Written by expert: Menzo, CEO Batavia Biosciences
The current biotech outsourcing market for biopharmaceuticals encompasses about $5.5 billion annually with by far the biggest spending in early development. It is estimated that about two-thirds of that annual spending is currently outsourced with about 90% being spent by small and mid-size biotech companies. In contrast, only 10% is outsourced by globally operating, large pharma companies, responsible for at least one quarter of the new drug pipeline. I have been working in both innovative biopharmaceutical drug development companies as well as service providers for more than 20 years. During my career, I have experienced both the benefits and hurdles associated with outsourcing. This knowledge me and my business partner, Chris Yallop, used to build our own uniquely positioned contract development organization, Batavia Biosciences.
Quality Assurance key market driver
The biopharmaceutical product development market is highly dynamic, fueled on one side by scientific discoveries that lead to novel classes of drugs and on the other side by innovative technologies that shorten development times, reduce costs and improve product efficacy. Both these market drivers, scientific discoveries and innovative technologies, constantly raise new challenges to ensure compliance with relevant biopharmaceutical regulatory guidelines. Therefore, quality assurance, rigorous in-process testing and in-depth knowledge on the development of for instance release assays is indispensable for a service provider to ensure manufacturing control and the ability to gather all information required for successful regulatory filing. In addition, a service provider must fully understand novel technologies to guide optimal translation of such technologies into regulatory documentation.
It is my firm believe that the lack of contract organizations capable of providing such in-depth product development know-how over the entire preclinical and early clinical trajectory has resulted in globally operating large pharma companies deciding not to outsource. Without a doubt, consistency in the regulatory dossier is essential for a smooth registration process which is poorly supported when forced to work with multiple contract organizations, each responsible for parts of the investigational new drug dossier (IND).
Future of contract organizations
It is therefore believed that contract organizations will evolve into full product development partners, capable of overseeing an entire IND project trajectory. Therefore, contract organizations will transform into biopharmaceutical development powerhouses, capable to offer end-to-end services for a full development process. As such it can be predicted that they will become leading experts. This will transition the relationships between a sponsor company and its contractor from typical one-off deliverable driven contracts to a more long-term partnership whereby both partners share equally in a symbiotic and quality driven drug development program.
Needless to say we build on our vision the high quality biopharmaceutical product development organization; Batavia Biosciences. This R&D organization, that consists of more than 45% PhD’s and 30% MSc’s with an average of 17.2 years of industry experience, knows the challenges its sponsors faces and has demonstrated in numerous cases its ability to provide practical, innovative solutions fully in line with current and future regulatory requirements.