The Future of CNS Clinical Development

A decade ago, CNS-focused therapeutics—traditionally a well-funded area of research—were facing a sharp decline in funding and their growth outlook was bleak. Today we face a different reality, one where third parties and large pharmaceutical companies like Acadia, Biogen, Novartis, and Denali are investing in neuroscience development programs. See why there is a resurgence and where we see the greatest potential in neuroscience therapeutics. Development of investigational new drugs is an expensive investment requiring funds which historically came from the profits of commercialized products in a company’s portfolio. Companies had to be selective in the compounds they chose to advance, and CNS programs typically had more challenges than other therapeutic areas. The complexities of neuroscience endpoint selection, the often-limited understanding of disease pathophysiology, and the poor predictive validity of preclinical models meant development in neurological indications was a risky investment. Over the past 10 years, there has been a sharp increase in funding from government agencies and public-private partnerships, much of which has gone to neuroscience programs. This new funding meant companies no longer had to rely on the profits of their approved products to advance new programs. Why the uptick? The renewed interest comes partially from the advancement in scientific understanding of many of these diseases. Medical breakthroughs have opened the door for therapeutics to be developed with biomarkers...

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Could a Cure for Alzheimer’s be Invented in the Triangle? Absolutely.

By The Editors of Talking Trials,
Old people with neurodegenerative diseases

Currently, the estimated annual cost of nine common neurological diseases totals to $800 billion, predictably increasing as the elderly population doubles by 2050. More specifically, there is a catastrophic unmet need in Alzheimer’s disease treatment, prevention and clinical research. In a recent segment with WRAL News’ Health Team with Dr. Allen Mask, Worldwide Clinical Trials’ chief operating officer, Peter Benton, discusses Worldwide’s uncommon approach to fighting against neurodegenerative diseases through its recent partnership with Datavant.

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GeNeuro and Worldwide Pursue First Clinical Efficacy Study of Breakthrough MS Drug

By The Editors of Talking Trials,
Multiple Sclerosis

Worldwide Clinical Trials recently teamed up with GeNeuro, a clinical stage pharmaceutical company, to develop a new approach to the treatment of autoimmune diseases. Currently, the teams are working on the first clinical efficacy study of GNbAC1, a promising new approach for the treatment of Multiple Sclerosis.

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Secure, Real-World Data Drives Enhanced Insights for Neurodegenerative Disease Trials

By Dr. Natalia Drosopoulou, Executive Director of Project Management and Franchise Area Lead in Neuroscience, Worldwide Clinical Trials,
Neurodegenerative diseases

Neurodegenerative disease clinical trials are challenging, but they don’t have to be. Optimizing clinical trial patient recruitment and outcomes with external data sets can open new opportunities for pharma and biotech companies seeking to enhance their clinical trials in areas such as compliance, adherence, enrollment, safety, and even efficacy.

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Insights into Brain Health and Central Nervous System (CNS) Clinical Trials

By the Editors of Talking Trials,
Brain Health, Michael Murphy

Brain health is one of 19 primary session topics that will be discussed at the Biotechnology Innovation Organization’s (BIO) annual conference. Neurological diseases are the leading cause of disability, according to a systematic analysis of data from 195 countries performed for the Global Burden of Disease Study 2015 (1). With 250.7 million years of healthy life lost due to death or disability caused by neurological disorders, this area of clinical research remains one of today’s most urgent challenges.

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A Methodology for Advancing the Selection of Biomarkers for Use in Psychiatric Clinical Trials – Part 1

By Natalia Drosopoulou, Ph.D., Executive Director of Global Project Management, Neuroscience, Worldwide Clinical Trials,
biomarkers in brain diagnostics

  For this two-part blog series, Talking Trials asked Worldwide’s Dr. Drosopoulou, author of the recent article, “A Methodology for Advancing the Selection of Biomarkers for Use in Psychiatric Clinical Trials,” published in the Journal for Clinical Studies, to weigh in on the use of biomarkers for clinical research. Clinical trials using biomarkers in patient selection have higher overall success probabilities than clinical trials without biomarkers.1 That’s one of the many compelling results from a recent study of drug development success published in the journal Biostatistics. Wong and colleagues found clinical trials using biomarkers to stratify patients exhibit almost twice the overall probability of success compared to trials without biomarkers (10.3% vs. 5.5%).

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Parkinson’s Disease Clinical Research: The Role of Vagotomy in Prevention of PD

By Tomislav Babic MD, PhD,

Early involvement of the gastrointestinal tract in development of Parkinson’s disease (PD) has been indicated by the presence of constipation in the premotor (prodromal) stage of PD. In fact, this is one of the earliest non-motor signs of PD, associated with occurrence of a-synuclein aggregation in gastrointestinal nerve endings forming Levy bodies in the gut several years before classical motor clinical presentation of Parkinson’s disease. Several recent studies of the gastrointestinal tract shed new light the prevention of PD and open avenues for larger neuroscience Parkinson’s disease research projects.

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