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JE

Justin Earp

FDA
Pharmacometric Reviewer, OCP, OTS, CDER
avatar for Matthew Eberle

Matthew Eberle

BizInt Solutions, Inc.
Lead Developer, Analytics & Custom Solutions
avatar for Hiroko Ebina

Hiroko Ebina

Proscribe KK
Principal Writer I
avatar for Helen Edelberg

Helen Edelberg

Bristol-Myers Squibb
Head of Medical Safety Assessment, Innovative Medicines & Global...
avatar for Benedikt Egersdoerfer

Benedikt Egersdoerfer

PAREXEL International
Vice President, Global Data Operations
avatar for Anne-Virginie Eggimann

Anne-Virginie Eggimann

bluebird bio, Inc.
Senior Vice President, Regulatory Science
ME

Michael Elashoff

Medidata Solutions
Patient Profiles
ME

Michael Elashoff

Medidata Solutions
Patient Profiles
avatar for Hanady Elhadidy

Hanady Elhadidy

Bristol-Myers Squibb
Associate Director, Medical Information
avatar for Mary Elmer

Mary Elmer

Merck & Co., Inc.
Director, Patient Experience Organization
avatar for Jennifer Emerson

Jennifer Emerson

Emerson Consulting & Clinical Research Services
Owner
avatar for Kurt von Emster

Kurt von Emster

Abingworth
Managing Partner
avatar for Eva Essig

Eva Essig

Intellia Therapeutics, Inc.
Vice President, Regulatory Affairs
avatar for Cheryle Evans

Cheryle Evans

Advanced Clinical
SVP Clinical and Medical Ops
avatar for Vivien Fagan

Vivien Fagan

QuintilesIMS
Director, Global Medical Writing and Document Publishing
avatar for Joseph Falcone

Joseph Falcone

Bristol-Myers Squibb
Lead, Medical Digital Solutions
avatar for Betsy Fallen

Betsy Fallen

BAFallen Consulting LLC
Consultant
avatar for Keith Fargo

Keith Fargo

Alzheimer's Association
Director of Medical and Scientific Relations
avatar for Ron Fassler

Ron Fassler

BBK Worldwide
Author and Actor
avatar for Christina Fawcett

Christina Fawcett

PRA Health Sciences
Director of Operations
avatar for Michael De Felippis

Michael De Felippis

Eli Lilly and Company
Senior Research Fellow, Biopharmaceutical Research and Development
avatar for Claudia Filozof

Claudia Filozof

Covance Inc.
Executive medical director
avatar for Ron Fitzmartin

Ron Fitzmartin

FDA
Sr. Informatics Advisor
avatar for Mary Fleres

Mary Fleres

Allergan
Senior Manager, Quality Management Services
avatar for Emuella Flood

Emuella Flood

ICON, plc.
Senior Director, Patient-Reported Outcomes
avatar for Drew Foglia

Drew Foglia

SAS Institute Inc., JMP Division
Principal Software Developer
avatar for Alice Ford-Hutchinson

Alice Ford-Hutchinson

Merck & Co., Inc.
Director, Global Project and Alliance Management
avatar for Kevin Fowler

Kevin Fowler

The Voice of the Patient, Inc.
President
avatar for Kelly Franchetti

Kelly Franchetti

Mapi Group, An ICON plc Company
Vice President, Global Patient Insights and Engagement, Patient...
avatar for Tammy Franklin

Tammy Franklin

UCB, Inc.
Senior Director, Global Medical Writing
avatar for Patrick Frey

Patrick Frey

FDA
Chief of Staff, Office of New Drugs, CDER
avatar for David Fryrear

David Fryrear

AbbVie, Inc.
Senior Director, R&D Quality Assurance
avatar for Carrie Furin

Carrie Furin

Eli Lilly and Company
Manager, Clinical Trial Management
avatar for Marc Gabriel

Marc Gabriel

Veeva Systems
Senior Director of Product Strategy
avatar for Sruthi Gaddam

Sruthi Gaddam

Rutgers, The State University of New Jersey
avatar for Shelley Gandhi

Shelley Gandhi

NDA Group
Strategic Advisor, Pharmacovigilance and Drug Safety
avatar for Juan Garcia-Burgos

Juan Garcia-Burgos

European Medicines Agency (EMA)
Head of Public Engagement Department
LG

Lili Garrard

FDA
Mathematical Statistician, Office of Biostatistics, OTS, CDER
avatar for Louis Garrison

Louis Garrison

University of Washington
Professor, Pharmaceutical Outcomes Research and Policy Program
DG

Drew Garty

Veeva Systems Inc.
Chief Technical Officer
TG

Timothy Garver

Impact Pharmaceutical Services
Chief Operating Officer and Executive Vice President
LG

Laura Gault

AbbVie, Inc.
Group Project Leader
avatar for Charu Gautam

Charu Gautam

QuintilesIMS
Head- Early Clinical Development, Asia Pacific
avatar for Jan Geissler

Jan Geissler

Patvocates
CEO
EG

Elena Gerasimov

Kids V Cancer
Director, Compassionate Use Navigator Program
avatar for Art Gertel

Art Gertel

MedSciCom, LLC
President and Principal Consultant
avatar for Kenneth Getz

Kenneth Getz

Center For the Study of Drug Development, Tufts University School of Medicine
Director of Sponsored Research Programs and Associate Professor
avatar for Harry Gewanter

Harry Gewanter

Alliance for Safe Biologic Medicines
Chairman
avatar for Vasudeo Ginde

Vasudeo Ginde

DiagnoSearch Life Sciences
President & Managing Director
avatar for Barbara Gladson

Barbara Gladson

Rutgers School of Health Professions
Director of Biopharma Initiative; Interim Chair, Health Informatics
avatar for Lucas Glass

Lucas Glass

QuintilesIMS
Head of Machine Learning Research
avatar for Richard Gliklich

Richard Gliklich

OM1
Chief Executive Officer
avatar for Michael Goedde

Michael Goedde

PAREXEL
Vice President, Clinical Data Management and Database Programming
MG

Michael Gold

AbbVie, Inc.
Head of Neuroscience
avatar for Jennifer Goldsack

Jennifer Goldsack

CTTI
Senior Project Manager
avatar for Jonathan Goldsmith

Jonathan Goldsmith

FDA
Associate Director for Rare Diseases, Office of New Drugs, CDER
GG

Gretchen Goller

ICON, plc.
Global Head of Patient Recruitment Services
avatar for Mercè Caturla Goñi

Mercè Caturla Goñi

Janssen Pharmaceutical Companies of Johnson & Johnson
Global Access Regulatory Leader, Regulatory Policy (Africa and WHO)
avatar for Christian Gossens

Christian Gossens

F. Hoffmann-La Roche Ltd.
Global Head, Early Development Workflows
EG

Elsie Grace

Eli Lilly and Company
Epidemiologist, Global Patient Safety
LG

Laurie Graham

FDA
Acting Director, DIPAP, OPPQ, OPQ, CDER
avatar for Kimberly Greco

Kimberly Greco

Amgen Inc.
Director, Research and Development Policy
avatar for Regina Greer-Smith

Regina Greer-Smith

Healthcare Research Associates LLC
President
avatar for Brandi Gregg

Brandi Gregg

UCB, Inc.
HCP Associate, UCBCares
avatar for Alberto Grignolo

Alberto Grignolo

Parexel
Corporate Vice President
SG

Susann Grill

University of Bremen
avatar for Bambi Grilley

Bambi Grilley

Baylor College of Medicine
Director, Clinical Research & Early Product Dev., Center for Cell...
AG

Aurélien Grolleau

Université Claude Bernard - Institut De Pharmacie Industrielle De Lyon
MSc Student
AG

Abhinav Gupta

TCS
Ast General Manager Client Relations
avatar for Chad Gwaltney

Chad Gwaltney

Gwaltney Consulting
Principal Consultant
avatar for Jonathan Haddad

Jonathan Haddad

GlaxoSmithKline
Director, Clinical Statistics
avatar for Tarek Hammad

Tarek Hammad

Merck Research Laboratories
Executive Director, Pharmacoepidemology
avatar for Gerrit Hamre

Gerrit Hamre

Clinical Trials Transformation Initiative (CTTI)
Clinical Project Manager
avatar for Michael Hamrell

Michael Hamrell

MORIAH Consultants
President
KH

Kelly Han

KoNECT
Business Development & Global Cooperation Manager
avatar for Vicky (Fengyun) Han

Vicky (Fengyun) Han

Johnson & Johnson Pte. Ltd.
Senior Director, Asia Pacific Regulatory Policy Group Lead, Asia...
avatar for Dave Handelsman

Dave Handelsman

Project Data Sphere, LLC
Vice President of Development
avatar for Bill Hanlon

Bill Hanlon

Covance Inc.
Chief Development Officer and Head of Global Regulatory Affairs
JH

James Harnett

Pfizer Inc.
Senior Director, Lead, Real World Data and Analytics, Patient &...
SH

Sema Hashemi

FDA
Director, Office of Regional and Country Affairs, OIP, OC
avatar for Sabine Haubenreisser

Sabine Haubenreisser

European Medicines Agency, European Union
Liaison to the US FDA
avatar for Karen Hauda

Karen Hauda

Novo Nordisk A/S
Senior Director, Regulatory Policy
avatar for Conrad Hawkins

Conrad Hawkins

KMR Group Inc.
Associate Consultant
avatar for Sara Hayes

Sara Hayes

Health Union, LLC
Director, Community Development
avatar for Kevin Haynes

Kevin Haynes

HealthCore Inc.
Director of Clinical Epidemiology
JH

Jorge Hechavarria

Celgene Corporation
Associate Director, U.S. REMS Quality Operations
AH

Amy Heimberger

University of Texas MD Anderson Cancer Center
Professor in the Department of Neurosurgery
avatar for Jonathan Helfgott

Jonathan Helfgott

Johns Hopkins University
Coordinator for Regulatory Science Program
avatar for Kevin Henderson

Kevin Henderson

Genentech, A Member of the Roche Group
MSL Field Operations and Resources Manager
avatar for Mike Henderson

Mike Henderson

SAS Institute Inc.
Sr Manager, Pre-Sales Support
BH

Barbara Hendrickson

AbbVie, Inc.
Senior Medical Director
avatar for Renee Heuser

Renee Heuser

AbbVie, Inc.
Director, Clinical Documentation Center
avatar for John Hicks

John Hicks

Eli Lilly and Company
Global Quality Auditing Manager
avatar for Pamela Hill

Pamela Hill

AstraZeneca
Open Innovation Program Director, Principal Scientist, Emerging...
avatar for Jeffrey Ho

Jeffrey Ho

Navitas Life Sciences
Principal
avatar for Todd Hobbs

Todd Hobbs

Novo Nordisk A/S
Vice President, Chief Medial Officer
avatar for Alan Hochberg

Alan Hochberg

F. Hoffmann-La Roche Ltd.
Scientific Enablement Leader
avatar for Melissa Hogan

Melissa Hogan

Project Alive
Founder/President
avatar for Melissa Hogan

Melissa Hogan

Project Alive
Founder/President
JH

Julie Holtzople

AstraZeneca
Clinical Trial Transparency Operations Director
RH

Robert Homolka

Shire
Clinical Pharmacology Group Lead
avatar for Anton Hoos

Anton Hoos

Amgen GmbH
Vice President and Medical Director, Europe
avatar for Kit Howard

Kit Howard

CDISC
Senior Director, Standards Development & Education
avatar for Deborah Howe

Deborah Howe

Bristol-Myers Squibb
Associate Director, Vendor Alliance Lead
YT

Yi Tzu Hsu

TFDA/Center For Drug Evaluation
Project Manager
avatar for Bevan Huang

Bevan Huang

Janssen Research & Development, LLC
Associate Scientific Director
avatar for Frank Hubbard

Frank Hubbard

Global Regulatory Writing Solutions Inc.
President
avatar for Sherri Hubby

Sherri Hubby

Premier Research
Senior Director, Quality Assurance, Risk, and Compliance
avatar for Emily Huddle

Emily Huddle

Gilead Sciences, Inc.
Regulatory Intelligence Manager
BH

Bev Hudson

AMPLEXOR Life Sciences
Vice President Life Sciences
avatar for Ian Hudson

Ian Hudson

Medicines and Healthcare products Regulatory Agency (MHRA)
Chief Executive
EH

Esther Huffman

Bristol-Myers Squibb
Associate Director, Monitoring Excellence
avatar for Candice Hughes

Candice Hughes

Hughes BioPharma Advisers LLC
CEO/Founder
avatar for Nicole Hurst

Nicole Hurst

PPD
Director, Project Management
NH

Noreen Hussain

Touro College of Pharmacy
avatar for Virginia Hussong

Virginia Hussong

FDA
Chief, Data Standards Program, CBER
avatar for Michael Ibara

Michael Ibara

Fathom Digital Healthcare Consulting
Managing Partner
avatar for Nita Ichhpurani

Nita Ichhpurani

Celerion
Senior Director, Global Clinical Development
CI

Covance Inc.

Covance Inc.
SI

SAS Institute Inc.

SAS Institute Inc
avatar for Simon Ingate

Simon Ingate

Pope Woodhead & Associates Ltd
Principal Consultant, Safety Gauge Product Manager
avatar for Simon Ingate

Simon Ingate

Pope Woodhead & Associates Ltd
Principal Consultant, Safety Gauge Product Manager
avatar for Ilan Irony

Ilan Irony

FDA
Deputy Director, DCEPT, OTAT, CBER
avatar for Telba Irony

Telba Irony

FDA
Deputy Director, Office of Biostatistics and Epidemiology, CBER
avatar for Maori Ito

Maori Ito

Pharmaceuticals and Medical Devices Agency (PMDA)
Office of Medical Informatics and Epidemiology
avatar for Aarthi Iyer

Aarthi Iyer

Advarra
Managing Director
CJ

Camille Jackson

Pharmaceutical Research and Manufacturers of America (PhRMA)
Associate Vice President, Science and Regulatory Advocacy
avatar for Nirdosh Jagota

Nirdosh Jagota

Merck & Co., Inc.
Vice President and Head, Regulatory CMC
avatar for Seema Jaitly

Seema Jaitly

Essjay Solutions Ltd
Managing Director
avatar for Jeffry James

Jeffry James

Wilmington Health, PLLC
Chief Executive Officer
PJ

Paul James

Genentech, A Member of the Roche Group
Associate Director, Medical Science Liaisons
avatar for Sophie Janssens

Sophie Janssens

UCB Pharma, Inc
Global Director Pricing and Market Access
avatar for Jonathan Jarow

Jonathan Jarow

FDA
Senior Medical Advisor
avatar for Theresa Jeary

Theresa Jeary

Lloyds Register Quality Assurance (LRQA)
Head of Notified Body
JJ

Julian Jenkins

GlaxoSmithKline
Vice President, Innovation Performance and Technology
GJ

Gina Johns

Ocean Consulting Solutions LLC
Founder/ Project Manager
avatar for Kimberly Johnson

Kimberly Johnson

Eli Lilly and Company
Field Medical Advisor
LL

Laura Lee Johnson

FDA
Director Division III, Office of Biostatistics, OTS, CDER
avatar for Jeremy Jokinen

Jeremy Jokinen

AbbVie, Inc.
Senior Director, Decision Sciences
JJ

John Joly

Genentech, A Member of the Roche Group
Senior Director Analytical Development and Quality Control
avatar for David Jones

David Jones

Medicines and Healthcare products Regulatory Agency (MHRA)
Expert Pharmacotoxicologist, Clinical Trials Unit
PJ

Patrick Jordan

QuintilesIMS
Enterprise Head, Next Gen
avatar for Candice Junge

Candice Junge

Amgen Inc.
Development Design Director
HK

HASSAN Kadhim

Boehringer Ingelheim Pharmaceuticals, Inc.
Business Consultant, IS BP R&DM
avatar for Dawn Kaminski

Dawn Kaminski

Accenture Accelerated R&D Services
Director, Clinical Data Strategies
LK

Lisa Kammerman

AstraZeneca
Senior Statistical Science Director
avatar for John Kamp

John Kamp

Coalition For Healthcare Communication
Executive Director
avatar for Beenu Kapoor

Beenu Kapoor

Cognizant
Sr.Director - Consulting, Life Sciences
KK

Kurt Karst

Hyman, Phelps & McNamara, PC
Director, Prescription Drugs and Biologics, Corporate Transactions,...
avatar for Sean Kassim

Sean Kassim

FDA
Director, Office of Study Integrity and Surveillance, OTS, CDER
avatar for Ellen Kelso

Ellen Kelso

KSE Ltd.
Head, Knowledge Strategy
avatar for Nicholas Kenny

Nicholas Kenny

INC Research
Executive Vice President, Oncology and Hematology
avatar for Akm Khairuzzaman

Akm Khairuzzaman

FDA
Branch Chief (Acting), Office of Process and Facilities, OPQ, CDER
avatar for Khairul Faizi Khalid

Khairul Faizi Khalid

Clinical Research Malaysia
Head of Business Development
avatar for Mustafa Khasraw

Mustafa Khasraw

University of Sydney
Associate Professor
avatar for Manish Khatri

Manish Khatri

Ernst and Young
Consulting Manager, Clinical SME - R&D Advisory Services
AK

Abel Kho

Northwestern University
Director, Institute for Public Health and Medicine (IPHAM)
avatar for Hady Khoury

Hady Khoury

ICON, plc.
Vice President, Global Head, Research Services, Commercialization and...
avatar for David Kiger

David Kiger

BioClinica
Chief Commercial Officer
avatar for Calvin Kim

Calvin Kim

Bayer
Senior GxP IT Auditor
avatar for Joseph Kim

Joseph Kim

Eli Lilly and Company
Senior Advisor, Clinical Innovation
avatar for Lisa Kim

Lisa Kim

Rutgers School of Health Professions
Director of Capstone / Lecturer
avatar for Tamy Kim

Tamy Kim

FDA
Associate Director for Regulatory Affairs, OHOP and OCE (Acting), CDER
MK

Michio Kimura

Hamamatsu University School of Medicine
Professor and Director, Department of Medical Informatics
GK

Gian King

Ernest Mario School of Pharmacy
avatar for Lynn King

Lynn King

PPD
Executive Director, Clinical Management
avatar for Helen Kitchen

Helen Kitchen

DRG Abacus
Senior Consultant
avatar for Agnes Klein

Agnes Klein

Health Canada
Director, Evaluation of Radiopharmaceuticals and Biotherapeutic...
avatar for Paul Kluetz

Paul Kluetz

FDA
Associate Director for Patient Outcomes (Acting), OCE
avatar for Adina Knight

Adina Knight

QuintilesIMS
Medical Director
avatar for Stephen Knowles

Stephen Knowles

Eli Lilly and Company
Senior Director, Global Patient Safety, Medical and Benefit Risk...
avatar for Laura Kolaczkowski

Laura Kolaczkowski

iConquerMS PPRN, PCORnet
Lead Patient Representative, Co-Principal Investigator
avatar for Tatsuya Kondo

Tatsuya Kondo

Pharmaceuticals and Medical Devices Agency (PMDA)
Chief Executive
TK

Tipsuda Kongtong

Eisai, Inc.
Manager, Clinical Quality Assurance
LK

Laura Koontz

FDA
Office of InVitro Diagnostics and Radiological Health (OIR), CDRH
avatar for Snehal Kothari

Snehal Kothari

QuintilesIMS
Chief Medical & Scientific Officer
avatar for Nathan Kreischer

Nathan Kreischer

Merck & Co., Inc.
Associate Director, Global Project and Alliance Management
avatar for James Kremidas

James Kremidas

Association of Clinical Research Professionals (ACRP)
Executive Director
AK

Angela Krueger

FDA
Acting Deputy Director, Office of Device Evaluation, CDRH
avatar for Mark Kryah

Mark Kryah

Eli Lilly and Company
Senior Advisor/COO, Bio-Medicines Business Unit
avatar for Bhakti Kshatriya

Bhakti Kshatriya

Truposha, LLC
Founder, Publication Practice Counsel
avatar for Jürgen Kübler

Jürgen Kübler

QSciCon
Owner
avatar for Caroline Kurtz

Caroline Kurtz

Synlogic
Head of Translational Science and Product Development
avatar for Sandra Kweder

Sandra Kweder

FDA
Deputy Director, Liaison to the EMA, Office of International...
avatar for Michael Laddin

Michael Laddin

LeaderPoint
Chief Executive Officer
DL

Dominique Lagrave

Amgen
Director, Global Regulatory Affairs and Safety Operations
avatar for Mary Jo Lamberti

Mary Jo Lamberti

Tufts Center for the Study of Drug Development
Associate Director of Sponsored Research, Research Assistant Professor
CO

C. Ola Landgren

Memorial Sloan Kettering Cancer Center
Profesor of Medicine and Chief of Myeloma Service
CF

Cecilie Freddie Lange

Novo Nordisk A/S
RBM Specialist
avatar for Kai Langel

Kai Langel

eClinicalHealth
Founder & Dir. Patient Solutions
avatar for Debra Lappin

Debra Lappin

FaegreBD Consulting
Head, Health Biosciences Practice
avatar for Petra Lebeau

Petra Lebeau

Rho, Inc.
Sr. Biostatistician III
avatar for Cecil Lee

Cecil Lee

Eli Lilly and Company
Knowledge Management Advisor, Global Customer Information
YJ

Yueh Jung (Cynthia) Lee

Autotelic Inc
Director of R&D
avatar for Phillip Lerner

Phillip Lerner

Aetna, Inc.
Vice President and National Medical Director
avatar for Jenny Lester

Jenny Lester

Samuel Oschin Comprehensive Cancer Institute
Research Manager
avatar for Dayna Lesueur

Dayna Lesueur

Alnylam Pharmaceuticals, Inc.
Regulatory Affairs Post-PharmD Fellow
avatar for Patricia Leuchten

Patricia Leuchten

The Avoca Group
President and Chief Executive Officer


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