Food and Drug Administration (FDA)

AAPS/DDDI Meeting Brings Drug Design and Discovery Experts to School of Pharmacy

The University of Maryland School of Pharmacy hosted the regional meeting of the American Association of Pharmaceutical Scientists (AAPS) Drug Discovery and Development Interface (DDDI) section in August. Designed to provide a forum for drug discovery and preclinical scientists to discuss recent advances in the field of pharmaceutical sciences, the event was attended by more than 50 researchers and featured seven engaging presentations focused on the theme of advancements in drug discovery .

“Faculty across the Department of Pharmaceutical Sciences (PSC) at the School of Pharmacy are involved in a number of professional and scholarly activities through AAPS,” said Andrew Coop, PhD, professor in PSC and associate dean for academic affairs for the school, who helped secure the location for the meeting. “Because the organization and our department share a common goal to advance the field of pharmaceutical sciences through the development of new therapies that improve global health, it was a natural fit for us to host the AAPS/DDDI regional meeting at the school. The turnout was phenomenal. We were truly proud to be part of such a successful event.”

Bringing together drug discovery and drug development

The DDDI section brings together researchers from academia, government, and industry whose work focuses on issues at the critical interface between drug discovery and drug development. Hazem E. Hassan, PhD, MS, RPh, RCDS, assistant professor in the PSC, and Steven Fletcher, PhD, associate professor in the PSC, are actively involved with the section and served as members of the program committee tasked with organizing the meeting.

The event featured three keynote lectures delivered by Mike Hageman, PhD, former executive director of discovery pharmaceutics at Bristol-Myers Squibb; Capt. Edward D. Bashaw, PharmD, director of the Division of Clinical Pharmacology at the Food and Drug Administration (FDA); and Justin Pennington, PhD, executive director of the Pharmaceutical Sciences Department: Biopharmaceutics and Specialty Product Development at Merck Research Laboratories. The remaining presentations were divided between two “Hot Topic” forums.

In addition to helping organize the event, Fletcher served as a moderator for the meeting’s keynote presentations and delivered a presentation during the first Hot Topic session, which focused on transforming skill sets in early development to meet the changing landscape in the drug discovery space. Titled “New Therapeutic Modalities,” his presentation focused on his team’s research to develop new therapeutics through the disruption of protein-protein interactions in the cell.

“With protein-protein interactions, we have a much larger interface that we need to target, so the question becomes, ‘How can we do that?’ ” Fletcher said. “Because targeting these interactions presents so many challenges, only a few researchers conducted studies in this area, even as late as the 1990s. However, thanks to recent advances in the field, we now have new treatment modalities aimed at these interactions that can be used to develop new therapeutics for a wide range of illnesses.”

Leveraging academia-industry partnerships

Moderated by Patrice Jackson-Ayotunde, PhD, associate professor in the School of Pharmacy and Health Professions at the University of Maryland, Eastern Shore, the second “Hot Topic” session highlighted academic collaborations and preparing current and future researchers for the drug discovery support role in industry. “When we think about collaborations between academia and industry, it is almost a perfect marriage. Scientists in both areas share the same goal to bring new compounds or drugs to the market for the benefit of patients. It is truly a mutual partnership and can be a ‘win-win’ for everyone involved,” she said.

A speed-networking event also was included in the agenda to provide attendees with a fun way to learn about each other’s research through brief, structured one-on-one exchanges.

“The AAPS/DDDI Regional Meeting hosted by the School of Pharmacy provided attendees with an amazing opportunity to interact with distinguished scientists from across academia, industry, and the FDA as they discussed recent changes in the pharmaceutical landscape,” Hassan said. “The quality of the presentations, the thought-provoking discussions during the ‘Hot Topic’ debates, the speed-networking event, and the participation from students were exceptional. I am thrilled by the positive feedback that we have received.”

Malissa Carroll Research, UMB NewsSeptember 19, 20170 comments

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

MS in Regulatory Science Program Celebrates Class of 2017

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.

Program administrators and course managers for the MS in regulatory science program at the School of Pharmacy were thrilled to celebrate the recent graduation of the 33 working professionals of the program’s Class of 2017. Although the program is hosted exclusively online, nearly all of the graduating students – including a student from Canada – traveled to Baltimore to attend the in-person convocation celebration held in Pharmacy Hall on May 18.

A Time for Celebration

Graduating student Lorena Gapasin, MSc, clinical research compliance manager for Johns Hopkins Medicine, provided a message on behalf of the Class of 2017. “The long hours spent working on team and individual projects, homework, and watching online lectures, combined with perseverance and the willpower to reach this milestone, now imbue me with a sense of fulfillment, pride, and satisfaction. It was all worth it,” she said.

Two graduating students were presented with awards for outstanding performance in regulatory science during the ceremony: Carol Rehkopf, MSc, chief for the Center for Biologics Evaluation and Research (CBER) Review Management in Business Operations Staff at the Food and Drug Administration (FDA), and Madhavi Yadavalli, MSc, pharmacovigilance scientist at AstraZeneca. Support for the awards was provided by GlaxoSmithKline.

Edward Rudnic, PhD, chief executive officer for DisperSol Technologies, also offered his thoughts and words of advice to the class. He spoke about how the discovery and development of new medicines, and their rigorous assessment, is a great human endeavor, and expressed how fortunate he feels to have been able to bring new medications to patients through his work with his many talented colleagues.

Students who enroll in the MS in regulatory science program typically have eight years of experience in drug and biologics development or regulatory assessment. As the director of the program, I continue to be amazed at how important completing this degree program is to these working professionals and their families. Convocation is a truly special event for our students, and it was a joy to be able to celebrate with them this year.

View photos from the event.

James Polli Education, People, University Life, USGAJune 20, 20170 comments

Exploring Careers in Public Health Pharmacy

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.

Can you imagine yourself working as a pharmacist in a prison, on a Native American reservation, or in a housing facility for immigrants seeking asylum within the United States? These are just some of the interesting career options discussed during the Public Health Roundtable sponsored by the School of Pharmacy’s Student Government Association (SGA) and Student Section of the Maryland Public Health Association (SMdPHA) in May.

A Chance to Gain New Insights

The Public Health Roundtable is an event that students look forward to each spring. In fact, in recent years, the School has had at least one graduating Doctor of Pharmacy (PharmD) student enter the U.S. Public Health Service (PHS) as a commissioned officer. This year, more than 30 students and eight officers from the PHS participated in the successful program held at the School of Pharmacy’s satellite campus at the Universities at Shady Grove.

The PHS officers, many of whom were graduates of the School, shared their career trajectory, described their unique experiences serving in the Corps, and provided advice about future career opportunities in the fields of pharmacy and public health. Among other topics, students had the opportunity to learn about careers in the Food and Drug Administration (FDA), the National Institutes of Health, Immigration and Customs Enforcement, the Indian Health Service, and the Federal Bureau of Prisons.

An Enjoyable Evening for All

Students from the Baltimore and Shady Grove campuses alike enjoyed this year’s experience, and are looking forward to planning next year’s event. Feedback from PHS officers was also very positive, with two officers offering the following kind words:

“The Public Health Roundtable was a great experience, and I found it incredibly inspiring to hear about where the students would like their professional careers to go. Best of luck to everyone and thank you again for the opportunity,” said LCDR Christine Corser, PharmD, RAC, health science policy analyst in the Office of Prescription Drug Promotion at the FDA.

“Thank you kindly for the opportunity. It was my pleasure to attend this lovely event and speak with students,” added LT Zakiya Chambers, PharmD, MPH, BCPS, recruitment specialist for the Office of the Surgeon General.

The School of Pharmacy continues to be committed to introducing students to opportunities in public health pharmacy, and looks forward to supporting more SMdPHA events in the future.

Robert Beardsley Education, University Life, USGAJune 14, 20170 comments

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 cersi@umd.edu.

James Polli Collaboration, Research, TechnologyMarch 3, 20170 comments