Committees

Committee members play a critical role in providing FDLI with subject-matter and editorial advisory expertise. Service on committees is limited to FDLI members. The nomination process for incoming committee service opens in the first few months of the year. Terms are three-years, staggered to roll on an annual basis.

The Academic Programs Committee advises FDLI staff in formulating and implementing policies and strategies consistent with FDLI’s mission, relating to programs and publications of interest to the academic legal community. The Committee discusses various programs, publications, pricing, dissemination vehicles, etc. that best facilitate expanding FDLI’s educational mission.

  • Marie Boyd (Vice-Chair) University of South Carolina
  • Jess Amchin (Committee Member) Drexel University
  • Katlin McKelvie Backfield (Committee Member) Backfield PLLC
  • Harvey Alan Berman (Committee Member) State University of NY at Buffalo
  • Sarah diFrancesca (Committee Member) Cooley LLP
  • Jean Frydman (Committee Member) Fox Rothschild LLP
  • Victoria W. Girard (Committee Member) Georgetown University
  • Ralph Hall (Committee Member) University of Minnesota
  • Mary Hendrickson (Committee Member) Sole Practitioner
  • Stuart Kim (Committee Member) Cardinal Health, Inc.
  • Ericka Lietzan (Committee Member) University of Missouri-Columbia School of Law
  • Sean Sweeney (Committee Member) University of Maine
  • Ralph S. Tyler (Committee Member) Venable LLP
  • Seth B Whitelaw (Committee Member) Life Science Compliance
  • Steven H. Armstrong (Chair) EAS Consulting
  • Cathy Burgess (Committee Member) Alston & Bird
  • Dan Kracov (Committee Member) Arnold & Porter Kaye Scholer LLP
  • Stuart Pape (Committee Member) Partner, Polsinelli

The H. Thomas Austern Writing Awards Committee members review and score all submitted student manuscripts, assist in determining which papers are most appropriate for awards, and make recommendations for potential publication in the Food and Drug Law Journal.

  • Deborah C. Attwood (Committee Member) Steptoe & Johnson LLP
  • Nigel Barrella (Committee Member) Law Office of Nigel Barrella
  • Albert F. Cacozza (Committee Member) Ropes & Gray LLP
  • Yolande Dufresne (Committee Member)
  • Igor Gorlach (Committee Member) King & Spalding LLP
  • Jane Kalinina (Committee Member)
  • Kristen Klesh (Committee Member)
  • Natasha V. Leskovsek (Committee Member) Cooley LLP
  • Chia-Feng Lu (Committee Member)
  • Caitlyn Ozier (Committee Member) King & Spalding LLP
  • Sung Park (Committee Member)
  • Gail L. Pilgrim (Committee Member) Temple University
  • Margaret F. Riley (Committee Member) University of Virginia
  • Celeste Wheeler (Committee Member) Kleinfeld, Kaplan & Becker, LLP
  • Devon Winkles (Committee Member) Kelley Drye & Warren LLP
  • Jeffrey N. Gibbs (Chair) Hyman, Phelps & McNamara, PC *
  • Allison M. Zieve JD (Immediate Past Chair) Public Citizen *
  • Frederick R. Ball (Treasurer) Duane Morris LLP *
  • Joy J. Liu (Secretary and General Counsel) Vertex Pharmaceuticals, Inc. *
  • Amy Comstock Rick (President & CEO) FDLI *
  • Jennifer L. Bragg (Committee Member) Skadden, Arps, Slate, Meagher & Flom LLP
  • Stacy L. Ehrlich (Committee Member) Kleinfeld, Kaplan & Becker, LLP
  • Miriam Guggenheim (Committee Member) Partner, Covington & Burling, LLP
  • Freddy A. Jimenez (Committee Member) Celldex Therapeutics, Inc.
  • Sandra Cohen Kalter (Committee Member) Vice President and Chief Regulatory Counsel, Medtronic
  • Daniel Kracov (Committee Member) Partner, Arnold & Porter Kaye Scholer, LLP
  • Scott M. Melville (Committee Member) Consumer Healthcare Products Association (CHPA)
  • Francis B. Palumbo PhD (Committee Member) University of Maryland School of Pharmacy
  • Bob Rhoades (Committee Member) Validant
  • Carmen Shepard (Committee Member) Mylan Pharmaceuticals, Inc.

* denotes Board Member is also a member of the Executive Committee

Learn more about the FDLI Board of Directors

The Drugs and Biologics Committee advises FDLI staff in formulating and implementing policies and strategies consistent with FDLI’s mission, relating to programs and publications of interest to the drugs and biologics industries. The Committee advises staff on the appropriateness of conferences and publications relating to pharmaceuticals and biologics by reviewing and commenting on proposals.

  • Ilisa B.G. Bernstein PharmD.,JD (Co-Chair) FDA – CDER
  • Cathy L. Burgess (Co-Chair) Alston & Bird LLP
  • Carolyn Alenci (Committee Member) Duane Morris LLP
  • Clay Alspach (Committee Member) Leavitt Partners
  • Cathy L. Burgess (Committee Member) Alston & Bird LLP
  • Rebecca Burnett (Committee Member) Framework Solutions
  • Krista Hessler Carver (Committee Member) Covington & Burling LLP
  • David V. Ceryak (Committee Member) Eli Lilly and Company
  • Maxine K. Fritz (Committee Member) NSF Health Sciences
  • William A. Garvin (Committee Member) Buchanan Ingersoll & Rooney PC
  • Carolyn Herrmann (Committee Member) Consumer Healthcare Products Association (CHPA)
  • Matthew Hill (Committee Member) Novo Nordisk Inc.
  • Wanda Hill (Committee Member) GlaxoSmithKline
  • Lori F. Hirsch (Committee Member) Merck & Co., Inc.
  • Jennifer Spokes Johansson (Committee Member) Putney Inc.
  • Elizabeth R. Jungman (Committee Member) The Pew Charitable Trusts
  • Aaron S. Kesselheim MD, JD (Committee Member) Harvard Medical School
  • Daniel A. Kracov (Committee Member) Arnold & Porter LLP
  • Areta L. Kupchyk (Committee Member) Foley Hoag LLP
  • Erika F. Lietzan (Committee Member) University of Missouri-Columbia School of Law
  • Brian J. Malkin (Committee Member) Arent Fox LLP
  • Christina M. Markus (Committee Member) King & Spalding LLP
  • Rikin S. Mehta (Committee Member) Pfizer, Inc.
  • Adora Ndu (Committee Member) BioMarin Pharmaceutical
  • George A. O’Brien (Committee Member) Hogan Lovells LLP
  • Jeffrey Peters (Committee Member) MacroGenics Inc.
  • Kai Peters (Committee Member) Gordon & Rees LLP
  • Christopher Pruitt (Committee Member) US Government
  • Lee Rosebush (Committee Member) BakerHostetler
  • Alicia Subasinghe (Committee Member) Novartis Pharmaceutical Corporation
  • Alexander J. Varond (Committee Member) Goodwin Procter LLP
  • Mason Weeda (Committee Member) Olsson Frank Weeda Terman Matz PC

The purpose of the Finance Committee is to ensure the responsible financial operations of FDLI. The Committee provides on-going oversight of the financial operations and investment policies of FDLI to ensure sound financial management. The Committee also advises the Board on the direction and control of financial matters. The Committee also ensures that the Board is well informed about the Institute’s finances.

  • Frederick R. Ball (Chair) Duane Morris LLP
  • Scott M. Melville (Board Liaison) Consumer Healthcare Products Association (CHPA)
  • Amy Norris (Committee Member) Cliff Bar & Company
  • Peter Pitts (Committee Member) Center for Medicine in the Public Interest

The Food and Dietary Supplements Committee advises FDLI staff in formulating and implementing policies and strategies consistent with FDLI’s mission, relating to programs and publications of interest to the food and dietary supplement industries. The Committee advises staff on the appropriateness of conferences and publications relating to foods and dietary supplements by reviewing and commenting on proposals.

  • Leslie T. Krasny (Co-Chair) Keller and Heckman LLP
  • Rend Al-Mondhiry (Committee Member) Council for Responsible Nutrition
  • Stephanie K. Barnes (Committee Member) Food Marketing Institute
  • Ted Elkin (Committee Member) FDA – CFSAN
  • Jennifer Erickson (Committee Member) FDA – CVM
  • Sandra B. Eskin Esq. (Committee Member) The Pew Charitable Trusts
  • Elizabeth Barr Fawell (Committee Member) Hogan Lovells LLP
  • James C. Huang (Committee Member) The Coca-Cola Company
  • Alissa Jijon (Committee Member) U.S. Pharmacopeia
  • Chi-Hua Lu (Committee Member) Abbott Nutrition
  • Diane C. McEnroe (Committee Member) Sidley Austin LLP
  • Meredith Q. Olearchik (Committee Member) Campbell Soup Company
  • Stuart M. Pape (Committee Member) Polsinelli PC
  • Ronald Y. Rothstein (Committee Member) Winston & Strawn LLP
  • Jason W. Sapsin (Committee Member) Faegre Baker Daniels LLP
  • Brooke Schumm III (Committee Member) Daneker, McIntire, Schumm
  • Suzanne Loonam Trigg (Committee Member) Haynes and Boone LLP
  • Amanda Triner (Committee Member) FDA – CFSAN

The Global Committee advises FDLI staff on international conferences and domestic meetings with global content as well as publications marketed to an international audience. Its duties and responsibilities include advising staff on ongoing developments in specific countries and helping staff keep current on global legal, regulatory and policy issues. The committee includes one ex-officio member from the following committees and editorial advisory boards: Academic Programs, Food and Dietary Supplements, Medical Devices and Diagnostics, Drugs & Biologics, Update, Food and Drug Law Journal and Food and Drug Policy Forum as well as other at-large members.

  • Robert A. Rhoades (Board Liaison) Quintiles Transnational Corporation
  • Philip S. Brewster (Committee Member) Brewster Law Firm LLC
  • Jill M. Daley (Committee Member) Sole Practitioner
  • Patrick C. Gallagher (Committee Member) Duane Morris LLP
  • Robert Kozak (Committee Member) Bayer Corporation
  • Otto B. Licks (Committee Member) Licks Advogados
  • Dorothy Linvill-Neal (Committee Member) Novartis Pharmaceuticals Corporation
  • Christian Lopez-Silva (Committee Member) Baker & McKenzie
  • Jacqueline Mailly (Committee Member) Hogan Lovells LLP
  • Maureen E. McGirr (Committee Member) Merck & Co., Inc.
  • Daniel Moelands (Committee Member) Medtronic
  • Jeff Nelligan (Committee Member) FDA – ORA
  • Peter Pitts (Committee Member) Center for Medicine in the Public Interest
  • Teresa Reguly (Committee Member) Torys LLP
  • Sarah Taylor Roller (Committee Member) Kelley Drye & Warren LLP
  • Denise Sturdy (Committee Member) Duke Clinical Research Institute
  • Sara Zborovski (Committee Member) Norton Rose Fulbright LLP
The Editorial Advisory Board promotes the educational, scholarly, and other purposes of the Food and Drug Law Journal. Members of the Board serve as peer reviewers for papers submitted for publication and recommend topics for “special / symposia” issues.

  • Anthony Anscombe (Committee Member) Sedgwick LLP
  • Barbara A. Binzak Blumenfeld PhD, JD (Committee Member) Buchanan Ingersoll & Rooney PC
  • Kellie B. Combs (Committee Member) Ropes & Gray LLP
  • Nathan G. Cortez (Committee Member) Southern Methodist University
  • Brian A. Dahl (Committee Member) Dahl Compliance Consulting LLC
  • Sandra DePaulis (Committee Member) FDA – CVM
  • Ian Fearon (Committee Member) British American Tobacco
  • James M. Flaherty Jr. (Committee Member) Fresenius Medical Care
  • Robert C. Giddings (Committee Member) Hutchison PLLC
  • Abraham Gitterman (Committee Member) Arnold & Porter LLP
  • Kimberly J. Gold (Committee Member) Norton Rose Fulbright LLP
  • Peter Barton Hutt (Committee Member) Covington & Burling LLP
  • John Johnson (Committee Member) FDAImports.com, LLC/ Benjamin L. England & Associates LLC
  • Alan C. Katz (Committee Member) toXcel, LLC
  • Sara Koblitz (Committee Member) Fish & Richardson P.C.
  • Laurie Lenkel (Committee Member) FDA – OC
  • Valerie Madamba (Committee Member) Sole Practitioner
  • Alan G. Minsk (Committee Member) Arnall Golden Gregory LLP
  • Nicole Negowetti (Committee Member) The Good Food Institute
  • James T. O’Reilly (Committee Member) University of Cincinnati
  • Joseph A. Page (Committee Member) Georgetown University
  • Francis B. Palumbo PhD (Board Liaison) University of Maryland School of Pharmacy
  • Sandra Retzky (Committee Member) FDA – CTP
  • Jessica Ringel (Committee Member) King & Spalding LLP
  • Joan R. Rothenberg (Committee Member) FDA – CFSAN
  • Jodi Schipper (Committee Member) FDA – CDER
  • Christopher Gail Van Gundy (Committee Member) Keller and Heckman LLP
  • James William Woodlee (Committee Member) Kleinfeld, Kaplan & Becker, LLP
  • Emily Wright (Committee Member) Pfizer, Inc.
  • Kimberly F. Yocum (Committee Member) Heartland
  • Lowell Zeta (Committee Member) Hogan Lovells LLP
  • Patricia Zettler (Committee Member) Georgia State University

The Medical Devices Committee advises FDLI staff in formulating and implementing policies and strategies consistent with FDLI’s mission, relating to programs and publications of interest to the Medical Devices industries. The Committee advises staff on the appropriateness of conferences and publications relating to medical devices by reviewing and commenting on proposals.

  • Paul Gadiock (Co-Chair) Arent Fox, LLP
  • Vernessa T. Pollard (Co-Chair) McDermott Will & Emery
  • Jeffrey N. Gibbs (Board Liaison) Hyman, Phelps & McNamara, PC
  • Linda D. Bentley (Committee Member) Mintz, Levin, Cohn, Ferris, Glovsky and Popeo, P.C.
  • David E. Chadwick PhD (Committee Member) Cook Group Incorporated
  • Michael E. Clark (Committee Member) Duane Morris LLP
  • David K. Elder (Committee Member) Greenleaf Health LLC
  • Sonali P. Gunawardhana (Committee Member) Wiley Rein LLP
  • John Hamilton (Committee Member) Burns & Levinson LLP
  • Sandra C. Kalter (Committee Member) Medtronic
  • Gregory H. Levine (Committee Member) Ropes & Gray LLP
  • Mark C. Levy (Committee Member) Eckert Seamans Cherin & Mellott, LLC
  • Kevin M. Madagan (Committee Member) Reed Smith LLP
  • John R. Manthei (Committee Member) Latham & Watkins LLP
  • Alexandra Marzelli (Committee Member) BD
  • Eileen M. McMahon (Committee Member) Torys LLP
  • Mary Monovoukas (Committee Member) Boston Scientific Corporation Inc.
  • Phoebe Mounts PhD (Committee Member) Morgan, Lewis & Bockius LLP
  • Maura Martin Norden (Committee Member) Greenleaf Health LLC
  • Kelly N. Reeves (Committee Member) King & Spalding LLP
  • Marc J. Scheineson (Committee Member) Alston & Bird LLP
  • Jeffrey K. Shapiro (Committee Member) Hyman, Phelps & McNamara, PC
  • Nancy Singer (Committee Member) Compliance-Alliance, LLC
  • Lynn C. Tyler (Committee Member) Barnes & Thornburg LLP
  • Marta L. Villarraga PhD (Committee Member) Exponent, Inc.
  • Kristi L. Wolff (Committee Member) Kelley Drye & Warren LLP
The Food and Drug Policy Forum Editorial Advisory Board promotes publication of research, dialogue, and idea generation on complex policy issues. Members provide peer review of submissions, and recommend topics for development.

  • Sarah Blankstein (Committee Member) Ropes & Gray LLP
  • Lisa E. Davis (Committee Member) DuBois Bryant & Campbell
  • Jeffrey K. Francer (Committee Member) Generic Pharmaceutical Association
  • Ralph F. Ives (Committee Member) AdvaMed
  • Marian J. Lee (Committee Member) Gibson Dunn & Crutcher LLP
  • Susan Lee (Committee Member) Hogan Lovells LLP
  • Jonathan R. McKnight (Committee Member) FDA – CBER
  • Nicholas J. Nowakowski (Committee Member) Oakland Law Group, PLLC
  • Jessica O’Connell (Committee Member) Covington & Burling LLP
  • Flora Chinyere Okereke (Committee Member) British American Tobacco
  • Megan L. Olsen (Committee Member) Kelley Drye & Warren LLP
  • Evangelia Pelonis (Committee Member) Keller and Heckman LLP
  • Christine Perez (Committee Member) American College of Cardiology
  • Matthew Reed (Committee Member) Sedgwick LLP
  • Barry Schaevitz (Committee Member) Fox Rothschild LLP
  • Laura Sim (Committee Member) Amgen Inc.
  • David C. Spangler (Committee Member) Consumer Healthcare Products Association (CHPA)
  • Josephine M. Torrente (Committee Member) Hyman, Phelps & McNamara, PC
  • Daron Watts (Committee Member) Sidley Austin LLP
  • Brian Joseph Wesoloski (Committee Member) Mylan Pharmaceuticals, Inc.

The Tobacco Committee advises FDLI staff in formulating and implementing policies and strategies relating to programs and publications about law, regulation and policy affecting tobacco products. Duties and Responsibilities include advising staff on the appropriateness of conferences and publications relating to this topic area by suggesting topics and reviewing and commenting on proposals.

  • Azim Chowdhury (Committee Member) Keller and Heckman LLP
  • Dean R. Cirotta (Committee Member) EAS Consulting Group, LLC
  • Gal Cohen (Committee Member) Pax Labs, Inc.
  • Stacy L. Ehrlich (Committee Member) Kleinfeld, Kaplan & Becker, LLP
  • Stacey Gagosian (Committee Member) Truth Initiative
  • Joseph Graham Gitchell (Committee Member) Pinney Associates, Inc.
  • Jonathan A. Havens (Committee Member) Saul Ewing Arnstein & Lehr LLP
  • Bryan M. Haynes (Committee Member) Troutman Sanders LLP
  • Dennis Henigan (Committee Member) Campaign for Tobacco-Free Kids
  • Ondrej Koumal (Committee Member) Philip Morris International
  • Marina A. Murphy (Committee Member) British American Tobacco
  • May D. Nelson (Committee Member) FDA – CTP
  • Valerie B. Solomon (Committee Member) Reynolds American, Inc.
  • James M. Solyst MS (Committee Member) Swedish Match North America
  • Liz Oestreich (Committee Member) Greenleaf Health LLC
  • Jim Swauger (Committee Member) Independent Consultant
The Update Editorial Advisory Board promotes educational and practice-focused written commentary on timely issues of interest to professionals in food and drug law. The Board provides peer review of author submissions, and serves as a resource for FDLI staff to develop feature theme ideas and acquire articles of interest to readers.

  • Joanne Hawana (Chair) Mintz, Levin, Cohn, Ferris, Glovsky and Popeo, P.C.
  • Kari K. Loeser (Vice-Chair) Jazz Pharmaceuticals, Inc.
  • Jacqueline Berman (Committee Member) Morgan, Lewis & Bockius LLP
  • Jacqueline Chan (Committee Member) Kleinfeld, Kaplan & Becker, LLP
  • Bridget C.E. Dooling (Committee Member) Office of Management & Budget
  • Shelly Garg (Committee Member) Sandler, Travis & Rosenberg, P.A.
  • Colleen M. Heisey (Committee Member) Jones Day
  • James R. Johnson (Committee Member) Hogan Lovells LLP
  • Elizabeth F. Lindquist (Committee Member) King & Spalding LLP
  • Gary C. Messplay (Committee Member) King & Spalding LLP
  • Timothy Moore (Committee Member) C.R. Bard, Inc.
  • Nneka C. Onwudiwe (Committee Member) FDA – CDER
  • Krasimira S Pekova (Committee Member) Northeastern University
  • Karen Sie (Committee Member) Norton Rose Fulbright LLP
  • Genevieve M. Spires (Committee Member) Buchanan Ingersoll & Rooney PC
  • Smitha G. Stansbury (Committee Member) King & Spalding LLP
  • James Valentine (Committee Member) Hyman, Phelps & McNamara, PC
  • Andrew Wasson (Committee Member) Haug Partners