| Number | Session | Link (if available) |
|
|---|---|---|---|
| 1 | Fast to market vs. robustness of the data | x | |
| 2 | Estimands – Celebrating the 5th anniversary of ICH E9(R1) – what have we learned and where do we need to go? | x | |
| 3 | Regulatory landscape in China | x | |
| 4 | Patient preferences | x | |
| 5 | Openstatsware - How can we build a scalable ecosystem? | x | |
| 6 | Regulatory and HTA updates | x | |
| 7 | Opportunities and barriers for innovative methodology in EU HTA | x | |
| 8 | Opportunities and barriers for innovative methodology in EU HTA (Part 2) | x | |
| 9 | Short Topics | x |
Recordings
Recordings of those sessions where all presenters have given consent:
Material
Opening
| Talk | Speaker and affiliation | Talk title | Download (if available) |
|---|---|---|---|
| 2 | Egbert Biesheuvel (Viatris, EFSPI president) | Opening remarks | x |
Session 1: Fast to market vs. robustness of the data
| Talk | Speaker and affiliation | Talk title | Download (if available) |
|---|---|---|---|
| 1 | Jenny Devenport (Roche) | How the pressure to be first, faster, puts pressure on us all and what we can do about it? | x |
| 2 | Eva Skovlund (NOMA, NO; CHMP member) | Conditional marketing authorisation | x |
| 3 | Kaspar Rufibach | CLL11 – a trial tailored to answer questions from many stakeholders efficiently | x |
| 4 | Karin Cerri and Lilla di Scala (J&J) | Fast and furious to market across Pharma, is it good for HTA? | x |
Short topics
| Talk | Speaker and affiliation | Talk title | Download (if available) |
|---|---|---|---|
| 1 | Judith Anzures-Cabrera, Annabelle Monnet, Alex Strasak (Roche) | Estimand Strategies for Handling Deaths in Early-Stage Neurological Disorder Studies | x |
| 2 | James Bell (Elderbrook Solutions GmbH), Thomas Drury (GlaxoSmithKline), Tobias Mütze (Novartis Pharma AG), Christian Bressen Pipper (Novo Nordisk A/S), Marian Mitroiu (Biogen International GmbH), Khadija Rerhou Rantell (MHRA), Marcel Wolbers (Roche), David Wright (AstraZeneca) | Estimation methods for estimands using the treatment policy strategy | x |
| 3 | Fredrik Öhrn (J&J) | Two trials rule versus pooled trials rule | x |
| 4 | Marc Buyse and Samuel Salvaggio (One2Treat) | Testing procedure for multiple treatments and multiple outcomes | x |
| 5 | Kostas Sechidis, Mark Baillie, and Bjorn Bornkamp (Novartis) | What are the Quality Standards for Exploratory Analyses? | x |
| 6 | Hong Sun (BMS) | Contribution of Sequence | x |
Session 2: Estimands – Celebrating the 5th anniversary of ICH E9(R1) – what have we learned and where do we need to go?
| Talk | Speaker and affiliation | Talk title | Download (if available) |
|---|---|---|---|
| 1 | Frank Bretz (Novartis) and Rob Hemmings (Consilium) | Estimands: Implemented, but not fully embraced | x |
| 2 | Miya Okada Paterniti (FDA) | Clinical Perspectives on Estimand Framework Implementation | x |
| 3 | Laura Rodwell (Medicines Evaluation Board) | Implementation of the estimand framework in the regulatory assessment: How it started and how it’s going | x |
Session 3: Regulatory landscape in China
| Talk | Speaker and affiliation | Talk title | Download (if available) |
|---|---|---|---|
| 1 | Duanduan Cong (NMPE) | Opportunities and Challenges in Clinical Research under China’s Scientific Regulatory System: Focusing on Innovative Drug Development | x |
| 2 | Jianhong Pan (NMPE) | Implementation of ICH Statistical Guidelines in China: from the Regulatory Perspective | |
| 3 | Yan Hou (Peking University) | Intelligent regulation and statistics promote the modern development of regulatory science in China | x |
| 4 | Xiaoni Liu (Novartis) | Joint Efforts for Innovative Drug Development in China | x |
Session 4: Patient preferences
| Talk | Speaker and affiliation | Talk title | Download (if available) |
|---|---|---|---|
| 1 | Brett Hauber (Pfizer) | Industry case study. How a patient preference study impacted the approval/SmPC | x |
| 2 | Francesco Pignatti (EMA) | ICH E22 General Considerations for Patient Preference Studies | x |
| 3 | Elina Asikanius (fimea, FI; SAWP member) and Mouna Akacha (Novartis) | Summary of Product Characteristics, Section 5.1: what can the industry statistician do to ensure patient relevant data is included? | x |
| 4 | Anna Wiksten (CH) | Selecting the treatment – my patient and statistician perspectives | x |
Session 5: Openstatsware - How can we build a scalable ecosystem?
| Talk | Speaker and affiliation | Talk title | Download (if available) |
|---|---|---|---|
| 1 | Sarianne Päivike (Fimea) | General GCP principles with focus on software | x |
| 2 | Juha-Pekka Perttola (Roche) | openstatsware, pharmaverse, validation, and Roche filing experience | x |
| 3 | Paul Schuette (FDA) | Experiences from FDA with open-source submissions | x |
Session 6: Regulatory and HTA updates
| Talk | Speaker and affiliation | Talk title | Download (if available) |
|---|---|---|---|
| 1 | Kit Roes (Chair of MWP EMA) | EMA Methodology Working Party update – bridge to the future | x |
| 2 | Greg Levin (FDA) | Statistical Updates from the United States Food and Drug Administration (FDA) Center for Drug Evaluation and Research (CDER) | x |
Session 7: Opportunities and barriers for innovative methodology in EU HTA
| Talk | Speaker and affiliation | Talk title | Download (if available) |
|---|---|---|---|
| 1 | Lara Wolfson (MSD) | Proper Prior Planning for Pre-specified Post-hoc (Analysis of) PICOs: How Statisticians can address the opportunities and challenges of EU HTA | x |
| 2 | Antonio Remiro Azócar (Novo Nordisk) | Considerations for Methodological Innovation for Indirect Treatment Comparisons in EU HTA | x |
| 3 | Wim Goettsch (Utrecht University and SUSTAIN-HTA) | SUSTAIN-HTA, an EU-wide initiative to build a supporting infrastructure to ensure the ongoing implementation of the latest and fit-for-purpose HTA methodologies and tools in practice | x |
Posters
| Talk | Speaker and affiliation | Talk title | Download (if available) |
|---|---|---|---|
| 1 | EIWG – reporting sub-team | Realizing the benefits of estimands when reporting and communicating study results – some recommendations | x |
| 2 | EIWG – estimands in non-inferiority trials | Considerations when Selecting Strategies for Intercurrent Events in Non-inferiority Studies | x |
| 3 | EIWG – intercurrent events | An Appraisal of the ICH E9(R1) Intercurrent Event Definition with Case Examples | x |
| 4 | Launch & Lifecycle ESIG | Data Voyagers: Navigating the Fascinating Universe of Medical Affairs Statistics | x |
| 5 | Regulatory ESIG | Regulatory Special Interest Group | x |
| 6 | Openstatsware (Software Engineering) ESIG | openstatsware – let’s improve open-source statistical software together! | x |
| 7 | Subgroup ESIG | Overview of Activities of Subgroup Analysis SIG | x |
| 8 | Causal inference ESIG | Introducing the Causal Inference Special Interest Group | x |
| 9 | RWD ESIG | Welcome to the Real World Data SIG! | x |
| 10 | HTA ESIG | Improving Patient Access during Phase 2-3 Design – Things to Consider | x |
| 11 | Oncology Estimand WG - Conditional and Marginal Effects Task Force | Outcome of Survey on Current Standards and Implementation of Covariate Adjusted and Stratified Analyses. | x |
| 12 | Biomarker ESIG | Biomarkers ESIG – mission and updates | x |
| 13 | Neuroscience Estimand Working Group | The Neuroscience Estimand eSIG - an overview. Scope, objectives and a look into the future. | x |
| 14 | BBS NextGen | Today, Tomorrow and the Future: Summary of BBS Next Generation in 2024 and going forward | x |