Regulatory Science Symposium: Bringing Drugs and Biologics to Market - Session 3: "Combination and Innovative Products"

Competencies: Combination Products, Innovative Products, Product Development, Quality Management System, Good Manufacturing Practice (GMP), Investigational New Drug (IND), Investigational Device Exemption (IDE), Regulatory Strategy, Regulatory Science, Clinical Research and Regulations, Clinical Trials, Regulatory and Quality Sciences, Clinical Trial Quality

Course Syllabus/Topics

1. Introduction
2. Preparing for the next generation of products
   1. Preparing for the Next Generation of Products
3. Definition of combination products
   1. Combine 2 entities between drug, device, and biological products
4. Evolutions of Drug Delivery: Infusion IV > Prefilled Syringe > Autoinjectors
   1. Increased Ease of use
5. Nanotherapeutics: future industry portfolio
   1. Disruptive medicine innovation
   2. Future product strategy
6. Breadth of delivery systems
   1. Oral Mixing & Delivery
   2. Intradermal Delivery
   3. Sub-cutaneous Delivery
   4. Ocular Delivery
7. Quality management system: understanding the landscape within a company
   1. Pharmaceutical Delivery System
   2. Device System
8. Characterization and GMP regulations
   1. Requirements on each
9. Current global regulatory landscape
10. Complex product development overview
    1. Device development integrated with medicinal development across the lifecycle for all device technologies in all therapeutic areas
11. Risk management within combination product development
    1. Need for usability studies and human factors reports
    2. Consider risks for the whole asset and not just the device or drug
12. Combination product risk analysis overview
13. Combination product characterization overview
    1. Regulatory Pathway: IND, IDE
    2. Need for product characterization
    3. Importance of data to substantiate
14. Characterization of Combination products
    1. Examples of combination product characterization to avoid regulatory issues
    2. Convenience kits
       1. Need for a collaborative approach between commercial and regulatory teams
15. Midway Q&A
16. Combination product IDE overview
    1. IDE Requirements
    2. Product classification
    3. Need for CMC testing data
    4. 8 areas that need to be noted within IDE
17. Combination Product IND Overview
    1. CMC areas (this included device components)
18. Case study
    1. Scenario A-combination product (drug/device)
       1. e.g.: Auto-injector delivering a medicinal product
       2. IND Submission
       3. Pre/Post Market Safety reporting
       4. Pharma/biologic reporting process, Design Control, Usability Engineering
       5. e.g.: Infusion Pump
    2. Scenario B - Combination Product (Device/Drug)
       1. e.g.: A drug-eluting stent (DES)
       2. IDE Submission
       3. Pre/Post Market Safety reporting
       4. Device reporting process
19. Overall: early product development planning is critical
    1. Importance of partnerships and investments, integration is key
    2. Regulatory submission, market plans, and reimbursement strategies in ensuring product success
    3. Need for comprehensive understanding of essential performance requirements and user needs
20. Q&A

Acknowledgements:
Accompanying text created by: Mahita Parasa, Student Worker; Karen Manrique, Program Administrator, SC CTSI (kmanriqu@usc.edu)