Loading…
Attending this event?
avatar for Michael Rosenblatt

Michael Rosenblatt

Greenhouse Consulting, United States
Managing Director
avatar for Elizabeth Rosenkrands-Lange

Elizabeth Rosenkrands-Lange

EMD Serono, Part of Merck KGaA, Darmstadt, Germany, United States
Senior Director/ Head of US Regulatory Scientific Policy
avatar for David Ross

David Ross

AstraZeneca, United States
Senior Director, Regulatory Data and Submissions
avatar for Cynthia Rothblum-Oviatt

Cynthia Rothblum-Oviatt

FDA, United States
Science Policy Analyst, Rare Disease Team, OND, CDER
avatar for Isabelle Rousse

Isabelle Rousse

Health Canada, Canada
Associate Director, Bureau of Metabolism, Oncology, Reproductive...
avatar for Debabrata Roy

Debabrata Roy

Drug Safety Research Unit, United Kingdom
Head of Epidemiology and Research
avatar for Todd Rudo

Todd Rudo

Clario, United States
EVP & Chief Medical Officer
avatar for Michelle Ruiz

Michelle Ruiz

Genentech, A Member of the Roche Group, United States
Principal Quality Data Analyst
avatar for Tanya Russell

Tanya Russell

Pfizer Inc, United States
Vice President, Integration Lead
avatar for Donna Rycroft

Donna Rycroft

AbbVie, United States
Director, Study Risk Management
avatar for Anindita Saha

Anindita Saha

FDA, United States
Associate Director Strategic Initiatives, Digital Health Center of...
MS

Michiyo Sakiyama

Pharmaceuticals and Medical Devices Agency (PMDA), Japan
Associate Senior Scientist for Clinical Medicine, Office of Vaccines...
avatar for Mary Jo Salerno

Mary Jo Salerno

FDA, United States
Science Policy Analyst, ORDPURM, OND, CDER
CS

Claudia Salinas

Eli Lilly and Company, United States
Senior Director, GPS Pharmacoepidemiology
avatar for Leslie Sam

Leslie Sam

Leslie Sam and Associates, LLC, United States
President
avatar for Bruna Sampaio

Bruna Sampaio

Hospital Israelita Albert Einstein, Brazil
Manager, Data management
avatar for Sharon Rivera Sanchez

Sharon Rivera Sanchez

Trials of Color, United States
Patient Advocate and CEO
avatar for Neetu Sangari

Neetu Sangari

Pragya Tech Leaders, United States
President/CEO
avatar for Toshiharu Sano

Toshiharu Sano

MSD K.K., Japan
Associate Vice President, Head of Clinical Operation Area
TS

Toshihiro Sano

Merck Sharp & Dohme LLC , United States
Associate Vice President, Head of Clinical Operations
avatar for Sakshi Sardar

Sakshi Sardar

Critical Path Institute, United States
Senior Director, Digital and Precision Medicine
avatar for Caprice Sassano

Caprice Sassano

HumanFirst, United States
Research and Data Products - Applied Sciences
SS

Steve Satek

Flourish Research, United States
Executive Vice President
avatar for Junko Sato

Junko Sato

Pharmaceuticals and Medical Devices Agency (PMDA), Japan
Associate Executive Director
avatar for Mayur Saxena

Mayur Saxena

Droice Labs, United States
Chief Executive Officer
avatar for Claudia Schaffer

Claudia Schaffer

EMD Serono, Germany
Sr. Director, Head Case and Vendor Management
avatar for Jörg Schläpfer

Jörg Schläpfer

Swissmedic, Switzerland
Head of Management Services and International Affairs
avatar for Tina Schlecht

Tina Schlecht

RxE2, United States
Chief Pharmacy Officer
avatar for Hollie Schmidt

Hollie Schmidt

Accelerated Cure Project, United States
Vice President of Scientific Operations
avatar for Norman Schmuff

Norman Schmuff

FDA, United States
Associate Director for Science, OPMA, OPQ
CS

Chris Schneiderman

Abbvie, United States
Epidemiologist
avatar for Andrew Schorr

Andrew Schorr

Patient Advocate, United States
Founder, Web-Savvy Health Consultants, LLC
avatar for Duane Schulthess

Duane Schulthess

Vital Transformation LLC, United States
Chief Executive Officer
avatar for James Schultz

James Schultz

Neighborhood Healthcare, United States
Chief Medical Officer
avatar for Rob Schulz

Rob Schulz

Suttons Creek, Inc., United States
President and COO
avatar for PPD, part of Thermo Fisher Scientific

PPD, part of Thermo Fisher Scientific

United States
avatar for John Scott

John Scott

FDA, United States
Division Director, Office of Biostatistics, CBER
avatar for Samantha Seepersad-Nayee

Samantha Seepersad-Nayee

Excision Biotherapeutics, United States
AD
avatar for Abi Seifert

Abi Seifert

Novartis , United States
Global Head Country Development Quality
avatar for Eri Sekine

Eri Sekine

CMIC Group, Japan
Executive Vice President
avatar for Earl Seltzer

Earl Seltzer

CTI, United States
Senior Director, Partnerships and Innovation
avatar for Leonardo Semprun

Leonardo Semprun

MSD, Panama
Global Regulatory Policy Lead-LatAm
avatar for Ana Sengupta

Ana Sengupta

Mirum Pharmaceuticals, Inc., United States
Associate Director Regulatory Affairs CMC
avatar for Elizabeth Seyfert

Elizabeth Seyfert

Fortrea, United States
Head of Site Engagement and Partnership Delivery
avatar for Anjali Shah

Anjali Shah

Bristol-Myers Squibb Company, United States
Executive Director, Business Capabilities and Innovation, WWPS
avatar for Saad Shakir

Saad Shakir

Drug Safety Research Unit, United Kingdom
Director
avatar for Subhan Sharief

Subhan Sharief

ArisGlobal LLC, United States
Senior Director
avatar for Khushboo Sharma

Khushboo Sharma

United States
Chief Regulatory Innovation Officer
avatar for Vishakha Sharma

Vishakha Sharma

Roche, United States
Senior Principal Data Scientist
avatar for T.J. Sharpe

T.J. Sharpe

Consultant, United States
Patient Engagement Expert
avatar for Laura Shaughnessy

Laura Shaughnessy

UCB Biosciences, United States
Clinical Program Director
avatar for Jie Shen

Jie Shen

AbbVie, United States
Director, Digital Science
avatar for Lichen Shen

Lichen Shen

Medidata, United States
Senior Director of Product R&D
RS

Roya Sherafat-Kazemzadeh

Mapi Research Trust, France
Scientific Director
avatar for Allison Cuff Shimooka

Allison Cuff Shimooka

TransCelerate Biopharma Inc, United States
Chief Operating Officer
avatar for Tricha Shivas

Tricha Shivas

Foundation For Sarcoidosis Research, United States
Chief of Staff and Strategy
avatar for Jonathan Shough

Jonathan Shough

Parexel , United States
Chief Information Officer
avatar for Jeffrey Siegel

Jeffrey Siegel

FDA, United States
Director, Office of Drug Evaluation Sciences, OND, CDER
avatar for Hiiti Sillo

Hiiti Sillo

World Health Organization (WHO), Switzerland
Unit Head, Regulation and Safety, Department of Regulation and...
avatar for Pamela Simpkins

Pamela Simpkins

Mezzopointe. LLC, United States
Managing Partner
avatar for Kanwaljit Singh

Kanwaljit Singh

Critical Path Institute, United States
Executive Director, International Neonatal Consortium
avatar for Romi Singh

Romi Singh

GRA Advisors, United States
Founder & Principal Advisor
avatar for Mukesh Singhal

Mukesh Singhal

Deloitte, United States
Partner
avatar for Ranjeeta Sinvhal

Ranjeeta Sinvhal

AbbVie, United States
Executive Medical Director, Medical Safety
avatar for Louise Lind Skov

Louise Lind Skov

Novo Nordisk A/S, Denmark
Head of Content Digitalisation
avatar for Renata Skros

Renata Skros

Network Partners Group, United States
Quality Consultant
avatar for Del Smith

Del Smith

Acclinate Inc., United States
Co-Founder and Chief Executive Officer
avatar for Meredith Smith

Meredith Smith

Evidera, Inc, United States
Senior Director, Implementation Science Pillar Lead
avatar for Cary Smithson

Cary Smithson

Leapahead Solutions, Inc., United States
Managing Partner
avatar for Cary Smithson

Cary Smithson

Leapahead Solutions, Inc., United States
Managing Partner
avatar for Paul Smolenski

Paul Smolenski

DEKA Research & Development Corp., United States
Regulatory
avatar for Patroula Smpokou

Patroula Smpokou

FDA, United States
Lead Physician, Division of Rare Diseases/Medical Genetics, OND, CDER
avatar for Donna Snyder

Donna Snyder

WCG, United States
Executive Physician
avatar for Rachel Sobel

Rachel Sobel

Regeneron , United States
Vice President, Head of Pharmacoepidemiology
avatar for Alexandru Socolov

Alexandru Socolov

Medidata Solutions, United States
Senior Data Scientist
avatar for Elizabeth Somers

Elizabeth Somers

Merck Sharp & Dohme LLC, United States
Executive Director, Global Project and Alliance Management
avatar for Sophie Sommerer

Sophie Sommerer

Health Canada, Canada
Director General
avatar for Toni Spears

Toni Spears

Sanofi, United States
Program Lead, Industry Collaborations
avatar for Jean Sposaro

Jean Sposaro

Bristol-Myers Squibb Company, United States
Director, Global Drug Development Operations, Industry Collaborations
avatar for Srivdya Srikant

Srivdya Srikant

Gilead Sciences, United States
Director, Global Regulatory Affairs- CMC
avatar for Fannie St-Gelais

Fannie St-Gelais

Health Canada, Canada
Manager, Health Product and Food Branch
avatar for Summer Starling

Summer Starling

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

Andrew Stelzer

Unlearn.ai, United States
Head of Business Development
avatar for Benjamin Stevens

Benjamin Stevens

GlaxoSmithKline, United States
Director CMC Policy and Advocacy
avatar for Mark Stewart

Mark Stewart

Friends of Cancer Research, United States
Vice President, Science Policy
avatar for Oliver Stoss

Oliver Stoss

Discovery Life Sciences Biomarker Services GmbH, Germany
Senior Vice President of Operations
avatar for Yoshiko Stowell

Yoshiko Stowell

Head of Regulatory Affairs
avatar for Nancy Styple

Nancy Styple

Bayer AG, United States
Project Management Leader
avatar for Ling Su

Ling Su

Shenyang Pharmaceutical University, Yeehong Business School, China
Research Fellow
avatar for Karthick Sukumaran

Karthick Sukumaran

Roche, United States
Technology Enablement Director
avatar for Linda Sullivan

Linda Sullivan

Tufts Center For the Study of Drug Development, United States
Senior Fellow
avatar for John Sun

John Sun

Novartis Pharmaceuticals Corporation, United States
Program Lead, Global Clinical Operation, Development
DS

Deeksha Surisetty

Georgetown University, United States
MS Biotechnology Student
avatar for Mike Sweeney

Mike Sweeney

QuickSTAT, France
Global Head of Strategy, CGT & DTP
avatar for Kirsten Swingle

Kirsten Swingle

Regeneron, United States
Manager, Regulatory Submission Project Management
avatar for Thomas Switzer

Thomas Switzer

Genentech, A Member of the Roche Group, United States
Principal Digital Health Scientist
CS

Chiang Syin

Meadows Biosolutions LLC, United States
President
avatar for Patricia Oliveira Pereira Tagliari

Patricia Oliveira Pereira Tagliari

ANVISA, Brazil
Associate Director
JT

Julie Tai

GlaxoSmithKline, United States
Director, GRA, Precision Medicine and Digital Health
avatar for Susan Talbot

Susan Talbot

Amgen, United States
Director Biostatistics
avatar for Bhavana Tallavajhula

Bhavana Tallavajhula

Bristol Myers Squibb, United States
Director
ST

Sharon Tamir

MT-Pharma, United States
Digital Healthcare Innovation, Business and Research Strategy
avatar for Daisuke Tanaka

Daisuke Tanaka

Pharmaceuticals and Medical Devices Agency (PMDA), Japan
Office Director, Office of International Programs
avatar for Keisuke Tanaka

Keisuke Tanaka

Pharmaceuticals and Medical Devices Agency (PMDA), Japan
Reviewer
avatar for Hiroya Taniguchi

Hiroya Taniguchi

Aichi Cancer Center Hospital, Japan
Department of Clinical Oncology
HT

HCL Technologies

United States
avatar for IQVIA Technologies

IQVIA Technologies

United States
avatar for Taimei Technology, Inc.

Taimei Technology, Inc.

United States
avatar for Ana Tediosi

Ana Tediosi

WEP Clinical, United Kingdom
Head of Expanded Access Strategy
avatar for Stacy Tegan

Stacy Tegan

Transcelerate Biopharma, Inc., United States
Program Director
avatar for Steffen Thirstrup

Steffen Thirstrup

European Medicines Agency, Netherlands
Chief Medical Officer
avatar for Alec Thompson

Alec Thompson

Gilead Sciences, United States
Senior Product Manager, Oncology
avatar for Chris Thompson

Chris Thompson

Woodley Trial Solutions, United Kingdom
Senior Operations Manager
avatar for Ramya Thota

Ramya Thota

Intermountain Medical Oncology - IMC, United States
Associate Professor
avatar for Aman Thukral

Aman Thukral

AbbVie, Inc., United States
Head of Digital Operations & Clinical Systems Data and...
avatar for Gert Thurau

Gert Thurau

F. Hoffmann-La Roche Ltd, Switzerland
Head of Manufacturing Technology Innovation in CMC Regulatory Policy
avatar for Julia Tierney

Julia Tierney

FDA, United States
Deputy Center Director for Strategy, Policy, and Legislation, CBER
BT

Bintou Timbine

University of Illinois Chicago, United States
PharmD Student
avatar for Wendy Tin

Wendy Tin

Gilead Sciences, United States
Associate Director, HIV PrEP Scientific Publications
avatar for Michael Torok

Michael Torok

Genentech, A Member of the Roche Group, United States
Vice President, Global Head of Quality Assurance Programs
avatar for Antonio Barra Torres

Antonio Barra Torres

ANVISA, Brazil
President Director
avatar for Cesar Torres

Cesar Torres

FDA, United States
Senior Mathematical Statistician, OB, OTS, CDER
avatar for Jeanette Towles

Jeanette Towles

Synterex, Inc., United States
President and CEO
avatar for Eveline Trachsel

Eveline Trachsel

Swissmedic, Switzerland
Head of Medicinal Product Authorisation and Vigilance
avatar for Kimberly Trautman

Kimberly Trautman

Trautman International Services, United States
Managing Director
avatar for Kelly Traverso

Kelly Traverso

Deloitte, United States
R&D Business Development
avatar for Phil Tregunno

Phil Tregunno

Medicines and Healthcare Products Regulatory Agency (MHRA), United Kingdom
Deputy Director - Patient Safety Monitoring
avatar for Sarah Tremethick

Sarah Tremethick

Roche Products Limited
Global Consortia Program Lead, Product Development Industry...
avatar for Kiernan Trevett

Kiernan Trevett

Genentech, A Member of the Roche Group, United States
Principal Quality Lead, PDQ Quality Assurance Process GVP
avatar for PCM Trials

PCM Trials

United States
avatar for Stelios Tsinontides

Stelios Tsinontides

FDA, United States
Office Director, OPMA, OPQ, CDER
avatar for Atsushi Tsukamoto

Atsushi Tsukamoto

Daiichi Sankyo, United States
Head is Therapeutic Area Strategies
avatar for Rachel Turow

Rachel Turow

Walmart, Inc., United States
Managing Counsel, FDA Regulatory
avatar for Peter Twomey

Peter Twomey

European Medicines Agency, Netherlands
Head of Inspections
YT

Yoni Tyberg

FDA, United States
Associate Director of Special Programs, Office of New Drugs, CDER
avatar for Katherine Tyner

Katherine Tyner

FDA, United States
FDA Liaison to the EMA, Office of Global Policy and Strategy, OC
SU

Stephanie Ueng

Roche, United States
Strategy Director
avatar for Joseph Unger

Joseph Unger

Fred Hutchinson Cancer Center, United States
Associate Professor
avatar for Yoshiaki Uyama

Yoshiaki Uyama

Pharmaceuticals and Medical Devices Agency (PMDA), Japan
Associate Executive Director
avatar for Pujita Vaidya

Pujita Vaidya

Sanofi, United States
North America Lead, Regulatory Science and Policy
avatar for Pujita Vaidya

Pujita Vaidya

Novartis Pharmaceuticals Corporation, United States
Director, US Patient Engagement
avatar for James Valentine

James Valentine

Hyman, Phelps & McNamara, PC, United States
Director
HV

Haleh Valian

Biogen, United States
Head of Decision Quality Analytics and Innovation
avatar for Haritha Vallabhaneni

Haritha Vallabhaneni

FDA, United States
Biological Reviewer, Office of Cellular Therapy and Human Tissue CMC,...
JV

Jacqueline Vanderpuye-Orgle

Parexel, United States
Vice President
avatar for Ruth Gómez Vargas

Ruth Gómez Vargas

MSD, Colombia
Senior Medical Writer
avatar for Naeiry Vartevan

Naeiry Vartevan

BASE Life Sciences, United States
VP, US R&D
AV

Akshay Vashist

Otsuka Pharmaceutical Development & Commercialization, United States
Exec Dir Head Medical Real World Data Analytics
avatar for Caroline Vass

Caroline Vass

RTI Health Solutions, United Kingdom
Senior Economist, Health Preference Assessment
avatar for Maria Vassileva

Maria Vassileva

DIA, United States
Global Head of Science and Scientific Strategy
AV

Ashkan Vaziri

Biosensics, United States
Founder and CEO
avatar for Monica Veldman

Monica Veldman

Alliance for Regenerative Medicine, United States
Director, Global Regulatory Policy
avatar for Karthik Venkatakrishnan

Karthik Venkatakrishnan

EMD Serono, United States
Vice President, Global Head of Quantitative Pharmacology
avatar for Rayna Venook

Rayna Venook

Genentech, A Member of the Roche Group, United States
Team Lead, Pharma Development Regulatory
AV

Arnold Ventures

United States
avatar for Rebecca Vermeulen

Rebecca Vermeulen

Genentech, A Member of the Roche Group, United States
Vice President, Global Patient Networks | PD Medical Affairs
avatar for Cynthia Verst

Cynthia Verst

IQVIA, United States
President, R&D Solutions D&DI; 2023 President
avatar for Shruti Vig

Shruti Vig

University of Maryland, College Park, United States
Graduate Student
avatar for Cesar Vinces

Cesar Vinces

Accumulus Synergy, United States
EU Interim and International Policy Lead
avatar for Alyssa Vincze

Alyssa Vincze

Milliman IntelliScript
Principal and Director, R&D
avatar for Anders Vinther

Anders Vinther

QBA Leaders, United States
Founder and Chief Executive Officer
avatar for Manu Vohra

Manu Vohra

Box, United States
Managing Director, Life Sciences
avatar for Carolyn Volpe

Carolyn Volpe

FDA, United States
Team Leader, OSI, OC, CDER
avatar for Niam Vora

Niam Vora

Srx Health Solutions, Canada
Pharmacist
avatar for Sejal Vora

Sejal Vora

BeiGene, United States
Director, Medical Information
avatar for James Wabby

James Wabby

AbbVie, United States
Global Head, Regulatory Affairs, Emerging Technologies and...
avatar for Brittin Wagner

Brittin Wagner

PointClickCare, Canada
Senior Research Scientist
avatar for Peter Wahl

Peter Wahl

CorEvitas, part of PPD clinical research business of Thermo Fisher Scientific, United States
Vice President, Global Head of Scientific Affairs
avatar for L'Oreal Walker

L'Oreal Walker

FDA, United States
Supervisory Consumer Safety, OBIMO, ORA
avatar for Paula Walker

Paula Walker

Roche Products Ltd., United Kingdom
Global Head of Risk Based Quality Management
avatar for Stuart Walker

Stuart Walker

Centre for Innovation In Regulatory Science (CIRS), United Kingdom
Professor and Consultant
avatar for Ramona Walls

Ramona Walls

Critical Path Institute, United States
Executive Director of Data Science, Data Collaboration Center
avatar for Matt Wampole

Matt Wampole

Clarivate, United States
Director, Solution Consulting
avatar for Hongwei Wang

Hongwei Wang

AbbVie, United States
Director/ Senior Research Fellow
avatar for Susan Wang

Susan Wang

Boehringer Ingelheim, United States
Global Head of Biostatistics and Data Sciences Inflammation
avatar for Jayne Ware

Jayne Ware

Merck Sharp & Dohme LLC, United States
Senior Director, Global Regulatory Policy
avatar for Jonathan Watanabe

Jonathan Watanabe

University of California Irvine, United States
Associate Dean, Pharmacy Assessment and Quality | Prof, Clinical...
avatar for Christina Waters

Christina Waters

RARE Science, Inc., United States
Chief Executive Officer and Founder
avatar for J. Kyle Wathen

J. Kyle Wathen

Cytel Inc., United States
Vice President, Scientific Strategy and Product Innovation
avatar for Susan Watson

Susan Watson

Eli Lilly and Company, United States
Associate Director, Bioethics
avatar for Max Wegner

Max Wegner

Bayer AG, Germany
Head Regulatory Affairs
BW

Brittany Weichers

Velocity, United States
Head of Global Patient Recruitment
avatar for Auren Weinberg

Auren Weinberg

Veradigm, United States
Chief Medical Officer
EW

Eli Weinberg

Bain & Co., United States
Partner
avatar for Steven Weisman

Steven Weisman

Lumanity Inc, United States
Global President, Clinical and Regulatory
avatar for Ellen Weiss

Ellen Weiss

PCM Trials, United States
Strategy, Decentralized Trials, Emeritus
KW

Kilian Weiss

Veeva, Germany
General Manager, Veeva Link and OpenData
avatar for Gerold Wharton

Gerold Wharton

FDA, United States
Program Analyst, Office of Clinical Policy and Programs, OC
avatar for Emily Whitehead

Emily Whitehead

Emily Whitehead Foundation, United States
Co-founder
avatar for Tom Whitehead

Tom Whitehead

Emily Whitehead Foundation, United States
Co-founder and President
avatar for Robin Whitsell

Robin Whitsell

Whitsell Innovations, Inc., United States
President
avatar for Mike Wierzba

Mike Wierzba

GlaxoSmithKline, United States
Director, GRA, Precision Medicine and Digital Health
avatar for Gary Wilkinson

Gary Wilkinson

Ryvu Therapeutics, Poland
Director of Clinical Pharmacology
SW

Sam Willcox

ACM Global Laboratories, United Kingdom
Section Manager - Large Molecule Bioanalysis
avatar for Kristin Willemsen

Kristin Willemsen

Canadian Generic Pharmaceutical Association, Canada
Vice President, Scientific and Regulatory Affairs
avatar for Kayla Williams

Kayla Williams

Takeda, United States
Director and Head, Oncology Medical Writing
avatar for Rebecca Williams

Rebecca Williams

Essex, Part of Emmes Group, United States
Senior Clinical Trials Subject Matter Expert
FW

Forrest Williamson

Eli Lilly and Company, United States
Director of Pediatrics, Statistical Innovation Center
avatar for Katherine Wilson

Katherine Wilson

Viatris, United States
Head, Global Regulatory Policy and Intelligence
avatar for Luman Wing

Luman Wing

Cell and Gene Therapies, United States
Consultant
1 2 3 4 5