Investigator Training Resources


Only Orphans Cote seminar series – Webinars on regulatory topics related to orphan drug designations.
Educational video library covering various clinical research related topics
Education | Overview: The e-C3i course is a newly launched online entrepreneurial education platform aimed at teaching academic innovators methods to assess the commercial value of their biomedical technologies.
Eligibility: Investigators from a research institution with active NIH-funded research projects
Application Due Date: May 25, 2021

C3i Validation / Execution | Overview: The C3i Program is an in-depth, entrepreneurial training experience designed to help biomedical innovators validate a market need and viable business opportunity, as well as develop a compelling pitch for prospective investors and partners.
Eligibility: Investigators from a research institution or small business with active NIH-funded research projects
Application Due Date: July 26, 2021

Acceleration | Overview: The C3i Accell program provides product development and business support to assist academic innovators in accelerating the translation of their biomedical technologies.
Eligibility: Investigators from a research institution with active NIH-funded research projects who have completed the C3i Program
Timeline: To be determined

Virtual SBIR/STTR Intensive Workshop – June 15 -16, 2021

Workshop is produced by the Center for Biotechnology at Stony Brook University in partnership with Columbia Technology Ventures.   Register here:

Global Tooth Regeneration Market Report, History and Forecast 2015-2026

Task Force Report: American Society for Bone and Mineral Research‐Orthopaedic Research Society Joint Task Force Report on Cell‐Based Therapies

Awareness of the Role of Science in the FDA Regulatory Submission Process: A Survey of the TERMIS-Americas Membership

The Regenerative Medicine Standards Landscape

This report provides a snapshot of the current landscape for regenerative medicine standards. It outlines existing and in-development standards, providing a reference that individual organizations can use to identify available standards to improve their operations.

Needed Standards in Regenerative Medicine

Community Perspectives: Needed Standards in Regenerative Medicine report. The objective of the report is to outline standards needs identified by the community that could have the greatest benefit to the field and improve the safety and quality of regenerative medicine products.

Proceedings of NAS Cell Manufacturing Workshop

FDA Guidance on Regenerative Medicine

2 new FDA guidance documents on regenerative medicine therapies:

  1. Click here to see the press release.

Osteology Research Guidelines:  Online version of the book series, Osteology Guidelines for Oral & Maxillofacial Regeneration, where leading experts present their tried and tested study protocols and general aspects on preclinical and clinical research.

  • Preclinical Models for Translational Research.  Editors – Prof. William V. Giannobile and Prof. Myron Nevins
  • Clinical Research.  Editors – William V. Giannobile, Niklaus P. Lang and Maurizio S. Tonetti
  1. Please register (free of charge) at
  2. After you have registered, go to Science, and then to the Osteology Research Guidelines:

Preclinical Animal Models for Temporomandibular Joint Tissue Engineering

Oral Regeneration Past Topics