In vivo Pig-a gene mutation assay
A workgroup of the International Life Sciences Institute (ILSI) Health and Environmental Sciences Institute (HESI) is developing an Organisation for Economic Co-operation and Development (OECD) Test Guideline (TG) for the in vivo Pig-a gene mutation assay. The TG will foster regulatory acceptance of the assay for conducting safety assessments. View the database online.
In this project, Dr. Bruce Yu is developing a simple and noninvasive technique to analyze sub-visible particulates in solutions. The method is based on the water proton NMR signal and can be carried out using desktop instruments without even taking the drug solution out of its vial. Sub-visible particulates formed by proteins is a safety concern for biologic products. Current analytics for such particulates are complex and invasive. A simple noninvasive analytical technology has the potential to enable effective regulation and control of sub-visible particulates in biologics.
Impact of Dose on In Vitro Dissolution Predictability
This projects extends on-going work by Dr James Polli to develop an in vitro dissolution test that predicts the absorption and pharmacokinetics of poorly soluble drugs that have been formulated via amorphous solid dispersion technology. In vitro dissolution is an important test of pharmaceutical quality. However, products of low solubility drugs that employ amorphous solid dispersion technology are complex. Results of these formulation and human pharmacokinetic studies aim to yield an in vitro test that others can rely upon.
Improving pre-clinical assessments of safety and efficacy
“Improving pre-clinical assessments of safety and efficacy” focuses on membrane transporters in drug development. Membrane transporters allow nutrients to move throughout the body, and also move drugs throughout the body. However, these doorways can be the basis for drug-to-drug interactions, where a “perpetrator drug” interferes with how a second “victim drug” normally uses a transporter. The University of Maryland is conducting experiments in collaboration with FDA scientists in order to aid FDA to develop decision trees. FDA decision trees will help industry and FDA scientists identify what membrane transporters are most important, in terms of the potential to cause drug-to-drug interactions. FDA decision trees will also provide guidance about how cell culture studies can be used to avoid or require human clinical testing, in order to advise health care professionals and patients about transporter-based drug-to-drug interactions. University of Maryland faculty contributing to the research are Drs. Yan Shu, James Polli, Peter Swaan, and Hongbing Wang.
Ensuring readiness to evaluate innovative and emerging technologies
Ensuring readiness to evaluate innovative and emerging technologies is an important goal for the M-CERSI, focusing on new technologies that will contribute to the scientific underpinning of two device-related product areas: (1) laser-based therapeutic devices; and (2) tissue engineering constructs.
Regarding the first subproject above, there is a lack of reliable, widely-accepted benchtop techniques for characterizing and assessing the sub-surface laser therapeutic dosage. As a result, the potential for understanding the device- and tissue-dependent effects, as well as laser therapy system performance, are diminished. These complicate the regulatory process and increase the burden on manufacturers to provide clinical studies to demonstrate safety and effectiveness. This project will develop and validate novel test methods that will enable rapid and reliable evaluation of laser therapy system performance and advance the innovation and translation of light-based therapeutic techniques.
The second subproject involves the creation of polymeric scaffolds that function within guided tissue regeneration strategies. These need precise control over the formative processing steps and also detailed and standardized characterization of the resulting properties. Here, we are developing methods to evaluate scaffold properties across manufacturers and between product iterations. By undertaking these studies, we anticipate the basis for standardization of scaffold characterization, in general. University of Maryland faculty contributing to the research are Drs. Yu Chen and John Fisher.
Harnessing diverse data through information sciences to improve health outcomes
This project focuses on patient prescriber agreements (PPAs) of prescription opioid analgesic drugs. In recent years, FDA has started to employ strategies to reduce misuse and abuse of opioid pain medications. PPAs are contracts between prescribers and their patients to at least list expectations of each the prescriber and the patient. With pain drugs a serious health issue, and opioids having abuse potential, there are several PPAs for various opioid pain medications. These PPAs often outline terms of treatment, patient responsibilities, education issues, addiction treatments, emergency issues, goals, and prescription limitations. University of Maryland faculty are conducting a review of PPAs currently in use, determining which healthcare professionals are using PPAs and the conditions of use. The researchers are also examining different formats and types of PPAs. University of Maryland faculty contributing to the research are Drs. Frank Palumbo, Francoise Pradel, Gail Rattinger, and Ilene Zuckerman.
M-CERSI Innovation Awards
In 2013-2014, the University of Maryland Center of Excellence in Regulatory Science and Innovation (M-CERSI) awarded two Innovation Awards, and five Innovations in Minority Health Awards. M-CERSI Innovations in Minority Health Awards are similar to Innovation Awards and additionally aim to address racial and ethnic health disparities.
Below are the two Innovation Award project recipients:
Absolute Protein and Protein Aggregate Concentration Measurement
This project, led by Dr. Michael Zachariah, focuses on demonstrating electrospay differential mobility analysis (ES-DMA) as a tool to quantify protein aggregation, and as an absolute number concentration primary standard for protein with a projected uncertainty of <5%.
Development of Computational Models to Predict Drug-Induced Liver Injury (DILI)
Dr. Peter Swaan and Dr. Hongbing Wang aim to develop and validate models that integrate all three transporters in a web-based environment that can be accessed by investigators in academia, industry, and the FDA.
Below are the five Minority Health awardees:
Addressing Chronic Disease Healthcare Disparities through the Patient-Centric Design of Health Information Technology
Dr. Monifa Vaughn-Cooke's research introduces a new paradigm of HIT that empowers patients to be more involved in their chronic disease management through enhanced patient-provider communication and shared treatment decision-making.
Improving Health Literacy and Cultural Competency in Current FDA Risk Communication
This project is led by Dr. Olivia Carter-Pokras, Department of Epidemiology and Biostatistics.
Racial/Ethnic Differences in Pediatric Antipsychotic Use by FDA Labeled Status
Dr. Julie Zito aims to study antipsychotic use in youth in relation to racial/ethnic differences, insurance type, and FDA labeled indication for use.
Qualitative Focus Group Studies: Clinical Trial Participation and Biospecimen (Tissue) Donation for Research
Barriers, Willingness to Participate in Clinical Trials, Willingness to Donate to Biobanks, and Informed Consent Preferences Among Rural and Urban Residents in Maryland's Eastern Shore, Rural Southern Shore, and Urban Baltimore City
Dr. Claudia Baquet (University of Maryland Baltimore School of Medicine) is leading an investigation on underserved populations that are underrepresented in clinical trial and biospecimen donation; that is, rural and urban communities in Maryland.
Investigating Factors Associated with Participating of Racial & Ethnic Minority POpulations in FDA Regulated Research
Dr. Sandra Crouse Quinn (School of Public Health) aims to ensure adequate representation of minorities in industry trials of drugs and devices and to strengthen the capacity of industry investigators to recruit and retain minority participants.