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.

Mr. Lantzy has over 20 years experience solving technology and people problems in government, vendor, consulting, and industry environments. He is a former member of CDER's Electronic Submission Support Team at the US FDA and currently leads the Global Regulatory Affairs Operations team at Novavax, Inc. His current interest is on improving the exchange and review of data between industry and regulatory health authorities, to ultimately provide safer and more effective products to patients and for public health.

Ron Fitzmartin is a Principal Consultant at Decision Analytics. Previously, Ron was Senior Advisor in the Data Standards Branch, Office of Regulatory Operations, Center for Biologics Evaluation and Research, FDA. He provided policy and strategy consultation on electronic regulatory submissions and standardized data. Ron served as Rapporteur for the ICH M11 Expert Working Group and as Co-chair of the Global IDMP Working Group. Prior to FDA, Ron held several leadership positions in industry: VP, Biostatistics and Data Management and VP, Informatics at Daiichi Medical Research and Daiichi Sankyo, respectively. Ron received his PhD in Statistics from the University of Maryland, College Park.

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.