Table 1.

Translational study team members, roles, and responsibilities

Team Member(s)	Roles and Responsibilities
Principal investigator	Ultimate responsibility for the project
	Study design for evaluation of the safety and efficacy of therapeutic candidate (preclinical phase of the project)
	Design and execution of the clinical trial protocol (clinical phase of the project)
	Analysis and interpretation of data
Basic research team	Assessment of the product’s safety and efficacy in in vitro and in vivo disease models (preclinical phase of the project)
Clinical research team	Subjects’ enrollment, treatment, and follow-up care (clinical phase of the project)
Project manager	Responsibility for meeting project timeline and sticking to budget
	Resource allocation and management
	Development and implementation of the strategy for mitigation of risks
	Facilitation of technology transfer
Product development and manufacturing experts	Responsibility for translating research protocols into current good manufacturing procedure (CGMP)-compliant manufacturing procedures for the large-scale production of clinical grade material
Regulatory experts	Regulatory oversight
	Involvement in the preparation of documents for review by regulatory authorities, such as US Food and Drug Administration (FDA), Institutional Review Board (IRB), and Data and Safety Monitoring Board (DSMB)
Quality assurance experts	Responsibility for the compliance of the product and manufacturing processes with the CGMP regulations and meeting predefined product release criteria
	Support in addressing product manufacturing issues
	Compliance audits
Quality control experts	Release testing of the clinical product
	Generation of data in support of CGMP compliance
Specific area experts	Provide an expert knowledge and support in the missing areas of expertise specific for the product of indication of use, i.e., support of transplant specialist might be needed during the development of cell replacement therapy product