Dr. Ray Yin to Moderate Hot Topic Discussion on Immunogenicity at AAPS
Newark, DE (May 18, 2012) – Dr. Ray Yin, President and Founder of ANP Technologies, Inc., has been selected to be the moderator of a Hot Topic Session at this year’s American Association of Pharmaceutical Scientists (AAPS) Conference scheduled for Wednesday, May 23rd at 4:15 PM. The subject is Post Market Immunogenicity Monitoring: an Emerging Need. Joining Dr. Yin on the panel will be Jack Ragheb, M.D., Ph.D., U.S. Food & Drug Administration and Thorsten Verch, Ph.D., Merck.
With the arrival of a large wave of biosimilars, a major regulatory concern is how to best assess their immunogenicity (IM) during clinical development and the post-market surveillance period. Because biopharmaceutical IM has been associated with serious adverse events, EMA guidelines strongly recommend pharmacovigilance programs including immunogenicity testing to monitor the efficacy and safety of biosimilar products post-approval. The U.S. FDA is considering similar requirements as well. Post-market monitoring of patients, especially those receiving chronic treatment, is currently not routinely performed and, if required, will create added burdens to both the patient and the physician since all IM methods currently available utilize centralized laboratory systems.
The session will offer a discussion of the evolving regulatory requirement for post-market IM monitoring, the benefits of providing Point of Care methods to answer this need, the growing body of experience and data using rapid IM tests, and the opportunity to use these rapid tests to assess pretreatment patient status and the presence of pre-existing antidrug antibodies.
Ask to comment on the announcement, Dr. Yin related, “I am honored and excited about the upcoming conference. I eagerly looked forward to speaking directly with my peers on the topic of Immunogenicity and look forward to a thought-provoking discussion.”
Dr. Yin’s company, ANP Technologies, will be located at Booth N210 during the length of the conference.
About ANP Technologies, Inc.
ANP Technologies, Inc. is a world leader in developing and commercializing various nanobiotechnology-based products for applications related to biodefense, biologic drug development/testing and therapeutic drug delivery.
Celebrating its tenth anniversary, ANP is headquartered in Newark, Delaware. For more information about ANP, please visit www.anptinc.com or telephone 302-283-1730.