Development of Gene Therapies: Strategic, Scientific, Regulatory, and Access Considerations (Chapman & Hall/CRC Biostatistics) - Hardcover

Hardcover

ISBN 10: 1032136553 ISBN 13: 9781032136554

Verlag: Chapman and Hall/CRC, 2024

Inhaltsangabe

Development of Gene Therapies: Strategic, Scientific, and Regulatory, and Access Considerations attempts to summarize the current state-of-the-art strategic, scientific, statistical, and regulatory aspects of GTx development.

Über diesen Titel

Über die Autorin bzw. den Autor

Avery McIntosh, Ph.D. is a drug developer working in rare diseases at Pfizer. He received his M.Sc. and Ph.D. in biostatistics from Boston University with a dissertation on Bayesian methods to model household tuberculosis transmission. He has managed teams of statisticians across study phases and in a variety of drug types and disease areas, including neurology, ophthalmology, infectious disease/ global health, hematology, and oncology. He has published peer-reviewed articles on various topics in drug development and biostatistics, including development of cell and gene therapies and qualification of digital endpoints in neurological diseases.

Oleksandr Sverdlov, Ph.D. is a Neuroscience Disease Area Statistical Lead at Novartis. He received B.Sc. in Applied Mathematics from V.N. Karazin Kharkiv National University, Ukraine, M.Sc. in Statistics from University of Maryland, Baltimore County (UMBC), and Ph.D. in Information Technology with Concentration in Statistical Science from George Mason University. He has been actively involved in methodological research and applications of innovative statistical approaches in drug development. He has co-authored over forty refereed articles, edited two monographs, and co-authored a book Mathematical and Statistical Skills in the Biopharmaceutical Industry: A Pragmatic Approach (CRC Press/Chapman & Hall, 2019). His most recent work involves design and analysis of clinical trials evaluating novel digital technologies

Details zur Ausgabe

• Verlag: Chapman and Hall/CRC
• Erscheinungsdatum: 2024
• Sprache: Englisch
• ISBN 10: 1032136553
• ISBN 13: 9781032136554
• Einband: Gebundene Ausgabe
• Auflage: 1
• Anzahl der Seiten: 490
• Herausgeber: McIntosh Avery, Sverdlov Oleksandr
• Kontakt zum Hersteller: preigu GmbH & Co. KG; mail@preigu.de; ; Lengericher Landstr. 19; Osnabrück; Niedersachsen; 49078; Deutschland