M-CERSI Scholars

The M-CERSI Scholars program promotes doctoral candidates and postdoctoral fellows who seek to amplify their knowledge in regulatory science while completing training at the University of Maryland.  In addition to their doctoral or postdoctoral training experience, M-CERSI Scholars benefit from participating in M-CERSI events that teach elements of regulatory science. 
 

Learn more about the current M-CERSI Scholars:

Heather Boyce

Heather is a Ph.D. candidate in pharmaceutical sciences at the University of Maryland. She has received a BS in chemistry from Temple University, and is working with Dr Stephen W. Hoag. Her thesis involves abuse deterrent formulations, and in particular how the excipient properties affect product performance.

Sharmila Das

Sharmila is a PhD student in pharmaceutical sciences at the University of Maryland. She received a PharmD degree from the University of Maryland, as well as BS in biology from University of Maryland Baltimore County. She is conducting clinical research on the equivalence of generic drugs to brand-name drugs, with an emphasis on anti-epileptic drugs. Her advisor is Dr James Polli.

Priyanka Gaitonde

Priyanka is a doctoral candidate in pharmaceutical health services research at the University of Maryland. She received a bachelor’s degree in pharmacy from University of Pune, India and a Master’s in Pharmacy Administration from St. John's University. Her PhD dissertation investigates the factors associated with the uptake and use of biologics among older adults with rheumatoid arthritis, and the impact of non-adherence to these medications on clinical and economic outcomes. Her advisor is Dr. Fadia Tohme Shaya.

Moshe Honick

Moshe is a PhD student in pharmaceutical sciences at the University of Maryland. He received a PharmD degree from the University of Maryland. He is investigating novel quality control tests to anticipate the in vivo pharmacokinetic performance of poorly water soluble drugs, which are more challenging drugs to reliably manufacture. His advisor is Dr James Polli.

Bryan Mackowiak

Bryan is a PhD candidate in pharmaceutical sciences at the University of Maryland. He received a bachelor’s degree in biochemistry from University of North Carolina at Chapel Hill. His PhD thesis project investigates metabolism-based alteration of drug efficacy/toxicity through xenobiotic receptors. His advisor is Dr. Hongbing Wang.

Heather Neu

Dr. Neu is a postdoctoral fellow in pharmaceutical sciences at the University of Maryland under the mentorship of Dr. Sarah Michel. Dr. Neu received her PhD in chemistry from Johns Hopkins University in 2015. Dr. Neu’s research focuses on developing high-throughput, FDA validated assays to measure iron release of iron nanoparticle drugs (non-biological complex drugs). These assays will be utilized as part of a bioequivalence study of sodium ferric gluoconate drug products.

Soo Hyeon Shin

Soo is a PhD candidate in pharmaceutical sciences at the University of Maryland. She received a Doctor of Pharmacy degree from Albany College of Pharmacy and Health Sciences in 2013. Her PhD thesis project is focused on evaluating in vitro and in vivo correlations of transdermal delivery systems with and without the influence of heat. Her advisors are Dr. Hazem Hassan and Dr. Audra Stinchcomb.

O’Mareen Spence

O’Mareen is a doctoral student in pharmaceutical health services research at the University of Maryland. She received her bachelor’s degree in Athletic Training (Sports Medicine) from the University of Charleston and her Masters of Public Health in Epidemiology from Florida Agricultural and Mechanical University. With a concentration in Pharmacoepidemiology, she is investigating two areas of drug utilization in population health: heterogeneity of treatment effects with antipsychotic augmentation among youth, as well as how the pharmaceutical industry conveys the results of research in the scientific literature and press releases. Her advisors are Dr. Susan dosReis and Dr. Peter Doshi.

Matthew Welch

Matt is a PhD candidate in pharmaceutical sciences at the University of Maryland. He received a BS degree in Biochemistry from the University of Washington, Seattle. His research focuses on the role of bile acid (BSEP, OSTalpha/beta) and multidrug resistance transporters (MRP3/4) in drug-induced liver injury. This project is a close collaboration with Dr. Kim Brouwer at the University of North Carolina, Chapel Hill. His advisor is Dr. Peter Swaan.

Leidos M-CERSI Scholars

The Leidos M-CERSI Undergraduate Research Award provides a unique opportunity for students interested in the development of new tools, standards and approaches to assess the safety, efficacy, quality and performance of FDA-regulated products. 

Learn more about the current Leidos M-CERSI Scholars:

Daniel Bogachek, B.S., Electrical Engineering

Daniel Bogachek created a system that learns and replicates users' handwriting to send automated handwritten messages to customers. He developed a 3D Cartesian pen plotter (CNC); automatic handwriting parsing, digitization, text planning, text plotting, and parallel device streaming software; PCB design; and a multi-server cloud-based application design.

Alex (Eli) Pottash, B.S., Bioengineering

Mr. Alex (Eli) Pottash is a first-year graduate student and alum (B.S. `16) of the Fischell Department of Bioengineering at the University of Maryland. He was recognized for his research evaluating bacterial motility in potential anti-biofilm technologies, under Dr. William Bentley's guidance.

Brett M. Potter, B.S., Mechanical Engineering

Brett M. Potter designed and manufactured a high-speed 3D printer from scratch and raised $22,000 for his efforts via Kickstarter. He also worked with dozens of clients as a freelance CAD designer and manager of the University of Maryland's rapid prototyping lab to design and create new products and prepare them for manufacturing.

Joe Puthumana

Joe Puthumana was recognized for his research in optical bioengineering.

 

 

Use of Non-Federal Funds Terms and Conditions:

All non-federal entity providing funds or in-kind contributions to the University of Maryland Center of Excellence in Regulatory Science and Innovation (CERSI) understands that: (a) contributions will be reasonably related to the costs of the collaboration with the CERSI; (b) the contributions will not result in undue influence on FDA regulatory decisions; (c) the contributions will not result in an endorsement of non-federal entity or any of its products or activities by FDA; (d) the contributions will not provide access to non-public product specific information from FDA; (e) the contribution may be publicly acknowledged by non-federal entity, but non-federal entity may not promote itself as having a relationship with FDA; and (f) FDA staff will abide by federal ethics rules regarding acceptance of gifts, honoraria, travel reimbursement and prospective employment. In particular, any FDA employee who commences employment discussions or otherwise seeks employment with a non-federal entity will immediately recuse themselves from official participation in any collaboration involving that entity and from all other particular government matters affecting the financial interests of that entity.