Dan O’Donnell, Director of Cell Therapy Logistics at Fisher BioServices, and Bruce C. Simpson, Director of Commercial Operations at Fisher BioServices, will speak at the upcoming Biologistics Summit, June 17–18th in San Diego, California. An annual event of ColdChainIQ, this years’ meeting will focus on maintaining regulatory-compliant transportation and management of biological materials, clinical specimens, and infectious substances.
Mr. O’Donnell will address common misconceptions regarding cryogenic shipping technologies on Tuesday, June 17th at 2:50 PM of the summit entitled, The Physics of Failure: Challenges of Monitoring and Validating Your Biologics in Hostile Environments, the presentation will apply Newton’s Law of Gravity and Thermal Capacity to the challenges of temperature monitoring, qualification and validation, and cell therapeutics storage. He will also provide a case study and review the performance of aryogenic shipping unit for a cell therapeutic drug in a clinical trial. If you are interested in this topic, please check out his video blog below, Delivering Your Cell Therapy: Getting Reliable Performance from Dry Shippers, on the challenges presented when attempting to overcome some of the most fundamental physical laws in pursuit of delivering cell-based drug product from manufacturer to the patient.
Mr. O’Donnell specializes in advising on the transport of cell-based therapies in dry shippers, and will discuss end-to-end chain of custody solutions for biologics that must be managed under ultra cold chain requirements. This includes maintaining materials at a temperature below -140°C for an extended period of time, and the equipment, facilities, costs, and risks involved in maintaining these materials at such an extreme temperature. Attendees will benefit from his practical information (when and how often should you test and qualify your dry shipper) as well as his perspective on ensuring the commercial success of cell-based therapies.
On Wednesday June 18th at 3:15 PM, Mr. Simpson will speak on Biobanking in an Era of Precision Medicine: Biospecimen Collection and Logistics Management for Clinical Trials and Mega Cohort Studies. Access to extensive collections of biological samples—Biobanks—are critical for research into the etiology of disease. Yet, the quality of the biospecimens needed for this research is limited by lack of standardization, cold chain management, and availability issues amongst the various stakeholders. He is a recognized expert in addressing complex cold chain challenges and protecting clinical trial materials in transit despite extreme environments. For those interested in shipping and distribution of biospecimens, click the image at the bottom to read his eBook, Defense in Depth: Off-Site Storage of Biological Specimens and Biopharmaceuticals for Risk Mitigation.
According to Mr. Simpson, the poor “translatability” of biomedical research into tangible health benefits has led to a paradigm shift in recent years, in the form of a more global and collaborative approach across biopharmaceutical, government, and academia/medical research organizations. However, this more collaborative approach is not yet reflected in biobanking practices. In his presentation, Mr. Simpson will provide an overview of the life cycle of the biospecimen, and the past, present, and future of sample management logistics. He will also highlight various logistical and other variables that may compromise the sample, including temperature considerations from sample collection to biobank storage. He will also provide insight on the difference between qualification and validation, and discuss risk management in biospecimen logistics.
ColdChainIQ, a division of IQPC (International Quality and Productivity Center), is an international forum focused on temperature control logistics and quality in the pharmaceutical and related industries. This year’s Biologistics Summit will include pre-conference workshops on Monday, June 16th, that will address the many challenges of handling, manufacturing, and distributing biologics, in addition to the case studies, round tables, and panel discussions of the main conference.