This week, the Journal of Clinical Neurophysiology published a special issue about recent innovations and their regulatory implications for clinical trials in multiple sclerosis. Dr. Mark Skeen, Senior Medical Scientist at VeraSci and Professor of Neurology at Duke University Medical Center served as a guest editor and contributor for the issue.

The issue includes the article “Biomarkers and Surrogate Endpoints in Multiple Sclerosis Clinical Trials: Regulatory Issues” co-authored by Dr. Skeen and Dr. Luca Pani, VP Regulatory Strategy and Market Access Innovation at VeraSci and former Director-General of the Italian Medicines Agency (AIFA).

Evoked potentials have long played a role in the diagnosis of Multiple Sclerosis (MS), but have recently gained attention as a possible outcome measure for use in clinical trials. Like any surrogate endpoint, evoked potentials must demonstrate their precision and reproducibility, the settings in which they are meaningful, and the degree to which they predict clinically significant outcomes to gain acceptance with regulatory agencies and payers in the further evaluation of a product’s potential for reimbursement. This article explores regulatory issues associated with using evoked potentials as biomarkers and surrogate endpoints for use in clinical trials.

View the article here.

The issue also includes the article “Changing Paradigms and Unmet Needs in Multiple Sclerosis: The Role of Clinical Neurophysiology” authored by Dr. Skeen which reviews the change in the understanding of MS over past years with the focus on axonal loss, remyelination, and progressive MS (read more here). Dr. Skeen also contributed an editorial entitled “The Use of Evoked Potentials in Multiple Sclerosis Clinical Trials” (read more here).

The 20Sense Report, a quarterly publication for Canada’s specialty pharmaceutical industry, featured VeraSci’s Dr. Luca Pani in their April 2021 issue discussing creative approaches to market access. The article compares the agreements that have been used in Italy to what could be done for Canada. During Dr. Pani’s time as Director General of the Italian Medicine Agency, he made Italy a leader in managed entry and outcome-based agreements. The article discusses many issues common to market access for gene therapy and other advanced therapies, including demonstrating duration of effect, the use of registries and value endpoints, and early access mechanisms.

Download the full report here.

VeraSci—a global clinical research company offering eClinical software, translation services, and expertise in endpoints and assessments—is pleased to announce a new partnership with Aural Analytics, Inc., a global leader in speech analytics for clinical research.

VeraSci has embedded the Aural Analytics’ A2ETM speech analytics mobile application SDK and web API into the Pathway eCOA platform in preparation for multiple upcoming pivotal trials, including a psychiatric trial, as well as a diagnostic program in a neurological indication. Speech analytics will be utilized alongside more conventional clinical outcome measures to provide a richer picture of patients’ neurological health. VeraSci is also exploring the potential use of speech analytics for upcoming studies in additional psychiatric conditions and neurological disorders.

Scientists have known for some time that patients’ speech patterns change with different clinical conditions. Automated analysis of speech can be used to identify and track neurological diseases and psychiatric disorders by measuring objective features of speech and language production, including articulation, prosody, verbal volition among others.  These measures have been investigated for use in diseases such as ALS, Parkinson’s disease, Alzheimer’s disease, migraine, and schizophrenia.

“Using speech analytics to provide a more comprehensive picture of cognitive and clinical symptoms in CNS disorders opens new avenues for assessing patients,” says VeraSci CEO Dr. Rich Keefe, “Our partnership with Aural Analytics advances our commitment to pairing scientific knowledge with cutting-edge technology to improve the tools and measurements available in clinical trials.”

VeraSci’s Pathway eCOA platform brings together scientifically driven processes with cutting edge technology to deliver higher quality data while reducing site and patient burden. The addition of Aural Analytics’ speech analysis capabilities to Pathway provides sponsors with a completely unique and state-of-the-art method for evaluating patients. Only VeraSci’s Pathway offers a single integrated device across a broad range of assessments, including clinical, cognitive, functional, and speech endpoints. In addition, speech analytics will play an important role as more clinical trials move to remote assessments virtual trials.

“We are proud to partner with VeraSci to embed A2E, our global speech collection and analytics suite, into VeraSci’s Pathway eCOA platform, enabling the seamless collection and analysis of speech alongside other digital assessments of neurological conditions,” said Daniel Jones, CEO and co-founder of Aural Analytics. “Speech analytics, coupled with VeraSci’s deeply scientific approach to data collection and analysis, will enable clinical researchers with a robust, unique, and compelling solution in today’s dynamic clinical research landscape.”

About VeraSci

VeraSci is a clinical research company offering eClinical software, translation services, and expertise in endpoints and assessments. VeraSci brings scientific expertise, strategic innovation, and unwavering commitment to each project, helping clients worldwide develop novel therapies. Learn more at www.verasci.com.

About Aural Analytics

Aural Analytics is the industry’s leading speech neuroscience company building the world’s most advanced clinical-grade speech analytics platform for health applications across the lifespan. Its suite of applications and embeddable SDKs and APIs are available in up to 30 languages across Android, iOS, and the web are easy to use, secure, and provide robust, clinically relevant, interpretable, and validated metrics reflecting the neurological and respiratory health of its users. For more information, please visit auralanalytics.com or follow Aural Analytics on Twitter, LinkedIn, Medium, and Facebook.

Durham, NC—January 19, 2021—VeraSci—a global clinical research company offering eClinical software, translation services, and expertise in endpoints and assessments—is pleased to announce a new partnership with ActiGraph, a leading provider of medical-grade wearable activity and sleep monitoring devices.

VeraSci’s Innovation Lab will be incorporating ActiGraph’s CentrePoint Insight Watch into an NIH-funded study examining the relationship between real-time measurements of gait and actigraphy collected by industry-grade wearables and established cognitive and functional endpoints that are sensitive to decline early in the Alzheimer’s disease continuum.

Preliminary data have indicated a correlation between remotely captured gait and actigraphy measures and established cognition and function measures. These data suggest that wearables can provide meaningful information regarding cognitive health and may ultimately contribute to continuous assessment of cognition and function in clinical trials.

“Wearables present an incredible opportunity to gather data in ways that haven’t been feasible before. We can gather information directly while patients are engaged in their daily lives” says VeraSci CEO Dr. Rich Keefe, “Our partnership with ActiGraph advances our commitment to pairing scientific knowledge with cutting-edge technology to improve the tools and measurements available in clinical trials.”

“This partnership between ActiGraph and VeraSci provides an exciting opportunity to better understand the relationship between real-world physical behavior, function, and cognition,” said Matt Biggs, ActiGraph’s Head of Business Operations. “We believe that these types of collaborations will help to jumpstart the creation of novel digital endpoints for global health communities.”

Research reported in this release was supported by the National Institute on Aging of the National Institutes of Health Small Business Innovation Research (SBIR) program under Award Number R44AG058345. The content is solely the responsibility of the authors and does not necessarily represent the official views of the National Institutes of Health.

About VeraSci

VeraSci is a clinical research company offering eClinical software, translation services, and expertise in endpoints and assessments. VeraSci brings scientific expertise, strategic innovation, and unwavering commitment to each project, helping clients worldwide develop novel therapies. Learn more at www.verasci.com.

About ActiGraph

ActiGraph is a leading provider of medical-grade physical activity and sleep monitoring solutions for the global scientific community. ActiGraph’s FDA-cleared wearable actigraphy monitors and robust analytics platform have been widely used to quantify human movement in academic and population health research for nearly two decades. In recent years, the company’s monitoring solutions have been steadily adopted by pharmaceutical and life sciences organizations seeking to capture real-world objective outcomes related to physical activity, mobility, and sleep behavior for patients enrolled in clinical trials. For more information, visit www.actigraphcorp.com.

 

Durham, NC—December 18, 2020—VeraSci—a global clinical research company offering eClinical software, translation services, and expertise in endpoints and assessments—is concluding a successful year marked by extensive hiring and expanded service offerings. This growth has allowed the company to successfully take on an increasing number of large, global clinical trials. VeraSci has hired 49 new employees in 2020 and added capabilities in remote clinical trials, placebo response mitigation, and wearable devices.

2020 has been a challenging year for companies that provide products and services for clinical trials as COVID-19 delayed or canceled many studies. VeraSci credits its continued success to having quickly adapted to implement remote assessment methods and revise standard methods to allow the safe collection of data. These new innovative solutions prevented delays and cancellations and allowed studies to proceed without missing data.

According to VeraSci CEO Dr. Rich Keefe, “We were able to present our clients with solutions that enabled critical research to continue. Through our expertise and adaptability, we have met the unique challenges that COVID-19 presented for our industry.”

VeraSci expects growth to continue into 2021 having recently been awarded several large phase 3 clinical trials. They are actively recruiting for several open positions to support this growth. Additionally, VeraSci has plans to launch new technology products in the first half of 2021.

“We are proud of our accomplishments this year and believe they position us well for future success,” says VeraSci President Caren Gadigian, “Growing our talent pool and expanding our capabilities allows us to take on larger projects with an extended global reach while maintaining the level of quality and service our clients expect.”

About VeraSci

VeraSci is a clinical research company offering eClinical software, translation services, and expertise in endpoints and assessments. VeraSci brings scientific expertise, strategic innovation, and unwavering commitment to each project, helping clients worldwide develop novel therapies.

Neuropsychopharmacology recently published “Placebo Response Mitigation with a Participant-Focused Psychoeducational Procedure: A Randomized, Single-Blind, All Placebo Study in Major Depressive and Psychotic Disorders”. Dr. Bill Horan, Vice President Clinical Science at VeraSci, and VeraSci CEO Dr. Rich Keefe co-authored the publication.

Development programs for CNS disorders face discouragingly low success rates. Placebo response has a potentially devastating impact on CNS trials and has contributed substantially to the late-stage failure of promising treatments. According to the paper, “no empirically-validated participant focused strategies to mitigate the phenomenon have been available.”

The paper presented results from a study evaluating the efficacy of the Placebo-Control Reminder Script (PCRS), a brief script read to participants immediately before administering study assessments. The study demonstrated that participants who received the PCRS reported significantly smaller reductions in depression than those who did not (all participants were receiving placebo).

“This is an important step forward in the development of new drugs for devastating CNS disorders including depression, schizophrenia, and chronic pain,” says Dr. Horan, “A scientifically-backed instrument that reduces placebo response will allow effective treatments to show a positive signal, a necessary step in bringing new treatments to market.”

About VeraSci

VeraSci is a clinical research company offering eClinical software, translation services, and expertise in endpoints and assessments. VeraSci brings scientific expertise, strategic innovation, and unwavering commitment to each project, helping clients worldwide develop novel therapies.