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Kyoto Conference

Challenges Toward Sound Scientific Regulation of Cell Therapy Products

Co-sponsored by Japan Science and Technology Agency (JST)

Date: March 7-8, 2014

Venue: Kyoto International Conference Center

This meeting will bring together an outstanding and diverse group of speakers, from regulatory agencies, industry, academia, all of whom are at the forefront of the cell therapy field. The meeting intends to increase awareness of the diverse views of our global partners, as well as to promote international dialogue and exchange of information and points of view in this evolving field. The starting point will be to share a common recognition of the essential scientific elements for early product development, evaluation and control of cell therapy products. Then we will move on to identify very critical points/issues to be solved, improved, and/or developed in terms of technical as well as scientific regulation in order to facilitate the availability of products in a rational and timely manner, which will be valuable globally to public health.

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Rockville Conference

Statistical and Data Management Approaches for Biotechnology Drug Development

Co-organized by IABS and FDA

Date: August 27-28

Venue: USP Headquarters, Rockville

This meeting is to bring together regulators, and scientists, from academia and industry, who are career statisticians or have a strong background in statistics, to help resolve existing challenges in ensuring the quality of biotechnology medicinal products and to bring high quality medicines to patients. Guidance on how to use statistics for a variety of activities required during biotechnology product development such as method development, improvement and replacement, product comparability, biosimilarity exercises and stability program development will be provided by the speakers and panel members. In addition, the complexity of the types of data and the volume being analysed is ever increasing and how best to manage such data will be discussed. The meeting will bring the right experts together to discuss the issues and through roundtables attempt to reach conclusions that will be valuable globally to public health.

Among the challenges that will be explored :

• Statistical Challenges with showing Comparability and Biosimilarity (Equivalence, small data sets, tolerance intervals etc.)

• Using statistics for Assay Methods (Statistics for development, qualification, validation and transfer of methods)

• The use of statistics and modelling when using Quality by Design (DoE, Bayesian, partial least squares, prior knowledge data sets)

• Managing large and/or complex datasets (Large data sets for monitoring variation, complex analytical methods – Mass Spec, NMR, historical data sets)

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Strasbourg Conference

Human Challenge Trials in Vaccine Development: Scientific and Regulatory Issues

Date: September 29 – October 1, 2014

Venue: European Directorate for the Quality of Medicines & Healthcare (EDQM)

Human challenge trials can help overcome some of the hurdles inherent in vaccine development as the results obtained in these studies have more relevance than those obtained in animal models. Nevertheless, human challenge studies also face a series of scientific, ethical and regulatory issues related to the design, the execution and the use of these studies. The volunteers, healthy adults, may not represent the final target population of the vaccine, in terms of age, status of immunity and environment. The microbial strains used for challenge may behave differently from the wild pathogens. Experiments that induce infections in healthy volunteers give rise to significant ethical and regulatory issues.

This IABS workshop will bring together representatives from academia, industry, regulatory and public health agencies to discuss the scientific, ethical and regulatory framework required for safe and ethical conduct of challenge trials. In addition, the workshop is expected to provide guidance on the best use of challenge trials for the definition of potential correlates of protection and for preliminary efficacy evaluation of investigational vaccines.

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WHO - ECBS documents posted on WHO biologicals web site

The following documents, adopted by the WHO ECBS in October 2013, were posted on WHO biologicals web site (http://who.int/biologicals/vaccines/en/ (on the right hand side, under New Publications), last week:

1. Guidelines on the nonclinical evaluation of vaccine adjuvants and adjuvanted vaccines

2. Guidelines on the quality, safety and efficacy of typhoid conjugate vaccines

3. Guidelines on the quality, safety, and efficacy of biotherapeutic protein products prepared by recombinant DNA technology, Replacement of Annex 3 of WHO Technical Report Series, No. 814.

Now available :

Vaccines and Diagnostics for Transboundary Animal Diseases

International Symposium, Ames, Iowa, September 2012: Proceedings

Editor(s): Roth J.A. (Ames, Iowa) ; Richt J.A. (Manhattan, Kansas); Morozov I.A. (Manhattan, Kansas)

Please use this link to order the book: http://www.karger.com/Book/Home/259868