Court Rules in Favor of FDA Over Partial Clinical Hold of Vanda’s Tradipitant Study

A U.S. court has ruled in favor of the FDA in a case filed by Vanda Pharmaceuticals alleging the agency didn’t provide an adequate scientific reason for a partial clinical hold issued in December 2018 for the company’s long-term study of tradipitant.

Vanda’s suit questions the FDA’s regulatory authority for placing the hold while requiring the company to conduct nine-month nonrodent toxicity studies as indicated in the agency’s M3(R2) guidance on nonclinical safety studies, claiming FDA guidances do not have the force of law.

The agency responded that “existing tradipitant studies in nonrodents contain sufficient troubling indications of toxicity such that—while shorter-term human studies may be safe enough to proceed—FDA needs to see if those toxicity markers increase during long-term nonrodent studies before allowing long-term human studies.” The U.S. District Court in the District of Columbia agreed.

Currently, a 12-week phase 3 trial is in progress while Vanda determines the appropriate next steps in response to the ruling.

The full ruling can be found online: https://bit.ly/2vfJCVh.

Active Biotech Backs Laquinimod, Despite Teva’s Failed Attempts in MS and Huntington’s Trials

Active Biotech, manufacturer of laquinimod, has announced it will continue to test the drug in Crohn’s disease and eye disorders after several failed attempts with the compound in previous late-stage studies of multiple sclerosis and Huntington’s disease.

Israeli pharma company Teva tested the compound in at least 15 clinical trials over 14 years without success. Teva finally decided to return laquinimod back to Active Bio in 2018 due to multiple failed attempts to find benefit.

Clinical activity of the drug, even in trials that did not meet the primary and secondary endpoints, has provided Active Bio some hope that laquinimod can be used in neurodegenerative disorders. Based on findings from a 2014 phase 2a study, Active Bio now states that the compound may show promise in Crohn’s disease.

Trial Employees Cite Lack of Resources, Job Definition as Key Challenges

Inadequate resources and a changing or lack of a defined role were cited most often as the biggest challenges for clinical trial professionals, according to a new survey of compensation and employee satisfaction.

The third biggest challenge was internal politics followed by lack of advancement opportunities, inadequate compensation, poor-performing technologies, and insufficient training and support, according to a survey SCORR Marketing and Applied Clinical Trials conducted in 2019 and released last week.

The survey found that salary does not correlate with job satisfaction. In men who have more than 20 years of experience (58 percent of whom have salaries of $150,000 or more), the overall job satisfaction was 3.27 based on a five-point scale. Men with 10 or fewer years had a slightly higher job satisfaction score of 3.42. Women (17 percent of whom have salaries of $150,000 or more) reported a lower job satisfaction score of 3.16, potentially correlating with their overall lower pay in this industry.

North American employees have higher salaries than European employees, the survey shows. Approximately 29 percent of North American residents have salaries of $150,000 or more, compared with only 12 percent of Europeans. Additionally, six percent of North American residents have salaries of less than $50,000, compared with 37 percent of European clinical trial workers.

To read the survey, click here: https://bit.ly/31z9EPm.

Trial Oversight and Trial Complexity Add to Increased Workload, Survey Shows

Eighty-one percent of clinical trial professionals say their increased workload is due to clinical trial oversight and trial complexity, according to a new survey. At the same time, 65 percent of respondents say they’re being asked to do more with fewer resources.

Additionally, nearly half of respondents believe they are spending their time on low-impact oversight tasks that have little effect on outcomes, according to the survey out last week from Medidata and Informa Pharma Intelligence.

Survey respondents said aggressive timelines, budgetary constraints and trial complexity are the biggest challenges in identifying operational issues quickly. A majority of respondents — 62 percent — also said their organization operated below best practice levels in their collaboration across functions during trials. Key barriers to collaboration in the report included financial limitations, system incompatibility and staffing levels.

In addition, only one-quarter of respondents said they had completed 75 percent of their clinical trial oversight tasks on time.

To read the survey, click here: https://bit.ly/2vRAk25.

FDA Guidance Calls for Innovative Trial Approaches to Rare Genetic Disease

Sponsors of treatments for the rare genetic disease mucopolysaccharidosis will be able to send the FDA evidence from one trial along with additional evidence of efficacy gathered from such sources as nonclinical data from an animal model or data showing the treatment’s effect on biochemical markers, under a draft guidance released on Feb. 4.

Comments on the draft guidance are due by April 3. Read the draft guidance here: https://bit.ly/2GSJM7J.

Verana Acquires PYA Analytics and Secures $100 Million Funding Round Led by GV

Real-world data analytics startup Verana Health has acquired PYA Analytics and $100 million in funding in a deal led by Google Ventures (GV) to help expand its trial services into new therapeutic areas.

Verana can now integrate claims, genomics and imaging data sources into its new data analysis and linking capabilities with the help from PYA Analytics, a small technology firm specializing in large-scale data solutions.

Verana, whose primary focus has been ophthalmology and neurology, offers four service areas: protocol optimization, patient recruitment, site engagement and real-world drug performance. A fifth service — regulatory-grade data for pragmatic trial control arms that can be taken to regulators — is in the works.

Chan–Zuckerberg Initiative to Fund 30 Patient Groups, Advance Research for Treating Rare Diseases

Thirty patient groups will each receive $450,000 over two years in clinical research grants for rare diseases under an initiative announced by Facebook founder Mark Zuckerberg and his spouse Dr. Priscilla Chan.

The Rare As One funding program will pair the grantees with patient group mentors and scientific advisers. The Chan-Zuckerberg Initiative will also host monthly webinars on rare disease research.

The Rare As One list of recipients is available at: https://bit.ly/2UxDqTe.