Today’s drug development pipeline includes many new and exciting opportunities – from precision medicine approaches to complex targeted therapies, compounds and drug-specific companion diagnostics. To improve the probability of success for this pipeline, collaborative teams with a wide range of expertise are required. The days when a single biopharmaceutical company might develop an oncology drug from preclinical research through market delivery are simply not as common as they once were.
The global precision medicine market alone is expected to reach to US$88 billion by 2022, driven in part in the U.S. by President Obama’s $1 billion Cancer ‘Moonshot’ initiative to accelerate development of new cancer detection and treatments. In addition, market reports estimate that the immunotherapy drugs market will be worth US$197 billion by 2020, with checkpoint inhibitors such as the anti-PD-1/PD-L1 antibodies delivering the fastest rate of growth over the next four years.
These drugs hold tremendous promise to treat previously terminal conditions, but they are far more complex and costly to develop than their predecessors. Highly specific protocols, small targeted populations, the need for complementary or companion diagnostics, and use of sophisticated biomarkers as primary endpoints are just a few of the many factors that make these trials more complicated to deliver.
To overcome these obstacles, sponsors need to think more strategically about all of the partners and vendors they work with to bring these products to fruition. One key player in this network of supporting partners is a global clinical trial research laboratory.
Blood to biologics
As trials become more complex, the laboratories that support them must evolve and continue to innovate. The ‘lab of the future’ has to transition from a provider of one-off testing services to a value-driven strategic partner who understands the shifting clinical development ecosystem. The lab must work in seamless partnership with sponsors, clinical research organizations (CRO), specialty labs and medical device manufacturers to deliver an end-to-end service offering that meets all of their customers’ scientific, logistic and operational needs.
In the past, biopharmaceutical companies relied on labs primarily for basic sample tests and safety monitoring. For today’s complex and evolving clinical research projects, such services barely scratch the surface. Advances in biomedical diagnostics as well as the success of immunotherapies are driving serious considerations to develop a new generation of endpoints more suitable for targeted drugs such as immune checkpoint inhibitors like PD-L1.
As a result, sponsors and CROs need their labs to have the knowledge and experience to deliver services quickly and efficiently across the drug development spectrum – from pharmacokinetic (PK) and routine clinical testing, to specialized biomarker services as well as genetic and genomic assays, to name a few. The clinical trial laboratories also need the expertise to understand where these tests should be deployed geographically to help sponsors craft protocols that will deliver the greatest level of ease for patient participation as well as the greatest efficiency and data quality for sponsors, trial sites and regulators. Today’s laboratory must provide actionable insights for better health. Such insights can help enhance the clinical trial experience for patients, enabling studies to better retain patients that may be have previously been lost due to unnecessarily invasive or complex protocols.
A network of sites
From a logistics and operational perspective, the lab of the future should also be able to drive down the time and administrative burden of operating or participating in a trial. The best labs will be able to leverage near-patient collection, specialty, referral and academic labs, as well as biorepositories to make all types of testing and sample storage more convenient for patients and site investigators. They also will have robust technology systems in place to rigorously track chain-of-custody for every sample, guarantee data integrity, and support real-time data access. Choosing labs that have such integrated technology solutions mean sponsors will get the most accurate results as quickly as possible so they can make better decisions about the therapy development process.
Complex clinical trials face many scientific, operational and logistical challenges that can delay recruiting, slow data capture, create risks to data quality and impact regulatory submissions. Many of these areas could be mitigated and potentially even avoided if sponsors select laboratory partners that have the expertise, experience, and network infrastructure in place to support and navigate a higher level of clinical research. The trial of the future can only succeed if the organizations supporting it have the same relentless commitment to quality, patient safety and data integrity to deliver the best drugs to market as quickly as they can. At the end of the day, there is a patient at the center of our work and we all must share the commitment to treat every sample – their sample – as if a life depends on it.