Clinical Trials Innovation Programme

Break

Welcome Registration & Itinerary Collection

Other

Welcome Address from World BI

Mansoor Nasir, World BI

Other

Chair Welcome Address

Aldir Medeiros Filho

Talk

Managing Multi-Country Trials with Varying GMP/GDP Requirements

Solange Corriol-Rohou, AstraZeneca

Keynote

Advancing Medical Device Clinical Investigations: Overcoming Challenges

Laura Bonino, SIFI

Talk

Creating the First Protocol Design with AI: Shortening Protocol Design Processes to Less than 3 Months

Dennis Velasquez, Biorce

Talk · Empowering Patient Voices

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, MENARINI Group

Talk · Empowering Patient Voices

Patient Safety: Toward Protecting the Safety of Participants

Antonella Cardone, Cancer Patients Europe - CPE

Break

Coffee Break Networking: Sip, Chat, Connect

Talk · Empowering Patient Voices

Patient Engagement in R&D: Transforming Healthcare Through Active Participation

Laura Risueño Ayerbe, Servier

Talk · Empowering Patient Voices

Enhancing Patient Engagement in Clinical Trials: Building Trust, Improving Communication, and Driving Retention

Karen Matthews, RDN Coordinating Centre (RDNCC) | National Institute for Health and Care Research

Panel · Empowering Patient Voices

Advocacy and Patient Involvement in Clinical Trials

Andrea Forgione, MENARINI Group · Sophie Wintrich, Acute Leukemia Advocates Network · Maria Dutarte, EUPATI

Talk · Empowering Patient Voices

Optimizing Clinical Trials Outsourcing: A Strategic Guide for Biostatistics and Data Management

Dmitri Petratchenko, Valos

Talk · Empowering Patient Voices

Engaging Patients in the Development, Oversight, and Safe Application of Medicines

Lembit Rago, Council for International Organizations of Medical Sciences (CIOMS)

Talk · Empowering Patient Voices

Capturing the Patient’s Voice and Co-Building the Real-life Journey in Type 2 Diabetes

Cecilia Simonelli

Break

Lunch Break (Dine & Discuss: Ideas on the Menu)

Panel · Empowering Patient Voices

The Role of Key Opinion Leaders (KOLs) in Shaping the Future of Clinical Trials

Andrea Forgione, MENARINI Group · Jessica Cordes · Thierry Schulmann, Sumitomo Pharma Switzerland · Francois Houyez, Eurordis - Rare Diseases Europe · Peter Adura, Bliss Biomedics

Talk · Transforming Clinical Development

Optimizing Early Phase Clinical Trial Design for Efficient Drug Development

Jessica Cordes

Talk · Transforming Clinical Development

Interviewing Trial Patients in Global Clinical Trials: What are the Challenges and Requirements?

Jens Harald Kongsø, CLINIGMA

Fireside chat · Transforming Clinical Development

Reimagining Clinical Operations: Navigating the Future of Efficiency and Innovation…an Outlook into the Year 2050

Jessica Cordes · Bernhard Glombitza, Bayer AG

Break

Coffee Break Networking: Sip, Chat, Connect

Talk · Transforming Clinical Development

Data Driven Leadership in Drug Development - Future Trends

Debarshi Dey, Galapagos

Talk · Transforming Clinical Development

Navigating Strategy and Processes for Innovation in Early Phases of Development: The Foundation for Success

Violaine Desort-Hénin, Restore Vision

Talk · Transforming Clinical Development

How to Approach the Design and Conduct of a Clinical Development Plan in the Rare Disease Space from a Biotech Perspective

Carl Bjartmar, Augustine Therapeutics

Talk · Transforming Clinical Development

Patient Involvement in the Development, Regulation, and Safe Use of Medicines

Christoph Gasteyger, Alexion, AstraZeneca Rare Disease

Talk · Transforming Clinical Development

Innovative Resource Management Strategies in Global Clinical Development and Operations

Piet Theisohn, theisolutions GmbH

Other

Chair Closing Remarks

Jennifer C. Smith-Parker

Networking

Happy Hour Session

Break

Welcome Registration & Itinerary Collection

Other

Welcome Address from World BI

Mansoor Nasir, World BI

Other

Chair Welcome Address

Jennifer C. Smith-Parker

Keynote

Leveraging Primary Care EHR Data to Enhance Interventional Research Through GP Questionnaires, Trial Recruitment, PROs, and Decentralised Pragmatic and Cluster Randomised Trial

Tim Williams, CPRD (MHRA)/Medicines and Healthcare products Regulatory Agency

Talk

Post Marketing Studies Beyond the Randomised Controlled Trials

Guna Dansone, Olpha LV

Talk

Global Clinical Trials: Building Multinational Studies That Work

Smadar Bustan, Institut Curie

Talk

Targeting HIV Where It Hurts

Tomáš Hanke, Oxford University

Talk

The Return of Individual Participant Data (RoIPD) by Design: Making Complex Ideas Possible

Johanna MC Blom, University of Modena and Reggio EMilia

Break

Coffee Break Networking: Sip, Chat, Connect

Talk

Delivering your Trial in Time and with Maximum Adherence: The New ANIMA Research Model

Erik Buntinx, ANIMA Research

Talk

Unlocking the Potential of AI for Clinical Trials and Innovation

Eric Hajjar, Former Biogen

Talk · Clinical Data and Technology

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

Talk · Clinical Data and Technology

TRIZ - A Practicable Theory of Innovations and Inventions for Clinical Trials in Precision Medicine?

Rudi Schmidt, Institute for Healthier Living Abu Dhabi

Break

Lunch Break (Dine & Discuss: Ideas on the Menu)

Talk · Clinical Data and Technology

The Clinical Research Data Revolution: EHR-to-EDC Delivers Transformative Results

Mats Sundgren, European Institute of Innovation through Health Data (i-HD)

Talk · Clinical Data and Technology

The Federate Digital Autonomous Organizations Based on Blockchain for Research Cooperative Groups: The New Standard in Data Mangament is Coming

Jose Manuel Cervera Grau, HM Hospitales

Talk · Clinical Data and Technology

AutoDossier in Action: See AI Draft SLR & IND in Minutes—So Experts Achieve Perfection Faster, Smoother, and with Less Than Half the Labor

Meelis Lootus, IEEE/Tehistark

Talk · Clinical Data and Technology

Laying the Groundwork for Clinical AI: A Data Lakehouse Transformation Story

Rafal Wojdan, Ryvu Therapeutics

Talk · Clinical Data and Technology

Professional Roles, AI, and The Future of Work

David Drodge, Roche

Break

Coffee Break Networking: Sip, Chat, Connect

Talk · Clinical Data and Technology

Causal Inference in Clinical Trials: Navigating Regulatory Challenges in the Era of Big Data

Amitava Mukhopadhyay, MorphoSys AG

Talk · Clinical Data and Technology

AI-Powered Approaches to Streamlining Clinical Trials: Enhancing Efficiency Through Advanced Computational Methods

Amhar Jabeer, Sanofi

Talk · Clinical Data and Technology

AI Driven Drug Discovery and Clinical Trials: How This New Era may Impact Clinical Supply Chains

Eamonn McArdle, Allergy Therapeutics

Panel · Clinical Data and Technology

Fit For the Future: Empowering Clinical Trials with Digital Technology

Aldir Medeiros Filho · Manan Trivedi, UCB · John Batchelor, DEEP Measures

Other

Snap & Share Contest

Other

Chair Closing Remarks with Coffee

Jennifer C. Smith-Parker