Past events: agendas, slidedecks, recordings
06.11.2023: Federated learning and new data modalities
| Speaker | Institution | Title | Download slides |
|---|---|---|---|
| Akexandros Giannakis | Accenture | Federated Learning – what is the art of the possible, the opportunities it creates, the key challenges and the prominent technical solutions | link |
| Anastasiia Koloskova | EPFL | Methodological aspects of federated learning, challenges and opportunities | link |
| Dominik Heinzmann | Roche | Collaborative acceleration for insights at scale via a federated data and biosample network in Neuroscience | link |
| Paul Delmar & Damien Eggenspieler | Roche & Synav | Overview on digital endpoints: Opportunities and impact on drug development | link |
| Craig Wang | Novartis | Radiogenomics investigation on the prognostic factors in metastatic breast cancer using data from Phase III ribociclib clinical trials | link |
| Stanislas Hubeaux | Roche | Opportunities and Challenges that arise with digital endpoints: A case example | link |
| Shyla Jagannatha | Janssen | Case example from Janssen on digital endpoints | link |
| BBS Assembly | Update on BBS | link |
16.10.2023: Estimands in Early Development (ED) across Therapeutic Areas
No recording available
No slides available
04.10.2023: Pre-approval and Post-approval Challenges in the Clinical Development and Reimbursement of CAR-T Cell Therapies
No recording available
| Speaker | Institution | Title | Download slides |
|---|---|---|---|
| Manisha Patel | Novartis | CAR-T regulatory and clinical development considerations: perspectives for today and the future | link |
| Revathi Ananthakrishnan | BMS | CAR T-cell Therapies: Challenges, Lessons Learned, and Implications for Future Studies | link |
| Benjamin Hofner | Paul-Ehrlich-Institut | Statistical considerations for CAR-T cell development – Updates from an European regulator | link |
| Sachin Vadgama & Francis Nissen | Kite, a Gilead company | Lessons learnt from long-term outcomes of CAR T therapies, HTA and RWE implications | link |
| Karen Facey | RWE4Decisions & Univ. of Edinburgh | RWE generation for CAR-Ts – Payers’ evolving approaches | link |
| Anja van Biezen | EBMT | RWE data: EBMT Registry – Challenges in Data Collection & Use of Data (in PASS) | link |
03.09.2023: CEN2023 Conference: From Data to Knowledge. Advancing Life Sciences.
No agenda available
No recording available
No slides available
21.06.2023: Next Generation event on soft-skills, professional development, and networking
No recording available
| Speaker | Institution | Title | Download slides |
|---|---|---|---|
| Justine Rochon | Boehringer-Ingelheim | Why is curiosity important? A journey into the benefits of being a lifelong learner | No presentation available (may be added later for recent events, after having received speaker approval) |
| Kaspar Rufibach | Roche | How to collaborate within X-industry working groups and some hard truths about work-life balance | link |
| Mouna Akacha | Novartis | Lightning talk 1 | link |
| Marisa Bacchi | J&J | Lightning talk 2 | link |
| Muriel Buri | Roche | Lightning talk 3 | link |
| Elsa Lozachmeur | Idorsia | Lightning talk 4 | link |
19.04.2023: Adaptive Designs and Multiple Testing Procedures 3-day Workshop
No recording available
No slides available
12.04.2023: Quantification of risk: ask the right questions or time to apply the estimand framework to safety!
| Speaker | Institution | Title | Download slides |
|---|---|---|---|
| Rima Izem (starts at 02:00 in 1st part) | Novartis | Welcome, scene setting and “Let us put the scientific objective first!” | link |
| Kaspar Rufibach (starts at 32:00 in 1st part) | Roche | Stop the abuse: A plea for a more principled approach to the analysis of time-to-event endpoints with varying follow-up times and/or competing risks, with a focus on analysis of AEs. | link |
| Andrew Thomson (discussant, beginning of 2nd part) | EMA | Comments (no slides) | No presentation available (may be added later for recent events, after having received speaker approval) |
| Shanti Gomatam (discussant, starts at 15:00 in 2nd part) | FDA | Quantification of risk: ask the right questions or time to apply the estimand framework to safety | link |
15.03.2023: Joint BES/BBS webinar: Real-World Data Quality
| Speaker | Institution | Title | Download slides |
|---|---|---|---|
| Massoud Toussi (starts at 5:38) | IQVIA | What is data quality, and how data types differ in terms of data quality | link |
| Nicole Mahoney (25:35) | Novartis | RWD for regulatory decisions | link |
| Clair Blacketer (39:48) | Janssen | EHDEN: Data Quality Dashboard | link |
| Daniel Morales (59:40) | EMA | EU Data quality framework | link |
| Dalia Dawoud (1:18:43) | NICE | COPD case study - The Use of the OMOP Common Data Model in Health Technology Assessment | link |
| Spencer James (1:41:34) | Roche/Genentech | Data quality in Flatiron | link |
| Gracy Crane (NB this talk in the panel discussion section was not recorded, but the slides are attached) | Roche | Transcelerate - How to bridge from framework to fitness for purpose demonstration? | link |
15.12.2022: Joint EFSPI & BBS virtual event - Addressing intercurrent events: Treatment policy and hypothetical strategies (day 2)
| Speaker | Institution | Title | Download slides |
|---|---|---|---|
| Frank Bretz & Mouna Akacha | Novartis | The hypothetical strategy: why, how, when? | link |
| Jinglin Zhong | Otsuka | A case study of hypothetical strategies in acute pain | link |
| Jonathan Bartlett | LSHTM | Hypothetical estimands – a unification of causal inference and missing data methods | link |
| Florian Lasch | EMA | g-estimation for the hypothetical strategy with an application to Alzheimer’s Disease and COVID-19-related intercurrent events | link |
| Ian White | University College London | Estimation with multiple intercurrent events and mixed estimand strategies | link |
| Kelly van Lancker | Ghent University | Discussion | link |
| Lei Nie | FDA | Discussion | No presentation available (may be added later for recent events, after having received speaker approval) |
08.12.2022: Joint EFSPI & BBS virtual event - Addressing intercurrent events: Treatment policy and hypothetical strategies (day 1)
| Speaker | Institution | Title | Download slides |
|---|---|---|---|
| David Wright | AstraZeneca | Reflections on the estimands addendum with a focus on the treatment policy strategy | link |
| Thomas Drury | GSK | Implementation of the treatment policy strategy for continuous longitudinal endpoints: A Comparison of Estimation Methods | link |
| Marcel Wolbers & Alessandro Noci | Roche | Treatment policy estimation based on standard and reference-based conditional mean imputation | link |
| Daniel Sabanés Bové | Roche | Other statistical software for continuous longitudinal endpoints: mmrm R package | link |
| James Roger | LSHTM | Other statistical software for continuous longitudinal endpoints: SAS macros for multiple imputation | link |
| Suzie Cro | Imperial College London | Discussion on treatment policy strategy | link |
30.11.2022: Next Generation Networking Seminar
| Speaker | Institution | Title | Download slides |
|---|---|---|---|
| Uli Burger | Roche | Welcome and Introduction to Event Series | No presentation available (may be added later for recent events, after having received speaker approval) |
| Youyou Hu & Antonella Mazzei | Roche & BMS | Getting started | No presentation available (may be added later for recent events, after having received speaker approval) |
| Julie Jones | Novartis | Communicating statistics to a lay audience | No presentation available (may be added later for recent events, after having received speaker approval) |
| Frank Bretz & Uli Burger | Novartis & Roche | Evolution of Biometrics within and across Pharma: Current trends and future insights | No presentation available (may be added later for recent events, after having received speaker approval) |
| Gabriele Bieska, Joerg Maurer, Valda Murphy, Simon Wandel, Marcel Wolbers | Roche, Roche, Novartis, Novartis, Roche | Not All Roads May Lead to Rome – Panelists’ Pitch on their career paths in industry | No presentation available (may be added later for recent events, after having received speaker approval) |
15.07.2022: On market approval and market access: Breaking the linear thinking or how to innovate in a crowded space?
| Speaker | Institution | Title | Download slides |
|---|---|---|---|
| Frank Bretz | Novartis | Welcome | link |
| Anja Schiel (starts at 00:04:00) | NOMA & EMA | Start thinking HTA early | link |
| Nigel Yateman (01:01:15) | Novartis | Challenges in developing next generation CAR-T | link |
| Iain Bennett (01:22:30) | Roche | No comparators no problem? | link |
| Karen Facey (01:42:50) | University of Edinburgh and self-employed | Comments to introduce panel discussion | link |
| Speakers + Gorana Capkun, Lilla di Scala, Andrew Thomson (01:58:15) | Panel discussion | No presentation available (may be added later for recent events, after having received speaker approval) |
23.06.2022: BBS / EFSPI Seminar Registry studies and HTA
| Speaker | Institution | Title | Download slides |
|---|---|---|---|
| Fred Sorenson | Xcenda, Switzerland | Welcome | No presentation available (may be added later for recent events, after having received speaker approval) |
| Eric Faulkner and Omar Dabbous | Novartis Gene Therapies, USA | An open dialog on the issues faced and lessons learned with respect to Novartis Gene Therapies’ Spinal Muscular Atrophy (SMA) registries | No presentation available (may be added later for recent events, after having received speaker approval) |
| Entela Xoxi | Università Cattolica del Sacro Cuore, Italy | AIFA registries: past and current & upcoming challenges | link |
| Jinma Ren and Friedhelm Leverkus | Pfizer, USA and Pfizer, Germany | Issues in the design and analysis of registry-based studies for regulatory and HTA purposes | link |
| Mei Yang | Happy Life Technology, China & USA | Registries in China: Guidelines, trends and new technologies | link |
| Rossella Di Bidino | Fondazione Policlinico Universitario Agostino Gemelli, Italy | Hospital Perspective on using Registry Data for HTA | link |
| Kirk Geale | Quantify Research, Sweden | Case studies using Registry Data for HTA in Scandinavia | link |
| Kat Belendiuk | Genentech, USA | FlywheelMS Case Study - A complete web-based digital registry of 5,000 patients with Multiple Sclerosis in the USA | No presentation available (may be added later for recent events, after having received speaker approval) |
24.05.2022: BBS Spring Seminar Transforming drug development and Assembly
| Speaker | Institution | Title | Download slides |
|---|---|---|---|
| Uli Burger | Roche, Basel | Welcome | No presentation available (may be added later for recent events, after having received speaker approval) |
| Pierre Verweij, Guy Braunstein, Colin Terry, Pavi Rallapalli, Dominik Heinzmann, Lisa Hampson, Marc Vandemeulebroecke, Heinz Schmidli, Sebastian Weber, Laurent Essioux | Idorsia Pharmaceuticals, Deloitte, Novo Nordisk, Novartis, Roche | BBS Spring Seminar Transforming drug development and assembly | link |
29.03.2022: Graphical approaches to multiple test problems
| Speaker | Institution | Title | Download slides |
|---|---|---|---|
| Marc Vandemeulebroecke | Novartis, Basel | Welcome | No presentation available (may be added later for recent events, after having received speaker approval) |
| Ekkehard Glimm, Frank Bretz & Dong Xi | Novartis & Gilead | Graphical approaches to multiple test problems | link |
21.02.2022: Machine Learning in clinical drug development
| Speaker | Institution | Title | Download slides |
|---|---|---|---|
| Markus Lange, Lorenz Uhlmann | Novartis, Basel | Machine Learning in clinical drug development | link |
| Markus Lange, Lorenz Uhlmann | Novartis, Basel | Questions from the chat, with answers | link |
| Markus Lange, Lorenz Uhlmann | Novartis, Basel | R exercises | link |
| Markus Lange, Lorenz Uhlmann | Novartis, Basel | Dataset used for exercises | link |
27.07.2021: Joint BBS/BES Webinar COVID-19 pandemic and how we deal with data
| Speaker | Institution | Title | Download slides |
|---|---|---|---|
| Hans Ulrich Burger | Roche, Basel | Welcome | No presentation available (may be added later for recent events, after having received speaker approval) |
| Tim Friede | University Medical Center Göttingen | Data and Statistics as a basis for decision making: A discussion of the Corona pandemic | link |
| Thorsten Lehr | Saarland University | Forecasting: What do we learn? | link |
| Thierry Van Effelterre | J&J | Vaccination trials: What do we know about long-term efficacy measures and other questions | link |
| Fei Chen | Janssen | Statistical Considerations Underlying a COVID-19 Vaccine phase 3 design | link |
28.06.2021: Joint EFSPI/BBS Meeting Precision & Innovative Medicine and Health Technology Assessment
| Speaker | Institution | Title | Download slides |
|---|---|---|---|
| Fred Sorensen | Xcenda | Welcome | link |
| Dan O’Connor | MHRA, UK | The UK’s Innovative Licensing and Access Pathway (ILAP) for medicines – A joint MHRA, NICE & SMC initiative | link |
| Karen Facey | University of Edinburgh | IMPACT HTA - Recommendations for Developing Rare Disease Treatments | link |
| Paul Cislo, Jinma Ren and Joseph C. Cappelleri | Pfizer | Adjusting Global Survival to Make Results More Relevant and Generalizable to Local Markets | link |
| Marc Buyse | IDDI and University of Hasselt, Belgium | Net benefit and correlation between benefit and harms | link |
| Mark Belger and Marie-Ange Paget | Eli Lilly UK & France | Closing the efficacy to effectiveness gap: Generalizing from RCTs to real world populations | link |
| Kirsten Herrmann | Exact Sciences, Germany | Assessments and reimbursement of gene expression signature tests in Europe | link |
| Janneke Boersma | Roche, Netherlands | Bridging the gap between Regulatory & HTA approval for Precision Medicine therapies: a case study from the Netherlands | link |
16.06.2021: BBS Webinar Impact of the COVID-19 Pandemic on Clinical Trials
| Speaker | Institution | Title | Download slides |
|---|---|---|---|
| Anja Schiel | Chair Scientific Advice Working Party, EMA | Overview on early experience of the impact of Covid-19 pandemic on clinical trials | link |
| Paul Delmar | Roche, Basel | COVID-19 pandemics : Impact on Clinical Trials in a chronic progressing disease | link |
| Eva Hua | Novartis, Basel | Hypothetical strategy for a case study affected by COVID-19 pandemic | link |
| Kelly Van Lancker | Ghent University | The hypothetical estimand and its potential estimators in clinical trials impacted by COVID-19 | link |
22.03.2021: BBS Webinar Statistical challenges in the clinical development of CAR T-cell therapies
| Speaker | Institution | Title | Download slides |
|---|---|---|---|
| Roland Marion-Gallois | BMS, Switzerland | Welcome and Introduction | link |
| Caroline Aarber Bath | CHUV, Switzerland | Introduction to Cell Therapies: A Clinical Perspective | link |
| Elina Asikanius | FIMEA, Finland | Perspective from EMA | link |
| Zhenzhen Xu | FDA, USA | Perspective from FDA | link |
| Khadija Rantell | MHRA, UK | Phase 2 / Phase 3, Treatment effect or therapeutic strategy effect? | link |
| Alessandro Previtali | BMS, Switzerland | Phase 2 / Phase 3, Estimands in the context of cell therapy development | link |
| Nigel Yateman | Novartis, Switzerland | Challenges for new CAR-T therapies | link |
| Oriana Ciani | Università Bocconi, Italy | Introduction on Post-Approval challenges, reimbursement and HTA assessments | link |
| Andrea Smith | G-BA, Germany | HTA-Perspective on the assessment of CAR-T-Cell Therapies | link |
| Marcelo Pasquini and Zhenuan Hu | CIBMTR, USA | CAR-T cell therapy registries | link |
08.03.2021: Graphics for decision-making in biomedical research and drug development
| Speaker | Institution | Title | Download slides |
|---|---|---|---|
| Dominik Heinzmann | Roche, Basel | Welcome | No presentation available (may be added later for recent events, after having received speaker approval) |
| Hannah Diehl and Tamara Broderick / Andy Stein and Niladri Roy Chowdhury | MIT and Novartis | The “See”-Value App: Visual Decision Making for Drug Development | link |
| Neil McQuarrie | Flatiron | Better understanding and reacting on impact of COVID-19 on RWD collection by combining statistics with visualization | link |
| Tadeusz Lewandowski | Roche, Basel | Interactive clinical study visualisation in enabling the faster decision making | link |
| Markus Lange | Novartis, Basel | Unraveling a single number – using graphics to explain Probability of Success | link |
| Anne-Marie Meyer | Roche, Basel | Population Level Analytics for pandemic response: Predicting vaccine uptake and vaccine hesitancy | link |
| Giusi Moffa | University of Basel | Closure | No presentation available (may be added later for recent events, after having received speaker approval) |
03.11.2020: Joint EFSPI / BBS Webinar: The application of estimands from a Neuroscience perspective
| Speaker | Institution | Title | Download slides |
|---|---|---|---|
| Hans Ulrich Burger | Roche, Basel | Welcome and introduction to the estimand framework | link |
| Nikolaos Sfikas | Novartis, Basel | Outline of an estimand strategy in MS | link |
| Mette Krog Josiassen and Peter Quarg | Lundbeck and Novartis | Outline of an estimand proposal in migraine prevention and neuropathic pain | link |
| Paul Delmar | Roche, Basel | Using the Estimand Framework to address challenges in AD clinical trial with a closer look at the hypothetical strategy | link |
| Carrie Li | Roche, Basel | Estimands in Huntington’s disease | link |
| Andrew Hartley | PPDI | Impact of Covid-19 on studies in Neuroscience | link |
| Joel Raffel and Khadija Rantell | MHRA, UK | Regulatory aspects of the estimand framework: Clinical and statistical perspectives | link |
| Anja Schiel | Chair Scientific Advice Working Party, EMA | Panel discussion including all speakers | link |
07.09.2020: BBS Webinar RCTs meeting causal inference: principal stratum strategy and beyond
| Speaker | Institution | Title | Download slides |
|---|---|---|---|
| Kaspar Rufibach | Roche, Basel | Welcome and scene setting | link |
| Vanessa Didelez | Keynote speaker, Leibniz Institute for Prevention Research and Epidemiology, BIPS, Bremen | Time-Varying Treatments in Observational Studies: Lessons for Clinical Trials | link |
| Jack Bowden | University of Exeter | Connecting Instrumental Variable methods for causal inference to the Estimand Framework | link |
| Kelly van Lancker | Ghent University | Efficient, doubly robust estimation of the effect of dose switching for switchers in a randomised clinical trial | link |
| Björn Bornkamp | Novartis, Basel | Principal Stratum Strategy: Potential Role in Drug Development | link |
| Dominik Heinzmann | Roche, Basel | Principal stratum strategy to investigate anti-drug antibody impact on cancer immunotherapy outcome | link |
| Aiesha Zia | Novartis, Basel | Exploring estimation approaches for principal stratum estimands in Phase III randomized trials in CAR-T anti-cancer therapy | link |
| Fabrizia Mealli | University of Florence | The ICH E9 addendum from an academic causal inference perspective and feedback on the previous talks | link |
| Giusi Moffa | University of Basel | Next webinars and closure | link |
| All | Question and Answers | link |
30.06.2020: BBS/EFSPI Webinar on HTA
| Speaker | Institution | Title | Download slides |
|---|---|---|---|
| Chrissie Fletcher | GSK, UK | Celebrating 10 Years HTA SIG | link |
| Christoph Schürmann | IQWiG, Germany | Health-related quality of life endpoints in benefit assessments: Demands and challenges as seen by IQWiG in Germany | link |
| Lara Wolfson | Merck, USA | Issues related to transparency with HTA dossiers | link |
| Mark Nuijten | A2M and Univ. of Maastricht, NL & ITU, Turkey | An innovative pricing model to assess the price of expensive drugs with an orphan indication | link |
| Fred Sorenson | Xcenda | Introduction to moderated panel discussion | link |
29.06.2020: Joint EFSPI / BBS Webinar: Estimands addendum is final: Anything new for oncology?
| Speaker | Institution | Title | Download slides |
|---|---|---|---|
| Kaspar Rufibach | Roche, Basel | Welcome and scene setting | link |
| Anja Schiel | Chair Scientific Advice Working Party, EMA | Experience with the estimand framework in oncology | link |
| Renaud Capdeville | Novartis, Basel | Challenges and open questions in hematology: RATIFY | link |
| Tina Nielsen | Roche, Basel | Challenges and open questions in hematology: GALLIUM | link |
| Hannes Buchner and Ingolf Griebsch | Staburo and Boehringer-Ingelheim | Treatment switching: challenges, estimands, and estimators | link |
| Stefan Englert | Abbvie | Commentary on previous talks taking COVID-19 into account | link |
| All | Question and Answers | link |
03.06.2020: BBS Webinar: Aspects of COVID-19 pandemic
No recording available
| Speaker | Institution | Title | Download slides |
|---|---|---|---|
| Jean Lang | Sanofi Pasteur | Overview on SARS-CoV2 and Challenges for COVID-19 Vaccine Development at Pandemic Speed | link |
| Christian Althaus | ISPM, University of Bern | Early transmission, pandemic spread and severity of COVID-19 | link |
| Karin Meiser | Novartis, Basel | Specific aspects of a clinical trial targeting Covid-19 | link |
| Jenny Devenport | Roche, Basel | The influence of investigator initiated studies in the COVID-19 pandemic | link |
06.05.2020: BBS Virtual Seminar: Impact of COVID-19 on clinical trials
No recording available
| Speaker | Institution | Title | Download slides |
|---|---|---|---|
| Frank Petavy | EMA | EMA perspective and guidance on COVID-19 | link |
| Natalie Dimier | Roche, Welwyn | Industry perspective on COVID-19 (1/3) | link |
| Mouna Akacha | Novartis, Basel | Industry perspective on COVID-19 (2/3) | link |
| Cristina Sotto | J&J | Industry perspective on COVID-19 (3/3) | link |
| Marcel Wolbers | Roche, Basel | Short Overview of Pharmaceutical Industry COVID-19 Biostatistics Working Group | link |
| Evgeny Degtyarev | Novartis, Basel | Short overview on COVID-19 from the Cross-Industry Oncology Estimands Working Group | link |
04.02.2020: BBS Seminar: Network meta-analysis: methods and applications
No recording available
| Speaker | Institution | Title | Download slides |
|---|---|---|---|
| Sylwia Bujkiewicz | Bivariate network meta-analysis for surrogate endpoint evaluation | link | |
| Gerta Rücker | Component network meta-analysis compared to a matching method in a disconnected network: a case study | link | |
| Georgia Salanti | CINeMA: a framework and web application to evaluate the confidence in network meta-analysis results | link | |
| Mark Pletscher | Network meta-analysis of treatments for previously untreated metastatic PD-L1-positive triple-negative breast cancer | link | |
| Bartosz Jenner | An experience with indirect treatment comparisons using MAIC methods in a rare disease | No presentation available (may be added later for recent events, after having received speaker approval) | |
| Marius Thomas | A network meta-analysis to compare efficacy of treatment options for relapsing-remitting multiple sclerosis | No presentation available (may be added later for recent events, after having received speaker approval) |
01.11.2019: BBS Seminar: Predictive modelling, machine learning and causality
No recording available
| Speaker | Institution | Title | Download slides |
|---|---|---|---|
| Ewout Steyerberg | Clinical prediction models in the age of artificial intelligence and big data | link | |
| Willi Sauerbrei | The EQUATOR networkand guidelines for prediction models | link | |
| Torsten Hothorn | Score-based transformation learning | link | |
| Peter Bühlmann | Causal regularization for distributional robustness and replicability | link | |
| Giusi Moffa | Predicting putative intervention effects after causal structure learning from survey data | link | |
| Andrew Shattock | Using machine learning and disease models to evaluate target product profiles of novel interventions (No slide deck available) | No presentation available (may be added later for recent events, after having received speaker approval) | |
| Federico Mattiello | Identifying high-risk patients in Non-Hodgkin lymphoma (and trying to get insights into the disease biology) | link | |
| Mark Baillie | Novartis benchmarking initiative: making sense of AI | link | |
| Chris Harbron | Experiences from running internal prediction challenges within a pharmaceutical company | link |
21.08.2019: BBS/BES Seminar: Causal inference in drug development: why, when, how?
No recording available
| Speaker | Institution | Title | Download slides |
|---|---|---|---|
| Miguel Hernan | Beyond intention-to-treat. Causal inference guidelines for causal inference | link | |
| Christine Fletcher | The Final ICH E9(R1) E9 addendum | link | |
| Frank Pétavy | A regulator’s perspective | No presentation available (may be added later for recent events, after having received speaker approval) | |
| Valentine Jehl | Adverse reactions confounded by prior medication: (how) can causal inference solve the problem? | No presentation available (may be added later for recent events, after having received speaker approval) | |
| Thibaut Sanglier | Treatment sequencing and effectiveness: challenges and considerations | No presentation available (may be added later for recent events, after having received speaker approval) | |
| Nikolaos Sfikas | Principal stratification techniques in the context of regulatory decision making | No presentation available (may be added later for recent events, after having received speaker approval) | |
| Jack Bowden | Implementing the Principal Stratum estimand strategy using Instrumental Variable methods: An emulation of the CANTOS trial | link |
04.06.2019: BBS/EFSPI Seminar: Precision medicine in drug development
No recording available
| Speaker | Institution | Title | Download slides |
|---|---|---|---|
| Niko Beerenwinkel | Bioinformatics for precision oncology | No presentation available (may be added later for recent events, after having received speaker approval) | |
| Stephen Senn | Precision medicine: The honeymoon is over. It’s high time for tough love | link | |
| Tomasz Burzykowski | Generalized pairwise comparisons for precision medicine | link | |
| Adam Heathfield | Valuation of Regenerative Medicine/Advance Therapeutics (RM/ATs): Challenges and opportunities for creating a better framework | link | |
| Jack Kuipers | Mutational interactions define novel cancer subgroups: can they inform precision oncology? | link | |
| Mario Ouwens | Difficulties with network meta-analysis when starting to use PDL1 thresholds | link | |
| Georgina Bermann | Cardiovascular medicine: approaches to the use of early biomarker response to identify a patient subgroup with enhanced therapeutic benefit | link | |
| Laurent Essioux | Examples of personalized Healthcare at Roche: statistical perspectives | link |
10.05.2019: BBS Spring Seminar: Synthetic controls - what do we need and how far can we go?
No recording available
| Speaker | Institution | Title | Download slides |
|---|---|---|---|
| Tom Brookland | RWD/RWE Global Regulatory Overview | link | |
| Kaspar Rufibach and Hans Ulrich Burger | External controls in drug development | link | |
| Somnath Sarkar | Considerations for Developing External Control Arm from Real-World Data | link | |
| Laurence Colin and Yue Li | Making better use of early phase safety data | link | |
| Cornelia Dunger-Baldauf | For the sake of the patient – reducing placebo exposure by using historical controls | link | |
| Gonzalo Duran-Pacheco | Electronic Health Records used to derive Control Arms for Single-Arm oncology trials: Proof of concept using RCT’s in lung cancer | link | |
| Chris Harbron | A Decision Making Framework For Utilising External Control Arms | link | |
| Meinhard Kieser | Synthetic controls – what do we need and how far can we go? Rejoinder | link | |
| Norbert Benda | Synthetic controls – what do we need and how far can we go? Rejoinder | link | |
| Kit Roes | Synthetic controls – what do we need and how far can we go? Rejoinder | link | |
| Jan Müller-Berghaus | Synthetic controls – what do we need and how far can we go? Rejoinder | No presentation available (may be added later for recent events, after having received speaker approval) | |
| Anja Schiel | Synthetic controls – what do we need and how far can we go? Rejoinder | No presentation available (may be added later for recent events, after having received speaker approval) |
27.06.2018: BBS/EFSPI Seminar: Small populations and level of evidence
No recording available
| Speaker | Institution | Title | Download slides |
|---|---|---|---|
| Fred Sorensen | European Statistical Meeting on Small populations and level of evidence | link | |
| Daniel O’Connor | Rare diseases and orphan drugs: A Regulator’s (clinical)Perspectives | link | |
| Stephen Senn | In search of the lost loss function | link | |
| Henriette Thole | The potential and challenges of registry use when generating evidence in small populations | link | |
| Anja Schiel | Rare diseases and orphan drugs:The HTA perspective | link | |
| Adele Morganti | Borrowing external controls for an event-driven pediatric trial in PAH: a case study | link | |
| Andreas Kaiser | Bayesian analysis for small sample size trials using informative priors derived from historical data | link | |
| Elina Asikanius | Using a non-interventional study to strengthen the evidence collected in a Phase III program: a Hemophilia A case Study | link | |
| Hans Hockey and Kristian Brock | Hockey sticks and broken sticks – a design for a single-treatment double-blind randomized clinical trial suitable for chronic diseases | link |
26.06.2018: BBS Seminar: RCTs, personalized medicine, and surrogacy
No recording available
| Speaker | Institution | Title | Download slides |
|---|---|---|---|
| Tomasz Burzykowski | Evaluation of Time-to-event Surrogate Endpoints Using Accelerated Failure-time Models | link | |
| Everardo D. Saad | Precision Medicine Needs Randomized Trials | link | |
| Marc Buyse | A statistical approach for personalized medicine and benefit / risk assessment | link |
17.04.2018: BBS Spring Seminar: New developments in HTA, adaptive designs and multiplicity – in remembrance of Willi Maurer
No recording available
| Speaker | Institution | Title | Download slides |
|---|---|---|---|
| Jason Wang | Sense and sensibility of estimands for health technology assessment (HTA) | link | |
| Christoph Gerlinger | EQ-5D-5L Utility Index for different countries | link | |
| Susan Edwards | Whose perspective? Implications on cost-effectiveness modelling of differences between country value sets (a case study) | link | |
| Carsten Schwenke | Real World Evidence and HTA – Experiences with IQWiG | link | |
| Tim Friede | HTA AND SAFETY Some results of the ATF / APF Project Group | link |
20.03.2018: BBS Seminar: Competing Risks and Multi-State Models
No recording available
| Speaker | Institution | Title | Download slides |
|---|---|---|---|
| Claudia Schmoor | Competing risks with applications to oncology | link | |
| Jan Beyersmann | Analysis of co-time-to-event outcomes in randomized clinical trials | link | |
| Ekkehard Glimm and Lillian Yau | A discrete semi-Markov model for the effect of need-based treatments on the disease states | link |
14.11.2017: BBS Seminar: Future of Biomedical Research: Are we ready?
No recording available
| Speaker | Institution | Title | Download slides |
|---|---|---|---|
| Damian Roqueiro | Machine Learning and Computational Biology Lab ETH Zurich | Applications of Machine Learning and Deep Learning | No presentation available (may be added later for recent events, after having received speaker approval) |
| Jonas Dorn | Novartis, Basel | Machine learning when the ground truth isn’t truth and privacy is a problem – case study from the Assess MS project | No presentation available (may be added later for recent events, after having received speaker approval) |
| Hans Ulrich Burger | Roche, Basel | Big clinical data: What should biometrician do with it? | No presentation available (may be added later for recent events, after having received speaker approval) |
11.09.2017: BBS Seminar Emerging topics for statistical methodology in drug development: Estimands and advanced analytics
No recording available
| Speaker | Institution | Title | Download slides |
|---|---|---|---|
| Stephen Ruberg | Eli Lilly | The patient perspective – the estimands they want | No presentation available (may be added later for recent events, after having received speaker approval) |
| Stef van Buuren, | Netherlands Organisation for Applied Scientific Research and University of Utrecht | Individual causal effect: What is it? Why we need it? How to estimate it? | No presentation available (may be added later for recent events, after having received speaker approval) |
| Baldur Magnusson | Novartis, Basel | Using principal stratification to disentangle post-randomization outcomes in a randomized controlled phase 3 study | No presentation available (may be added later for recent events, after having received speaker approval) |
| Teresa Barata | Roche, Basel | Estimands in early Parkinson disease | No presentation available (may be added later for recent events, after having received speaker approval) |
| Stephen Ruberg | Eli Lilly | Making what’s advanced today routine tomorrow | No presentation available (may be added later for recent events, after having received speaker approval) |
| Jouni Kerman | Causal Measurement using Geo Experiments in a Time-Based Regression Framework | No presentation available (may be added later for recent events, after having received speaker approval) | |
| Cornelia Dunger-Baldauf | Novartis, Basel | A Smartphone-Based Study Capturing Longitudinal Vision Test Data, Movement Scores and User-reported Outcomes | No presentation available (may be added later for recent events, after having received speaker approval) |
| Fabio Pellegrini | Biogen | Individualized medicine based on a treatment response continuous score | No presentation available (may be added later for recent events, after having received speaker approval) |
26.06.2017: BBS Seminar Innovative model-based dose escalation designs: what next?
No recording available
| Speaker | Institution | Title | Download slides |
|---|---|---|---|
| Daniel Sabanés Bové | Model-based D/E designs: Current status and next steps | link | |
| Daniel Lorand | Tailoring dose escalation designs to early clinical development goals | link | |
| Andreas Krause | Guiding dose escalation studies in Phase 1 with unblinded modeling | link |
15.06.2017: BBS / PSI 1-Day Scientific Meeting: Empower the immune system to fight cancer
No recording available
| Speaker | Institution | Title | Download slides |
|---|---|---|---|
| Jorge Martinalbo | Realising the potential of cancer immunotherapy | link | |
| Andrew Stone | Statistical issues in the development of cancer immunotherapy | link | |
| Daniel Sabanés Bové | Bayesian Learning in Early Phase Cancer Immunotherapy: A Case Study | link | |
| Matt Whiley | An adaptive phase II basket trial design | link | |
| Dominik Heinzmann | Statistical, clinical and ethical considerations when minimizing | link | |
| Claude Berge | Statistical Challenges in Immunotherapy: Non Proportional Hazard Model | link | |
| Sergio Fracchia | Challenges in development and approval: the case of cell based therapeutics | link | |
| Fred Sorenson | Cancer Immunotherapy from the Health Technology Assessment (HTA) and Payer Perspectives | link | |
| Nicholas Latimer | Estimating survival benefit for health technology assessment: New challenges presented by immuno-oncology treatments? | link |
05.05.2017: BBS Spring Seminar The use of external data for decision making
No recording available
| Speaker | Institution | Title | Download slides |
|---|---|---|---|
| David Evans | Reality and Real-World Data | link | |
| Ralf Bender | Use of registries and observational data in the benefit assessment of medical interventions | link | |
| Frank Bretz | Threshold-crossing: A Useful Way to Establish the Counterfactual in Clinical Trials? | link | |
| David Dejardin | Dynamic borrowing of historical data: Performance and comparison of existing methods based on a case study | link | |
| Eva-Maria Didden | GetReal: 3 Years on! | link | |
| Tim Friede | The Use of External Data for Decision Making | link |
13.03.2017: BBS Seminar: Biomarker analyses
No recording available
| Speaker | Institution | Title | Download slides |
|---|---|---|---|
| Werner Vach | Universitätsspital Basel | Statistical perspectives on umbrella trials | No presentation available (may be added later for recent events, after having received speaker approval) |
| Kaspar Rufibach | Roche, Basel | Comparison of clinical development plans for a confirmatory trial with subpopulation selection | link |
29.11.2016: BBS Seminar: Safety monitoring during the life cycle of a drug
No recording available
| Speaker | Institution | Title | Download slides |
|---|---|---|---|
| Conny Berlin | Safety monitoring during the life cycle of a drug | link | |
| Yusuf Tanrikulu | Signal Detection – Quantitative Analysis of Safety Data | link | |
| Pritibha Singh | Adverse Drug Reaction (ADR) screening in clinical trials | link | |
| Gianmario Candore | Screening for adverse reactions in EudraVigilance | link | |
| Soheila Aghlmandi | Choice of priors in rare events meta-analysis | link |
14.11.2016: BBS Seminar: Synthesis of Evidence: Observational studies and Meta-analysis
No recording available
| Speaker | Institution | Title | Download slides |
|---|---|---|---|
| Kay Brodersen | Google, Zurich | Inferring causal effects in the absence of an experiment using CausalImpact | No presentation available (may be added later for recent events, after having received speaker approval) |
| David Rasmussen | ETH Zurich | Using HIV phylogenetics to quantify how human mobility impacts antiretroviral-based prevention strategies | No presentation available (may be added later for recent events, after having received speaker approval) |
| Almut Mecke | Roche, Basel | Different endpoints for meta-analyses of safety information | No presentation available (may be added later for recent events, after having received speaker approval) |
| Friedhelm Leverkus | Pfizer Germany | Meta-analysis in support of the German Benefit Assessment for Reimbursement (Arzneimittelmarkt-Neuordnungsgesetz – AMNOG | No presentation available (may be added later for recent events, after having received speaker approval) |
17.10.2016: BBS Seminar: Missing Data and Graphical Models
No recording available
| Speaker | Institution | Title | Download slides |
|---|---|---|---|
| Jane Hutton | Uni Warwick | Missing data and how to see biased results using Chain Event Graphs | No presentation available (may be added later for recent events, after having received speaker approval) |
| Giusi Moffa | Novartis, Basel | Cancer profiling and subtype discovery with Bayesian inference for acyclic digraphs | No presentation available (may be added later for recent events, after having received speaker approval) |
| Markus Elze | Roche, Basel | Propensity scores methods and covariate adjustment in practice | No presentation available (may be added later for recent events, after having received speaker approval) |
14.09.2016: PSI/BBS One Day Meeting: Time-to-Event and Recurrent Event Endpoints
No recording available
| Speaker | Institution | Title | Download slides |
|---|---|---|---|
| Lilla Di Scala | Actelion, Basel | Informative censoring in a rare disease: a regulatory experience in PAH | No presentation available (may be added later for recent events, after having received speaker approval) |
| Dominic Magirr | AstraZeneca | Unblinded sample-size reassessment in time-to-event clinical trials | No presentation available (may be added later for recent events, after having received speaker approval) |
| Tobias Bluhmki | Universität Ulm | Analyzing non-monotonous time-to-event outcome probabilities in randomized clinical trials | No presentation available (may be added later for recent events, after having received speaker approval) |
| Jennifer Rogers | University of Oxford | The analysis of recurrent events: A summary of methodology | No presentation available (may be added later for recent events, after having received speaker approval) |
| Mouna Akacha | Novartis, Basel | Recurrent event data endpoints in chronic heart failure studies: What is the estimand of interest? | No presentation available (may be added later for recent events, after having received speaker approval) |
| Ekkehard Glimm | Novartis, Basel | Sample size and interim analysis considerations for recurrent event data analyses | No presentation available (may be added later for recent events, after having received speaker approval) |
04.05.2016: BBS Seminar: Adaptive Designs
No recording available
| Speaker | Institution | Title | Download slides |
|---|---|---|---|
| Franz König | Regulatory and methodological issues in adaptive designs for confirmatory trials | link | |
| Peter Bauer | DMC membership experience | link | |
| David Lawrence | Using a DMC for dose selection in a phase IIb/III adaptive design: the INHANCE study | link | |
| Alexander Strasak | Adaptive seamless phase II/III study in gastric cancer | No presentation available (may be added later for recent events, after having received speaker approval) |
28.04.2016: BBS Spring Seminar
No recording available
| Speaker | Institution | Title | Download slides |
|---|---|---|---|
| Kaspar Rufibach | Event projection: quantify uncertainty and manage expectations of broader teams | link | |
| Beat Neuenschwander | Predicting milestone events for time-to-event trials | link | |
| Melissa Penny | Model-based public health impact and cost-effectiveness estimates informing the WHO recommendation on malaria vaccine RTS | No presentation available (may be added later for recent events, after having received speaker approval) | |
| Iain Bennett | Designing in Treatment Switching (case study review and recommendations) | link | |
| Viktoriya Stalbovskaya | Practical aspects of handling treatment switching in randomized clinical trials | link | |
| Daniel Sabanes | Cancer immunotherapies: Which efficacy endpoints and statistical analyses to use? | link | |
| Andrew Stone | Non-Proportional Hazards – So What? | link | |
| Karine Lheritier | Complex study design in patients with Hereditary Periodic Fevers | No presentation available (may be added later for recent events, after having received speaker approval) | |
| David Dejardin | Bayesian dual endpoint decision making in combination studies | link | |
| Alessandro Matano | Bayesian approach for Combination Phase I Trials in Oncology | No presentation available (may be added later for recent events, after having received speaker approval) |
13.01.2016: BBS Seminar: Disease and Product Registries
No recording available
| Speaker | Institution | Title | Download slides |
|---|---|---|---|
| Tim Friede | Clinical registries: Use and Emerging Best Practices | link | |
| Eva‐Maria Didden | Learning and Predicting Real‐World Treatment Effect based on Randomized Controlled Trials and Registry Data – A Case Study in Rheumatoid Arthritis | link | |
| Heiner C. Bucher | Making Better Use of Registry Data in Designing Pragmatic Trials | link | |
| Yvonne Geissbühler | Use of Registries to Collect Pregnancy Data | link | |
| Brian Hennessy | Registries in Rare Diseases / Orphan Drugs along with 2 Case Studies | No presentation available (may be added later for recent events, after having received speaker approval) | |
| Helene Karcher | Leveraging Real‐World Registry Data to Optimize the Design of Phase 3 Studies – a Case Study in Schizophrenia | link |
27.10.2015: BBS Seminar: Prediction
No agenda available
No recording available
| Speaker | Institution | Title | Download slides |
|---|---|---|---|
| Kaspar Rufibach | Bayesian Predictive Power: the bathtub problem | link | |
| Evgeny Degtyarev | Designing Phase 2 to predict success in Phase 3 study | No presentation available (may be added later for recent events, after having received speaker approval) |
23.06.2015: Joint BBS/EFSPI Seminar: Health Technology Assessment
No recording available
| Speaker | Institution | Title | Download slides |
|---|---|---|---|
| Chrissie Fletcher & Matthias Egger | Amgen & University of Bern | IMI GetReal Initiative Update | No presentation available (may be added later for recent events, after having received speaker approval) |
| Panelists | Expert panel discussion on trends and burning issues, eg. Structured benefit risk and real world evidence; dual EMA-HTA consultation | No presentation available (may be added later for recent events, after having received speaker approval) | |
| Pascale Brasseur | Medtronic | Overview of HTA for medical devices and diagnostics | No presentation available (may be added later for recent events, after having received speaker approval) |
| Sheryl Warttig | NICE | NICE’s approach to the development of guidance for medical devices and diagnostics | No presentation available (may be added later for recent events, after having received speaker approval) |
| Karsten Berndt | Roche Diagnostics | EUnetHTA core model applied to Colorectal Cancer screening | No presentation available (may be added later for recent events, after having received speaker approval) |
| Valéry Risson | Novartis | Uses of Social Media for Outcomes Research – results of a real-world pilot | No presentation available (may be added later for recent events, after having received speaker approval) |
| Claire Watkins | AstraZeneca | Adjusting overall survival for treatment switch/crossover | No presentation available (may be added later for recent events, after having received speaker approval) |
| Pierre Ducorneau | Roche, Basel | Using the EUnetHTA HTA core model as a framework for planning, generating and presenting evidence | No presentation available (may be added later for recent events, after having received speaker approval) |
| Yovanna Castro | Roche, Basel | Predicting long term survival using nonparametric Bayesian methods: the melanoma case | No presentation available (may be added later for recent events, after having received speaker approval) |
| Nathalie Barbier | Novartis | Reimbursement challenges with new emerging cancer therapies | No presentation available (may be added later for recent events, after having received speaker approval) |
| Won Lee | Xcenda | The value of Oncology therapies and emerging access hurdles in Canada and the United States | No presentation available (may be added later for recent events, after having received speaker approval) |
13.04.2015: BBS Seminar: Bayesian Methods in Adaptive Dose-Finding Trials
No recording available
| Speaker | Institution | Title | Download slides |
|---|---|---|---|
| Daniel Sabanes Bove | Bayesian Learning in Oncology: A Case Study | link | |
| Ying Yuan | Bayesian Data Augmentation Continual Reassessment Method (DA-CRM) for Phase I Trials with Delayed Toxicities | link | |
| Daniel Lorand | Bayesian modelling for combination dose-escalation trial that incorporates pharmacokinetic data | link |
13.11.2014: Joint BBS-EFSPI Seminar: Data Sharing in Clinical Development
No recording available
| Speaker | Institution | Title | Download slides |
|---|---|---|---|
| Sabine Atzor | Clinical Trial Data Transparency – Environment & Expectations | link | |
| Stefan Driessen | EFSPI position on EMA policy on publication of clinical data | link | |
| Franz König | Big thunder | link | |
| Rebecca Sudlow | Overview of Data Sharing Initiatives in Industry and Current Experiences | link | |
| Janice Branson | Practicalities of accessing and using data – Advice for Researchers | link | |
| Sally Hollis | Considerations for analysis plans for data sharing requests | link | |
| Katherine Tucker | Principles to maintain patient confidentiality+H211 | link | |
| Guilliaume Breton | Patient Confidentiality Implementation | link |
02.10.2014: BBS Seminar: Meta-Analysis of Clinical Safety Data
No recording available
| Speaker | Institution | Title | Download slides |
|---|---|---|---|
| Stephen Evans | Do meta-analyses of adverse events have adverse effects? | link | |
| Brenda Crowe | Comparison of Bayesian and Frequentist Meta-Analytical Approaches for Analyzing Time to Event Data | link | |
| Michael Gaffney | Model Selection in Meta‐Analysis of Clinical Safety Data – Fixed or Random Study Effect | link | |
| Amy Xia | Bayesian Meta-Analysis in Drug Safety Evaluation | link | |
| Jim Slattery | Meta-analysis in EU regulation | link | |
| Tarek A. Hammad | Sources of Bias in Meta-analysis of RCTs | link | |
| Mark Levenson | Meta‐Analysis for Safety: Context and Examples at US FDA | link |
07.05.2014: BBS Seminar: Applications for statisticians working with “Real-World Data”
No recording available
| Speaker | Institution | Title | Download slides |
|---|---|---|---|
| Pamela Landsman-Blumberg | Applications for statisticians working with “Real-World Data” | No presentation available (may be added later for recent events, after having received speaker approval) | |
| Fred Sorensen | No presentation available (may be added later for recent events, after having received speaker approval) |
04.02.2014: BBS seminar: Adaptive / Flexible Designs in early development
No agenda available
No recording available
No slides available
18.06.2013: BBS Seminar: IPD meta-analysis of treatment-covariate interaction with a continuous predictor
No agenda available
No recording available
| Speaker | Institution | Title | Download slides |
|---|---|---|---|
| Willi Sauerbrei, Patrick Royston, Benjamin Kasenda and Matthias Briel | A method for IPD meta-analysis of treatment-covariate interaction with a continuous predictor in randomised trials | link | |
| Willi Sauerbrei and Patrick Royston | Towards stratified medicine – instead of dichotomization | link | |
| Willi Sauerbrei and Patrick Royston | A new strategy for meta-analysis of continuous covariates in observational studies with IPD | link |
04.06.2013: Joint BBS/EFSPI Seminar: Health Technology Assessment
No recording available
| Speaker | Institution | Title | Download slides |
|---|---|---|---|
| Mike Branson | Welcome | link | |
| Fred Sorenson | Health Technology Assessment – Why is it so important? | link | |
| Matthias Egger and Mike Chambers | Moving HTA forward: The challenges of incorporating real world evidence into Health Technology Assessment | link | |
| Mike Chambers and Matthias Egger | GetReal: Clinical effectiveness in drug development | link | |
| Claudia Nicolay | Health Technology Assessment – What’s in for Stats? | link | |
| Jens Grüger | HTA and personalized healthcare | link | |
| Skip Olson | HTA – Use of observational | link | |
| Bruno Falissard | The place of subjectivity in the French system (HAS): a good thing or an archaism? | link | |
| Ralf Bender | Biometrical topics of Health Technology Assessment in Germany | link | |
| Friedhelm Leverkus | 30 Months AMNOG Health Technology Assessment: Outcomes and Issues | link | |
| Lou Garrison | HTA in Emerging Markets: A Framework and Examples | link | |
| Richard Nixon | Using early health economic models to support drug development decisions | link | |
| Chrissie Fletcher | Using indirect treatment comparisons to support an HTA | link | |
| All | Summary of event | link |
28.11.2012: BBS Seminar: Optimal Design for Non-linear Models
No recording available
| Speaker | Institution | Title | Download slides |
|---|---|---|---|
| Anthony Atkinson | London School of Economics | Experiments for Building Enzyme Kinetic Models | No presentation available (may be added later for recent events, after having received speaker approval) |
| Tobias Mielke | Aptiv Solutions | Optimal Population Designs for Non-linear Mixed Effects Models | No presentation available (may be added later for recent events, after having received speaker approval) |
| Barbara Bogacka | Queen Mary College, University of London | Population Optimum Design for Non-linear Mixed Effects Models in the Presence of Covariates | No presentation available (may be added later for recent events, after having received speaker approval) |
25.09.2012: BBS Seminar: Benefit-Risk & Comparative Effectiveness
No recording available
| Speaker | Institution | Title | Download slides |
|---|---|---|---|
| Andrea Beyer | Understanding the risk tolerance of regulatory assessors in Europe: the role of quantitative models in risk communication | link | |
| Christoph Dierig and Richard Nixon | A case study using the BRAT framework for benefit risk assessment | link | |
| Christian Hove Rasmussen | Benefit-risk assessment from a clinical point of view: a structured approach with focus on transparency | link | |
| Ralf Bender | Biometrical requirements in (early) benefit assessments | link | |
| Fred Sorenson | Benefit-risk assessment and comparative effectiveness research: are they really converging? | link |
09.07.2012: BBS Seminar: Emerging Topics in Pharmaceutical Statistics
No recording available
| Speaker | Institution | Title | Download slides |
|---|---|---|---|
| Stephen A. Julious | Sample sizes for multiple must-win trials | link | |
| Eric Derobert | A parameterized strategy of gatekeeping | link | |
| Mouna Akacha & Günther Müller-Velten | Recurrent event approaches in cardiovascular outcome trials | No presentation available (may be added later for recent events, after having received speaker approval) | |
| Lisa Hampson | Group sequential tests for delayed responses | link |
22.05.2012: BBS Seminar: Experiences in the Development and Implementation of Flexible Designs
No agenda available
No recording available
No slides available
29.11.2011: BBS Seminar
No recording available
| Speaker | Institution | Title | Download slides |
|---|---|---|---|
| Boris Choy | Business School The University of Sydney | Nonignorable dropout models for longitudinal binary data with random effects: An application of Monte Carlo approximation through the Gibbs output | No presentation available (may be added later for recent events, after having received speaker approval) |
| Mouna Akacha | Novartis, Basel | Implementing Current Regulatory Guidance on the Treatment of Missing Data: An Industry Perspective | No presentation available (may be added later for recent events, after having received speaker approval) |
16.09.2011: BBS Fall Conference: Current Topics in Pharmaceutical Statistics: Dose Finding and Multiregional Trials
No recording available
| Speaker | Institution | Title | Download slides |
|---|---|---|---|
| Andy Grieve | Dose Selection in Drug Development: What Can Go Wrong? Can we put it Right? | link | |
| Didier Renard | Use of modeling & simulation to support design and analysis of a new dose and regimen finding study | link | |
| Bjoern Bornkamp | On the efficiency of two-stage adaptive designs | link | |
| Georg Gutjahr | Powerful Modification of Step Down Procedures for Dose Finding | No presentation available (may be added later for recent events, after having received speaker approval) | |
| H.M. James Hung | Planning and Analyzing Multi-regional Clinical Trials: A Regulatory Perspective | link | |
| Philip Hougaard | Global drug development strategies | link | |
| Jorgen Seldrup | Designing clinical trials in a multiregional regulatory environment | No presentation available (may be added later for recent events, after having received speaker approval) | |
| Kevin J. Carroll | Consistency of treatment effect across regions in a multi-regional trial: reasonable goal or unrealistic requirement? | link |
21.07.2011: BBS Seminar Quantitative Benefit-Risk: What Matters to Whom and How? – Getting the Values and Weights
No recording available
| Speaker | Institution | Title | Download slides |
|---|---|---|---|
| John Ferguson | Structured Benefit-Risk Optimization (BRO): A Framework Quantitative Decision Support Tools | link | |
| Gordon Francis | Clinical Perspective on Benefit-Risk Assessments | link | |
| Lawrence Phillips | Quantitative Benefit-Risk: Determining Values & Assessing Weights | link | |
| Andrea Beyer | Beyond the Probability of Risk: Measuring Perception | link |
10.05.2011: BBS Spring Conference: Comparative Quantitative Assessments: Benefit-Risk & Effectiveness
No recording available
| Speaker | Institution | Title | Download slides |
|---|---|---|---|
| Chrissie Fletcher | Industry Perspective on Comparative Effectiveness Research (CER) and the impact of Health Technology Assessment (HTA) in Europe | link | |
| Melvin (Skip) Olson | Some Issues with Indirect Comparisons | link | |
| Friedhelm Leverkus | Health Care Reform in Germany and Update on IQWiG Requirements | link | |
| John Doyle | Effect of Comparative Effectiveness Research on Drug Development Innovation: a 360° Appraisal and Summary Discussion | link | |
| Deborah Ashby | Current Methodological Approaches to Benefit-Risk Decision-Making | link | |
| John Ferguson | Structured Benefit-Risk Optimization (BRO): State-of-the-art and Role of Fully Quantitative Decision Support Tools | link | |
| Michael Forstner | Considerations for Implementing a Quantitative Benefit-Risk Assessment | link | |
| Richard Nixon | Benefit-Risk Assessment of Multiple Sclerosis Treatments: Lessons Learnt in the use of Multi-Criteria Decision Analysis | link | |
| John Doyle | Convergence of CER and BRA and Concluding Summary Discussion | link |
07.05.2011: BBS Spring Seminar: Multiplicity in Clinical Trials
No recording available
| Speaker | Institution | Title | Download slides |
|---|---|---|---|
| Huque Mohammad | Some key multiplicity questions on primary and secondary endpoints of RCCTs and possible answers | link | |
| Ferber Georg | Confirmatory statistics in PK/PD studies | link | |
| Kornelius Rohmeyer | gMCP: A GUI for graphical multiple test procedures | No presentation available (may be added later for recent events, after having received speaker approval) | |
| Wolf Michael | Control of the false discovery rate under dependence using the bootstrap and sub sampling | link | |
| Maurer Willi / Glimm Ekkehard | Multiple and repeated testing of primary | link |
13.01.2011: BBS Seminar: Statistical Challenges in Biomedical Research
No recording available
| Speaker | Institution | Title | Download slides |
|---|---|---|---|
| Kalisch Markus | Can one extract causal information from high-dimensional observational data? | link | |
| Sauerbrei Willi | Regression model-building with continuous variables – multivariable fractional polynomials | link |
30.11.2010: BBS Seminar
No recording available
| Speaker | Institution | Title | Download slides |
|---|---|---|---|
| Harald Binder | Fitting and evaluating risk prediction models with high-dimensional molecular data | No presentation available (may be added later for recent events, after having received speaker approval) | |
| Martin Wolkewitz | Healthcare epidemiology hospital-acquired infections statistical modeling of outbreaks | No presentation available (may be added later for recent events, after having received speaker approval) |
04.10.2010: BBS Fall Conference
No recording available
| Speaker | Institution | Title | Download slides |
|---|---|---|---|
| Helmut Schäfer | University of Marburg | Optimized and flexible designs for genome-wide associations studies | No presentation available (may be added later for recent events, after having received speaker approval) |
| Maximo Carreras | Roche, Basel | Point Estimation in Two-Stage Adaptive Designs With Mid-Trial Treatment Selection | No presentation available (may be added later for recent events, after having received speaker approval) |
| David Lawrence | Novartis, Basel | The A to Z of DMC interaction in a phase II/III adaptive design with treatment selection | No presentation available (may be added later for recent events, after having received speaker approval) |
| Reinhard Eisebitt | ClinResearch | Methods to protect the blinding, including controlled emergency unblinding, in adaptive design trials with flexible randomization schemes | No presentation available (may be added later for recent events, after having received speaker approval) |
| Tim Friede | University of Göttingen | The role of DMCs in adaptive design trials: The perspective of a DMC member | No presentation available (may be added later for recent events, after having received speaker approval) |
| Sue-Jane Wang | FDA | Adaptive Design Consideration: A Regulatory Perspective on How to Maintain Validity and Integrity of Trials | link |
| James Hung | FDA | Emerging Challenges in Design and Analysis of Non-inferiority Trials | link |
| Franz König | EMA | No presentation available (may be added later for recent events, after having received speaker approval) | |
| Ralf Bender | IQWiG | The importance of Non-inferiority testing in benefit assessments of medical interventions | link |
| Heinz Schmidli | Novartis, Basel | Estimating the placebo-effect in a non-inferiority trial: a case study | No presentation available (may be added later for recent events, after having received speaker approval) |
| Georg Gutjahr, Werner Brannath, Peter Bauer | Bremen and Vienna | Unblinded SampleSize Modification for Fisher’s Exact Test | link |
24.06.2010: BBS/EFSPI European Statistical Meeting on Oncology
No recording available
| Speaker | Institution | Title | Download slides |
|---|---|---|---|
| Bertil Jonsson | Medical Products Agency | Understanding Progression-free Survival | No presentation available (may be added later for recent events, after having received speaker approval) |
| Marc Buyse | IDDI and University of Hasselt | The Time to Progression Ratio for Phase II Trials of Personalized Medicine | No presentation available (may be added later for recent events, after having received speaker approval) |
| Stuart Bailey | Novartis, Basel | Adaptive Bayesian Designs for Phase I Oncology Trials | No presentation available (may be added later for recent events, after having received speaker approval) |
| Simon Wandel | Novartis, Basel | Bayesian Hierarchical Modelling of Clinical Response in NSCLC Subpopulations | No presentation available (may be added later for recent events, after having received speaker approval) |
| Claire Watkins | AstraZeneca | IRESSA: A Journey of Experience from Broad to Biomarker Populations | No presentation available (may be added later for recent events, after having received speaker approval) |
| Cong Chen | Merck | Optimal Cost-Effective Go-No Go Decisions in Late-Stage Oncology Drug Development | No presentation available (may be added later for recent events, after having received speaker approval) |
| Jonas Wiedemann | Roche, Basel | Oncology Dose Finding – A Case Study | No presentation available (may be added later for recent events, after having received speaker approval) |
28.04.2010: BBS Seminar Epidemiology
No recording available
| Speaker | Institution | Title | Download slides |
|---|---|---|---|
| Noah Jamie Robinson | Roche, Basel | Epidemiology: the basics and in practice (at Roche) | No presentation available (may be added later for recent events, after having received speaker approval) |
| Jim Young | Basel Institute for Clinical Epidemiology and Biostatistics | Approximate Bayesian methods for the analysis of epidemiological data | link |
12.03.2010: BBS Seminar
No agenda available
No recording available
| Speaker | Institution | Title | Download slides |
|---|---|---|---|
| Benda Norbert | The use of adaptive designs in dose finding studies | link | |
| Brannath Werner | Challenges in the application of adaptive phase II/III designs in oncology | link | |
| Fleischer Frank | Statistical modeling in the context of progression-free survival | link | |
| Friede Tim | Blinded sample size reestimation with count data | link | |
| Glimm Ekkehard | Some lessons learned from designing and adaptive clinical trial with time-to-event as the primary endpoint | link | |
| Guthjahr Georg | Multiple Type I error control in response adaptive Phase II/III designs with treatment selection | link | |
| Wang Sue-Jane | U.S. FDA Draft Guidance on Adaptive Design Clinical Trials – Statistical Considerations and Issues | link |
12.01.2010: BBS Seminar: Enhanced Statistical Methodology
No recording available
| Speaker | Institution | Title | Download slides |
|---|---|---|---|
| Leonhard Held | University of Zürich | A Nomogram for P Values | No presentation available (may be added later for recent events, after having received speaker approval) |
| Kaspar Rufibach | University of Zürich | Estimation of two ordered monotone regression curves | No presentation available (may be added later for recent events, after having received speaker approval) |
07.12.2009: BBS Seminar: Challenges and Evaluation of Biomarkers
No recording available
| Speaker | Institution | Title | Download slides |
|---|---|---|---|
| Eric Holmgren | Genentech | Quantifying the usefulness of PD biomarkers in phase 2 screening trials of oncology drugs | No presentation available (may be added later for recent events, after having received speaker approval) |
| Martin Schumacher | Novartis, Basel | Class prediction with gene expression data | No presentation available (may be added later for recent events, after having received speaker approval) |
26.10.2009: BBS Seminar: Operational and Implementation Considerations in Adaptive Designs
No recording available
| Speaker | Institution | Title | Download slides |
|---|---|---|---|
| Eva Miller | ICON Clinical Research | Logistical Considerations in the Implementation of Adaptive Trial Designs | No presentation available (may be added later for recent events, after having received speaker approval) |
| Norbert Benda | Novartis, Basel | Considerations and Experiences in Adaptive Dose Finding | No presentation available (may be added later for recent events, after having received speaker approval) |