Good Morning Meeting | Optimizing the Transition from early to late phase trials in oncology
September 19, 2023
We are pleased to invite you to the IDDI & MVA complimentary meeting to explore the challenges of the transition from early (phase 1, expansion cohorts and single-arm phase 2) trials to later phases of clinical development
September 19th | 8:30am – 11am CEST
Medicon Valley Alliance, Arne Jacobsens Allé 15, 2300 Copenhagen S, Denmark – Meeting room: Auditorium
The transition from early (phase 1, expansion cohorts and single-arm phase 2) trials to later phases of clinical development poses several challenges. While many of these challenges are of strategic and financial natures, some usual methodological pitfalls can be addressed in a somewhat systematic fashion.
In this presentation,
- We will explore these pitfalls and attempt to outline the key aspects that need to be taken into account to mitigate risks and optimize the chances of successful drug development in oncology, even though the concepts to be discussed are applicable to any other indication where precision medicine is of interest.
- The most salient issues to be discussed include:
- “Regression to the mean” (a key reason why phase 3 results often do not reproduce those from phase 2),
- The overreliance on historical data, misconceptions about the impact on sample size from randomizing early on,
- The assessment of more promising subgroups for development of precision therapy in biomarker-defined subsets, and some key aspects related to accelerated approval by the US Food and Drug Administration and conditional marketing authorization by the European Medicines Agency.
- 08:30: Networking, registration and breakfast
- 09:00: Welcome – David Munis Zepernick, Director, Member Engagement & Communication, Medicon Valley Alliance
- 09:05: Optimizing the transition from early to late phase trials in oncology – Everardo D. Saad, MD, Medical Director, International Drug Development Institute
- 10:00: Q&A
- 10:30: Networking
- 11:00: End of Good Morning Meeting
Everardo D. Saad, MD, Medical Director, International Drug Development Institute (IDDI)
Dr. Everardo Saad has nearly 20 years of experience in Medical Oncology and clinical-trial design. He graduated in Medicine and trained in Internal Medicine in Sao Paulo, and did his fellowship in Medical Oncology at the University of Texas M.D. Anderson Cancer Center, in Houston. After practicing for several years, he shifted his professional career towards education and research in Medical Oncology, and has a special interest in clinical trial methodology, the assessment of endpoints, and the development of novel therapies for cancer patients.