Mr. Gensinger is the deputy director of CDER’s Office of Business Informatics (OBI). OBI is responsible for the Center’s electronic submission initiatives. Gary has been involved in electronic submissions since joining FDA in 1996 and is a frequent speaker at DIA and other forums.

Mark has over 30 years’ experience in Information Technology & Management. Mark began his career developing commercial applications and has been working for FDA for over 30 years. Mark’s FDA responsibilities have included software development and project management in CBER; Director of Applications Development & Services in CDER; PDUFA IT Program Director; Director, Division of Data Management Services & Solutions managing CDER’s electronic submission program, and ICH M8 (eCTD) Rapporteur. Mark has been with CBER's data standards group since 2014, and his current responsibilities include representing CBER in the development and implementation of international electronic submission standards.

Jared Lantzy, PMP, is a Lead Associate in Booz Allen Hamilton's Civilian Services Group. His expertise is in the development, implementation, and maintenance of data standards for the life sciences. Mr. Lantzy is a former member of the FDA CDER electronic submission support team (eSUB team) and is a former employee of a leading electronic submission tool vendor.

Ron Fitzmartin is Senior Informatics Advisor, Office of Regulatory Operations, Center for Biologics Evaluation and Research, Food and Drug Administration. In this role Ron provides policy and strategy consultation and support on a wide range of topics focused on electronic regulatory submissions and standardized data. Some of Ron’s activities include: chair of the PDUFA VI information technology committee, Regulatory Chair of the ICH M11 Expert Working Group on the standardized clinical protocol template, and chair of the IDMP Working Group under the International Pharmaceutical Regulators Programme. Ron received a PhD in statistics from the University of Maryland and MBA from University of New Haven.

Interdisciplinary Scientist and Technical Lead in Office of Business Informatics in CDER and has been with the Agency over five years. Has extensive Information Technology experience ; over 25 years of prior experience including Contract Research Organization (CRO), Process Control and SCADA Systems, Transportation and Energy/Nuclear Systems, and Financial and Management Systems. Has PhD in Information Technology, MS Management Information Systems, and BS in Production Decision Sciences.

Dr. Kiester is an Associate Director for the Office of Prescription Drug Promotion and the chair of the OPDP electronic submissions working group. Dr. Kiester is a graduate of Mylan School of Pharmacy and completed a residency in managed care Pharmacy.