Why are Biotech’s & Pharma Using Human Challenge Studies for Drug Development?

What is a human challenge study?

In a human challenge study, healthy volunteers are intentionally infected with a virus/bacteria or parasite in a quarantine facility. The volunteers are monitored under 24/7 supervision by medical experts. These trials are strictly regulated and approved by the applicable regulators and ethics committee. These studies are performed to help further scientific research and drug development.

Human challenge studies allow for data collection in a controlled environment, this data gives further insights to see if a vaccine or antiviral is effective and contributes to a deeper understanding of how an infectious disease affects a group of volunteers in a controlled medical environment.

How are vaccines and therapeutics developed?

Human challenge models are featured in phase II stages of clinical research, but in a number of specific cases can be used as a pivotal trial.

What is the difference between a Field Trial and a Human Challenge Trial?

Why do Healthcare providers such as Biotechs & Pharma use Human Challenge Studies?

Human challenge studies can be an important factor for healthcare providers, such as biotech's and pharma as they generate valuable data in dosing, safety and efficacy data. They also can be performed in a short time-frame (by comparison of the drug development journey – getting from idea to market) and be used as a supportive measure to prove the effectiveness of the challenged drug or antiviral.

It is important to note that human challenge studies are widely accepted by global regulators, and are of great interest to the healthcare industry, due to their validity and their ability to provide further scientific understanding.

How can the hVIVO Group help with a Drug Development plan?

As the hVIVO Group compromises of two companies, hVIVO & subsidiary Venn Life Sciences, the organization offers a full-service solution.

Venn Life Sciences is an integrated drug development consultancy, which offers CMC (chemistry, manufacturing and controls), preclinical, Phase I & II clinical trials design and execution. Together the companies offer a full-service solution, from consultancy and drug development, to running the human challenge model.

hVIVO, the world leader in testing infectious and respiratory disease vaccines and therapeutics using human challenge clinical trials. The Group provides end-to-end early clinical development services to its large, established and growing repeat client base, which includes four of the top 10 largest global biopharma companies.

The Group includes:

• Unique portfolio of 11+ human challenge models to test a broad range of infectious and respiratory disease products
• World class challenge agent manufacturing
• Specialist drug development and clinical consultancy services via its Venn Life Sciences brand,
• Laboratory Services offering through the hLAB brand, which includes virology, immunology biomarker and molecular testing.
• The Group offers additional clinical field trial services such as patient recruitment and clinical trial site services.

hVIVO runs challenge studies in London from the Whitechapel quarantine clinic, a state-of-the-art QMB clinic with its highly specialised on-site virology and immunology laboratory, and a lab in Plumbers Row. To recruit volunteers/patients for its studies, the Company leverages its unique clinical trial recruitment capacity via its FluCamp volunteer screening facilities in London (Plumbers Row) and Manchester.

Building on decades of unrivalled experience, hVIVO provides world class expertise and capabilities in challenge agent manufacture, a unique portfolio of established human challenge models to test a broad range of infectious and respiratory disease products, and specialist drug development and clinical consultancy services.

To learn more about the advantages of a Human Challenge Trial, read our Director of Business Development, Egle Payvde’s blog here.