fdli 2018 annual conference attendee list (current as of 5 ... · first name last name job title...

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First Name Last Name Job Title Company Name City and State Anna Abram Deputy Commissioner for Policy, Planning, Legislation, and Analysis FDA - OC Silver Spring, MD Issa Abuaita Corporate Counsel Fumari, Inc. San Diego, CA Mahmoud Abuelroos Sr. Systems Integration Consultant Deloitte Consulting LLP McLean, VA David Adams Principal Adams Law Potomac, MD Shawnte Adams Supervisory Regulatory Counsel FDA - CTP Silver Spring, MD Jill Adleberg Congressional Affairs Specialist FDA - OC Silver Spring, MD Jenny Agila Sefen Lead Consumer Safety Officer FDA - CDER Silver Spring, MD Sara Aguel Policy Analyst FDA - CDRH Silver Spring, MD Janet Aho VP, Regulatory Affairs & Product Safety, Flavors MANE Lebanon, OH Hazel Aker Senior Vice President and General Counsel Dermata Therapeutics, LLC Santa Fe, NM Carolyn Alenci Associate Duane Morris LLP Boston, MA Meg Alexander EVP Syneos Health New York, NY Alexander Alfano Associate Axinn, Veltrop & Harkrider LLP Hartford, CT Ferdous Al-Faruque Reporter Medtech Insight (formerly The Gray and Silver Sheet) Rockville, MD Meghna Alimchandani Medical Officer FDA - CBER Silver Spring, MD Grabriel Alves Journalist Folha de S.Paulo São Paulo, Brazil Diana Amador-Toro Pharmaceutical Division Director FDA - ORA Parsippany, NJ Kathleen Anderson Deputy Director, OUDLC FDA - CDER Rockville, MD Margaret Anderson Managing Director Deloitte Consulting LLP Arlington, VA Robert Anderson Division Counsel AbbVie North Chicago, IL Charles Andres Associate Wilson Sonsini Goodrich & Rosati Washington, DC Yvette Appleby PMO Lead Software Medical Devices Pfizer, Inc. Richmond, VA Steven Armstrong Independent Advisor EAS Consulting Group, LLC Naples, FL Emilio Arocho Director, Technology and Digital Strategy Food and Drug Law Institute (FDLI) Washington, DC Amy Arthur Operations Harm Reduction Therapeutics Debra Asay Marketing Director Deloitte Consulting LLP Philadelphia, PA Donald Ashley Director, Office of Compliance FDA - CDER Silver Spring, MD Kalah Auchincloss Greenleaf Health, Inc. Silver Spring, MD Deborah Autor SVP/Head of Strategic Global Quality & Regulatory Policy Mylan Pharmaceuticals, Inc. Washington, DC Katlin Backfield Principal Backfield PLLC Washington, DC Joseph Baglieri Law Clerk Summit County Juvenile Court Hudson, OH Lauren Baham Regulatory Counsel FDA - CFSAN College Park, MD Luciana Bahia post-doc student STAT Rio de Janeiro, RJ Meaghan Bailey Executive Director, NSF Medical Devices NSF International Washington, DC Laura Bailis General Attorney FDA - OC Silver Spring, MD Kristin Ball Consumer Safety Officer FDA - CDER Silver Spring, MD Frederick Ball** Partner Duane Morris LLP Boston, MA Scott Ballin Tobacco and Health Policy Consultant No Account Washington, DC Germana Barba Vice President Regulatory Strategy & Engagement Philip Morris International Lausanne, Switzerland Rose Barbella Principle Law Offices of Rosemarie Barbella Milford, NJ Sarah Barkow Lead Consumer Safety Officer FDA - CDER Silver Spring, MD Kenita Barrow Senior Corporate Attorney Otsuka America Pharmaceutical, Inc. Rockville, MD Clive Bates Director Counterfactual Consulting Limited London, England Erica Battaglia Divisional Vice President & Associate General Counsel, Legal Regulatory & Compliance Abbott Laboratories Abbott Park, IL Jeannie Baumann Reporter Bloomberg Law Arlington, VA Virginia Beakes-Read Executive Director, Global Regulatory and R&D Policy Amgen Inc. Chevy Chase, Maryland Nathan Beaver Partner Foley & Lardner LLP Washington, DC Andrew Becher General Attorney FDA - OC Silver Spring, MD Carolyn Becker Director, OUDLC FDA - CDER Silver Spring, MD Donald Becker Assistant General Counsel Turning Point Brands, Inc. Louisville, KY Dan Bellingham Policy Analyst FDA - CDER Silver Spring, MD FDLI 2018 Annual Conference Attendee List (current as of 5/2/2018)

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Page 1: FDLI 2018 Annual Conference Attendee List (current as of 5 ... · First Name Last Name Job Title Company Name City and State Anna Abram Deputy Commissioner for Policy, Planning, Legislation,

First Name Last Name Job Title Company Name City and State

Anna Abram Deputy Commissioner for Policy,

Planning, Legislation, and Analysis

FDA - OC Silver Spring, MD

Issa Abuaita Corporate Counsel Fumari, Inc. San Diego, CA

Mahmoud Abuelroos Sr. Systems Integration Consultant Deloitte Consulting LLP McLean, VA

David Adams Principal Adams Law Potomac, MD

Shawnte Adams Supervisory Regulatory Counsel FDA - CTP Silver Spring, MD

Jill Adleberg Congressional Affairs Specialist FDA - OC Silver Spring, MD

Jenny Agila Sefen Lead Consumer Safety Officer FDA - CDER Silver Spring, MD

Sara Aguel Policy Analyst FDA - CDRH Silver Spring, MD

Janet Aho VP, Regulatory Affairs & Product Safety,

Flavors

MANE Lebanon, OH

Hazel Aker Senior Vice President and General

Counsel

Dermata Therapeutics, LLC Santa Fe, NM

Carolyn Alenci Associate Duane Morris LLP Boston, MA

Meg Alexander EVP Syneos Health New York, NY

Alexander Alfano Associate Axinn, Veltrop & Harkrider LLP Hartford, CT

Ferdous Al-Faruque Reporter Medtech Insight (formerly The Gray

and Silver Sheet)

Rockville, MD

Meghna Alimchandani Medical Officer FDA - CBER Silver Spring, MD

Grabriel Alves Journalist Folha de S.Paulo São Paulo, Brazil

Diana Amador-Toro Pharmaceutical Division Director FDA - ORA Parsippany, NJ

Kathleen Anderson Deputy Director, OUDLC FDA - CDER Rockville, MD

Margaret Anderson Managing Director Deloitte Consulting LLP Arlington, VA

Robert Anderson Division Counsel AbbVie North Chicago, IL

Charles Andres Associate Wilson Sonsini Goodrich & Rosati Washington, DC

Yvette Appleby PMO Lead Software Medical Devices Pfizer, Inc. Richmond, VA

Steven Armstrong Independent Advisor EAS Consulting Group, LLC Naples, FL

Emilio Arocho Director, Technology and Digital Strategy Food and Drug Law Institute (FDLI) Washington, DC

Amy Arthur Operations Harm Reduction Therapeutics

Debra Asay Marketing Director Deloitte Consulting LLP Philadelphia, PA

Donald Ashley Director, Office of Compliance FDA - CDER Silver Spring, MD

Kalah Auchincloss Greenleaf Health, Inc. Silver Spring, MD

Deborah Autor SVP/Head of Strategic Global Quality &

Regulatory Policy

Mylan Pharmaceuticals, Inc. Washington, DC

Katlin Backfield Principal Backfield PLLC Washington, DC

Joseph Baglieri Law Clerk Summit County Juvenile Court Hudson, OH

Lauren Baham Regulatory Counsel FDA - CFSAN College Park, MD

Luciana Bahia post-doc student STAT Rio de Janeiro, RJ

Meaghan Bailey Executive Director, NSF Medical Devices NSF International Washington, DC

Laura Bailis General Attorney FDA - OC Silver Spring, MD

Kristin Ball Consumer Safety Officer FDA - CDER Silver Spring, MD

Frederick Ball** Partner Duane Morris LLP Boston, MA

Scott Ballin Tobacco and Health Policy Consultant No Account Washington, DC

Germana Barba Vice President Regulatory Strategy &

Engagement

Philip Morris International Lausanne, Switzerland

Rose Barbella Principle Law Offices of Rosemarie Barbella Milford, NJ

Sarah Barkow Lead Consumer Safety Officer FDA - CDER Silver Spring, MD

Kenita Barrow Senior Corporate Attorney Otsuka America Pharmaceutical, Inc. Rockville, MD

Clive Bates Director Counterfactual Consulting Limited London, England

Erica Battaglia Divisional Vice President & Associate

General Counsel, Legal Regulatory &

Compliance

Abbott Laboratories Abbott Park, IL

Jeannie Baumann Reporter Bloomberg Law Arlington, VA

Virginia Beakes-Read Executive Director, Global Regulatory and

R&D Policy

Amgen Inc. Chevy Chase, Maryland

Nathan Beaver Partner Foley & Lardner LLP Washington, DC

Andrew Becher General Attorney FDA - OC Silver Spring, MD

Carolyn Becker Director, OUDLC FDA - CDER Silver Spring, MD

Donald Becker Assistant General Counsel Turning Point Brands, Inc. Louisville, KY

Dan Bellingham Policy Analyst FDA - CDER Silver Spring, MD

FDLI 2018 Annual Conference

Attendee List (current as of 5/2/2018)

Page 2: FDLI 2018 Annual Conference Attendee List (current as of 5 ... · First Name Last Name Job Title Company Name City and State Anna Abram Deputy Commissioner for Policy, Planning, Legislation,

Carol Bennett Deputy Director, Office of Regulatory

Policy

FDA - CDER Silver Spring, MD

Heather Bennett General Attorney FDA - OC Silver Spring, MD

Linda Bentley Member Mintz, Levin, Cohn, Ferris, Glovsky and

Popeo, P.C.

Boston, MA

Gary Bergman Practice Director Oxford Global Resources Chandler, AZ

Eitan Bernstein Associate Latham & Watkins LLP Washington, DC

Ilisa Bernstein Deputy Director, Office of Compliance FDA - CDER Silver Spring, MD

James Bertram Policy Analyst FDA - CDRH Silver Spring, MD

Aruni Bhatnagar Professor of Medicine and Distinguished

University Scholar

University of Louisville Louisville, KY

Stephanie Billings Compliance Analyst The TJX Companies, Inc Marlborough, MA

Barbara Binzak

Blumenfeld

Partner Buchanan Ingersoll & Rooney PC Washington, DC

Benjamin Bishop Interdisciplinary Scientist/Pharmacist FDA - CDER Silver Spring, MD

Ivan Blackwell Regulatory Counsel FDA - CTP Silver Spring, MD

Erica Blake Payne Regulatory Counsel FDA - CDRH Silver Spring, MD

Cherron Blakely Acting Deputy Director for Quality and

Clinical Affairs

FDA - CDRH Silver Spring, MD

Sarah Blankstein Associate Director & Corporate Counsel Vertex Pharmaceuticals, Inc. Boston, MA

Bronwen Blass General Attorney FDA - CDER Silver Spring, MD

David Bloch Principal Legal Counsel, Corporate Legal

Regulatory

Medtronic Washington, DC

Janet Bloom Sales and Marketing Specialist E.M.M.A. International Consulting

Group, Inc.

Farmington Hills, MI

Michael Blume Partner Venable LLP Washington, DC

George Bogart Senior Attorney U.S. Government Accountability Office Washington, DC

Susan Bond Vice President, Regulatory Affairs Kerry, Inc. Beloit, Wisconsin

Brigid

DeCoursey

Bondoc FDA Regulatory Associate Sidley Austin LLP Washington, DC

Frances Bormel Director, Division of Prescription Drugs,

OUDLC

FDA - CDER Rockville, MD

Matt Bowen Program Management & Analysis Staff

(PMAS)

FDA - OC Silver Spring, MD

Jennifer Boyd Chr. Hansen Milwaukee, WI

Jennifer Bragg** Partner Skadden, Arps, Slate, Meagher & Flom

LLP

Washington, DC

Tiffany Branch Director FDA - OC Silver Spring, MD

Kyle Brierly Presidential Management Fellow Department of Health & Human

Services/Departmental Appeals Board

(DAB)

Washington, DC

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

Elizabeth Brown GENERAL ATTORNEY FDA - OC Silver Spring, MD

Laura Brown Director, Educational Programs Food and Drug Law Institute (FDLI) Washington, DC

Mark Brown Chair FDA & Life Sciences Practice King & Spalding LLP Washington, DC

Nathan Brown Partner Akin Gump Strauss Hauer & Feld LLP Washington, DC

Regina Brown Consumer Safety Officer FDA - CDER Silver Spring, MD

Leah Brownlee Of Counsel Squire Patton Boggs LLP Cleveland, OH

Kristiana Brugger Regulatory Counsel FDA - CDER Silver Spring, MD

Marissa Brykman Regulatory Counsel FDA - CDER Silver Spring, MD

Kurt Buechle Associate Kilyk & Bowersox, PLLC Vienna, VA

Shelby Buettner Associate McDermott Will & Emery Washington, DC

Cathy Burgess Partner Alston & Bird LLP Washington, DC

Lauren Burke Coordinator, Membership Food and Drug Law Institute (FDLI) Washington, DC

Brian Burns Chief Executive Officer Validant Framingham, MA

Vanessa Burrows Historian FDA - OC Silver Spring, MD

Marcy Busch Acting Special Assistant to the Deputy

Commissioner

FDA - OC Silver Spring, MD

Cynthia Cabrera President The Cating Group Hallandale, FL

Kristan Callahan International Relations Specialist FDA - OC Silver Spring, MD

Khatereh Calleja Senior Vice President, Technology and

Regulatory Affairs

AdvaMed Washington, DC

Jeannie Cameron Managing Director - JCIC JCIC International London, England

Page 3: FDLI 2018 Annual Conference Attendee List (current as of 5 ... · First Name Last Name Job Title Company Name City and State Anna Abram Deputy Commissioner for Policy, Planning, Legislation,

Jose Campos Vargas Partner Sanchez Devanny Mexico City, Mexico

Arthur Caplan Drs. William F. and Virginia Connolly

Mitty Professor of Bioethics and

Founding Director, Division of Medical

Ethics

New York University New York, NY

Melissa Card-Abela Associate Director/Professor Michigan State University East Lansing, MI

Massimo Cardinali Senior Regulatory Affairs Manager National Institutes of Health Bethesda, MD

Coleen Carney Food and Drug Law Institute (FDLI) Washington, DC

Hayley Carpenter Director of Operations Food and Drug Law Institute (FDLI) Washington, DC

Carla Cartwright* Director, Federal Affairs Johnson & Johnson Washington, DC

Krista Carver Partner Covington & Burling LLP Washington, DC

Marcus Cato Senior Regulatory Health Project

Manager

FDA - CDER Silver Spring, MD

Anthony Cea Executive Vice President Oxford Global Resources Chandler, AZ

Cynthia Cecil Senior Editor, PMTA Submissions Altria Client Services LLC Richmond, VA

David Ceryak Sr. Director - Assistant General Counsel,

Regulatory Legal Team

Eli Lilly and Company Indianapolis, IN

Andrea Chamblee Regulatory Counsel FDA - ORA Silver Spring, MD

Andrew Chang Vice President, Quality and Regulatory

Compliance, Quality Intelligence and

Inspection, Corporate Quality

Novo Nordisk Inc. Washington, DC

Michelle Chavis Reviewer (Biomedical Engineer) FDA - CDRH Silver Spring, MD

Glen Cheng Regulatory Counsel FDA - CDER Silver Spring, MD

Tien Cheng Agency Legal Specialist North Carolina Department of

Agriculture and Consumer Services

Raleigh, NC

David Chesney Principal and General Manager DL Chesney Consulting, LLC Exeter, NH

Mantej Chhina Director, Regulatory Policy & FDA

Engagement

BioMarin Pharmaceutical Inc. Potomac, MD

Loretta Chi Senior Regulatory Counsel, Informatics

Staff/UDI

FDA - CDRH Silver Spring, MD

Mary Ann Chirba Professor Boston College Newton Centre, MA

Lee Chirtel Regulatory Counsel FDA - CTP Silver Spring, MD

Shovaughn Chism National Academy of Medicine Washington, DC

Atiq Chowdhury Regulatory Review Officer FDA - CDRH Silver Spring, MD

Azim Chowdhury Partner Keller and Heckman LLP Washington, DC

Katherine Chowdhury Health Science Administrator FDA - OC Silver Spring, MD

Charlotte Christin Senior Advisor FDA - OC Silver Spring, MD

Julie Chronis Regulatory Counsel, OPDP FDA - CDER Salt Lake City, UT

Katherine Ciambrone Chief Compliance Officer and Senior Vice

President

ITG Brands Greensboro, NC

Michael Cipriano Reporter The Pink Sheet Washington, DC

Dominic Cirincione Regulatory Counsel FDA - CDER Silver Spring, MD

Dean Cirotta President & COO EAS Consulting Group, LLC Bristol, TN

Richard Cleland Assistant Director, Bureau of Consumer

Protection, Division of Advertising

Practices

Federal Trade Commission Washington, DC

Catherine Clements Counsel, Regulatory Legal Team Eli Lilly and Company Indianapolis, IN

Leann Clymer Regulatory Affairs Aquestive Therapeutics Warren, NJ

Alexandra Cohen Attorney Advisor Department of Health & Human

Services/Departmental Appeals Board

(DAB)

Washington, DC

Ariella Cohen Associate, Health Care Products The Pew Charitable Trusts Washington, DC

Ariella Cohen Associate, Health Care Products The Pew Charitable Trusts Washington, DC

Barbara Cohen Social Science Analyst,Division of

Nonprescription Clinical Evaluation

FDA - CDER Silver Spring, MD

Jonathan Cohen Partner K&L Gates LLP

Carrie Cole Assistant Controller Food and Drug Law Institute (FDLI) Washington, DC

Sharon Coleman Regulatory Counsel FDA - CDER Silver Spring, MD

Jamie Colgin President Colgin Consulting, Inc. Moorpark, CA

Christopher Collings Partner Saul Ewing Arnstein & Lehr Miami, FL

Katherine Collins Regulatory Counsel FDA - CTP Rockville, MD

Kellie Combs Partner Ropes & Gray LLP Washington, DC

Dale Cooke President PhillyCooke Consulting Penn Valley, PA

Justin Coon Attorney, Medical Countermeasure

Systems

U.S. Army Medical Research &Materiel

Command

Fort Detrick, MD

Page 4: FDLI 2018 Annual Conference Attendee List (current as of 5 ... · First Name Last Name Job Title Company Name City and State Anna Abram Deputy Commissioner for Policy, Planning, Legislation,

Karena Cooper Director, FDA/OIP Office of Comm. &

Policy Coordination

FDA - OC Silver Spring, MD

Katherine Cooper Regulatory Counsel FDA - CBER Silver Spring, MD

Karen Corallo Of Counsel Greenberg Traurig, LLP Washington, DC

Helena Correia Vice President, Regulatory Affairs Keryx Biopharmaceuticals, Inc

Dara Corrigan Associate Commissioner for Global

Regulatory Policy

FDA - OC Silver Spring, MD

Jacqueline Corrigan-Curay Director, OMP FDA - CDER Silver Spring, MD

Gabrielle Cosel FDA - CDER Washington, DC

Thomas Cosgrove Partner Covington & Burling LLP Washington, DC

Brooke Courtney Senior Regulatory Counsel FDA - OC Silver Spring, MD

Philip Crooker Regulatory Counsel FDA - CDER Silver Spring, MD

Meghan Crowley Manager, Program Innovation Food and Drug Law Institute (FDLI) Washington, DC

Courtney Culbert Sr. Staff Scientist RAI Services Company Winston-Salem, North Carolina

Brittani Cushman External Affairs Turning Point Brands, Inc. Louisville, KY

Erin Cutts Biomedical Engineer FDA - CDRH Silver Spring, MD

James Czaban Partner DLA Piper LLP (US) Washington, DC

Christine Czarniecki Chief Of Regulatory Affairs National Institutes of Health Rockville, MD

Kavita Dada Senior Health Promotions Officer FDA - CDER Silver Spring, MD

Brian Dahl Compliance Practice Lead Officer E.M.M.A. International Consulting

Group, Inc.

Farmington Hills, MI

Mark Dahlby FDA Regulatory and Healthcare

Compliance Counsel

IBM Chicago, IL

Kristin Davenport Of Counsel Covington & Burling LLP Washington, DC

Claire Davies General Attorney FDA - OC Silver Spring, MD

Ryan Davies Georgetown University Washington, DC

Ruwanda Davis Government Information Specialist FDA - CDER Silver Spring, MD

Sugato De Principal Consultant Parexel International Corporation Silver Spring, MD

Michael de la Torre CEO FDAzilla Pleasanton, CA

Kevin Dean SVP and Life Sciences Product Manager Ironshore Insurance Services, LLC Weatogue, CT

Kris DeAngelo Student Michigan State University

John DeCarlo Executive, Watson Health Policy IBM

Robert Decker Managing Director Deloitte Consulting LLP Arlington, VA

Susan DeCorte Asset Team Leader Pfizer, Inc. Groton, CT

Inge Delfosse Director MD & Partners Brussels,

Debra Demeritt Consumer Safety Officer FDA - CDRH Silver Spring, MD

Marina Denicoff FDA - CTP Silver Spring, MD

Lesley DeRenzo Regulatory Counsel FDA - CDER Silver Spring, MD

Patricia DeSantis VP, Global Regulatory Policy Biogen, Inc. Washington, DC

Philip Desjardins Vice President, Global Regulatory Affairs

Policy & Intelligence, Medical Devices

Johnson & Johnson Washington, DC

Tricia Desmarais Attorney Law Office of Tricia Desmarais Santa Monica, CA

Jennifer Devine Vice President, Global Legal Affairs U.S. Pharmacopeia Rockville, MD

Neil DiSpirito* Of Counsel Ballard Spahr LLP Washington, DC

David Dobbins Cheif Operating Officer Truth Initiative Washington, DC

Mike Dobias Senior Associate The Pew Charitable Trusts Washington, DC

Julie Dohm Senior Science Advisor for Compounding FDA - CDER Silver Spring, MD

Mike Dohmann Georgetown University Washington, DC

Cindy Domecus No Account Hillsborough, CA

Lauren Dooley Deloitte Consulting LLP McLean, VA

Jennifer Dooren Program Manager FDA - OC Silver Spring, MD

Daniel Dormont Associate Chief Counsel Drug Enforcement Administration Springfield, VA

Heather Dorsey Attorney Advisor FDA - CDER Silver Spring, MD

Tracy Dowling Associate General Counsel Spark Therapeutics Philadelphia, PA

Scott Drenkard Director of State Projects Tax Foundation Washington, DC

Carol Drew Senior Regulatory Counsel FDA - OC Silver Spring, MD

Kayla Drogosz Regulatory Counsel FDA - CTP Silver Spring, MD

Kathryn Drzewiecki AIMBE Scholar FDA - CDRH Silver Spring, MD

Royce DuBiner Associate McGuireWoods LLP Atlanta, GA

Andrew Dufor Chemist FDA - CDRH Silver Spring, MD

Yolande Dufresne Senior Associate Torys LLP Toronto, Ontario

Ryan Durazo Business Development - CORE Latham & Watkins LLP Washington, DC

Bradley Dworak Consumer Safety Officer FDA - CBER Silver Spring, MD

Page 5: FDLI 2018 Annual Conference Attendee List (current as of 5 ... · First Name Last Name Job Title Company Name City and State Anna Abram Deputy Commissioner for Policy, Planning, Legislation,

Daniel Dwyer Partner Kleinfeld, Kaplan & Becker, LLP Washington, DC

Matthew Eckel Director, EU, Harmonization, Trade Staff FDA - OC Silver Spring, MD

Anna Edney Reporter Bloomberg News Washington, DC

Nasir Egal Head of Global Manufacturing Quality

(GMQ)

Sanofi Bridgewater, NJ

Meg Egan-Auderset Medical & Regulatory Writer Thomson Reuters Philadelphia, PA

Stacy Ehrlich** Partner Kleinfeld, Kaplan & Becker, LLP Washington, DC

Darren Eicken Regulatory Counsel FDA - CDER Silver Spring, MD

Adam Ekonomon Vice President and Deputy General

Counsel

J.M. Smucker Company Orrville, OH

Michelle Ellerbe-Williams Management Analyst FDA - CDER Silver Spring, MD

Brian Ellman Vice President Analysis Group, Inc. Boston, MA

William Elwood Intergovernmental Affairs Specialist FDA - OC Silver Spring, MD

Khair Elzarrad Deputy Director, Office of Medical Policy FDA - CDER Silver Spring, MD

Benjamin England Founder and CEO FDAImports.com, LLC/ Benjamin L.

England & Associates LLC

Glen Burnie, MD

Lorie Erikson Consumer Safety Officer FDA - CDRH Columbia, MD

Brian Erkkila Director of Regulatory Science Foundation for a Smoke-Free World

Sandra Eskin Director, Safe Food Project The Pew Charitable Trusts Washington, DC

Sandra Eskin Director, Safe Food Project The Pew Charitable Trusts Washington, DC

Denise Esposito Partner Covington & Burling LLP Washington, DC

Linda Evans O'Connor Head of Business Processes and

Regulatory

Lachman Consultants Westbury, NY

Natasha Facey Health Science Administrator FDA - CDER Silver Spring, MD

Owen Faris Clinical Trial Director, Office of Device

Evaluation

FDA - CDRH Silver Spring, MD

Matthew Farmer Corporate Counsel Sanofi Cambridge, MA

Kaitlin Farquharson Staff Attorney U.S. Government Accountability Office Washington, DC

Ciara Farrell Associate, Life Sciences Law Arthur Cox Unlimited Company Dublin,

Jeremiah Fasano Consumer Safety Officer FDA - CFSAN College Park, MD

Robin Fastenau Regulatory Counsel FDA - CDER Silver Spring, MD

Anthony Fauci Director, NIAID National Institutes of Health Bethesda, MD

Brian Feito Associate Editor International Trade Today Washington, DC

Karen Fikes Regulatory Counsel FDA - CDRH Silver Spring, MD

Rochelle Fink Senior Health Science Project Specialist FDA - CDRH Silver Spring, MD

Anne Finley President Biotech Policy Group Milwaukee, WI

Wendy Finn Director, Membership and Marketing Food and Drug Law Institute (FDLI) Washington, DC

Aliza Fishbein, MPH JD student Johns Hopkins University Baltimore, MD

Ellen Flannery Deputy Center Director for Policy, Office

of Medical Products & Tobacco, Office of

the Center Director

FDA - CDRH Washington, DC

Daniel Flint Associate McCarter & English LLP Washington, DC

Maya Florence Counsel, Health Care and Life Sciences Skadden, Arps, Slate, Meagher & Flom

LLP

Boston, MA

Nicholas Florko Reporter InSide Washington Publishers Arlington, VA

Anna Flynn Consumer Safety Officer FDA - CBER Silver Spring, MD

Carole Folmar Director, Regulatory Affairs & Associate

General Counsel

ITG Brands Greensboro, NC

Jennifer Forde Regulatory Counsel FDA - CDER Silver Spring, MD

Pamela Forrest Partner Covington & Burling LLP Washington, DC

Neal Fortin Professor and Director Michigan State University Okemos, MI

Gregory Fortsch Sr. Legal Counsel, Regulatory The Nature's Bounty Co. Ronkonkoma, NY

Jonette Foy Associate Director for Policy FDA - CDRH Silver Spring, MD

Jeffrey Francer** Senior Vice President and General

Counsel

Association for Accessible Medicines Washington, DC

Meredith Francis Deputy Director FDA - CDER Silver Spring, MD

Joseph Franklin Associate Director for Policy, Therapeutic

Biologics and Biosimilars Staff

FDA - CDER Silver Spring, MD

Page 6: FDLI 2018 Annual Conference Attendee List (current as of 5 ... · First Name Last Name Job Title Company Name City and State Anna Abram Deputy Commissioner for Policy, Planning, Legislation,

Joseph Franklin Associate Director for Policy, Therapeutic

Biologics and Biosimilars Staff

FDA - CDER Silver Spring, MD

James Fraser General Attorney FDA - OC Silver Spring, MD

Elizabeth Friedman Regulatory Counsel FDA - CDER Silver Spring, MD

Jean Frydman Partner Fox Rothschild LLP Lawrence Township, NJ

Jennifer Fuerch Domain Specialist Lead MITRE Arlington, VA

Christian Fulda Partner Jones Day Munich,

Sonja Fulmer Regulatory Counsel FDA - CDRH Silver Spring, MD

Allison Fulton Partner Sidley Austin LLP Washington, DC

John Fuson Partner Crowell & Moring LLP Washington, DC

Paul Gadiock Senior Attorney Arent Fox LLP Washington, DC

Stacy Gagosian* Managing Director of Public Policy Truth Initiative Washington, DC

Ronald Gahagan Assistant General Counsel Altria Client Services LLC Richmond, VA

Hayden Galante Educational Programs Coordin Food and Drug Law Institute (FDLI) Washington, DC

Isabella Galeano LLM Candidate Georgetown University Washington, DC

Christopher Galvin Program Analyst FDA - OIG Miami Lakes, FL

Asina Gant Associate Senior Counsel Actelion Pharmaceuticals U.S., Inc. San Francisco, CA

Heather Garecht Market Specialist-Life Sciences McDermott Will & Emery Washington, DC

Carlos Garner Vice President Eli Lilly and Company

Tara Garraty Administrative Coordinator Food and Drug Law Institute (FDLI) Rockville, MD

John Garvey Principal, Chief Executive Officer Compliance Architects LLC Hamilton, NJ

M. Katie Gates Calderon Partner Shook, Hardy & Bacon LLP Kansas City, MO

Paulette Gaynor Senior Regulatory Project Manager FDA - CFSAN College Park, MD

Shawn Gebhardt Associate Attorney Winston & Strawn LLP Chicago, IL

Cassandra George Associate General Counsel, Head of

Regulatory Law

Purdue Pharma L.P. Stamford, CT

June Germain Program Coordinator FDA - CDER Silver Spring, MD

Nazanin Ghassemian Biomedical Engineer FDA - CDRH Silver Spring, MD

Suchira Ghosh Counsel Axinn, Veltrop & Harkrider LLP New York, NY

Jeffrey Gibbs** Director Hyman, Phelps & McNamara, PC Washington, DC

Jaycie Gibney Assistant Chief Counsel FDA - OC Silver Spring, MD

Robert Giddings Attorney Hutchison PLLC Gainesville, FL

Moira Gilchrist Vice President Scientific and Public

Communications

Philip Morris International Lausanne, Switzerland

Anastasia Gilmartin Associate Attorney Ashby Law Group Seattle, WA

Derrick Gingery Reporter The Pink Sheet Rockville, MD

Joseph Gitchell President Pinney Associates, Inc. Bethesda, MD

Abraham Gitterman Associate Arnold & Porter LLP Washington, DC

Steve Glavin Senior Vice President Oxford Global Resources Chandler, AZ

Rachel Goeriz Managing Scientist Exponent, Inc. Menlo Park, CA

Kelly Goldberg Vice President, Law/Senior Counsel for

Biopharmaceutical Regulation

PhRMA Washington, DC

Rebecca Goldberg General Attorney FDA - OC Rockville, MD

Ed Golden Deloitte Consulting LLP McLean, VA

Marta Gonzalez Consumer Safety Officer FDA - CDER Silver Spring, MD

Steven Gonzalez Associate Polsinelli PC Washington, DC

Michael Goodman Associate Haynes and Boone LLP Denver, CO

Stephanie Goodwin Sr. Manager, Regulatory Affairs Nutricia North America

Andrea Gormley Pharmacist / Regulatory Counsel FDA - CDER Silver Spring, MD

Eric Gotting Partner Keller and Heckman LLP Washington, DC

Daniel Gottlieb Regulatory Counsel FDA - CDER Silver Spring, MD

Scott Gottlieb Commissioner FDA - OC Silver Springs, MD

Janet Gottlieb Executive Director, Medical

Communications

Allergan, Inc. Irvine, CA

Robyn Gougelet Senior Associate Pinney Associates, Inc. Bethesda, MD

Linda Gousis Senior Advisor, Coverage and Analysis

Group, Center for Clinical Standards and

Quality

Centers for Medicare & Medicaid

Services (CMS)

Baltimore, MD

Rubens Granja Lawyer Mattos Muriel Kestener Advogados São Paulo, Brazil

John Green Director, Contracts Legal Radius Health, Inc. Parsippany, NJ

Joyce Greenleaf Regional Inspector General FDA - OIG Boston, MA

Kate Greenwood Regulatory Counsel FDA - CDER Silver Spring, MD

Cory Gregan Policy Analyst FDA - CTP Silver Spring, MD

Jana Grieb Counsel McDermott Will & Emery Washington, DC

Rebecca Griffith Senior Marketing Counsel Unilever

Page 7: FDLI 2018 Annual Conference Attendee List (current as of 5 ... · First Name Last Name Job Title Company Name City and State Anna Abram Deputy Commissioner for Policy, Planning, Legislation,

Nicole Grimm Counsel Skadden, Arps, Slate, Meagher & Flom

LLP

Washington, DC

Danuta Gromek-Woods Senior Chemist FDA - CDER Silver Spring, MD

Melanie Gross Senior Corporate Counsel Genentech, Inc. South San Francisco, CA

Lewis Grossman Professor of Law American University Arlington, VA

Miriam Guggenheim** Partner Covington & Burling LLP Washington, DC

Robert Guidos Head, Pharmaceutical Regulatory Affairs

& Policy

Corning Inc. Washington, DC

Christopher Guiton Senior Counsel Johnson & Johnson New Brunswick, NJ

Sonali Gunawardhana Of Counsel Shook, Hardy & Bacon LLP Washington, DC

Elizabeth Guo Associate Covington & Burling LLP Washington, DC

Ji Guo Chemist FDA - CDER Silver Spring, MD

Robert Guzman Regulatory Counsel Thompson Hine LLP Washington, DC

Laura Haak Digital Coordinator Food and Drug Law Institute (FDLI) Washington, DC

J. Benneville Haas Partner Latham & Watkins LLP Washington, DC

Abeba Habtemariam Associate Arnold & Porter LLP Washington, DC

Martin Hahn Partner Hogan Lovells US LLP Washington, DC

Carol Haley Director Pfizer, Inc. New York, NY

Kimera Hall Member Frost Brown Todd LLC Dallas, TX

Ralph Hall Professor of Practice University of Minnesota Minneapolis, MN

Todd Halpern Partner Venable LLP Washington, DC

Amanda Hamilton Associate Haug Partners LLP Washington, DC

Leila Hann Science Policy Analyst FDA - CDER Silver Spring, MD

Roy Hardiman CBO Principia Biopharma Inc South San Francisco, CA

Stacy Harker Associate Director, Medical

Communications

Allergan, Inc. Irvine, CA

Carrie Harney Director, US Advocacy U.S. Pharmacopeia Rockville, MD

Ellen Hart Staff Fellow FDA - CVM Rockville, MD

Martine Hartogensis Deputy Director, Office of Surveillance

and Compliance

FDA - CVM Rockville, MD

Kim Hasili Primary Review Director AstraZeneca Pharmaceuticals Wilmington, DE

Heather Hatcher Regulatory Scientist Womble Bond Dickinson (US) LLP Winston-Salem, NC

Karen Hauda Senior Director Novo Nordisk Inc. Washington, DC

Jonathan Havens Associate Saul Ewing Arnstein & Lehr Baltimore, MD

Stephanie Havrilla Senior Instructional Designer, NSF

Medical Devices

NSF International Ann Arbor, MI

Joanne Hawana Of Counsel Mintz, Levin, Cohn, Ferris, Glovsky and

Popeo, P.C.

Washington, DC

Nancy Hayes Acting Director, Office of Regulatory

Policy

FDA - CDER Silver Spring, MD

Bryan Haynes Partner Troutman Sanders LLP Richmond, VA

Margo Heath-Chiozzi Senior Vice-President, Regulatory Affairs Celldex Therapeutics, Inc. Hampton, NJ

Lindsey Heinz Partner Shook, Hardy & Bacon LLP Kansas City, MO

Colleen Heisey Partner Jones Day Washington, DC

Michael Helbing General Attorney FDA - OC Silver Spring, MD

Laura Helbling Senior Writer Prevision Policy LLC Washington, DC

Seth Heller Axinn, Veltrop & Harkrider LLP Hartford, CT

Emily Helms Williams Regulatory Counsel FDA - CDER Silver Spring, MD

Mary Hendrickson Vice President, Regulatory Compliance &

Ethics

McKesson Corporation Irving, TX

Dennis Henigan Vice President, Legal and Regulatory

Affairs

Campaign for Tobacco-Free Kids Washington, DC

Corey Henry Manager Media Relations, Philip Morris International Washington, DC

Melissa Herbert VP Support Services Neogen Corporation Lansing, MI

Carolyn Herrmann Associate General Counsel Consumer Healthcare Products

Association (CHPA)

Washington, DC

Steven Hertz Consumer Safety Officer FDA - CDER Silver Spring, MD

Mary Hiatt Corporate Counsel Pfizer, Inc. New York, NY

Robert Hibbert Partner Morgan, Lewis & Bockius LLP Washington, DC

Gary Higginbothem Thompson Information Services Bethesda, MD

Nina Hill VP Science Policy Pfizer, Inc. New York, NY

Bethany Hills Member, Chair FDA Practice, Regulatory

and Reimbursement Attorney

Mintz, Levin, Cohn, Ferris, Glovsky and

Popeo, P.C.

New York, NY

Michael Hinckle Partner K&L Gates LLP Morrisville, NC

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Lori Hirsch* VP of Regulatory Compliance and

External Engagement

Bristol-Myers Squibb Company New Brunswick, NJ

Colleen Hittle Managing Director Navigant Consulting, Inc. Indianapolis, IN

Angela Hoague Regulatory Information Specialist FDA - CDER Silver Spring, MD

Angela Ho-Chen Senior Counsel Altria Client Services LLC Richmond, VA

Hilary Hoffman Analyst FDA - CVM Rockville, MD

Katie Hoffman Senior Manager, Public Policy &

Government Affairs

Biogen, Inc. Washington, DC

Kelsy Hoffman Regulatory Officer FDA - CBER Silver Spring, MD

Michael Hoffmann Supervisory Biomedical Engineer FDA - CDRH Silver Spring, MD

Kathleen Hoke Professor & Director, Network for Public

Health Policy and Center for Tobacco

Regulation

University of Maryland Carey School of

Law

Baltimore, MD

Elizabeth Hollis Staff Writer, BioWorld Medtech Thomson Reuters Washington, DC

Matthew Holman Director Office of Science FDA - CTP Rockville, MD

David Horowitz Partner Hogan Lovells US LLP Washington, DC

August Horvath Partner Foley Hoag LLP New York, NY

Aila Hoss Professor Indiana University School of Law -

Indianapolis

Indianapolis, IN

Sarah Hostetler Account Director SmartBrief.com Washington, DC

Christina Houck Regulatory Officer FDA - CBER Silver Spring, MD

Elizabeth Houston Regulatory Counsel FDA - CDER Silver Spring, MD

Paul Howard ADV. Commissioner Consultant FDA - OC Silver Spring, Maryland

Heather Howell Executive Vice President, Medical Device

Training

NSF International Washington, DC

James Huang Director, Food Contact Materials The Coca-Cola Company Atlanta, GA

John Huang Consumer Safety Officer FDA - CDRH Silver Spring, MD

Minerva Hughes Regulatory Counsel FDA - CDRH Silver Spring, MD

Rosanne Hurwitz Regulatory Counsel FDA - CDER Silver Spring, MD

Sana Hussain Regulatory Counsel FDA - CDER Silver Spring, MD

Emily Hussey Associate Attorney Reed Smith LLP Chicago, IL

Sunup Hwang Ph.D. Director, Medical Communications Allergan, Inc. Irvine, CA

Mehrban Iranshad Regulatory Counsel FDA - CDER Silver Spring, MD

Jeanne Ireland Principal Ireland Strategies LLC Silver Spring, MD

Robert Iser VP Parexel International Corporation Bethesda, MD

Alexandra Jabs Law Clerk FDA - OC Baltimore, MD

Erica Jackson Partner K&L Gates LLP Morrisville, NC

Peter Jaensch Regulatory Counsel FDA - CVM Rockville, MD

Gregory Jaffe Director, Biotechnology Project Center for Science in the Public

Interest

Washington, DC

Richard Jahn Director Pfizer, Inc. Collegeville, PA

William Janssen Professor of Law Charleston School of Law Charleston, SC

Daniel Jarcho Partner Alston & Bird LLP Washington, DC

Marianna Jasiukaitis Attorney Advisor Department of Health & Human

Services/Departmental Appeals Board

(DAB)

Washington, DC

David Jaworski Consumer Safety Officer FDA - CDER Silver Spring, MD

Erica Jefferson Vice President, Corporate

Communications

Dermira, Inc. Menlo Park, CA

John Jenkins Principal, Drug and Biological Products Greenleaf Health, Inc. Washington, DC

Dina Jerebitski Policy Analyst FDA - CDRH Silver Spring, MD

Kathryn Jernigan Division Counsel, Regulatory Abbott Laboratories Abbott Park, IL

Elizabeth Jex Attorney Advisor, Office of Policy

Planning

Federal Trade Commission Washington, DC

Alissa Jijon Senior Counsel, Global Legal Affairs -

Standards

U.S. Pharmacopeia Rockville, MD

Freddy Jimenez** Vice-President, Law and Compliance Celldex Therapeutics, Inc. Hampton, NJ

Karina Jimenez-Donovan FDA Tobacco Regulatory Science Fellow National Academy of Medicine Olney, MD

Aurielle Johnson Administrative Officer FDA - CDRH Silver Spring, MD

Elizabeth Johnson Principal & Founder Food Directions, LLC Shady Side, MD

Eshael Johnson SRO Branch Director FDA - CTP Silver Spring, MD

Jismi Johnson Policy Analyst FDA - CDRH Silver Spring, MD

John Johnson Senior Associate Attorney FDAImports.com, LLC/ Benjamin L.

England & Associates LLC

Columbia, MD

Matia Johnson Public Health Advisor FDA - CDRH Silver Spring, MD

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Philip Johnson Senior Director IQVIA Durham, NC

Jacquin Jones Program Management FDA - CDER Silver Spring, MD

Linda Jong Regulatory Counsel FDA - CDER Silver Spring, MD

Paul Joseph General Attorney FDA - OC Silver Spring, MD

David Joy Division Director BRP IV FDA - CDER Silver Spring, MD

Ruey Ju Acting Senior Advisor for Compounding

and Enforcement

FDA - CDER Silver Spring, MD

Christopher Juenger Consumer Safety Officer FDA - CBER Silver Spring, MD

Elizabeth Jungman Director, Public Health Programs The Pew Charitable Trusts Washington, DC

Suzanne Junod Historian FDA - OC Derwood, MD

Alexandra Jurewitz Consumer Safety Officer FDA - CFSAN College Park, MD

Ryan Kaat Senior Director, Law PhRMA Washington, DC

Christine Kain Partner Faegre Baker Daniels LLP Minneapolis, MN

Jodi Kalagher Senior Counsel Philip Morris International New York, NY

Jane Kalinina Associate Hogan Lovells US LLP Washington, DC

Sandra Kalter** Vice President and Chief Regulatory

Counsel

Medtronic Washington, DC

Jennifer Kane Manager, Policy Analysis & Stakeholder

Engagement

Altria Client Services LLC Washington, DC

Kristin Kaplan Senior Counsel Altria Client Services LLC Richmond, VA

Laura Karas Researcher, Department of Health Policy

and Management

Johns Hopkins University Baltimore, MD

George Karavetsos Partner DLA Piper LLP (US) Washington, DC

Elaine Katrivanos Policy Analyst FDA - CDRH Silver Spring, MD

Maia Kats Director of Litigation Center for Science in the Public

Interest

Washington, DC

Erin Katzelnick-Wise Director PhRMA Washington, DC

Erin Keegan Lead Reviewer FDA - CDRH

Jeremiah Kelly Attorney for Medical Product

Development & Regulation

U.S. Army Medical Research &Materiel

Command

Fort Detrick, MD

John Kendzior Attorney (Associate) Reed Smith LLP Chicago, IL

Kevin Kenny Chief Operating Officer Decernis LLC Rockville, MD

Nam Kim Director, Division of Regulatory Policy III FDA - CDER Silver Spring, MD

Stella Kim Post-doc Fellow University of Maryland Baltimore, MD

Christine Kirk Attorney Advisor FDA - CDER Silver Spring, MD

Cathy Kiss Senior Director, Meetings and

Partnerships

Food and Drug Law Institute (FDLI) Washington, DC

Sara Klein Chief Legal Officer Principia Biopharma Inc South San Francisco, CA

David Kluft Partner Foley Hoag LLP Boston, MA

Virginia Knapp Dorell General Attorney FDA - OC Silver Spring, MD

Ethan Knowlden Vice President of Legal & Compliance Medicines360 San Francisco, CA

Laura Koontz OIR/Staff Fellow FDA - CDRH Silver Spring, MD

Kimberly Koop Post-Doctoral Fellow, Global Regulatory

Affairs

Amgen Inc. Thousand Oaks, CA

Eunah Kostal Program Analyst FDA - CDER Silver Spring, MD

Sarah Kotler Division Director FDA - OC Rockville, MD

Ondrej Koumal Director Reduced Risk Products,

Corporate Affairs

Philip Morris International Washington, DC

Daniel Kracov** Partner Arnold & Porter LLP Washington, DC

Leslie Krasny Partner Keller and Heckman LLP San Francisco, CA

Stefanie Kraus Attorney-Advisor FDA - CDER Silver Spring, MD

Angela Krueger Acting Deputy Director Engineering &

Science Review

FDA - CDRH Silver Spring, MD

Nickie Kubasak Associate General Counsel Amgen Inc. Thousand Oaks, CA

Dinesh Kumar General Attorney FDA - ORA Silver Spring, MD

Areta Kupchyk partner Foley Hoag LLP Washington, DC

Anna Laakmann Of Counsel Greenberg Traurig, LLP Washington, DC

Sonya Lambkin Supervisor, Post-Market Compliance

Animal Food Team

FDA - CVM Rockville, MD

Chad Landmon Partner Axinn, Veltrop & Harkrider LLP Hartford, CT

Greg Langlois Senior Legal Editor, Healthcare and

Litigation

Bloomberg BNA Arlington, VA

Megan Larkin General Attorney FDA - OC Silver Spring, MD

Carly Larson Associate Senior Counsel Actelion Pharmaceuticals U.S., Inc. South San Francisco, California

Scott Lassman Partner Goodwin Procter LLP Washington, DC

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Sherrill Lathrop Macura Biologist FDA - CDRH Silver Spring, MD

Kelly Laudon Of Counsel Ballard Spahr LLP Minneapolis, MN

Michael Lavery Principal Piper Jaffray New York, NY

Andrew Leboeuf Regulatory Counsel FDA - CDER Washington, DC

Cailin Lechner Associate Hogan Lovells US LLP Washington, DC

Bill Lee Executive Vice President, U.S. Programs Campaign for Tobacco-Free Kids Washington, DC

Jill Lee Sr Attorney Novo Nordisk Inc. Plainsboro, NJ

Marian Lee Partner Gibson Dunn & Crutcher LLP Washington, DC

Susan Lee Partner Hogan Lovells US LLP Washington, DC

Isabelle Lefebvre VP, Regulatory Affairs Valeant Pharmaceuticals North

America

Aliso Viejo, CA

Julianna LeMieux Senior Fellow in Molecular Biology American Council on Science & Health New York, NY

Keagan Lenihan Associate Commissioner FDA - OC

Laurie Lenkel Regulatory Counsel FDA - OC Silver Spring, MD

Emily Leongini Associate Arent Fox LLP Washington, DC

Leonard Lescosky Vice President, CMC Regulatory Affairs AbbVie North Chicago, IL

Eric Lester Deputy Director Department of Health & Human

Services/Departmental Appeals Board

(DAB)

Washington, DC

Celeste Letourneau Partner Reed Smith LLP Washington, DC

Gregory Levine Partner Ropes & Gray LLP Washington, DC

David Levy Professor, Lombardi Comprehensive

Cancer Center

Georgetown University Washington, DC

Mark Levy Member Eckert Seamans Cherin & Mellott, LLC Philadelphia, PA

Suzanne Levy Friedman Associate Hogan Lovells US LLP Washington, DC

Debra Lewis Acting Director, Office of Orphan

Products Development

FDA - OC Rockville, MD

Erika Lietzan Associate Professor University of Missouri-Columbia School

of Law

Columbia, MO

Jonathan Light Assistant General Counsel Paratek Pharmaceuticals, Inc. Frazer, PA

Eric Lindblom Director, Tobacco Control and Food &

Drug Law

O'Neill Institute for National and

Global Health Law, Georgetown Law

Washington, DC

Elaine Lippmann Regulatory Counsel FDA - CDER Silver Spring, MD

Yusi Liu Managing Consultant Navigant Consulting, Inc. Washington, DC

Joy Liu** VP, Commercial and Regulatory Legal Vertex Pharmaceuticals, Inc. Cambridge, MA

Deborah Livornese Of Counsel Arnall Golden Gregory LLP Atlanta, GA

Tryggve Ljung Vice President Scientific Affairs Swedish Match Stockholm,

Toby Lowe Policy Analyst FDA - CDRH Silver Spring, MD

Ryan Lubert Regulatory Counsel FDA - CDRH Silver Spring, MD

Adela Lucero Lead Health Policy Analyst MITRE McLean, VA

Eithu Lwin Regulatory Health Project Manager FDA - CDER Silver Spring, MD

Mark Lynch Vice President, Management Parexel International Corporation North Potomac, MD

Dina Lyon Regulatory Science Student Johns Hopkins University

Bei Ma Vice President, Global Healthcare

Business Development

British Standards Institution (BSI

Group)

Herndon, VA

Suzanne Mack Associate Pepper Hamilton LLP Philadelphia, PA

Kevin Mackiw Manager, Medical Devices NSF International Washington, DC

Kevin Madagan Partner Reed Smith LLP Washington, DC

Paige Magness Altria Client Services LLC Richmond, VA

Jill Mahoney Associate Keller and Heckman LLP Washington, DC

Regina Maia Head of Corporate Communications Souza Cruz Cenro, Rio de Janeiro, RJ

John Maiers Regulatory Counsel FDA - CDRH Silver Spring, MD

Julie Maleck Compliance Analyst The TJX Companies, Inc

Stephen Maleson Attorney U.S. Army Medical Research &Materiel

Command

Frederick, MD

Brian Malkin Counsel Arent Fox LLP Washington, DC

Angela Malzahn Assistant General Counsel -Regulatory Astellas Pharma Technologies, Inc. Northbrook, Illinois

Jessica Maneval Associate Steptoe & Johnson LLP Washington, DC

Kaarish Maniar Marketing Intern Axinn, Veltrop & Harkrider LLP Hartford, CT

Joseph Manik Consumer Safety Officer FDA - CBER Silver Spring, MD

Mark Mansour Partner Foley Hoag LLP Washington, DC

Page 11: FDLI 2018 Annual Conference Attendee List (current as of 5 ... · First Name Last Name Job Title Company Name City and State Anna Abram Deputy Commissioner for Policy, Planning, Legislation,

John Manthei* Partner Latham & Watkins LLP Washington, DC

Kathie Mantine Health Science Project Manager FDA - CDER Silver Spring, MD

Christopher Mapes Associate Manager Gilead Sciences, Inc. Foster City, CA

David Markert Attorney Advisor FDA - CDER Silver Spring, MD

Peter Marks Director, Center for Biologics Evaluation

and Research

FDA - CBER Silver Spring, MD

John Marshall Director, Regulatory Communications

and Training

Altria Client Services LLC Richmond, VA

Alexandra Marzelli General Attorney FDA - OC Silver Spring, MD

Sharon Mayl Senior Advisor for Policy, Office of Foods

and Veterinary Medicine

FDA - OC Silver Spring, MD

Susan Mayne Director, Center for Food Safety and

Applied Nutrition

FDA - CFSAN College Park, MD

Michael McCaughan Editor Prevision Policy LLC Washington, DC

Marcie McClintic Coates Head of Global Policy Mylan Pharmaceuticals, Inc. Morgantown, WV

Brian McCormick Vice President & Chief Regulatory

Counsel

TEVA Pharmaceuticals USA, Inc. Horsham, PA

Jean McCue Regulatory Counsel FDA - CDER Silver Spring, MD

Michele McDonald President & Senior Consultant for

Medical Devices

Compliance Scout Chicago, IL

Madeleine McDonough Chair Shook, Hardy & Bacon LLP Kansas City, MO

Donnelly McDowell Associate Kelley Drye & Warren LLP Washington, DC

David McFarland Editor FDA Review Camp Hill, PA

Scott McFarland OIR Associate Director, Regulatory

Counsel

FDA - CDRH Silver Spring, MD

Daniel McGee General Counsel & Chief Compliance

Officer

Fontem US, Inc. Charlotte, NC

John McShane VP Quality Compliance Validant San Francisco, CA

Carlyle McWilliams SR. ADV to Commissioner FDA - OC Silver Spring, Maryland

Gregory Measer Regulatory Counsel FDA - OC Silver Spring, MD

Deidre Meehan Senior Counsel Johnson & Johnson New Brunswick, NJ

Rikin Mehta Head of Regulatory Affairs Aquestive Therapeutics Warren, NJ

Scott Melton Veterinary Medical Officer FDA - CVM Rockville, MD

Scott Melville** President and CEO Consumer Healthcare Products

Association (CHPA)

Washington, DC

Maureen Melvin Supervisor, Health Science Administrator FDA - CDER Silver Spring, MD

Lubna Merchant Deputy Director FDA - CDER Silver Spring, MD

Ingrid Mezo News Analyst Informa PLC Frederick, MD

Lisa Michels, J.D. General Counsel and Regulatory Expert Regulatory Compliance Associates Inc. Greenehaven, AZ

Christopher Mikson Partner Mayer Brown LLP Washington, DC

Douglas Miller Manager, Commercial Regulatory Affairs Bristol-Myers Squibb Company Lawrence Township, NJ

Elizabeth Miller Vice President, US Regulatory Affairs U.S. Pharmacopeia Rockville, MD

Lauren Miller Regulatory Counsel FDA - CDER Silver Spring, MD

Lisa Miller Staff Fellow FDA - CDRH Silver Spring, MD

Mollie Miller National Academy of Medicine Rockville, MD

Patricia Miller Director, Regulatory Affairs Altria Client Services LLC Richmond, VA

Thomas Miller Legal Director, Commercial Counsel Indivior Inc. North Chesterfield, VA

Lauren Milner Health Science Policy Analyst FDA - CDER Silver Spring, MD

Kim Milone Director, Regulatory Affairs and

Regulatory Attorney

Decernis LLC Houston, TX

Judit Milstein CPMS FDA - CDER silver spring, MD

Khara Minter Assistant Director, Training Programs Food and Drug Law Institute (FDLI) Washington, DC

David Mitchell Vice President of Regulatory Affairs and

Quality

Aeglea BioTherapeutics Austin, TX

Mara Mitchell Client Engagement Manager Validant San Francisco, CA

Bronwyn Mixter Reporter Bloomberg Law Arlington, VA

Roxane Modares Consumer Safety Officer FDA - CDRH Silver Spring, MD

Rachel Mohseni Regulatory Counsel FDA - CTP Silver Spring, MD

Maria Monroy-Osorio Research Associate NSF International Ann Arbor, MI

Allison Monyei Associate Ombudsman FDA - CTP Silver Spring, MD

Mi Sun Moon Commissioner Fellow FDA - OC College Park, MD

Kirsten Moore Independent Consultant with Non-Profits No Account Washington, DC

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Elizabeth Mulkey Associate Arnall Golden Gregory LLP Washington, DC

Zersha Munir Manager, Marketing Food and Drug Law Institute (FDLI) Washington, DC

Gabriel Muniz Supervisory Consumer Safety Officer FDA - ORA Miami Lakes, FL

Jose Murillo Vice President, Regulatory Affairs Altria Client Services LLC Richmond, VA

Anne Marie Murphy Practical Law Washington, DC

Joan Murphy Reporter Food Chemical News Arlington, VA

John Murphy Deputy General Counsel Biotechnology Innovation Organization Washington, DC

Ryan Murray Advisor - Global Regulatory Affairs Eli Lilly and Company Indianapolis, IN

Bill Myers Reporter FDANews Falls Church, VA

Matthew Myers President Campaign for Tobacco-Free Kids Washington, DC

Madhusoodana Nambiar Regulatory Counsel FDA - CDRH Silver Spring, MD

Asha Natarajan Associate DLA Piper LLP (US) New York, NY

Sonia Nath Associate Chief Counsel for Enforcement FDA - OC Silver Spring, MD

Kooshan Nayerahmadi Counsel Merck & Co., Inc. Whitehouse Station, NJ

Adora Ndu Executive Director, Regulatory Policy,

Research & Engagement

BioMarin Pharmaceutical Inc. Novato, CA

Kelley Nduom Regulatory Counsel FDA - CDER Atlanta, GA

Nicole Negowetti Clinical Instructor, Harvard Food Law and

Policy Clinic

Harvard Law School Cambridge, MA

Mitchell Neuhauser Vice President and Assistant General

Counsel

Reynolds American, Inc. (RAI) Winston-Salem, NC

Lisa Newberry Microbiology Branch Director FDA - ORA Bothell, WA

Wendy Ng Progam Analyst FDA - CDER Silver Spring, MD

Anthony Nguyen Senior Writer Analyst Wolters Kluwer Law & Business Riverwoods, IL

Martha Nguyen Regulatory Counsel FDA - CDER Rockville, MD

Trinh Nguyen Manager, Market Support Philip Morris International Washington, DC

Raymond Niaura Professor, Dept. of Social and Behavioral

Sciences

New York University New York City, NY

Louisa Nickerson General Attorney FDA - OC Silver Spring, MD

Pallavi Nithyanandan Pharmacologist FDA - CDER Silver Spring, MD

Karen Noonan Vice President of Global Regulatory Policy Association of Clinical Research

Organizations

Washington, DC

Amy Norris* Chief Counsel Clif Bar & Company Emeryville, CA

Jennifer Nowak Associate Holland & Knight LLP Washington, DC

Nicholas Nowakowski Attorney at Law Oakland Law Group, PLLC Farmington Hills, MI

Bianca Nunes Covington & Burling LLP Washington, DC

Joanelle O'Cleirigh Partner Arthur Cox Unlimited Company Ireland,

Elizabeth Oestreich Vice President, Regulatory Compliance Greenleaf Health, Inc. Washington, DC

Michael Ogden Senior Director of Regulatory Oversight Reynolds American, Inc. (RAI) Winston Salem, NC

Judith O'Grady Partner Pepper Hamilton LLP Washington, DC

Meredith Olearchik Vice President and Associate General

Counsel - Intellectual Property, Marketing

and Food Law

Campbell Soup Company Camden, NJ

Beth Oliva Associate Fox Rothschild LLP New York, NY

Megan Olsen Assistant General Counsel Council for Responsible Nutrition Washington, DC

Jeremy Olson Associate Alston & Bird LLP Washington, DC

Suzan Onel Partner Kleinfeld, Kaplan & Becker, LLP Washington, DC

Yetunde Oni Associate Reed Smith LLP Washington, DC

Nneka Onwudiwe Pharmacist, PRO/PE Regulatory Review

Officer

FDA - CDER Silver Spring, MD

Daniel Orr Partner Womble Bond Dickinson (US) LLP Washington, DC

Elizabeth Orr Senior Reporter Medtech Insight (formerly The Gray

and Silver Sheet)

Rockville, MD

Ryan Ortega Reviewer (Biomedical Engineer) FDA - CDRH Silver Spring, MD

Michele Oshman Director, Global Advocacy & Professional

Relations

Eli Lilly and Company Washington, DC

Jeff Overley Senior Reporter Law360 New York, NY

Laura Leigh Oyler Senior Director Policy & Advocacy RAI Services Company Winston-Salem, NC

Monica Pagan Motta Team Leader FDA - CDRH Silver Spring, MD

Tiffany Palmer Biomedical Engineer FDA - CDRH Silver Spring, MD

Julie Paluch Principal Paluch Law. P.C. Los Angeles, CA

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Francis Palumbo** Professor and Executive Director University of Maryland School of

Pharmacy

Baltimore, MD

Abhijit Pangu Director, US Regulatory Affairs Ferring Pharmaceuticals, Inc. Parsippany, NJ

Carolina Panico Commissioner Fellow FDA - OC Silver Spring, MD

Stuart Pape Shareholder, Practice Chair Polsinelli PC Washington, DC

Imelda Paredes FDA - CTP Silver Spring, MD

Glen Park Executive Director, Regulatory Affairs &

Quality Assurance

Scynexis, Inc. Jersey City, NJ

Lisa Parks VP of Sciences and Regulatory Affairs Association for Accessible Medicines Washington, DC

Priscilla Pastrana Consumer Safety Officer FDA - CBER Silver Spring, MD

Archita Patel Pharmacist FDA - CDER

Bakul Patel Associate Director for Digital Health FDA - CDRH Silver Spring, MD

Dharmesh Patel Policy Analyst FDA - CDRH Silver Spring, MD

Neha Patel Associate Arnold & Porter LLP Washington, DC

Rinku Patel Program Management FDA - CDER Silver Spring, MD

Natasha Pattanshetti Manager, Regulatory Policy American Academy of Dermatology

Suzanne Pattee Regulatory Counsel FDA - CDER Silver Spring, MD

Dinesh Patwardhan Supervisory Chemist FDA - CDRH Rockville, MD

Sudhanshu Patwardhan Senior International Engagement

Manager

British American Tobacco London, England

William Paulson Editor In Chief International Pharmaceutical Quality Bethesda, MD

Anthony Pavel Senior Food Lawyer Cargill, Inc. Washington, DC

Vasum Peiris Medical Officer FDA - CDRH Silver Spring, MD

Rodrigo Perez Biomedical Engineer FDA - CDRH Silver Spring, MD

Jeannie Perron* Partner Covington & Burling LLP Washington, DC

John Pinney President Pinney Associates, Inc. Bethesda, MD

Vivek Pinto Supervisory Mechanical Engineer FDA - CDRH Silver Spring, MD

Raqiyyah Pippins Counsel Arnold & Porter LLP Washington, DC

Greg Pishko Policy Analyst FDA - CDRH Silver Spring, MD

Peter Pitts President Center for Medicine in the Public

Interest

New York, NY

Anne Marie Polak Senior Director Leavitt Partners, LLC Washington, DC

Vernessa Pollard Partner McDermott Will & Emery Washington, DC

Carlos Pontes Gantois Journalist JOTA

Rachael Pontikes Partner Reed Smith LLP Chicago, IL

Gerard Porreca VP QRM C.R. Bard, Inc. Murray Hill, NJ

Julia Post Associate Covington & Burling LLP Washington, DC

Paul Price Regulatory Officer National Institutes of Health Rockville, MD

Marco Quina Partner Foley Hoag LLP Boston, MA

Julie Rachlin Director of Marketing Thompson Information Services Bethesda, MD

Lisa Rachlin Associate Director & Corporate Counsel Vertex Pharmaceuticals, Inc. Boston, MA

Girish Ramachandran Staff Fellow FDA - CBER Silver Spring, MD

Reena Raman Regulatory Counsel FDA - CDER Silver Spring, MD

Sesquile Ramon Director, Science and Regulatory Affairs Biotechnology Innovation Organization washington, DC

Rashmi Rawat Microbiologist FDA - CDER Silver Spring, MD

Uta Rawson General Attorney FDA - OC Silver Spring, MD

Rama Rayavarapu Commissioner's Fellow FDA - OC Silver Spring, MD

Fatemeh Razjouyan Associate Director, Regulatory Policy Becton Dickinson (BD) Washington, DC

Daniel Reed Regulatory Counsel FDA - CTP Silver Spring, MD

Teresa Reguly Partner Torys LLP Toronto, ON

Abraham Rein Principal, White Collar Group Post & Schell, P.C. Philadelphia, PA

Judy Rein Director of Publications Food and Drug Law Institute (FDLI) Washington, DC

Heather Rennie Executive Director, Legal Merck & Co., Inc. North Wales, PA

Sumaiya Reza Client Engagement Manager Validant San Francisco, CA

Robert Rhoades** Managing Partner Validant San Francisco, CA

Constance Richard-Math Director in the Compliance Practice Lachman Consultants Westbury, NY

Elizabeth Richards Associate Latham & Watkins LLP Washington, DC

Elizabeth Richardson Director, Health Care Products Project The Pew Charitable Trusts Washington, DC

Amy Rick** President and CEO Food and Drug Law Institute (FDLI) Washington, DC

Karen Riley Senior Advisor, Office of External Affairs FDA - OC Silver Spring, MD

Margaret Riley** Professor, School of Law University of Virginia Charlottesville, VA

Page 14: FDLI 2018 Annual Conference Attendee List (current as of 5 ... · First Name Last Name Job Title Company Name City and State Anna Abram Deputy Commissioner for Policy, Planning, Legislation,

Jacintha Roberts Director dicentra Davie, FL

Megan Robertson Associate Epstein Becker & Green, PC Washington, DC

Eric Rogers Global Head, Regulatory and

Development Law

Alcon Laboratories, Inc. Fort Worth, TX

Hannah-Alise Rogers Attorney Advisor Department of Health & Human

Services/Departmental Appeals Board

(DAB)

Washington, DC

Sarah Roller Partner Kelley Drye & Warren LLP Washington, DC

William Rose Associate Axinn, Veltrop & Harkrider LLP Washington, DC

Sydney Rosebraugh Regulatory Counsel FDA - CDER Silver Spring, MD

Lee Rosebush Partner BakerHostetler Washington, DC

David Rosen Partner Foley & Lardner LLP Washington, DC

Jennifer Ross Regulatory Counsel FDA - OC Silver Spring, MD

Lauren Roth Senior Advisor to the Chief FDA - OC Silver Spring, MD

Sara Rothman Senior Policy Advisor, Office of

Unapproved Drugs and Labeling

Compliance

FDA - CDER Silver Spring, MD

Karen Rothschild Regulatory Counsel FDA - CDER Silver Spring, MD

Zachary Rothstein Associate Vice President, Technology &

Regulatory Affairs

AdvaMed Washington, DC

David Roza Associate FDA Week Arlington, VA

Toam Rubinstein Associate Reed Smith LLP Washington, DC

Coretta Saadu Consumer Safety Officer FDA - CDER Silver Spring, MD

Anindita Saha Director, External Expertise and

Partnerships

FDA - CDRH Silver Spring, MD

Schevon Salmon Associate Attorney FDAImports.com, LLC/ Benjamin L.

England & Associates LLC

Glen Burnie, MD

Paige Samson Assistant Director, Educational Programs Food and Drug Law Institute (FDLI) Washington, DC

Marc Sanchez FDA & USDA Regulatory Attorney Contract In-House Counsel &

Consultants, LLC

Charlotte, NC

Michael Santalucia Vice President Global Regulatory Affairs Terumo BCT, Inc. Lakewood, CO

Kathleen Sanzo Partner Morgan, Lewis & Bockius LLP Washington, DC

Jason Sapsin Counsel Faegre Baker Daniels LLP Boulder, CO

Ana Lucia Saraiva Scientific Affairs Manager Souza Cruz Centro, Rio de Janeiro, RJ

Allen Sayler Senior Director of Food Consulting

Services

EAS Consulting Group, LLC Alexandria, VA

Melissa Scales Assistant Director, Educational Programs Food and Drug Law Institute (FDLI) Washington, DC

Mark Scallon Sr. Principal IQVIA Richmond, VA

Rick Scarpello CEO and Founder MC Management LLC Denver, CO

Barry Schaevitz Partner Fox Rothschild LLP New York, NY

Jennifer Scharpf Associate Director for

Policy/OBRR/CBER/FDA

FDA - CBER Silver Spring, MD

Marc Scheineson Partner Alston & Bird LLP Washington, DC

Cassie Scherer* Principal Legal Counsel, Corporate Legal

Regulatory

Medtronic Washington, DC

Lowell Schiller SR. Counselor to the Commissioner FDA - OC Silver Spring, Maryland

Lanny Schimmel General Counsel, North America Kerry, Inc.

Jodi Schipper Regulatory Counsel FDA - CDER Silver Spring, MD

Cynthia Schnedar Executive Vice President, Regulatory

Compliance

Greenleaf Health, Inc. Washington, DC

Daniel Schultz Principal, Medical Devices & Combination

Products

Greenleaf Health, Inc. Washington, DC

William Schultz* Partner Zuckerman Spaeder LLP Washington, DC

Brooke Schumm President and Principal Daneker, McIntire, Schumm Baltimore, MD

Shane Schwartz In House Legal/Legal Affairs Otsuka America Pharmaceutical, Inc. Reisterstown, MD

Suzanne Schwartz Associate Director for Science and

Strategic Partnerships

FDA - CDRH Silver Spring, MD

Melicia Seay Program Specialist FDA - OIG Washington, DC

Richard Sellers Senior Vice President of Public Policy and

Education

American Feed Industry Assn Arlington, VA

Daniello Sepe Advisory Consultant Deloitte Consulting LLP McLean, VA

Juan Serrano Leets Partner Sanchez Devanny Mexico City,

Page 15: FDLI 2018 Annual Conference Attendee List (current as of 5 ... · First Name Last Name Job Title Company Name City and State Anna Abram Deputy Commissioner for Policy, Planning, Legislation,

Jesse Sevcik Sr. Director, Global Government Affairs,

Elanco Animal Health

Eli Lilly and Company Indianapolis, IN

Anuj Shah Regulatory Counsel FDA - CDER Silver Spring, MD

Nisha Shah Regulatory Counsel FDA - CDER Silver Spring, MD

Shrina Shah Regulatory Affairs Senior Associate Gilead Sciences, Inc. Foster City, CA

Shaila Shaheed Project Manager FDA - OC Silver Spring, MD

Samir Shaikh Operations Research Analyst FDA - OC Silver Spring, MD

Umang Shastri Senior Counsel Johnson & Johnson New Brunswick, NJ

Keo Shaw Associate, Intellectual Property Baker & McKenzie Washington, DC

Lance Shea Partner BakerHostetler Washington, DC

Carol Sheets Consumer Safety Officer FDA - CDRH Silver Spring, MD

Deborah Shelton Partner McCarter & English LLP Washington, DC

Carmen Shepard Senior Vice President, Global Policy &

Regulatory Counsel

Mylan Pharmaceuticals, Inc. Washington, DC

Nathan Shiu Regulatory Counsel FDA - CDER Silver Spring, MD

Comyar Shoghi Regulatory Counsel FDA - CDER Silver Spring, Maryland

Anne Showalter GlaxoSmithKline Durham, NC

Patricia Shrader Senior Counsel Hogan Lovells US LLP Baltimore, MD

Jeffrey Shuren Director, Center for Devices and

Radiological Health

FDA - CDRH Silver Spring, MD

Faraz Siddiqui Associate Sidley Austin LLP Washington, DC

Bruce Silverglade Principal Olsson Frank Weeda Terman Matz PC Washington, DC

Joshua Silverstein Policy Analyst FDA - CDRH Silver Spring, MD

Laura Sim Senior Counsel Amgen Inc. Washington, DC

J.B. Simko VP & Associate General Counsel Philip Morris International New York, NY

Christine Simmon Executive Director, Biosimilars Council

and Senior Vice President, Policy &

Strategic Alliances

Association for Accessible Medicines Washington, DC

Kathy Simpson Vice President, Quality and Regulatory NxThera, Inc Maple Grove, MN

Michele Sinoway Manager Lachman Consultants Westbury, NY

Grail Sipes Director, Office of Regulatory Policy FDA - CDER Silver Spring, MD

Sanjay Sitlani Regulatory Counsel, Office of Regulatory

Policy

FDA - CDER Silver Spring, MD

Howard Sklamberg Partner Akin Gump Strauss Hauer & Feld LLP Washington, DC

Tara Sklar Professor of Health Law and Director of

Graduate Health Sciences Programs

University of Arizona

Nicole Smith Senior Johnson & Johnson New Brunswick, NJ

Steven Solomon Director, Center for Veterinary Medicine FDA - CVM Silver Spring, MD

Valerie Solomon Managing Counsel, R&D and Regulatory RAI Services Company Winston Salem, NC

Cassandra Soltis Corporate Counsel Starbucks Corporation Seattle, WA

James Solyst Vice President, Federal Regulatory Affairs Swedish Match North America Severna Park, MD

Susan Souder Sr. Director, Compliance Operations &

Strategy

Jazz Pharmaceuticals, Inc. Philadelphia, PA

Constance Soves Policy Analyst FDA - CDRH Silver Spring, MD

David Spangler Senior Vice President, Policy & General

Counsel & Secretary

Consumer Healthcare Products

Association (CHPA)

Washington, DC

Amy Speros Associate Latham & Watkins LLP Washington, DC

Anne Spiggle Of Counsel Polsinelli PC Washington, DC

Robert Spiller Contract Instructor (in FDA Law) No Account Penn Laird, VA

Christian Springer Associate Foley Hoag LLP Washington, DC

Nancy Stade Partner Sidley Austin LLP Washington, DC

Sarah Stec Associate Squire Patton Boggs LLP Washington, DC

Edward Steele Chairman & CEO EAS Consulting Group, LLC Alexandria, VA

Kathryn Stein Senior Manager Deloitte Consulting LLP McLean, VA

Julie Steinberg Senior Legal Editor BNA, Inc. Arlington, VA

Laurie Sternberg Supervisory, Regulatory Counsel FDA - CTP Rockville, MD

Sarah Stewart General Attorney FDA - OC Silver Spring, MD

Kerri Stone Associate Director IQVIA Durham, NC

Andrew Storey Vice President, Global Regulatory

Strategy

AbbVie North Chicago, IL

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Jur Strobos Partner Baker & McKenzie Washington, DC

Emily Strunk Associate Mayer Brown LLP Washington, DC

Elizabeth Stutts Attorney No Account Maidens, VA

Ted Sullivan Partner Quarles & Brady LLP Washington, DC

Leslie Sussan Deputy Chair Department of Health and Human

Services

Washington, DC

Jolyda Swaim Principal Olsson Frank Weeda Terman Matz PC Washington, DC

Ronald Swann Supervisory Consumer Safety Officer,

ASDB, DMQ

FDA - CDRH Silver Spring, MD

Ike Swetiltz Washington Correspondent STAT News Boston, MA

Brian Sylvester Special Counsel Wiley Rein LLP Washington, DC

Joyce Taber Senior Counsel Actelion Pharmaceuticals U.S., Inc. San Francisco, CA

Peter Tabor Vice President, Regulatory &

International Affairs

Pet Food Institute Washington, DC

Xiaorui Tang Senior Lead Reviewer FDA - CDRH Silver Spring, MD

Peter Taschenberger Senior Counsel FDA - OIG Cheverly, MD

Dana Tasic Manager, Regulatory Operations Intuitive Surgical Inc. Sunnyvale, CA

Anne Taylor REGULATORY COUNSEL FDA - CVM

Isabel Tejero Consumer Safety Officer FDA - CDRH Silver Spring, MD

Marinka Tellier Director of Regulatory Affairs, Pharma

Biotech

NSF International Washington, DC

Adaeze Teme Regulatory Counsel FDA - CDRH Silver Spring, MD

Eva Temkin General Attorney FDA - CDER Silver Spring, MD

Stuart TenHoor President Stuart TenHoor Legal Search Columbia, MD

Nikhil Thakur Program Manager FDA - CDER Silver Spring, MD

Jennifer Thomas Interim Director for FSMA Operations FDA - CFSAN College Park, MD

Julia Tierney* Senior Policy Advisor for Strategic

Planning and Legislation

FDA - CBER Silver Spring, MD

Lindsay Tobias Policy Analyst FDA - CTP Silver Spring, MD

Mark Tobolowsky Attorney Fox Kiser Washington, DC

Sharon Tonetta Vice President, Regulatory Affairs Bausch & Lomb, Incorporated Madison, NJ

Dennis Tosh Managing Editor Thompson Information Services Bethesda, MD

Maryll Toufanian Acting Director, Office of Generic Drug

Policy

FDA - CDER Silver Spring, MD

Jennifer Tran Sr. Manager, Medical Communications Allergan, Inc. Irvine, CA

Suzanne Trigg Partner Haynes and Boone LLP Dallas, TX

Ian Trimble Associate Norton Rose Fulbright Canada LLP Toronto, Ontario

Joi True Assistant General Counsel, Specialist Genentech, Inc. South San Francisco, CA

Whitney Tull Senior Director, Government Affairs Zimmer Biomet New York, NY

Rachel Turow Executive Counsel ? Regulatory Law TEVA Pharmaceuticals USA, Inc. Washington, DC

Lynn Tyler Partner Barnes & Thornburg LLP Indianapolis, IN

Robyn Tyler Lead Regulatory Counsel FDA - CDER Silver Spring, MD

Steve Usdin Senior Editor BioCentury Washington, DC

Mark Vaders Counsel Womble Bond Dickinson (US) LLP Winston Salem, NC

James Vail Director of Business Development 22nd Century Group, Inc.

Riette van Laack Director Hyman, Phelps & McNamara, PC Washington, DC

LieAnn Van-Tull Regulatory Counsel FDA - CTP Silver Spring, MD

Alexander Varond Associate Goodwin Procter LLP Washington, DC

Leticia Vazquez Santos RRP Regulatory Initiatives Manager Japan Tobacco International

Megan Velez Senior Policy Advisor FDA - OC Rockville, MD

Domenic Veneziano Independent Advisor for Import

Operations

EAS Consulting Group, LLC Alexandria, VA

Vitolis Vengris Veterinary Medical Officer FDA - CVM Rockville, MD

Laura Venker Associate McGuireWoods LLP Washington, DC

Sarah Venti Regulatory Counsel FDA - CDER Silver Spring, MD

Leigh Verbois Assistant Commissioner for International

Programs (Acting)

FDA - OC Silver Spring, MD

Cid Vianna Postdoc student STAT Rio de Janeiro, RJ

Denizar Vianna Araujo Postdoc student STAT Rio de Janeiro, RJ

Todd Vinson Associate Director & Associate General

Counsel

The Procter & Gamble Company Cincinnati, OH

Chelsea Virgile Commissioner's Fellow FDA - CDRH Silver Spring, MD

Kavita Vyas Chemist FDA - CDER Silver Spring, MD

Carrie Wade Director of Harm Reduction Policy and

Senior Fellow

R Street Institute Washington, DC

Page 17: FDLI 2018 Annual Conference Attendee List (current as of 5 ... · First Name Last Name Job Title Company Name City and State Anna Abram Deputy Commissioner for Policy, Planning, Legislation,

Jeffrey Walker CEO Teton Regulatory Sciences Jackson, WY

Todd Walker Senior Vice President Government Affairs Altria Client Services LLC Washington, DC

Anne Walsh Director Hyman, Phelps & McNamara, PC Washington, DC

Beth Wang Reporter InSide Washington Publishers Arlington, VA

Felicia Wang Associate Guest Checkout Account FDLI Store

Erin Warren Associate General Counsel, Fontem

VenturesAndrew Wasson Partner Haug Partners LLP New York, NY

Keith Watson Regulatory Counsel FDA - CTP Silver Spring, MD

Sara Beth Watson Of Counsel Steptoe & Johnson LLP Washington, DC

Kent Watts Project Manager, Brand Marketing,

Cigars

ITG Brands Greensboro, NC

Jill Wechsler Washington Editor Pharmaceutical Executive Magazine Chevy Chase, MD

Janice Weiner Regulatory Counsel FDA - CDER Silver Spring, MD

John (Barr) Weiner Associate Director for Policy and Product

Classification Officer

FDA - OC Silver Spring, MD

Mary Wen Policy Analyst FDA - CDRH Silver Spring, MD

Alexis Wermuth Ethics & Compliance Officer Fresenius Medical Care Waltham, MA

Michael Werner* Partner Holland & Knight LLP Washington, DC

Amy Westergren Associate Cooley LLP New York, NY

Celeste Wheeler Associate Kleinfeld, Kaplan & Becker, LLP Washington, DC

Valerie Whipp Supervisory Consumer Safety Officer FDA - ORA Rockville, MD

Lee Whitener Consumer Safety Officer FDA - CDRH Silver Spring, MD

Ryan Wick Philip Morris International

Elizabeth Wille Policy Analyst FDA - CDRH Silver Spring, MD

Chalana Williams Associate Crowell & Moring LLP Washington, DC

Cheyenne Williams Manager, Meetings Food and Drug Law Institute (FDLI) Washington, DC

Erin Williams CTH Portfolio Mgr, FDA MITRE McLean, VA

Michael Williams Sr Corporate Counsel Regeneron Pharmaceuticals, Inc. Rensselaer, NY

Susan Williams General Attorney FDA - OC Silver Spring, MD

Gregory Wilson Director, Regulatory Affairs Altria Client Services LLC Richmond, VA

Matthew Winters Partner Peterson Wilmarth and Robertson, LLP

(PWR)

Washington, DC

Carolina Wirth Counsel Porzio, Bromberg & Newman, P.C. Washington, DC

James Wise Senior Vice President Height Capital Markets Washington, DC

Alexander Wohl Writer Editor FDA - OC Silver Spring, MD

Benjamin Wolf Associate Keller and Heckman LLP Washington, DC

Kelly Wood Global Compliance Manager Fontem US, Inc.

Rebecca Wood Chief Counsel FDA - OC Silver Spring, MD

Janet Woodcock Director, Center for Drug Evaluation and

Research

FDA - CDER Silver Spring, MD

Mark Yacura Partner Quarles & Brady LLP Washington, DC

Peter Yang Policy Analyst FDA - CDRH Silver Spring, MD

Tony Yang National Academy of Medicine Washington, DC

Zimu Yang Associate Sidley Austin LLP Washington, DC

Maheeta Yelamanchi Regulatory Counsel FDA - CTP Silver Spring, MD

Susan Yim Board Member Department of Health & Human

Services/Departmental Appeals Board

(DAB)

Washington, DC

Gary Yingling Senior Counsel Morgan, Lewis & Bockius LLP Washington, DC

William Yoder Partner Shook, Hardy & Bacon LLP Washington, DC

Aaron Young Attorney Advisor FDA - CDER Silver Spring, MD

Christina Young Consultant King & Spalding LLP Washington, DC

Donna Young Senior Reporter, Healthcare S&P Global News Washington, DC

Johnny Yu Managing Director Deloitte Consulting LLP McLean, VA

Andrew Zacher General Attorney FDA - OC Silver Spring, MD

Alyse Zadalis Associate Shook, Hardy & Bacon LLP Kansas City, MO

Andrew Zaman Corporate Affairs Philip Morris International Lausanne,

Mitchell Zeller Center Director FDA - CTP Silver Spring, MD

Michael Zercher VP Global Business Development 22nd Century Group, Inc. Buffalo, NY

Rebekah Zinn Biologist FDA - OC Silver Spring, MD

Olivia Ziolkowski Regulatory Counsel FDA - CDER Silver Spring, MD

Frances Zipp President Lachman Consultants Westbury, NY

David Zook Partner Faegre Baker Daniels Consulting Washington, DC

*Member, Conference Planning Committee

Page 18: FDLI 2018 Annual Conference Attendee List (current as of 5 ... · First Name Last Name Job Title Company Name City and State Anna Abram Deputy Commissioner for Policy, Planning, Legislation,

**Member, FDLI Board of Directors