Chinese biopharmaceuticals are expanding development beyond generics to focus on producing more personalized medicine, novel therapies, biomarkers and companion diagnostics. Steven Anderson, PhD, chief scientific officer at Covance, recently discussed his thoughts on biomarkers and precision medicine in China's drug development and translational medicine landscape.
"Efficacy of a drug therapy can vary widely and adverse effects can be common, but these parameters are not easily predicted," explained Anderson. "That's why biomarker-based, targeted treatments can guide therapy decision-making and better identify those individuals most likely to benefit."
In the US, biomarker data is increasingly submitted to the FDA, signaling the growing evolution of personalized medicine. But in some parts of the Asia Pacific region, biomarker development remains a relatively new area of exploration.
"Even global companies are still thinking about how to incorporate biomarkers into a trial setting due to some of the unique challenges in China," said Anderson. "When it comes to performing any sort of genetic testing, China has more restrictions than the rest of the world. Sponsors will need approval from regulatory agencies, even for in-country testing."
Anderson also discussed the challenges presented with commercialization. "In the US, we have reference labs, hospital-based labs and a reimbursement system that facilitates the use and coverage of these tests. In China, there is a more fragmented healthcare system where the mechanism of payment or reimbursement is less certain and may vary from region to region," he said. "Companies need to carefully determine how to commercialize across the diagnostic landscape in China."
Despite these hurdles, both emerging biotech and established large pharma in China can benefit from opportunities to bring novel therapeutics to market domestically and then export globally, in contrast with the more common model of developing drugs in the US or EU and then testing them within China.
In China and the rest of the world, evolving technologies will continue to affect the companion diagnostics landscape. Multiplex technologies, such as next-generation sequencing and gene expression profiling, can examine genomic variations and discover clinically relevant biomarkers with increasing power and speed.
Liquid biopsy technologies also have gained recognition as non-invasive methods to provide insights on drug resistance and potentially help determine appropriate, targeted treatments by identifying and analyzing circulating tumor cells (CTCs) and circulating free tumor DNA (cfDNA) from blood.
Regardless of the technologies used and their potential benefits, it's important to think about incorporating biomarker and companion diagnostics earlier in the development continuum to guide planning and take advantage of downstream efficiencies.
Anderson cited contract research organizations (CROs) as filling a valuable role by helping pharmaceutical companies proactively plan to become leaders in the use of biomarkers not only within their own country but also globally.
"A partner with a strong, current knowledge of global regulatory requirements can address local differences in trial design and regulatory submission," said Anderson. "CROs also offer alliances with key diagnostic instrument manufacturers to ensure open engagement during the development process and deliver the broadest possible commercial outreach."
While most CROs with central lab capabilities have a wide range of installed instrumentation to support standard laboratory testing, they also must have the flexibility to stay current with new technologies and instrumentation as the needs of the clients change. Given the current global nature of clinical trials, any supporting partner should provide global logistics capabilities with laboratories located in key regions of the world to meet turnaround time requirements and overcome any issues with export of samples.
With preclinical facilities in China offering nonclinical safety assessment, bioanalysis, in vivo pharmacology and drug metabolism and pharmacokinetics (DMPK), Covance can support Chinese biopharmaceuticals as they move from lead optimization to an IND and beyond. "Our experience helps clients facilitate and expedite development in China and then potentially export the technology to reach global markets," said Anderson.
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