SESSION 1 – INTEGRATION OF REGULATORY ASSESSMENT AND THE ASSESSMENT
OF REIMBURSEMENT

Adaptive pathway development: a clinical approach in Fabry disease, Prof. Carla Hollak (Amsterdam University Medical Center, NL)

ILAP – co-operation and accelerated approval, Dan O’Connor (MHRA, UK)

Industry experience with ILAP, Daniel Martin (Merck Healthcare KGaA, DE)

Moving the statistical analysis of randomized trials from a single endpoint to a patient-centric benefit-risk assessment, Marc Buyse (IDDI, BE)

SESSION 2 – REFLECTION ON CDDF WORKSHOPS 2021

Endpoints in cancer drug development, Chitkala Kalidas (Bayer, US)

Digital tools and artificial intelligence, Nafsika Kronidou Horst (Roche, CH)

CDDF-AAADV satellite session on the global pediatric neuro-oncology network, Kim Lyerly (AAADV, US)

Gene and cell therapies in oncology, Jaap Verwei (CDDF, UK)

SESSION 3 – ENHANCING THE FUTURE OF CLINICAL TRIALS

CTFG’s perspective on enhancing the future of clinical trials, Elke Stahl (BfArM, DE) – did not give consent to have the presentation published

Delivering on innovative trials: an industry’s perspective, Mireille Muller (Novartis, CH)

Patient-centric, decentralized clinical trials – a national project, Gunilla Andrew-Nielsen (Swedish MPA, SE)

SESSION 4 – LESSONS LEARNED FROM ACCELERATION IN PEDIATRIC ONCOLOGY
PROGRAMS

C4C IMI project, Heidrun Hildebrand (Bayer, DE)

Academic & industry perspective, Peter Adamson (Sanofi, US)

A European perspective on collaborations to accelerate global paediatric oncology drug developments, Dominik Karres (EMA, DE)

Research Foundation perspective: How nonprofits can be the changemakers, Annette Bakker, Ph.D. (President of Children’s Tumor Foundation US and chair of CTF Europe, US)

Lessons learned from AAADV meeting + FDA experience with pediatric accelerated programs, Gregory Reaman (FDA, US)

SESSION 5: COLLABORATION IN THE POST-COVID REGULATORY ENVIRONMENT

Boosting international regulatory collaboration, Agnes Saint-Raymond (Former EMA Head of International Affairs Division, NL)

Project Orbis, experience and expansion, Angelo DeClaro (FDA, US)

Swissmedic: Current Status & Future Considerations on International Regulatory Collaborations, Ulrich Peter Rohr (Swissmedic, CH) – did not give consent to have the presentation published