Loren Israelsen NDI Status Report Session 1
NDI Guidance III: Roadmap to a Viable Policy NDI Status Report Loren Israelsen, President United Natural Products Alliance Salt Lake City, Utah February 9, 2017
UNPA © 2015
SESSION 1: NDI Status Report • The NDI Guidance: Ranking the priorities and how to achieve them — Loren Israelsen, President, UNPA • How the Trump administration is changing Washington and what that means for FDA — Susan Winckler, Chief Risk Management Officer, Leavitt Partners
• Enforcing NDI Policy: What are FDA’s priorities and options? — Larisa Pavlick, VP, Global Regulatory & Compliance, UNPA
UNPA © 2017
SESSION 2: Tutorials on Key Technical Issues
• Synthetic Botanicals: The new world of synthetic biology and dealing with synthetic botanicals — Jim Thomas, Program Director, ETC Group
• Nanotechnology • GRAS and NDI: What is the best approach now? • ODI List Progress Report: Working toward an authoritative ODI list: What we have, what we need and how to get there — Marian Boardley, Independent Consultant; Skye Lininger, CEO, Healthnotes; Loren Israelsen
UNPA © 2017
SESSION 3: Building a Roadmap Toward A Viable NDI Policy • Discussion and Polling • UNPA Proposition for a Viable NDI Policy: Protecting consumers, building business and keeping innovation alive — Loren Israelsen, President, UNPA
UNPA © 2017
SESSION 4: Conclusions and Go-Forwards
• Industry Representation: Messaging to Congress, consumers, media and FDA
— Loren Israelsen, President, UNPA; Ashish R. Talati, Member and Chair, Food and Drug Practice, Amin Talati & Upadhye; Frank Lampe, VP, Communications and Industry Relations, UNPA
UNPA © 2017
What are the Priorities Now That… • • • •
New Administration New Uncertainty Old Tasks (ODI List) Emerging Issues (Synbots, Nano)
UNPA © 2015
Here’s what our NDI II audience thought back on September 8, 2016
•
UNPA © 2015
• Knowing what we know now, we’d like to ask those same questions….
What’s Up With… • • • • • •
DC? FDA? Synthetic everything? Nanotechnology? ODI List? GRAS?
UNPA © 2015
Loren Israelsen President United Natural Products Alliance 1075 E Hollywood Ave Salt Lake City, UT 84105 p: 801.474.2572 e: [email protected] unpa.com
UNPA © 2015
UNPA © 2015
SESSION 1: NDI Status Report • The NDI Guidance: Ranking the priorities and how to achieve them — Loren Israelsen, President, UNPA • How the Trump administration is changing Washington and what that means for FDA — Susan Winckler, Chief Risk Management Officer, Leavitt Partners
• Enforcing NDI Policy: What are FDA’s priorities and options? — Larisa Pavlick, VP, Global Regulatory & Compliance, UNPA
UNPA © 2017
SESSION 2: Tutorials on Key Technical Issues
• Synthetic Botanicals: The new world of synthetic biology and dealing with synthetic botanicals — Jim Thomas, Program Director, ETC Group
• Nanotechnology • GRAS and NDI: What is the best approach now? • ODI List Progress Report: Working toward an authoritative ODI list: What we have, what we need and how to get there — Marian Boardley, Independent Consultant; Skye Lininger, CEO, Healthnotes; Loren Israelsen
UNPA © 2017
SESSION 3: Building a Roadmap Toward A Viable NDI Policy • Discussion and Polling • UNPA Proposition for a Viable NDI Policy: Protecting consumers, building business and keeping innovation alive — Loren Israelsen, President, UNPA
UNPA © 2017
SESSION 4: Conclusions and Go-Forwards
• Industry Representation: Messaging to Congress, consumers, media and FDA
— Loren Israelsen, President, UNPA; Ashish R. Talati, Member and Chair, Food and Drug Practice, Amin Talati & Upadhye; Frank Lampe, VP, Communications and Industry Relations, UNPA
UNPA © 2017
What are the Priorities Now That… • • • •
New Administration New Uncertainty Old Tasks (ODI List) Emerging Issues (Synbots, Nano)
UNPA © 2015
Here’s what our NDI II audience thought back on September 8, 2016
•
UNPA © 2015
• Knowing what we know now, we’d like to ask those same questions….
What’s Up With… • • • • • •
DC? FDA? Synthetic everything? Nanotechnology? ODI List? GRAS?
UNPA © 2015
Loren Israelsen President United Natural Products Alliance 1075 E Hollywood Ave Salt Lake City, UT 84105 p: 801.474.2572 e: [email protected] unpa.com
UNPA © 2015
