Urte Fultinaviciute

London

Reporter at Citeline

Healthcare Reporter at Generics Bulletin, previously at Clinical Trials Arena

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Articles

2023 in review: Are clinical trial sponsors and regulators in sync?

Dec 19, 2023 | clinicaltrialsarena.com | Urte Fultinaviciute

The past year marked significant regulatory updates and changes across the globe, as regulators tried to keep up with the evolving and maturing clinical trial industry. While the US Food and Drug Administration (FDA) finally released its draft guidance on decentralised clinical trials (DCTs) and efforts to improve trial diversity, the European Medicines Agency (EMA) said farewell to the old clinical trial platform for new trial applications.
Diversity and ePROs: Still siloed concepts in the era of DCTs?

Dec 13, 2023 | clinicaltrialsarena.com | Irena Maragkou |Urte Fultinaviciute

Decentralised clinical trials (DCTs) are often pinned as a silver bullet to increase a trial’s footprint and reach various populations that otherwise would not participate in research. But as the industry takes off its rose-tinted glasses after a few years of hype surrounding DCTs, it is time to evaluate whether decentralisation actually helps improve diversity. One of the most patient-centric methodologies in the DCT toolbox is electronic patient-reported outcomes (ePROs).
Delpor on track with schizophrenia implant late-stage trials

Dec 7, 2023 | clinicaltrialsarena.com | Urte Fultinaviciute

Delpor is sketching out late-stage clinical trial plans for its drug-device combination implant DLP-114 (risperidone) in schizophrenia. After presenting topline results from a Phase Ib/IIa trial (NCT04418466) in November, the US-based biopharma company is currently making some changes to the product based on the learnings from the previous study, CEO Tassos Nicolaou told Clinical Trials Arena.
Viriom outlines plans for upcoming infectious disease trials

Dec 5, 2023 | clinicaltrialsarena.com | Urte Fultinaviciute

Viriom plans to extend a Phase I trial investigating its influenza pill AV5124, according to chief science officer Dr David Pauza. The US-based company announced the completion of the Phase I trial last month. However, the study was conducted by a drug development partner outside of the US. Viriom wants to do additional research to extend the dose range before committing to a final dose, Pauza told Clinical Trials Arena.
4Moving Biotech shares innovative trial plans for GLP-1 osteoarthritis drug

Nov 30, 2023 | clinicaltrialsarena.com | Urte Fultinaviciute

After recently completing the recruitment for its Phase I trial, 4Moving Biotech is already laying out plans for the upcoming Phase IIb trial investigating 4P004 (liraglutide) in knee osteoarthritis. The France-based biotech plans to initiate the next trial at the end of next year, executive chairwoman Revital Rattenbach, PhD, told Clinical Trials Arena. To establish itself in the osteoarthritis space, 4Moving Biotech is seeking to include innovative endpoints in the study.
BerGenBio to power ongoing NSCLC trial with synthetic control arm

Nov 23, 2023 | clinicaltrialsarena.com | Urte Fultinaviciute

BerGenBio plans to add a synthetic control arm to its ongoing Phase Ib/IIa trial investigating bemcentinib in non-small-cell lung cancer (NSCLC), CEO Martin Olin told Clinical Trials Arena. The Norway-based biopharma company is going to have a digital twin to look at real-world data and match Phase IIa trial participants with a synthetic control. The real-world match will be NSCLC patients with the same status as the trial subjects but only receiving standard-of-care treatments.
Profit vs inquiry: Clash of objectives in academic and commercial trials

Nov 15, 2023 | clinicaltrialsarena.com | Irena Maragkou |Urte Fultinaviciute

Academic institutions and commercial entities play an important role in drug development and improving human health. While both types of sponsors are intertwined with each other, a different set of internal and external pressures influence how they conduct research.
Q&A: Pharma’s trial diversity goals may not answer health equity problems

Nov 14, 2023 | clinicaltrialsarena.com | Urte Fultinaviciute

Health is a fundamental human right, yet health inequity is one of the major problems across the world. Although the pharmaceutical industry is more aware of this problem due to regulatory efforts to improve clinical trial diversity and access to medicine, there is still a lot of work needed.
AI and regulatory changes at the forefront of industry's mind

Nov 13, 2023 | clinicaltrialsarena.com | Urte Fultinaviciute

After a few years of disruption caused by the Covid-19 pandemic, it seems that the pharma and biotech industries can barely take a breath. With technological advancements such as artificial intelligence (AI) moving faster than ever, the industry is grappling with major regulatory demands. Indeed, even the FT Global Pharma and Biotech Summit’s tagline perfectly paints the picture of the current environment: driving life sciences innovation in a disrupted world.
Health equity and trial diversity questions still not answered by pharma

Nov 9, 2023 | clinicaltrialsarena.com | Urte Fultinaviciute

While global players are more aware of health equity problems across the world, there are still lingering problems, according to Access to Medicine Foundation CEO Jayasree Iyer. Speaking at the panel discussion ‘Health Equity – How Can Pharma Make a Difference?’ on the last day of the FT Global Pharma and Biotech Summit in London, UK, Iyer highlighted that commercial and access incentives need to be put together to improve health equity.