FDA
Clinical Outcome Assessments (COA) Staff, OND, CDER
Janssen Pharmaceuticals, Inc.
Vice President, Global Head Quantitative Sciences
Association of Clinical Research Professionals (ACRP)
Executive Director
Eli Lilly and Company
Senior Advisor/COO, Bio-Medicines Business Unit
HL7
Chief Technology Officer
CSL Behring GmbH
Global Head, Quantitative Safety Sciences
CSL Behring GmbH
Global Head, Quantitative Safety Sciences
PK
Texila American University
PhD Candidate
DIA
Global Chief Executive
Japan Self-Medication Industry
President
Janssen R & D, LLC
Senior Director, External Alliances
CDISC
President and Chief Executive Officer
FDA
Deputy Director, Liaison to the EMA, Office of International...
LeaderPoint
Chief Executive Officer
DL
Amgen
Director, Global Regulatory Affairs and Safety Operations
Touro College of Pharmacy
Student
Tufts Center for the Study of Drug Development
Associate Director of Sponsored Research, Research Assistant Professor
KL
TKL Research, Inc.
Director, Clinical Operations
CL
Gilead Sciences
Sr. Clinical Trial Manager
Claude Bernard Lyon 1 University
PhD Candidate, Pharmacology
Addario Lung Cancer Medical Institute
Senior Director of Strategic Alliances
Merck & Co., Inc.
Senior Vice President, Head of Global Clinical Trial Operations
Eli Lilly and Company
Knowledge Management Advisor, Global Customer Information
mProve Health
Chief Executive Officer
Quintiles
Associate Director, Site and Patient Networks
NTM Info & Research
Director of Policy & Advocacy
Quintiles
Associate Global Feasibility Lead
JL
Eli Lilly and Company
Consultant, Global Informed Business Lead
LL
Bristol-Myers Squibb Company
Senior Medical Writer
The Avoca Group
Chief Executive Officer and President
GL
FDA
Mathematical Statistician, Office of Translational Sciences, CDER
Janssen Research & Development, LLC
Senior Director, Benefit-Risk Assessment, Department of Epidemiology
Food and Drug Administration
Deputy Director, Office of Orphan Products Development
CL
Teva Pharmaceuticals
Statistician
Centre for Innovation in Regulatory Science (CIRS)
Executive Director
Quintiles
Regional Clinical Innovation and Operational Excellence Head
YP
National University of Singapore
Student
DIA
Global Director of Engagement
University of Sydney
Senior Research Fellow, Centre for Values, Ethics and the Law in...
DL
Beijing Clinical Service Center
Chief Scientific Officer
GlaxoSmithKline
Manager, Statistics, RD Projects Clinical Platforms and Sciences
KL
Merck & Co. Inc.
Senior Principal Scientist
RL
FDA
Acting Director, Office of Policy for Pharmaceutical Quality, OPQ,...
FDA
Biologist, Office of Cellular, Tissue and Gene Therapies, CBER
Covance Inc.
Vice President, Regulatory Compliance Quality Assurance
RM
PAREXEL Access Consulting
Senior Consultant
Accenture Accelerated R&D Services
Director, Life Sciences
Astellas Pharma US, Inc.
Director, Clinical Pharmacy
Oracle Health Sciences
Senior Manager, Product Management
JM
Bayer HealthCare Pharmaceuticals
Deputy Director, Regulatory Policy and Intelligence
European Medicines Agency (EMA),
Head of Committees and Inspections Department
FDA
Assistant Commissioner, Office of Health and Constituent Affairs, OC
GlobalCare Clinical Trials
SVP Business Development & Strategic Initiatives
Baxter International, Inc.
Vice President, Global Program Management Office
FDA
Director, Center for Biologics Evaluation and Research
Janssen Pharmaceutical Companies of Johnson & Johnson
Head Randomization and Trial Supply Management
LM
KMR Group Inc.
President and Founder
Philadelphia College of Pharmacy, University of the Sciences
Student
Johnson & Johnson
Vice President, Regulatory Policy and Global Analytics
JM
Algorithme Pharma
Director, Clinical Pharmacology and Regulatory Affairs
National Institutes of Health (NIH)
Mathematical Statistician, Office of Equal Opportunity and Customer...
Matheus BD Connections
President
YPrime Inc
Director, Business Development
RM
Rutgers, The State University of New Jersey
Post-Doctoral Fellow, Medical Affairs
Gifu Pharmaceutical University
Student, Global Regulatory Science, Pharmaceutical Science
Bristol-Myers Squibb Company
Sr. Compliance Specialist
Merck & Co., Inc.
Director
Pope Woodhead & Associates Ltd
Principal Consultant
Johnson & Johnson International
Vice President Global Policies, Procedures & Training, Healthcare...
Centre For Innovation In Regulatory Science (CIRS)
Director
Sandoz, Inc
Global Head Biopharm and Oncology Injectables Development
Quintiles Inc.
Senior Benefit Risk Management Director
FasterCures, A Center of the Milken Institute
Managing Director
NM
ICON Clinical Research
Executive Vice President, Clinical Quality Compliance
DM
Imperial
Director, Business Development
Merck & Co., Inc.
Assistant Vice President, Center for Observational and Real-world...
MM
Merck & Co., Inc.
Senior Scientist
Roche Products Limited
Patient Engagement and Media
RM
Covance Inc.
Statistical Fellow
Jett Foundation
Executive Director
Johnson & Johnson
Senior Director/ Head, BioResearch Quality and Compliance, Consumer...
Topiwala National Medical College & BYL Nair Charitable Hospital
SOUSEIKAI Global Clinical Research Center
Senior Manager
FDA
Deputy Office Director, OMEPRM, OSE, CDER
APCER Life Sciences
Vice President-PV and Clinical Safety North America and Global...
FDA
Dir., Off. of New Drug Products; Dir. (Acting), Off. of Surveillance,...
Touro College of Pharmacy
Pharmacy Student, Phi Lambda Sigma Chapter President
Roche Products Limited
Operational Intelligence Leader
Self-Employed
Independent Biostatistical Consultant
FDA
Health Scientist Policy Analyst, Office of Medical Policy, CDER
Merck Research Laboratories
Senior Vice President, Head of Global Regulatory Affairs and Clinical...
Eli Lilly and Company
Advisor, Expedited Reporting Global Patient Safety
Tufts Center for the Study of Drug Development
Director of Research and Research Associate Professor
ICON Peri-Approval and Observational Research
Senior Vice President, Global Head Operations and Strategic Planning
Arnall Golden Gregory LLP
Partner, Head of Food and Drug Team
Life Science Connect
Editor
Salutramed Group, LLC
Managing Partner
CM
Choroideremia Research Foundation
President
Medicines and Healthcare products Regulatory Agency (MHRA),
Director of Policy
Merck & Co., Inc.
Head of External Affairs (Quality)
Link Global Solution Inc.
Executive Director
Health Canada
Director General, Policy, Planning and International Affairs...
LM
Parkinson's Disease Foundation
Patient Representative FDA, Research Advocate; Chair, Patient...
Gifu Pharmaceutical University
Student, Global Regulatory Science, Pharmaceutical Science
Colorado School of Public Health
Professor Health Systems, Management and Policy
EM
ClinCapture
Director, Product Operations
Johnson & Johnson
Vice President, Strategy Realization
EMB Statistical Solutions, LLC
Director, Biostatistics
Synteract HCR
Chief Medical Advisor
Synteracthcr
Chief Medical Advisor
European Medicines Agency, European Union
Head of Patients and Healthcare Professionals Department
Novartis Pharmaceuticals Corporation
Global Head Franchise Quality Assurance
FDA
Deputy Division Director, Gastroenterology and Inborn Errors...
FDA
Medical Officer, Senior Policy Advisor, OSI, OC, CDER
FDA
Associate Director for Strategic Initiatives, OCD, CDER
CM
Canadian Digestive Health Foundation
Executive Director (CDHF)
MM
Pharmaceuticals and Medical Devices Agency (PMDA)
Unit Chief, Division of Regulatory Cooperation, Office of...
NM Consulting
Representative
MM
FDA
Director, Office of Pediatric Therapeutics, Office of Special Medical...
KM
Shire Pharmaceuticals
Director, Global CMC Regulatory Affairs
Bristol-Myers Squibb Company
Associate Director, Diversity and Patient Engagement
Eli Lilly and Company
Global PRA Advisor, Autoimmune
Merck & Co., Inc.
Vice President and Deputy Chief Medical Officer
PAREXEL
Associate Director, Biostatistics
AMPLEXOR Life Sciences, LLC
Vice President, Sales and Sales Training
AMPLEXOR Life Sciences, LLC
Vice President, Sales & Sales Training
Medical Marketing Economics LLC (MME)
Global President and CEO
Catalyst Healthcare Consulting, Inc
President and Founder
Genentech, A Member of the Roche Group
Head, Operational Intelligence and Innovation
RN
FDA
Medical Officer, DPARP, OND, CDER
MN
Mitsubishi Tanabe Pharma Corporation
Manager, Pharmacovigilance Cordination & Administration Department....
Ministry of Health, Labour and Welfare (MHLW)
Director, Office of International Regulatory Affairs
University of North Texas Health Science Center
Student, College of Pharmacy
NDA Group
Biologics and Advanced Therapies Expert
GlaxoSmithKline
Vice President, CMC Regulatory Strategy
Roche
Digital Strategist, Operational Intelligence and Innovation
Louisiana Public Health Institute (LPHI)
Research Director, Research Action for Health Network (REACHnet)
QuintilesIMS
Associate Director, Patient Recruitment Programs, Asia Pacific
Vital Connect, Inc.
Chairman and Chief Executive Officer
DN
Merck & Co., Inc.
Director, Global Project Management
Genentech, A Member of the Roche Group
Senior Clinical Program Leader
FDA
Deputy Director & Senior Pediatric Ethicist, Ofc of Pediatric...
Endocyte
Associate Director, Quality
Medpace
Senior Director, Clinical Trial Management
Allergan
Executive Vice President, Brand R&D
Genentech, A Member of the Roche Group
Head, Industry Collaborations
Eli Lilly and Company
Global Benefit-Risk Lead, Global Patient Safety
Health Products Regulatory Authority (HPRA)
Chief Executive
Duke University
Product Manager, Maestro Care (Epic) for Research and eSource
Quintiles
Vice President, Clinical Development Strategic Partnerships
JN
Beyond Celiac
Vice President
Accenture Accelerated R&D Services
Manager, Regulatory Affairs
Pfizer Inc
Vice President, Global CMC
C3i Healthcare Connections
Vice President, Sales
Semantica LLC
President and Chief Medical Officer
Novartis Pharmaceuticals Corporation
Global Head, Development and Regulatory Policy
Global Genes - Allies In Rare Disease
Senior Manager, Patient Advocacy
Pharmaceuticals and Medical Devices Agency (PMDA)
Technical Officer, Application Review Division I, Office of Relief...
Novo Nordisk Inc.
Vice President, Clinical Trial Management
Paarlberg & Associates LLC
Principal
MP
FDA
Associate Director for Genomics and Targeted Therapy, OCP, CDER
CP
FDA
Program Lead for Pharmacovigilance, OSE, CDER
FDA
Director, Office of Surveillance and Epidemiology
IP
UBC: An Express Scripts Company
Senior Research Scientist
ZQ
Amgen Inc.
Senior Manager, Biostatistics
EP
FDA
Associate Director, Clinical Outcome Assessments Staff, OND, CDER
AP
University of Southern California
PhD candidate
Bayer HealthCare Pharmaceuticals
Vice President and Head of North American Regulatory Affairs
NP
CitiusTech Inc.
Healthcare Consultant
Janssen Pharmaceutical Companies of Johnson & Johnson
Postdoctoral Fellow
Rutgers, The State University of New Jersey
Associate Professor
AP
Virginia Commonwealth University School of Pharmacy
PhD Candidate, Department of Pharmacotherapy and Outcomes Science
FDA
Associate Director for Digital Health, Office of the Center Director,...
Rocket Pharmaceuticals
Vice President, Head of Regulatory, Pharmacovigilance, and Compliance
University of Arizona
PhD Student, Pharmaceutical Economics, Policy, and Outcomes
PP
Centre For Innovation In Regulatory Science (CIRS)
Manager, Global Development Programme
RP
Cognizant
Manager, Life Sciences Business Consulting
Merck & Co., Inc.
Director, Regulatory Submission Planning and Portfolio Management
MyHealthTeams
Co-founder and Chief Executive Officer
Association of Clinical Research Organizations (ACRO)
Executive Director
PharmApprove, a member of the NDA Group
Director, Coaching and Client Engagement
VP
FDA
Senior Advisor for Regulatory Science, IDMP Topic Lead, CBER
Gemini Group
Founder and President
Pope Woodhead
Head of Development Consulting
NNIT Inc.
Regulatory Affairs SME
Sanofi US
Director, Medical Information Services, Diabetes
Sanofi US
Director, Medical Information Services, Diabetes
MP
ICON plc
Director, Product Innovation
Health Decisions, Inc.
Chief Executive Officer
IBM Watson Health
Lead Partner Life Sciences Strategy and Analytics
