Despite the availability of antivirals and preventative vaccines for decades, chronic hepatitis B (CHB) continues to afflict hundreds of millions of people worldwide. Currently available antivirals have led to viral suppression, but not elimination from infected individuals. Recent advances in the understanding of CHB virology and immunology have led to new therapeutic strategies and a hope for, if not a complete cure, at least a functional cure that likely will employ the use of combined antiviral and immunomodulatory agents.
Parexel is well-suited for supporting patient-centric CHB clinical trials, building on our extensive experience involving hepatitis B vaccines and antiviral therapy, together with our work in infectious diseases and gastroenterology/hepatology. We also bring to bear expertise in translational medicine (genomics and biomarkers), feasibility, real-world evidence, biostatistics, and regulatory affairs, with a global operational footprint that spans those areas where CHB is highly endemic. This multidisciplinary expertise for managing CHB studies has coalesced in the Parexel Viral Hepatitis and Liver Disease Working Group.
The accomplishments of this working group and the organization as a whole have encompassed:
hepatitis B studies in the past 5 years in 154 unique centers
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biomarker/genomic studies in the past 5 years
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liver disease studies in the past 5 years
Parexel also has strong vaccine experience:
- In the government segment including BARDA and EMA, having conducted 200 trials
- In our expanded site networks, which include 500 vaccine alliance members with access to 18,700+ vaccine investigators
- In our Phase I units (Baltimore, Los Angeles, London, Berlin – hospital based), having conducted 27 first in human Phase I vaccine trials