Clinical Development

Lost in translation? – How you can smoothly progress to clinical development and beyond

by Diane Seimetz

For a smooth transition to clinical development stage, careful and intertwined upfront planning across important drug development disciplines is essential. Based on our experience, even mature research teams and start-up companies often underestimate the challenge to progress their product candidates as well as their teams from the R-stage (Research) to the D-stage (Development). In this article, Diane Seimetz tackles the issue and provides solutions.

Three important factors to consider for successful clinical development

by Diane Seimetz

Clinical studies are not only a pre-requisite to bring new therapies to patients, they are substantial value drivers within the biopharmaceutical industry. By progressing to the review of the marketing authorization application, the value of a drug increases to approx. 1,300 million. Yet, an analysis performed by our Biopharma Excellence team shows that consistently about 20% of marketing authorization applications fail. To achieve the goal of selecting the right patients while at the same time managing uncertainty within the drug development process, adaptive clinical trial designs and biomarkers are important development instruments.

In this article, Diane Seimetz shares insights on three important factors for successful clinical development.

Development of biopharmaceuticals: How challenges can be smartly addressed or even transformed into opportunities and value creation?

Dr Diane Seimetz, Co-Founder of Biopharma Excellence, chaired the session “challenges & opportunities in the clinical development of biopharmaceuticals” at the DIA Euromeeting in April 2016.

Biopharmaceuticals already account for about half of the drugs now in the biopharmaceutical R&D pipeline, with that share expected to grow. Compared to small molecules biopharmaceuticals are more demanding to develop. Due to complexity of the manufacturing process, the cost of goods are substantially higher.