The major advances in the field of biotechnology and molecular biology in the 21st century has led to a better understanding of pathophysiology of diseases. A new generation of biopharmaceuticals has emerged including a wide and heterogeneous range of innovative therapies. These aim to prevent or treat chronic or serious life-threatening diseases, previously considered incurable. This unique book series focuses on how the regulatory environment has evolved to analyse and review those therapies while HTA agencies and payers remain resistant. It provides insight into current learning, how those products will be accessible and which policy changes will be required to permit patient access.
By Tingting Qiu, Mondher Toumi
May 23, 2023
A comprehensive review of the challenges that exist in patient accessibility to advanced therapy medicinal products (ATMPs), presenting clinical trials, marketing authorization, HTA, pricing, reimbursement, affordability, payment and partnership agreements of RMs and commercialisation. Specfically,...
By Mondher Toumi, Szymon Jarosławski
June 24, 2022
Market entry agreements (MEA) for pharmaceuticals have become extremely popular and widespread geographically. Emerging countries that have not yet begun to introduce MEAs are now actively engaged in doing so. This book examines the concept of MEAs, detailing how depreciation of some specific ...
By Eve Hanna, Mondher Toumi
May 26, 2020
The major advances in the field of biotechnology and molecular biology in the twenty-first century have led to a better understanding of the pathophysiology of diseases. A new generation of biopharmaceuticals has emerged, including a wide and heterogeneous range of innovative cell and gene ...
