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Regulatory Science and Innovation Take Center Stage at One-Day Conference

The University of Maryland Center for Excellence in Regulatory Science and Innovation (M-CERSI), offers a forum for scientists from the Food and Drug Administration (FDA), the University of Maryland community, and the public to discuss current issues in regulatory science – the science of developing new tools, standards, and approaches to assess the safety, efficacy, quality, and performance of FDA-regulated products.  Speakers will also present the latest M-CERSI research, training and exchange activities.

The one-day conference will be held on Thursday, September 5, 2013, at the University of Maryland School of Pharmacy, located at 20 North Pine Street in Baltimore, MD.  For information on registration, accommodations, parking and directions may be found at http://www.pharmacy.umaryland.edu/centers/cersievents/mcersiday/.

The morning agenda is open to all attendees.

8:30am-9:00am     Registration and Light Breakfast

9:00am-9:15am     Welcome and Introduction

9:15am-9:40am     Innovative Trial Designs: A Triple Win for Patients, Health Care Providers, and Manufacturers

9:40am-10:05am   Improving Consistency through Product Review Modernization

10:05am-10:30am  Biomarker As A Drug Development Tool and Biomarker Qualification at FDA/CDER  

10:30am-11:00am  Break

11:00am-11:25am  Streamlining the Development and Approval Processes for 505(B)(2) NDA Applications

11:25am-11:50am  Research Initiatives in FDA Office of Generic Drugs

11:50am-1:00pm    Lunch and Poster Session

The afternoon agenda is open only to UM and FDA researchers, M-CERSI Advisory Panel Members, and M-CERSI Industrial Consortia Members.

The University of Maryland’s Center of Excellence in Regulatory Science and Innovation (M-CERSI) is funded by an initial $1 million grant from the FDA. In a new FDA effort, the center focuses on modernizing and improving the ways drugs and medical devices are reviewed and evaluated.

The center is a collaborative partnership between the University of Maryland, College Park (UMCP), and the University of Maryland, Baltimore (UMB), and is co-chaired by William Bentley, PhD, (shown at right above) professor and chair of the Fischell Department of Bioengineering, A. James Clark School of Engineering, UMCP and James Polli, PhD, (shown at right below) professor in the Department of Pharmaceutical Sciences, School of Pharmacy, UMB.

Researchers from both campuses work with FDA staff to support the development of new tools, standards and approaches to assess the safety, efficacy, quality and performance of FDA-regulated products. Through M-CERSI, researchers, regulators and industry professionals can learn from one other in the effort to develop regulatory science practices that promote innovation in medical devices and pharmaceuticals, while also addressing critical safety concerns.

For more information, contact Ann Anonsen at UMCP, aanonsen@umd.edu, 301-405-0285 or Rebecca Ceraul at UMB, rceraul@pharmarcy.umaryland.edu, 410-706-1690.

M-CERSI is an initiative of The University of Maryland, MPowering the State, a collaboration between the two largest campuses of the University of Maryland designed to promote innovation.