|By PR Newswire||
|September 2, 2014 05:30 PM EDT||
BOULDER, Colo., Sept. 2, 2014 /PRNewswire/ -- Dr. Jeanne M. Novak, President and CEO of Boulder, Colorado-based CBR International Corp.®, a full-service biopharmaceutical product, clinical, medical device and regulatory development and compliance group, has been invited by Dr. Larry Zeitlin, President of Mapp Biopharmaceutical to attend the World Health Organization's Investigational Treatment for Ebola conference in Geneva, Switzerland, September 4 – 5. Over the last several months, CBR International's expert team of clinical, regulatory and scientific consultants has been supporting and collaborating with Mapp Biopharmaceutical, Inc., the San Diego-based biotech company responsible for developing ZMappTM, the monoclonal antibody cocktail that has been employed for compassionate use in the current Ebola outbreak.
Working side-by-side with Mapp Biopharmaceutical, Inc., Kentucky Bioprocessing (KBP), Emory University Hospital (Atlanta), ELWA Hospital (Paynesville City/Monrovia, Liberia), London's Royal Free Hospital (UK) and the U.S. Food and Drug Administration (FDA), CBR International has helped to ensure that the proper dosing, safety monitoring and all regulatory procedures were followed for the administration of ZMapp.
"CBR International Corp. has been committed to supporting Mapp Biopharmaceutical during the emergency use of the investigational product," said Dr. Jeanne M. Novak, President and CEO of CBR International Corp. "We will continue to support Mapp throughout its ongoing clinical development while also lending our expertise to the myriad of other affiliated health and regulatory organizations during this crisis."
Dr. Kevin Whaley, CEO of Mapp Biopharmaceutical noted that, "Without the collaboration and support of CBR International associates, especially Dr. Jeanne M. Novak, Dr. Miles Brennan, Mr. Kevin Hennegan, Dr. Tara Nyhuis, Dr. James Merritt, and Dr. Dana Weinberger, patients may not have had the opportunity to volunteer to receive ZMapp."
The WHO meeting in Geneva will address leading experimental treatments and vaccines for Ebola, including potential risks and benefits, short- and long-term availability, potential use and key considerations for deployment in West Africa, as well as clinical testing and ethics. Its goal is to help develop strategies to pave the road for future Ebola preparedness.
About Dr. Jeanne M. Novak
Dr. Jeanne M. Novak founded CBR International Corp. in 1999 (originally Colorado BioReg). She is an internationally-recognized authority in the biotechnology and pharmaceutical industries and is currently consulting in numerous product development areas including recombinant biotechnology, naturally-derived products, cell and gene therapy, devices and vaccines. She is an author, lecturer and strategic development advisor to industry executives worldwide.
Additionally, Dr. Novak has almost 20 years of experience in product and assay development and validation, clinical trial design and oversight, quality assurance systems development, cGMP manufacturing and compliance and global regulatory development to advise cost and time-optimized development for new and established biotech and pharma companies.
Prior to founding CBR International, Dr. Novak served as Senior Scientist in the Center for Biologics Evaluation and Research (CBER) responsible for several programs and policy development. Before joining the FDA, Dr. Novak conducted scientific research in the area of recombinant vaccine development at United States Army Medical Research Institute of Infectious Diseases.
Dr. Novak received a Ph.D. in Experimental Pathology (Cell Biology) and Immunology and a B.S. in Biology from the University of Utah.
About CBR International Corp.
CBR International Corp. is a full-service product, clinical, and strategic regulatory group dedicated to providing comprehensive product development services to the biotechnology, pharmaceutical, and device industries worldwide. The Company's expert staff of scientists is experienced in an all-encompassing range of indications for drugs, novel antibodies, recombinant protein therapeutics, small molecules, vaccines, cell therapy, devices and combination products throughout all phases of program development and commercialization. For more information, please visit www.cbrintl.com.
SOURCE CBR International Corp.
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