Strategy and Clinical Trial Design Specialist Provides Expertise for the Clinical Trial Design and Regulatory Requirements of QBM-001
NEW YORK, January 16, 2019 /PRNewswire/ --
- Strategy and Clinical Trial Design Specialist Provides Expertise for the Clinical Trial Design and Regulatory Requirements of QBM-001
- QBM-001 Developed to Treat a Pediatric Non-Verbal Disorder which impacts 18,000 children each year in the U.S and a similar amount in Europe.
Q Biomed Inc. (OTCQB: QBIO), a biotechnology acceleration company, announced today that Pamela Ventola Phd, from Yale University has joined its Advisory Committee for its QBM-001 clinical program. QBM-001 is being developed and tested for the treatment of minimally verbal or non-verbal toddlers with an Autism Spectrum Disorder (ASD).
Dr. Ventola serves as a clinical psychologist and assistant professor at Yale University’s Child Study Center with a clinical and research focus in: behavioral treatment for autism spectrum disorders, Pivotal Response Treatment (PRT), biological markers of treatment response, and dissemination and implementation of treatment for ASD. Dr. Ventola also directs the Rare Disease and Pediatric Center of Excellence at Cogstate, a publicly traded company that supports pharmaceutical companies in clinical trial design, methodologies, and rater training services as it relates to cognitive and other clinical outcome assessments.
“Children with ASD need safe, effective and targeted treatments that are tested under conditions that take their best interests into consideration to ensure a successful trial,” explained Dr. Ventola. “I am inspired that Q BioMed has the same vision and am excited to ensure QBM-001 has the best chance to help their targeted subgroup.”
Denis Corin, CEO of Q BioMed added, “We are very grateful that Dr. Pamela Ventola has joined our Advisory Committee for QBM-001. She is a leader in clinical trial design and biomarker research for the autism spectrum, which is a perfect fit for the subgroup Q BioMed is targeting. Dr. Ventola will be an asset to our development program as we prepare our Investigational New Drug Application (IND) for submission to the FDA in this important indication for which no drugs are currently available.”
QBM-001 targets toddlers with pediatric developmental nonverbal disorder, where it is believed that an underlying commonality leads to developmental delay, an autism diagnosis and eventual nonverbal or very minimally verbal capability for the rest of their lives.
About Pediatric Development Nonverbal Disorder
There are approximately 18,000 new cases of pediatric developmental nonverbal disorder in the US each year and a similar amount in Europe. The majority of the children are diagnosed as young children and fall within the autism and epilepsy spectrum disorders. Individually, the economic costs for toddlers that become non- or minimally verbal is ten million dollars on average per person over their life. Collectively, an estimated $200 billion is spent yearly on individuals who are nonverbal in the US. Not all individuals who are nonverbal will benefit from QBM-001. However, with validated biomarkers, testing from trained specialists and genetic testing, children who fall in this targeted population can be identified, and will have a higher likelihood of responding to treatment.
About Dr. Pamela Ventola
Pam Ventola, Ph.D. is an Assistant Professor at Yale University School of Medicine, Child Study Center. She also holds the position of Senior Science Director, Rare Disease and Pediatric Center of Excellence at Cogstate, where she provides pharmaceutical sponsors with strategic oversight and expert guidance throughout all stages of their study planning and execution - from endpoint selection, rater training and strategic monitoring to final statistical analysis. A licensed clinical psychologist, Dr. Ventola is an expert in pediatric neuropsychology and specifically developmental disabilities. Her research interests specifically involve individuals with Autism Spectrum Disorder (ASD), and among her recent research is a study on brain-based mechanisms of treatment response ASD. She is also utilizing eye-tracking paradigms as a novel outcome of clinical trials in ASD and is involved in studies on novel pharmacological therapeutics in individuals with ASD.
Dr. Ventola received her Doctor of Philosophy in Clinical Psychology from University of Connecticut and completed her clinical training and Postdoctoral Fellowship at the Yale University School of Medicine, Child Study Center. She serves on the editorial review board of multiple academic journals. Dr. Ventola has authored numerous peer-reviewed manuscripts, book chapters and scientific presentations.
About the Child Study Center at Yale University
The Yale Child Study Center is a multidisciplinary department of the Yale University School of Medicine. Over the past 100 years, the YCSC has taken advantage of its unique position to bring together a faculty with extraordinary breadth of research and clinical interests. This faculty includes internationally recognized experts from multiple disciplines all under one roof including child psychiatry, pediatrics, psychology, genetics, neurobiology, cognitive neuroscience, nursing, social work, and social policy. The YCSC plays a key national and international role in research, training, and professional activities related to childhood mental health and developmental disabilities.
About Cogstate
Cogstate Ltd (ASX: CGS) is a leading science and technology solutions provider dedicated to optimizing the clinical outcome assessments in clinical trials, academic research and healthcare. Cogstate provides enabling technologies and professional services for higher quality neuropsychological assessments and is a pioneer in commercializing rapid, reliable and highly sensitive computerized cognitive tests. Cogstate customers include the world’s leading biopharmaceutical companies; elite sporting organizations and military; physicians and patients; renowned academic institutions and public-private partnerships. For more information, please visit www.cogstate.com.
About Q BioMed Inc.
Q BioMed Inc. is a biomedical acceleration and development company. We are focused on licensing and acquiring undervalued biomedical assets in the healthcare sector. Q BioMed is dedicated to providing these target assets; strategic resources, developmental support, and expansion capital to ensure they meet their developmental potential, enabling them to provide products to patients in need.
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Contact:
Denis Corin
CEO
Q BioMed Inc.
+1(646)884-7017
SOURCE Q BioMed Inc.
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