons from meetings of the FDA Medical Devices Advisory Committee. As the ASA now has webinar capabilities, we will consider a webinar event during the course of the year”.
"I have been working at the Center of Devices and Radiology Health of FDA for last 5 years, mainly on the evaluation of diagnostic devices, especially in vitro diagnostic tests (IVDs) and cardiovascular diagnostic device. My experience also include presenting/organizing/chairing statistical sessions at various statistical conferences (e.g. JSM, FDA/Industry, FDA/AdvaMed) to enhance the communication between FDA and Industry and also provide a glimpse of the latest development of statistical methodologies for the evaluation of evolving medical devices.
As the Communications Secretary, I will continue to deliver timely and relevant information to, from, and for all statisticians interested in medical devices and diagnostics."
I’m currently a statistician at the Center for Devices and Radiological Health of FDA. I have more than six years of experiences on different aspects of clinical trials, including statistical review work, as well as guidance writing and research development. I have the privilege to contribute to the statistical community in different roles including serving as a journal referee for statistical journals, publishing research work in peer-reviewed journals, presenting, organizing and chairing different sessions at statistical conferences and workshops, including JSM, FDA/AdvaMed workshops, FDA/Industry workshop, etc. I served as CDRH Center Representative to the FDASA (FDA Statistical Association) and the Treasurer for FDASA and am on the FDA/Industry Workshop steering committee. I have a Ph. D. on statistics from Carnegie Mellon University.
As the Correspondence Secretary, I will take minutes at MDD meetings and help prepare the logistics of committee meetings. I will work with the Communications Secretary to update the MDD website when appropriate. I will also coordinate the MDD newsletter compilation with the editor and other efforts (such as media coverage of MDD activities and member news) to raise awareness of MDD.
"Since 2001, I have worked in the medical device industry, at Boston Scientific, as a Senior Biostatistics Manager on the design, analysis, and interpretation of clinical trials, for the regulatory approval and commercialization of medical devices in endoscopy, urology, and gynecology. Prior to that, I worked on clinical trials in the diagnostics industry, to develop tissue classification algorithms for diagnostic devices. I have been an ASA member since 2005. Prior to that, I was a long-time member of both the Statistical Society of Australia, including some time as chair of the Biostatistics section, and the International Biometric Society. Since 2006 I have co-organized, chaired, and presented papers on statistical design & analysis at both the annual AdvaMed/FDA Statistics Workshop and the SIGMEDD contributed-topics sessions of JSM. Each year at JSM, I have attended the organizational business meeting of SIGMEDD.
As the MDD Section Representative, I will promote to the ASA Council of Sections the application and appropriate use of statistical designs and analyses in medical devices and diagnostics, to raise the profile of statistics in decision-making within these industries. Prior to SIGMEDD becoming the MDD Section, I attended meetings of the Council of Sections as the Observer for SIGMEDD, and to promote the formation of the MDD Section. Having a MDD Section will further raise the profile of statistics in devices and diagnostics among ASA members, and Section activities will highlight that these industries provide many opportunities for statistical innovation and leadership. Section activities include sponsoring our own sessions on devices and diagnostics at JSM, as well as at smaller meetings such as the annual FDA/Industry Statistics Workshop, to raise our visibility to others considering different career paths and to grow our Section membership. As Section Representative, I will liaise with the ASA Council of Sections to achieve these aims, and I will represent members not just from industry but also from academia and FDA in this capacity, many of whom I have worked closely with in co-organizing both MDD sessions for JSM and sessions for the AdvaMed/FDA Statistics Workshop."
Program Chair Elect
Norberto Pantoja-Galicia is a mathematical statistician in the Division of Biostatistics at the FDA Center of Devices and Radiological Health. He joined FDA after completing a post-doctoral research fellowship at Harvard University School of Public Health, Department of Biostatistics. He obtained his PhD in Statistics from the University of Waterloo, Canada, where he also worked as an instructor in statistics and completed a research fellowship in Statistics Canada. His interests include design, analyses, guidance writing and reporting of clinical studies to evaluate medical diagnostic devices in areas such as diagnostic imaging, infectious diseases, molecular genetics , medical countermeasures, as well as ROC curve methodology, complex survey data and benefit-risk analyses for diagnostics.
Dr. Pantoja-Galicia has been a regular FDA presenter at Advisory Panel Meetings and is a member of the Editorial Board of Statistical Communications in Infectious Diseases (SCID), and the ENAR JSM 2017 program committee. He is a recent recipient of the Best contributed paper at JSM from the ASA MDD section.