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Ciby Abraham

AstraZeneca, United States
Senior Director and Group Manager, Project and Product Leadership
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Maria Paula Bautista Acelas

DIA, United States
Research Associate
AA

Anina Adelfio

Association of Clinical Research Organizations (ACRO), United States
Vice President, Industry Relations
EA

Eishita Agarwal

GSK, India
Digital Innovation Manager, Medical Writing
LA

Linda Akunne

FDA
Chief, Project Management Staff, ORO, OND, CDER
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Hillary Andrews

Friends of Cancer Research, United States
Director, Regulatory and Research Partnerships
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Artem Andrianov

Cyntegrity Germany GmbH
CEO
LA

Luk Arbuckle

IQVIA Applied AI Science
Global AI Practice Leader
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Barbara Isquith Arone

IQVIA
Vice President, Evidence Generation for Medical Affairs
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Troy Astorino

PicnicHealth, United States
CTO
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Junaid Bajwa

Pioneering Intelligence, United Kingdom
Senior Partner, Head of UK, and Science Partner, Pioneering...
DD

Denyse D Baker

Eli Lilly and Company
Assoc. Vice President Global Quality Compliance, External Engagement...
VB

Venkatraman Balasubramanian

VB Insights, LLC
Healthcare and Life Sciences Strategic Advisor
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Greg Ball

ASAPprocess
Safety Data Scientist
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Deepak Bandyopadhyay

Janssen, United States
Interim Head, Quality Analytics Data Sciences
JB

Jim Barrett

Uppsala Monitoring Centre (UMC), Sweden
Senior Data Scientist
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Robyn Bent

FDA
Director, Patient Focused Drug Development, OCD, CDER
SB

Saba Berhane

IFPMA, Switzerland
Manager, Regulatory Affairs
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Amy Bertha

Bayer, United States
Executive Director, Regulatory Policy and Innovation
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Sanghita Bhattacharya

Johnson & Johnson Innovative Medicine, United States
Associate Director Data Science , Feasibility and Analytics, Clinical...
AB

Asia Blackwell

FDA, United States
Consumer Safety Officer
CB

Cheyenne Blanchette

Inedo
Event Coordinator
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Claire Blanchette

Consultant
Executive Drug Development Program Leader
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Sandra Blumenrath

DIA
Managing Editor, Scientific Publications
WB

William Blumentals

Sanofi, United States
Head of Pharmacoepidemiology, Specialty Care
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Anna Bode

Kearney, Germany
Principal
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Paul Bolot

Bayer Consumer Care AG, Switzerland
Global Regulatory Strategist
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Jaclyn Bosco

IQVIA, United States
Vice President and Global Head of Epidemiology
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Tywnia Brewton

Astellas , United States
Executive Director, Human Resources
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Denise Bronner

Empactful Ventures, United States
Founder & CEO
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James Browning

Amgen, United States
Director of Biostatistical Programming, Center for Observational...
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James Buchanan

Covilance LLC, United States
President
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Mandy Budwal-Jagait

Medicines and Healthcare products Regulatory Agency (MHRA), United Kingdom
Head of GCP
KB

Kevin Bugin

Amgen
Head of Global Regulatory Policy and Intelligence
HB

Huwaida Bulhan

Roche Kenya Limited, Kenya
Senior Clinical Research Operations Lead Area Africa
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Mehmet Burcu

Merck & Co., Inc., United States
Senior Director, Epidemiology
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Amanda Burkhardt

University of Southern California, United States
Assistant Professor, Alfred E. Mann School of Pharmacy and Pharma...
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Bill Byrom

Signant Health
Vice President, Product Strategy and Innovation
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Bill Byrom

Signant Health
Vice President, Product Intelligence and Positioning; Principal, eCOA...
XC

Xiaoyu Cai

FDA
Mathematical Statistician
GC

Gina Calarco

Critical Path Institute
Senior Scientific Director
EC

Eleanor Caplan

Johnson & Johnson Innovative Medicine
Senior Principal Scientist
BC

Brooke Casselberry

Epista Life Sciences
Vice President, Advisory and Delivery
JC

June Cha

Milken Institute, United States
Policy Director
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Meghana Chalasani

FDA, United States
Associate Director for Clinical Trial Innovation, Office of New...
JC

Jennifer Chambers

Assistant Head of School
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Joan Chambers

Tufts CSDD, United States
Senior Consultant
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Ankush Chandna

ZS Associates , United States
Data Science Lead, Research and Development Excellence
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Andrew Chang

Novo Nordisk, United States
Vice President, Quality and Regulatory Compliance
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Rachel Chasse

AbbVie
Associate Director, Digital Science Strategy
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Karla Childers

Johnson & Johnson
Head, Bioethics-Based Science and Technology Policy
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Stephanie Choi

EMD Serono, United States
Director, US Global Regulatory and Scientific Policy (GRASP)
AC

Ashar Choudhry

Bristol Myers Squibb, United States
Executive Director, Enterprise Operational Excellence
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Terry Church

University of Southern California
Associate Professor, Alfred E Mann School of Pharmacy and Pharma...
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James Clark

kt cloudware
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Christine Colvis

National Center for Advancing Translational Sciences (NCATS)
Director, Drug Development Partnership Programs
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Torrey Cope

Sidley Austin LLP
Partner
KC

Karen Correa

Boehringer Ingelheim
Vice President, Clinical Development Operations
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Solange Corriol-Rohou

AstraZeneca
Senior Director, Global Regulatory Affairs & Policy, R&D, Europe
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Stephen Corson

Phastar
Associate Director, Statistics and Technical Solutions
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Stephanie Crawford

University of Illinois at Chicago, United States
Professor, Pharmacy Systems, Outcomes and Policy
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Alysha Croker

Health Canada
Manager, Office of Paediatrics and Patient Involvement
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Alysha Croker

Health Canada
Director of the Centre for Policy, Pediatrics and International...
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Matthew Curin

Galderma
Nemolizumab Project Management Lead
PD

Patricia Davidson

Tufts Center For the Study of Drug Development, United States
PALADIN Consortium Director
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Suranjan De

FDA
Deputy Director, Regulatory Science, OSE, CDER
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Chris Decker

CDISC, United States
President and Chief Executive Officer
SD

Sai Dharmarajan

Sarepta Therapeutics
Director, Biostatistics
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Monica Dias

European Medicines Agency
Head of Supply and Availability of Medicines and Devices, a.i.
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Victoria DiBiaso

Sanofi, France
Global Head, Patient Informed Development and Health Value Translation
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Robert DiCicco

TransCelerate Biopharma Inc., United States
Vice President, Portfolio Management
AD

Abigail Dirks

Tufts CSDD, United States
Data Scientist
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Bridget Doherty

Janssen Scientific Affairs, United States
Director, Market Access Scientific and External Strategy
AD

Amanda Donovan

Takeda, United States
Director Emerging Priorities & Innovation
CD

Carolyn Dorgan

Sutton's Creek, Inc., United States
Director, Technical Service
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Megan Doyle

Eli Lilly & Company
Associate Vice President, Assistant General Counsel - Diagnostics
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Megan Doyle

Eli Lilly & Company, United States
Associate Vice President, Assistant General Counsel - Diagnostics
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Nancy Dreyer

Dreyer Strategies LLC
Founder
ND

Natalie Dreyer

Temple Beth Am Day School
Second Grade Teacher
JD

Joseph Dustin

eClinical Consulting
Founder and Managing Partner
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Danielle Friend Economo

Johnson & Johnson Innovative Medicine, United States
Senior Director, US Head Regulatory Policy and Intelligence
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Tamei Elliott

DIA, United States
Associate Director, Scientific Programs
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Jennifer Emerson

Boehringer Ingelheim, Germany
Head Quality Analytics & Risk Management
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Andrew Emmett

Pfizer Inc, United States
FDA Liaison | US Regulatory Policy and Global Intelligence
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Sarah Fairfield

AbbVie
Associate Director, RA Device and Combination Products (Digital...
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Jessica Federer

Bayer AG, United States
ex-CDO
SC

Sérgio Cavalheiro Filho

IFPMA
Manager, Regulatory Affairs
LF

Lawrence Fine

Lawrence Fine, LLC
Business Consultant
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Kelly Fitzgerald

WCG , United States
Executive IRB Chair and Vice President of IBC Affairs
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Ron Fitzmartin

FDA, United States
Senior Advisor, Office of Regulatory Operations, CBER
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Ruby Ford

Tufts School of Medicine
Research Analyst
JF

Jeffrey Francer

Eli Lilly and Company, United States
Vice President, Head of Global Regulatory Policy & Strategy
PF

Pedro Franco

Merck Serono Limited
Senior Director for Global Regulatory & Scientific Policy (GRASP)
JF

Julie Frearson

Charles River Laboratories, United States
Senior Vice President, Chief Scientific Officer
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David Fryrear

Astellas, United States
Executive Vice President and Head of Quality Assurance
avatar for Juan Garcia-Burgos

Juan Garcia-Burgos

European Medicines Agency
Head of Public and Stakeholders Engagement Department
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Emily Gebbia

FDA
Associate Director for Regulatory Development, OSI, OC, CDER
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Kenneth Getz

Tufts University School of Medicine
Tufts Center for the Study of Drug Development
avatar for Alicia Gilsenan

Alicia Gilsenan

RTI Health Solutions, United States
Vice President, Epidemiology
avatar for Cammilla Horta Gomes

Cammilla Horta Gomes

Roche, Brazil
LATAM Regulatory Policy Lead
JN

Julien Nunes Goncalves

Cyntegrity, South Africa
RBQM Solutions Architect
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Robert (Mac) Gordon

Johnson & Johnosn Innovative Medicines
Director, Biostatistics
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Cheryl Grandinetti

FDA
Associate Director for Clinical Policy, CDER/OC/OSI/DCCE
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Courtney Granville

GO2 For Lung Cancer, United States
Chief Scientific Officer
SH

Sema Hashemi

FDA
Senior International Policy Advisor, OGPS, OC
LH

Lani Hashimoto

Novartis Pharmaceuticals Corporation
Clinical Trial Intelligence Manager
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Sabine Haubenreisser

European Medicines Agency
Principal Scientific Administrator, Stakeholders and Communication...
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Adam Heathfield

Pfizer
Senior Director, Patient and Health Impact
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Melissa Heidelberg

Takeda
Director, Global Bioethics and Technology Ethics Lead
MP

Melissa Pauline Herman

Lundbeck A/S
Senior Specialist, Patient Insights
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Ralf Herold

European Medicines Agency
Head of Regulatory Science and Academia Workstream (ad interim)
HH

Hideki Hiraoka

Pharmaceuticals and Medical Devices Agency
Reviewer
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Paula Horowitz

AbbVie
Program Manager, QA, GCP Software Validation
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Ryan Hoshi

AbbVie, United States
Director, Regulatory Policy and Intelligence
SH

Stacy Hurt

Ms,Stella O Houligan's Catnip Quilts
Artist
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Stacy Hurt, MBA, MHA

Parexel
Chief Patient Officer
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Huong Huynh

Critical Path Institute
Director of Regulatory Science
TH

TAE HYUN

FDA CDER
Senior Statistical Reviewer
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David Iacovelli

Digi International
Engineering Manager
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Edward Ian

Mediscience Planning Inc., Japan
Senior Executive Officer
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Ana-Claudia Ianos

Pfizer Inc, Switzerland
Senior Director, Safety Risk
DI

David Isom

Pfizer Inc
Senior Director, Global Regulatory Policy and Intelligence, Pfizer...
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Sheila Mahoney Jewels

LifeSciHub
Drug Development Multi-Functionalist
avatar for Emily (Xianghong) Jing

Emily (Xianghong) Jing

FDA, United States
Associate Director for Scientific Coordination, OBP, OPQ, CDER
TJ

Tony Johnson

Mallinckrodt Pharmaceuticals, United States
Senior Director, Clinical Quality
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Jeremy Jokinen

Bristol-Myers Squibb Company
Vice President and Head, Safety Evidence and Sciences
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Brad Jordan

Flatiron Health, United States
Senior Director, Head of Regulatory Affairs Policy
ZJ

Zhanna Jumadilova

Pfizer Inc, United States
Senior Director
AJ

Andrea Jux

Genmab US, Inc., United States
Senior Director, Development Program Management
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Linda Kalilani

GlaxoSmithKline, United States
Senior Director and Head of Oncology Epidemiology
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Nareen Katta

AbbVie, United States
Head of Data Science & Analytics
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Lindsay Kehoe

Clinical Trials Transformation Initiative (CTTI), United States
Senior Project Manager
FK

Fatima Khaiser

AbbVie, United States
Associate Director, Regulatory Affairs IVD and CDx
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Irfan Khan

Circuit Clinical
Founder and Chief Executive Officer
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Jennifer Kim

Tufts Center for the Study of Drug Development, United States
Research Assistant Professor
JK

Joseph Kim

Proofpilot
Chief Strategy Officer
LK

Lene Kirstein

H. Lundbeck A/S
Head of Regulatory Science & Strategy
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Jesper Kjaer

Novo Nordisk
Global Director for Public, Private Partnerships, Strat Ops, Global...
HK

Holly Kleinschrodt

Astellas, United States
Head, Device Quality
AK

Armin Koch

Hannover Medical School
Head, Institute of Biometry
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Ulrike Kochendoerfer

Pfizer Inc
Director, Medical Writing
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Leila Lackey

FDA
Program Lead, Decision Support Service, OPSA, OSP, CDER
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Dominique Lagrave

Accumulus Synergy
Senior Vice President of Regulatory Innovation
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Mary Jo Lamberti

Tufts Center for the Study of Drug Development
Director of Sponsored Research, Research Associate Professor
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Celeste Frankenfeld Lamm

Merck Sharp & Dohme LLC
Senior Director, Global Regulatory Affairs – CMC
LL

Laura Lasiter

Astrazeneca, United States
Regulatory Affairs Director- Digital Health
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Agathe Le Lay

H. Lundbeck A/S, Denmark
Global Head of Value Evidence & Patient Insights
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Cathryn Lee

FDA, United States
Director, Office of Program Operations, PDIMS, OND, CDER
KL

Kevin Lee

BMS
Senior Director of Biometrics & Data Science
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Bennett Levitan

Johnson & Johnson
Executive Director, Benefit-Risk Assessment / Epidemiology
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Hangyu Liu

Biogen, United States
Senior Manager, Data Scientist
JL

John Lockwood

Cencora Pharmalex, United States
Sr. Director
KV

Katherine Van Loon

UCSF Helen Diller Family Comprehensive Cancer Center, United States
Director, Global Cancer Program
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Jingyu (Julia) Luan

AstraZeneca, United States
Executive Regulatory Science Director, BioPharmaceuticals R&D
NM

Nell Meosky Luo

Folia Health
Chief Executive Officer
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Tara MacCannell

Vertex Pharmaceuticals
Head of RWE
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Demetra Macheras

AbbVie
Director, Regulatory Policy and Intelligence - Regulatory Affairs
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Nicole Mahoney

Novartis Pharmaceuticals Corporation, United States
Executive Director US Regulatory Policy & Intelligence
MM

Madhurima Majumder

Bayer US LLC, United States
Associate Director, Clinical Statistics and Analytics
TM

Tariro Makadzange

Zimbabwe Clinical Research Center, United States
Executive Director, Founder
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Alison Maloney

Bayer HealthCare Pharmaceuticals, United States
Head of Regulatory Affairs Americas
LM

Lynda Mante

IQVIA, Ghana
Director, Clinical Trial Regulatory Management
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Anabela Marcal

European Medicines Agency
EMA Liaison Official to the US FDA
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Ingrid Markovic

FDA
Senior Science Advisor for CMC, Office of the Center Director, CBER
KM

Kristi Martin

Camber Collective, United States
Director
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Sarah Martin

Eli Lilly & Co., United States
Senior Director - Global Regulatory Policy (Oncology)
MM

Miguelina Matthews

Sanofi, United States
Head of External Liaison
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Christine Mayer-Nicolai

Merck Healthcare KGaA
Vice President, Regulatory and Scientific Policy
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Christy Mazzarisi

Kinapse
Associate Director, Development Operations, Q&C/CTD
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Christy Mazzarisi

Network Partners Group
Quality and Clinical COE Lead
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Katherine McCarthy

AbbVie
Head of US/Canada, Regulatory Policy and Intelligence
KM

Kevin McCarthy

Afinety
President
MM

Michael McDonald

Health Products Regulatory Authority
Scientific and Technical Advisor to the Chief Executive
AM

Allison McDougall

G3 Translate , United States
Executive Director
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Lindsay McNair

Equipoise Consulting
Principal Consultant
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Melodi McNeil

AbbVie
Director, Regulatory Policy and Intelligence
DM

David Meats

Certara
Director, Regulatory Services Management
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Ann Meeker-O'Connell

FDA
Director, Office of Clinical Policy, Office of Clinical Policy and...
AM

Angela Men

The Whiteoak Group, Inc, United States
Chief Executive Officer
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Timothe Menard

F. Hoffmann-La Roche Ltd, Switzerland
Global Head, Quality Excellence Digital | Ambassador Global Bioethics...
AM

Amber Meriwether

Astellas Pharma, United States
Director
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Danielle Metzger

PharmaQ Consulting, United States
Principal Quality Consultant
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Pallavi Mishra-Kalyani

FDA, United States
Deputy Division Director, DBV, OB, CDER
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May Mo

Amgen, United States
Executive Director, Biostatistics
CM

Carol Morales

Astellas, United States
Lead, Quality Management and Capabilities
JA

Jodi Ann Mossie

DIA
Sr. Manager, Business & Digital Technology
FM

Florence Mowlem

Umotif, United Kingdom
Chief Scientific Officer
WM

Willie Muehlhausen

SAFIRA Clinical Research
Co-Founder
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David Mukanga

Bill & Melinda Gates Foundation, United States
Deputy Director, Africa Regulatory Systems
SM

Saurabh Mukhopadhyay

Abbvie, United States
Research Fellow, Statistical Innovations
EM

Erin Mulrooney

Daiichi Sankyo, Inc
Director, Portfolio Management
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Monica Munoz

FDA
Division Director, Division of Pharmacovigilance-I, OSE, CDER
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Nancy Myers

Catalyst Healthcare Consulting
CEO and Founder
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Jane Myles

Decentralized Trials and Research Alliance
Program Director
SN

Sridevi Nagarajan

Independent
DIA Communities Lead for AI in Healthcare
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Meera Nagaria

Johnson & Johnson
Senior Data Scientist
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Mehdi Najafzadeh

Medidata AI, United States
Senior Director
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Susan Neadle

Combination Products Consulting Services LLC
Principal Consultant and President
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Christiane Niederlaender

Parexel International, United Kingdom
Vice President, Technical
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Perla Nunes

Community Outreach and Clinical Research DEI Consultant, United States
Patient Advocate
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