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avatar for Bennett Levitan

Bennett Levitan

Janssen Research & Development, LLC
Senior Director, Benefit-Risk Assessment, Department of Epidemiology
ML

Meng Li

University of Macau
Master Student
avatar for Rebecca Li

Rebecca Li

Brigham and Women's Hospital
Executive Director, Harvard MRCT Clinical Trials Center
NL

Nina Liang

Novo Nordisk Inc.
Associate Director, Regulatory Affairs
avatar for Lawrence Liberti

Lawrence Liberti

Centre for Innovation in Regulatory Science (CIRS)
Executive Director
GL

Gracie Lieberman

Genentech, A Member of the Roche Group
Director Regulatory Policy
YP

Yen Ping Lim

National University of Singapore
Student
avatar for Robert Lionberger

Robert Lionberger

FDA
Director, Office of Research and Standards, Office of Generic Drugs,...
avatar for Craig Lipset

Craig Lipset

Pfizer Inc
Head of Clinical Innovation, Global Product Development
avatar for Rory Littlebury

Rory Littlebury

Medicines and Healthcare products Regulatory Agency (MHRA)
Pharmacovigilance Inspector
avatar for Iris Loew-Friedrich

Iris Loew-Friedrich

UCB, Inc.
Chief Medical Officer, Executive VP and Head, Development and Medical...
LL

LaShanda Long

FDA
Supervisor, Office of Scientific Investigations, OC, CDER
avatar for Ulrike Lorch

Ulrike Lorch

Richmond Pharmacology Ltd.
Medical Director
avatar for Sara Loud

Sara Loud

Accelerated Cure Project
Chief Operating Officer
avatar for Chung H. (Lou) Lu

Chung H. (Lou) Lu

Otonomy, Inc
Senior Director - Medical Affairs and Medical Information
LL

Lou Lu

Otonomy, Inc
Senior Director - Medical Affairs and Medical Information
avatar for Tyler Ludlow

Tyler Ludlow

Eli Lilly and Company
Senior Decision Scientist
JL

Jenny Ly

ERT
Clinical Science Advisor
JM

Jia Ma

ICON, plc.
avatar for Tom Macfarlane

Tom Macfarlane

Accenture Accelerated R&D Services
Director, Life Sciences
JM

John Maddox

Infusion Pharma Consulting LLC
Founder & Managing Director
avatar for Carmen Maher

Carmen Maher

FDA
Acting Assistant Commissioner for Counterterrorism Policy, OCS, OC
avatar for William Maier

William Maier

Mapi
Chief Scientific Officer, Head, Patient-Centered Sciences
KM

Kirolous Makarious

Touro College of Pharmacy
PharmD Candidate
CM

Christoph Male

Medical University of Vienna
Associate Professor of Paediatrics
avatar for Joanne Malia

Joanne Malia

Regeneron Pharmaceuticals
Associate Director, Clinical Documentation Management
avatar for Raleigh Malik

Raleigh Malik

DIA
Senior Scientific Liaison
avatar for Marie Manley

Marie Manley

Bristows LLP
Partner and Head of the Regulatory Practice
avatar for Anabela Marcal

Anabela Marcal

European Medicines Agency (EMA),
Head of Committees and Inspections Department
avatar for Olga Marchenko

Olga Marchenko

QuintilesIMS
Vice President, Advisory Analytics
CM

Cathy Marino

Celgene Corporation
Sr. Director, Customer Care
avatar for John Markman

John Markman

University of Rochester
Professor of Neurosurgery and Neurology
avatar for Peter Marks

Peter Marks

FDA
Director, Center for Biologics Evaluation and Research
avatar for Kevin Marsh

Kevin Marsh

Evidera
Executive Director
avatar for David Martin

David Martin

FDA
Associate Director for Real World Evidence Analytics, OMP, CDER
avatar for Stephane Marzabal

Stephane Marzabal

SYNOV Solutions LLC
Co Founder
avatar for Andrea Masciale

Andrea Masciale

Johnson & Johnson
Vice President, Regulatory Policy and Global Analytics
avatar for Chris Matheus

Chris Matheus

Matheus BD Connections
President
avatar for Steve Mayall

Steve Mayall

Pope Woodhead & Associates Ltd
Principal Consultant
RM

Ryan Mazon

Educational Measures
Senior Vice President, Business Development
avatar for Katie Mazuk

Katie Mazuk

Janssen Research & Development, LLC
Senior Director, Investigator and Patient Engagement
avatar for K. Kimberly McCleary

K. Kimberly McCleary

FasterCures, A Center of the Milken Institute
Managing Director
avatar for Susan McCune

Susan McCune

FDA
Director, Office of Pediatric Therapeutics, OSMP, OC
avatar for Anastasia McManus

Anastasia McManus

Alnylam Pharmaceuticals, Inc.
Medical Affairs Fellow
avatar for Jill McNair

Jill McNair

CISCRP
Senior Director, Patient Engagement
avatar for Lindsay McNair

Lindsay McNair

WIRB-Copernicus Group (WCG)
Chief Medical Officer
avatar for Melodi McNeil

Melodi McNeil

AbbVie, Inc.
Director
avatar for Christine McSherry

Christine McSherry

Jett Foundation
Executive Director
avatar for Ann Meeker-O'Connell

Ann Meeker-O'Connell

Johnson & Johnson
Senior Director/ Head, BioResearch Quality and Compliance, Consumer...
avatar for Munish Mehra

Munish Mehra

Tigermed
Executive Director
avatar for Niraj Mehta

Niraj Mehta

FDA
Associate Director for Global Regulatory Policy, GO, OC
avatar for Matthew Meitzner

Matthew Meitzner

Merck & Co., Inc.
Associate Director, Project Management
avatar for Andrew Melli

Andrew Melli

SOUSEIKAI Global Clinical Research Center
Senior Manager
avatar for Steven Mendivil

Steven Mendivil

Amgen Inc.
Senior Advisor International Quality
avatar for Mildred Menos

Mildred Menos

The Life Raft Group
Director of Project Management
MM

Michael Mentesana

PriceWaterhouseCoopers LLP
Partner, Global Pharmaceutical and Life Sciences R&D, Advisory...
avatar for Melissa Mielcarz

Melissa Mielcarz

QuintilesIMS
AD, Clinical Operations
avatar for Sanjeev Miglani

Sanjeev Miglani

APCER Life Sciences
Vice President-PV and Clinical Safety North America and Global...
avatar for Sarah Pope Miksinski

Sarah Pope Miksinski

FDA
Dir., Off. of New Drug Products; Dir. (Acting), Off. of Surveillance,...
avatar for Chris Miller

Chris Miller

3D Communications
Biostatistician, Communications Strategist, Medical Writer
VM

Vincent Miller

Duke Clinical Research Institute
Project Coordinator
avatar for Sandra Milligan

Sandra Milligan

Merck Research Laboratories
Senior Vice President, Head of Global Regulatory Affairs and Clinical...
MM

Mary Mills

Mary Mills & Associates, LLC
President
avatar for Jules Mitchel

Jules Mitchel

Target Health, Inc.
President
AM

Andrew Mitchell

Synchronoss
Director of Life Sciences
avatar for Nozomu Miyawaki

Nozomu Miyawaki

SOUSEIKAI Global Clinical Research Center
Senior Manager
avatar for Jonathan Mogford

Jonathan Mogford

Medicines and Healthcare products Regulatory Agency (MHRA),
Director of Policy
TM

Timothy Montague

GlaxoSmithKline
Director, Clinical Statistics
avatar for Gaz Monteath

Gaz Monteath

Link Global Solution Inc.
Executive Director
avatar for Mike Montello

Mike Montello

QuintilesIMS
VP, IT
BM

Benjamin Moody

QuintilesIMS
Clinical Analytics and Simulations Lead
avatar for Christine Moore

Christine Moore

Merck Research Laboratories
Global Head and Executive Director, GRACS CMC - Policy
avatar for Anne Morant

Anne Morant

H. Lundbeck A/S
Senior Specialist, Regulatory Science & Advocacy
avatar for Kazuhiko Mori

Kazuhiko Mori

Ministry of Health, Labour and Welfare (MHLW)
Councilor for Pharmaceutical Affairs, Minister’s Secretariat
avatar for Bruce Morimoto

Bruce Morimoto

Celerion
Vice President, Scientific Affairs
avatar for Richard Moscicki

Richard Moscicki

FDA
Deputy Center Director for Science Operations, OCD, CDER
avatar for Michael Mosier

Michael Mosier

EMB Statistical Solutions, LLC
Director, Biostatistics
avatar for Jay Mouser

Jay Mouser

Janssen Scientific Affairs, LLC
Principal, Medical Science Liaison
JM

Jamie Mullen

AstraZeneca
Global Clinical Leader
avatar for Theresa Mullin

Theresa Mullin

FDA
Associate Director for Strategic Initiatives, OCD, CDER
avatar for Mary Murray

Mary Murray

Bristol-Myers Squibb
Associate Director, Diversity and Patient Engagement
avatar for Sharon Murray

Sharon Murray

PAREXEL
Associate Director, Biostatistics
avatar for Bob Muzerall

Bob Muzerall

AMPLEXOR Life Sciences, LLC
Vice President, Sales & Sales Training
avatar for Jack Mycka

Jack Mycka

Medical Marketing Economics LLC (MME)
Global President and CEO
avatar for Laurie Myers

Laurie Myers

Merck & Co., Inc.
Global Health Literacy Director
avatar for Nancy Myers

Nancy Myers

Catalyst Healthcare Consulting, Inc
President and Founder
avatar for Jane Myles

Jane Myles

Genentech, A Member of the Roche Group
Head, Operational Intelligence and Innovation
avatar for Vineeth Nair

Vineeth Nair

Rutgers, The State University of New Jersey
Post-Doctoral Fellow
RN

Ritu Nalubola

FDA
Senior Policy Advisor, Office of Policy, Office of the Commissioner
avatar for Daina Nanchanatt

Daina Nanchanatt

Rutgers, The State University of New Jersey
Post-Doctoral Fellow
avatar for Moheb Nasr

Moheb Nasr

GlaxoSmithKline
Vice President, CMC Regulatory Strategy
avatar for Saumya Nayak

Saumya Nayak

QuintilesIMS
Associate Director, Patient Recruitment Programs, Asia Pacific
avatar for Anita Nelsen

Anita Nelsen

PAREXEL
Vice President and Head, Translational Medicine
avatar for Judith Ng-Cashin

Judith Ng-Cashin

INC Research
Chief Scientific Officer
avatar for Amanda Nguyen

Amanda Nguyen

Novartis/MCPHS
Post-Doctoral Fellow
avatar for Dawn Niccum

Dawn Niccum

Endocyte
Associate Director, Quality
avatar for Dawn Niccum

Dawn Niccum

Inseption Group
Director, Quality Assurance
MN

Mona Nili

St. John's University
Student
avatar for Lorraine Nolan

Lorraine Nolan

Health Products Regulatory Authority (HPRA)
Chief Executive
avatar for Roger Nosal

Roger Nosal

Pfizer Inc
Vice President, Global CMC
IN

Irene Nunes

Daiichi Sankyo Co., Ltd.
Executive Director, Global Regulatory Affairs
GO

Gwenn Oakes

Merck & Co., Inc.
Senior Scientist, Clinical Research, Global Trial Optimization
avatar for Terrance Ocheltree

Terrance Ocheltree

AbbVie, Inc.
Senior Director Regulatory Policy and Intelligence
avatar for Laura Odwazny

Laura Odwazny

Department of Health and Human Services
Senior Attorney, Office of Human Subject Protection, Office of...
avatar for Sam Oh

Sam Oh

UCSF School of Medicine
Director of Epidemiology, Asthma Collaboratory
avatar for David Olaleye

David Olaleye

SAS Institute Inc.
Senior Manager and Principal Research Statistician
avatar for Darin Oppenheimer

Darin Oppenheimer

Merck & Co., Inc.
Executive Director, Drug Device Center of Excellence
avatar for Paul O'Donohoe

Paul O'Donohoe

CRF Health
Director, Health Outcomes
avatar for Michael O'Kelly

Michael O'Kelly

QuintilesIMS
Senior Director, Centre for Statistics in Drug Development, Innovation
avatar for Robert Paarlberg

Robert Paarlberg

Paarlberg & Associates LLC
Principal
MP

Michael Pacanowski

FDA
Associate Director for Genomics and Targeted Therapy, OCP, CDER
avatar for Jeffery Painter

Jeffery Painter

Jivecast
Chief Executive Officer/Founder
JP

John Pakulski

Mylan Inc.
Head, Regulatory Science, Biologics
avatar for Katie Palermo

Katie Palermo

Ann and Robert H. Luie Childrens' Hospital Kids Advisory Board
Member
avatar for Melissa Palmer

Melissa Palmer

Shire
Global Development Lead, NASH
avatar for Gerald Dal Pan

Gerald Dal Pan

FDA
Director, Office of Surveillance and Epidemiology
EP

Elektra Papadopoulos

FDA
Associate Director, Clinical Outcome Assessments Staff, OND, CDER
avatar for Sudip Parikh

Sudip Parikh

DIA
Senior Vice President and Managing Director, DIA Americas
avatar for Cathy Parker

Cathy Parker

Health Canada
Director General, Biologics & Genetic Therapies Directorate HPFB
FP

Fatima Paruk

Allscripts Analytics
Chief Medical Officer
avatar for Nikunj Patel

Nikunj Patel

FDA
Clinical Outcome Assessments Reviewer, OND, CDER
avatar for Shivam Patel

Shivam Patel

University of North Carolina
Global Regulatory Affairs Fellow
KP

Katelyn Patterson

Leidos Biomedical Research, Inc
avatar for Elaine Paul

Elaine Paul

GlaxoSmithKline
Senior Director Clinical Development
KP

Krista Payne

Evidera
Vice President and Senior Research Scientist; RWE
avatar for Eric Peacock

Eric Peacock

MyHealthTeams
Co-founder and Chief Executive Officer
avatar for Michael Pencina

Michael Pencina

Duke Clinical Research Institute
Director of Biostatistics, Faculty Associate Director
avatar for Vada Perkins

Vada Perkins

Identifica, LLC
Identifica, LLC
avatar for Thomas Permutt

Thomas Permutt

FDA
Associate Director for Statistical Science and Policy, OB, OTS, CDER
AP

Aris Persidis

Biovista Inc.
President
avatar for Maryrose Petrizzo

Maryrose Petrizzo

Clinical Quality Assured, LLC
President and Principal Consultant
avatar for Vincent Philiponis

Vincent Philiponis

ICON, plc.
Medical Director, Medical Affairs
avatar for Michael Phinney

Michael Phinney

QuintilesIMS
Engagement Leader
avatar for Cinzia Piccini

Cinzia Piccini

Eli Lilly and Company
Medical Quality Organization, Biometrcis Consultant
avatar for Christine Pierre

Christine Pierre

Society for Clinical Research Sites
President
avatar for Marie-Helene Pinheiro

Marie-Helene Pinheiro

European Medicines Agency (EMA)
Industry Stakeholder Liaison, Corporate Stakeholders Department
avatar for Jill Platko

Jill Platko

CRF Health
Senior Scientific Advisor
PP

Paul Plumb

Rebiotix, Inc.
Head of Clinical Operations
avatar for Sandra van der Poel

Sandra van der Poel

Xendo Pharmacovigilance B.V.
Principal Consultant
avatar for Vaishali Popat

Vaishali Popat

FDA
Associate Director of Biomedical Informatics and Safety Analytics,...
avatar for Ronald Portman

Ronald Portman

Novartis Pharmaceuticals Corporation
Executive Director, Pediatric Therapeutic Area
avatar for Valerie Powell

Valerie Powell

Mapi
Director, Patient Insights and Engagement
avatar for John Powers

John Powers

George Washington University School of Medicine
Professor of Clinical Medicine
avatar for Sy Pretorius

Sy Pretorius

PAREXEL
Executive Vice President, Chief Medical & Scientific Officer
avatar for Gil Price

Gil Price

Propharma Group
Chief Medical Officer
avatar for Ranjini Prithviraj

Ranjini Prithviraj

DIA
Global Associate Director, Content Collaboration
avatar for Jill Pulley

Jill Pulley

Vanderbilt University Medical Center
Executive Director, Vanderbilt Institute for Clinical and...
JP

Jill Pulley

Vanderbilt University Medical Center
Executive Director, Vanderbilt Institute for Clinical and...
avatar for Nancy Pultorak

Nancy Pultorak

Audubon PM Associates
Project Manager
avatar for Vladimir Pyagay

Vladimir Pyagay

TransPerfect
Product Manager
XQ

Xiaoling Qin

China Food and Drug Adminsitration (CFDA)
Deputy Director General, Department of International Cooperation
avatar for Kim Quaintance-Lunn

Kim Quaintance-Lunn

Bayer
Vice President and Head, Regulatory Policy, North American...
avatar for Nusrat Rabbee

Nusrat Rabbee

Covance Inc.
Senior Statistical Fellow
avatar for Mirza Rahman

Mirza Rahman

Otsuka Pharmaceutical Development & Commercialization, Inc.
Vice President, Global Head of Pharmacovigilance and Medical Afairs
avatar for Srinivas Pai Raikar

Srinivas Pai Raikar

QuintilesIMS
Director
avatar for Mahesh Ramanadham

Mahesh Ramanadham

FDA
Division Director (Acting), Div. of Inspectional Assessment, OPF,...
avatar for Penny Randall

Penny Randall

IQVIA
Vice President and Head, CNS Center of Excellence
avatar for Gayatri Rao

Gayatri Rao

FDA
Director, Office of Orphan Products Development, Office of the...
avatar for Guido Rasi

Guido Rasi

European Medicines Agency (EMA)
Executive Director
avatar for Colleen Ratliffe

Colleen Ratliffe

FDA
Project Management Officer, Office of Strategic Programs, CDER
avatar for Charles Raymond

Charles Raymond

ICON, plc.
Manager, Commercial Affairs
avatar for Masooma Razvi

Masooma Razvi

University of North Carolina-GlaxoSmithKline
Regulatory Affairs Postdoctoral Fellow, GlaxoSmithKline
avatar for Juliana Reed

Juliana Reed

Coherus BioSciences
Vice President, Government Affairs
avatar for Jim Reilly

Jim Reilly

Veeva Systems
VP, Vault Clinical
avatar for John Reites

John Reites

THREAD
Chief Product Officer, Partner
avatar for Badri Rengarajan

Badri Rengarajan

Actelion
Medical Affairs Lead, ASPIRE Unit
DR

Dennis Revicki

Evidera
Senior Vice President, and Executive Director, COE for Outcomes...
RR

Robert Reynolds

Pfizer Inc.
Vice President, Epidemiology, Worldwide Safety, Research and...
avatar for Kim Ribeiro

Kim Ribeiro

AbbVie, Inc.
Manager, Strategic Patient Recruitment and Retention
avatar for Margaret Richards

Margaret Richards

Mapi
Vice President, Data Analytics and Epidemiology, RW Strategy and...
avatar for Patrick Ricucci

Patrick Ricucci

FDA
Associate Director of Regulatory Affairs (Acting), ONDP, OPQ, CDER
avatar for James Riddle

James Riddle

Advarra
Executive Vice President
avatar for MaryAnne Rizk

MaryAnne Rizk

Oracle Health Sciences
VP, Global CRO Partner Business
avatar for Amanda Roache

Amanda Roache

FDA
Operations Research Analyst, OCD, CDER
avatar for Mitra Rocca

Mitra Rocca

FDA
Associate Director, Medical Informatics, Office of Translational...
avatar for Tracy Rockney

Tracy Rockney

OneSource Regulatory
Co-Founder and Managing Partner
IR

Isabel Romero

Health Canada
Director, International Affairs
JR

Josh Rose

QuintilesIMS
Vice President, Strategic Operations
KR

Klaus Rose

klausrose Consulting
Chief Executive Officer
avatar for Samuel Rosen

Samuel Rosen

Mavens
Technical Architect
LR

Len Rosenberg

Leukemia & Lymphoma Society
Head, Clin Ops
avatar for Elizabeth Rosenkrands-Lange

Elizabeth Rosenkrands-Lange

LEO Pharma
Senior Manager, Regulatory Policy and Intelligence
avatar for Matthew Rotelli

Matthew Rotelli

Eli Lilly and Company
Director, Global PK/PD and Pharmacometrics
avatar for Nicky Rousseau

Nicky Rousseau

QuintilesIMS
Senior Director, Sales Organization Development
avatar for Upal Basu Roy

Upal Basu Roy

LUNGevity Foundation
Director of Translational Research Program/Director of Patient FoRCe
CR

Chi-Tun Ruan

TFDA
Reviewer
avatar for Keith Ruark

Keith Ruark

INC Research
Executive Director, Strategy Consulting
SR

Shamim Ruff

Sarepta Therapeutics
Senior Vice President of Regulatory Affairs and Quality
avatar for Daragh Ryan

Daragh Ryan

Actelion
eClinical and mHealth Consultant
avatar for Pierre Sabourin

Pierre Sabourin

Health Canada
Assistant Deputy Minister, Health Products and Food Branch
LS

Leonard Sacks

FDA
Associate Director for Clinical Methodology, Office of Medical...
avatar for Agnès Saint-Raymond

Agnès Saint-Raymond

European Medicines Agency (EMA)
Head of International Affairs, Head of Portfolio Board
MS

Mio Saito

Keio University
avatar for Angela van der Salm

Angela van der Salm

DADA Consultancy
Director Pharmacovigilance
avatar for Sloane Salzburg

Sloane Salzburg

Prescriptions For A Healthy America
Executive Director
avatar for Leslie Sam

Leslie Sam

Eli Lilly and Company
Director, Global Quality Systems, Safety, Efficacy and Customer...
WS

William Sarraille

Sidley Austin, LLP
Partner
MA

Muntazir Ali Sayed

RCSM Government Medical College; CPR General Hospital
Medical Student


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