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avatar for Danielle Abatemarco

Danielle Abatemarco

Bristol Myers Squibb
WWPS Innovation & Publications Management
SA

Stephanie Abbott

Western Washington Medical Group
Director of Research
avatar for Anna Adams

Anna Adams

Medicines and Healthcare products Regulatory Agency (MHRA)
Senior GPvP Inspector, Inspection, Enforcement and Standards
AA

Adebola Adedimeji

Albert Einstein College of Medicine
Associate Professor of Epidemiology and Population Health
avatar for Joan Affleck

Joan Affleck

Merck & Co., Inc.
Executive Director, Head of Medical Writing
avatar for Kaia Agarwal

Kaia Agarwal

PharmApprove, A Member of the NDA Group
Strategic Lead
avatar for Dean Aguiar

Dean Aguiar

Tuberous Sclerosis Alliance
Director, Preclinical Research
avatar for Shazia Ahmad

Shazia Ahmad

UBC, United States
Senior Director, Patient and Physician Services
IA

Imad Al-Dakkak

Huron Consulting Group
Director
avatar for Rinol Alaj

Rinol Alaj

TransCelerate Biopharmaceuticals
Director, COA and Innovation, Regeneron; Representative
AA

Albert Allen

Eli Lilly and Company, United States
Senior Medical Fellow, Pediatric Capabilities
avatar for Jeff Allen

Jeff Allen

Friends of Cancer Research, United States
President and Chief Executive Officer
avatar for Mitzi Allred

Mitzi Allred

Merck & Co., Inc., United States
Director, Clinical Operations
avatar for Dawn Anderson

Dawn Anderson

Deloitte Consulting, United States
Managing Director, Life Sciences
avatar for Jonathan Andrus

Jonathan Andrus

Clinical Ink, United States
Chief Business Officer
avatar for Kristin Anthony

Kristin Anthony

PTEN Hamartoma Tumor Syndrome Foundation
President
avatar for Yoko Aoi

Yoko Aoi

Pharmaceuticals and Medical Devices Agency (PMDA)
Principal reviewer, Office of New Drug V
avatar for John April

John April

Eli Lilly & Company
Content Strategy Advisor, Global Scientific Communications
avatar for Hiroyuki Arai

Hiroyuki Arai

Pharmaceuticals and Medical Devices Agency (PMDA)
Director of Center for Product Evaluation and Center of Regulatory...
RR

Rajeswara Rao Arasada

The Ohio State University
MACPR Student
CA

Christine Årdal

Norwegian Institute of Public Health
Senior Advisor
avatar for Lauri Arnstein

Lauri Arnstein

Envision Pharma Group
Patient Partnership Liaison
avatar for Vinod Arora

Vinod Arora

Syneos Health
Associate Director, Consulting
avatar for Stacey Arrambide

Stacey Arrambide

Advanced Clinical
Senior Vice President, Functional Service Solutions
avatar for Christopher Austin

Christopher Austin

National Institutes of Health (NIH)
Director, National Center for Advancing Translational Sciences
avatar for Mark Avigan

Mark Avigan

FDA
Associate Director, Office of Pharmacovigilance and Epidemiology,...
avatar for Kassa Ayalew

Kassa Ayalew

FDA
Branch Chief, Office of Scientific Investigations, Office of...
avatar for Ryan Baehl

Ryan Baehl

Covance
Vice President of Global Operations for CLS
PB

Pavel Balabanov

European Medicines Agency
Head of Therapies for Neurological and Psychiatric Disorders
avatar for Venkatraman Balasubramanian

Venkatraman Balasubramanian

Orion Business Innovation
Senior Vice President, Life Sciences
avatar for Matt Baldwin

Matt Baldwin

Advance Research Associates, Inc (ARA), United States
Senior Biostatistician
avatar for Greg Ball

Greg Ball

Merck & Co., Inc., United States
Senior Principal Biostatistician
avatar for Phil Ball

Phil Ball

Independent Consultant
Health Policy, Biopharmaceutical Development Strategy
avatar for Deepak Bandyopadhyay

Deepak Bandyopadhyay

Janssen
Associate Director, Quality Analytics
avatar for Mark Barnes

Mark Barnes

Ropes & Gray, LLP
Partner
avatar for Carla Barrett

Carla Barrett

PRA Health Sciences
Sr Director, Patient Safety Risk Mgmt
avatar for Merith Basey

Merith Basey

Universities Allied For Essential Medicines (UAEM)
Executive Director, North America
avatar for Marilena Bassi

Marilena Bassi

Health Canada
Senior Executive Director, Therapeutic Products Directorate
avatar for Steven Beales

Steven Beales

WIRB-Copernicus Group (WCG)
Senior Vice President, Scientific and Regulatory Review
avatar for Steven Beales

Steven Beales

WCG
Senior Vice President, Scientific & Regulatory Review
avatar for Matt Becker

Matt Becker

SAS Institute Inc
Advisory Industry Consultant
avatar for Emmanuel Belabe

Emmanuel Belabe

ArisGlobal, United States
Associate Vice President, Safety
avatar for Kimberly Belsky

Kimberly Belsky

Mallinckrodt Pharmaceuticals
Executive Director, Regulatory Policy and Intelligence, Regulatory...
JB

Jasmine Benger

CISCRP
Research Services Senior Project Manager
avatar for Tyler Benning

Tyler Benning

Mayo Clinic
Medical Student
avatar for Robyn Bent

Robyn Bent

FDA, United States
Director, Patient Focused Drug Development Program, OCD, CDER
avatar for Aaron Berger

Aaron Berger

UBC, United States
Executive Director, US Late Stage Operations & Real World Evidence
EB

Elise Berliner

Agency For Healthcare Research and Quality (AHRQ)
Director, Technology Assessment Program
AB

Aaron Bernstein

Aaron Bernstein Consulting, LLC
Principal
avatar for Michael Berntgen

Michael Berntgen

European Medicines Agency, Netherlands
Head of Scientific Evidence Generation
avatar for Amy Bertha

Amy Bertha

Bayer, United States
Senior Director, Regulatory Policy
avatar for Melanie Bhatnagar

Melanie Bhatnagar

FDA
Associate Director for Pediatric Education & Outreach, OPT, OC
avatar for Barbara Bierer

Barbara Bierer

Harvard Medical School
Faculty Director, MRCT Center; Professor of Medicine
avatar for Claire Blanchette

Claire Blanchette

Bayer
Vice President, Program Management - Oncogenic Signaling
avatar for Michael Blum

Michael Blum

FDA, United States
Deputy Director, Office of Pharmacovigilance and Epidemiology, CDER
avatar for Ashley Boam

Ashley Boam

FDA, United States
Director, Office of Policy for Pharmaceutical Quality, OPQ, CDER
avatar for Mariette Boerstoel-Streefland

Mariette Boerstoel-Streefland

Alexion Pharmaceuticals, Inc.
Senior Vice President Global Drug Safety
avatar for Sébastien Bohn

Sébastien Bohn

IBM Watson Health
Offering Manager Executive
CB

Christopher Boone

AbbVie, United States
Vice President, Global Head, Health Economics and Outcomes Research
avatar for Poonam Bordoloi

Poonam Bordoloi

Organon & Co., United States
Executive Director, Head of Global Medical Affairs Capabilities
avatar for Vanessa Boulanger

Vanessa Boulanger

National Organization for Rare Disorders (NORD), United States
Director of Research Programs
avatar for Linda Bowen

Linda Bowen

Seagen, United States
Head of Regulatory Policy and Intelligence
avatar for David Bowers

David Bowers

PPD, United States
Senior Director, Operations
avatar for Jim Box

Jim Box

SAS Institute Inc
Principal Data Scientist
avatar for Brian Bradbury

Brian Bradbury

Amgen, United States
Vice President, Center for Observational Research
KB

Kate Bradford

Arena Pharmaceuticals
Head of International Field Based Medicine
avatar for Sonja Brajovic

Sonja Brajovic

FDA
Medical Officer, OSE, CDER
avatar for Jennifer Brandl

Jennifer Brandl

Kezar Life Sciences
Senior Clinical Trial Manager
KV

Kim Van Naarden Braun

Bristol-Myers Squibb Company
Associate Director, Translational Epidemiology, Informatics and...
avatar for Andrew Briggs

Andrew Briggs

London School of Hygiene and Tropical Medicine (LSHTM)
Professor of Health Economics
avatar for Rachel Brodie

Rachel Brodie

Pacific Business Group on Health
Senior Director, Measurement and Accountability
avatar for Philip (P.J.) Brooks

Philip (P.J.) Brooks

National Center for Advancing Translational Sciences (NCATS), NIH, United States
Program Director, Office of Rare Diseases Research
avatar for Sam De Brouwer

Sam De Brouwer

doc.ai
Cofounder and COO
avatar for Daniela Brunner

Daniela Brunner

Science Forward/PsychoGenics
Founder/CIO
GB

Gillian Buckley

The National Academies of Sciences, Engineering, and Medicine
Senior Program Officer, Health and Medicine Division
avatar for Michael Buckley

Michael Buckley

Memorial Sloan Kettering Cancer Center
Manager, Clinical Research Informatics and Technology Enterprise...
avatar for Joan Buenconsejo

Joan Buenconsejo

AstraZeneca
Senior Director, Biostatistics
avatar for Kevin Bugin

Kevin Bugin

FDA
Director of Special Programs, Office of New Drugs, CDER
avatar for Magda Bujar

Magda Bujar

Centre for Innovation in Regulatory Science (CIRS), United Kingdom
Manager, Strategic Development
avatar for Kristin Bullok

Kristin Bullok

Eli Lilly and Company, United States
Benefit-Risk Management Scientist, Global Patient Safety
avatar for Brandon Burch

Brandon Burch

Nuventra, Inc.
Associate Director, Scientific Writing and Regulatory Affairs
avatar for Jennifer Burgess

Jennifer Burgess

TransCelerate BioPharma Inc.
Vice President, Global Engagement and Communications
SB

Scott Burian

Rho, Inc.
Senior Scientist
avatar for Victoria Burk

Victoria Burk

AbbVie, Inc.
Senior Director R&D Quality Assurance
LB

Lisa Burke

Rhythm
Senior Director, Field Medical
avatar for David Burrow

David Burrow

FDA, United States
Director, Office of Scientific Investigations, OC, CDER
avatar for Bill Byrom

Bill Byrom

Signant Health
Vice President, Product Strategy and Innovation
avatar for Gina Calarco

Gina Calarco

Covance
Director of Pediatric Strategy and Planning
avatar for Susan Callery-D'Amico

Susan Callery-D'Amico

AbbVie, Inc.
Vice President, R&D Quality Assurance
avatar for Michelle Campbell

Michelle Campbell

FDA, United States
Senior Clinical Analyst for Stakeholder Engagement, ON, OND, CDER
avatar for Susan Cantrell

Susan Cantrell

Academy of Managed Care Pharmacy (AMCP), United States
Chief Executive Officer
avatar for Yi Cao

Yi Cao

Center for Food and Drug Inspection (CFDI)
Deputy Division Director, Div 4
avatar for Katherine Capperella

Katherine Capperella

Janssen Pharmaceutical Companies of Johnson & Johnson
Global Patient Engagement Leader
NC

Nicholas Cappuccino

Dr. Reddy's Laboratories
Consultant, Compliance, Quality and Scientific Affairs
LC

Luca Cariolato

UBC
Senior Safety Scientist
avatar for Gillis Carrigan

Gillis Carrigan

Amgen, United States
Director, Center for Observational Research
avatar for Suzanne Caruso

Suzanne Caruso

WCG
Vice President, Clinical Solutions
avatar for Nina Cauchon

Nina Cauchon

Amgen, United States
Director Regulatory Affairs CMC
avatar for Patrizia Cavazzoni

Patrizia Cavazzoni

FDA, United States
Director, Center for Drug Evaluation
avatar for Catherine Celingant

Catherine Celingant

Pfizer Inc
Oncology Therapeutic Area Lead, Data Monitoring and Management (DMM)
avatar for Aloka Chakravarty

Aloka Chakravarty

FDA
Deputy Director, Office of Biostatistics, Office of Translational...
avatar for Meghana Chalasani

Meghana Chalasani

FDA, United States
Lead, Science Strategies, Office of New Drugs, CDER
KC

Karen Chan

University of Southern California
Pharmacy Student
MC

May Chan-Liston

BMS
Global Risk Management Lead, Hematology and Cell Therapy
avatar for Andrew Chang

Andrew Chang

Novo Nordisk Inc., United States
Vice President, Quality and Regulatory Compliance
avatar for Lien-Cheng Chang

Lien-Cheng Chang

TFDA
Section Chief, Division of Medicinal Products
avatar for Pascal Chanu

Pascal Chanu

Genentech, A Member of the Roche Group
Modeling and Simulation Expert
avatar for She-Chia Chen

She-Chia Chen

FDA
ORISE Fellow, Office of Medication Error Prevention & Risk...
avatar for Ta-Jen Chen

Ta-Jen Chen

FDA, United States
Project Management Officer, OSP, CDER
avatar for Yeh-Fong Chen

Yeh-Fong Chen

FDA
Mathematical Statistician (Team Lead), Office of Translational...
avatar for Monica Chiaramonte

Monica Chiaramonte

AstraZeneca
Medical Communications Scientist
avatar for Karla Childers

Karla Childers

Johnson & Johnson, United States
Bioethics & Strategic Projects Leader, Office of the Chief...
avatar for Jennifer Christian

Jennifer Christian

IQVIA
Vice President, Clinical Evidence and Epidemiology
avatar for Leah Christl

Leah Christl

Amgen, United States
Exec Director, Global Biosimilars Regulatory Affairs & Regulatory...
avatar for David Churchward

David Churchward

Medicines and Healthcare products Regulatory Agency (MHRA)
Deputy Unit Manager, Inspectorate Strategy and Innovation (Expert GMP...
avatar for Antony Chuter

Antony Chuter

Independent
Patient Champion
JC

Jennifer Clark

FDA
Mathematical Statistician, OB, OTS, CDER
avatar for Aria Cohen

Aria Cohen

Apellis Pharmaceuticals
Senior Director, US Market Access
avatar for Evi Cohen

Evi Cohen

Appian
Vice President, Global Life Sciences & Healthcare
avatar for Oren Cohen

Oren Cohen

Covance
Chief Medical Officer and Head of Clinical Pharmacology Services
avatar for Ellen Coleman

Ellen Coleman

VOZ Advisors
President and CEO
avatar for Susan Colilla

Susan Colilla

Teva Pharmaceuticals
Director and Lead, Epidemiology and RWE
avatar for Sylva Collins

Sylva Collins

FDA
Director, Office of Biostatistics, OTS, CDER
avatar for Seya Colloud

Seya Colloud

F. Hoffmann-La Roche Ltd
Global Regulatory Director
avatar for Deborah Collyar

Deborah Collyar

Patient Advocates In Research (PAIR), United States
President
avatar for Michael Colopy

Michael Colopy

UCB Biosciences
Safety Statistics and Decision Scientist
VC

Vivian Combs

Eli Lilly and Company
Advisor/Process Owner, Clinical Systems and Supply Planning
SC

Sabrina Comic-Savic

The Medicines Company
Vice President, Quality Assurance, Clinical Project Oversight
avatar for Gary Condran

Gary Condran

Health Canada, Canada
Manager, Generic Drugs Quality Division, Bureau of Pharmaceutical...
avatar for Freda Cooner

Freda Cooner

Amgen, United States
Director, Global Biostatistics
avatar for Stephen Joel Coons

Stephen Joel Coons

Critical Path Institute
Executive Director, PRO Consortium
avatar for Fernanda Copeland

Fernanda Copeland

AVROBIO, Inc
Executive Director, Global Head of Patient Advocacy and Engagement
avatar for Charline Coquerel

Charline Coquerel

Novo Nordisk A/S
Director, Global Patient Relations
MC

Madeline Corrigan

SmithSolve
Senior Account Manager
avatar for Christine Crandall

Christine Crandall

GlaxoSmithKline
Head of Clinical Project Management
avatar for Stephanie Crawford

Stephanie Crawford

University of Illinois at Chicago, United States
Professor, Pharmacy Systems, Outcomes and Policy
avatar for Donatello Crocetta

Donatello Crocetta

Takeda Pharmaceuticals International Gmbh
Global Medical Head, Rare Immunology and Rare Metabolic Franchises
avatar for Alysha Croker

Alysha Croker

Health Canada
Manager, Office of Paediatrics and Patient Involvement
avatar for Michelle Crouthamel

Michelle Crouthamel

AbbVie, Inc.
Director of Digital Health and Innovation
avatar for William Crown

William Crown

Optumlabs
Chief Scientific Officer
JC

Jonathan Crowther

Pfizer Inc
Director, Site Intelligence
avatar for Linda Danielson

Linda Danielson

IDDI Inc
Chief Operating Officer and Executive Vice President
avatar for Ebony Dashiell-Aje

Ebony Dashiell-Aje

Biomarin Pharmaceutical Inc.
Director, Patient-Centered Outcomes Research
avatar for Ruthie Davi

Ruthie Davi

Acorn AI, A Medidata Company, United States
Vice President, Data Science and Statistician
avatar for Jeannie David

Jeannie David

FDA
Senior Program Management Officer, Drug Shortage Staff, CDER
avatar for Patricia Davies

Patricia Davies

Parkinson's Foundation
Reasearch Advocate
avatar for Larry Davis

Larry Davis

EVERSANA
Vice President, Medical and Clinical Affairs
avatar for Susan DeHaven

Susan DeHaven

Sanofi
Director, Data Standards and Business Applications
avatar for Richard Dennett

Richard Dennett

PPD
Senior Director Regulatory Affairs CMC
avatar for Corey Dennis

Corey Dennis

Sanofi
Lead, US Privacy Officer
avatar for Frederick Derosier

Frederick Derosier

Covance
Executive Director, Rare Diseases
SD

Sameen Desai

Bristol Myers Squibb
Senior Director, Pharmacovigilance Innovation
avatar for Shyam Deval

Shyam Deval

Boston Technology Corporation
President
avatar for Robert DiCicco

Robert DiCicco

IBM Watson Health
Deputy Chief Health Officer
avatar for Michael DiMaio

Michael DiMaio

Ropes & Gray LLP
Attorney
avatar for Arielle Dipasquale

Arielle Dipasquale

Rutgers, The State University of New Jersey
PharmD Candidate, Class of 2021, Ernest Mario School of Pharmacy
avatar for Rachael DiSantostefano

Rachael DiSantostefano

Janssen Research & Development, LLC, United States
Senior Director, Epidemiology
SD

Sahith Doppalapudi

Bristol Myers Squibb
Manager, Safety Data Management and Analytics
avatar for Brian Dow

Brian Dow

Janssen Research & Development, LLC
Scientist, Dossier Development and Operations
avatar for AnnCatherine Downing

AnnCatherine Downing

Eli Lilly and Company
Senior Research Advisor - Clinical
avatar for Nicholas Drago

Nicholas Drago

Bayer
Associate Director, Regulatory Policy and Intelligence
avatar for Nancy Dreyer

Nancy Dreyer

IQVIA, United States
Chief Scientific Officer and Senior Vice President
BD

Brian Dreyfus

Bristol-Myers Squibb Company, United States
Senior Director
avatar for João Duarte

João Duarte

Alexion Pharmaceuticals, France
Director, Chief of Staff & Regulatory Science
avatar for David Dubin

David Dubin

AliveandKickn
Founder
DD

David Dubinsky

Blueprint Medicine
Head of Global Patient Affairs
avatar for Shalini Dwivedi

Shalini Dwivedi

Kinapse India Scientific Services Pvt. Ltd.
Director, Development Operations
avatar for Fabian D'Souza

Fabian D'Souza

Boston Strategic Partners, Inc, United States
Founder and President
avatar for Edye Edens

Edye Edens

First Class Solutions, Inc.
Senior Research Compliance Consultant
avatar for Brian Egan

Brian Egan

TransCelerate BioPharma Inc., United States
Senior Manager, Communications and Engagement
avatar for Falk Ehmann

Falk Ehmann

European Medicines Agency
Chair of Innovation Task Force
avatar for Lukas Eichmann

Lukas Eichmann

Novo Nordisk
Associate Patient Relations Manager
avatar for Mary Elmer

Mary Elmer

Merck & Co., Inc.
Executive Director, Patient Innovation Organization
avatar for Jeff Elton

Jeff Elton

Concerto HealthAI
Chief Executive Officer
avatar for M. Khair ElZarrad

M. Khair ElZarrad

FDA, United States
Deputy Director, Office of Medical Policy, CDER
avatar for Sonya Eremenco

Sonya Eremenco

Critical Path Institute, United States
Director, PRO Consortium
avatar for Karen Erickson

Karen Erickson

Patient Advocate
CTTI Steering Committee Member
avatar for Sini Eskola

Sini Eskola

European Federation of Pharmaceutical Industries and Associations (EFPIA)
Director Regulatory Affairs
avatar for Harmonie Etienne

Harmonie Etienne

Dr. Ebeling & Assoc. GmbH
Pharmacovigilance Advisor
KE

Kathryn Evans

WCG Analgesic Solutions, United States
Associate Clinical Scientist
JF

John Farley

FDA, United States
Director, Office of Infectious Diseases, OND, CDER
avatar for Federico Feldstein

Federico Feldstein

Johnson & Johnson, United States
Vice President, Global Head of R&D Quality Compliance
avatar for Kristen Felthousen

Kristen Felthousen

University of Southern California School of Pharmacy, United States
Program Administrator, Department of Regulatory and Quality Sciences
avatar for Phyllis Ferrell

Phyllis Ferrell

Eli Lilly and Company
Global Head, External Engagement, Alzheimer's Disease and...
AF

Amy Fesmire-Baus

Bristol-Myers Squibb Company
Senior Medical Writer
DF

Daniel Fiebig

Rutgers University
Faculty
avatar for Ron Fitzmartin

Ron Fitzmartin

FDA, United States
Senior Informatics Advisor, Office of the Director, CBER
RF

Robert Fontana

University of Michigan
Professor of Medicine
avatar for Gail Francis

Gail Francis

Medicines and Healthcare products Regulatory Agency (MHRA), United Kingdom
Expert Inspector, GCP
avatar for Celeste Frankenfeld

Celeste Frankenfeld

Merck & Co., Inc., United States
Director
avatar for Emily Freeman

Emily Freeman

Sanofi
Senior Director, Global Regulatory Behavioral Science
avatar for David Fryrear

David Fryrear

Astellas, United States
Executive Vice President and Head of Quality Assurance
avatar for Yasuhiro Fujiwara

Yasuhiro Fujiwara

Pharmaceuticals and Medical Devices Agency (PMDA), Japan
Chief Executive
avatar for Andrea Furia-Helms

Andrea Furia-Helms

FDA, United States
Director, Office of Patient Affairs
MS

M. Scott Furness

FDA, United States
Deputy Director, Office of New Drug Products, OPQ, CDER
avatar for Sandra Gallagher

Sandra Gallagher

Viela Bio
Director of Project Management
avatar for Laura Galuchie

Laura Galuchie

Merck & Co., Inc. (MSD outside US and Canada)
Director, Global Clinical Trial Operations
avatar for Shelley Gandhi

Shelley Gandhi

NDA Group
Strategic Advisor, Pharmacovigilance and Drug Safety
CG

Carlos Garner

Eli Lilly and Company
Vice-President Global Regulatory Affairs
avatar for Elizabeth Garner

Elizabeth Garner

ObsEva SA
Chief Medical Officer


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