Develop and implement undergraduate or graduate level curriculum, or a continuing education training for the existing workforce to support broader implementation of critical underpinning standards…

The National Institute of Standards and Technology (NIST) has awarded a $500,000 Cooperative Agreement under the Science, Technology, Business and/or Education Outreach program (CFDA 11.620) to Brammer Bio MA, LLC to develop and implement undergraduate or graduate level curriculum, as well as continuing education training for the existing workforce, to support broader implementation of critical underpinning standards in regenerative medicine.

The project team will create a set of learning resources, including verbal, visual, and action-based training modules, focused on standardized methods used across cell therapy workflows relevant to CAR-T and iPSC applications. The training materials will cover topics such as ISO 23022, ISO 23095, and ISO 20391-1 & 2, and are intended to benefit researchers, technologists, and early-stage cell therapy professionals involved in early development destined for GMP. The award has an expected completion date of September 30, 2027.

Purpose

The purpose of this grant is to develop and implement undergraduate or graduate level curriculum, or a continuing education training for the existing workforce to support broader implementation of critical underpinning standards in regenerative medicine.

Activities

The project team will develop and implement courses for regenerative medicine standards with an embedded principle of "start with the end in mind" to facilitate smooth translation of methods towards scalable manufacturing. The project team will create a set of learning resources for emerging professionals interested in learning the business, science, and manufacturing of cell therapies. Curriculum development, content creating and training deployment will include verbal, visual, and action learning modules. A program development committee will be instituted to review the training materials design and construction with periodic assessment and evaluation. For training program effectiveness, the team will implement smart goals with specific measurable, achievable, relevant, and time-bounded metrics.

Expected outcomes

The project team will develop and implement training modules for standardized methods that are used across cell therapy workflows and relevant to car-t and ipsc workflows (e.g. ISO 23022, ISO 23095, and ISO 20391-1 & 2). Each module will have verbal training (e-learning and handbooks), visualization (how-to videos), and action-based (simulated virtual lab) materials with knowledge assessments. This resource can serve as a seed content for the resource library, which can be continually improved and expanded with new content. The content is geared towards continuing education and certifications.

Intended beneficiaries

The training is geared towards researchers, technologists, and early stage cell therapy professionals involved in early development destined for GMP. Regenerative medicine standards stakeholders including manufacturers/ industry workforce, academia, government and regulatory bodies, professional societies, and standards development organizations will benefit from these regenerative medicine standards training programs.

Subrecipient activities

The recipient does not intend to subaward funds.