Although we don’t publish many articles on Regulatory Aspects of Drug Development, its importance to the development of important medicines cannot be overstated. Any ideas for future ideas are always welcome!! The articles in this month’s offering cover a wide range of related articles, from NDAs to the FDA and how this process can be streamlined. There is also an article dealing with the potential implications of Britain’s exit from the European Community and the implications to research, patients and health systems. There is also an analysis of authorization applications to the EMA by small and medium sized enterprises and the objections and outcomes.

The first article is by William F. Salminen, Marc E. Wiles and Ruth E. Stevens of Camargo Pharmaceutical Services, Cincinnati, OH, USA and is entitled: “Streamlining nonclinical drug development using the FDA 505(b)(2) new drug application regulatory pathway”. The article is a particularly interesting guide to how the regulatory process can be streamlined, with a specific emphasis on non-clinical programmes. The authors give an overview of  The 505(b)(2) NDA regulatory approval pathway and how it allows sponsors to use existing public data in lieu of conducting studies. As a result it can potentially offer significant drug development and marketing advantages. Nonclinical testing programs for 505(b)(2) submissions are often reduced and, in some cases, are not even required.

If you live in the UK at the moment, you would be forgiven for being tired of the seemingly never-ending stream of discourse upon what has become known as Brexit. For health industries, however, the process has imposed significant stress and enterprise as they plan for what, even now, is still an unknown outcome. The article by Tim K. Mackey and John Annaloro of The University of San Diego, USA entitled “‘Bioexit’: navigating the policy and regulatory pathways for the biotechnology industry in a post-Brexit landscape” examines some of the possible outcomes that might arise dependant upon the nature of the actual departure. Four possible models are considered: The European Economic Area (EEA) affiliation (Norwegian Model); negotiated bilateral access (Swiss Model); limited participation in EU Customs Union (Turkish Model); or independence under the World Trade Organization (WTO) designation. The article also considers strategies to maintain regulatory synergy and continue patient access to drugs and devices.

The final article by Nadia Amaouche, Hélène Casaert Salomé, Olivier Collignon, Mariana Roldao Santos and Constantinos Ziogas of the EMA, the Luxembourg Institute of Health, and the United Nations Development Programme entitled: “Marketing authorisation applications submitted to the European Medicines Agency by small and medium-sized enterprises: an analysis of major objections and their impact on outcomes” is, perhaps, a more straightforward analysis of  how human and financial resourcing can be challenging for such smaller organisations and how this can result in problems for drug development and regulatory compliance. The article examines such challenges by defining the nature of the major objections raised by the EMA to such applications.

Steve Carney was born in Liverpool, England and studied Biochemistry at Liverpool University, obtaining a BSc.(Hons) and then read for a PhD on the Biochemistry and Pathology of Connective Tissue Diseases in Manchester University, in the Departments of Medical Biochemistry and Histopathology. On completion of his PhD he moved to the Kennedy Institute of Rheumatology, London, where he worked with Professor Helen Muir FRS and Professor Tim Hardingham, on the biochemistry of experimental Osteoarthritis. He joined Eli Lilly and Co. and held a number of positions in Biology R&D, initially in the Connective Tissue Department, but latterly in the Neuroscience Department. He left Lilly to take up his present position as Managing Editor, Drug Discovery Today, at Elsevier. Currently, he also holds an honorary lectureship in Drug Discovery at the University of Surrey, UK. He has authored over 50 articles in peer-reviewed journals, written several book chapters and has held a number of patents. On the media front, Dr. Carney has been busy on some hush-hush projects that will be reported on later in the year.