Rockville, Maryland (PRWEB) January 24, 2013
(January 22nd, 2013) — Fisher BioServices, the world’s leading provider of biospecimen storage, cell therapy logistics and related clinical trial services, announced today that Mr. Dan O’Donnell, Associate Director of Cell Therapy Logistics at Fisher BioServices, and Mr. Bruce C. Simpson, Director of Commercial Operations at Fisher BioServices, will be presenting at the 2013 Phacilitate Cell & Gene Therapy Forum, January 28-30, in Washington, DC. This year’s Forum focuses on bringing therapeutics “From Promise to Products” and features presentations and roundtable discussions on positioning new cell and gene therapies for commercial success.
Companies with cell-based therapies nearing clinical trials and FDA approval face the challenge of transporting their product in compliance with FDA requirements for cold chain / chain of custody documentation. Mr. O’Donnell and Mr. Simpson are recognized industry experts on the handling and distribution of gene and cell-based therapies, and will be sharing the latest innovations on the distribution of cell-based products and regenerative medicines from the manufacturer to the patient, while complying with all applicable Title 21 CFR criteria.
The critical issues of commercial viability will be addressed in the first plenary session, and will include valuing cell therapies, reimbursement in the current healthcare environment, and other factors that may influence a product’s commercial success, including distribution systems.
During this session, Mr. O’Donnell will outline the variables that must be considered during every point of transfer in the delivery of cell therapies to the patient, and will discuss the challenges and technical considerations involved in moving cryogenically frozen products around the world.
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