Regulatory Readiness for Life Sciences Investment
Investor Academy Seminar: Understanding Regulatory Pathways in Medical Technology and Life Sciences
Presented by Keiretsu Forum MST and Accorto Regulatory Services
Agenda
1:00 PM – 1:10 PM ET | Welcome and Opening Remarks
Howard Lubert, Moderator
Howard Lubert, Moderator
- Introduction to the seminar and objectives
- Speaker introductions
1:10 PM – 1:50 PM ET | Navigating the Regulatory Process for Medical Technology and Life Sciences
Accorto Regulatory Services
Accorto Regulatory Services
- Overview of regulatory classifications and pathways for medical devices
- Key cost and risk factors in regulatory strategy
- FDA expectations and compliance considerations
- Market entry strategies: wellness vs. medical device classification
- Case study examples
1:50 PM – 2:00 PM ET | Legal and Business Considerations for Medical Device Companies
Steve Cohen, Morgan Lewis Bockius
Steve Cohen, Morgan Lewis Bockius
- Regulatory approval and market entry strategy
- M&A readiness and strategic acquirer considerations
- Key legal issues: intellectual property, compliance, liability, and tax structure
2:00 PM – 2:10 PM ET | Intellectual Property and Regulatory Strategy
Michael Dunham
Michael Dunham
- Protecting innovations while navigating regulatory hurdles
- IP considerations in clinical trials and approvals
- Patent strategy alignment with regulatory pathways
2:10 PM – 2:20 PM ET | Insights from a Life Sciences and MedTech CEO
Todd Wallach
Todd Wallach
- Firsthand experience navigating regulatory challenges
- Lessons learned from bringing a product to market
- Investor considerations in regulatory planning
2:20 PM – 3:00 PM ET | Q&A and Closing Remarks
Howard Lubert, Moderator
Howard Lubert, Moderator
- Panel discussion and audience questions
- Final thoughts and key takeaways