Results for 'Commercial Development'
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Emmanuelle Jacqueta, Ghania Kerouani-Lafayeb, Francoise Grudeb, Sergio Goncalvesb, Annie Lorenced, Florence Turcryb, Liora Brunelb, Laetitia Belgodereb, Adrien Monardc, Gaëlle Guyaderb, Lotfi Boudalib, Nicolas Albin
Comparative study on anticancer drug access times between FDA, EMA and the French temporary authorisation for use program over 13 years
Apr 7th • 12 mins read
Adela Rodriguez, Francis Esposito, Helena Oliveres, Ferran Torres and Joan Maurel
Are Quality of Randomized Clinical Trials and ESMO-Magnitude of Clinical Benefit Scale Two Sides of the Same Coin, to Grade Recommendations for Drug Approval?
Feb 11th • 3 mins read
Jayson L. Parker, Sebnem S. Kuzulugil, Kirill Pereverzev, Stephen Mac, Gilberto Lopes, Zain Shah, Ashini Weerasinghe, Daniel Rubinger, Adam Falconi, Ayse Bener, Bora Caglayan, Rohan Tangri, Nicholas Mitsakakis
Does biomarker use in oncology improve clinical trial failure risk? A large-scale analysis
Feb 23rd • 8 mins read
Charles L. Bennett , Sumimasa Nagai , Andrew C. Bennett , Shamia Hoque , Chadi Nabhan , Martin W. Schoen , William J. Hrushesky , Stefano Luminari , Paul Ray , Paul R. Yarnold , Bart Witherspoon , Josh Riente , Laura Bobolts , John Brusk , Rebecca Tombles
The First 2 Years of Biosimilar Epoetin for Cancer and Chemotherapy-Induced Anemia in the U.S.: A Review from the Southern Network on Adverse Reactions
Mar 12th • 7 mins read
Ali Raza Khaki
Loose Regulatory Standards Portend a New Era of Imprecision Oncology
Dec 1st • 4 mins read
Sonoko Kawakatsu, René Bruno, Matts Kågedal, Chunze Li, Sandhya Girish, Amita Joshi, Benjamin Wu
Confounding factors in exposure–response analyses and mitigation strategies for monoclonal antibodies in oncology
Nov 20th • 12 mins read
J. Remon, R. García-Campelo, E. de Álava, R. Vera, J. L. Rodríguez-Peralto, Á. Rodríguez-Lescure, B. Bellosillo, P. Garrido, F. Rojo & R. Álvarez-Alegret
Liquid biopsy in oncology: a consensus statement of the Spanish Society of Pathology and the Spanish Society of Medical Oncology
Sep 26th • 17 mins read
Shani Paluch-Shimon, Nathan I. Cherny, Elisabeth G.E. de Vries, Urania Dafni, Martine J. Piccart, Nicola Jane Latino, Fatima Cardoso
Application of the ESMO-Magnitude of Clinical Benefit Scale (V.1.1) to the field of early breast cancer therapies
Sep 6th • 20 mins read
Peter N Morcos, Junyi Li, Iraj Hosseini, Chi‐Chung Li
Quantitative Clinical Pharmacology of T‐Cell Engaging Bispecifics: Current Perspectives and Opportunities
Nov 18th • 15 mins read
Stefanie Broes, Robbe Saesen, Denis Lacombe, Isabelle Huys
Past, Current, and Future Cancer Clinical Research Collaborations: The Case of the European Organisation for Research and Treatment of Cancer
Aug 16th • 8 mins read
Consolación Molto MD, Thomas J. Hwang AB, Maria Borrell MD, Marta Andres MD, Ignasi Gich MD, PhD, Agustí Barnadas MD, PhD, Eitan Amir MD, PhD, Aaron S. Kesselheim MD, JD, MPH, Ariadna Tibau MD, PhD
Clinical benefit and cost of breakthrough cancer drugs approved by the US Food and Drug Administration
Jul 22nd • 12 mins read
Dean Bottino, Rachael Liu, Hojjat Bazzazi, Karthik Venkatakrishnan
Quantitative Translation in Immuno-Oncology Research and Development
Jul 9th • 3 mins read
Cornelius F Waller & Adriano Friganovi´c
Biosimilars in oncology: key role of nurses in patient education
Jun 15th • 10 mins read
Nidal Al-Huniti, Yan Feng, Jingyu (Jerry) Yu, Zheng Lu, Mario Nagase, Diansong Zhou, Jennifer Sheng
Tumor Growth Dynamic Modeling in Oncology Drug Development and Regulatory Approval: Past, Present, and Future Opportunities
Jun 26th • 18 mins read
Mateusz T. Wasylewski, Karolina Strzebonska, Magdalena Koperny, Maciej Polak, Jonathan Kimmelman, Marcin Waligora
Clinical development success rates and social value of pediatric Phase 1 trials in oncology
Jun 21st • 28 mins read
Haiqing Isaac Dai, Yulia Vugmeyster, Naveen Mangal
Characterizing Exposure–Response Relationship for Therapeutic Monoclonal Antibodies in Immuno-Oncology and Beyond: Challenges, Perspectives, and Prospects
Jun 18th • 30 mins read
Melissa H. Roberts & Gary T. Ferguson
Real-World Evidence: Bridging Gaps in Evidence to Guide Payer Decisions
Jun 18th • 6 mins read
Eric Q. Konnick
The regulatory landscape of precision oncology laboratory medicine in the United States - Perspective on the past 5 years and considerations for future regulation
May 22nd • 8 mins read
Dylan V Neel, David S Shulman, Clement Ma, Florence Bourgeois, Steven G DuBois
Sponsorship of oncology clinical trials in the United States according to age of eligibility
Apr 29th • 8 mins read
Nicole Grossmann, Martin Robausch, Eleen Rothschedl, Claudia Wild, Judit Simon
Publicly accessible evidence of health-related quality of life benefits associated with cancer drugs approved by the European Medicines Agency between 2009 and 2015
Feb 23rd • 12 mins read
