Event Schedule
Have a look at Schedule
8:00
Welcome Registration & Itinerary Collection
8:50
Welcome Address form World BI
Mansoor Nasir
World BI
8:55
Chair Welcome Address
Aldir Medeiros Filho
Clinical Data Scientist
9:00
Opening Keynote Presentation
Medical Affairs Strategies for Global Health Unit
9:20
Partner Slot 1
Creating the First Protocol Design with AI: Shortening Protocol Design Processes to Less than 3 Months
Dennis Velasquez
Head of Clinical Solutions, Biorce
Track 1: Empowering Patient Voices
Track Emcee
Andrea Forgione, HSBA
Global Head of Access Policy, Patient Advocacy and Engagement - Primary and Specialty Care, MENARINI Group
9:35
Presentation 1
Health Literacy and Understanding of Patients' Hidden Values: The First and Last Mile on the Path that Leads to an Efficient Clinical Outcome
Andrea Forgione, HSBA
Global Head of Access Policy, Patient Advocacy and Engagement - Primary and Specialty Care, MENARINI Group
9:55
Presentation 2
Managing Multi-Country Trials with Varying GMP/GDP Requirements
Dr Solange Corriol-Rohou, MD
Sr Regulatory Affairs & Global Policy Director, AstraZeneca
10:15
Coffee Break Networking: Sip, Chat, Connect
10:45
Presentation 3
Patient Safety: Toward Protecting the Safety of Participants
Antonella Cardone
Chief Executive Officer, Cancer Patients Europe - CPE
11:05
Deep-Dive Session
Patient Engagement in R&D: Transforming Healthcare Through Active Participation
Laura Risueño Ayerbe
R&D Patient Officer, Global Patient Affairs, Servier
11:25
Featured Presentation
TBC
Dr. Karen Matthews
Senior Business Development Manager, RDN Coordinating Centre (RDNCC) | National Institute for Health and Care Research
11:45
Give and Take Chat
Advocacy and Patient Involvement in Clinical Trials
Moderator
Andrea Forgione, HSBA
Global Head of Access Policy, Patient Advocacy and Engagement - Primary and Specialty Care, MENARINI Group
Panelists
Sophie Wintrich
Patient Advocate, Acute Leukemia Advocates Network
Maria Dutarte
EUPATI Executive Director, EUPATI
12:05
Partner Slot 2
Strategies for Recruiting Diverse Patient Populations
Valos
12:20
Featured Presentation
Patient Involvement in the Development, Regulation, and Safe Use of Medicines
Lembit Rägo
Secretary General, Council for International Organizations of Medical Sciences (CIOMS)
12:40
Case-Study Presentation
Capturing the Patient’s Voice and Co-building the Real-life Journey in Type 2 Diabetes
Cecilia Simonelli
Menarini Executive Consultant
13:00
Lunch Break (Dine & Discuss: Ideas on the Menu)
13:50
Fish-Bowl Session
The Role of Key Opinion Leaders (KOLs) in Shaping the Future of Clinical Trials
Andrea Forgione, HSBA
Global Head of Access Policy, Patient Advocacy and Engagement - Primary and Specialty Care, MENARINI Group
Jessica Cordes
Senior Consultant
Thierry Schulmann
Sr Director Medical Affairs Strategy, Sumitomo Pharma Switzerland
Francois Houyez
Treatment Information and Access Director / Health Policy Advisor, Eurordis - Rare Diseases Europe
Track 2: Transforming Clinical Development
Track Emcee
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Jennifer C. Smith-Parker
PR and Communications Consultant
14:20
Presentation 4
Optimizing Early Phase Clinical Trial Design for Efficient Drug Development
Jessica Cordes
Senior Consultant
14:40
Presentation 5
Data Driven Leadership in Drug Development - Future Trends
Debarshi Dey
Vice President, Head of Data Science, Galapagos
15:00
Coffee Break Networking: Sip, Chat, Connect
15:20
Fire-Side Chat
Reimagining Clinical Operations: Navigating the Future of Efficiency and Innovation…an Outlook Into the Year 2050
Moderator
Jessica Cordes
Senior Consultant
Panelist
Dr. Bernhard Glombitza
Head Clinical Customer Engagement and Clinical Operations EMEA/LATAM, Bayer AG
15:50
Presentation 6
Navigating Strategy and Accélération Processes for Innovation in Early Phases of Development: The Foundation For Success
Dr Violaine Desort-Hénin
Regulatory Advisor/Strategy Orphan Diseases | CMO | Entrepreneur in Residence & Future CEO, Restore Vision
16:10
Deep-Dive Session
How to Approach the Design and Conduct of a Clinical Development Plan in the Rare Disease Space from a Biotech Perspective
Carl Bjartmar
Chief Medical Officer, Augustine Therapeutics
16:30
Presentation 7
Patient Involvement in the Development, Regulation, and Safe Use of Medicines
Christoph Gasteyger
Executive Director, Global Program Team Lead, Alexion, AstraZeneca Rare Disease
16:50
Featured Presentation
Innovative Resource Management Strategies in Global Clinical Development and Operations
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piet (Peter) theisohn
Managing Director, Former Bayer/ theisolutions GmbH
17:10
Chair Closing Remarks
Jennifer C. Smith-Parker
PR and Communications Consultant
17:15
Happy Hour Session
8:00
Welcome Registration & Itinerary Collection
8:50
Welcome Address form World BI
Mansoor Nasir
World BI
8:55
Chair Welcome Address
Jennifer C. Smith-Parker
PR and Communications Consultant
9:00
Opening Keynote Presentation
Leveraging Primary Care EHR Data to Enhance Interventional Research Through GP Questionnaires, Trial Recruitment, PROs, and Decentralised Pragmatic and Cluster Randomised Trial
Tim Williams
Head of Interventional Research, CPRD (MHRA)/Medicines and Healthcare products Regulatory Agency
9:20
Presentation 8
Post Marketing Studies Beyond the Randomised Controlled Trials
Guna Dansone
Head of Clinical Research, Olpha LV
9:40
Presentation 9
Global Clinical Trials: Building Multinational Studies That Work
Dr. Smadar Bustan
Senior International Clinical Research and Project Management (Industry / Public) / Clinical Scientist, Institut Curie
10:00
Featured Presentation
Targeting HIV Where It Hurts
Tomáš Hanke
Professor, Oxford University
10:20
Coffee Break Networking: Sip, Chat, Connect
10:50
Deep Dive Session
TBC
Erik Buntinx
Founding CEO, ANeuroTech & Anima Research Center
11:10
Presentation 10
Advancing Medical Device Clinical Investigations: Overcoming Challenges
Laura Bonino
Head of Clinical Development, SIFI
Track 3: Clinical Data and Technology
Track Emcee
Aldir Medeiros Filho
Clinical Data Scientist
11:30
Introductory Presentation
What Could ClinOps & QAs Experts on IND & NDA Clinical Research Teach AI Researchers About Using Patient’s Clinical Datasets? That, Maybe, They are ‘Barking up the Wrong Tree
Aldir Medeiros Filho
Clinical Data Scientist
12:00
Featured Presentation
TRIZ - A Practicable Theory of Innovations and Inventions for Clinical Trials in Precision Medicine?
Rudi Schmidt
COO, Institute for Healthier Living Abu Dhabi
12:20
Presentation 11
The Clinical Research Data Revolution: EHR-to-EDC Delivers Transformative Results
Mats Sundgren
Sr. Director, European Institute of Innovation through Health Data (i-HD)
12:40
Lunch Break (Dine & Discuss: Ideas on the Menu)
13:40
Presentation 12
Causal Inference in Clinical Trials: Navigating Regulatory Challenges in the Era of Big Data
Amitava Mukhopadhyay
Associate Director Biostatistics, MorphoSys AG
14:10
Deep Dive Session
Professional Roles, AI, and The Future of Work
 Drodge.webp)
David (Dave) Drodge
Digital Transformation Lead, Roche
14:30
Presentation 13
The Federate Digital Autonomous Organizations Based on Blockchain for Research Cooperative Groups: The New Standard in Data Mangament is Coming
Dr. Jose Manuel Cervera Grau
Assistant Attending Physician Comprehensive Oncology Centre Clara Campal CIOCC, HM Hospitales
14:50
Presentation 14
The Future of Regulatory Affairs: Leveraging AI for Strategic Planning and Review
Dr. Meelis Lootus
CEO and Founder, IEEE/Tehistark
15:10
Presentation 15
Laying the Groundwork for Clinical AI: A Data Lakehouse Transformation Story
Rafal Wojdan
Director of Data Science, Ryvu Therapeutics
15:30
Coffee Break Networking: Sip, Chat, Connect
15:50
Presentation 16
AI-Powered Approaches to Streamlining Clinical Trials: Enhancing Efficiency Through Advanced Computational Methods
Amhar Jabeer
Computational Scientist, Sanofi
16:10
Presentation 17
Unlocking the Potential of AI for Clinical Trials and Innovation
Eric Hajjar
Associate Director, Global Medical Research Operations, Former Biogen
16:30
Presentation 18
AI Driven Drug Discovery and Clinical Trials: How This New Era may Impact Clinical Supply Chains
Eamonn McArdle
Lead Clinical Supply Chain Pharmacist, Allergy Therapeutics
16:50
Give and Take Chat
Fit For the Future: Empowering Clinical Trials with Digital Technology
Moderator
Aldir Medeiros Filho
Clinical Data Scientist
Panelist
Manan Trivedi
Associate Director - EU CTR Project Lead, UCB
17:10
Snap & Share Contest
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17:20
Chair Closing Remarks with Coffee
Jennifer C. Smith-Parker
PR and Communications Consultant