PRZOOM - /newswire/ -
Princeton, NJ, United States, 2010/06/22 - PharmaNet Development Group, announced that it will host two one-day, free-of-charge symposia to discuss clinical, scientific and regulatory issues related to the development of biosimilars.
PharmaNet Development Group, a leading provider of drug development services to the pharmaceutical, biotechnology, generic drug and medical device industries, today announced that it will host two one-day, free-of-charge symposia to discuss clinical, scientific and regulatory issues related to the development of biosimilars. Entitled “Global Development of Biosimilars: Challenges and Opportunities”, the symposia will take place on July 27, in Seoul, Korea and on July 30, in Beijing, China.
Drawing upon PharmaNet’s experience, the symposia will provide insights into the global regulatory framework for biosimilars and discuss the main considerations for pre-clinical and clinical studies, assessing comparability, immunogenicity testing, and clinical pharmacokinetic/pharmacodynamic studies. In addition, a number of case studies on the US regulatory perspective on follow-on biologics will be presented. Delegates will have the opportunity to discuss any issues during two planned Q & A sessions.
Biologics are driving significant growth in the prescription drug segment, being increasingly used in hard-to-treat diseases such as cancer, autoimmune and orphan diseases. Biologics worth a total of $25 billion are expected to go off-patent by 2016 creating a significant market opportunity for biosimilars. With its portfolio of biologics and biosimilars services, PharmaNet is well placed to enable companies to capitalize on these market opportunities. PharmaNet’s services include Phase I-IV clinical development programs, bioanalysis and consulting for small and large molecule products.
Jeffrey Freitag, M.D, Senior Vice President, Consulting at PharmaNet Development Group commented, “PharmaNet’s staff has extensive experience and knowledge in the development of innovator drugs, generics and biosimilars. With the expected growth of the biosimilars market, we are well placed to provide advice and services covering the entire spectrum of development and therapeutic areas. Hosting the symposia will give us the opportunity to share our extensive knowledge and expertise and help sponsors enhance the productivity of biosimilar development.”
Over 30% of the clinical research performed by PharmaNet is in biotechnology, with over a hundred studies conducted for biologic molecules and dozens for monoclonal antibodies. Pharmaceutical customers can also benefit from bioanalytical support including immuno- and cell-based assays, proprietary ELISAs or the validation of commercial kits. In addition, analytical structure elucidation, characterization and similarity assessment capabilities are offered.
For further information about PharmaNet Development Group’s symposia and for registration details, please contact Patricia Hall at phall[.]pharmanet.com.
About PharmaNet Development Group, Inc.
PharmaNet Development Group, Inc. (pharmanet.com), a global drug development services company, provides a comprehensive range of services to the pharmaceutical, biotechnology, generic drug and medical device industries. The Company offers early and late stage consulting, Phase I clinical studies and bioanalytical analyses, and Phase II, III and IV clinical development programs. With approximately 2,300 employees and 42 facilities throughout the world, PharmaNet is a recognized leader in outsourced clinical development.