Navigating Gene Therapy Commercialization in Europe: A Q&A with Novartis’ Joshi Venugopal
Navigating Gene Therapy Commercialization in Europe A Q&A with Joshi Venugopal, General Manager of Gene Therapies and Rare Diseases, Europe Opinions expressed here are personal and not that of Novartis* Gene therapies hold immense promise for revolutionizing the treatment of rare diseases, offering potential cures where previously only symptom management was possible. However, the path […]
RARE DISEASE CLINICAL TRIALS: A Collaborative Approach to Design and Execution
Rare Disease Clinical Trials A Collaborative Approach to Design and Execution Patients who suffer from rare diseases need access to effective and safe medications. Given the low incidence of the diseases, the collaboration between regulatory authorities, producers, insurances, and market access teams is essential for pharmaceutical companies seeking to bring new medications to patients and […]
Demystifying the Maze: Centralized vs. National Procedures for Rare Disease Drug Registration in the EU
Demystifying The Maze Centralized vs. National Procedures for Rare Disease Drug Registration in the EU Introduction The European market presents a compelling opportunity for US pharma and biotech companies developing life-changing therapies for rare diseases. Engaged patient communities and sophisticated healthcare systems create a fertile ground for innovation. However, navigating the intricacies of the European […]
The Ultimate Guide to EMA Approval for Rare Disease Therapies: Unlocking European Access
Your Ultimate Parter for EMA Approval of Rare Disease Therapies Unlocking European Access Developing a therapy for a rare disease is a noble endeavour, but the path to market is complex, especially in Europe. This guide equips rare disease pharma/biotech startups worldwide with the knowledge and strategies to successfully navigate the European Medicines Agency (EMA) […]
The Geopolitics of Hope
The Geopolitics of Hope A Flourishing Market, Yet Millions in Europe Lack Access to Rare Disease Treatments Did you know that over 30 million people in Europe live with a rare disease, often lacking access to effective treatments due to the complexities of market entry? This challenge highlights a missed opportunity. According to 2022 global […]
