2019 Speakers

Keynote Speakers

Avril England
Veeva Systems
General Manager, Veeva Vault
Peter Gassner
Veeva Systems
Founder and CEO
Joe Jimenez
Former CEO of Novartis
Henry Levy
Veeva Systems
GM Vault CDMS
Rob Metcalf
Eli Lilly and Company
VP, Clinical Design Delivery & Analytics
Paul Sekhri
eGenesis Bio
President and CEO

Session Speakers

Lale Akca
University of Louisville
Executive Director
Mohammed al-Adeeb
Veeva Systems
Senior Product Manager
Gaurav Anand
NNIT
Associate Vice President, Life Sciences Application Services
Dana Baird
PRA Health Sciences
Manager, Process and Learning Management
Hironmay Basu
Veeva Systems
Director, Product Management
Danielle Beaulieu
Bristol-Myers Squibb
Group Leader, Global Regulatory Business Capabilities
Rachel Belani
Veeva Systems
Director, Vault RIM (SMB)
Brian Bialkowski
Veeva Systems
Senior Product Manager, Vault Study Startup
Christopher Boschen
Veeva Systems
Senior Product Manager, Vault Quality
Tim Brodeur
Veeva Systems
Director, R&D Customer Success
Amit Chachra
Gilead Sciences
Director, IT
James Choi
Samsung BioLogics
VP, Chief Information Officer
Kelly Contrino
Roche Diagnostics
Principal Compliance Systems Analyst
Stephen Cook
GSK
Regulatory Processes and Systems Program Lead
Aaron Corona
Amicus Therapeutics
Associate Director, Regulatory Affairs Project Manager
Paul Crean
Valiance Partners
Director, Delivery Services, Europe
Anthony Davis
Dicerna Pharmaceuticals
Global Head of Quality and Compliance
Tom Dekker
Veeva Systems
Director of Product Management, Clinical Operations
Janine Del Vecchio
Insmed
Director of Data Management
Maryanne DiMarco
REGENXBIO Inc.
Manager, Regulatory Operations
Evelyn Dorsey
Cara Therapeutics
Associate Director of Data Management
Tanya du Plessis
Bioforum the Data Masters
VP, Data Strategies and Solutionsv
Tanya du Plessis
Bioforum the Data Masters
VP, Data Strategies and Solutions
Maggie Enterline
Foamix Pharmaceuticals
Senior Manager, Quality
Wil Foster
Eisai
Executive Director, Global Regulatory Operations Head
Monica Frechette
TESARO
Manager QA/Quality Systems QMS System Adminstrator
Rich Fredericks
TESARO
Director, Regulatory Systems and Information Management
Sandra Freeman
Johnson & Johnson
GCO U.S. Director, MAO Supported Studies
Regina Freunscht
Merck Healthcare KGaA
Vice President, Head of Global Regulatory Operations
Drew Garty
Veeva Systems
Chief Technology Officer, CDMS
Craig Gassman
Vericel Corporation
Director, Regulatory Operations
Graham Gelwicks
Veeva Systems
Senior Product Manager, Vault Platform
David Gemzik
Veeva Systems
Practice Manager, CDMS
Steve Gens
Gens and Associates Inc.
Managing Partner
Joby George
Veeva Systems
Sr. Product Manager, Quality
Lorena Gomez
Allergan
Global Director, Study Start Up
Ashley Gregory
Xeris Pharmaceuticals
Corporate Training Manager
Vikas Gulati
Vertex Pharmaceuticals
Executive Director, Clinical Data Management and Metrics
Andy Han
Veeva Systems
VP Technology, Vault
Eric Hanson
Sarah Cannon
IT Manager
Steve Harper
Veeva Systems
VP Product Management, Clinical Operations
Michelle Harrison
Vertex Pharmaceuticals
Director, Clinical Data Management
Neeraj Jindal
Gilead Sciences
Sr. IT Business System Domain Manager
Brittany Johnson
Eli Lilly and Company
Trial Master File Consultant
Michael Jovanis
Veeva Systems
VP, Vault Quality
Sonja Alexander Justice
Amicus Therapeutics
Director, GRA - Operations
David Katzoff
Valiance
Co-Founder & Managing Director
Bob Kenney
Veeva Systems
Senior Customer Success Manager, Quality
Sandra Komadinic
Veeva Systems
Senior Product Manager, Regulatory
Andrea Krueger
Lotus Clinical Research
Clinical Data Manager
Dominique Lagrave
Amgen
Head Global Regulatory Operations
Christian Lamont
Bristol-Myers Squibb
Director, Global QMS Programs
Monte Levinson
Veeva Systems
Director, Vault Submissions Publishing
Sharon Lin
Veeva Systems
Principal Product Manager, Vault CDMS
Brian Longo
Veeva Systems
Senior Vice President and General Manager, Veeva Vault Safety
Melanie Lougheed
PRA Health Sciences
Director, Process & Learning Management
Michael Martelli
Blueprint Medicines
Associate Director, Regulatory Operations
Caroline Masterman-Smith
Kinapse a Syneos Health company
Senior Manager, Technology & Innovation
Courtney McGaw
Sarah Cannon
Product Analyst
Sean McNiff
Tesaro
Senior Director, RegOps
Ami Mehr
Veeva Systems
Vice President, Vault CDMS Services Sales & Strategy
Aatif Mehraj
Kinapse a Syneos Health Company
Consulting Manager
Jean-Christophe Meriaux
Veeva Systems
Director of Product Management, Vault Platform
Rich Merrick
Veeva Systems
Senior Product Manager, Vault RIM
Scott Mitreuter
Veeva Systems
Senior Product Manager, Vault Quality
Tanay Nagjee
Veeva Systems
Senior Product Manager, Vault Quality
Jennifer Nezzer
Lotus Clinical Research
Director of Biometrics
Bob Ng
Veeva Systems
Product Manager, Vault Platform
Anthony Ochoa
Myovant Sciences
Associate Director, Regulatory Operations
Bella Oguno
Global Blood Therapeutics
Director, Clinical Operations
Christopher Otto
Eli Lilly and Company
Senior Director, Clinical Labs & Data Sciences
Shelley Padgett
Eli Lilly and Company
Sr. Director of IT, Clinical Development
Bonnie Pappacena
Foamix Pharmaceuticals
Vice President, Quality
Anders Persson
AstraZeneca
Transformation Leader
Lexie Pieper
Celularity, Inc.
Sr. Director Quality
Shelly Plapp
Melinta Therapeutics, Inc.
Director, Regulatory Operations
Narayan Ramakrishna
Celgene
Sr. Manager, IT Systems Delivery
Uri Reich
Veeva Systems
Vice President, Product Management, Vault RIM
Jim Reilly
Veeva Systems
Vice President of Clinical Market Strategy
Rolando Sa
Veeva Systems
Director, Product Management, Vault RIM
Rob Saiter
Accenture
Managing Director
Kate Santoro
Alkermes
CTM, Clinical Systems & Documentation
Doug Schantz
AstraZeneca
Executive Director, Development Operations
Richard Schmidt
Veeva Systems
Senior Consultant, Development Cloud
Jamie Scialdone
Agios Pharmaceuticals
Director, Regulatory Operations
Nima Shah
Veeva Systems
VP, Product Management, Quality
Nicole Sheetz
Eli Lilly and Company
Advisor, Clinical Systems & Supply Planning, Clinical Design, Delivery & Analytics
Rachel Sheppard
University of Louisville
Clinical and Regulatory Director
Harbal Sidhu
ICON
Senior Manager, Data Management
Eric Silverman
Bristol Myers-Squibb
Associate Director R&D & Quality Global IT
Rebecca Smissen
Vertex Pharmaceuticals
Director, Head RIM Strategy
Linda Sorrentino
Celgene
Director, IT Business Partnership
Kyle Stephenson
Veeva Systems
Product Manager, Clinical
Nick Tasse-Guillen
Veeva Systems
Senior Product Manager, Vault RIM
David Templeton
Penumbra, Inc.
Manager, Clinical Systems
Jamie Toth
Daiichi Sankyo, Inc.
Director, TMF Operations
Jennifer Trundle
Gilead Sciences
Associate Director, Quality Management Systems
Tony Tsai
Veeva Systems
Senior Product Manager, Vault CDMS
Igor Tsives
Veeva Systems
Director, Product Management
Todd Tullis
Veeva Systems
Director of Product Management, SiteVault
Vincent Tuminelli
Veeva Systems
Product Manager
Leah Weitz
Veeva Systems
Product Manager, eTMF
Kate Wilber
Veeva Systems
Director, Product Management, Vault RIM
Heather Wilson
Xencor
Senior Manager, QA/RA
Richard Young
Veeva Systems
VP, Strategy, Vault CDMS
Jan Paul Zonnenberg
PWC
Operations Management Consulting Partner