Letter from the Program Chair :
Objectives of the Workshop
This meeting will bring together an outstanding and diverse group of speakers from regulatory agencies, industry, and academia, all of whom are at the forefront of the cell therapy field. The major objective of the meeting is to highlight the important regulatory considerations that are unique to human cell therapy products, as well as to promote international dialogue and exchange of information and points of view in this evolving field. The scope of the cell therapy products that will be covered in this meeting are human cell derived and substantially manipulated cell therapy products (hCTPs). To develop novel hCTPs and to translate them more efficiently and effectively into products that contribute more to human health care, it is essential that they be based on a sound scientific rationale. Manufacturers and control authorities should take into account common scientific core elements, as well as the specifics of the cell source, manufacturing process, product administration procedures, and diseases in question. As a part of such an endeavor, it is critical to share a common recognition among interested parties with respect to the essential scientific and technological elements for CMC, pre-clinical and clinical studies of all types of substantially manipulated hCTPs. In other words, a challenge should be made so that we can develop a minimum consensus package that encompasses scientific principle/concepts, general considerations and technical requirements commonly applicable to all hCTPs. Also, as an important aspect of sound scientific regulatory considerations for hCTPs, it is very important to recognize the differences between “traditional” biological/biotechnological products and hCTPs regarding relevant scientific and technical elements. By taking such an approach, we intend to clarify specific points to consider for the evaluation and control of hCTPs that are different from those of traditional biological/biotechnological protein products with respect to quality, safety and efficacy. Throughout these discussions, it is also expected that the minimum requirements for each regulatory concern will be identified. For individual products, relevant technical and medical requirements should be added to the minimum consensus package taking into account the nature, specific characteristics, intended clinical use and ways of transplantation of the product in question. In addition, we also will identify special points/issues to consider for specific type of products, as well as very critical points/issues for various type of products, which have to be resolved, improved, and/or developed in terms of sound scientific regulation in order to facilitate the availability of products in a rational and timely manner, and which will be valuable globally to public health.
Takao HAYAKAWA, Ph. D.
IABS Board Member
IABS(International Alliance for Biological Standardization)では、JST及び先端医療振興財団のご支援のもと、2014年3月7-8日に、国立京都国際会館で第１回IABS再生医療に関する国際会議（"Challenges Toward Sound Scientific Regulation of Cell Therapy Products"）を開催し、成功裡に終えることができました。
第2回IABS再生医療に関する国際会議は、テーマを、“International Regulatory Endeavor towards Sound Development of Human Cell Therapy Products”と設定しました。そのアジェンダにつきましては、国内外の官・学・産のトップレベルの演者の参画を得ております。