The Journal of Parkinson’s Disease recently published “Virtual Reality Functional Capacity Assessment Tool (VRFCAT-SL) in Parkinson’s Disease” co-authored by Dr. Travis Turner, Dr. Alex Atkins, and Dr. Rich Keefe. The article examines the application of an abbreviated version of the standard VRFCAT (the VRFCAT-SL) the application of the VRFCAT-SL in measuring functional capacity in patients with Parkinson’s disease. The study looked at 29 patients seen in clinic for comprehensive neuropsychological testing, 15 of which met the criteria for mild cognitive impairment (PD-MCI). These encouraging results demonstrate that the VRFCAT-SL provides a convenient and valid measure of functional capacity in Parkinson’s disease that is not confounded by motor symptoms.
WCG today announced the acquisition of VeraSci, a global provider of specialty scientific expertise and eClinical software to support the design and execution of clinical trials focused on central nervous system (CNS) disorders. The addition of VeraSci, based in Durham, North Carolina, deepens WCG’s scientific and patient engagement capabilities, and complements its CNS offerings, including those available via the Company’s MedAvante, ProPhase and Analgesic Solutions businesses. With this expansion, WCG is addressing the growing demand for proven scientific and technology solutions to power remote data capture, hybrid virtual studies and fully decentralized clinical trials in key CNS therapeutic areas.
“WCG’s acquisition of VeraSci represents a natural next step and an exciting growth opportunity,” said Donald A. Deieso, Ph.D., Executive Chairman and CEO of WCG. “On behalf of WCG, I’m proud to welcome VeraSci, an organization that shares our dedication to improving the clinical trial experience for patients and sites, commitment to scientific rigor and passion for bringing novel technologies into clinical trial processes. This is a marriage of two premier global teams with a common vision.”
VeraSci provides clients around the world with innovative solutions that improve data quality in clinical trials, including endpoint and assessment services, rater training and certification, language and translation support, and eCOA and ePRO technologies. With its Pathway technology platform, which can be easily configured to meet the needs of any study across the globe, VeraSci enables the collection of high-quality data that can be used to assess symptoms, cognition and functional capacity in a wide range of therapeutic indications.
“Since our inception, we have invested in expanding VeraSci’s expertise and capabilities to include a variety of clinical and regulatory endpoints covering a range of diseases and disorders. We have also pioneered technological advances that are changing the way subjective endpoint assessments are conducted in clinical research,” said Rich Keefe, Ph.D., CEO and Co-Founder of VeraSci. “Now, as part of WCG, we are positioned to be the go-to research partner around the globe. We can scale and further strengthen our offerings, including our industry-leading CNS services and solutions.”
Dr. Keefe added: “For all of us at VeraSci, it’s truly an honor to join WCG and a thrill to work alongside colleagues who are just as committed to enabling well-designed, science-focused processes and technologies to drive more effective, efficient and patient-centric clinical trials.”
Caren Gadigian, President and Co-founder of VeraSci remarked, “Dr. Keefe and I have worked tirelessly for 16 years to develop VeraSci to where it is now. We look forward to maintaining our commitment to science and to the benefit of patients in need through our new partner.”
As an industry leader in neurocognitive measurement and with its deep therapeutic and technical expertise in psychiatric disorders, VeraSci also enriches WCG’s capabilities designed to solve the overarching challenges of CNS clinical study planning and execution. VeraSci’s experience encompasses all phases of development, from single-site, phase I studies to global phase III trials, with hundreds of raters and thousands of patients.
“Whether we’re discussing stroke or migraine, epilepsy or multiple sclerosis, or Alzheimer’s or Parkinson’s disease, on average, developing drugs to treat CNS disorders takes 20% longer than drugs for other indications and 38% longer to secure regulatory approvals. These challenges are largely due to limitations in understanding the underlying disease, as well as in identifying and measuring appropriate clinical endpoints,” said Lindsay McNair, MD, Chief Medical Officer of WCG. “The VeraSci team is composed of highly-respected scientists, industry thought leaders and operational experts, including Dr. Keefe and Dr. Luca Pani, VeraSci’s Vice President of Regulatory Strategy and Market Access Innovation, who is also the former Director General of the Italian Medicines Agency. Their combined experience and expertise in clinical psychology, neuroscience, clinical pharmacology and regulatory science, with particular emphasis on technology-enabled, remote endpoint assessments, will be extremely valuable to clients and, more broadly, our industry, as we work together to enable advances in CNS treatments, which improvements in the clinical trial process have tremendous potential to accelerate.”
Emmanuel Olart, WCG’s Chief Applications Officer, noted: “Since our founding in 2012, WCG has been preparing for what we have seen coming as the future of clinical research, working hand-in-hand with sponsors, CROs and sites, and providing them with innovative technologies and solutions to improve clinical trial efficiency and effectiveness. Acquiring VeraSci is part of that ongoing effort, bringing clinical trials closer to patients, reducing the burden of participating and making the experience better for them via solutions that enable remote data capture, hybrid virtual studies and fully decentralized clinical trials.”
Moving forward, VeraSci will be known as WCG VeraSci. The organization will retain its leadership structure and continue to operate from its headquarters in North Carolina.
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.
WCG is the world’s leading provider of solutions that measurably improve the quality and efficiency of clinical research. Comprised of two segments, Ethical Review and Clinical Trials Solutions (CTS), WCG enables biopharmaceutical companies, CROs, and institutions to advance the delivery of new treatments and therapies to patients, while maintaining the highest standards of human participant protection. For more information, please visit www.wcgirb.com, www.wcgclinical.com or follow us on Twitter @WCGClinical or LinkedIn.
The Framework for Clinical Trial Participants’ Data Reutilization for a Fully Transparent and Ethical Ecosystem (FACILITATE) is a new Innovative Medicines Initiative (IMI) funded project to find an ethical and GDPR compliant framework for returning clinical trial data to study participants, a key step in reconciling the promise of avoiding useless repetitions of studies with privacy rights of individuals. VeraSci will serve on the Medical and Technical Expert Decision Committee for the project. Dr. Luca Pani, VP Regulatory Strategy and Market Access Innovation at VeraSci will serve as the Project Coordinator in his role as Professor Pharmacology and Clinical Pharmacology at the University of Modena and Reggio Emilia in Italy.
There has been growing concern that the EU General Data Protection Regulation (GDPR) safeguards will make Europe non-competitive in the innovative drug development space. Here are a few ways GDPR may complicate clinical trials in drug development:
- The principle of data minimization may preclude machine learning
- Privacy by default and design may preclude predictive analytics
- Clinical data reutilization requires access to enough “detailed information,” which GDPR restrictions could make difficult or impossible
In addition to creating an ethical and GDPR compliant framework to return clinical trial data to study participants, FACILITATE seeks to:
- Find legally robust and ethically forward-looking ways to allow patients’ data to be accessed, used, and re-used
- Generate a partnership where patients are at the center of data governance
- Show how a patient-centered data-driven approach can make the entire drug development and approval process better
- Avoid storing clinical data in siloed systems where there is no possibility to use them beyond their original (and often single-sided) purpose
The journal Clinical Drug Investigation recently published the article “New Models for the Evaluation of Specialized Medicinal Products: Beyond Conventional Health Technology Assessment and Pricing” which was co-authored by Dr. Luca Pani, VP Regulatory Strategy and Market Access Innovation at VeraSci. As the number of advanced therapy medicinal products (ATMPs), such as gene therapies, increases, it becomes clear that the existing health technology assessment (HTA) process is not sufficient anymore to give the right value to such treatments. The objectives of this article are to discuss why the current HTA process is inadequate for evaluating these new therapies, how evidence should be continuously generated and presented to regulators and payers to support their use, and to propose new approaches to pricing models. Without new approaches or adaptation of existing frameworks, certain ATMPs may not reach patients in some or all countries or be at risk of withdrawal from the market.
Today, Boehringer Ingelheim announced that they are partnering with VeraSci on an innovative phase III program in cognitive impairment associated with schizophrenia (CIAS) for the investigational treatment BI 425809. The FDA has granted Breakthrough Therapy Designation (BTD) for BI 425809 for the treatment of CIAS.
The program will be using VeraSci’s Pathway eCOA platform, including VeraSci’s Virtual Reality Functional Capacity Assessment Tool (VRFCAT), which simulates key instrumental activities of daily living in a realistic and interactive virtual environment. The VRFCAT, which is sensitive to functional capacity deficits, has been accepted into the FDA’s Clinical Outcome Assessment Qualification Program. The trials will also utilize speech biomarker technology from Aural Analytics, which will provide a richer picture of trial participants’ language function alongside more traditional clinical outcome measures.
“VeraSci is excited to take part in this landmark innovative trial in CIAS,” says VeraSci CEO Dr. Rich Keefe. “Innovative solutions are imperative to making meaningful progress in this difficult illness. We are hopeful that this research will be an important step forward for the field.”
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.
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).