FDLI 2018 Annual Conference Attendee List (current as of 5 ...

[Pages:18]First Name

Last Name

Anna

Abram

Issa Mahmoud David Shawnte Jill Jenny Sara Janet

Abuaita Abuelroos Adams Adams Adleberg Agila Sefen Aguel Aho

Hazel

Aker

Carolyn Meg Alexander Ferdous

Alenci Alexander Alfano Al-Faruque

Meghna Grabriel Diana Kathleen Margaret Robert Charles Yvette Steven Emilio

Alimchandani Alves Amador-Toro Anderson Anderson Anderson Andres Appleby Armstrong Arocho

Amy Debra Donald Kalah Deborah

Arthur Asay Ashley Auchincloss Autor

Katlin Joseph Lauren Luciana Meaghan

Backfield Baglieri Baham Bahia Bailey

Laura Kristin Frederick Scott Germana

Bailis Ball Ball** Ballin Barba

Rose Sarah Kenita

Barbella Barkow Barrow

Clive Erica

Bates Battaglia

Jeannie Virginia

Nathan Andrew Carolyn Donald Dan

Baumann Beakes-Read

Beaver Becher Becker Becker Bellingham

FDLI 2018 Annual Conference

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

Job Title

Company Name

Deputy Commissioner for Policy,

FDA - OC

Planning, Legislation, and Analysis

Corporate Counsel

Fumari, Inc.

Sr. Systems Integration Consultant

Deloitte Consulting LLP

Principal

Adams Law

Supervisory Regulatory Counsel

FDA - CTP

Congressional Affairs Specialist

FDA - OC

Lead Consumer Safety Officer

FDA - CDER

Policy Analyst

FDA - CDRH

VP, Regulatory Affairs & Product Safety, MANE

Flavors

Senior Vice President and General

Dermata Therapeutics, LLC

Counsel

Associate

Duane Morris LLP

EVP

Syneos Health

Associate

Axinn, Veltrop & Harkrider LLP

Reporter

Medtech Insight (formerly The Gray

and Silver Sheet)

Medical Officer

FDA - CBER

Journalist

Folha de S.Paulo

Pharmaceutical Division Director

FDA - ORA

Deputy Director, OUDLC

FDA - CDER

Managing Director

Deloitte Consulting LLP

Division Counsel

AbbVie

Associate

Wilson Sonsini Goodrich & Rosati

PMO Lead Software Medical Devices

Pfizer, Inc.

Independent Advisor

EAS Consulting Group, LLC

Director, Technology and Digital Strategy Food and Drug Law Institute (FDLI)

City and State Silver Spring, MD

San Diego, CA McLean, VA Potomac, MD Silver Spring, MD Silver Spring, MD Silver Spring, MD Silver Spring, MD Lebanon, OH

Santa Fe, NM

Boston, MA New York, NY Hartford, CT Rockville, MD

Silver Spring, MD S?o Paulo, Brazil Parsippany, NJ Rockville, MD Arlington, VA North Chicago, IL Washington, DC Richmond, VA Naples, FL Washington, DC

Operations Marketing Director Director, Office of Compliance

SVP/Head of Strategic Global Quality & Regulatory Policy Principal Law Clerk Regulatory Counsel post-doc student Executive Director, NSF Medical Devices

Harm Reduction Therapeutics Deloitte Consulting LLP FDA - CDER Greenleaf Health, Inc. Mylan Pharmaceuticals, Inc.

Backfield PLLC Summit County Juvenile Court FDA - CFSAN STAT NSF International

Philadelphia, PA Silver Spring, MD Silver Spring, MD Washington, DC

Washington, DC Hudson, OH College Park, MD Rio de Janeiro, RJ Washington, DC

General Attorney Consumer Safety Officer Partner Tobacco and Health Policy Consultant Vice President Regulatory Strategy & Engagement Principle Lead Consumer Safety Officer Senior Corporate Attorney

FDA - OC FDA - CDER Duane Morris LLP No Account Philip Morris International

Silver Spring, MD Silver Spring, MD Boston, MA Washington, DC Lausanne, Switzerland

Law Offices of Rosemarie Barbella FDA - CDER Otsuka America Pharmaceutical, Inc.

Milford, NJ Silver Spring, MD Rockville, MD

Director

Counterfactual Consulting Limited

Divisional Vice President & Associate Abbott Laboratories

General Counsel, Legal Regulatory &

Compliance

Reporter

Bloomberg Law

Executive Director, Global Regulatory and Amgen Inc.

R&D Policy

Partner

Foley & Lardner LLP

General Attorney

FDA - OC

Director, OUDLC

FDA - CDER

Assistant General Counsel

Turning Point Brands, Inc.

Policy Analyst

FDA - CDER

London, England Abbott Park, IL

Arlington, VA Chevy Chase, Maryland

Washington, DC Silver Spring, MD Silver Spring, MD Louisville, KY Silver Spring, MD

Carol

Heather Linda

Gary Eitan Ilisa

James Aruni

Stephanie Barbara

Benjamin Ivan Erica Cherron

Sarah

Bronwen David

Janet

Michael George

Susan Brigid DeCoursey Frances

Matt

Jennifer Jennifer

Tiffany Kyle

Bennett

Bennett Bentley

Bergman Bernstein Bernstein

Bertram Bhatnagar

Billings Binzak Blumenfeld Bishop Blackwell Blake Payne Blakely

Blankstein

Blass Bloch

Bloom

Blume Bogart

Bond Bondoc

Bormel

Bowen

Boyd Bragg**

Branch Brierly

M. Jason Elizabeth Laura Mark Nathan

Regina Leah Kristiana Marissa Kurt Shelby Cathy Lauren Brian Vanessa Marcy

Cynthia Kristan Khatereh

Jeannie

Brooke Brown Brown Brown Brown

Brown Brownlee Brugger Brykman Buechle Buettner Burgess Burke Burns Burrows Busch

Cabrera Callahan Calleja

Cameron

Deputy Director, Office of Regulatory Policy General Attorney Member

Practice Director Associate Deputy Director, Office of Compliance

FDA - CDER

Silver Spring, MD

FDA - OC

Silver Spring, MD

Mintz, Levin, Cohn, Ferris, Glovsky and Boston, MA

Popeo, P.C.

Oxford Global Resources

Chandler, AZ

Latham & Watkins LLP

Washington, DC

FDA - CDER

Silver Spring, MD

Policy Analyst Professor of Medicine and Distinguished University Scholar Compliance Analyst Partner

FDA - CDRH University of Louisville

The TJX Companies, Inc Buchanan Ingersoll & Rooney PC

Silver Spring, MD Louisville, KY

Marlborough, MA Washington, DC

Interdisciplinary Scientist/Pharmacist Regulatory Counsel Regulatory Counsel Acting Deputy Director for Quality and Clinical Affairs Associate Director & Corporate Counsel

FDA - CDER FDA - CTP FDA - CDRH FDA - CDRH

Vertex Pharmaceuticals, Inc.

Silver Spring, MD Silver Spring, MD Silver Spring, MD Silver Spring, MD

Boston, MA

General Attorney Principal Legal Counsel, Corporate Legal Regulatory Sales and Marketing Specialist

Partner Senior Attorney

FDA - CDER Medtronic

Silver Spring, MD Washington, DC

E.M.M.A. International Consulting Farmington Hills, MI

Group, Inc.

Venable LLP

Washington, DC

U.S. Government Accountability Office Washington, DC

Vice President, Regulatory Affairs FDA Regulatory Associate

Kerry, Inc. Sidley Austin LLP

Beloit, Wisconsin Washington, DC

Director, Division of Prescription Drugs, OUDLC Program Management & Analysis Staff (PMAS)

Partner

Director Presidential Management Fellow

Director GENERAL ATTORNEY Director, Educational Programs Chair FDA & Life Sciences Practice Partner

FDA - CDER

Rockville, MD

FDA - OC

Silver Spring, MD

Chr. Hansen

Milwaukee, WI

Skadden, Arps, Slate, Meagher & Flom Washington, DC

LLP

FDA - OC

Silver Spring, MD

Department of Health & Human

Washington, DC

Services/Departmental Appeals Board

(DAB)

Navigant Consulting, Inc.

Washington, DC

FDA - OC

Silver Spring, MD

Food and Drug Law Institute (FDLI) Washington, DC

King & Spalding LLP

Washington, DC

Akin Gump Strauss Hauer & Feld LLP Washington, DC

Consumer Safety Officer Of Counsel Regulatory Counsel Regulatory Counsel Associate Associate Partner Coordinator, Membership Chief Executive Officer Historian Acting Special Assistant to the Deputy Commissioner President International Relations Specialist Senior Vice President, Technology and Regulatory Affairs Managing Director - JCIC

FDA - CDER Squire Patton Boggs LLP FDA - CDER FDA - CDER Kilyk & Bowersox, PLLC McDermott Will & Emery Alston & Bird LLP Food and Drug Law Institute (FDLI) Validant FDA - OC FDA - OC

The Cating Group FDA - OC AdvaMed

JCIC International

Silver Spring, MD Cleveland, OH Silver Spring, MD Silver Spring, MD Vienna, VA Washington, DC Washington, DC Washington, DC Framingham, MA Silver Spring, MD Silver Spring, MD

Hallandale, FL Silver Spring, MD Washington, DC

London, England

Jose Arthur

Campos Vargas Caplan

Melissa Massimo Coleen Hayley Carla Krista Marcus

Anthony Cynthia David

Andrea Andrew

Card-Abela Cardinali Carney Carpenter Cartwright* Carver Cato

Cea Cecil Ceryak

Chamblee Chang

Michelle Glen Tien

David Mantej

Loretta

Mary Ann Lee Shovaughn Atiq Azim Katherine Charlotte Julie Katherine

Michael Dominic Dean Richard

Chavis Cheng Cheng

Chesney Chhina

Chi

Chirba Chirtel Chism Chowdhury Chowdhury Chowdhury Christin Chronis Ciambrone

Cipriano Cirincione Cirotta Cleland

Catherine Leann Alexandra

Clements Clymer Cohen

Ariella Ariella Barbara

Jonathan Carrie Sharon Jamie Christopher Katherine Kellie Dale Justin

Cohen Cohen Cohen

Cohen Cole Coleman Colgin Collings Collins Combs Cooke Coon

Partner Drs. William F. and Virginia Connolly Mitty Professor of Bioethics and Founding Director, Division of Medical Ethics Associate Director/Professor Senior Regulatory Affairs Manager

Director of Operations Director, Federal Affairs Partner Senior Regulatory Health Project Manager Executive Vice President Senior Editor, PMTA Submissions Sr. Director - Assistant General Counsel, Regulatory Legal Team Regulatory Counsel Vice President, Quality and Regulatory Compliance, Quality Intelligence and Inspection, Corporate Quality

Sanchez Devanny New York University

Michigan State University National Institutes of Health Food and Drug Law Institute (FDLI) Food and Drug Law Institute (FDLI) Johnson & Johnson Covington & Burling LLP FDA - CDER

Oxford Global Resources Altria Client Services LLC Eli Lilly and Company

FDA - ORA Novo Nordisk Inc.

Mexico City, Mexico New York, NY

East Lansing, MI Bethesda, MD Washington, DC Washington, DC Washington, DC Washington, DC Silver Spring, MD

Chandler, AZ Richmond, VA Indianapolis, IN

Silver Spring, MD Washington, DC

Reviewer (Biomedical Engineer) Regulatory Counsel Agency Legal Specialist

Principal and General Manager Director, Regulatory Policy & FDA Engagement Senior Regulatory Counsel, Informatics Staff/UDI Professor Regulatory Counsel

Regulatory Review Officer Partner Health Science Administrator Senior Advisor Regulatory Counsel, OPDP Chief Compliance Officer and Senior Vice President Reporter Regulatory Counsel President & COO Assistant Director, Bureau of Consumer Protection, Division of Advertising Practices Counsel, Regulatory Legal Team Regulatory Affairs Attorney Advisor

Associate, Health Care Products Associate, Health Care Products Social Science Analyst,Division of Nonprescription Clinical Evaluation Partner Assistant Controller Regulatory Counsel President Partner Regulatory Counsel Partner President Attorney, Medical Countermeasure Systems

FDA - CDRH FDA - CDER North Carolina Department of Agriculture and Consumer Services DL Chesney Consulting, LLC BioMarin Pharmaceutical Inc.

FDA - CDRH

Boston College FDA - CTP National Academy of Medicine FDA - CDRH Keller and Heckman LLP FDA - OC FDA - OC FDA - CDER ITG Brands

The Pink Sheet FDA - CDER EAS Consulting Group, LLC Federal Trade Commission

Silver Spring, MD Silver Spring, MD Raleigh, NC

Exeter, NH Potomac, MD

Silver Spring, MD

Newton Centre, MA Silver Spring, MD Washington, DC Silver Spring, MD Washington, DC Silver Spring, MD Silver Spring, MD Salt Lake City, UT Greensboro, NC

Washington, DC Silver Spring, MD Bristol, TN Washington, DC

Eli Lilly and Company Aquestive Therapeutics Department of Health & Human Services/Departmental Appeals Board (DAB) The Pew Charitable Trusts The Pew Charitable Trusts FDA - CDER

Indianapolis, IN Warren, NJ Washington, DC

Washington, DC Washington, DC Silver Spring, MD

K&L Gates LLP

Food and Drug Law Institute (FDLI) Washington, DC

FDA - CDER

Silver Spring, MD

Colgin Consulting, Inc.

Moorpark, CA

Saul Ewing Arnstein & Lehr

Miami, FL

FDA - CTP

Rockville, MD

Ropes & Gray LLP

Washington, DC

PhillyCooke Consulting

Penn Valley, PA

U.S. Army Medical Research &Materiel Fort Detrick, MD

Command

Karena

Katherine Karen Helena Dara

Jacqueline Gabrielle Thomas Brooke Philip Meghan Courtney

Brittani Erin James Christine Kavita Brian

Mark

Kristin Claire Ryan Ruwanda Sugato Michael Kevin

Kris John Robert Susan Inge Debra Marina Lesley Patricia Philip

Cooper

Cooper Corallo Correia Corrigan

Corrigan-Curay Cosel Cosgrove Courtney Crooker Crowley Culbert

Cushman Cutts Czaban Czarniecki Dada Dahl

Dahlby

Davenport Davies Davies Davis De de la Torre Dean

DeAngelo DeCarlo Decker DeCorte Delfosse Demeritt Denicoff DeRenzo DeSantis Desjardins

Tricia Jennifer Neil David Mike Julie

Mike Cindy Lauren Jennifer Daniel Heather Tracy Scott Carol Kayla Kathryn Royce Andrew Yolande Ryan Bradley

Desmarais Devine DiSpirito* Dobbins Dobias Dohm

Dohmann Domecus Dooley Dooren Dormont Dorsey Dowling Drenkard Drew Drogosz Drzewiecki DuBiner Dufor Dufresne Durazo Dworak

Director, FDA/OIP Office of Comm. & Policy Coordination Regulatory Counsel Of Counsel Vice President, Regulatory Affairs Associate Commissioner for Global Regulatory Policy Director, OMP

Partner Senior Regulatory Counsel Regulatory Counsel Manager, Program Innovation Sr. Staff Scientist

FDA - OC

FDA - CBER Greenberg Traurig, LLP Keryx Biopharmaceuticals, Inc FDA - OC

FDA - CDER FDA - CDER Covington & Burling LLP FDA - OC FDA - CDER Food and Drug Law Institute (FDLI) RAI Services Company

External Affairs Biomedical Engineer Partner Chief Of Regulatory Affairs Senior Health Promotions Officer Compliance Practice Lead Officer

FDA Regulatory and Healthcare Compliance Counsel Of Counsel General Attorney

Government Information Specialist Principal Consultant CEO SVP and Life Sciences Product Manager

Turning Point Brands, Inc. FDA - CDRH DLA Piper LLP (US) National Institutes of Health FDA - CDER E.M.M.A. International Consulting Group, Inc. IBM

Covington & Burling LLP FDA - OC Georgetown University FDA - CDER Parexel International Corporation FDAzilla Ironshore Insurance Services, LLC

Student Executive, Watson Health Policy Managing Director Asset Team Leader Director Consumer Safety Officer

Regulatory Counsel VP, Global Regulatory Policy Vice President, Global Regulatory Affairs Policy & Intelligence, Medical Devices

Michigan State University IBM Deloitte Consulting LLP Pfizer, Inc. MD & Partners FDA - CDRH FDA - CTP FDA - CDER Biogen, Inc. Johnson & Johnson

Attorney Vice President, Global Legal Affairs Of Counsel Cheif Operating Officer Senior Associate Senior Science Advisor for Compounding

Law Office of Tricia Desmarais U.S. Pharmacopeia Ballard Spahr LLP Truth Initiative The Pew Charitable Trusts FDA - CDER

Program Manager Associate Chief Counsel Attorney Advisor Associate General Counsel Director of State Projects Senior Regulatory Counsel Regulatory Counsel AIMBE Scholar Associate Chemist Senior Associate Business Development - CORE Consumer Safety Officer

Georgetown University No Account Deloitte Consulting LLP FDA - OC Drug Enforcement Administration FDA - CDER Spark Therapeutics Tax Foundation FDA - OC FDA - CTP FDA - CDRH McGuireWoods LLP FDA - CDRH Torys LLP Latham & Watkins LLP FDA - CBER

Silver Spring, MD

Silver Spring, MD Washington, DC

Silver Spring, MD

Silver Spring, MD Washington, DC Washington, DC Silver Spring, MD Silver Spring, MD Washington, DC Winston-Salem, North Carolina

Louisville, KY Silver Spring, MD Washington, DC Rockville, MD Silver Spring, MD Farmington Hills, MI

Chicago, IL

Washington, DC Silver Spring, MD Washington, DC Silver Spring, MD Silver Spring, MD Pleasanton, CA Weatogue, CT

Arlington, VA Groton, CT Brussels, Silver Spring, MD Silver Spring, MD Silver Spring, MD Washington, DC Washington, DC

Santa Monica, CA Rockville, MD Washington, DC Washington, DC Washington, DC Silver Spring, MD

Washington, DC Hillsborough, CA McLean, VA Silver Spring, MD Springfield, VA Silver Spring, MD Philadelphia, PA Washington, DC Silver Spring, MD Silver Spring, MD Silver Spring, MD Atlanta, GA Silver Spring, MD Toronto, Ontario Washington, DC Silver Spring, MD

Daniel Matthew

Anna Nasir

Meg Stacy Darren Adam

Michelle

Brian William Khair

Benjamin

Lorie Brian Sandra Sandra Denise Linda

Natasha Owen

Matthew Kaitlin

Ciara Jeremiah Robin Anthony Brian Karen Rochelle

Anne Wendy Aliza Ellen

Dwyer Eckel

Edney Egal

Egan-Auderset Ehrlich** Eicken Ekonomon

Ellerbe-Williams

Ellman Elwood Elzarrad

England

Erikson Erkkila Eskin Eskin Esposito Evans O'Connor

Facey Faris

Farmer Farquharson

Farrell Fasano Fastenau Fauci Feito Fikes Fink

Finley Finn Fishbein, MPH Flannery

Daniel Maya

Nicholas Anna Carole

Jennifer Pamela Neal Gregory Jonette Jeffrey

Meredith Joseph

Flint Florence

Florko Flynn Folmar

Forde Forrest Fortin Fortsch Foy Francer**

Francis Franklin

Partner

Kleinfeld, Kaplan & Becker, LLP

Director, EU, Harmonization, Trade Staff FDA - OC

Washington, DC Silver Spring, MD

Reporter Head of Global Manufacturing Quality (GMQ) Medical & Regulatory Writer Partner Regulatory Counsel Vice President and Deputy General Counsel Management Analyst

Bloomberg News Sanofi

Thomson Reuters Kleinfeld, Kaplan & Becker, LLP FDA - CDER J.M. Smucker Company

FDA - CDER

Washington, DC Bridgewater, NJ

Philadelphia, PA Washington, DC Silver Spring, MD Orrville, OH

Silver Spring, MD

Vice President

Analysis Group, Inc.

Intergovernmental Affairs Specialist

FDA - OC

Deputy Director, Office of Medical Policy FDA - CDER

Boston, MA Silver Spring, MD Silver Spring, MD

Founder and CEO

Consumer Safety Officer Director of Regulatory Science Director, Safe Food Project Director, Safe Food Project Partner Head of Business Processes and Regulatory Health Science Administrator Clinical Trial Director, Office of Device Evaluation Corporate Counsel Staff Attorney

, LLC/ Benjamin L. England & Associates LLC FDA - CDRH Foundation for a Smoke-Free World The Pew Charitable Trusts The Pew Charitable Trusts Covington & Burling LLP Lachman Consultants

Glen Burnie, MD

Columbia, MD

Washington, DC Washington, DC Washington, DC Westbury, NY

FDA - CDER FDA - CDRH

Silver Spring, MD Silver Spring, MD

Sanofi

Cambridge, MA

U.S. Government Accountability Office Washington, DC

Associate, Life Sciences Law Consumer Safety Officer Regulatory Counsel Director, NIAID Associate Editor Regulatory Counsel Senior Health Science Project Specialist

Arthur Cox Unlimited Company FDA - CFSAN FDA - CDER National Institutes of Health International Trade Today FDA - CDRH FDA - CDRH

Dublin, College Park, MD Silver Spring, MD Bethesda, MD Washington, DC Silver Spring, MD Silver Spring, MD

President

Biotech Policy Group

Director, Membership and Marketing Food and Drug Law Institute (FDLI)

JD student

Johns Hopkins University

Deputy Center Director for Policy, Office FDA - CDRH

of Medical Products & Tobacco, Office of

the Center Director

Milwaukee, WI Washington, DC Baltimore, MD Washington, DC

Associate

McCarter & English LLP

Washington, DC

Counsel, Health Care and Life Sciences Skadden, Arps, Slate, Meagher & Flom Boston, MA

LLP

Reporter

InSide Washington Publishers

Arlington, VA

Consumer Safety Officer

FDA - CBER

Silver Spring, MD

Director, Regulatory Affairs & Associate ITG Brands

Greensboro, NC

General Counsel

Regulatory Counsel

FDA - CDER

Silver Spring, MD

Partner

Covington & Burling LLP

Washington, DC

Professor and Director

Michigan State University

Okemos, MI

Sr. Legal Counsel, Regulatory

The Nature's Bounty Co.

Ronkonkoma, NY

Associate Director for Policy

FDA - CDRH

Silver Spring, MD

Senior Vice President and General

Association for Accessible Medicines Washington, DC

Counsel

Deputy Director

FDA - CDER

Silver Spring, MD

Associate Director for Policy, Therapeutic FDA - CDER

Silver Spring, MD

Biologics and Biosimilars Staff

Joseph

Franklin

James Elizabeth Jean Jennifer Christian Sonja Allison John Paul Stacy Ronald Hayden Isabella Christopher Asina Heather Carlos Tara John M. Katie Paulette Shawn Cassandra

June Nazanin Suchira Jeffrey Jaycie Robert Moira

Anastasia Derrick Joseph Abraham Steve Rachel Kelly

Rebecca Ed Marta Steven Michael Stephanie Andrea Eric Daniel Scott Janet

Robyn Linda

Fraser Friedman Frydman Fuerch Fulda Fulmer Fulton Fuson Gadiock Gagosian* Gahagan Galante Galeano Galvin Gant Garecht Garner Garraty Garvey Gates Calderon Gaynor Gebhardt George

Germain Ghassemian Ghosh Gibbs** Gibney Giddings Gilchrist

Gilmartin Gingery Gitchell Gitterman Glavin Goeriz Goldberg

Goldberg Golden Gonzalez Gonzalez Goodman Goodwin Gormley Gotting Gottlieb Gottlieb Gottlieb

Gougelet Gousis

Rubens John Joyce Kate Cory Jana Rebecca

Granja Green Greenleaf Greenwood Gregan Grieb Griffith

Associate Director for Policy, Therapeutic FDA - CDER Biologics and Biosimilars Staff

General Attorney Regulatory Counsel Partner Domain Specialist Lead Partner Regulatory Counsel Partner Partner Senior Attorney Managing Director of Public Policy Assistant General Counsel Educational Programs Coordin LLM Candidate Program Analyst Associate Senior Counsel Market Specialist-Life Sciences Vice President Administrative Coordinator Principal, Chief Executive Officer Partner Senior Regulatory Project Manager Associate Attorney Associate General Counsel, Head of Regulatory Law Program Coordinator Biomedical Engineer Counsel Director Assistant Chief Counsel Attorney Vice President Scientific and Public Communications Associate Attorney Reporter President Associate Senior Vice President Managing Scientist Vice President, Law/Senior Counsel for Biopharmaceutical Regulation General Attorney

Consumer Safety Officer Associate Associate Sr. Manager, Regulatory Affairs Pharmacist / Regulatory Counsel Partner Regulatory Counsel Commissioner Executive Director, Medical Communications Senior Associate Senior Advisor, Coverage and Analysis Group, Center for Clinical Standards and Quality Lawyer Director, Contracts Legal Regional Inspector General Regulatory Counsel Policy Analyst Counsel Senior Marketing Counsel

FDA - OC FDA - CDER Fox Rothschild LLP MITRE Jones Day FDA - CDRH Sidley Austin LLP Crowell & Moring LLP Arent Fox LLP Truth Initiative Altria Client Services LLC Food and Drug Law Institute (FDLI) Georgetown University FDA - OIG Actelion Pharmaceuticals U.S., Inc. McDermott Will & Emery Eli Lilly and Company Food and Drug Law Institute (FDLI) Compliance Architects LLC Shook, Hardy & Bacon LLP FDA - CFSAN Winston & Strawn LLP Purdue Pharma L.P.

FDA - CDER FDA - CDRH Axinn, Veltrop & Harkrider LLP Hyman, Phelps & McNamara, PC FDA - OC Hutchison PLLC Philip Morris International

Ashby Law Group The Pink Sheet Pinney Associates, Inc. Arnold & Porter LLP Oxford Global Resources Exponent, Inc. PhRMA

FDA - OC Deloitte Consulting LLP FDA - CDER Polsinelli PC Haynes and Boone LLP Nutricia North America FDA - CDER Keller and Heckman LLP FDA - CDER FDA - OC Allergan, Inc.

Pinney Associates, Inc. Centers for Medicare & Medicaid Services (CMS)

Mattos Muriel Kestener Advogados Radius Health, Inc. FDA - OIG FDA - CDER FDA - CTP McDermott Will & Emery Unilever

Silver Spring, MD

Silver Spring, MD Silver Spring, MD Lawrence Township, NJ Arlington, VA Munich, Silver Spring, MD Washington, DC Washington, DC Washington, DC Washington, DC Richmond, VA Washington, DC Washington, DC Miami Lakes, FL San Francisco, CA Washington, DC

Rockville, MD Hamilton, NJ Kansas City, MO College Park, MD Chicago, IL Stamford, CT

Silver Spring, MD Silver Spring, MD New York, NY Washington, DC Silver Spring, MD Gainesville, FL Lausanne, Switzerland

Seattle, WA Rockville, MD Bethesda, MD Washington, DC Chandler, AZ Menlo Park, CA Washington, DC

Rockville, MD McLean, VA Silver Spring, MD Washington, DC Denver, CO

Silver Spring, MD Washington, DC Silver Spring, MD Silver Springs, MD Irvine, CA

Bethesda, MD Baltimore, MD

S?o Paulo, Brazil Parsippany, NJ Boston, MA Silver Spring, MD Silver Spring, MD Washington, DC

Nicole

Danuta Melanie Lewis Miriam Robert

Christopher Sonali Elizabeth Ji Robert Laura J. Benneville Abeba Martin Carol Kimera Ralph Todd Amanda Leila Roy Stacy

Carrie Ellen Martine

Kim Heather Karen Jonathan Stephanie

Joanne

Nancy

Bryan Margo

Lindsey Colleen Michael Laura Seth Emily Mary

Dennis

Corey Melissa Carolyn

Steven Mary Robert Gary Nina Bethany

Grimm

Gromek-Woods Gross Grossman Guggenheim** Guidos

Guiton Gunawardhana Guo Guo Guzman Haak Haas Habtemariam Hahn Haley Hall Hall Halpern Hamilton Hann Hardiman Harker

Harney Hart Hartogensis

Hasili Hatcher Hauda Havens Havrilla

Hawana

Hayes

Haynes Heath-Chiozzi

Heinz Heisey Helbing Helbling Heller Helms Williams Hendrickson

Henigan

Henry Herbert Herrmann

Hertz Hiatt Hibbert Higginbothem Hill Hills

Michael

Hinckle

Counsel

Senior Chemist Senior Corporate Counsel Professor of Law Partner Head, Pharmaceutical Regulatory Affairs & Policy Senior Counsel Of Counsel Associate Chemist Regulatory Counsel Digital Coordinator Partner Associate Partner Director Member Professor of Practice Partner Associate Science Policy Analyst CBO Associate Director, Medical Communications Director, US Advocacy Staff Fellow Deputy Director, Office of Surveillance and Compliance Primary Review Director Regulatory Scientist Senior Director Associate Senior Instructional Designer, NSF Medical Devices Of Counsel

Acting Director, Office of Regulatory Policy Partner Senior Vice-President, Regulatory Affairs

Skadden, Arps, Slate, Meagher & Flom Washington, DC

LLP

FDA - CDER

Silver Spring, MD

Genentech, Inc.

South San Francisco, CA

American University

Arlington, VA

Covington & Burling LLP

Washington, DC

Corning Inc.

Washington, DC

Johnson & Johnson Shook, Hardy & Bacon LLP Covington & Burling LLP FDA - CDER Thompson Hine LLP Food and Drug Law Institute (FDLI) Latham & Watkins LLP Arnold & Porter LLP Hogan Lovells US LLP Pfizer, Inc. Frost Brown Todd LLC University of Minnesota Venable LLP Haug Partners LLP FDA - CDER Principia Biopharma Inc Allergan, Inc.

New Brunswick, NJ Washington, DC Washington, DC Silver Spring, MD Washington, DC Washington, DC Washington, DC Washington, DC Washington, DC New York, NY Dallas, TX Minneapolis, MN Washington, DC Washington, DC Silver Spring, MD South San Francisco, CA Irvine, CA

U.S. Pharmacopeia FDA - CVM FDA - CVM

Rockville, MD Rockville, MD Rockville, MD

AstraZeneca Pharmaceuticals Womble Bond Dickinson (US) LLP Novo Nordisk Inc. Saul Ewing Arnstein & Lehr NSF International

Wilmington, DE Winston-Salem, NC Washington, DC Baltimore, MD Ann Arbor, MI

Mintz, Levin, Cohn, Ferris, Glovsky and Washington, DC

Popeo, P.C.

FDA - CDER

Silver Spring, MD

Troutman Sanders LLP Celldex Therapeutics, Inc.

Richmond, VA Hampton, NJ

Partner

Shook, Hardy & Bacon LLP

Kansas City, MO

Partner

Jones Day

Washington, DC

General Attorney

FDA - OC

Silver Spring, MD

Senior Writer

Prevision Policy LLC

Washington, DC

Axinn, Veltrop & Harkrider LLP

Hartford, CT

Regulatory Counsel

FDA - CDER

Silver Spring, MD

Vice President, Regulatory Compliance & McKesson Corporation

Irving, TX

Ethics

Vice President, Legal and Regulatory

Campaign for Tobacco-Free Kids

Washington, DC

Affairs

Manager Media Relations,

Philip Morris International

Washington, DC

VP Support Services

Neogen Corporation

Lansing, MI

Associate General Counsel

Consumer Healthcare Products

Washington, DC

Association (CHPA)

Consumer Safety Officer

FDA - CDER

Silver Spring, MD

Corporate Counsel

Pfizer, Inc.

New York, NY

Partner

Morgan, Lewis & Bockius LLP

Washington, DC

Thompson Information Services

Bethesda, MD

VP Science Policy

Pfizer, Inc.

New York, NY

Member, Chair FDA Practice, Regulatory Mintz, Levin, Cohn, Ferris, Glovsky and New York, NY

and Reimbursement Attorney

Popeo, P.C.

Partner

K&L Gates LLP

Morrisville, NC

Lori

Colleen Angela Angela Hilary Katie

Kelsy Michael Kathleen

Hirsch*

Hittle Hoague Ho-Chen Hoffman Hoffman

Hoffman Hoffmann Hoke

Elizabeth Matthew David August Aila

Sarah Christina Elizabeth Paul Heather

James John Minerva Rosanne Sana Emily Sunup Mehrban Jeanne Robert Alexandra Erica Peter Gregory

Richard William Daniel Marianna

Hollis Holman Horowitz Horvath Hoss

Hostetler Houck Houston Howard Howell

Huang Huang Hughes Hurwitz Hussain Hussey Hwang Ph.D. Iranshad Ireland Iser Jabs Jackson Jaensch Jaffe

Jahn Janssen Jarcho Jasiukaitis

David Erica

John

Dina Kathryn Elizabeth

Alissa

Freddy Karina

Aurielle Elizabeth Eshael Jismi John

Matia

Jaworski Jefferson

Jenkins

Jerebitski Jernigan Jex

Jijon

Jimenez** Jimenez-Donovan

Johnson Johnson Johnson Johnson Johnson

Johnson

VP of Regulatory Compliance and External Engagement Managing Director Regulatory Information Specialist Senior Counsel Analyst Senior Manager, Public Policy & Government Affairs Regulatory Officer Supervisory Biomedical Engineer Professor & Director, Network for Public Health Policy and Center for Tobacco Regulation Staff Writer, BioWorld Medtech Director Office of Science Partner Partner Professor

Account Director Regulatory Officer Regulatory Counsel ADV. Commissioner Consultant Executive Vice President, Medical Device Training Director, Food Contact Materials Consumer Safety Officer Regulatory Counsel Regulatory Counsel Regulatory Counsel Associate Attorney Director, Medical Communications Regulatory Counsel Principal VP Law Clerk Partner Regulatory Counsel Director, Biotechnology Project

Director Professor of Law Partner Attorney Advisor

Consumer Safety Officer Vice President, Corporate Communications Principal, Drug and Biological Products

Bristol-Myers Squibb Company

New Brunswick, NJ

Navigant Consulting, Inc. FDA - CDER Altria Client Services LLC FDA - CVM Biogen, Inc.

Indianapolis, IN Silver Spring, MD Richmond, VA Rockville, MD Washington, DC

FDA - CBER

Silver Spring, MD

FDA - CDRH

Silver Spring, MD

University of Maryland Carey School of Baltimore, MD

Law

Thomson Reuters FDA - CTP Hogan Lovells US LLP Foley Hoag LLP Indiana University School of Law Indianapolis FDA - CBER FDA - CDER FDA - OC NSF International

Washington, DC Rockville, MD Washington, DC New York, NY Indianapolis, IN

Washington, DC Silver Spring, MD Silver Spring, MD Silver Spring, Maryland Washington, DC

The Coca-Cola Company FDA - CDRH FDA - CDRH FDA - CDER FDA - CDER Reed Smith LLP Allergan, Inc. FDA - CDER Ireland Strategies LLC Parexel International Corporation FDA - OC K&L Gates LLP FDA - CVM Center for Science in the Public Interest Pfizer, Inc. Charleston School of Law Alston & Bird LLP Department of Health & Human Services/Departmental Appeals Board (DAB) FDA - CDER Dermira, Inc.

Atlanta, GA Silver Spring, MD Silver Spring, MD Silver Spring, MD Silver Spring, MD Chicago, IL Irvine, CA Silver Spring, MD Silver Spring, MD Bethesda, MD Baltimore, MD Morrisville, NC Rockville, MD Washington, DC

Collegeville, PA Charleston, SC Washington, DC Washington, DC

Silver Spring, MD Menlo Park, CA

Greenleaf Health, Inc.

Washington, DC

Policy Analyst Division Counsel, Regulatory Attorney Advisor, Office of Policy Planning Senior Counsel, Global Legal Affairs Standards Vice-President, Law and Compliance FDA Tobacco Regulatory Science Fellow

FDA - CDRH Abbott Laboratories Federal Trade Commission

U.S. Pharmacopeia

Celldex Therapeutics, Inc. National Academy of Medicine

Silver Spring, MD Abbott Park, IL Washington, DC

Rockville, MD

Hampton, NJ Olney, MD

Administrative Officer Principal & Founder SRO Branch Director Policy Analyst Senior Associate Attorney

Public Health Advisor

FDA - CDRH Food Directions, LLC FDA - CTP FDA - CDRH , LLC/ Benjamin L. England & Associates LLC FDA - CDRH

Silver Spring, MD Shady Side, MD Silver Spring, MD Silver Spring, MD Columbia, MD

Silver Spring, MD

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