Novotech, a global full-service contract research organization, won the Research and Development and Marketing awards in the 2025 Clinical Trials Arena Excellence Awards for accelerating complex clinical programs and delivering credible, decision-useful scientific communications.
Novotech won the Research and Development award for expediting a multi‑study HDV program through accelerated regulatory pathways and a tightly aligned partnership model. It also won the Marketing award for clearly and credibly explaining complex hepatitis science via a trusted platform that helped sponsors make informed decisions.
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Rapid trial execution: Translating FDA/EMA designations into measurable cycle-time gains
Chronic hepatitis D (CHD) is the most severe form of hepatitis, affecting a small percentage (<5%) of patients with chronic hepatitis B (CHB). People with CHB who are coinfected with CHD have a greatly increased risk of cirrhosis, liver cancer and death compared to those with CHB alone and yet, CHD has no approved therapies in the US and limited treatment options elsewhere in the world.
To address this challenging enrollment landscape, Bluejay Therapeutics and Novotech established an integrated partnership to advance brelovitug (BJT-778) across four studies: a Phase 1/2 and 3 registrational trials. Brelovitug is an investigational, fully human, high-affinity monoclonal antibody (mAb) that targets hepatitis B virus surface antigen (anti-HBsAg). Brelovitug received Breakthrough Therapy Designation from the US Food and Drug Administration (FDA) and Orphan and PRIME designations from the European Medicines Agency (EMA), which required accelerated yet disciplined execution.
Novotech’s remit was to convert these designations into operational speed. The team coordinated regulatory and clinical activities across multiple countries, securing approvals and achieving first patient dosed (FPD) in the Phase 3 program in March 2025. Novotech was able to effectively identify and enroll CHD patients despite the orphan nature of the disease. Enrollment was enabled by established site relationships and a multi‑country principal investigator (PI) network. Start-up and FPD timelines held, across geographies, with minimal deviation from plan.
Execution rested on governance rigor. By aligning operations, endpoints, and data strategy to a surrogate endpoint–oriented regulatory approach, the partnership reduced protocol amendments and rework—typical sources of delay in late‑phase programs. Real-time regulatory responsiveness was another determinant. Coordinated teams provided timely answers to agency queries under the intensity associated with Breakthrough designation, keeping activities on the critical path. A co‑accountable operating model further shortened decision times compared with conventional vendor arrangements. In combination, these measures translated special regulatory statuses into measurable cycle‑time gains across multiple late‑phase studies and supported advancement toward a potential licensure pathway for a CHD therapy.
Scientific storytelling: Turning complex HBV science into sponsor‑ready insights
Novotech’s recognition for marketing excellence highlights its ability to make complex science accessible, credible and actionable for sponsors. In The Next Frontier, a global series presented by the Biotechnology Innovation Organization (BIO) and produced for them by BBC StoryWorks Commercial Productions, Novotech’s film on hepatitis B (HBV) illustrates how clarity of narrative and operational detail can guide critical development choices.
Set in New Zealand the film showcases a model environment for—early‑phase clinical research combining efficient regulatory environment, an experienced investigator network, and access to trial-ready patient populations. It demonstrates how Novotech’s connected presence across Asia‑Pacific, North America, and Europe supports faster site selection and study startups – factors essential to moving from concept to clinic. The story goes beyond communication: it connects mechanism to execution. By distilling scientific themes such as viral suppression and gene modulation into real-world operational requirements, Novotech delivers insights that help sponsors design more effective studies.
Presented through a trusted global platform like Biotechnology Innovation Organization (BIO) and BBC StoryWorks Commercial Productions, the film spotlights Novotech’s role in advancing clinical innovation through credible, insight-driven communication that informs sponsor decision-making.
Integrated execution and communication under accelerated timelines
Viewed holistically, the Bluejay partnership chronic hepatitis D and the HBV film demonstrate disciplined execution coupled with evidence‑based communication. The development program benefited from co‑accountability, strong governance, and rapid regulatory engagement that produced measurable cycle‑time efficiencies across four studies. The communications program translated complex liver‑disease science into decision‑useful insights grounded in operational realities and place‑based strengths. These factors explain Novotech’s recognition this year for rapid trial execution and scientific storytelling.
“We’re honored to receive this recognition, which reflects our scientific and operational contributions to Hepatitis clinical development and the strong partnerships we form with our sponsors.”
– Dr. John Moller, CEO, Novotech
Contact Details
Toyna Chin
USA: +1 415 364 8135
Links
Website: https://novotech-cro.com/
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