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
Matt Wallach
Veeva
Co-founder and Board Member, Veeva

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
Douglas Arnold
Merck & Co.
Director
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
Derek Bullock
Neurocrine Biosciences, Inc.
Clinical Operations Systems Specialists
Amit Chachra
Gilead Sciences
Director, IT
James Choi
Samsung BioLogics
VP, Chief Information Officer
Stephen Cook
GSK
Regulatory Processes and Systems Program Lead
Aaron Corona
Amicus Therapeutics
Associate Director, Regulatory Affairs Project Manager
Anthony Davis
Dicerna Pharmaceuticals
Global Head of Quality and Compliance
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
Tonya Edison
Eli Lilly and Company
Director, Trial Capabilities, Trial Master File, Records Management
Wil Foster
Eisai
Executive Director, Global Regulatory Operations Head
Sandra Freeman
Johnson & Johnson
GCO U.S. Director, MAO Supported Studies
Regina Freunscht
Merck Healthcare KGaA
Vice President, Head of Global Regulatory Operations
Craig Gassman
Vericel Corporation
Director, Regulatory Operations
David Gemzik
Veeva Systems
Practice Manager, CDMS
Lorena Gomez
Allergan
Global Director, Study Start Up
Ashley Gregory
Xeris Pharmaceuticals
Corporate Training Manager
Eric Hanson
Sarah Cannon
IT Manager
Michelle Harrison
Vertex Pharmaceuticals
Director, Clinical Data Management
Brittany Johnson
Eli Lilly and Company
Trial Master File Consultant
Sonja Alexander Justice
Amicus Therapeutics
Director, GRA - Operations
David Katzoff
Valiance
Co-Founder & Managing Director
Bob Kenney
Veeva Systems
Senior Customer Success Manager, Quality
Andrea Krueger
Lotus Clinical Research
Clinical Data Manager
Dominique Lagrave
Amgen
Head Global Regulatory Operations
Christian Lamont
Bristol-Myers Squibb
Director, Global QMS Programs
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
Jennifer Nezzer
Lotus Clinical Research
Director of Biometrics
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
Rob Saiter
Accenture
Managing Director
Kate Santoro
Alkermes
CTM, Clinical Systems & Documentation
Doug Schantz
AstraZeneca
Executive Director, Development Operations
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
Kristofer Spahr
Daiichi Sankyo, Inc.
Director of Regulatory Information Management
David Templeton
Penumbra, Inc.
Manager, Clinical Systems
Jamie Toth
Daiichi Sankyo, Inc.
Director, TMF Operations
Tony Tsai
Veeva Systems
Senior Product Manager, Vault CDMS
Heather Wilson
Xencor
Senior Manager, QA/RA
Jan Paul Zonnenberg
PWC
Operations Management Consulting Partner