Boston | October 20-21, 2026

Powerful Community, Fresh Ideas

Speakers

Keynote Speakers

Torkil Fredborg

Eli Lilly and Company
Associate VP, Regulatory Delivery & Excellence

Andreas Rauscher

Merck & Co.
Executive Director Veeva Platform & Partnership

Rachel Nering

Sanofi
Global Head of Early Development Clinical Operations and the Head of eDevelopment

Elizabeth Humes

UCB
Head Global Pharmacovigilance Reporting Operations

Jonas Maselis

UCB
Head of Digital Technology Patient Safety

Marc Gabriel

Veeva
Vice President, Regulatory

Peter Gassner

Veeva
Founder and CEO

Jared Katz

Veeva
Senior Director, Development Cloud Strategy

Pat McQueen

Veeva
Chief Technology Officer

Session Speakers

Melody Chessia

Accumulus Technologies
Director of Product Management

Manish Sikligar

Amgen
Director, Technology Strategy Lead

Wolfgang Bradler

Amgen
Executive Director, Technology – Veeva Enterprise Lead

Petra Cramer

Amgen
Director, Clinical App and Analytical Services

Harshal Mahajan

Amgen
Senior Manager, Data Management

Tine De Pla

Amgen
Development Operations Innovation Director

Randhir Singh

Amgen
Senior Manager, Technology Veeva Governance Lead

Peter Silas

AMR-Clinical
Principal Investigator and Regional Medical Director

Dawn Cox

Amylyx Pharmaceuticals, Inc.
Director, Pharmacovigilance Operations

Joe Wong

Amylyx Pharmaceuticals, Inc.
Vice President, Patient Safety & Pharmacovigilance

Sadia Chaudhry-Zutshi

Aquestive Therapeutics, Inc.
Regulatory Technical Writer

Debbie Stanier

AstraZeneca
Senior Director, Regulatory Systems

Robert Bergann

Bayer
VP, Clinical Digital Transformation

Emma Earl

Bayer
Head of Clinical Trial Management Services and Solutions

Swathi Veluri

Bayer
Head Of Data Provisioning

Christopher Doan

BeOne Medicines
Associate Director, Global Regulatory Solutions Enablement

Sharon Chan

Biogen
Director, Global ICSR Processes and Systems

Shane Dickinson

Bora Pharmaceuticals
Senior Director, Global Quality Systems

Angie Badgett

Celerion
Executive Director, Global Project Management & Strategic Solutions

Dylan Berger

Celerion
Veeva Vault Administrator

Megan Shannon

Celerion, Inc.
Director, Clinical Data Management – EDC

Staci McDonald

Celerion
Vice President Global Scientific Clinical Operations

Dan Schell

Clinical Leader
Chief Editor

Michael Epstein

Cytokinetics, Incorporated
Executive Director, Regulatory Operations and Submission Management

Shailesh Thapa

Deciphera Pharmaceuticals
Director, Analytical Operations and QC

Charles Brunet

Disc Medicine
Director, Clinical Quality Control

Todd Gerig

Eli Lilly and Company
Product Owner, RIM Publishing

Ashik Sunny

Eli Lilly and Company
Manager, Global Regulatory RD&E

Nancy Wetzel

Eli Lilly and Company
Director, Clinical Trial Foundations, Clinical Result Systems

Nihar Baxi

Emergent BioSolutions
Senior Director, Regulatory Affairs

Praveen Vangeti

Exelixis
Executive Director, IT – Drug Development, Supply Chian and Quality

Melanie Hullings

Formation Bio
Director, Data Management & Analytics

Robert Windsor

Fortrea
Senior Quality Metrics & Data Analyst

Jennifer Ly

Gilead Sciences
Director, Quality Systems

Michael Morad

Gilead Sciences
Executive Director, Quality

Brian Grant

GSK
Sr Dir, Regulatory Systems Operations

Bob Reid

GSK
Product Owner, Senior Manager

Kathy Roberts

Incyte
Vice President, Global Pharmacovigilance

Eric Hardy

Indero
Senior Director, Biometrics

Vanessa Flemming

Ionis Pharmaceuticals, Inc.
Assistant Director, GxP Quality Systems | GMP Vendor Management

JT Soley

Ionis Pharmaceuticals, Inc.
Assistant Director, Development IT Portfolio

Sabrina Steffen

IQVIA
Vice President, Head of Clinical Data Management and Data Sciences Innovation

Tara Foltz

Johnson & Johnson
Manager, Clinical Trial Learning & Training

Stephen van Arcken

Kailera Therapeutics
Associate Director, Clinical Systems

Dee DeOliveira

Kailera Therapeutics
Senior Director, Regulatory Operations

Sandi Harrison

Keenova Therapeutics
Director eTMF & Inspection Readiness

Kailash Rathi

Kindeva
Director of Global Quality Systems and Engineering

Joseph McDonnell

Merck & Co.
Senior Director Health Registration Management

Jody McNaughton

NMDP
Senior Application Business Owner

Jared Lantzy

Novavax, Inc.
Executive Director, Global Regulatory Affairs Operations

Catherine Munera

Oruka Therapeutics
Vice President, Biometrics

Jennifer Budich

Pacira BioScience
Director, Clinical Data Management

Christie Wilkins

Parexel
Senior Director, Solution Enablement, Operational Excellence

Emma Meagher

Perelman School of Medicine, University of Pennsylvania
Senior Vice Dean, Clinical and Translational Research

Gisele Fahmi

Pfizer
Director, QC Operations Digitization and Master Data (IMOQ)

Amha Lawson

Regeneron Pharmaceuticals
Senior Manager, Regulatory Information Management & Innovation

Amy Keum

Roche
Senior Regulatory Submission Manager

Erin Stackowitz

Sanofi
Senior Director, Clinical Digital Transformation Implementation Lead

Jamison Johnson

Sarepta Therapeutics, Inc.
Associate Director, Clinical Systems

Kelci Miclaus

Snowflake
Head of Life Sciences AI

Kelsey Edwards

Takeda Pharmaceuticals
Director, RIM

Ryan Hernandez

Teva Pharmaceuticals
Senior Director, Head of Global Regulatory Operations

Matthew McMenamin

The Sentinel Consulting Group LLC
Principal

Brook Darnell

Tolmar Inc
Senior Quality Systems Specialist – Training

Arash Naeim

UCLA
Chief Medical Office for Clinical Research

Michelle Royals

Veloxis Pharmaceuticals
Senior Director, QMS and Compliance

Ilona Barskaya

Votum Consulting
Managing Partner

Anthony Ochoa

Votum Consulting
Managing Partner

Eric Zubee

Zubee Consulting Inc
President / Principal Consultant

Peter Alcocer

Veeva
Director of eLearning Compliance

Crystal Allard

Veeva
Senior Director, Government Strategy

Igor Altman

Veeva
Vice President, Product Management eCOA

Brad Arnold

Veeva
Director, Product Management, Falcon Writer

Mark Arnold

Veeva
Directory, Product Management – Developer Experience

Reeves Bell

Veeva
Developer Support Engineer

Nicole Bradley

Veeva
Product Expert

Kimberly Brown

Veeva
Solution Consultant, Site Solutions

Stephen Chelladurai

Veeva
Director of Product Management

Ryan Clemens

Veeva
Senior Solution Consultant, Quality

Rylan Collins

Veeva
Head of R&D Business Consulting

Erin Coppola

Veeva
Senior Product Manager

Anthony Corso

Veeva
Vice President, Public Policy

Eldar Curovic

Veeva
VP, Product Management

Paola DePaso

Veeva
Senior Director, QualityDocs Strategy

Mike Edwards

Veeva
Director, Batch Release Strategy

Mike Ferrell

Veeva
Principal Product Expert, Vault Platform

Kelly Finlan-Dansbury

Veeva
Senior Product Manager, Registrations

Alice Foltyn

Veeva
Senior Solution Consultant

Tom Frattarola

Veeva
Senior Solution Consultant

Nick Frenzer

Veeva
General Manager, Site Solutions

Drew Garty

Veeva
Chief Technology Officer, Clinical Data

Graham Gelwicks

Veeva
Senior Director of Product, Vault Platform

Joby George

Veeva
Director, Product Management, LIMS

Nader Girgawy

Veeva
Director, Regulatory Strategy

Ruben Gottardi

Veeva
Senior Solution Consultant, Validation Management

Lisa Greene

Veeva
Principal Product Manager

Andy Han

Veeva
SVP Products, Vault AI and Vault Platform

Jason Hardin

Veeva
Senior Product Manager

Jim Horstmann

Veeva
Senior Product Manager, Veeva eTMF

Manaphan Huntrakoon

Veeva
Senior Director of Product Management

Crystal Isgro

Veeva
Senior Director, Regulatory Strategy

Eric Jacobson

Veeva
Senior Manager, North American Solution Consulting, Clinical Data

Kevin Johns

Veeva
VP, Global Clinical Operations Business Consulting

Ancy Johnson

Veeva
Principal Business Consultant

Amos Kendall

Veeva
Senior Product Manager, Vault Platform

Taylor Kiakotos

Veeva
Principal Consultant, North America R&D Business Consulting

Ryan Kimble

Veeva
Senior Product Manager

Nick Klatt

Veeva
Senior Solutions Consultant

Justin Lavimodiere

Veeva
Senior Director, Veeva LIMS Strategy

Ray Letulle

Veeva
Senior Vice President, Clinical Data

Cindy Ling

Veeva
Senior Product Manager, Vault AI (RIM)

Fernando Londoño

Veeva
VP, Global Quality Business Consulting

Radha Maharaj

Veeva
Product Manager, Submissions Publishing

Alex Margolis

Veeva
Principal, Quality Business Consulting

Alison Marjanowski

Veeva
Senior Director, Veeva Labeling

Jim Markley

Veeva
Director, TMF Strategy

Eric Matelyan

Veeva
Developer Support Engineer

Lucy McCanna

Veeva
Solution Consultant, Clinical Data

Rich Merrick

Veeva
Vice President, Product Management, Regulatory

Jason Methia

Veeva
Vice President, Falcon Clinical and Head of TMF

Chad Mills

Veeva
Solution Consultant, Veeva Batch Release

Kaitlyn Moore

Veeva
Senior Product Manager

Kayla Mujkanovic

Veeva
Senior Product Manager, Clinical Operations

Angela Nguyen

Veeva
Product Manager, Regulatory

Carl Ning

Veeva
Senior Director, Veeva QMS Strategy

Sarah O’Hora

Veeva
AVP, Clinical Operations Business Consulting

Graham O’Keeffe

Veeva
General Manager, LearnGxP

Mrinal Pahwa

Veeva
Associate Vice President, Global Safety Business Consulting

Pratyusha Pallavi

Veeva
Executive Director, Falcon Regulatory Strategy

Cindhuja Pandian

Veeva
Associate Vice President, Global Clinical Data Business Consulting

Rachael Payne

Veeva
Senior Solution Consultant

Kristie Petrella

Veeva
Senior Solution Consultant, Veeva LIMS

Chris Pontisso

Veeva
Director – Product Management

Alexis Pyles

Veeva
Senior Solution Consultant, eCOA

Nina Ricciardelli

Veeva
Senior Director, Validation Management Strategy

Taylor Richardson

Veeva
Product Manager, Submissions

Luke Rooney

Veeva
Associate Vice President, Global Regulatory Business Consulting

Erita Rothschild

Veeva
Senior Product Manager, Site Connect

Lena Schafer

Veeva
Director, Regulatory Strategy

Brian Sohmers

Veeva
Senior Director, Product Management, Veeva Batch Release

Caríosa Switzer

Veeva
Product Manager, Registrations

Beth Tanner

Veeva
Vice President, EHS Strategy

John Tanner

Veeva
Senior Product Manager, RIM Connections

Nick Tasse-Guillen

Veeva
Director, Product Management, Labeling

Nathan Thomas

Veeva
Associate Vice President, R&D Business Consulting

Joseph Traficanti

Veeva
Director, Regulatory Strategy

Cooper VanLare

Veeva
Vice President Product

Bryden Waggott

Veeva
Vice President Product – EHS

Jordan Williams

Veeva
Senior Product Manager, Falcon

Jon Young

Veeva
Senior Director, Strategy, Clinical Data (SMB)

Advance Life Sciences R&D and Quality

Boston | October 20-21, 2026