Adopting an AI-forward approach to the R&D IT ecosystem means moving beyond experimentation to embedding AI into core business processes across safety, regulatory, quality, and medical affairs.
Real-world impact depends on more than deploying models—it requires integration into workflows, data harmonization, and user trust. A platform-first approach, underpinned by strong data governance and cloud scalability, ensures AI becomes a true co-pilot across functions. As pharma companies evolve toward digital maturity, operationalizing AI across the R&D value chain will be a critical lever for speed, compliance, and innovation.
Reasons to Attend
Featured Speakers
Denny Lorenz
Managing Director and Principal Consultant
Lorenz Bratti GmbH
Myra Abousabe
Exec. Dir, Strategy & Application Operations, Drug Development IT
Bristol Myers Squibb
Bina Patel
AVP, Pharmacovigilance Operations
Amgen
Sanjay Sahoo
Deputy Chief Information Officer (Acting)
FDA
Raj Ratwani
VP of Scientific Affairs at MedStar Health Research Institute and Director of the MedStar Health National Center for Human Factors in Healthcare
MedStar Health Research Institute
Sam Wallis
Head of Case Management, Patient Safety
Bristol Myers Squibb
Deborah Cooper
Senior Director
MSD
Julie Thomas
Vice President, Global Medical Safety Operations
Johnson & Johnson
Felix Arellano
Global Head of Pharmacovigilance
Roche
Hans-Jörg Römming
Executive Director, Head of RQS Information, Systems & Insights
Merck Healthcare
Alexander Kluczka
Head of PV Operations and Systems
Bristol Myers Squibb
Alice Hsu
Senior Director Signal Management
Amgen
Sanjeev Sachdeva
Global Head, Advisory and Business Process Services, Life Sciences
Tata Consultancy Services
Sumit Nagpal
Senior Director, Digital Insights, Analytics, Reporting & Data Governance, Worldwide Patient Safety
Bristol Myers Squibb
Marta Higuera
AI Labs Director
Insud Pharma
Michael Sonntag
Director Global Regulatory Affairs & Pharmacovigilance
Worwag
Brindusa Taranu
Head Product Safety Surveillance
Philip Morris International
Mariette Boerstoel
Senior Vice President, Worldwide Patient Safety Officer
Bristol Myers Squibb
Fabrice Besle
Head of Technology and Digital, Patient Safety
Ipsen
Beth MacEntee Pileggi
Head of Global Case and Safety Data Management (GC&DM)
Johnson & Johnson
Claudia Schaffer
Head of ICSR Management
Merck KGaA
Ana-Maria Iliescu
Director, Patient Safety Surveillance Systems
AstraZeneca
Alejandra Rodríguez Llerena
Data Manager Consultant
Novartis
Frits Stulp
Partner – Life Sciences
Implement Consulting Group
Griselda Saldana
Senior Director, Global Safety
Amgen
Jitendra Sinha
Head of Technology – Innovative Medicine Development
Johnson & Johnson
Ellen Mishalov
Executive Director, Head of PV Transformation and Technology
Astellas
Attila Olah
Head of Global Patient Safety
Gedeon Richter
Claudia Lehmann
Head of Global Pharmacovigilance Operations
Boehringer Ingelheim
Simon Ashworth
Global Head of Safety
Menarini
Andrea Rogers
Executive Director, R&D Informatics
Amgen
Preeya Beczek
Regulatory Affairs and Compliance – Director and Co-founder
BECZEK.COM
Steve Gens
Managing Partner
Gens & Associates
Mara Magni
Director of IT & RD
Alfasigma
Sandy Diaz
Independent PV Expert
Pharmacovigilance Solutions
Yvonne Schäfer
Head of PSPV Systems Business Solutions
Boehringer Ingelheim
Amrit Gill
Global Head of Safety (PV)
Opella
Remco Munnik
Owner & Founder
Arcana
Sandeepa Raina
Senior Director, IT Business Partner, Worldwide Patient Safety – R&D Informatics
Bristol Myers Squibb
Spencer Michelson
Director
Nordic Capital
Aman Wasan
Chief Executive Officer
ArisGlobal
Lucinda Smith
Chief Safety Product Officer
ArisGlobal
Jason Bryant
SVP, Product Manager, Data & AI
ArisGlobal
Sukrit Singh
SVP, Customer Excellence
ArisGlobal
Hear from Our Attendees
“One of the best conferences with meaningful information“
Worldwide Patient Safety Officer
“The overall energy was very powerful—the perfect opportunity to meet our vendors in person, connect beyond the screens, collaborate with peers, learn from leading pharma companies, and gain new ideas.”
Global Head of Regulatory Operations
“Great opportunity to learn, network with a variety of people and have good ideas and experiences under one roof. The opportunity to listen, ask questions and seek advice from people was really great.”
Head Global PV Operations
Discussions you won’t want to miss
Travel & Info
VENUE
We are thrilled to bring Breakthrough 2026 to
Madrid, Spain on February 10-11.
The Palace
Pl. de las Cortes,
7, Centro, 28014 Madrid, Spain
The ArisGlobal room block at The Palace Hotel is currently at capacity. All Breakthrough attendees are still able to book a room at standard rate at The Palace Hotel.
Additional nearby hotels:
*Please note: Whilst ArisGlobal recommends these hotels no room block has been secured
About
Breakthrough 2026 is ArisGlobal’s annual flagship event, bringing together life sciences leaders, pharmaceutical innovators, and regulatory authorities.
Join us for keynotes, panels, and networking sessions that explore how PV and Regulatory teams are making AI a core part of daily operations.
Experience live demos of LifeSphere and LifeSphere NavaX in the Innovation Center, and connect with ArisGlobal’s partners through our open ecosystem.
ArisGlobal reserves the right to deny registrants upon review.
