Agenda & Speakers Slides

Friday, November 15

8:45 – 9:15 AM 

Registration and Continental Breakfast

9:15 – 9:20 AM 

Welcome and Announcements
Paige Samson, Director, Innovative Programs and Publications, FDLI

9:20 – 10:35 AM 

“FDA Regulation of Adipose Stem Cell Therapies: Separating Fat from Fiction” | Abstract

Mary Ann Chirba, Professor, Boston College Law School

“Public Perception and Policy Development in Consent Standards for Human Research—How Competing Views on Public Goods and Private Interests Shape Data Sharing, Big Data Research, and Other Activities Using Human Data and Materials” | Abstract

Valerie Bonham, Counsel, Ropes & Gray LLP
David Peloquin, Associate, Ropes & Gray LLP

Discussant: Kalah Auchincloss, Senior Vice President, Regulatory Compliance and Deputy General Counsel, Greenleaf Health
Moderator: Barbara Binzak Blumenfeld, Shareholder, Buchanan Ingersoll & Rooney PC

10:35 – 11:15 AM

“With Great Influence Comes Great Responsibility” | Abstract

Tamany Vinson Bentz, Partner, DLA Piper LLP (US)
Carolina Veltri, Associate, DLA Piper LLP (US)

Discussant: Beth P. Weinman, Counsel, Ropes & Gray LLP 
Moderator:
 Carl Fischer, Senior Director, WW Regulatory & Quality Strategy, Becton Dickinson (BD)

11:15 – 11:30 AM

Networking and Coffee Break

11:30 AM – 12:45 PM 

“A Shifting Regulatory Framework for Digital Health: The Impact of Silicon Valley on the FDA’s Mission to Promote and Protect the Public Health” | Abstract

M. Jason Brooke, Director, Navigant Consulting, Inc.

“Development and Regulation of Innovations: In the Current State of Facts vs. Public Opinions, the Truth Does Not Always Prevail” | Abstract

Sangeeta Abraham, Consultant, Managing Scientist, Exponent, Inc.
Nicholas Benetatos, Manager, Exponent, Inc.
Michael Frohbergh, Senior Associate, Exponent, Inc.
Kevin Ong, Principal Engineer, Exponent, Inc.

Discussant: Nathan Brown, Partner, Akin Gump Strauss Hauer & Feld LLP
Moderator: Karen C. CoralloOf Counsel, Skadden, Arps, Slate, Meagher & Flom LLP

12:45 – 1:45 PM

Luncheon

1:45 – 3:00 PM 

“Modernizing Food Labeling: The Narratives of Food Innovation and Deciphering Mixed Messages” | Abstract

Nicole Negowetti, Lecturer on Law and Clinical Instructor, Harvard Law School

“’NonGMO Labels’—Absence Claims—The Law, Congressional Intent, and FDA Policy” | Abstract

L. Val Giddings, Senior Fellow, Information Technology & Innovation Foundation

Discussant: Nigel Barrella, Attorney, Barrella Law PLLC
Moderator: Laurie Beyranevand, Associate Dean for Academic Affairs, Vermont Law School

3:00 – 3:15 PM 

Networking and Coffee Break

3:15 – 4:00 PM

3:15–4:00 PM
“Strengthening the Information Quality Act to Improve Federally Disseminated Public Health Information” | Abstract

Daren Bakst, Senior Research Fellow in Agricultural Policy, Institute for Economic Freedom, The Heritage Foundation

Discussant: Lewis Grossman, Professor of Law, American University
Moderator: James O’Reilly, Professor, University of Cincinnati

4:00

Symposium Adjournment and Closing Remarks

Reception