Since 2018, more than 30 drugs with the potential to impair driving ability have been approved without a dedicated driving study, despite clearly meeting the FDA criteria for such studies based on a conservative application of these criteria.
Proactive Mitigation to Support Program Success
Cognitive Research Corporation (CRC), a leading CNS-focused clinical research organization, proudly announces the addition of four distinguished professionals to its medical leadership team: Dr. Albena Patroneva, Dr. Mark Versavel, Dr. Sandeep Vaishnavi, and Dr. Djouher Hough. These accomplished experts bring deep specialization in neurology, psychiatry, analgesia, and psychedelic research, further enhancing CRC’s ability to deliver advanced scientific guidance and innovative solutions in clinical research. Mark Versavel, M.D., Ph.D., MBA , has over 30 years of experience in clinical development, specializing in neurology, clinical pharmacology, and pain management. His leadership roles at Pfizer, Sunovion, Zalicus, Alzheon, Neurobo, Cavion, and Eliem Therapeutics, as well as his work as a clinical drug development consultant, have been instrumental in bringing innovative therapies to market. He has been key in securing FDA approvals for therapies including Aptiom® for epilepsy and Lyrica® for fibromyalgia, epilepsy, and neuropathic pain. Dr. Versavel also has extensive experience in translational medicine, establishing a pharmaco-EEG and computerized cognition test unit and contributing significantly to the clinical pharmacology development of nimodipine (Nimotop®), ipsapirone, and metrifonate for Alzheimer’s disease. He also initiated and managed laser evoked pain studies for the evaluation of several novel non-opioid experimental medicines. Albena Patroneva, M.D., MBA , brings 25 years of expertise in neurology and psychiatry clinical development, with key roles at AstraZeneca, Neurogene, Harmony Biosciences, Marinus Pharmaceuticals, Teva Pharmaceuticals, and Takeda Pharmaceuticals. She has led the development of therapies across all phases, including securing IND clearances and contributing to FDA approvals and product launches for PRISTIQ® and TRINTELLIX in major depressive disorder and WAKIX® in narcolepsy. Dr. Patroneva possesses extensive experience in protocol design and regulatory affairs, having led FDA negotiations for over 20 programs. Sandeep Vaishnavi, M.D., Ph.D., FANPA , has over 20 years of expertise in neuropsychiatry and research, specializing in ADHD, major depressive disorder, PTSD, and Alzheimer’s disease. His work includes serving as a principal investigator for trials that resulted in FDA approval for Rexulti® for Alzheimer’s disease-related agitation, and trials supporting the FDA clearance of Rejoyn™ as an adjunct treatment for MDD and EndeavorRx® for ADHD in children, adolescents, and adults. Djouher Hough, Psy.D . , brings over 15 years of experience in schizophrenia, substance use disorders, major depressive disorder, and psychedelic research. She has played significant roles in clinical trials for schizophrenia, contributing to the FDA approvals of KarXT, Latuda®, and Austedo®. Dr. Hough has also led Human Abuse Liability trials and worked on trials assessing ketamine infusions and psilocybin for the treatment of MDD. Building on CRC’s Strong Foundation “We are excited to welcome Dr. Versavel, Dr. Patroneva, Dr. Vaishnavi, and Dr. Hough to CRC’s medical leadership team,” said Tom Zoda, Ph.D., CEO of Cognitive Research Corporation. “Their exceptional expertise will strengthen our medical and scientific capabilities, enhancing our ability to provide high-quality, tailored solutions for our clients. We are confident that their contributions will add significant value to our clients’ programs.” With the addition of these esteemed Medical Directors, CRC is well-positioned to advance its mission of improving patient outcomes and delivering the highest level of expertise and quality to support our clients’ needs. About Cognitive Research Corporation (CRC) Cognitive Research Corporation is a leading full-service clinical research organization specializing in CNS disorders, including neurology, psychiatry, and pain management. CRC is dedicated to providing high-quality clinical trial services and driving the development of life-changing treatments. With a focus on innovation, collaboration, and scientific excellence, CRC partners with sponsors, specialized clinical trial sites, and CNS experts to bring new drugs through rigorous testing to support FDA submissions and ultimately improve patient outcomes. To read the full press release, visit PR Newswire . Contact: Hampton Corley hcorley@cogres.com .