Navigating the 'valley of death' in Biopharmaceutical product development
You are all very welcome at an open presentation by Dr. Menzo Havenga, President and CEO of Batavia Biosciences (https://www.bataviabiosciences.com/). Batavia Biosciences has a worldwide presence and actively develops know-how and technologies to support global health initiatives and the biopharmaceutical industry to bring new and improved medicines to the market. There will be time after the presentation for questions and networking; please contact email@example.com if you would be interested in a one-to-one meeting.
Navigating the “valley of death” in biopharmaceutical product development
Wednesday 14th March, 2018
10am – 11am
‘The Gannochy’ Seminar Room 3, Wolfson School Medical Building, Gilmorehill Campus
Talk summary: Once a proof of concept has been established for a new biopharmaceutical the next step is to file an investigational new drug dossier (IND) to enable testing for product safety and efficacy in human subjects. This phase in product development is often referred to as the “valley of death” as statistics tell us that only 1 out of every 50 molecules makes it beyond this phase and onto the market. The deliverables associated with an IND filing as well as the challenges that lead to the high attrition rate will be discussed.
To improve the success rate in bringing biopharmaceuticals from bench to clinic, Batavia has developed two distinct guiding principles, i.e., “think from the back-end” and “fail fast” and the relevance of these principles in navigating the valley of death will be explained. Whereas the first guiding principle provides for a strategic planning tool, the “fail fast” principle is supported by a toolbox and unique technologies that allow for the rapid and cost effective production of biopharmaceuticals, be it recombinant proteins, antibodies, viruses, or viral vectors. Such tools and technologies allow Batavia to conclude very early in a product development trajectory whether the biopharmaceutical can be successfully developed further. An overview of these tools, technologies as well as a few case studies will be presented.
First published: 4 April 2018