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4th Cell Therapy Conference
Manufacturing and Testing of Pluripotent Stem Cells
The International Alliance for Biological Standardization
with support from and in collaboration with the
California Institute for Regenerative Medicine
Los Angeles, California
June 5-6, 2018
Objectives and Expected Outcomes
The 2018 Cell Therapy conference will identify key unresolved issues that need to be addressed for the manufacture and testing of pluripotent stem cell-based therapies and provide scientific consensus on selected aspects to inform the drafting of future national and international guidance. The meeting will bring together representatives from industry, academia, health services and regulatory bodies.
The overall goal of the conference is to provide the target audience with an appreciation of the importance of a well-controlled manufacturing process for cell therapies that are in development, and to highlight specific areas that should be considered during early product development in order to avoid issues in later stages. The target audience includes those individuals and organizations actively pursuing research and development of cell therapies with the intent of achieving pluripotent stem cell therapy products that meets regulatory requirements for approval, thus becoming generally available to treat patients with unmet medical needs.
We will build on previous meetings that generally addressed broader themes of cell therapy studies and manufacturing issues. In addition to reviewing information on the state-of-the-art and recently generated data, this conference ill drill down to key practical issues facing cell therapy developers and regulators to expedite the safe and efficient introduction of new treatments for important diseases where unmet medical needs exist.
More specifically, the conference is expected to provide a basis for new and/or additional guidance on regulatory expectations for developing acceptable pluripotent cell therapy products including testing requirements during manufacture. Concrete conclusions and recommendations will be important outcomes, which are expected to stimulate the field to move forward in a transparent and coordinated manner.
Register HERE for the conference
More information coming soon
SAVE THE DATE
Implementing nonanimal approaches to human and veterinary vaccine testing:
Achieving scientific and regulatory success for rabies and beyond
Natcher Conference Center
National Institutes of Health
October 16-17, 2018
The meeting is co-organized by the National Toxicology Program Interagency Center
for the Evaluation of Alternative Toxicological Methods
International Alliance for Biological Standardization
North America Affiliate, California, USA
More information soon
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5th Statistical Approaches for CMC Development and
Lifecycle Management of Biotherapeutics and Vaccines
November 26-28, 2018
Venue: US Pharmacopeia
This meeting is to bring together regulators and scientists to discuss statistical approaches used to help develop and manage processes, which ensure the quality and availability of biotherapeutics and vaccines. Speakers and panel members will engage with meeting participants on challenges and solutions related to CMC development and lifecycle management of biologics. Areas of attention will include Quality by Design in process and analytical development, comparability and biosimilarity, stability study design and analysis, validation, and continuous process and analytical verification. Statistical challenges related to introduction of new technologies and Big Data will be discussed. Special emphasis will be devoted to collaboration and communication, between scientists and statisticians as well as industry and regulators. The meeting will bring experts together to discuss the issues and through roundtables attempt to reach conclusions that will add value to global public health.
More information about this meeting coming soon.