VeraSci’s Innovation Lab Launches Wearable Technology Validation Study

Testing Industry-Grade Wearable Devices for Real-Time Functional Assessment.

VeraSci’s Innovation Lab led by Dr. Alexandra Atkins has begun evaluating the ease of use, sensitivity, and reliability of two industry-grade wearable devices for the real-time capture of gait and actigraphy measures. VeraSci, a global clinical technology, research, and development services company, is making significant strides toward the inclusion of validated wearable technologies for continuous passive data collection in clinical trials for those at risk for Alzheimer’s Disease (AD) and related disorders.

If appropriately implemented, measurements from certified wearable technologies have the potential to revolutionize the future of AD prevention trials by facilitating the development of siteless clinical trial designs. The project will also assess the relationship between wearable device endpoints and standard performance-based measures of cognition and function. The study enrolled the first of 100 older adults with and without subjective cognitive decline in late October.

Devices under investigation include a wireless insole worn in standard footwear that allows for continuous assessment of gait, walking and balance, and a wrist-worn device that offers continuous measurement of heart rate, motor activity, skin temperature, Galvanic Skin Response, and sleep. The devices were selected based on their potential to produce reliable endpoints that may ultimately pass the high bar set for use in regulated clinical trials. Primary considerations included measurement accuracy, data security, and potential for compliance with HIPAA and FDA-Part 11 regulations.

Dr. Luca Pani, VeraSci VP for Regulatory Strategy and Market Access Innovation, and former Director General of the Italian Medicines Agency commented, “The potential for greater integration of wearables in CNS trials to collect high quality real world evidence (RWE) before, during and after product approval is enormous. To be truly informative, however, endpoints collected by these devices must undergo the same clinical and technological validation process required by other currently accepted tools.”

Through their Innovation Lab, VeraSci continually seeks to improve the tools and methods of measurement in clinical trials in multiple therapeutic areas. Prior work includes the collection of robust normative data for 650 cognitively healthy individuals on the tablet-based Brief Assessment of Cognition (BAC) and the Virtual Reality Functional Capacity Assessment Tool (VRFCAT), a performance-based functional assessment that was recently accepted into the FDA qualification program for cognitive impairment in schizophrenia.

Moving the Conversation from Cost to Value: VeraSci Offers New Approach to HEOR and HTA Consulting Led by Dr. Luca Pani

VeraSci, a leading provider of innovative scientific and technology services, announces the addition of a new service offering, Value Consulting, a HEOR and HTA consulting service line, addressing the emerging need to demonstrate the pharmacoeconomic value of novel therapies earlier in the development process. As clinical trials grow in scope and complexity, VeraSci provides the scientific and operational clarity needed for optimal trial performance and accelerated drug development. Dr. Luca Pani, VP of Regulatory Strategy and Market Access Innovation at VeraSci and former AIFA Director General, will be leading the Value Consulting team.

“Conventional Health Technology Assessment evaluations that employ classical reimbursement agreements such as cost-sharing and risk-sharing and link them to effectiveness data at the time of first approval are no longer sufficient to support today’s challenging payer environment. Soon after a lifesaving product receives regulatory approval, the assessment of clinical effectiveness and the subsequent economic impact can change substantially. Accordingly, traditional modeling-based methods, such as cost-effectiveness and QALYs, will slowly lose their relevance in guiding reimbursement contracts. Our services will ensure that pharmaceutical, biotech, and digital therapeutic sponsors have the right evidence to stay ahead of the curve,” said Dr. Pani.

VeraSci’s Value Consulting will provide services such as:

  • Value-based strategic pricing models
  • Payer strategic consulting-including mock negotiation
  • Market access strategy development
  • Value Endpoint Trial Design and Implementation
  • HTA & Evidence reviews

Value Consulting will identify the value endpoints, which can convert product efficacy and safety data into reimbursement variables, to create clinical trial designs to facilitate market access negotiations and reimbursement along with regulatory approval.

VeraSci Receives FDA Grant to Support Qualification of the Virtual Reality Functional Capacity Assessment Tool (VRFCAT)

VeraSci, a leading provider of innovative scientific and biotechnology services, announced today that they have received an FDA grant to conduct further research on the VRFCAT, their proprietary functional capacity assessment. The VRFCAT has recently been accepted into the FDA’s COA Qualification Program as a measure of functional capacity for schizophrenia treatment trials. This project will use qualitative research methods to establish the clinical meaningfulness of this measure to patients, family members, and peer support specialists. Qualitative evidence supporting the clinical meaningfulness of the VRFCAT from patient and caregiver perspectives will help advance the VRFCAT through the FDA qualification process and is a key component of interest for payers and health care providers.

The VRFCAT is an eCOA task that simulates key instrumental activities of daily living (iADLS) in a realistic and interactive virtual environment. With demonstrated sensitivity to accepted measures of cognitive and functional deficits in multiple CNS disorders, the VRFCAT was developed in VeraSci’s Innovation Lab to improve clinical trials by detecting functionally meaningful improvements in patients’ everyday lives. The VRFCAT has numerous advantages over conventional assessments, and meets the highest psychometric standards, with strong support from industry sponsors, NIH and FDA as a functional co-primary outcome measure.

If you are interested in learning more about or demoing the VRFCAT, visit https://verasci.com/vrfcat/.

VeraSci’s Virtual Reality Functional Capacity Assessment Tool (VRFCAT) Accepted into the FDA’s Clinical Outcome Assessment (COA) Qualification Program

VeraSci, a leading provider of innovative scientific and biotechnology services, announced today that their proprietary functional capacity assessment, the VRFCAT has officially been accepted into the FDA’s COA Qualification Program. This FDA program is intended to qualify drug development tools that can be relied on to have a specific interpretation and application in any drug development program and regulatory review. VeraSci is in the process of collecting the additional data required to submit a full qualification package to the FDA.

The VRFCAT is an eCOA task that simulates key instrumental activities of daily living (iADLS) in a realistic and interactive virtual environment. With demonstrated sensitivity to accepted measures of cognitive and functional deficits in multiple CNS disorders, the VRFCAT was developed in VeraSci’s Innovation Lab to improve clinical trials by detecting functionally meaningful improvements in patients’ everyday lives. The VRFCAT has numerous advantages over conventional assessments, and meets the highest psychometric standards, with strong support from industry sponsors, NIH and FDA as a functional co-primary outcome measure.

If you are interested in learning more about or demoing the VRFCAT, visit https://verasci.com/vrfcat/.

VeraSci Welcomes William P. Horan, PhD as VP of Clinical Science

William P. Horan, PhD VeraSci, a leading provider of innovative scientific and technology services, announced today that William P. Horan, PhD will join the company as Vice President of Clinical Science. In this role, Dr. Horan will use his expertise in cognition, clinical neuroscience, and symptom assessment to provide scientific and operational support for clinical trials in psychiatric disorders.

Over the past 20 years, Dr. Horan’s clinical research has focused on understanding and developing treatments for motivational, social cognitive, and neurocognitive disturbances that impact functional outcomes in schizophrenia and other neuropsychiatric conditions. Specific interests include negative symptoms, translational affective and social cognitive neuroscience, reward processing, effort-based decision making, and development of novel physiological and behavioral tasks for use as endpoints in clinical trials.

Dr. Horan is well respected in the schizophrenia research community. His research has been funded by NIMH, VA, and foundation grants, and he served as a Principal Investigator in the NIMH Collaboration to Advance Negative Symptom Assessment in Schizophrenia.  “We are thrilled to have Dr. Horan joining our team of world-class scientists joining the effort to bring life-changing treatments to people with CNS disorders,” said VeraSci CEO Dr. Richard Keefe. “Dr. Horan has been pushing innovative assessments and treatment strategies for a variety of different conditions for two solid decades, and his experience and expertise will contribute immediately to our unique capacity for thought partnership.”

Prior to joining VeraSci, Dr. Horan was Professor-in-Residence in the Department of Psychiatry & Biobehavioral Sciences at UCLA and Chief of the Psychosis Section at the VA Greater Los Angeles Healthcare System. He also serves on the Editorial Boards of Schizophrenia Bulletin, Schizophrenia Research: Cognition, and Journal of Abnormal Psychology (Associate Editor). He has over 130 peer-reviewed articles and has been recognized as a Thomson Reuters Highly Cited Researcher (Top 1% in Psychiatry/ Psychology).

Leading Provider of Innovative Scientific and Technology Services Welcomes Mark Skeen, MD as Senior Medical Scientist

Mark Skeen, MD as Senior Medical ScientistVeraSci recently welcomed Mark Skeen, MD as Senior Medical Scientist. In this role Dr. Skeen will provide disease state expertise for a broad range of neurologic diseases as well as the perspective of the clinician conducting clinical trials. As part of his role at VeraSci, he will assist in the implementation of the trials of both relapsing and progressive forms of multiple sclerosis (MS).

Dr. Skeen officially joined VeraSci after assisting with the development of the Multiple Sclerosis Individual Outcome Assessment (MSIOA), a structured interview designed to address the need for a patient-centric account of MS symptoms throughout the course of a clinical trial, and an eCOA version of the Neurostatus EDSS. Both of these tools are based in Pathway, VeraSci’s eCOA Platform.

Dr. Skeen brings with him over three decades of clinical experience from general internal medicine to neurology subspecialty care. For the past 15 years, his focus has been on multiple sclerosis and related autoimmune conditions. He is board certified in Internal Medicine, Neurology, and Clinical Neurophysiology and has broad clinical experience in neurology clinical trials in several disease states.

Dr. Skeen is recognized as a thought leader in MS and has been recognized for both clinical and research expertise. “We are delighted to have Mark join our team at VeraSci,” said VeraSci CEO Richard Keefe. “Given the explosion of new mechanisms of action in MS and other neurologic conditions, we are excited to have a tremendously accomplished and knowledgeable leader to provide expertise in this area of work and help round out VeraSci’s team of scientific partners to industry research trials.”

Dr. Skeen also serves as an Associate Professor of Neurology at Duke University Medical Center and is the head of the division of MS and Neuroimmunology. He is a Fellow of the American College of Physicians and the American Academy of Neurology. Dr. Skeen has many longstanding partnerships throughout the pharmaceutical industry and brings a distinctly clinical neurologic perspective to VeraSci.