Thought Leadership
At NDA our experts stay abreast with the evolving environment and the new regulatory requirements that it gives rise to. One of the results of these activities is a stream of articles, commentaries and white papers that we publish for the benefit of our clients and followers. It captures the state of the art of our industry today.
We call it Thought Leadership.
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13-06-2023
Single-Arm Trials in Oncology: Key Insights from the Latest EMA and FDA Guidance
This white paper written by Adriana Andrić, Senior Consultant at NDA Group, explores the regulatory guidance considerations in relation to the design, planning, conduct, analysis, and interpretation of results derived from SATs.
09-05-2023
Project Optimus – A Reform in the Dose Optimization and Selection in Oncology Drug Development
In this white paper, Dr Laurie Smaldone Alsup, Chief Medical & Scientific Officer at NDA, explores the goals of Project Optimus and how it can impact time to approval.
23-04-2021
Project Orbis: What a pharmaceutical company needs to know
In this article, NDA's Senior Consultant and Project Orbis lead Claudia Reichle provides background and practical information on the FDA driven initiative Project Orbis.
21-04-2021
NDA Webinars Project Orbis: What you need to know
In this webinar our Senior Consultant and Project Orbis Lead, Claudia Reichle provides a closer look at Project Orbis and discusses what you should think about if you are offered the possibility to take part.
23-09-2020
Integrated product development for ATMPs
In this article, published in the September issue of MedNous, Claes and Paula discuss why an integrated product development strategy for ATMPs is essential to meet both regulatory and HTA requirements.
01-09-2020
Market access for immune-oncology products in the EU
In this article, published in Volume 22 September 2020 of Pharmafocus, Claes Buxfeldt discusses key considerations in early development to succeed with market access for immune-oncology products in the EU.