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Joshua Korzenik

Brigham and Women's Hospital
Director, Crohn's and Colitis Center
avatar for Sarrit Kovacs

Sarrit Kovacs

Clinical Outcome Assessments (COA) Staff, OND, CDER
avatar for Michael Krams

Michael Krams

Janssen Pharmaceuticals, Inc.
Vice President, Global Head Quantitative Sciences

Michael Kranz

Experient, Inc.
avatar for James Kremidas

James Kremidas

Association of Clinical Research Professionals (ACRP)
Executive Director
avatar for Mark Kryah

Mark Kryah

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

Wayne Kubick

Chief Technology Officer
avatar for Jürgen Kübler

Jürgen Kübler

CSL Behring GmbH
Global Head, Quantitative Safety Sciences
avatar for Jürgen Kübler

Jürgen Kübler

CSL Behring GmbH
Global Head, Quantitative Safety Sciences

Prajna Kumar

Texila American University
PhD Candidate
avatar for Barbara Lopez Kunz

Barbara Lopez Kunz

Global Chief Executive
avatar for Tatsuo Kurokawa

Tatsuo Kurokawa

Japan Self-Medication Industry
avatar for John Kurtz

John Kurtz

Janssen R & D, LLC
Senior Director, External Alliances
avatar for Rebecca Kush

Rebecca Kush

President and Chief Executive Officer
avatar for Sandra Kweder

Sandra Kweder

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

Michael Laddin

Chief Executive Officer

Dominique Lagrave

Director, Global Regulatory Affairs and Safety Operations
avatar for Reshma Lakhram

Reshma Lakhram

Touro College of Pharmacy
avatar for Mary Jo Lamberti

Mary Jo Lamberti

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

Terri Landis


Karyn Lasky

TKL Research, Inc.
Director, Clinical Operations

Camilla Lau

Gilead Sciences
Sr. Clinical Trial Manager
avatar for Hai-Ha Le

Hai-Ha Le

Claude Bernard Lyon 1 University
PhD Candidate, Pharmacology
avatar for David LeDuc

David LeDuc

Addario Lung Cancer Medical Institute
Senior Director of Strategic Alliances
avatar for Andy Lee

Andy Lee

Merck & Co., Inc.
Senior Vice President, Head of Global Clinical Trial Operations
avatar for Cecil Lee

Cecil Lee

Eli Lilly and Company
Knowledge Management Advisor, Global Customer Information
avatar for Jeffrey Lee

Jeffrey Lee

mProve Health
Chief Executive Officer
avatar for Jessie Lee

Jessie Lee

Associate Director, Site and Patient Networks
avatar for Amy Leitman

Amy Leitman

NTM Info & Research
Director of Policy & Advocacy
avatar for Bhavish Lekh

Bhavish Lekh

Associate Global Feasibility Lead

Jennifer Lentz

Eli Lilly and Company
Consultant, Global Informed Business Lead

Lauralee Leonard

Bristol-Myers Squibb Company
Senior Scientific Writer
avatar for Patricia Leuchten

Patricia Leuchten

The Avoca Group
Chief Executive Officer and President

Gregory Levin

Deputy Director, DBIII, OB, OTS, CDER
avatar for Bennett Levitan

Bennett Levitan

Janssen Research & Development, LLC
Senior Director, Benefit-Risk Assessment, Global R&D Epidemiology
avatar for Debra Lewis

Debra Lewis

Food and Drug Administration
Deputy Director, Office of Orphan Products Development

Charles Li

Teva Pharmaceuticals
avatar for Lawrence Liberti

Lawrence Liberti

Centre for Innovation in Regulatory Science (CIRS)
Head, Regulatory Collaborations
avatar for Xiu Wei Lim

Xiu Wei Lim

Regional Clinical Innovation and Operational Excellence Head

Yen Ping Lim

National University of Singapore
avatar for Elizabeth Lincoln

Elizabeth Lincoln

Global Director of Engagement
avatar for Wendy Lipworth

Wendy Lipworth

University of Sydney
Senior Research Fellow, Centre for Values, Ethics and the Law in...
avatar for Daniel Liu

Daniel Liu

Beijing Clinical Service Center
Chief Science Officer
avatar for Feng Liu

Feng Liu

Manager, Statistics, RD Projects Clinical Platforms and Sciences

Kenneth Liu

Merck & Co. Inc.
Senior Principal Scientist

Richard Lostritto

Acting Director, Office of Policy for Pharmaceutical Quality, OPQ,...
avatar for Victor Lu

Victor Lu

Biologist, Office of Cellular, Tissue and Gene Therapies, CBER
avatar for Elizabeth Luczak

Elizabeth Luczak

Covance Inc.
Vice President, Regulatory Compliance Quality Assurance

Richard Macaulay

Parexel Access
Senior Director
avatar for Tom Macfarlane

Tom Macfarlane

Accenture Accelerated R&D Services
Director, Life Sciences
avatar for Cheryl Mahon

Cheryl Mahon

Astellas Pharma US, Inc.
Director, Clinical Pharmacy
avatar for Amita Malik

Amita Malik

Oracle Health Sciences
Senior Manager, Product Management

John Manganaro

Bayer HealthCare Pharmaceuticals
Deputy Director, Regulatory Policy and Intelligence
avatar for Anabela Marcal

Anabela Marcal

European Medicines Agency (EMA),
Head of Committees and Inspections Department
avatar for Heidi Marchand

Heidi Marchand

Assistant Commissioner, Office of Health and Constituent Affairs, OC
avatar for Robin Marcus

Robin Marcus

GlobalCare Clinical Trials
SVP Business Development & Strategic Initiatives
avatar for Karen Marks

Karen Marks

Baxter International, Inc.
Vice President, Global Program Management Office
avatar for Peter Marks

Peter Marks

Director, Center for Biologics Evaluation and Research
avatar for Micheline Marshall

Micheline Marshall

Janssen Pharmaceutical Companies of Johnson & Johnson
Head Randomization and Trial Supply Management

Linda Martin

KMR Group Inc.
President and Founder
avatar for Scott Martin

Scott Martin

KMR Group Inc.
avatar for Philip Masaitis

Philip Masaitis

Philadelphia College of Pharmacy, University of the Sciences
avatar for Andrea Masciale

Andrea Masciale

Johnson & Johnson
Vice President, Regulatory Policy and Global Analytics

Julie Massicotte

Algorithme Pharma
Director, Clinical Pharmacology and Regulatory Affairs
avatar for Tammy Massie

Tammy Massie

National Institutes of Health (NIH)
Mathematical Statistician, Office of Equal Opportunity and Customer...
avatar for Chris Matheus

Chris Matheus

Matheus BD Connections LLC
avatar for Christopher Matheus

Christopher Matheus

YPrime Inc
Director, Business Development

Ramya Mathew

Rutgers, The State University of New Jersey
Post-Doctoral Fellow, Medical Affairs
avatar for Tomoko Matsumoto

Tomoko Matsumoto

Gifu Pharmaceutical University
Student, Global Regulatory Science, Pharmaceutical Science
avatar for Christa Maurer

Christa Maurer

Bristol-Myers Squibb Company
Sr. Compliance Specialist
avatar for Russell Maus

Russell Maus

Merck & Co., Inc.
avatar for Steve Mayall

Steve Mayall

Pope Woodhead & Associates Ltd
Principal Consultant
avatar for Philomena McArthur

Philomena McArthur

Johnson & Johnson International
Vice President Global Policies, Procedures & Training, Healthcare...
avatar for Neil McAuslane

Neil McAuslane

Centre for Innovation in Regulatory Science (CIRS)
avatar for Mark McCamish

Mark McCamish

Sandoz, Inc
Global Head Biopharm and Oncology Injectables Development
avatar for Deirdre McCarthy

Deirdre McCarthy

Quintiles Inc.
Senior Benefit Risk Management Director
avatar for K. Kimberly McCleary

K. Kimberly McCleary

FasterCures, A Center of the Milken Institute
Managing Director

Neil McCullough

ICON Clinical Research
Executive Vice President, Clinical Quality Compliance

Dan McDonald

Director, Business Development
avatar for Newell McElwee

Newell McElwee

Merck & Co., Inc.
Assistant Vice President, Center for Observational and Real-world...

Maureen McGee

Merck & Co., Inc.
Senior Scientist
avatar for Denisa McKnight

Denisa McKnight

Roche Products Limited
Patient Engagement and Media

Richard McNally

Covance Inc.
Statistical Fellow
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 Manthan Mehta

Manthan Mehta

Topiwala National Medical College & BYL Nair Charitable Hospital
avatar for Andrew Melli

Andrew Melli

SOUSEIKAI Global Clinical Research Center
Senior Manager
avatar for Lubna Merchant

Lubna Merchant

Deputy Office Director, OMEPRM, OSE, CDER
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

Dir., Off. of New Drug Products; Dir. (Acting), Off. of Surveillance,...
avatar for Christopher Milan

Christopher Milan

Touro College of Pharmacy
Pharmacy Student, Phi Lambda Sigma Chapter President
avatar for Lewis Millen

Lewis Millen

Roche Products Limited
Operational Intelligence Leader
avatar for Colin Miller

Colin Miller

avatar for Eva Miller

Eva Miller

Independent Biostatistical Consultant
avatar for Kristen Miller

Kristen Miller

Health Scientist Policy Analyst, Office of Medical Policy, CDER
avatar for Sandra Milligan

Sandra Milligan

Merck Research Laboratories
Senior Vice President, Head of Global Regulatory Affairs and Clinical...
avatar for Marsha Millikan

Marsha Millikan

Eli Lilly and Company
Advisor, Expedited Reporting Global Patient Safety
avatar for Christopher Milne

Christopher Milne

Tufts Center for the Study of Drug Development
Director of Research and Research Associate Professor
avatar for Michael Minor

Michael Minor

ICON Peri-Approval and Observational Research
Senior Vice President, Global Head Operations and Strategic Planning
avatar for Alan Minsk

Alan Minsk

Arnall Golden Gregory LLP
Partner, Head of Food and Drug Team
avatar for Ed Miseta

Ed Miseta

Life Science Connect
avatar for Kenneth Moch

Kenneth Moch

Salutramed Group, LLC
Managing Partner

Christopher Moen

Choroideremia Research Foundation
avatar for Jonathan Mogford

Jonathan Mogford

Medicines and Healthcare products Regulatory Agency (MHRA),
Director of Policy
avatar for Ganapathy Mohan

Ganapathy Mohan

Merck & Co., Inc.
Head of External Affairs (Quality)
avatar for Gaz Monteath

Gaz Monteath

Link Global Solution Inc.
Executive Director
avatar for Ed Morgan

Ed Morgan

Health Canada
Director General, Policy, Planning and International Affairs...

Linda Morgan

Parkinson's Disease Foundation
Patient Representative FDA, Research Advocate; Chair, Patient...
avatar for Daichi Mori

Daichi Mori

Gifu Pharmaceutical University
Student, Global Regulatory Science, Pharmaceutical Science
avatar for Elaine Morrato

Elaine Morrato

Colorado School of Public Health
Professor Health Systems, Management and Policy

Eric Morrie

Director, Product Operations
avatar for Sandra Morris

Sandra Morris

Johnson & Johnson
Vice President, Strategy Realization
avatar for Michael Mosier

Michael Mosier

EMB Statistical Solutions, LLC
Director, Biostatistics
avatar for Stephan de la Motte

Stephan de la Motte

Synteract HCR
Chief Medical Advisor
avatar for Stephan de la Motte

Stephan de la Motte

Chief Medical Advisor
avatar for Isabelle Moulon

Isabelle Moulon

European Medicines Agency, European Union
Head of Patients and Healthcare Professionals Department
avatar for Willie Muehlhausen

Willie Muehlhausen

Head of Innovation
avatar for JoAnn Muir

JoAnn Muir

Novartis Pharmaceuticals Corporation
Global Head Franchise Quality Assurance
avatar for Andrew Mulberg

Andrew Mulberg

Deputy Division Director, Gastroenterology and Inborn Errors...
avatar for Jean Mulinde

Jean Mulinde

Policy Advisor, Division of Clinical Compliance Evaluation, OSI, OC,...

Rebecca Mullen

Northwestern University
avatar for Theresa Mullin

Theresa Mullin

Associate Director for Strategic Programs, CDER

Catherine Mulvale

Canadian Digestive Health Foundation
Executive Director (CDHF)

Madoka Murakami

Pharmaceuticals and Medical Devices Agency (PMDA)
Unit Chief, Division of Regulatory Cooperation, Office of...
avatar for Noriaki Murao

Noriaki Murao

NM Consulting

Mary Murphy

Director, Office of Pediatric Therapeutics, Office of Special Medical...

Kristin Murray

Shire Pharmaceuticals
Director, Global CMC Regulatory Affairs
avatar for Mary Murray

Mary Murray

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

Nathan Murray

Eli Lilly and Company
Global PRA Advisor, Autoimmune
avatar for Richard Murray

Richard Murray

Merck & Co., Inc.
Vice President and Deputy Chief Medical Officer
avatar for Sharon Murray

Sharon Murray

Associate Director, Biostatistics
avatar for Bob Muzerall

Bob Muzerall

AMPLEXOR Life Sciences, LLC
Vice President, Sales and Sales Training
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 Nancy Myers

Nancy Myers

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

Jane Myles

Head, Decentralized Trials Implementation

Raj Nair

Medical Officer, DPARP, OND, CDER

Masahide Nakajima

Mitsubishi Tanabe Pharma Corporation
Manager, Pharmacovigilance Cordination & Administration Department....
avatar for Nobumasa Nakashima

Nobumasa Nakashima

Ministry of Health, Labour and Welfare (MHLW)
Director, Office of International Regulatory Affairs
avatar for Mehdi Namil

Mehdi Namil

University of North Texas Health Science Center
Student, College of Pharmacy
avatar for Gopalan Narayanan

Gopalan Narayanan

NDA Group
Biologics and Advanced Therapies Expert
avatar for Moheb Nasr

Moheb Nasr

Vice President, CMC Regulatory Strategy
avatar for Nariman Nasser

Nariman Nasser

Digital Strategist, Operational Intelligence and Innovation
avatar for Elizabeth Nauman

Elizabeth Nauman

Louisiana Public Health Institute (LPHI)
Research Director, Research Action for Health Network (REACHnet)
avatar for Saumya Nayak

Saumya Nayak

Associate Director & Head, Clinical Planning & Analytics Asia...
avatar for Nersi Nazari

Nersi Nazari

Vital Connect, Inc.
Chairman and Chief Executive Officer

Diane Neiman

Merck & Co., Inc.
Director, Global Project Management
avatar for Hilary Nelson

Hilary Nelson

Genentech, A Member of the Roche Group
Senior Clinical Program Leader
avatar for Robert Nelson

Robert Nelson

Deputy Director & Senior Pediatric Ethicist, Ofc of Pediatric...
avatar for Dawn Niccum

Dawn Niccum

Associate Director, Quality
avatar for Derenda Nichols

Derenda Nichols

Senior Director, Clinical Trial Management
avatar for C. David Nicholson

C. David Nicholson

Executive Vice President, Brand R&D
avatar for Virginia Nido

Virginia Nido

Genentech, A Member of the Roche Group
Head, Industry Collaborations
avatar for Rebecca Noel

Rebecca Noel

Eli Lilly and Company
Global Benefit-Risk Lead, Global Patient Safety
avatar for Lorraine Nolan

Lorraine Nolan

Health Products Regulatory Authority (HPRA)
Chief Executive
avatar for Amy Nordo

Amy Nordo

Duke University
Product Manager, Maestro Care (Epic) for Research and eSource
avatar for Jami Norris

Jami Norris

Vice President, Clinical Development Strategic Partnerships

Jennifer North

Beyond Celiac
Vice President
avatar for Kim Northam

Kim Northam

Accenture Accelerated R&D Services
Manager, Regulatory Affairs
avatar for Roger Nosal

Roger Nosal

Pfizer Inc
Vice President, Global CMC
avatar for Chris O'Shaughnessy

Chris O'Shaughnessy

C3i Healthcare Connections
Vice President, Sales
avatar for Armando Oliva

Armando Oliva

Semantica LLC
President and Chief Medical Officer
avatar for Sharon Olmstead

Sharon Olmstead

Novartis Pharmaceuticals Corporation
Global Head, Development and Regulatory Policy
avatar for Carrie Ostrea

Carrie Ostrea

Global Genes - Allies In Rare Disease
Senior Manager, Patient Advocacy
avatar for Naohiro Otaki

Naohiro Otaki

Pharmaceuticals and Medical Devices Agency (PMDA)
Technical Officer, Application Review Division I, Office of Relief...
avatar for Kate Owen

Kate Owen

Novo Nordisk Inc.
Vice President, Clinical Trial Management
avatar for Robert Paarlberg

Robert Paarlberg

Paarlberg & Associates LLC

Michael Pacanowski

Associate Director for Genomics and Targeted Therapy, OCP, CDER

Carol Pamer

Program Lead for Pharmacovigilance, OSE, CDER
avatar for Gerald Dal Pan

Gerald Dal Pan

Director, Office of Surveillance and Epidemiology, CDER

Irene Pan

UBC: An Express Scripts Company
Senior Research Scientist

Zhiying "Jean" Pan

Amgen Inc.
Senior Manager, Biostatistics

Elektra Papadopoulos

Associate Director for the Clinical Outcome Assessment Staff, OND,...

Anna Papinska

University of Southern California
PhD candidate
avatar for Todd Paporello

Todd Paporello

Vice President and Head of Regulatory Affairs Americas

Nihar Parikh

CitiusTech Inc.
Healthcare Consultant
avatar for Samarth Parikh

Samarth Parikh

Janssen Pharmaceutical Companies of Johnson & Johnson
Postdoctoral Fellow
avatar for Min Soo Park

Min Soo Park

avatar for James Parrott

James Parrott

Rutgers, The State University of New Jersey
Associate Professor

Anisha Patel

Virginia Commonwealth University School of Pharmacy
PhD Candidate, Department of Pharmacotherapy and Outcomes Science
avatar for Bakul Patel

Bakul Patel

Director, Digital Health Division, CDRH
avatar for Kinnari Patel

Kinnari Patel

Rocket Pharmaceuticals
Vice President, Head of Regulatory, Pharmacovigilance, and Compliance
avatar for Mira Patel

Mira Patel

University of Arizona
PhD Student, Pharmaceutical Economics, Policy, and Outcomes

Prisha Patel

Centre For Innovation In Regulatory Science (CIRS)
Manager, Global Development Programme

Rohini Patil

Manager, Life Sciences Business Consulting
avatar for Matthew Pazdernik

Matthew Pazdernik

Merck & Co., Inc.
Director, Regulatory Submission Planning and Portfolio Management
avatar for Eric Peacock

Eric Peacock

Co-founder and Chief Executive Officer
avatar for Doug Peddicord

Doug Peddicord

Association of Clinical Research Organizations (ACRO)
Executive Director
avatar for Lisa Peluso

Lisa Peluso

PharmApprove, a Member of the NDA Group
Principal Consultant, Strategic Communications

Vada Perkins

Senior Advisor for Regulatory Science, IDMP Topic Lead, CBER
avatar for Jane Perlmutter

Jane Perlmutter

Patient Advocate
Founder and President
avatar for Mark Perrott

Mark Perrott

Pope Woodhead
Head of Development Consulting
avatar for Debbie Persaud

Debbie Persaud

Regulatory Affairs SME
avatar for Julia Petses

Julia Petses

Sanofi US
Director, Medical Information Services, Diabetes
avatar for Julia Petses

Julia Petses

Sanofi US
Director, Medical Information Services, Diabetes

Michael Phillips

ICON plc
Director, Product Innovation
avatar for Patrick Phillips

Patrick Phillips

Health Decisions, Inc.
Chief Executive Officer

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