About FDLI Committees

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 December, we invite our membership to volunteer to serve on these groups. (Committee appointments are made in the first quarter of the following 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.

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 (Monographs) 
Editorial Advisory Board (Policy Forum) 
Editorial Advisory Board (Update) 
Executive Committee  
Finance Committee 
Food and Dietary Supplements 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
  • James T. O'Reilly (Vice Chair) University of Cincinnati
  • Frederick R. Ball (Board Liaison) Duane Morris LLP
  • Wade Ackerman (Committee Member) FDA - OC
  • Richard H. Alpert (Committee Member) Suffolk University Law School
  • 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
  • Areta L. Kupchyk (Committee Member) Nixon Peabody LLP
  • Peter R. Mathers (Committee Member) Kleinfeld, Kaplan & Becker, LLP
  • Ross H. Pifer (Committee Member) Penn State Dickinson School of Law
  • Herman M. Rhee Ph.D. (Committee Member) Sole Practitioner
  • Roseann B. Termini JD, MEd (Committee Member) Widener University School of Law
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Audit Committee

  • Sheila M. Hemeon-Heyer (Chair) Heyer Regulatory Solutions LLC
  • Karen M. Becker (Committee Member) Precision for Medicine
  • Jennifer L. Bragg (Committee Member) Skadden, Arps, Slate, Meagher & Flom LLP
  • William H. Kitchens (Committee Member) Arnall Golden Gregory LLP
  • Scott M. Lassman (Committee Member) Kleinfeld, Kaplan & Becker, 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 (Vice Chair) PRA International, Inc.
  • Daniel F. Shaw (Board Liaison) H.J. Heinz Company
  • Maya P. Florence (Committee Member) Skadden, Arps, Slate, Meagher & Flom LLP
  • Colleen Heisey (Committee Member) JONES DAY
  • Erika F. Lietzan (Committee Member) Covington & Burling LLP
  • Kari K. Loeser (Committee Member) Genentech, Inc.
  • Jolyda S. Swaim (Committee Member) Olsson Frank Weeda Terman Matz PC
  • Julia C. Tierney (Committee Member) FDA - OC
  • Gregory Wartman Esq. (Committee Member) Saul Ewing LLP
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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.

  • Elizabeth F. Gluck (Chair) King & Spalding LLP
  • James M. Flaherty Jr. (Vice Chair) Foley Hoag LLP
  • Daniel F. Shaw (Board Liaison) H.J. Heinz Company
  • Elinor Hart (Committee Member) Duane Morris LLP
  • Paula Katz (Committee Member) FDA - CDER
  • Shannon G. May (Committee Member) Winston & Strawn LLP
  • Suzanne Loonam Trigg (Committee Member) Haynes and Boone, LLP
  • Sara Wexler (Committee Member) Sidley Austin LLP
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Board of Directors

  • Elizabeth H. Anderson (Chair) Personal Care Products Council
  • Philip Katz (Vice Chair) Hogan Lovells LLP
  • Geoffrey M. Levitt (Immediate Past Chair) Pfizer, Inc.
  • Patricia B. Shrader (Treasurer) Medtronic, Inc.
  • Jeffrey N. Gibbs (Secretary and General Counsel) Hyman, Phelps & McNamara, P.C.
  • 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
  • Sheila M. Hemeon-Heyer (Committee Member) Heyer Regulatory Solutions LLC
  • Kay Holcombe (Committee Member) Genzyme Corporation
  • Leslie T. Krasny (Committee Member) Keller and Heckman LLP
  • Desiree Ralls-Morrison (Committee Member) Johnson & Johnson
  • 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 - OC
  • Cathy L. Burgess (Co-Chair) Alston & Bird LLP
  • Lewis A. Grossman JD, PhD (Board Liaison) Covington & Burling LLP
  • Kay Holcombe (Board Liaison) Genzyme Corporation
  • Noel G. Bertman (Committee Member) Chubb Group of Insurance
  • David L. Chesney (Committee Member) PAREXEL Consulting
  • Jordan D. Cooper (Committee Member) Cephalon, Inc.
  • Diane Darvey (Committee Member) National Association of Chain Drug Stores
  • Sandra J.P. Dennis (Committee Member) Biotechnology Industry Organization
  • 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.
  • Paul T. Kim (Committee Member) Foley Hoag LLP
  • Patricia Knight (Committee Member) FoxKiser
  • 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.
  • Deborah E. Tolomeo (Committee Member) Genentech, Inc.
  • 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.

  • Jeffrey M. Senger (First Vice Chair) Sidley Austin LLP
  • Bridget C.E. Dooling (Second Vice Chair) Executive Office of The President
  • Philip Katz (Board Liaison) Hogan Lovells LLP
  • Judith E. Beach (Committee Member) Quintiles Transnational Corporation
  • Esther Bleicher (Committee Member) FDA - OC
  • Abigail E. Brandel (Committee Member) FDA - OC
  • Philip S. Brewster (Committee Member) Brewster Law Firm LLC
  • Michael Bui (Committee Member) Bayer Corporation
  • Christine P. Bump (Committee Member) Goodwin Procter LLP
  • Azim Chowdhury (Committee Member) Keller and Heckman LLP
  • Brian A. Dahl (Committee Member) ProPharma Group, Inc.
  • Erin M. Duffy (Committee Member) Duane Morris LLP
  • Daniel R. Dwyer (Committee Member) Kleinfeld, Kaplan & Becker, LLP
  • Sam Halabi (Committee Member) University of Tulsa College of Law
  • Ilene Ringel Heller (Committee Member) Sole Practitioner
  • Geetha Jayan (Committee Member) FDA - CDRH
  • Jeremiah J. Kelly (Committee Member) US Army
  • Joy J. Liu (Committee Member) Ropes & Gray LLP
  • Angela Lynch (Committee Member) toXcel, LLC
  • Francis B. Palumbo PhD (Committee Member) University of Maryland School of Pharmacy
  • Kelly N. Reeves (Committee Member) King & Spalding LLP
  • Joan R. Rothenberg (Committee Member) FDA - CFSAN
  • Jennifer Schwartz (Committee Member) Covington & Burling LLP
  • Arthur Y. Tsien (Committee Member) Olsson Frank Weeda Terman Matz PC
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Editorial Advisory Board (Monograph)

  • Joanne Hawana (Chair) Arent Fox LLP
  • Brian J. Malkin (Vice Chair) Frommer Lawrence & Haug LLP
  • Peter E. Tamborski (Board Liaison) Sugar Creek Packing Company
  • Sharon M. Bradley (Committee Member) Hunton & Williams LLP
  • Kellie B. Combs (Committee Member) Ropes & Gray LLP
  • Peggy Cooley (Committee Member) Arthrex, Inc.
  • Jennifer Devine (Committee Member) FDA - OC
  • Andrea Fus (Committee Member) FDA - CDER
  • Terrence Joyce (Committee Member) Town of Hudson Massachusetts
  • Eric David Kupferberg PhD (Committee Member) Northeastern University
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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) Sole Practitioner
  • 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) Bristol-Myers Squibb Company
  • 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.

  • Elizabeth Barr Fawell (Chair) Hogan Lovells LLP
  • Margaret Sova McCabe (Vice Chair) University of New Hampshire School of Law
  • Desiree Ralls-Morrison (Board Liaison) Johnson & Johnson
  • Barry A. Berger (Committee Member) Temple University
  • Mitchell A. Cheeseman PhD (Committee Member) Steptoe & Johnson LLP
  • Steven J. Ellcessor (Committee Member) Frost Brown Todd LLC
  • Hope S. Freiwald (Committee Member) Dechert LLP
  • Lori F. Hirsch (Committee Member) Merck & Co., Inc.
  • Kari K. Loeser (Committee Member) Genentech, Inc.
  • Alexandra Marzelli (Committee Member) BD
  • Srikumaran Melethil (Committee Member) Law and Science Consulting
  • Jessica O'Connell (Committee Member) FDA - OC
  • Peggy Pence (Committee Member) Symbion Research International, Inc.
  • Diane E. Robertson Ph.D. (Committee Member) PWR
  • Alex Stack (Committee Member) Gilbert's LLP
  • Cicely N. Vaughn (Committee Member) FDA - ORA
  • Cara Welch (Committee Member) Natural Products Association
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Executive Committee

  • Elizabeth H. Anderson (Chair) Personal Care Products Council
  • Philip Katz (Vice Chair) Hogan Lovells LLP
  • Geoffrey M. Levitt (Immediate Past Chair) Pfizer, Inc.
  • Patricia B. Shrader (Treasurer) Medtronic, Inc.
  • 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.
  • Barbara A. Binzak Blumenfeld PhD, JD (Board Liaison) Buchanan Ingersoll & Rooney PC
  • Don L. Bell II (Committee Member) National Association of Chain Drug Stores
  • Kellie B. Combs (Committee Member) Ropes & Gray LLP
  • David M. Fox (Committee Member) Hogan Lovells LLP
  • Madeleine M. McDonough (Committee Member) Shook, Hardy & Bacon L.L.P.
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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.

  • Stephen L. Lacey (Co-Chair) Abbott Laboratories
  • Michael M. Landa JD (Co-Chair) FDA - CFSAN
  • Leslie T. Krasny (Board Liaison) Keller and Heckman LLP
  • Rend Al-Mondhiry (Committee Member) Council for Responsible Nutrition
  • Ann M. Boeckman (Committee Member) Kraft Foods Global
  • 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
  • Benjamin L. England (Committee Member) FDAImports.com, LLC
  • 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) Nestle USA-Nutrition Division
  • Ashish R. Talati (Committee Member) Amin Talati LLC
  • Peter E. Tamborski (Committee Member) Sugar Creek Packing Company
  • James William Woodlee (Committee Member) Kleinfeld, Kaplan & Becker, 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 LLP
  • Denise D. Dion (Committee Member) EduQuest, Inc.
  • Andrew C. Fish (Committee Member) AdvaMed
  • Iris Rolander Gibbs (Committee Member) Genzyme Corporation
  • Andrew S. Ittleman (Committee Member) Fuerst Ittleman David & Joseph, PL
  • Karen Mahoney (Committee Member) Johnson & Johnson
  • Kos Makrodimitri Ph.D. (Committee Member) Sole Practitioner
  • Carole E. Marcot Esq. (Committee Member) Sole Practitioner
  • Rebecca Jones McKnight (Committee Member) DLA Piper LLP
  • Nahed Mohsen PhD (Committee Member) Sole Practitioner
  • Karl M. Nobert (Committee Member) Squire Sanders
  • 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.

  • 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
  • Mark Greenwold (Committee Member) Campaign for Tobacco-Free Kids
  • J. Benneville Haas (Committee Member) Latham & Watkins LLP
  • William A. McGrath (Committee Member) Wiley Rein LLP
  • Mitchell A. Neuhauser (Committee Member) RAI Services Company
  • James M. Solyst MS (Committee Member) Swedish Match North America
  • Gregory Wilson (Committee Member) Altria Client Services, Inc.
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