60-Minute On-Demand Webinar Available in CD, MP4 and PDF Transcript.

or Call 1-800-303-0129 ext. 506

Regenerative medicine and tissue engineering biotechnology companies continue to look for cost-effective ways to conduct in vitro and in vivo studies to support cell-based product development, and often turn to academic laboratories as the solution.

By entering into a sponsored research agreement with a biotechnology company, the academic laboratory will be under a contractual obligation to perform the work in a manner consistent with federal regulatory agency requirements. These requirements are often unfamiliar to academic investigators, and at times may not even be compatible with the practices in the academic laboratory.

During this interactive Webinar your expert presenter will cover the general requirements for manufacturing and testing cell-based products in a regulatory compliant manner, sponsor expectations, awardee responsibilities, project control, and publications rights.

Key Take-Aways:

  • Understand the general requirements for manufacturing and testing cell-based products in a regulatory compliant manner
  • Learn how cell-based products are evaluated
  • Study protocol development
  • How to develop “Good Laboratory Practices” that meet the needs of the academic researcher and the biotechnology company researcher
  • Acquire tissue engineered and regenerative medicine product definitions
  • Why discussions regarding ownership of IP need to take place well in advance

Who Should Attend:

Academic PI’s, managers, scientists, post-docs, graduate students, technicians.

Limited-Time Offer:

  • CD-ROM with PDF Handouts — Price: $197 $147
  • MP4 with PDF Handouts — Price:$197 $147
  • PDF Transcript with Handouts — Price:$197 $147

Meet Your Presenter:

Dr. John Ludlow, joined Tengion Inc. in 2005 and is currently the Senior Director of Process Research and Assay Development. After spending 10 years conducting tumor suppressor research at the University of Rochester Cancer Center, Dr. Ludlow went on to become Director of the Cell Therapy Program for Incara Pharmaceuticals, and then Senior Director of the Cell Therapy Program at Vesta Therapeutics. He has authored over 90 scientific publications, developed and managed research and pre-clinical programs, initiated clinical trial sites, directed development activities for cell therapy and tissue engineered products, and had worked closely with regulatory agencies and consultants to help ensure approval of the company’s products.


This Webinar presentation is brought to you as a training tool by the Principal Investigators Association, which is an independent organization. The presentation, tools presented and their contents are not connected with the National Institutes of Health (NIH), nor are they endorsed by this agency. All views expressed are those personally held by the presenter and are not official government policies or opinions.