See You in Boston
September 9-10, 2024
Stay Informed

Speakers


Keynote Speakers

Cortney Gilbert
Merck
Senior Director, Business System Management and Innovation, PV Operations & Global Process Enablement

Jennifer Trundle
Gilead Sciences
Director, Quality Information Systems

Penny Carlson
Takeda
Vice President, Head of Innovation & Data

RJ Doornbos
Amgen
Vice President, Quality Operating System, Services and Sciences

Raghu Nandan
Bristol Myers Squibb
Global Head, Veeva Drug Development and Quality Cloud

Regina Norelli
Replimune
Senior Director, Clinical Data Management

Scott Cleve
Daiichi Sankyo
Vice President, Regulatory Operations, Information & Compliance

Avril England
Veeva Systems
General Manager, Vault

Derek Wagland
Veeva Systems
Vice President, Products, Vault Safety

Eldar Curovic
Veeva Systems
Vice President, Product Management Vault RIM

James Reilly
Veeva Systems
Vice President, Development Cloud Strategy

Jared Katz
Veeva Systems
Development Cloud Architect, Director of Strategy

John Lawrie
Veeva Systems
Vice President, Vault Safety

Marc Gabriel
Veeva Systems
Vice President, Vault RIM

Michael Jovanis
Veeva Systems
Vice President, Vault Quality & Manufacturing

Peter Gassner
Veeva Systems
Founder and CEO

Rik Van Mol
Veeva Systems
Senior Vice President, Development Cloud


Session Speakers

Abhishek Miglani
Astellas
Director Information & Systems Strategy

Achim Schultze
Madrigal Pharmaceuticals
Executive Director, GMP Quality Assurance

Allison Lusis
Amylyx Pharmaceuticals
Lead, Regulatory Affairs Strategy

Andrew Laughhunn
Forge Biologics
Senior Director, Quality Control

Ann O’Heney
Teva Pharmaceuticals
Senior Director, Clinical IT R&D Lead

Armand Matejunas
Pacira BioSciences
Senior Director, Clinical Data Operations

Badri Devuni
Seagen, Inc.
Senior Director, IT

Basvaraj Pinna
Jeev Lifeworks LLP
Head of Engineering

Benjamin Zwirn
Vertex Pharmaceuticals
Director, Business Engagement & Technology – Clinical Systems

Bireshwar Saha
Fortrea
Head of Global Programming and Analytics

Bonne Adams
Tracon Pharmaceuticals Inc.
COO

Brian Grant
GSK
Veeva CoE Service & Strategy Lead

Carolyn Jin
Kura Oncology
Director, Clinical Systems and Document Management

Christina Garcia
AmplifyBio
System Administrator

Christopher Doan
Atara Biotherapeutics
Senior Manager, Regulatory Affairs Operations

Claire Freitag
AmplifyBio
Director, Quality Assurance

Claudine Guild
Takeda
Senior Manager, Process, Training, and Digital Solutions

Colin Noble
Xencor
Senior TMF Systems Administrator

Dan Wheeler
Daelight Solutions
Founder & CEO

Dana Glisson
Fortrea
Global Head of Site Readiness and Regulatory

Daniela Trogolo
Roche
RIM Process Lead

David Berglund
AstraZeneca
Executive Director, Global Regulatory Operations

David Cook
Roche
Senior Business Systems Lead

David Levy
Scitara Corporation
Vice President, Strategy and Partnerships

Devante Bignall
Accenture
Management Consultant

Dilliraja Purushothaman
Fortrea
Principal Programmer

Dionna Scott
Novo Nordisk
Submission Manager, Regulatory Operations

Donna Wolfington
Sanofi
Associate Vice President, Head of Global Submissions Management

Dr. Sadia Chaudhry-Zutshi
Pharming Healthcare
Associate Director, Medical Writer

Emma Earl
Bayer
Head of Systems Support

Eva Sauerova
Merck
IT Quality Director

Fabio Fernandes
Gilead Sciences
Senior Director, Regulatory Systems

Faizan Rahim
Roche
Senior Manager, Regulatory Submission

Gillian Gadenne
Jazz Pharmaceuticals
Senior Manager, RIM

Grace DaFonseca
Cerevel Therapeutics
Manager, Quality Operations

Grishma Sharma
Accenture
Managing Director

Guillaume Pasquier
Takeda
Head Development Technology

Heather Frankhouser
Janssen
Associate Director, Clinical Trial Management Solutions

Jamie Toth
BeiGene
Senior Director, TMF Management & Records

Jenn Showalter
Eli Lilly and Company
Advisor, Clinical Data Strategist

Jennifer DiMinni
Minaris Regenerative Medicine
Global Head, Director, GxP Training, L&D

Jennifer Grant-Hyman
Regeneron
Associate Director

Jeremiah Genest
Amylyx Pharmaceuticals
Head of Quality Management Systems

John Reilly
GSK
Head R&D Development (Veeva) CoE

Joseph McLaughlin
Sanofi
Head of Business Process & Innovation for Regulatory

Joseph Wong
Amylyx Pharmaceuticals
Head, PV Operations and Alliance Management

Julian Rimmer
Abbvie
Director Information Research

Justin O’Keefe
Gilead Sciences
Senior Manager, Quality Information Systems

Karen Whitson
AbbVie
Associate Director, Study Start Up Operations

LaToya Lee Jones
Clarkston Consulting
Partner

Lance Kupka
Abbvie
Director, Clinical Data Systems (EDC & IRT)

Lauren Wallace
Virginia Commonwealth University
Director of Clinical Research Regulatory Affairs

Leianne Ebert
Alcon
Head of Clinical Data Operations

Leonie Christianson
Syneos Health
Director, R&D Advisory

Marc Nephtali
Moderna
Senior Director Digital PV and Clinical

Mary Ann Petty
Haleon
Systems, Data, and Processes Lead

Matt Neal
Atara Biotherapeutics
Senior Director, Global Regulatory & Quality

Meg Richie
Atorus Research
Vice President, Clinical Data Management

Mike McDevitt
Syneos Health
Senior VP Biometrics

Mike Tarsa
Arcus Biosciences
Senior Director, IT Quality Security and Compliance

Muralikrishnan Sundararajan
Seagen
Executive Director, Business Technology

Nicholas Darwall-Smith
NDS Consulting
Owner

Nick Kurkjy
Takeda
Product Lead, Clinical Trial Management

Nicole Pederson
Madrigal Pharmaceuticals
Vice President, Quality Assurance

Parag Shah
Genentech, a member of the Roche Group
Director, Digital Quality Excellence

Patricia Naughton
Genentech, a member of the Roche Group
Quality Director, Computer Systems Operations Chapter Lead

Patrick (Pat) Spracklin
AbbVie
Senior Director, Strategic Operations

Patty Openshaw
Fortrea
Associate Director, Clinical Systems Operational Support

Paula Bradshaw
Immunity Bio, Inc
Vice President, Clinical Business Operations

Peter Goodwin
Genentech, a member of the Roche Group
Regulatory Data and Content Leader

Peter Jons
AstraZeneca
Director, Global Regulatory Operations

Punit Chordia
BASE life science
Senior Practice Engagement Manager

Rachael Borromeo
Krystal Biotech
Senior Director, Regulatory CMC and Operation

Rinat Lifshitz-Shovali
Teva
Head of Systems & Innovation

Ryan Bridenstine
AmplifyBio
Quality Systems Supervisor

Rynita Julien
CSL
Senior Director, Information Technology

Sandra Strauss
AbbVie
Senior Director. IT – Safety, Quality, and Medical Affairs Solutions

Sanjay Bhardwaj
AbbVie
Global Head, Clinical Technology Strategy and Operations

Sara Kraft
AstraZeneca
Transformation Director

Seb Moity
UCB
IT Lead Digital Clinical Solutions

Sharon Klein
Eli Lilly and Company
Director, Clinical Results Systems

Sriram Ananthanarayanan
Moderna
Director, Digital QC

Stayce Murray
UCB
Head of IT Digital Clinical Development

Stephani Berger
Gilead Sciences
Director, Regulatory Affairs CMC

Steve Shimek
Spotline
Principal, Life Sciences

Tammy Griffin
Sarepta Therapeutics
Director, Global GxP Quality Systems

Tanya du Plessis
Bioforum the Data Masters
Chief Data Strategist and Solutions Officer

Thomas Videbech
BASE life science
Senior Manager

Tiffany Chamberlain
Novo Nordisk
Manager, Regulatory Operations

Tina Bowdish
Vanderbilt-Ingram Cancer Center
Senior Director, Clinical Research Administration

Tina Fuson
Eli Lilly and Company
Senior Manager, Regulatory Affairs

Tracey Robertson
Boehringer Ingelheim Pharmaceuticals inc.
Head of Patient & Site Engagement Capabilities

Valrie Patterson
University of South Alabama
Clinical Research Nurse

Vasilis Mavrogenis
CSL Behring
VP Of Quality

Venkat Prathivada
Arcus Biosciences
Manager, IT Validation

Verchel Wunpheng
Seagen
Senior Manager, Regulatory Information Management

Vinay Kumar
GSK
Product Director, Site Engagement & UAM

Viviënne van de Walle
PT&R
PI / CMO

Wade Harwick
Amylyx Pharmaceutical, Inc
Head, Global Business Applications

Wim DHaeze
Sarepta Therapeutics
Senior Director, Global Regulatory Operations, RIMS/DMS Lead

Abigail Sasdelli
Veeva Systems
Team Manager, Vault RIM

Andrew Gebbie
Veeva Systems
Principal Solution Consultant, Clinical Data

Andrew Rohrbaugh
Veeva Systems
General Manager, ePRO & eClinRO

Andy Han
Veeva Systems
Vice President Product Management, Vault Platform & Technology

Annie Linker
Veeva Systems
Product Manager, Clinical Operations

Anusha Shetty
Veeva Systems
Director, Strategy, Study Startup

Asi Roll
Veeva Systems
Director Product Management, Vault Safety

Bernat Rocarols
Veeva Systems
Solution Consultant, Quality

Bipin Patel
Veeva Systems
Senior Solution Consultant, Clinical Data

Bree Burks
Veeva Systems
Vice President, Strategy, Site Solutions

Brian Bialkowski
Veeva Systems
Director, Product Management, Clinical Operations

Brian Sohmers
Veeva Systems
Senior Director, Product Management, Vault Quality

Bryan Lim
Veeva Systems
Senior Product Manager

Chris Boschen
Veeva Systems
Senior Product Expert

Christina Howe
Veeva Systems
Practice Manager, Vault RIM

Christina Kim
Veeva Systems
Senior Director, Vault Safety

Cindy Ling
Veeva Systems
Senior Product Manager, Vault RIM Submissions

Drew Garty
Veeva Systems
Chief Technology Officer, Vault CDMS

Elizabeth Kreisler
Veeva Systems
Senior RTSM Project Manager

Eric Jacobson
Veeva Systems
Senior Manager, North American Solution Consulting, Clinical Data

Eric Matelyan
Veeva Systems
Associate Developer Support Engineer

Eric Shooman
Veeva Systems
Vice President, Study Portal

Eric Woolven
Veeva Systems
Senior Product Manager, SafetyDocs

Erin Coppola
Veeva Systems
Senior Product Manager, Vault Training

Erita Rothschild
Veeva Systems
Product Manager, Clinical Operations

Faisal Sufi
Veeva Systems
Senior Director, CDMS Strategy

Glen DeGuzman
Veeva Systems
Senior Solution Consultant, Quality

Graham Gelwicks
Veeva Systems
Director, Product Management, Vault Platform

Graham O’Keeffe
Veeva Systems
General Manager, LearnGxP

Harshad Kamble
Veeva Systems
Solution Consultant, Quality

Jason Boyd
Veeva Systems
Senior Director, Vault LIMS Strategy

Jason Cox
Veeva Systems
Manager, Customer Success, Quality & Regulatory

Jennifer England
Veeva Systems
Solution Consultant, Veeva RTSM

Jennifer Stacey
Veeva Systems
Vice President, Strategy, Link Clinical

Jessica Kelley
Veeva Systems
Product Expert, Vault QualityDocs

Joby George
Veeva Systems
Director, Product Management

John Tanner
Veeva Systems
Senior Product Manager, RIM

Jon Young
Veeva Systems
Director, Vault CDMS Strategy

Jonathan Chalifoux
Veeva Systems
Senior Solutions Consultant

Joseph George
Veeva Systems
Director Computer Systems Validation Strategy, R&D Services and Quality

Justin Lavimodiere
Veeva Systems
Senior Director, Vault LIMS

Kaitlyn Moore
Veeva Systems
Senior Product Manager, Clinical Operations

Karen Kestin
Veeva Systems
Global Program Manager

Kelly Finlan-Dansbury
Veeva Systems
Product Manager, Vault Registrations

Kelsey Donegan
Veeva Systems
Solution Consultant

Kenny Kong
Veeva Systems
Vice President of Strategy – Site Connect

Kim Brownrigg
Veeva Systems
Practice Manager, Regulatory Business Consulting

Kunal Morparia
Veeva Systems
Senior Product Manager, Vault Platform

Kyle Boelter
Veeva Systems
Principal Consultant – Quality

Kyle Stephenson
Veeva Systems
Director of Product Management, ePRO & eClinRO

Lee Gamble
Veeva Systems
Director, Product Management Veeva RTSM

Lisa Musick
Veeva Systems
Senior Product Manager

Lyubena Travaglini
Veeva Systems
Product Expert, Vault RIM Registrations

Manaphan Huntrakoon
Veeva Systems
Senior Director, Vault Product Management, QMS

Manny Vazquez
Veeva Systems
Director, Vault CDMS Strategy

Marius Mortensen
Veeva Systems
Vice President, Product Management, Vault Safety Suite

Mark Arnold
Veeva Systems
Director, Product Management, Vault API & SDK

Mary Anne Potok
Veeva Systems
Product Expert, Submissions, Archive and Publishing

Mary Gallagher
Veeva Systems
Practice Manager, Vault RIM

Matt DeFranco
Veeva Systems
Senior Director, Clinical Strategy, Vault Disclosures

Matthew Carlson
Veeva Systems
Product Manager, Vault Clinical Operations

Melissa Aron
Veeva Systems
Vice President, Vault Safety Services

Michael Ferrell
Veeva Systems
Product Expert, Vault Platform

Michelle Marlborough
Veeva Systems
Senior Vice President, Product Management, Sites & Patients

Mike Kruczek
Veeva Systems
Senior Director, Vault Safety Strategy

Mollie Gaede
Veeva Systems
Senior Solution Consultant, Clinical Operations

Natalie Townsend
Veeva Systems
Vice President, Strategy, Veeva RTSM

Nathan Thomas
Veeva Systems
Team Manager, R&D Business Consulting

Nick Tasse-Guillen
Veeva Systems
Principal Product Manager, Vault Registrations & MedTech

Nima Shah
Veeva Systems
Vice President, Product Management, Vault Quality & Manufacturing

Pam Pagnotta
Veeva Systems
Practice Manager, Vault RIM Services

Pavel Burmenko
Veeva Systems
General Manager, CDB

Peter Alouche
Veeva Systems
Director, Product Management

Prannoy Kothari
Veeva Systems
Senior Product Manager, VPS, QRM, and MedTech Quality

Pukar Bhandari
Veeva Systems
Senior Product Manager, Vault Platform Reports and Dashboards

Radha Maharaj
Veeva Systems
Product Manager, RIM-PromoMats Connection

Raymond Letulle
Veeva Systems
Senior Vice President, Products, Vault CDMS

Rich Merrick
Veeva Systems
Senior Director, Product Management, Vault RIM

Richard Young
Veeva Systems
Vice President, Strategy, Vault CDMS

Ruben Gottardi
Veeva Systems
Senior Solutions Consultant, Vault Validation Management

Ryan Kimble
Veeva Systems
Senior Product Manager

Rylan Collins
Veeva Systems
Head of R&D Business Consulting, North America

Scott Davenport
Veeva Systems
Sr. Services Engagement Manager

Scott Immel
Veeva Systems
Principal Solutions Consultant, Safety

Shad Ayoub
Veeva Systems
Senior Director, Study Training

Shanul Srivastava
Veeva Systems
Solution Consultant

Stephen Chelladurai
Veeva Systems
Director, Product Management

Steve Simmerman
Veeva Systems
General Manager, Veeva RTSM

Steve Snow
Veeva Systems
Product Manager, Vault QMS

T.J. Hynes
Veeva Systems
Practice Manager, Vault Submissions Publishing

Tom Dekker
Veeva Systems
Vice President Product Management, Vault Clinical Operations

Tom Frattarola
Veeva Systems
Senior Solution Consultant, Clinical Ops

Tristram Liddiard
Veeva Systems
Director Product Management, Vault Safety

Vera Lvovich
Veeva Systems
Senior Product Manager, Vault RIM Submissions Archive

Walid Abou-Chalha
Veeva Systems
Senior Product Manager, Vault Platform