FDLI Committees

As a membership organization, we depend on the dedication and commitment of our committee volunteers to enhance Institute activity. FDLI committees consist of volunteer members who provide expertise regarding conferences, publications and other actions.

Our volunteer committees include editorial advisory boards and product sector committees (e.g., Drugs and Biologics). Each January, we invite our membership to volunteer to serve on these groups (committee appointments are made in the first quarter of the same year). Committee terms, typically three years in duration, begin and conclude in April. New, standing, and outgoing committee members are invited to participate at ‘committee day’ held the day before FDLI’s Annual Conference each Spring in Washington, DC.

If you are a member and interested in serving, email Customer Service to be considered.

Academic Programs Committee 
Audit Committee 
Austern Writing Awards Committee - Long Papers 
Austern Writing Awards Committee - Short Papers 
Board of Directors 
Drugs and Biologics Committee 
Editorial Advisory Board (Journal) 
Editorial Advisory Board (Primer) 
Editorial Advisory Board (Policy Forum) 
Editorial Advisory Board (Update) 
Executive Committee  
Finance Committee 
Food and Dietary Supplements Committee
Global Committee
Medical Devices Committee 
Tobacco Committee 


Academic Program Committee

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.

  • Marsha Cohen (Chair) UC Hastings College of The Law
  • Frederick R. Ball (Board Liaison) Duane Morris LLP
  • Barbara Evans PhD, JD (Committee Member) University of Houston
  • Arnold I. Friede (Committee Member) University of Miami
  • Sonali P. Gunawardhana (Committee Member) Wiley Rein LLP
  • Ralph F. Hall (Committee Member) University of Minnesota
  • James T. O'Reilly (Committee Member) University of Cincinnati
  • Herman M. Rhee Ph.D. (Committee Member) Sole Practitioner
  • Roseann B. Termini JD, MEd (Committee Member) Widener University School of Law
  • Seth B Whitelaw (Committee Member) Deloitte & Touche LLP
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Audit Committee

  • Barbara A. Binzak Blumenfeld PhD, JD (Chair) Buchanan Ingersoll & Rooney PC
  • Karen M. Becker (Committee Member) Precision for Medicine
  • Jennifer L. Bragg (Committee Member) Skadden, Arps, Slate, Meagher & Flom LLP
  • Freddy A. Jimenez (At-Large) Johnson & Johnson
  • William H. Kitchens (At-Large) Arnall Golden Gregory LLP
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Austern Writing Awards Committee - Long Papers

The H. Thomas Austern Writing Awards Committee assists FDLI staff in determining the award recipient(s) for the best student papers submitted for publication. Members of the Committee (with subcommittees for long and short papers) develop publicity for and promote the competition, and subsequently review all submitted student manuscripts, determining which are most appropriate for awards and/or publication.

  • William A. Garvin (Chair) Buchanan Ingersoll & Rooney PC
  • Robert C. Giddings (Chair) AbbVie
  • Colleen M. Heisey (Vice Chair) JONES DAY
  • Daniel F. Shaw (Board Liaison) H.J. Heinz Company
  • Erika F. Lietzan (Committee Member) University of Missouri-Columbia School of Law
  • Kari K. Loeser (Committee Member) Jazz Pharmaceuticals, Inc.
  • Julia C. Tierney (Committee Member) FDA - OC
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Austern Writing Awards Committee - Short Papers

The H. Thomas Austern Writing Awards Committee assists FDLI staff in determining the award recipient(s) for the best student papers submitted for publication. Members of the Committee (with subcommittees for long and short papers) develop publicity for and promote the competition, and subsequently review all submitted student manuscripts, determining which are most appropriate for awards and/or publication.

  • James M. Flaherty Jr. (Chair) Fresenius Medical Care
  • Elizabeth F. Lindquist (Chair) King & Spalding LLP
  • Daniel F. Shaw (Board Liaison) H.J. Heinz Company
  • Elinor Hart (Committee Member) Duane Morris LLP
  • Paula Katz (Committee Member) FDA - CDER
  • Sara Koblitz (Committee Member) Fish & Richardson P.C.
  • Suzanne Loonam Trigg (Committee Member) Haynes and Boone, LLP
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Board of Directors

  • Philip Katz (Chair) Hogan Lovells LLP
  • Sheila M. Hemeon-Heyer (Vice Chair) Heyer Regulatory Solutions LLC
  • Elizabeth H. Anderson (Immediate Past Chair) Personal Care Products Council
  • Patricia B. Shrader (Treasurer) Medtronic, Inc.
  • Jeffrey N. Gibbs (Secretary and General Counsel) Hyman, Phelps & McNamara, P.C.
  • Steven H. Armstrong (Committee Member) Campbell Soup Company
  • Frederick R. Ball (Committee Member) Duane Morris LLP
  • Barbara A. Binzak Blumenfeld PhD, JD (Committee Member) Buchanan Ingersoll & Rooney PC
  • Lewis A. Grossman PhD, JD (Committee Member) American University
  • Leslie T. Krasny (Committee Member) Keller and Heckman LLP
  • Joy J. Liu (Committee Member) Ropes & Gray LLP
  • Desiree Ralls-Morrison (Committee Member) Boehringer Ingelheim Pharmaceuticals
  • Daniel F. Shaw (Committee Member) H.J. Heinz Company
  • Peter E. Tamborski (Committee Member) Sugar Creek Packing Company
  • Allison M. Zieve JD (Committee Member) Public Citizen
  • Susan C. Winckler RPh, JD (President & CEO) FDLI
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Drugs and Biologics Committee

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
  • Joy J. Liu (Board Liaison) Ropes & Gray LLP
  • Noel G. Bertman (Committee Member) Chubb Group of Insurance
  • David L. Chesney (Committee Member) PAREXEL Consulting
  • Diane L. Darvey (Committee Member) National Association of Chain Drug Stores
  • Neil P. Di Spirito (Committee Member) Rumberger, Kirk & Caldwell
  • John H. Fuson (Committee Member) Crowell & Moring LLP
  • Todd H. Halpern (Committee Member) Pfizer, Inc.
  • Judson M. Katz (Committee Member) Allergan, Inc.
  • Minnie Mildwoff (Committee Member) Biogen Idec, Inc.
  • Neal B. Parker (Committee Member) AbbVie
  • Laura A. Rich (Committee Member) FDA - CBER
  • Angela M. Seaton (Committee Member) Shook, Hardy & Bacon L.L.P.
  • Jason Sol Zielonka M.D. (Committee Member) Eli Lilly and Company
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Editorial Advisory Board (Journal)

The Journal 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.

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Editorial Advisory Board (Primer)

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Policy Forum Editorial Board

  • Sheila D. Walcoff (Chair) Goldbug Strategies LLC
  • Victoria W. Girard (Vice Chair) Georgetown University
  • Barbara A. Binzak Blumenfeld PhD, JD (Board Liaison) Buchanan Ingersoll & Rooney PC
  • Christina L. Anderson (Committee Member) Medtronic, Inc.
  • Brendan Benner (Committee Member) Medical Device Manufacturers Association
  • James A Boiani (Committee Member) Epstein Becker & Green, P.C.
  • Thomas Cluderay (Committee Member) Environmental Working Group
  • Eric Feldman (Committee Member) University of Pennsylvania
  • Paul A. Franz (Committee Member) The Procter & Gamble Company
  • Robert L. Guenther (Committee Member) United Fresh Produce Association
  • Jennifer J. Hillman Pharm.D (Committee Member) University Health System
  • Mary Clare Kimber (Committee Member) Plasma Protein Therapeutics Association
  • Beth A Krewson (Committee Member) Incyte Corporation Experimental Station
  • Erik R. Lieberman (Committee Member) Food Marketing Institute
  • Gary C. Messplay (Committee Member) Hunton & Williams LLP
  • Kirsten Paulson (Committee Member) The Pew Charitable Trusts
  • Peter Pitts (Committee Member) Center for Medicine in the Public Interest
  • Lori M. Reilly (Committee Member) PhRMA
  • Robert Rosado (Committee Member) Food Marketing Institute
  • Mark I. Schwartz (Committee Member) FDA - OC
  • Alan Traettino (Committee Member) Stryker Corporation
  • Pamela Wilger (Committee Member) Cargill, Inc.
  • Lisa Ann Zoks (Committee Member) Drug Information Association
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Editorial Advisory Board (Update)

The Update Editorial Advisory Board promotes the highest levels of professional, educational, and scholarly written commentary on timely issues of interest to professionals in the areas of foods, drugs, biologics, medical devices, other healthcare technologies, and cosmetics in FDLI's magazine The Board serves as a resource for FDLI staff to develop feature theme ideas, acquire articles of interest to readers, and advise on the magazine's quality and success in serving the interests and needs of its readers.

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Executive Committee

  • Philip Katz (Chair) Hogan Lovells LLP
  • Sheila M. Hemeon-Heyer (Vice Chair) Heyer Regulatory Solutions LLC
  • Elizabeth H. Anderson (Immediate Past Chair) Personal Care Products Council
  • Patricia B. Shrader (Treasurer) Medtronic, Inc.
  • Jeffrey N. Gibbs (Secretary and General Counsel) Hyman, Phelps & McNamara, P.C.
  • Susan C. Winckler RPh, JD (President & CEO) FDLI
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Finance Committee

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.

  • Patricia B. Shrader (Chair) Medtronic, Inc.
  • Frederick R. Ball (Board Liaison) Duane Morris LLP
  • Don L. Bell II (At-Large) National Association of Chain Drug Stores
  • Kellie B. Combs (Committee Member) Ropes & Gray LLP
  • David M. Fox (Committee Member) Hogan Lovells LLP
  • David C. Spangler Esq. (At-Large) Consumer Healthcare Products Association (CHPA)
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Food and Dietary Supplements Committee

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.

  • Steven H. Armstrong (Board Liaison) Campbell Soup Company
  • Leslie T. Krasny (Board Liaison) Keller and Heckman LLP
  • Rend Al-Mondhiry (Committee Member) Council for Responsible Nutrition
  • Sarah L. Brew (Committee Member) Faegre Baker Daniels LLP
  • George A. Burdock PhD (Committee Member) Burdock Group
  • Ricardo Carvajal (Committee Member) Hyman, Phelps & McNamara, P.C.
  • Caroline Smith DeWaal JD (Committee Member) Center for Science in the Public Interest
  • Karin A. Gregory (Committee Member) Sole Practitioner
  • James C. Huang (Committee Member) Bemis Company
  • John Kraus (Committee Member) H.J. Heinz Company
  • Claudia A. Lewis (Committee Member) Venable LLP
  • Markus Lipp PhD (Committee Member) U.S. Pharmacopeia
  • Emilia Lonardo (Committee Member) Grocery Manufacturers Association
  • Julie Lovas (Committee Member) FDA - OC
  • James Pepin (Committee Member) Nestlé HealthCare Nutrition
  • James William Woodlee (Committee Member) Kleinfeld, Kaplan & Becker, LLP
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Global Committee

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.

  • David W. K. Acheson MD (Chair) The Acheson Group
  • Susan de Mars (Vice Chair) U.S. Pharmacopeia
  • Barbara A. Binzak Blumenfeld PhD, JD (Board Liaison) Buchanan Ingersoll & Rooney PC
  • Wade Ackerman (At-Large) Senate Committee on HELP
  • Michael Bui (Committee Member) Teva Pharmaceutical Industries Ltd.
  • Michael Bui (At-Large) Bayer Corporation
  • Li Cai (At-Large) Pfizer, Inc.
  • Ricardo Carvajal (At-Large) Hyman, Phelps & McNamara, P.C.
  • Jill M. Daley (At-Large) Norton Rose Fulbright LLP
  • Jennifer Devine (At-Large) FDA-Office of Global Regulatory Operation and Policy
  • Christian Fulda (At-Large) JONES DAY
  • Francine F. Guise (Committee Member) Sole Practitioner
  • Sonali P. Gunawardhana (At-Large) Wiley Rein LLP
  • Francine Lamoriello (Committee Member) Personal Care Products Council
  • Erik R. Lieberman (At-Large) Food Marketing Institute
  • Dorothy Linvill-Neal (At-Large) Novartis Pharmaceuticals Corporation
  • David Mitchell (At-Large) AbbVie
  • Daniel Moelands (At-Large) Medtronic, Inc.
  • Robert A. Rhoades (At-Large) Quintiles Consulting
  • Fredric J. Richman (At-Large) Transnational Strategy Group
  • Vicente Rodriguez Fuentes (At-Large) Legal Agrifood
  • Eliana A. Silva de Moraes PhD (At-Large) Silva de Moraes Advogados Associados
  • Benny Spiewak (At-Large) Zancaner Costa, Bastos e Spiewak Advogados
  • Deborah E. Tolomeo (At-Large) Genentech, Inc.
  • Sara Zborovski (At-Large) Davis LLP
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Medical Devices Committee

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.

  • Philip R. Desjardins (Co-Chair) FDA - CDRH
  • Suzan Onel (Co-Chair) K&L Gates LLP
  • Jeffrey N. Gibbs (Board Liaison) Hyman, Phelps & McNamara, P.C.
  • Sheila M. Hemeon-Heyer (Board Liaison) Heyer Regulatory Solutions LLC
  • Michele L. Buenafe (Committee Member) Morgan, Lewis & Bockius LLP
  • Mark Dahlby (Committee Member) Hall Render Killian Heath & Lyman
  • Jill M. Daley (Committee Member) Norton Rose Fulbright LLP
  • Denise D. Dion (Committee Member) EduQuest, Inc.
  • Iris Rolander Gibbs (Committee Member) Genzyme Corporation
  • Andrew S. Ittleman (Committee Member) Fuerst Ittleman David & Joseph, PL
  • Karen Mahoney (Committee Member) Johnson & Johnson
  • Carole E. Marcot Esq. (Committee Member) Sole Practitioner
  • Rebecca Jones McKnight (Committee Member) DLA Piper LLP
  • Karl M. Nobert (Committee Member) The Nobert Group
  • Kai Peters (Committee Member) Gordon & Rees LLP
  • Laurie H. Roberts (Committee Member) Sunrise Medical, Inc.
  • Nancy M. Singer (Committee Member) Compliance-Alliance, LLC
  • Nicole Taylor Smith (Committee Member) FDA - OC
  • Marta L. Villarraga PhD (Committee Member) Exponent, Inc.
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Tobacco Committee

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.

  • Mark Greenwold (Co-Chair) Campaign for Tobacco-Free Kids
  • Ann L. Simoneau RPh, JD (Co-Chair) FDA - CTP
  • Allison M. Zieve JD (Board Liaison) Public Citizen
  • Carlos T. Angulo (Committee Member) Zuckerman Spaeder LLP
  • Dean R. Cirotta (Committee Member) EAS Consulting Group, LLC
  • J. Benneville Haas (Committee Member) Latham & Watkins LLP
  • William A. McGrath (Committee Member) Potomac Law Group
  • Gregory Wilson (Committee Member) Altria Client Services, Inc.
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