Office of Internal Communications
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Streamlining, Increasing Medical Device Approvals Goal of Two-day Event New medical devices have to be tested on human subjects, but protecting the rights of those subjects can present considerable challenges for researchers. A national conference devoted to exploring the FDA critical pathway for approval of new medical products while protecting human subjects, co-sponsored by the Food and Drug Administration and the University of Houston, will be held at UH April 21-22. One of only three annual conferences sponsored by the U.S. Department of Health and Human Services’ Office of Human Research Protections (OHRP), UH is hosting “The Critical Path to New Medical Products: The Challenges in Protecting Human Subjects.” The two days of presentations, panels and breakout sessions will be held at the Hilton UH Hotel and Conference Center. “While the increased potential is tremendous for new medicines, biologicals and genomic-based treatments and devices that prevent and cure diseases, fewer new medical devices are reaching the marketplace,” said Isaac D. Montoya, clinical professor in the UH College of Pharmacy. “The shortest distance between two points is a straight line; however, the line that leads to developing new medical devices is rarely short or straight. This conference will explore options and approaches for meeting this challenge while protecting human subjects.” The “critical path” of medical product development includes the process and crucial steps that determine whether and how quickly a medical discovery becomes a reliable device for patient use. With a number of challenges and issues concerning the protection of human subjects, this “critical path” will be thoroughly examined. Participants will be given practical information about conducting biomedical research, as well as being provided an update on the regulations and presented with an overview of the challenges, issues and potential solutions facing government and the private sector in conducting federally funded research involving human subjects. The conference is designed to benefit principal investigators, research staff and coordinators, those involved in institutional review boards (IRBs), institutional officials, pharmaceutical research personnel and medical personnel with an interest in human subjects protection, as well as graduate and undergraduate students. In completing the two-day program, participants can expect to demonstrate a better overall understanding of the Code of Federal Regulations from the Office for Protection from Research Risks that govern research funded by Title 45 Part 46 on public welfare and the protection of human subjects. Additional benefits include the ability to apply ethical principles and regulations to research involving human subjects, identify opportunities and solutions to compliance issues in human research studies conducted by academia and the private sector, apply examples and definitions provided to complex and difficult research issues, and demonstrate knowledge of government initiatives such as the “critical path” of medical product development and marketing. In order to promote the next generation who will oversee the protection of human subjects in research, a call for abstracts has been put out for student work in the field. The deadline for submissions is Friday, April 15. The poster sessions are intentionally limited to students so that they have the opportunity to showcase their work to a group of senior researchers. The organizers want to highlight and encourage work in this field and are interested in any work students are doing or have done in the area of protecting human subjects, ethics and other related topic areas. Abstracts are submitted online (http://www.uh.edu/pharmacy/ohrp/callforabstracts.htm). Montoya, the conference moderator and coordinator, will introduce Jay Gogue, chancellor of the UH System and president of UH, who will officially open the conference at 9 a.m., April 21. To kick off day one, OHRP Director Bernard A. Schwetz, D.V.M, will deliver the first keynote address – “Aspects of the Human Subjects Enterprise.” Following, will be David A. Lepay, M.D., senior adviser for clinical science at the FDA, who will provide insight to FDA regulations involving the protection of human subjects in clinical trials and the organization’s oversight role. Offering a number of panel discussions that provide
a wide range of perspectives from the federal government, private
industry and academia, many notable figures will be in attendance,
as well as giving presentations on topics such as the use of unapproved
devices, bioterrorism and space research. Included in this prestigious
list is Charles F. Sawin, the chief NASA scientist serving as chair
of the Committee for Protection of Human Subjects and chair of the
Human Research Multilateral Review Board at NASA’s Johnson
Space Center (JSC). As a top figure in the IRBs of JSC and the International
Space Station, Sawin will discuss issues relating to conducting
research in space that involves human subjects. In addition, CEO’s
from MicroMed Technology, Pharma Frontiers and BioHouston also will
be on hand to discuss issues experienced facing the private sector.
“While UH is the host, the conference is very
much a community effort,” Montoya said. “Among an impressive
array of speakers will be top Texas Medical Center representatives
and faculty from The University of Texas Health Science Center,
Baylor College of Medicine and M.D. Anderson Cancer Center. We’ve
also had pre-med students from the local chapter of the American
Medical Student Association sign on as volunteers. I’m really
pleased with the level of involvement and the unity exhibited by
so many in this important event.” Lisa Merkl
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