M Gamalo

Affiliations

Lilly Research Laboratory, Eli Lilly and Company, Indianapolis, IN, USA.

Publications (23)

Baricitinib in patients with moderate-to-severe atopic dermatitis and inadequate response to topical corticosteroids: results from two randomized monotherapy phase III trials.

The British journal of dermatology

Avec: E L Simpson , J-P Lacour , L Spelman , R Galimberti , L F Eichenfield , R Bissonnette , B A King , J P Thyssen , J I Silverberg , T Bieber , K Kabashima , Y Tsunemi , A Costanzo , E Guttman-Yassky , L A Beck , J M Janes , A M DeLozier , D R Brinker , T Cardillo , F P Nunes , A S Paller , A Wollenberg , K Reich

Baricitinib in patients with moderate-to-severe atopic dermatitis: Results from a randomized monotherapy phase 3 trial in the United States and Canada (BREEZE-AD5).

Journal of the American Academy of Dermatology

Avec: Eric L Simpson , Seth Forman , Jonathan I Silverberg , Matthew Zirwas , Emanual Maverakis , George Han , Emma Guttman-Yassky , Daniel Marnell , Robert Bissonnette , Jill Waibel , Fabio P Nunes , Amy M DeLozier , Robinette Angle , Margaret Gamalo , Katrin Holzwarth , Orin Goldblum , Jinglin Zhong , Jonathan Janes , Kim Papp

Power priors with entropy balancing weights in data augmentation of partially controlled randomized trials.

Journal of biopharmaceutical statistics

Avec: Guanglei Yu , Yuanyuan Bian , Margaret Gamalo

Extent of safety database in pediatric drug development: types of assessment, analytical precision, and pathway for extrapolation through on-target effects.

Journal of biopharmaceutical statistics

Avec: Margaret Gamalo , Yihua Zhao , Aijun Gao , Jingjing Ye , Junjing Lin , Eiji Eshida , YounJeong Choi , Robert Nelson

Extrapolation as a Default Strategy in Pediatric Drug Development.

Therapeutic innovation & regulatory science

Avec: Margaret Gamalo , Christina Bucci-Rechtweg , Robert M Nelson , Linh Vanh , Ariel Porcalla , Helen Thackray , Freda Cooner , Lauren Cutler , Danielle Friend , Ron Portman

Platform trials to evaluate the benefit-risk of COVID-19 therapeutics: Successes, learnings, and recommendations for future pandemics.

Contemporary clinical trials

Avec: Joan Buenconsejo , Ran Liao , Junjing Lin , Pritibha Singh , Freda Cooner , Samiran Ghosh , Margaret Gamalo , Estelle Russek-Cohen , Névine Zariffa

Strategies to facilitate adolescent access to medicines: Improving regulatory guidance.

Clinical trials (London, England)

Avec: Christina Bucci-Rechtweg , Angeliki Siapkara , Kristina An Haack Bonnet , Solange Corriol Rohou , Elin Haf Davies , Martine Dehlinger Kremer , Margaret Gamalo , Carmen Moreno , Robert M Nelson , Rhian Thomas Turner

Efficacy and safety of the oral Janus kinase inhibitor baricitinib in the treatment of adults with alopecia areata: Phase 2 results from a randomized controlled study.

Journal of the American Academy of Dermatology

Avec: Brett King , Justin Ko , Seth Forman , Manabu Ohyama , Natasha Mesinkovska , Guanglei Yu , Jill McCollam , Margaret Gamalo , Jonathan Janes , Emily Edson-Heredia , Katrin Holzwarth , Yves Dutronc

Composite Likelihoods with Bounded Weights in Extrapolation of Data.

Journal of biopharmaceutical statistics

Avec: Margaret Gamalo , Yoonji Kim , Fan Zhang , Junjing Lin

Recent Use of Pediatric Extrapolation in Pediatric Drug Development in US.

Journal of biopharmaceutical statistics

Avec: Jingjing Ye , Vickie Zhang , Foteini Strimenopoulou , Yihua Zhao , Haitao Pan , Mayadah Shabbout , Margaret Gamalo

Estimands for atopic dermatitis clinical trials: Expert opinion on the importance of intercurrent events.

Journal of the European Academy of Dermatology and Venereology : JEADV

Avec: R Bissonnette , L F Eichenfield , E Simpson , D Thaçi , K Kabashima , J P Thyssen , E Guttman-Yassky , F P Nunes , F Ahmad , M Kuligowski , K Sun , C Pipper , A W Christensen , P D'Angelo , M Milutinovic , A Guettner , J I Silverberg

Unlocking the Potential: A Systematic Review of Master Protocol in Pediatrics.

Therapeutic innovation & regulatory science

Avec: Yimei Li , Robert Nelson , Rima Izem , Kristine Broglio , Rajiv Mundayat , Margaret Gamalo , Yansong Wen , Haitao Pan , Hengrui Sun , Jingjing Ye

Efficacy and Safety of Baricitinib Combined With Topical Corticosteroids for Treatment of Moderate to Severe Atopic Dermatitis: A Randomized Clinical Trial.

JAMA dermatology

Avec: Kristian Reich , Kenji Kabashima , Ketty Peris , Jonathan I Silverberg , Lawrence F Eichenfield , Thomas Bieber , Aleksandra Kaszuba , Jill Kolodsick , Fan E Yang , Margaret Gamalo , Dennis R Brinker , Amy M DeLozier , Jonathan M Janes , Fabio P Nunes , Jacob P Thyssen , Eric L Simpson

Baricitinib in adult patients with moderate-to-severe atopic dermatitis: A phase 2 parallel, double-blinded, randomized placebo-controlled multiple-dose study.

Journal of the American Academy of Dermatology

Avec: Emma Guttman-Yassky , Jonathan I Silverberg , Osamu Nemoto , Seth B Forman , August Wilke , Randy Prescilla , Amparo de la Peña , Fabio P Nunes , Jonathan Janes , Margaret Gamalo , David Donley , Jim Paik , Amy M DeLozier , Brian J Nickoloff , Eric L Simpson

Analysis and reporting of pediatric growth and development assessment from clinical trials: overview and challenges.

Journal of biopharmaceutical statistics

Avec: YounJeong Choi , Nathalie Barbier , Sabine Fürst-Recktenwald , Jingjing Ye , Dalia Ballas Wajsbrot , Eiji Ishida , Margaret Gamalo

A win ratio approach for comparing crossing survival curves in clinical trials.

Journal of biopharmaceutical statistics

Avec: Sirui Zheng , Duolao Wang , Junshan Qiu , Tao Chen , Margaret Gamalo

A comprehensive review and shiny application on the matching-adjusted indirect comparison.

Research synthesis methods

Avec: Ziren Jiang , Joseph C Cappelleri , Margaret Gamalo , Yong Chen , Neal Thomas , Haitao Chu

Pediatric Age Groups and Approach to Studies.

Therapeutic innovation & regulatory science

Avec: Kathleen M Job , Margaret Gamalo , Robert M Ward

Pooled safety analysis of baricitinib in adult patients with atopic dermatitis from 8 randomized clinical trials.

Journal of the European Academy of Dermatology and Venereology : JEADV

Avec: T Bieber , J P Thyssen , K Reich , E L Simpson , N Katoh , A Torrelo , M De Bruin-Weller , D Thaci , R Bissonnette , M Gooderham , J Weisman , F Nunes , D Brinker , M Issa , K Holzwarth , E Riedl , J Janes

Estimands, Handling of Missing Data and Impact on Assumed Effect Size and Power in Pivotal COVID-19 Treatment Trials.

Journal of biopharmaceutical statistics

Avec: Sujatro Chakladar , Ran Liao , Margaret Gamalo

Real-World Data as External Controls: Practical Experience from Notable Marketing Applications of New Therapies.

Therapeutic innovation & regulatory science

Avec: Rima Izem , Joan Buenconsejo , Ruthanna Davi , Jingyu Julia Luan , LaRee Tracy , Margaret Gamalo

Win ratio approach for analyzing composite time-to-event endpoint with opposite treatment effects in its components.

Pharmaceutical statistics

Avec: Ran Liao , Sujatro Chakladar , Margaret Gamalo

Matching within a hybrid RCT/RWD: framework on associated causal estimands.

Journal of biopharmaceutical statistics

Avec: Junjing Lin , Guanglei Yu , Margaret Gamalo

Réseau de co-auteurs

Margaret Gamalo 20 collaborations

Jingjing Ye 4 collaborations

Junjing Lin 4 collaborations

R Bissonnette 3 collaborations

J P Thyssen 3 collaborations

Eric L Simpson 3 collaborations

Jonathan I Silverberg 3 collaborations

Fabio P Nunes 3 collaborations

Amy M DeLozier 3 collaborations

Jonathan Janes 3 collaborations

Guanglei Yu 3 collaborations

Ran Liao 3 collaborations

E L Simpson 2 collaborations

L F Eichenfield 2 collaborations

J I Silverberg 2 collaborations

T Bieber 2 collaborations

K Kabashima 2 collaborations

E Guttman-Yassky 2 collaborations

F P Nunes 2 collaborations

K Reich 2 collaborations

Seth Forman 2 collaborations

Emma Guttman-Yassky 2 collaborations

Katrin Holzwarth 2 collaborations

Yihua Zhao 2 collaborations

YounJeong Choi 2 collaborations

Robert Nelson 2 collaborations

Christina Bucci-Rechtweg 2 collaborations

Robert M Nelson 2 collaborations

Freda Cooner 2 collaborations

Joan Buenconsejo 2 collaborations

Haitao Pan 2 collaborations

Rima Izem 2 collaborations

Sujatro Chakladar 2 collaborations

J-P Lacour 1 collaboration

L Spelman 1 collaboration

R Galimberti 1 collaboration

B A King 1 collaboration

Y Tsunemi 1 collaboration

A Costanzo 1 collaboration

L A Beck 1 collaboration

J M Janes 1 collaboration

A M DeLozier 1 collaboration

D R Brinker 1 collaboration

T Cardillo 1 collaboration

A S Paller 1 collaboration

A Wollenberg 1 collaboration

Matthew Zirwas 1 collaboration

Emanual Maverakis 1 collaboration

George Han 1 collaboration

Daniel Marnell 1 collaboration

Robert Bissonnette 1 collaboration

Jill Waibel 1 collaboration

Robinette Angle 1 collaboration

Orin Goldblum 1 collaboration

Jinglin Zhong 1 collaboration

Kim Papp 1 collaboration

Yuanyuan Bian 1 collaboration

Aijun Gao 1 collaboration

Eiji Eshida 1 collaboration

Linh Vanh 1 collaboration

Ariel Porcalla 1 collaboration

Helen Thackray 1 collaboration

Lauren Cutler 1 collaboration

Danielle Friend 1 collaboration

Ron Portman 1 collaboration

Pritibha Singh 1 collaboration

Samiran Ghosh 1 collaboration

Estelle Russek-Cohen 1 collaboration

Névine Zariffa 1 collaboration

Angeliki Siapkara 1 collaboration

Kristina An Haack Bonnet 1 collaboration

Solange Corriol Rohou 1 collaboration

Elin Haf Davies 1 collaboration

Martine Dehlinger Kremer 1 collaboration

Carmen Moreno 1 collaboration

Rhian Thomas Turner 1 collaboration

Brett King 1 collaboration

Justin Ko 1 collaboration

Manabu Ohyama 1 collaboration

Natasha Mesinkovska 1 collaboration

Jill McCollam 1 collaboration

Emily Edson-Heredia 1 collaboration

Yves Dutronc 1 collaboration

Yoonji Kim 1 collaboration

Fan Zhang 1 collaboration

Vickie Zhang 1 collaboration

Foteini Strimenopoulou 1 collaboration

Mayadah Shabbout 1 collaboration

E Simpson 1 collaboration

D Thaçi 1 collaboration

F Ahmad 1 collaboration

M Kuligowski 1 collaboration

K Sun 1 collaboration

C Pipper 1 collaboration

A W Christensen 1 collaboration

P D'Angelo 1 collaboration

M Milutinovic 1 collaboration

A Guettner 1 collaboration

Yimei Li 1 collaboration

Kristine Broglio 1 collaboration

Rajiv Mundayat 1 collaboration

Yansong Wen 1 collaboration

Hengrui Sun 1 collaboration

Kristian Reich 1 collaboration

Kenji Kabashima 1 collaboration

Ketty Peris 1 collaboration

Lawrence F Eichenfield 1 collaboration

Thomas Bieber 1 collaboration

Aleksandra Kaszuba 1 collaboration

Jill Kolodsick 1 collaboration

Fan E Yang 1 collaboration

Dennis R Brinker 1 collaboration

Jonathan M Janes 1 collaboration

Jacob P Thyssen 1 collaboration

Osamu Nemoto 1 collaboration

Seth B Forman 1 collaboration

August Wilke 1 collaboration

Randy Prescilla 1 collaboration

Amparo de la Peña 1 collaboration

David Donley 1 collaboration

Jim Paik 1 collaboration

Brian J Nickoloff 1 collaboration

Nathalie Barbier 1 collaboration

Sabine Fürst-Recktenwald 1 collaboration

Dalia Ballas Wajsbrot 1 collaboration

Eiji Ishida 1 collaboration

Sirui Zheng 1 collaboration

Duolao Wang 1 collaboration

Junshan Qiu 1 collaboration

Tao Chen 1 collaboration

Ziren Jiang 1 collaboration

Joseph C Cappelleri 1 collaboration

Yong Chen 1 collaboration

Neal Thomas 1 collaboration

Haitao Chu 1 collaboration

Kathleen M Job 1 collaboration

Robert M Ward 1 collaboration

N Katoh 1 collaboration

A Torrelo 1 collaboration

M De Bruin-Weller 1 collaboration

D Thaci 1 collaboration

M Gooderham 1 collaboration

J Weisman 1 collaboration

F Nunes 1 collaboration

D Brinker 1 collaboration

M Issa 1 collaboration

K Holzwarth 1 collaboration

E Riedl 1 collaboration

J Janes 1 collaboration

Ruthanna Davi 1 collaboration

Jingyu Julia Luan 1 collaboration

LaRee Tracy 1 collaboration