James Polli

M-CERSI Cooperative Agreement Grant Renewed by Food and Drug Administration

October 3, 2018

Latest renewal allows for up to $5 million per year over five years, and will help M-CERSI further advance its mission to promote the development of new tools, standards, and approaches to assess the safety, efficacy, quality, and performance of FDA-regulated products.

Ensuring Prescription Drug Quality for All Patients

May 24, 2018

Dr. James Polli’s extraordinary accomplishments in the field of regulatory science make him a UMB Champion of Excellence.

Annual Competition Spotlights Student Innovation in Regulatory Science

February 12, 2018

Third-year student pharmacists take the gold for their proposal to develop a transparent tracking system for emerging CAR T-cell gene therapies.

CERSI Conference Shows Quality is Key in Patient-Centric Drug Development

June 27, 2017

Researchers discuss how to leverage a variety of dissolution and translational modeling strategies to ensure patients continue to have access to safe, effective medications.

Talent Competition Highlights Student Innovation in Regulatory Science

February 3, 2017

First-ever undergraduate competitor takes the gold for project to develop a universal labeling system for hazardous drugs.

SOP Talent Competition Brings Student Innovation to the Forefront

February 19, 2016

Fourth annual M-CERSI “America’s Got Regulatory Science Talent” competition awards third-year student pharmacists first prize for novel solution to improve FDA’s post-marketing surveillance program.

School of Pharmacy Sees Unparalleled Growth in Research Funding

December 7, 2015

New grants and contracts from a multitude of non-profit and government organizations, as well as the private sector, help the School of Pharmacy achieve the highest funding increase among all professional and graduate schools at the University of Maryland, Baltimore.

CERSI Symposium Highlights Use of Biomarkers in Drug Development

August 28, 2015

More than 500 researchers from academia, government, and industry gather to gain perspective on biomarker development and the application of biomarkers in preclinical and clinical research.

UMB Conducts First-of-a-Kind Study on Bioequivalency of Anti-Epileptic Drug

August 14, 2015

Collaborative study helps validate effectiveness of FDA’s bioequivalence standard, showing no significant differences between major brand name and generic medication used to treat patients with epilepsy.

SOP’s Polli Testifies for GDUFA Renewal at National Public Meeting

August 6, 2015

Testimony examined the impact of FDA-supported research in generic drugs and advocated for continued funding through renewal of the Generic Drug User Fee Amendments of 2012 (GDUFA).

SOP Faculty Receive $1.5 Million from the FDA to Study Iron Medications

February 24, 2015

Interdisciplinary group will research the effectiveness of brand versus generic iron medications used to treat anemia in kidney disease patients

Talent Competition Highlights Student Innovation in Regulatory Science

February 11, 2015

Winners of student regulatory science talent competition propose mobile application to help improve patient medication knowledge.