Today’s pharmaceutical and biotechnology organizations must constantly innovate and evolve to meet novel requirements of developing increasingly effective (but increasingly complex) biotherapeutic innovations. This has spurred the need for new, more efficient approaches to biologics development, and while outsourcing has always played a key role in the bioanalytical field, the way pharma and biotech are using outsourced partners is continuing to change. A recent survey conducted by Bioanalysis Zone of leading pharma, biotech, and CRO organizations reveals some interesting outsourcing trends and gives us a glimpse into the role that bioanalytical laboratories like BioAgilytix will play in future of our industry.
An Increase in Outsourced Bioanalysis
According to the survey, by 2018 the number of companies that are outsourcing less than 40% of their bioanalytical work will decrease by 14%. Conversely, the amount of companies that are currently outsourcing more than 60% of their bioanalytical work will increase by 11%. In fact, 58% of CROs surveyed said that the number of samples they receive for analysis has increased in the last two years. So what is driving this demand?
I believe that more and more pharma and biotech companies are realizing that, instead of making hefty time and cost investments in building out all the internal capabilities needed for better, faster bioanalysis, they can drive more efficiency with outsourced relationships. Working with a bioanalytical CRO partner, they gain immediate access to all types of specialized expertise without the need for costly, extensive hiring. We’ve found that our customers really benefit from that fact that they can call on us on a project by project basis, and rapidly tap into our highly specialized large molecule knowledge to help them navigate increasingly complex bioanalytical challenges. They have ready access to the infrastructure, experts, and capacity needed to get their projects done faster, while maintaining high quality and reliable results.
These thoughts are backed up by Bioanalysis Zone’s survey results, which cite the top 3 reasons for change in outsourcing as 1) reductions in in-house capabilities; 2) the increasing complexity of molecules; and 3) time pressures. It makes sense that pharma and biotech companies would seek out partners that are already steeped in key bioanalytical solution areas, especially those with proven ability to deliver more specialized services, and that can be more agile in their execution of assays within compressed timelines.
Bridging the Gaps to Seamless Outsourcing
According to the Bioanalysis Zone survey, there are still barriers that CROs must overcome related to negative experiences some pharma and biotech organizations have had working with outsourced partners. Those challenges named most often were unresponsiveness, a lack of technical/scientific expertise, lack of compliance, and unmet timelines. But, both sides agree that these can be overcome with things like better communication, a better understanding of expectations prior to project start, and shared training. Interestingly, communication was named as the most important element for outsourced work.
Communication has been a cornerstone of BioAgilytix’s approach since our founding, and our business was built to mitigate many of the roadblocks traditionally faced by sponsors when they outsource their large molecule bioanalysis. Every BioAgilytix project is not only led by a seasoned scientist as the Bioanalytical Project Manager (BPM), but staffed by a team averaging 15+ years of post-schooling bench experience and supported by a Quality team averaging over 20 years of experience upholding regulatory compliance. Our BPM model ensures every customer has a single point of contact and visibility into their project at all times, so they know that budgets and timelines are staying on track and can be confident our assays produce the reliable, accurate results they need.
As more and more pharma and biotech companies look to outsourcing, many CROs and bioanalytical labs will need to evolve the way they deliver services to fully benefit the sponsor and the CRO. I feel confident that our approach already makes us a leader in the future world of outsourcing, and that our way of doing things – ‘the BioAgilytix Way’ – puts us in a strong position to support growing bioanalytical outsourcing demands.