Bernard Sebastien

Affiliations

Sanofi R&D Data and Data Science, Clinical Modeling & Evidence Integration, 450 Water Street, Cambridge, MA, 02142, USA. bernard.sebastien@sanofi.com.

Publications (12)

Empirical bayes approach for dynamic bayesian borrowing for clinical trials in rare diseases.

Journal of pharmacokinetics and pharmacodynamics

Avec: Bernard Sebastien

Matching-adjusted indirect comparisons: Application to time-to-event data.

Statistics in medicine

Avec: Jihane Aouni , Nadia Gaudel-Dedieu , Bernard Sebastien

Use of pharmacodynamic modeling for Bayesian information borrowing in pediatric clinical trials.

Journal of biopharmaceutical statistics

Avec: Bernard Sebastien , S Y Amy Cheung , Solange Corriol-Rohou , Margaret Gamalo-Siebers , Rana Jreich , Rajesh Krishna , Jing Liu

Pediatric Rare Diseases Development in the Pharmaceutical Industry: An International Consortium for Innovation and Quality in Pharmaceutical Development, Clinical Pharmacology Leadership Group-Pediatrics Working Group, Rare Diseases Subteam Whitepaper Examining the Current Landscape and Recommendations for the Future.

Clinical pharmacology and therapeutics

Avec: Rajesh Krishna , Bernard Sebastien , Solange Corriol-Rohou , S Y Amy Cheung , Jing Liu , Satyendra Suryawanshi

Exposure-response analyses for selection/confirmation of optimal isatuximab dosing regimen in combination with pomalidomide/dexamethasone treatment in patients with multiple myeloma.

CPT: pharmacometrics & systems pharmacology

Avec: Fatiha Rachedi , Kimiko Koiwai , Nadia Gaudel-Dedieu , Bernard Sebastien , Hoai-Thu Thai , Claire Brillac , Jean Baptiste Fau , Laurent Nguyen , Helgi van de Velde , Christine Veyrat-Follet , Dorothée Semiond

Randomized Phase III Study of Amcenestrant Plus Palbociclib Versus Letrozole Plus Palbociclib in Estrogen Receptor-Positive, Human Epidermal Growth Factor Receptor 2-Negative Advanced Breast Cancer: Primary Results From AMEERA-5.

Journal of clinical oncology : official journal of the American Society of Clinical Oncology

Avec: Javier Cortés , Sara A Hurvitz , Joyce O'Shaughnessy , Suzette Delaloge , Hiroji Iwata , Hope S Rugo , Patrick Neven , Dheepak Kanagavel , Patrick Cohen , Gautier Paux , Sylvaine Cartot-Cotton , Maya Stefanova-Urena , Laure Deyme , Jihane Aouni , Bernard Sebastien , Aditya Bardia

Joint modelling and simulation of M-protein dynamics and progression-free survival for alternative isatuximab dosing with pomalidomide/dexamethasone.

British journal of clinical pharmacology

Avec: Hoai-Thu Thai , Nadia Gaudel , Marc Cerou , Geraldine Ayral , Jean-Baptiste Fau , Bernard Sebastien , Helgi van de Velde , Dorothée Semiond , Christine Veyrat-Follet

Development and validation of a predictive model to guide the use of plerixafor in pediatric population.

Bone marrow transplantation

Avec: Bernard Sebastien , Peter Cheverton , Catherine Magnin , Jihane Aouni , Remi Castan

An Overview of Current Methods for Real-world Applications to Generalize or Transport Clinical Trial Findings to Target Populations of Interest.

Epidemiology (Cambridge, Mass.)

Avec: Albee Y Ling , Maria E Montez-Rath , Paulo Carita , Karen J Chandross , Laurence Lucats , Zhaoling Meng , Bernard Sebastien , Kris Kapphahn , Manisha Desai

Cardiac risk assessment based on early Phase I data and PK-QTc analysis is concordant with the outcome of thorough QTc trials: an assessment based on eleven drug candidates.

Journal of pharmacokinetics and pharmacodynamics

Avec: Puneet Gaitonde , Yeamin Huh , Borje Darpo , Georg Ferber , Günter Heimann , James Li , Kaifeng Lu , Bernard Sebastien , Kuenhi Tsai , Steve Riley

Design optimization for dose-finding trials: a review.

Journal of biopharmaceutical statistics

Avec: Jihane Aouni , Jean Noel Bacro , Gwladys Toulemonde , Pierre Colin , Loic Darchy , Bernard Sebastien

Comparison of statistical methodologies used to estimate the treatment effect on time-to-event outcomes in observational studies.

Journal of biopharmaceutical statistics

Avec: Rana Jreich , Bernard Sebastien

Réseau de co-auteurs

Jihane Aouni 4 collaborations

Nadia Gaudel-Dedieu 2 collaborations

S Y Amy Cheung 2 collaborations

Solange Corriol-Rohou 2 collaborations

Rana Jreich 2 collaborations

Rajesh Krishna 2 collaborations

Jing Liu 2 collaborations

Hoai-Thu Thai 2 collaborations

Helgi van de Velde 2 collaborations

Christine Veyrat-Follet 2 collaborations

Dorothée Semiond 2 collaborations

Margaret Gamalo-Siebers 1 collaboration

Satyendra Suryawanshi 1 collaboration

Fatiha Rachedi 1 collaboration

Kimiko Koiwai 1 collaboration

Claire Brillac 1 collaboration

Jean Baptiste Fau 1 collaboration

Laurent Nguyen 1 collaboration

Javier Cortés 1 collaboration

Sara A Hurvitz 1 collaboration

Joyce O'Shaughnessy 1 collaboration

Suzette Delaloge 1 collaboration

Hiroji Iwata 1 collaboration

Hope S Rugo 1 collaboration

Patrick Neven 1 collaboration

Dheepak Kanagavel 1 collaboration

Patrick Cohen 1 collaboration

Gautier Paux 1 collaboration

Sylvaine Cartot-Cotton 1 collaboration

Maya Stefanova-Urena 1 collaboration

Laure Deyme 1 collaboration

Aditya Bardia 1 collaboration

Nadia Gaudel 1 collaboration

Marc Cerou 1 collaboration

Geraldine Ayral 1 collaboration

Jean-Baptiste Fau 1 collaboration

Peter Cheverton 1 collaboration

Catherine Magnin 1 collaboration

Remi Castan 1 collaboration

Albee Y Ling 1 collaboration

Maria E Montez-Rath 1 collaboration

Paulo Carita 1 collaboration

Karen J Chandross 1 collaboration

Laurence Lucats 1 collaboration

Zhaoling Meng 1 collaboration

Kris Kapphahn 1 collaboration

Manisha Desai 1 collaboration

Puneet Gaitonde 1 collaboration

Yeamin Huh 1 collaboration

Borje Darpo 1 collaboration

Georg Ferber 1 collaboration

Günter Heimann 1 collaboration

James Li 1 collaboration

Kaifeng Lu 1 collaboration

Kuenhi Tsai 1 collaboration

Steve Riley 1 collaboration

Jean Noel Bacro 1 collaboration

Gwladys Toulemonde 1 collaboration

Pierre Colin 1 collaboration

Loic Darchy 1 collaboration