NEWARK, N.J., April 23, 2013 /PRNewswire-USNewswire/ -- The Food and Drug Administration is still waiting for pharmaceutical companies to begin submitting the first new medicines in a class of prescription drugs known as biosimilars, according to Rachel Sherman, an official with the agency's Center for Drug Evaluation and Research.
Sherman, who is the center's director of medical policy, will be among the speakers addressing some of the pressing issues and major trends facing the biopharmaceutical industry during Rutgers Business School's annual healthcare symposium on Tuesday, April 30, beginning at 8:30 a.m.
The symposium is sponsored by the Blanche and Irwin Lerner Center for the Study of Pharmaceutical Management Issues. The center has positioned itself as a source of innovative activities and provocative discussions about the drug manufacturing industry.
"The primary purpose of the symposium is to have a meaningful dialogue among the researchers and professionals in the bio-pharmaceutical area from around the country and those at Rutgers," said Professor Mahmud Hassan, director of the Lerner Center.
In addition to the FDA's Sherman, featured speakers will include Seyed Mortazavi, president of IMS Health's U.S. operations; Joseph Herring, chairman and CEO of Covance; and Scott Gottlieb, a resident fellow with the American Enterprise Institute.
John Castellani, president and CEO of Pharmaceutical Research and Manufacturers of America, will offer his perspective on trends in the industry as the symposium's keynote speaker. Castellani leads the trade association, known familiarly as PhRMA, that represents the nation's major pharmaceutical research and biotechnology companies.
The symposium will delve into some of the industry's most pressing issues, including the latest innovations to make clinical trials more cost efficient, the progress of FDA efforts to expedite the development of "breakthrough'' drugs, regulatory crackdowns on the manufacturing of injectable medicines and the status of efforts to supply the nation with new anti-infectives.
Sherman is also expected to provide an update on the widely anticipated introduction of biosimilars, new, slightly modified versions of existing biologic medicines that include many powerful cancer-fighters.
The medicines, which have been available in Europe for nearly five years, were expected to provide U.S. patients with alternatives to the high-priced biologics and to help major pharmaceutical companies boost revenues.
"The agency is committed to moving the science forward as soon as possible," Sherman said in an interview leading up to the symposium, "but to date, the FDA has not received an application."
There are no indications that regulators will be reviewing one of the new medicines within the next 10 months. The progress of their development, Sherman said, sits with the drug makers.
"We are doing everything we can," she said, "not to be the stumbling block, by providing for a clear and transparent pathway."
Rutgers Business School offers one of the top-rated MBA programs in pharmaceutical management, and the Blanche and Irwin Lerner Center has strengthened the school's reputation for providing management training and for producing leading academic research.
The Lerner Center thrives in a state rich with pharmaceutical and healthcare giants such as Johnson & Johnson, Celgene and Merck. The industry remains one of the engines fueling the New Jersey economy.
The concentration of pharmaceutical manufacturing and research in New Jersey helped to spur creation of the center at Rutgers Business School in 2007, and it continues to benefit students graduating with a Rutgers MBA in pharmaceutical management.
Professor Hassan, who is also director of the MBA pharmaceutical management program, said the drug research and manufacturing industry is the largest employer of Rutgers MBA graduates, employing nearly 40 percent of them.
"The growth of this industry not only affects the economy of New Jersey, it affects our MBA program as well," Hassan said.
The healthcare symposium will be held at Rutgers Business School, Newark Campus, 1 Washington Park, Room 118. The event runs from 8:30 a.m. until 1:30 p.m.
In addition to MBA and doctoral students, attendees of the symposium will include biopharmaceutical industry executives and professional as well as Rutgers faculty.
Registration is required to be admitted. To RSVP
SOURCE Rutgers Business School