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avatar for Kelly FitzGerald

Kelly FitzGerald

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

Ron Fitzmartin

Decision Analytics, United States
Principal Consultant
avatar for Kevin Fitzpatrick

Kevin Fitzpatrick

AbbVie, United States
Senior Vice President, Quality Assurance
PF

Philip Floyd

AbbVie, United States
Global Vice President, Analytical R&D
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Jeffrey Francer

Eli Lilly and Company, United States
Vice President, Head of International Regulatory Affairs and Global...
MF

Marc Franklin

Cipla, United States
CEO - North America
avatar for Daniel R. Coradi de Freitas

Daniel R. Coradi de Freitas

ANVISA, Brazil
GENERAL MANAGER
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Pete Fronte

Altura, United States
Founder and Chief Executive Officer
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Ellie Froslan

University of Southern California, United States
Student
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Motoki Fujii

EPS Group, Japan
Exective Professional
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Andrew Funk

NABP, United States
Director, Member Relations/Government Affairs
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Patricia Furlong

Parent Project Muscular Dystrophy, United States
Founding President and Chief Executive Officer
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Susan Furth

Children's Hospital of Philadelphia, United States
Executive Vice President and Chief Scientific Officer
SG

Shanelle Gabriel

Building Constellations, LLC, United States
Patient Advocate/Speaker/Poet
SG

Shanelle Gabriel

N/A, United States
Patient Advocate
avatar for Shelley Gandhi

Shelley Gandhi

Eliquent Life Sciences, United Kingdom
Partner & PV trainer
avatar for Helga Gardarsdottir

Helga Gardarsdottir

Utrecht University, Netherlands
Professor RWD for decision making on medicines
avatar for Carlos Garner

Carlos Garner

Eli Lilly and Company, United States
Senior Vice-President Global Regulatory Affairs and Head, Lilly...
EG

Eric Gascho

CRD Associates, United States
Vice President
avatar for Vera Gattás

Vera Gattás

Instituto Butantan , Brazil
QPPV
LG

Lauren Geary

Eli Lilly and Company, United States
Senior Director, GSC, Regulatory Writing and Submission Capabilities
avatar for Emily Gebbia

Emily Gebbia

FDA, United States
Associate Director for Regulatory Development, OC, OSI, CDER
HG

Heran Gerba

Ethiopian Food and Drug Authority (EFDA), Ethiopia
Director General
avatar for Ellyn Getz

Ellyn Getz

CSL Behring, United States
Director, R&D Patient Engagement
avatar for Kenneth Getz

Kenneth Getz

Tufts University School of Medicine, United States
Tufts Center for the Study of Drug Development
JG

Jonathan Gilbert

Eli Lilly and Company, United States
Senior Director, Ecosystem Growth and Contributor Partnerships
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Eileen Girten

Pfizer, United States
Medical Writing Therapeutic Area Lead
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Richard Gliklich

OM1, United States
Founder & Director
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Joga Gobburu

Vivpro Corp, United States
Co-Founder
WY

Wan Yee Goh

Singapore Economic Development Board, Singapore
Senior Vice President and Head, Healthcare
avatar for Melissa Gottschlich

Melissa Gottschlich

Accellacare, United States
Senior Director Site Network
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Cheryl Grandinetti

FDA, United States
Associate Director for Clinical Policy, CDER/OC/OSI/DCCE
TG

Timothy Graul

Pfizer, United States
Senior Director
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Mary Gray

Microsoft Research, United States
Senior Principal Researcher
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Audrey Greenberg

Venture Partner and Chair, Mayo Ventures, United States
Mayo Clinic
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Catherine Gregor

Florence Healthcare, United States
Chief Clinical Trial Officer
CG

Cassie Gregson

AstraZeneca, United States
VP Head of AI Enterprise Process & Innovation Center
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Alberto Grignolo

DIA Global Forum, United States
Editor-in-Chief
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Simina Grigoriu

Accent Therapuetics, United States
Director, R&D Operations
MG

Mindy Gruba

Moderna, United States
Associate Director, Clinical Trial Digital Health
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Julie Guery

Sanofi, United States
Global Regulatory Affairs Labeling Head
JG

Ji Guo

FDA, United States
Chemist, OPQ, CDER
JS

Jingchuan Serena Guo

Purdue University, United States
Associate Professor
MG

Mansi Gupta

None, United States
none
avatar for Rahul Gupta

Rahul Gupta

GATC Health, United States
President
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Thomas Haag

Cardinal Solutions Consuting, LLC, United States
Principal Consultant
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Samantha Hadfield

Thermo Fisher Scientific, United Kingdom
Vice President, Operational Delivery, PPD FSP solutions
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Mary Thanh Hai

FDA, United States
Deputy Director for Clinical, OND, CDER
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Jackson Hanf

University of Southern California, United States
Student
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Morgan Hanger

Clinical Trials Transformation Initiative (CTTI), United States
Executive Director
NH

Nadia Harhen

SandboxAQ, United States
General Manager, AI Simulation
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Matt Harrington

Syneos Health, United States
Global Head, Clinical Product, Syneos Technology Solutions
JH

Jason Harris

National Psoriasis Foundation, United States
Vice President, Government Relations and Advocacy
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Sema Hashemi

FDA, United States
Senior International Policy Advisor
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Lani Hashimoto

Hashimoto Consulting Services, United States
Consultant, Patient Experience
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Farrell Healion

Optitrial, United Kingdom
Founder & Managing Director
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Syneos Health

United States
RH

Rhonda Hearns-Stewart

FDA, United States
Senior Physician
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Martin Heitmann

International Society for Pharmaceutical Engineering (ISPE), Germany
Volunteer – ISPE GAMP Guide Artificial Intelligence Co-Lead,...
FH

Famina Hemani

Tourmaline Bio, United States
Vice President, Head of Pharmacovigilance
FH

Famina Hemani

Tourmaline Bio, United States
Vice President, Head of Pharmacovigilance
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David Henderson

Google Cloud, United States
AI Customer Engineer, Life Sciences
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Rachele Hendricks-Sturrup

Duke-Margolis Institute For Health Policy (DMI), United States
Research Director, Real-World Evidence
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Adrian Hernandez

Duke Clinical Research Institute , United States
Professor of Medicine; Executive Director
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Rohini Hernandez

Amgen, United States
Director, Center for Observational Research
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Loriana Hernandez-Aldama

Armorup Media, United States
Patient Advocate|2x Survivor| Founder, ArmorUp for Life
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Mitch Herndon

UCB Biosciences, United States
Head, Patient Experience & Recruitment
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Joanne Hilton

GlaxoSmithKline, United Kingdom
VP, Global Medical Writing
LH

Laura Hilty

HealthX Ventures, United States
Principal
KH

Kaveen Hiniduma

Ohio State University, United States
Graduate Research Associate
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Karen Hinkle

Boehringer Ingelheim , United States
Associate Director, Medical Writing
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Peter Hjelmstrom

Uppsala Monitoring Centre (UMC), Sweden
Director/CEO
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Martin Hodosi

Kearney, United States
Partner, Healthcare and Life Sciences Practices
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Donna Holder

HDMA Advisory, United States
Principal
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Sabhorak Horn

Eli Lilly and Company, United States
Medical Omnichannel Education Manager
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Endang Hoyaranda

Indonesian Association For the Study of Medicinals (IASMED), Indonesia
President
avatar for BI-KAI HSU

BI-KAI HSU

Center For Drug Evaluation, Taiwan, Taiwan
Senior Project Manager
avatar for Kevin Hudziak

Kevin Hudziak

Eli Lilly and Company, United States
Senior Director - Patient Engagement, Clinical Trial Retention
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Lindsay Hughes

IQVIA, United States
Principal, RDS
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Valerie Huh

Propharma, United States
Director, Global Innovation and Implementation
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Stacy Hurt, MBA, MHA

Parexel, United States
Chief Patient Officer
RL

Renato Lopes Hurtado

ANVISA, Brazil
head the Management of Inspection and Health Surveillance of...
avatar for Ana-Claudia Ianos

Ana-Claudia Ianos

Pfizer, United States
Senior Director, Safety Risk Management Lead
SI

Sameera Ibrahim

Bristol Myers Squibb, United Kingdom
Head of Risk Governance & Operations, R&D Quality
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Taruna Ikrar

Indonesia Food and Drug Authority, Indonesia
Chairperson
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William Illis

Novartis , United States
Executive Director, Technology and Scientific Computing
CI

CGS Immersive

United States
KI

Kaisa Immonen

European Medicines Agency, Netherlands
Patient and Consumer Liaison
FH

Faro Health Inc.

United States
avatar for Akihiro Ishiguro

Akihiro Ishiguro

Pharmaceuticals and Medical Devices Agency (PMDA), Japan
Head of PMDA, Washington D.C. Office
avatar for Alex Juma Ismail

Alex Juma Ismail

University of Hertfordshire, United Kingdom
PhD Student
RJ

Ross Jackson

Ross Jackson Consulting, United Kingdom
Patient Recruitment Specialist
SJ

Samir Jain

Medidata, a Dassault Systèmes Company, United States
Head of EHR and Interoperability Solutions
avatar for Sarah Jarvis

Sarah Jarvis

ZS Associates, United States
Global Medical & Evidence Lead
LJ

Laura Jawidzik

FDA, United States
Division Director, Division of Neurology 2 (DN2), OND, CDER
avatar for Dhruv Jayanth

Dhruv Jayanth

OpenAI, United States
Business Lead, Life Sciences
avatar for Neda Jiveh

Neda Jiveh

Pfizer, United States
Medical Information and Review Fellow
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Wenora Johnson

United States
Administrative Support & Research/Patient Advocate
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Jeremy Jokinen

Argenx, United States
Vice President Global Patient Safety
avatar for Karin Jonczak

Karin Jonczak

Bristol Myers Squibb, United States
Clinical Capabilities Lead, Director
JJ

Jeremy Jones

BeOne Medicines, United States
Director, R&D Quality Operations & Excellence
avatar for Ashley Jones-Mitchell

Ashley Jones-Mitchell

Accumulus Synergy, United States
Head of Global Regulatory Policy
avatar for Angelika Joos

Angelika Joos

MSD, Belgium
Executive Director, Science & Regulatory Policy
avatar for Brad Jordan

Brad Jordan

Eli Lilly and Company, United States
Associate Vice President, Regulatory Policy and Strategy
JB

Joaquim Berenguer Jornet

European Medicines Agency, Netherlands
AI Implementation lead, Digital Business Transformation Task Force
avatar for Ali Al Juboori

Ali Al Juboori

Azurity Pharmaceuticals, United States
Medical Science Liaison
avatar for Zhanna Jumadilova

Zhanna Jumadilova

Pfizer, United States
Clinical Lead
avatar for Elizabeth Jungman

Elizabeth Jungman

Hogan Lovells US LLP, United States
Partner, Global Regulatory
avatar for MIDHUN RAJ K

MIDHUN RAJ K

IQVIA, India
Associate Director, Signal Management
RK

Rohit Kadam

TATA CONSULTANCY SERVICES LIMITED, INDIA, India
Researcher, TCS ADD
avatar for Linda Kalilani

Linda Kalilani

GSK, United States
Executive Director and Head of Oncology Epidemiology
avatar for Joseph Kannarkat

Joseph Kannarkat

Johns Hopkins University School of Medicine, United States
Physician
TK

TzuYuan Kao

University of Washington, United States
Student
MK

Meghana Karnaty

Northeastern University, United States
masters in regulatory affairs
avatar for Raymond Kassekert

Raymond Kassekert

GSK, United States
Executive Director, PV Systems Management
avatar for Akanksha Kaushal

Akanksha Kaushal

PhRMA, United States
Director, Science and Regulatory Advocacy
BK

Brian Kennedy

Global Alliance for Patient Access, United States
Executive Director
avatar for Sean Khozin

Sean Khozin

Roundtable on Cancer (CEORT) and Project Data Sphere (PDS), United States
CEO
avatar for Tina Kiang

Tina Kiang

FDA, United States
Director, Division of Regulation and Guidance, OPPQ, OPQ, CDER
CK

Cameron Kieffer

Takeda, United States
Director, Global Regulatory Intelligence and Policy Research
EK

Edward Kim

FDA, United States
Analyst
avatar for Jennifer Kim

Jennifer Kim

Tufts Center for the Study of Drug Development, United States
Research Associate Professor
avatar for Josh Kim

Josh Kim

Artos AI, United States
CEO
JH

Ju Hwan Kim

Sungkyunkwan University, Korea, Republic of
Research Professor
avatar for Sabina Kineen

Sabina Kineen

Fabry Support & Information Group, United States
Lived Experience Expert
OK

Olaf Klungel

Utrecht University, Netherlands
Professor of Pharmacoepidemiologic Methods
avatar for Chaitanya Koduri

Chaitanya Koduri

US Pharmacopeia, United States
Director, International Government and Regulatory Engagement
avatar for Daisuke Koga

Daisuke Koga

Pharmaceuticals and Medical Devices Agency (PMDA), Japan
Director, Office of International Strategy and Planning
avatar for Evdokia Korakianiti

Evdokia Korakianiti

European Medicines Agency, Netherlands
Head of Quality and Safety of Medicines
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Becky Kottschade

Mayo Clinic, United States
Administrator, Clinical Research
CL

Carolina Lopes Krahn

ANVISA, Brazil
Health Regulation Specialist
avatar for Nathan Kreischer

Nathan Kreischer

Merck & Co., Inc., United States
Director, Global Project & Alliance Management
LK

Lauren Krupp

NYU Langone Health, United States
Director, Multiple Sclerosis Comprehensive Care Center
avatar for Ayaka Kubota

Ayaka Kubota

Pharmaceuticals and Medical Devices Agency (PMDA), Japan
Office of Safty II
MK

Michael Kuchenreuther

Numerof & Associates, United States
Director Research & Analytics
avatar for Raju Kucherlapati

Raju Kucherlapati

Harvard Medical School, United States
Paul C. Cabot Professor of Genetics and Professor of Medicine
MM

Maggie McGuire Kuhl

The Michael J. Fox Foundation For Parkinson's Research, United States
Vice President, Patient Engagement
avatar for Irene Kuhlman

Irene Kuhlman

Bayer, Netherlands
Global Labeling Strategist
KK

Kaili Kulbacki

Solaire Solutions, United States
Clinical Research Professional
VK

Vijay Kumar

FDA, United States
Acting Director OTP/CBER
HK

Houshen Kuo

Taiwan Food and Drug Administration, Taiwan
reviewer
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Robin Kuprewicz

Georgetown University, United States
Clinical Trials Director
JK

Joseph Kutza

Eli Lilly and Company, United States
Senior Director Regulatory Policy - CMC
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Hyeonmin Kwon

Korea Institute of Drug Safety and Risk Management (KIDS), Korea, Republic of
Assistant Manager
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Leila Lackey

Pfizer, United States
Director, Patient Preference Evidence Generation
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Dominique Lagrave

Accumulus Technologies, United States
Chief Regulatory Officer
avatar for Dominique Lagrave

Dominique Lagrave

Accumulus Technologies, United States
Chief Regulatory Officer
avatar for Bahar Lakeh

Bahar Lakeh

Georgetown University School of Medicine, United States
Student
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Celeste Frankenfeld Lamm

Merck & Co., Inc., United States
Senior Director, Global Quality and Reg CMC Policy
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David Vulcano Landis

Association of Clinical Research Professionals (ACRP), United States
CEO
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Susan Landis

Association of Clinical Research Professionals (ACRP), United States
CEO
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Elizabeth Lange

EMD Serono, United States
Executive Director/ Head of Regulatory Scientific Policy
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Joseph Laudano

IQVIA, United States
Medical Director
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Anthony Lawler

Therapeutic Goods Administration, Australia
Deputy Secretary, Health Products Regulation Group
SL

SAMIR LEDADE

Alexion Pharmaceuticals, Canada
ASSOCIATE DIRECTOR
EL

Emma Lee

Gilead Sciences, United States
Executive Director and Head, US Medical Affairs Patient Access and...
avatar for Eui-Kyung Lee

Eui-Kyung Lee

SKKU (sungkyunkwan University), Korea, Republic of
Professor, School of Pharmacy
JL

Jeff Lee

Medstar Health Research Institute, United States
Board Director
JL

Jong-Hoon Lee

FDA, United States
Senior Physician
PL

Po-Hung Lee

Taiwan's Food and Drug Administration (TFDA), Taiwan
Associate Reviewer
AL

Aaron Leibtag

Pentavere, Canada
CEO
avatar for Julie Lepin

Julie Lepin

BeOne Medicines, United States
Senior Vice President & Chief Regulatory Officer
avatar for Joshua Levin

Joshua Levin

GSK, United States
Director, Global Regulatory Affairs, Precision Medicine and Digital...
avatar for Bruce Levine

Bruce Levine

Perelman School of Medicine at the University of Pennsylvania, United States
Barabara and Edward Netter Professor in Cancer Gene Therapy
avatar for Bennett Levitan

Bennett Levitan

Johnson & Johnson, United States
Executive Director, Benefit-Risk Assessment / Epidemiology
avatar for Jessie Li

Jessie Li

Fifth Quadrant, United States
Director of Project Delivery
avatar for Ji Li

Ji Li

FDA, United States
Reviewer, Division of Clinical Outcome Assessment, OND, CDER
LL

Linghui Li

Takeda, United States
Associate Director
ML

Michael Lingzhi Li

Harvard Business School, United States
Assistant Professor
avatar for Lawrence Liberti

Lawrence Liberti

The Kim Center/ USC DRQS, United States
Director, D.K. Kim International Center for Regulatory Science
avatar for Carmen Lin

Carmen Lin

Roche, Canada
Global Regulatory Affairs Content Strategist Specialist
avatar for Elaine Lippmann

Elaine Lippmann

Leavitt Partners, United States
Principal
avatar for Anran Liu

Anran Liu

FDA, United States
ORISE Postdoctoral Fellow
avatar for ChiaPing Liu

ChiaPing Liu

Taiwan Food and Drug Administration, Taiwan
Senior Technical Specialist
avatar for Jingyu (Julia) Luan

Jingyu (Julia) Luan

AstraZeneca, United States
Executive Regulatory Science Director
TL

Tricia Luhn

Genentech, United States
RWD Oncology
TL

Tricia Luhn

Genentech, A Member of the Roche Group, United States
RWD Oncology
SL

Sydney Lupkin

National Public Radio (NPR), United States
NPR Pharmaceutical Correspondent
avatar for Jennifer Lyons

Jennifer Lyons

Harvard Pilgrim Health Care Institute, United States
Research Scientist
avatar for Jeff MacDonald

Jeff MacDonald

BeOne Medicines, United States
Associate Director, Global Regulatory Policy and Intelligence
avatar for Christina Mack

Christina Mack

IQVIA, United States
CSO RWE and SVP AAIS
KM

Kristi Malone

Boehringer Ingelheim, United States
Lay Language & New Media Medical Writer
avatar for Alison Maloney

Alison Maloney

Bayer , United States
Head of Regulatory Affairs North America
avatar for Lesley Maloney

Lesley Maloney

Genentech, A Member of the Roche Group, United States
Regulatory Policy Lead
avatar for Cezar Jr. Manansala

Cezar Jr. Manansala

Centro Escolar University, Philippines
Student
HM

Himanshu Manchanda

Bayer, Germany
Machine Learning Scientist
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Shweta Maniar

Google, United States
Global Director, Strategic Industries - Life Sciences
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Jeppe G. Manuel

Novo Nordisk A/S, Denmark
Data Science External Affairs & Intelligence Director
avatar for Judith Maro

Judith Maro

Harvard Medical School, United States
Associate Professor, Department of Population Medicine
avatar for Katrina Mateo

Katrina Mateo

Regeneron Pharmaceuticals, United States
Associate Director, Development Innovation
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Arun Mathew

AbbVie, United States
Director
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Yoshihiro Matsuda

Pharmaceuticals and Medical Devices Agency (PMDA), Japan
Senior Scientist (for Quality), Pharmacist
AM

Alison Matsui

Genentech, A Member of the Roche Group, United States
Senior Principal PCOR Scientist
RM

Ruri Matsumoto

Pharmaceuticals and Medical Devices Agency (PMDA), Japan
Office of Non-clinical and Clinical Compliance I
JM

Julia Mauro

DIA, United States
Project Specialist
MM

Michael Mayrosh

Eli Lilly and Company, United States
Associate Director Global Regulatory Policy and Strategy
avatar for Christy Mazzarisi

Christy Mazzarisi

Network Partners Group, United States
Partner, Quality
avatar for Megan McCabe

Megan McCabe

The University of Alabama at Birmingham, United States
Assistant Professor, Department of Biostatistics
avatar for Sorcha McCrohan

Sorcha McCrohan

DIA, United States
Sr. Scientific Project Manager
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