University of Maryland Center of Excellence in Regulatory Science and Innovation (M-CERSI) posts displayed by tag

CERSI Conference

Patient-Centric Drug Development Conference

The University of Maryland School of Pharmacy welcomed more than 150 researchers from across academia, government, and industry to Pharmacy Hall in May for “Dissolution and Translational Modeling Strategies Enabling Patient-Centric Product Development,” a multiday conference organized by the University of Maryland Center of Excellence in Regulatory Science and Innovation (M-CERSI) in collaboration with the Food and Drug Administration (FDA). To help address regulatory agencies’ need for a patient-centric assessment of drug product quality in today’s global pharmaceutical environment, the conference featured numerous presentations and breakout sessions that aimed to help attendees better understand the use of dissolution and modeling/simulation approaches in drug product approvals and highlight novel approaches for developing new dissolution testing methods.

“Ensuring quality over the course of a drug product’s life cycle can be challenging,” said James Polli, PhD, the Shangraw/Noxell Endowed Chair in Industrial Pharmacy and Pharmaceutics in the Department of Pharmaceutical Sciences (PSC) at the School of Pharmacy and co-principal investigator for M-CERSI. “The organizers of this conference worked tirelessly to put together an event that I am confident will facilitate many fruitful discussions and help advance our collective understanding of the role of dissolution testing in promoting drug product development and assessment. My special thanks to Dr. Sandra Suarez Sharpe for her efforts to organize the FDA’s participation in this workshop, as well as to the regulatory representatives from Europe, Canada, and Japan who attended our event.”

Meeting a Critical Need

Drug dissolution testing is an analytical test used to detect physical changes in a drug’s active pharmaceutical ingredient as well as in the finished drug product. It is a requirement for all solid oral dosage forms and provides researchers in regulatory agencies and industry with important in vitro (outside of a living organism) drug release information for both quality control and drug development purposes.

Because it is a key enabler of drug product development and often required by regulatory agencies such as the FDA to justify certain process and formulation changes, effective strategies for developing in vitro dissolution testing methods and establishing corresponding acceptance criteria to ensure product quality are needed throughout a product’s life cycle. However, recent advances in formulation and manufacturing technologies, evolving regulatory expectations, and the development of new testing methods have resulted in inconsistencies in dissolution terminology, limitations for the current regulatory framework, and a lack of understanding on how to effectively implement in vitro and in silico (computer-simulated) approaches to advance product understanding.

“Over the past two decades, we have identified a number of issues related to dissolution testing that remain relevant today,” said Lawrence Yu, PhD, deputy office director for the Center for Drug Evaluation and Research (CDER) at the FDA, in his opening remarks. “My hope is that this conference becomes a starting point for discussions about how we can make progress in this field. Whether it is in how we collect our data or leverage new mathematical modeling approaches, there are many opportunities of which we can take advantage.”

Seeking Opportunities, Overcoming Challenges

The conference kicked-off with a day of presentations and breakout sessions dedicated to helping attendees better understand the role of dissolution testing in drug product development and as a quality control test. Presenters spoke about the challenges and opportunities that currently exist in the development of new in vitro testing methods to guide product development as well as the justification of quality control method conditions and acceptance criteria.

“Product quality is truly the foundation on which safety and efficacy rests,” said Sarah Pope Miksinski, PhD, office director for CDER at the FDA. “Think about the parent who is awake at 3 a.m. looking for a medication for his or her sick child. That parent is not thinking about the quality of that medication at that moment. He or she expects that the medication will work exactly as its intended. That is a really powerful concept, and it is inherent on us as regulators to remember individuals like that parent, and to make the right decisions using the best available evidence as we review and approve new medications for consumer use.”

During the second day, attendees learned more about the need to establish an in vitro-in vivo (inside of a living organism) link for dissolution testing, including novel approaches and in silico tools currently used in the development of dissolution and permeability testing. The conference concluded on the third day with a discussion of the regulatory applications for dissolution testing.

“This conference truly exceeded my expectations,” said Rob Ju, PhD, head of dissolution sciences for AbbVie. “I am thrilled to have been involved in the many meaningful, logical discussions held over the past three days and cannot wait to attend the next workshop. The knowledge that I gained here will certainly have a lasting impact on my work.”

“All of us attended this conference because we care about patients,” added Andreas Abend, PhD, director at Merck. “Patients rely on the quality of the medications that we develop, and it is our responsibility to ensure that those products work every time they are consumed. It is also symbolic that this event was held at the University of Maryland School of Pharmacy. When you enter a university, you are most likely there to teach or to learn. I think that approach can be applied to many of our attendees – we are all here to learn, to teach, and to influence the direction in which science will lead us.”

Support for the conference was provided in part by AbbVie, Merck, and Novartis.

Malissa Carroll ABAE, Bulletin Board, Collaboration, Education, People, Research, UMB NewsJune 28, 20170 comments
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Working Toward Regulatory Acceptance of Gene Mutation Assay

Editor’s Note: This post was originally published on Inside SOP, the University of Maryland School of Pharmacy’s blog. It is reprinted here with permission.

The University of Maryland Center of Excellence in Regulatory Science and Innovation (M-CERSI) is a collaborative partnership between the University of Maryland, Baltimore (UMB) and the University of Maryland, College Park. Funded by the Food and Drug Administration (FDA), this partnership facilitates collaboration between researchers at UMB and College Park, including many of my colleagues at the School of Pharmacy, and staff from the FDA to help modernize and improve the ways in which drugs and medical devices are reviewed and evaluated. As a co-principal investigator of M-CERSI, I help lead a number of the center’s initiatives, including our efforts to develop internationally accepted, consensus guidelines for conducting the in vivo Pig-a gene mutation assay.

Enhancing Drug Safety Assessments

For this particular initiative, researchers from M-CERSI have been collaborating with scientists from the International Life Sciences Institute (ILSI) Health and Environmental Sciences Institute (HESI) to develop an Organization for Economic Cooperation and Development (OECD) Test Guideline for the in vivo Pig-a gene mutation assay. The Pig-a gene mutation assay measures in vivo gene mutation in a more rapid and cost effective manner than existing assays, and shows great promise for integration with other toxicology studies to promote the “three Rs” principle:

  • Replacement: Support the development of new methods that avoid or replace the use of animals in research.
  • Reduction: Employ methods that allow researchers to obtain comparable levels of information from fewer animals.
  • Refinement: Use methods that alleviate or minimize potential pain, suffering, or distress and enhance animal welfare for animals used.

Once developed, the test guideline will foster regulatory acceptance of the assay for conducting drug safety assessments. In fact, it has already received an endorsement from the International Workshop on Genotoxicity Testing, and is anticipated by several regulatory agencies. It is also recommended in the International Council for Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) M7 guideline for evaluating the safety of human drug impurities.

Accessing the Data

One of the greatest aspects of this project (at least for you as readers) is that data generated in the assay are now available to the public. Researchers interested in using the data can access it through the School of Pharmacy’s website.

The website also allows simple searches of the data according to criteria such as:

  • Test agent
  • Animal species
  • Test methods used

Spreadsheets containing data files also can be downloaded for secondary applications. In the future, we plan to use the data for a retrospective performance analysis of the assay, as well as other applications, including quantitative dose-response analysis.

Researchers who have questions about the data or would like more information about this project are encouraged to contact M-CERSI at

James Polli Collaboration, Research, TechnologyMarch 3, 20170 comments
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