There’s never a perfect time to outsource your pharmaceutical R&D, but when is the right time?
Pharmaceutical R&D is fast-paced and workflows can be easily stalled by capacity issues, expertise gaps and busy reporting schedules. You may need help with method development and transfer, or perhaps your start-up has a hard deadline to nominate a candidate for your flagship research program?
Whatever your reasoning, contracting-in expertise and quality assurance provision could be the best way to maximize productivity, develop better quality products and get them to market – or at least to the next milestone – more quickly.
But when should you outsource? In this blog post, we pose five scenarios in pharmaceutical development & manufacturing where outsourcing to an expert service provider could have a positive impact on your program.
1. We are a small and talented team and have plenty of leads, but limited capacity to develop them further
The main argument against outsourcing is that capacity gaps can be solved by aggressive recruitment of the right people. While this can sometimes be true, the wider pharmaceutical industry is operating in a challenging recruitment market making this hard to achieve. Contract research organizations operate a nimble business model and have a deep pool of available expertise ready to start working towards your goals without delay. In addition, their built-in flexibility means that priorities can be changed in real-time as you engage with the experts at the bench delivering your project.
2. We’ve identified a new potential drug substance, but don’t yet have the expertise to progress to the clinic
A common misconception is that by outsourcing your R&D activities, you lose control of your project’s direction. The right contract service provider will be able to handle complex, multi-faceted projects as easily as smaller, simple pieces of work, and will treat each end of the scale with equal care and attention. Malvern Panalytical and Concept Life Sciences, for example, house experts in all aspects of drug discovery and development and can help expedite your project to the next development stage or to meet your next deadline. An in-house steering committee and renowned industrial thought leaders will guide you through the often difficult-to-navigate drug discovery decision-making process, but always keep you at the helm to confirm the direction of your project.
3. We need to overcome bottlenecks in our pipeline that depend on different internal teams
If you are constantly juggling project requirements alongside managing different stakeholders, it might be easy to view outsourcing as just one more headache – but this couldn’t be further from the truth! Contract research organizations have a breadth of experience of dealing with this type of issue – they have to be adaptable and pragmatic to deliver on a plethora of projects containing different problems to be overcome on a daily basis. Furthermore, the provision by the CRO of an experienced and highly skilled program manager means that complex workflows can be managed smoothly on your behalf. This single-point-of-contact can maintain a two-way dialogue to update you on progress and ensure changing priorities are communicated to the project team on a schedule that suits you.
4. We want to test a new technique, but don’t want to invest in the instrumentation until we know it really works
Contract providers offer services predominantly based on two models. The Full-Time Equivalent (FTE) model allows you to purchase a set amount of time for delivery on a project and can range, for example, from 10 organic chemists for a year to uncover a lead compound, to a single formulation scientist for 3 months to develop your drug project. This model is usually ideal for complex longer-term projects. On the other hand, the Fee For Service (FFS) model allows you to buy a single experiment without any further commitment. For instance, if you want to analyze the binding of your new biologic to a protein of interest using a Malvern Panalytical MicroCal ITC and understand the resulting data, a contract research organization can help you with exactly that!
5. We want to invest in a new analytical instrument but don’t know where to start
Identifying which analytical instrumentation to invest in can be a daunting prospect due to the large investment of capital involved, but contract research organizations can help. They have access to proven, state-of-the-art technology and analytical instrumentation and are expert in method transfer and development. Concept Life Sciences is home to a number of experts who know how to get the best data from a huge range of technologies – including, but not limited to, Malvern Panalytical systems. We can support you with method development and the transfer of methods between instruments, and also offer support with a bespoke AI-driven diagnostics platform to ensure your analytical technology performs at its very best from day one.
Still in doubt? Speak to the experts
Pharmaceutical contract service providers work across the development pipeline and can step in at any stage from target to clinic to provide a bespoke service designed to meet your needs. Whether it’s specific expertise, increased headcount or state-of-the-art instrumentation you are looking for, outsourcing could provide the perfect solution.
At Malvern Panalytical and Concept Life Sciences we offer a comprehensive range of discovery and development services and analytical solutions across the pharmaceutical, biotechnology and agrochemical sectors, from discovery through to API manufacture.
Have a query? Drop us a line and we’ll put you in touch with an expert!