Top Experts Review Future Of Immunogenicity To Biologics - New Report Says

A new report would help companies prepare for new product launches as it specifically analyses new US White Papers on immunogenicity to bioloigcs and provides regulatory advice on working with the Food and Drug Administration (FDA) and the European Medicines Agency (EMEA). End Quote

(1888PressRelease) December 19, 2007 - Report Buyer, the online destination for business intelligence for major industry sectors, has added a new report, written by leading scientists in the field, which outlines and assesses the implications of patient reactions to biotech drugs. The study specifically analyses immunogenicity, the body's response to therapeutic proteins in relation to the new guidelines The Committee on Medical Products for Human Use (CHMP).

“Immunogenicity to Biologics- Implications of Reactions against Biotech Drugs” which is available at www.reportbuyer.com/go/ BKP00009, finds that immunogenicity, is vitally important in the development and marketing of biotech drugs. It says failure to predict and monitor levels of immunogenicity can have disastrous results for patients and for companies. For instance, managing immunogenicity in trials and in the approval process can add 18 months to development times and $75 million to costs.

Authors of the report include leading experts in the field such as Dr Stephen Swanson, Department of Clinical Immunology, Amgen, Dr Harald Kropshofer, Immunosafety of Biologics, F. Hoffman La Roche, Robin Thorpe, National Institute for Biological Standards and Control, UK and Dr Deborah Finco-Kent, Immunogenicity Assay Coordinator, Pfizer among others.

The publication would help companies prepare for new product launches as it specifically analyses new US White Papers and provides regulatory advice on working with the Food and Drug Administration (FDA) and the European Medicines Agency (EMEA). It contains risk management strategies and outlines the commercial implications of immunogenicity.
"Immunogenicity to Biologics- Implications Of Reactions Against Biotech Drugs” is available from Report Buyer.
For more information go to: http://www.reportbuyer.com/pharma_healthcare/biotechnology/immunogenicity_biologics.html

Report Buyer product ID: BKP00009

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