How to Source, Vet, and Oversee Medical Product Development Contractors to Ensure Efficient, Timely, and High-quality Studies and Data for Regulatory Submissions

Event description

Presenters: Dr. Greg Gatto and Dr. Willie Salminen

This webinar which will be presented by Greg Gatto and Willie Salminen who have extensive experience sourcing and vetting medical product development contractors. The webinar will provide practical advice for outsourcing medical product development studies at 3rd party laboratories (e.g., Contract Research Organizations [CROs]) and manufacturers (e.g., Contract Development and Manufacturing Organizations [CDMOs]). This will include highlighting the importance of vetting and selecting CROs and CDMOs, oversight of the work, and final reporting and wrapping-up projects. As a case example, the webinar will focus on designing, contracting, monitoring, and reporting Investigational New Drug Application (IND)-enabling Good Laboratory Practice (GLP) nonclinical studies, which encompasses pivotal toxicology studies to support first-in-human clinical trials. However, the general concepts are applicable to all work that is outsourced to 3rd parties such as Clinical Studies and Chemistry, Manufacturing, and Controls (CMC) work and some examples of these activities will also be covered.

Webinar presented on July 20, 2022 to an invited audience.

This video is provided for educational purposes only.

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Chapters

0:00
Webinar Intro
1:30
Goals of Presentation
3:30
Importance of Active Involvement
12:15
Examples of Outsourcing Issues - Nonclinical
17:52
Examples of Outsourcing Issues –Synthesis/Stability
20:00
Examples of Outsourcing Issues – Analytical/Component Selection
20:55
Example of Outsourcing Issues – Clinical Study design/Sample collection & storage/Study data
22:30
Process of Outsourcing GLP Nonclinical Studies
22:50
Location of CRO
25:05
Types of Laboratories
27:45
Screening Potential CROs
30:55
Selecting the CRO to Run Your Study
36:54
The Importance of Active Study Involvement
37:00
Scientific Needs, Logistical Feasibility, and Regulatory Compliance
39:54
General Study Design Issues That Require Input/Involvement
42:05
Protocol and Standard Operating Procedures (SOPs)
43:40
Key Determinants of Success
44:10
GLPs
46:10
Animal Welfare
48:40
Conclusions
49:20
Q&A
This research was, in part, funded by the National Institutes of Health (NIH) Agreement OT2 HL157844-01. The views and conclusions contained in this document are those of the authors and should not be interpreted as representing the official policies, either expressed or implied, of the NIH.