How Do We Create the Most Value With Limited Resources?

Questions to Consider From the Beginning: Drug development is a time and resource expensive proposition and most if not all companies pursuing such a path must find ways to make the greatest progress as fast as possible within their resource limitations. This article intends to help the reader understand some of the necessary considerations to achieve this efficiency by providing answers to these questions: How do we utilize limited time, money and talent to achieve the most value the most efficiently? How do we focus these resources on the critical questions and risks or opportunities? How do we assure that expended resources are delivering the intended product? How do we prepare for our final or intermediate submissions as the work are being conducted minimizing the turnaround time? How do we organize, manage, store and maintain the integrity of our data? Keeping the End in Mind From the Beginning: What are the attributes of a therapeutic product that are needed to achieve a successful launch and commercialization? How do the current marketed products stand up? What are the products in the development pipeline and how will they differ in hurdles and potential? Keeping the end in mind from the beginning is a fundamental requirement to achieving the ultimate goal effectively. Of course at first there are goals that must be met on the way to keep the ball rolling and the funds coming. How do these intermediate goals impact the ultimate success or failure of the intended product? There are many approaches to creating a map for the final product profile. The FDA and industry have worked together to provide...

5 Key Facts About EMA

If you are working in the pharmaceutical industry and are used to dealing with the US FDA, looking across the Atlantic might cause some bewilderment and confusion. The European Medicines Agency’s (EMA) place within the EU regulatory landscape, its set-up and workings can be puzzling to say the least, but this feeling should not have a negative impact on your plans for expanding your drug development or regulatory filing strategy to Europe.   Here are 5 key facts that just might improve your understanding of the EMA:   European Union 101 – The set-up You don’t need to be familiar with the intricacies of the set-up of the European Union, but understanding the EMA’s principle role in the EU regulatory landscape is essential. Think of EMA as a virtual agency set up in 1995 (in London) as a scientific consultancy to the European Commission (EC), the EU executive body located in Brussels. As such, EMA has no legal power to grant the actual marketing authorizations for the medicinal products they regulate – the agency’s remit is to do the medical and scientific assessment and to issue an opinion to the EC, who will base their ultimate (legal) decision on this scientific judgment. The goal of this new agency was to pool the best available scientific and regulatory expertise from all EU Member States for the assessment of the most innovative and cutting edge medicinal products. The scientific assessment is done by the 7 scientific committees (most notably the CHMP, but also PDCO, COMP and PRAC etc.) that meet at the EMA’s premises in Canary Wharf, London. However, the expert...