Barnett Institute Hosts Short Course For FDA Examiners
May 13, 2011
Recognized for its cutting-edge research and advanced training in analytical chemistry for biomedical applications, the Barnett Institute at Northeastern University was invited to host a two-day short course on state-of-the-art protein characterization as applied to regulatory science to FDA examiners on the National Institutes of Health (NIH) campus in March.
The course was taught by Barnett Institute Director Prof. Barry Karger; Prof. John Engen, Barnett Faculty Fellow and associate professor of chemistry & chemical biology; Prof. Pauline Rudd of the National Institute for Bioprocessing Research and Training (NIBRT, Dublin, Ireland); and Dr. Robert Garnick, president and CEO of Lone Mountain Biotechnology and Medical Devices.
Topics discussed during the short course included mass spectrometric analysis of proteins, H/D exchange for protein characterization, glycosylation analysis, and strategies for drug development of biosimilars. “The course went very well,” said Karger. “The enthusiasm of the attendees and the positive response that we received was very good, and at the same time, through discussions and informal exchanges, we, the instructors, learned a great deal as well.”
With patents on major biopharmaceuticals set to expire in the next few years, this course could not have come at a better time. In fact, it is estimated that as much as $50 billion in revenue will go off patent by 2015. Thus, many companies, including big pharma, are focusing on biosimilars -- the copied version of the current commercial biotech products.
Once the patents expire, biosimilars will attempt to make it into the marketplace, and the FDA will have a major role in deciding which new drugs to approve for the market.
Unlike small molecule generic drugs, the approval process for biosimilars will be very involved because biologics are much more complicated and are manufactured from living organisms.
The FDA is expected to release guidance to the industry on the approval process of biosimilars in the near future.
That’s why training sessions, like the one given by the Barnett Institute to FDA examiners, are so important.
Dr. Karger and the Barnett Institute have offered similar courses here on campus.
For the past two years, Karger and other faculty members have been teaching CARA (the Center for Advanced Regulatory Analysis) short courses in the area of biopharmaceutical protein characterization.
Both the CARA courses and the FDA short course have been instrumental in generating ideas and partnerships between the biotech industry, instrument companies and faculty here at Northeastern University. In fact, the Barnett Institute is seeing significant growth in collaboration with industry at the present time.