12.03.15
Marinus Pharmaceuticals Inc., a biopharmaceutical company dedicated to the development of innovative therapeutics to treat epilepsy and neuropsychiatric disorders, has named Jaakko Lappalainen, as vice president of clinical development and Kimberly McCormick, as head of regulatory affairs. Dr. Lappalainen has 10 years of experience in the design, monitoring, interpretation and reporting of clinical trials at pharmaceutical research and development companies, including AstraZeneca. Dr. McCormick has more than 15 years of regulatory strategy and submissions experience at major pharmaceutical firms, including Shire and Pfizer. Both individuals will report to Marinus’s chief medical officer, Albena Patroneva.
“We are delighted to have Drs. Lappalainen and McCormick join Marinus at such a pivotal time for our company,” said Dr. Patroneva. “Dr. Lappalainen will be responsible for advancing our CNS-selective GABAA modulator, ganaxolone through clinical trials to commercialization and Dr. McCormick will oversee all efforts related to global regulatory oversight for ganaxolone. The additional expertise in executing quality clinical trials and interacting with the regulatory agencies will be invaluable as we continue to advance the late stage clinical development of ganaxolone, and expand our reach into the acute care setting with our IV formulation.”
Dr. Lappalainen is a U.S. board certified psychiatrist with extensive experience in clinical practice and medical research. Most recently, he served as executive director, drug development services at Premier Research CRO, where he oversaw the safety and medical monitoring of clinical trials and provided consultations on clinical trial design and drug development.
Dr. McCormick is an experienced senior regulatory affairs professional with more than 15 years of regulatory strategy and experience in leading the development and registration of products across many different regions and therapeutic areas, with a focus in Neuroscience. Most recently, she served as senior director, global regulatory affairs, Lifitegrast and ADHD/Vyvanse new uses for Shire Pharmaceuticals.
“We are delighted to have Drs. Lappalainen and McCormick join Marinus at such a pivotal time for our company,” said Dr. Patroneva. “Dr. Lappalainen will be responsible for advancing our CNS-selective GABAA modulator, ganaxolone through clinical trials to commercialization and Dr. McCormick will oversee all efforts related to global regulatory oversight for ganaxolone. The additional expertise in executing quality clinical trials and interacting with the regulatory agencies will be invaluable as we continue to advance the late stage clinical development of ganaxolone, and expand our reach into the acute care setting with our IV formulation.”
Dr. Lappalainen is a U.S. board certified psychiatrist with extensive experience in clinical practice and medical research. Most recently, he served as executive director, drug development services at Premier Research CRO, where he oversaw the safety and medical monitoring of clinical trials and provided consultations on clinical trial design and drug development.
Dr. McCormick is an experienced senior regulatory affairs professional with more than 15 years of regulatory strategy and experience in leading the development and registration of products across many different regions and therapeutic areas, with a focus in Neuroscience. Most recently, she served as senior director, global regulatory affairs, Lifitegrast and ADHD/Vyvanse new uses for Shire Pharmaceuticals.