M-CERSI Day Highlights Regulatory Science
|On Sept. 5, the University
of Maryland School of Pharmacy hosted the second annual M-CERSI Day
to celebrate the work and progress made by the University of Maryland's Center of
Excellence in Regulatory Science and Innovation (M-CERSI) since its
inception in 2011. The event, which featured speakers from industry and
the Food and Drug Administration (FDA), also offered participants the
opportunity to discuss current issues in regulatory science.
"Collaborative projects such as the Center of Excellence in Regulatory
Science and Innovation are the wave of the future," said Natalie D. Eddington, PhD, FAAPS, FCP,
dean and professor at the School of Pharmacy. "This center signifies
the fantastic scope of research capabilities across the campuses of the
University of Maryland, Baltimore
and the University of Maryland, College
Park; the synergy shared by faculty who specialize in health
science, engineering, public health, and regulatory science; and
highlights our collective expertise in the area of regulatory science."
kicked off with remarks from Eddington; James Polli, PhD, the
Shangraw/Noxell Endowed Chair in Industrial Pharmaceutics at the School
of Pharmacy and co-principal investigator of M-CERSI; and Frank Weichold, MD, PhD, director of
regulatory science and innovation at the FDA. Polli spotlighted the America's
Got Regulatory Science Talent competition hosted by M-CERSI
earlier this year, emphasizing the unique way that the competition
engaged students in the regulatory science field.
While last year's M-CERSI Day spotlighted speakers from industry, this
year the focus was on regulatory science initiatives currently underway
at the FDA. "The FDA can play a significant role in stimulating
dialogue, defining problems, and interacting with researchers to
modernize and improve the pathway of product review and approval,"
Cooper, MD, medical officer in the Office of Translational Sciences
at the FDA, and Shashi
Amur, PhD, biomarker qualification scientific coordinator at the
FDA, presented potential approaches to streamline and modernize the
review and approval process for drugs and medical devices. Cooper
advocated for additional review standards and improved consistency
among reviewers, while Amur noted the important role of biomarkers as a
potential drug development tool.
"The FDA has initiated biomarker qualification to help determine which
biomarkers can be relied upon to have a specific interpretation and
application in drug development and regulatory review," said Amur.
"Although it is currently a voluntary process, it remains a very
valuable pathway for the indication of biomarkers that can be used in
multiple drug development programs."
Industry speakers included Jason
Connor, PhD, a statistical scientist at Berry Consultants, and Sanjay
Sehgal, PhD, managing director at Aexelar Regulatory Experts, LLC.
Connor offered his thoughts about how clinical trials could be
redesigned to benefit patients, health care providers, and
manufacturers, saying, "I propose that we end clinical trials as soon
as we know the answer to help optimize the drug development process and
ensure that these trials are conducted in the most efficient manner
possible. The faster we can do trials, the faster we can report answers
and submit new drugs for approval."
Sehgal examined how the process required to submit a specific type of
new drug application (NDA) - a 505(B)(2) NDA, which is often filed by
companies that seek to reposition a drug that has already been approved
by the FDA - could be streamlined to encourage innovation in drug
development and avoid duplicated studies.
Closing the morning session, Robert
Lionberger, PhD, acting deputy director for science in the Office
of Generic Drugs at the FDA, spoke about ongoing research initiatives
in his office and the important role that regulatory science has in
ensuring that the office continues to produce safe and effective
generic drugs for the American public.
"Regulatory science leads to better decision making in both the FDA and private industry," said Lionberger. "It helps the FDA provide better
advice and support for its recommendations to companies before those
companies begin the drug approval process. It also helps to improve the industry's drug development process. When both the FDA and industry
follow good science, there's an increased likelihood that there will be
an alignment between the two sectors, particularly on areas for which
guidances and other regulatory standards have not yet been established."
The afternoon agenda consisted of four closed-door sessions attended by
researchers from the University of Maryland and the FDA, members of the
M-CERSI Advisory Panel, and members of the M-CERSI Industrial
Consortia. These sessions focused on ongoing research related to four
key priorities at the FDA, including improving pre-clinical assessments
of safety and efficacy, ensuring readiness, harnessing diverse data,
and minority health.
M-CERSI is funded by an initial $3 million grant from the FDA, and is
co-directed by Polli and William
Bentley, PhD, the Robert E. Fischell Distinguished Professor of
Engineering and founding chair of the Fischell Department of
Bioengineering at the University of Maryland, College Park. The center
is a collaborative partnership between the FDA, the University of Maryland, Baltimore, and the University of Maryland, College Park that focuses on modernizing and improving the ways in which drugs and medical devices are reviewed and evaluated. To build on the progress made this year, the center plans to launch two new academic programs - a certificate program in regulatory science and engineering at the University of Maryland, College Park and an exclusively online master's program in regulatory science at the University of Maryland School of Pharmacy, and a personalized education program to better leverage the expertise of faculty at both campuses.
|Posting Date: 09/18/2013
|Contact Name: Malissa Carroll
|Contact Phone: 410-706-1690
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