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The President’s Message

Check out the November issue of The President’s Message. It includes Dr. Perman’s column on UMB’s outreach to alumni, a wrap-up of Founders Week, Derreck Kayongo’s Politics and Policy presentation, MPower seed grant recipients and an award for the BioPark, stories on RISING Baltimore and the schools’ Mission of Mercy community service, a safety tip, and a roundup of student, faculty, and staff achievements.

Chris Zang Bulletin Board, Clinical Care, Collaboration, Community Service, Contests, Education, For B'more, People, Research, Technology, UMB News, University Life, USGANovember 10, 20170 comments
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Dean Delivers State of the School of Pharmacy Address

On Sept. 11, faculty, staff, students, alumni, and officials from across the University of Maryland, Baltimore gathered in Pharmacy Hall to listen as Natalie D. Eddington, PhD, FCP, FAAPS, dean and professor of the University of Maryland School of Pharmacy, delivered her State of the School of Pharmacy Address. The address, which Eddington also presented at the Universities at Shady Grove on Sept. 6, highlighted the school’s recent accomplishments and advancements in its strategic plan areas of pharmacy education, research, practice, community engagement, and pharmapreneurship.

“Great institutions are committed to their strategic plans, and the School of Pharmacy is no exception,” Eddington said. “The latest iteration of our five-year strategic plan was implemented in 2016 and sets forth lofty goals to achieve before its conclusion in 2021. This year’s State of the School of Pharmacy Address provides an opportunity for us to reflect on those goals that we have already realized while offering a glimpse into the future at new initiatives on which we will embark in the years to come.”

Celebrating a milestone year

Eddington began her address with a recap of the School’s recent 175th anniversary celebration, which began in January 2016 and featured events attended by faculty, staff, students, alumni, and friends of the school. The 18-month celebration not only reflected on the school’s history but also highlighted its ambitions for the future, culminating in a once-in-a-lifetime event that honored nine of the school’s most extraordinary alumni as its Founding Pharmapreneurs and heralded the next era of innovation at the School – an era of pharmapreneurism.

“Our goal is to emulate and follow the example set by our nine founding pharmapreneurs, and offer our faculty, students, and staff every opportunity to be innovators of their own,” Eddington said. “Following their lead, the school will move in a direction in the years to come that no other pharmacy school in the country has conceived of – the creation of programs and initiatives focused on pharmapreneurism.”

Advancing academics

Speaking about the School’s leadership in the area of education, Eddington explained that the Doctor of Pharmacy (PharmD) program remains the largest academic program at the school, receiving an average of 1,000 applications for each class of 160 students. She also noted that the School’s two doctoral programs – the PhD in Pharmaceutical Health Services Research (PHSR) and the PhD in Pharmaceutical Sciences (PSC) – continue to attract the best and brightest students, commending the PhD in PSC program’s participation in the Meyerhoff Graduate Fellowship Program at the University of Maryland, Baltimore County, which aims to increase diversity among students pursuing doctoral degrees in biomedical and behavioral sciences. Eight graduate students currently enrolled in the program are Meyerhoff fellows.

Showcasing the expansion of the school’s academic catalog, Eddington highlighted its three online master’s degree programs – the MS in Regulatory Science, MS in Pharmacometrics, and MS in Palliative Care. Led by Mary Lynn McPherson, PharmD, MA, MDE, BCPS, CPE, professor in the Department of Pharmacy Practice (PPS) and executive director for advanced postgraduate education in palliative care at the school, the MS in Palliative Care launched in the spring of 2017 and has enrolled 80 students, including 14 physicians, 25 nurses, 11 pharmacists, six social workers, and two veterinarians. “The diverse careers held by students in the MS in Palliative Care program illustrate the truly interprofessional nature of this field and further support the demand for advanced knowledge in the field,” she said.

Breaking new ground in research

Shifting the focus to research, Eddington spotlighted the school’s integrative approach to drug discovery and development, innovative patient care, and medication outcomes and their economic impact. She reported that faculty, postdoctoral fellows, pharmacy residents, and graduate students at the school were awarded more than $28.1 million in grants and contracts during Fiscal Year 2017 – a 5 percent increase when compared to Fiscal Year 2016.

In addition to highlighting several faculty members who recently received or renewed multimillion-dollar grants with leading funding agencies such as the National Institues of Health and the National Science Foundation, Eddington presented a number of pioneering research initiatives in which the school is involved, including its participation in the National Institute for Innovation in Manufacturing Biopharmaceuticals (NIIMBL) and a new partnership with the University of California, San Francisco to accelerate the pace of innovation in pediatric drug and device development.

She also explained how interdisciplinary efforts spanning the school’s three departments are helping to combat drug addiction across the nation, including efforts by researchers in PSC to develop a new opioid compound with no abuse liability, work by faculty in PPS to establish criteria for analyzing data from the state’s prescription drug monitoring program to help identify potentially harmful drug interactions and inappropriate prescribing, and initiatives led by researchers in PHSR to help shape state and federal policy surrounding prescription drug abuse and medication quality in long-term care and mental health.

“Nowhere is our focus as a comprehensive school of pharmacy more evident than in our approach to addiction,” she said. “This impressive body of work encompassing our education, research, practice, and community mission areas focuses on one of our nation’s top public health crises and demonstrates our commitment to playing a major role in curbing the dangerous trends of opioid addiction.”

Leading the pharmacy profession

In the area of practice, Eddington reported that faculty in PPS provided care for nearly 23,000 patients across Maryland in a variety of settings, including outpatient clinics, hospital units, and community pharmacies. She spotlighted the recent launch of the Applied Therapeutics, Research, and Instruction at the University of Maryland (ATRIUM) Cardiology Collaborative and congratulated Magaly Rodriguez de Bittner, PharmD, BCPS, FAPhA, professor in PPS and associate dean for clinical services and practice transformation, on being named the inaugural population health fellow with the University of Maryland Medical System, which helped pave the path for the school to partner with the medical system through a contract with its Quality Care Network to provide pharmacy services and case management support to about 125,000 patients.

Partnering with the local community

Underscoring the school’s commitment to engaging with the local community, Eddington spoke about how members of the Patient-Centered Involvement in Evaluating the Effectiveness of Treatments (PATIENTS) program, which empowers patients to ask questions about their health care concerns and actively participate in studies to answer those questions, hosted or participated in 350 community events throughout West Baltimore, reaching 1,500 patients and community members. She also applauded the work of the school’s numerous student organizations, which organized more than 70 events for members of the greater Baltimore community, noting that several of those initiatives were part of national campaigns, including the National Script Your Future Challenge, or recognized with national awards, such as the school’s American Association of Pharmaceutical Scientists student chapter receiving the organization’s 2016 Student Chapter of the Year Award.

Major charitable giving events also were spotlighted during the presentation, including the success of the school’s inaugural online Giving Day and the creation of new scholarships as a result of endowments made by the family of Felix A. Khin-Maung-Gyi, BSP ’83, PharmD, MBA, who founded and served as chair of Chesapeake Research Review before his death in 2014, and Ellen H. Yankellow, BSP ’73, PharmD ’96, president and chief executive officer of Correct Rx Pharmacy Services.

Looking toward the future

To conclude her address, Eddington offered a look into the future at the School of Pharmacy – a future made even brighter with the recent launch of its new initiative in pharmapreneurism.

“As we move into our next 175 years, the School of Pharmacy remains committed to providing our faculty, students, and staff with the tools and resources they need to solve the perennial, long-term problems facing health care, research, and society,” Eddington said. “Exclusive to the School of Pharmacy, pharmapreneurism formalizes this commitment, allowing us to focus on building innovative pharmapreneurial programs that can be incorporated into every facet of the school.”

Malissa Carroll Clinical Care, Community Service, Education, Research, UMB NewsSeptember 26, 20170 comments
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New Slideshows Coming Soon

Our web slideshows are getting a face-lift! The new designs, to be released Tuesday, Sept. 5, feature an engaging new look as well as some useful functional adjustments.

Web content managers: If you use the slideshow and slide content types on your web pages, please prepare to update your content as soon as possible. New fields and image size requirements can be reviewed in the UMB Web Manual. Don’t be caught off guard when the template is updated next month. This announcement affects,,, and

Amir ChamsazTechnologyAugust 14, 20170 comments
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School Hosts 175th Anniversary Luncheon

Distinguished alumni and their guests gathered in Pharmacy Hall on April 29, as the University of Maryland School of Pharmacy hosted its 175th Anniversary Alumni Awards of Service and Excellence Luncheon. Held to commemorate the School’s 175th anniversary, the event celebrated 37 outstanding alumni who were nominated for the honor by their fellow alumni and who epitomize expertise, influence, and impact in the School’s mission areas of education, research, practice, and community service.

“I am tremendously grateful to host this first-of-its-kind celebration at the School honoring our extraordinary alumni, both past and present,” said Natalie D. Eddington, PhD ‘89, FCP, FAAPS, dean and professor of the School, as she welcomed attendees to the event. “The School of Pharmacy has long known about your contributions and successes, and has looked forward to an opportunity such as this to celebrate your accomplishments. As the recipients of today’s Alumni Awards of Service and Excellence, you are the true embodiment of the School of Pharmacy’s legacy, and account for a large part of our 175 years of history and our unparalleled success.”

Established in 1841, the School of Pharmacy is the fourth oldest pharmacy school in the United States. It celebrated its 175th anniversary in 2016. The presentation of Alumni Awards of Service and Excellence marked one of the culminating events for this milestone anniversary celebration.

Honoring Research and Community Service Trailblazers

The event kicked off with the presentation of awards in the categories of research and community service. Research honorees were recognized for their efforts to combine the knowledge that they learned at the School with their unique expertise to help advance scientific knowledge across the spectrum of drug discovery, health services, and practice-based and translational research. Community service honorees were celebrated for their service to professional organizations at both the state and national levels, as well as their work to provide care to patients, mentor the next generation of pharmacy practitioners, and promote healthy communities.

“It has been a wonderful experience to have this opportunity to reconnect with my great-grandfather’s alma mater,” said John (Jay) Dunning, Jr., who attended the event with his father John Dunning to accept an Alumni Award of Service and Excellence in Community Service on behalf of H.A.B. Dunning, PhG 1897, the inventor of mercurochrome – an iconic antiseptic product found in almost every American’s medicine cabinet for nearly half a century. “Our family has a longstanding relationship with the University System of Maryland, so it was an honor to visit this respected institution.”

“When I think about the other alumni receiving awards today, I feel incredibly honored to be recognized alongside them,” added DeAnna “Dixie” Leikach, BSP ’92, who received an Alumni Award of Service and Excellence in Community Service for her work as vice president of Catonsville, Finksburg, and Paradise Professional Pharmacies and service as president and chief executive officer of Pharmacy Ethics, Education, and Resources (PEER), a nonprofit organization that she established in 2015. “It is an incredible experience to be here today and to take part in this extraordinary event.”

Recognizing Excellence in Practice and Education

Following a short break for lunch, the event continued with the presentation of awards in the practice and education categories. Practice honorees included community pharmacists, academicians who also care for patients, consultants, and other experts who work to advance pharmacy practice while improving outcomes for patients. Education honorees were described as the “cream of the crop” in higher education, and included alumni who teach at or lead respected academic institutions, or who have established educational opportunities for students within their professional arenas.

“I am humbled to be here today in the company of such distinguished alumni whom I deeply appreciate and respect,” said Wanda T. Maldonado-Dávila, BSP ’82, PharmD ’86, dean and professor of the University of Puerto Rico School of Pharmacy, who accepted an Alumni Award of Service and Excellence in Education for her work to advance pharmacy education in Puerto Rico, including the implementation of a number of interprofessional education initiatives and development of a new residency program in community pharmacy and certificate in academia for pharmacy residents. “When I first enrolled at the School as a student, I could not have imagined the impact that the experience I was embarking on would have on me as a person and as a professional. I am truly grateful to the School of Pharmacy for providing me with the opportunity to be part of this great community of pharmacists, teachers, learners, scientists, and patient advocates who strive to make a difference in our society.”

“As a student pharmacist, I never expected to pursue a career in academia, so receiving this recognition today is quite humbling,” added Anthony K. Wutoh, BSP ’90, PhD ’96, provost and chief academic officer for Howard University, who accepted an Alumni Award of Service and Excellence in Education for his leadership at Howard University and participation in a multitude of international programs aimed at advancing pharmacy education around the world. “In addition to my father, who was a professor at the University of Maryland, Eastern Shore, I attribute a lot of the success that I have experienced in my career to the education, training, and mentoring that I received at the School of Pharmacy. The faculty at the School helped me understand how a career in academia would allow me to work with students and participate in research in a field that was particularly meaningful to me.”

Looking Toward the Next 175 Years

Eddington, who was also honored with an Alumni Award of Service and Excellence in Education in recognition of her continued service to the School, concluded the event with a call to action for the award winners, encouraging them to continue their trailblazing work while also advocating and serving as an ambassador for the School of Pharmacy. She also introduced “pharmapreneurism” – the umbrella under which the School of Pharmacy will continue to innovate in education, practice, research, and community service – noting that honorees could expect to hear more about this transformational concept at an upcoming gala that will celebrate the School’s founding pharmapreneurs on May 10.

“Today marks the start of a new relationship between the School of Pharmacy, all of our honorees, and between each of you – a relationship strengthened by your shared connection as recipients of Alumni Awards of Service and Excellence,” said Eddington. “I challenge you all to continue your incredible work with the added pride of this recognition and the bond you now share with both your fellow honorees and the School. You are all pharmapreneurs, as evidenced by the innovations that you have implemented in practice, research, academia, and service, and you now have the distinction of being recognized as all-time award winners. However, with that recognition comes responsibility – helping us continue to be the best school of pharmacy.”

To view a complete list of honorees for the Alumni Awards of Service and Excellence, visit this webpage.

Malissa Carroll Bulletin Board, Education, People, UMB News, University Administration, University LifeMay 8, 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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UMMC Urgent Care

UMMC Urgent Care

The UMMC Urgent Care Center, which opened in the fall of 2016, is a great choice when you can’t see your primary care provider but need same-day care for conditions that are not life threatening but require care within 24 hours. No appointment is needed.

University of Maryland Urgent Care

105 Penn St.
(Around the corner from the Emergency Department)
Monday through Friday
8 a.m. to 8 p.m.
Walk-ins only

Primary Target Audience

Residents of Baltimore City and the UMMC service area


Accepts most insurance

Scope of Services

Radiology (plain film X-ray)
Facilitation of UM FPI specialist appointments to assure timely access

Erin CorcoranBulletin Board, Clinical Care, For B'moreFebruary 7, 20170 comments
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January Employee of the Month - Curry

IMET’s Curry Named Employee of Month

When President Jay A. Perman, MD, entered his Saratoga conference room on Jan. 25, the dozen employees amassed there rose to their feet. “You’re not from around here are you?” Perman playfully said, urging the group to sit.

Actually they were from 1.4 miles away, the Institute of Marine and Environmental Technology (IMET) on Pratt Street, and some were a little confused, even concerned, as to why they were there.

“Priya [DasSarma] said she had a meeting with HR and asked me to join her since I do the HR work at IMET,” said research administrator Kimberly Curry, MBA. “Outside the conference room when I heard Dr. Perman was going to be there, I’m like, ‘Priya, WHAT did you do?’ And when we walked in and saw [10 colleagues from IMET] it was like ‘is this an intervention or something?’”

Perman turned Kim and Priya’s worried looks to smiles announcing that Curry had been named UMB’s January Employee of the Month.

“People wrote a lot of nice things about you in your nomination,” Perman told Curry, mentioning her knowledge about research grants, her service orientation, the fact she does things with a smile, and is a great team player.

“Frankly, another reason I’m happy you’re the Employee of the Month is that I’ve been doing this for seven years and this is the first time I’m quite sure that we have kept in mind that UMB is larger than the campus proper,” Perman said. “We have all these wonderful people who happen to be a mile or two away in this case as well as people in Montgomery County and elsewhere. So you’re also representing a group of great employees who aren’t on campus every day but who make UMB better.”

‘Wear Different Hats’

Curry, who admits she was “completely stunned” by the award and its $250 prize, has worked at UMB for nearly 16 years, starting out in the Department of Biochemistry and Molecular Biology and moving to IMET in 2013.

Created by the University System of Maryland Board of Regents in July 2010, IMET is a collaborative effort between the University of Maryland School of Medicine, the University of Maryland, Baltimore County (UMBC), and the University of Maryland Center for Environmental Science (UMCES).

Asked her duties, Curry says she “does everything required to manage a program. Payroll to pre-award grant submissions, post-award grant management, anything that’s required for the UMB faculty at IMET. I know a lot of the departments have four or five people. Here I’m it. So I wear a lot of different hats.”

“Here” is the Columbus Center near Pier VI on the Inner Harbor. With a huge sail across its atrium, long gleaming hallways, tanks of specially purified water with fish in the basement, great views of the harbor from the top floors, and test tubes and research galore, IMET is housed in quite a building.

“This is a gorgeous area to be in,” Curry said of the pros and cons of working in a satellite center. “You do lose some of that campus feel when you are down here. But everything else makes up for it. They’re doing such great things here with the ARC facility, the IMET incubator Harbor Launch, and also bringing in all these companies. It’s kind of like the BioPark. We also have the USM chancellor with us now.”

Years in Secret Service

Curry’s more modest office has its own accoutrements. Artwork and pictures of her three kids and an official sign above her desk that makes one take notice: “Kimberly M. Curry/U.S. Secret Service.”

“I did three years with the Secret Service before I joined UMB, right here at the Baltimore field office,” Curry said. It wasn’t the Secret Service depicted in Hollywood. “I sat in an office and typed up orders, process counterfeit bills and that sort of thing. I did get to meet Bill Clinton and Al Gore.”

Then Curry came to UMB and became a star in her own right.

In her nomination form, DasSarma, who is laboratory research supervisor at Columbus Center for her husband, Shiladitya DasSarma, PhD, a pioneering microbiologist celebrating 30 years running his lab in the School of Medicine, said: “Kim is a real gem for the faculty and staff at IMET. She always has a bright energy about her and carries through all tasks with gusto. She is positive, professional, and willing to make an extra call, take an extra step, or give an extra smile. In addition to many other things, including providing special care for foreign students and faculty, she understands the scientific process and its unique needs.”

‘Be the Best You Can Be’

Asked why she goes to such lengths, Curry modestly said it’s part of the job.

“You should always be the best you can be. I know that I would want someone to do that for me and you should always treat people the way you would want to be treated,” she said. “I think it just makes for a happier environment. I try to walk through all of my five labs at least once a week and I try to do it with a bubbly attitude and a smile and I feel that kind of rubs off.”

Sure enough, minutes later as she was leading a visitor on a tour, her IMET colleagues couldn’t have been nicer, explaining their research, pointing out where to get the best views of the harbor, and citing a large framed equation of the human genome.

“I work with fantastic people. IMET is a fun group,” said Curry, who added nothing brings her more joy than when “my faculty” are awarded a research grant or when excited students first arrive. “We exemplify collaboration, our UMB core value, down here at IMET. I work very closely with administration at UMBC and UMCES on a daily basis, as well as the microbiology and biochemistry groups on campus. But when you’ve been on campus as long as I have, and serve on so many committees, you have friends all over.”

Chris Zang Clinical Care, Collaboration, Contests, Education, People, Research, Technology, University LifeFebruary 2, 20170 comments
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Welcome Month

Campus Life Presents: UMB Welcomes You!

Whether you’re brand new to the University of Maryland, Baltimore (UMB), or returning for another year of classes, Campus Life Services would like to welcome you with a series of exciting events.

Join us for ice cream, an outdoor movie, a festival, and more!

Start off the year by making connections with other students, learning about UMB, and getting to know your campus and the surrounding city.

For a full list of events, please visit

Stephanie ZingerABAE, Bulletin Board, Collaboration, Community Service, Education, People, UMB Go Green, University Life, USGAAugust 10, 20160 comments
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State of the University

State of the University: Improve the Human Condition. Serve the Public Good.

University of Maryland, Baltimore (UMB) President Jay A. Perman, MD, invites you to attend his third annual State of the University address on May 4 at 3 p.m. in the School of Nursing auditorium. This year’s State of the University address, “Improve the Human Condition. Serve the Public Good.” will revisit UMB’s 2015 highlights and look ahead to 2016. Reception to follow – light refreshments will be served.


Clare BanksBulletin Board, Education, Global & Community Engagement, People, UMB News, University LifeApril 14, 20160 comments
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The Effectiveness of Anti-Epileptic Drugs

A collaborative research project led by the Food and Drug Administration (FDA) with support from the Center for Translational Medicine (CTM) at the University of Maryland School of Pharmacy and the Pediatric Epilepsy Academic Consortium for Extrapolation (PEACE) has concluded that extrapolation of anti-epileptic drug efficacy results from adults to children ages four years and older with partial onset seizures is acceptable, and that independent clinical trials for efficacy in children will no longer be needed.

“The CTM works with organizations around the world to streamline drug development through the continuous assessment of current practices, with the goal of developing and implementing new, more efficient drug development processes,” says Joga Gobburu, PhD, MBA, professor in the Department of Pharmacy Practice and Science (PPS) and director of the CTM at the School. “In the field of pediatric drug development, we know that performing clinical trials in the pediatric patient population is challenging for a number of reasons. Through this collaborative research project, we sought to determine whether additional clinical trials are truly necessary to show efficacy of anti-epileptic drugs in children once other trials have shown those drugs to be effective in adults.”

Convening the Experts

Anti-epileptic drugs refer to a diverse group of medications used to treat various types of epileptic seizures. These medications are often developed as supplemental therapy to treat partial onset seizures – the most common type of seizure experienced by patients with epilepsy – in adults. Prior to the completion of this project, these medications were only prescribed to pediatric patients after they had been approved for use in adults and at least one well-controlled clinical trial had been conducted in pediatric patients.

To assess whether the accumulated evidence from past clinical trials with multiple anti-epileptic drugs was sufficient to support extrapolation of efficacy from adult to pediatric patients for the treatment of partial onset seizures, and under what circumstances such extrapolation would be appropriate, the FDA turned to the CTM. Gobburu reached out to PEACE – a consortium that includes experts from a number of organizations external to the FDA, including academia and the pharmaceutical industry – to provide supportive clinical expertise in describing disease and intervention similarities between adult and pediatric patients.

“PEACE was established in 2012, and includes representatives from numerous organizations across academia, government, and industry,” says John Pellock, MD, a member of PEACE and professor and senior associate dean of continuing medical education at Virginia Commonwealth University School of Medicine. “When Dr. Gobburu first introduced the project to the consortium, we recognized its relevance to the work that we do every day, and were excited to get involved. The child neurologists in the consortium were instrumental in assessing the similarity of focal epilepsy in adults and children, while Dr. Gobburu led other members in further pharmacometric analyses in conjunction with the FDA.”

Gaining Hands-On Training

Funded by the FDA’s Center for Drug Evaluation and Research Critical Path program, the project required screening all approved anti-epileptic drugs to identify those for which efficacy clinical trials had been conducted in both adult and pediatric patients for supplemental therapy of partial onset seizures. Quantitative pharmacokinetic (PK) and pharmacokinetic/pharmacodynamics (PK/PD) analyses were then conducted for PK/PD and clinical endpoints datasets collected from both FDA databases and the pharmaceutical companies. Shailly Mehrotra, a graduate student mentored by Gobburu in the PhD in Pharmaceutical Sciences (PSC) program at the School, was afforded the unique opportunity to gain hands-on experience analyzing the data at the FDA, where she assisted with the creation of a clinical trial database and performed exposure-response analyses to bridge partial onset seizures’ supplemental treatment data between adult and pediatric patients.

“I am grateful to the CTM for offering me the opportunity to complete a fellowship with the FDA,” says Mehrotra. “The CTM has played a pivotal role in providing me with excellent training to help hone my technical skills, while helping to elucidate complex drug development concepts that I will be able to apply towards influencing decisions.”

She adds, “As a graduate student, it was a unique experience to work with the immensely talented scientists at the FDA, as well as the brilliant clinicians from PEACE. I feel fortunate to have been involved in a project that directly impacted public health and patient care through accelerating the pediatric drug development of anti-epileptic drugs. Not only did this fellowship provide a platform to help me further develop my core skills as a researcher, but – more importantly – it also provided me with a broad overview of pediatric drug development. It taught me how innovative, out-of-the-box thinking, combined with team collaborations can help tackle challenging problems. The lessons that I learned during my fellowship at the FDA, coupled with the meticulous training that I have received at the CTM, have truly laid a strong foundation for my professional career.”

Lasting Implications

Based on the analyses conducted by Mehrotra and other researchers, the FDA concluded that extrapolation of efficacy from adult to pediatric patients ages four years and older with partial onset seizures is acceptable.

“The FDA thanks Dr. Gobburu for his truly pivotal role in bringing together external collaborators to work with our agency on this project,” says Mehul Mehta, PhD, FAAPS, director of the Division of Clinical Pharmacology I in the Office of Clinical Pharmacology at the FDA. “Those rich collaborations, combined with Shailly’s exhaustive and complex analysis of a large number of clinical trials, helped to form the backbone for the success of this project.”

Echoing Mehta’s sentiment, Gobburu notes that it was the level of collaboration that occurred between the FDA, CTM, and PEACE throughout the project that made the initiative exceptionally trailblazing. “Putting the outcome of the project aside, it was the collaborative process in which all of the stakeholders engaged that helped to make this project a success. This project brought together a consortium, an academic institution, and the FDA to solve a common problem, creating a template for teamwork that we can implement across other projects. It is very fulfilling to know that our Center and the School of Pharmacy were instrumental in bringing all of the parties together to make this happen.”

Malissa CarrollCollaboration, Education, People, Research, UMB NewsMarch 25, 20160 comments
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