Ed has more than 20 years of executive finance and operational leadership experience in publicly traded biotechnology companies from early stage through commercial stage.
Edward F. Smith, Vice President, Chief Financial Officer, Secretary and Treasurer
Ed has more than 20 years of executive finance and operational leadership experience in publicly traded biotechnology companies from early stage through commercial stage. As CFO of Marinus, Ed oversees finance, accounting, information technology, operations, human resources, and investor relations. Throughout his career, he has raised hundreds of millions of dollars from IPOs, follow-on equity raises, private placements, convertible securities, and debt issuances. Prior to Marinus, Ed served as CFO of PolyMedix, Inc., and executive director of finance at InKine Pharmaceutical Company, Inc., where he assisted with the acquisition of the company by Salix Pharmaceuticals, Inc. Earlier in his career, Ed held various positions of increasing responsibility in public accounting, most recently in the audit practice at Deloitte & Touche, LLP.
Ed holds a B.S. in business administration from the University of Hartford and was licensed as a Certified Public Accountant in Pennsylvania.
Lorianne has more than 20 years of experience building and expanding high value pipelines in the biopharmaceutical industry that have resulted in drug approvals and strategic alliances.
Lorianne Masuoka, MD, Chief Medical Officer
Lorianne has more than 20 years of experience building and expanding high value pipelines in the biopharmaceutical industry that have resulted in drug approvals and strategic alliances. She is a board-certified neurologist that has successfully created and overseen high performing teams to lead the clinical development of new medicines, many with a focus in neurology, CNS, and pain. Lorianne served as chief medical officer of InVivo Therapeutics, Cubist Pharmaceuticals, and Nektar Therapeutics where, as a member of executive management, she oversaw and managed teams in the areas of clinical research, drug safety, biostatistics and data management, regulatory affairs, reimbursement and clinical operations. Previously, she held various roles of increasing responsibility at FivePrime Therapeutics and Chiron.
Lorianne received her medical degree from the University of California, Davis, where she also completed her residency in neurology. She completed her epilepsy fellowship at Yale University and is board certified by the American Board of Psychiatry and Neurology.
T.J. has over 25 years of transactional and commercial experience in the life sciences and health care industries.
Thomas J. Lyons, Vice President, Corporate & Business Development and Commercial Planning
T.J. has over 25 years of transactional and commercial experience in the life sciences and health care industries. Prior to joining Marinus, T.J. was a managing partner at Fidem Capital, a boutique, transactional advisory firm focused on mergers & acquisitions, equity financings, and corporate development for health care and technology companies in the lower middle market. T.J. has held corporate & business development positions at Oscient Pharmaceuticals and Cempra Pharmaceuticals as well as a variety of commercial positions of increasing responsibility at Abbott Laboratories and Cephalon, Inc. He has also been a managing partner of Vector Advisory, a consultancy concentrating on corporate development and strategic advisory to life sciences companies. Throughout his various roles, T.J. has completed a wide array of transactions including product in-/out-licensing, M&A, asset acquisitions/divestitures/spin-outs, financings, co-promotions, joint ventures, and strategic alliances for private and public entities ranging from start-ups to Fortune 50 international corporations.
T.J. holds a B.S. in business administration & marketing from Boston College and an M.B.A in finance & entrepreneurship from Babson College. He maintains FINRA Series 7, 63 & 79 licenses for securities transactions and investment banking.
Dave is a global pharmaceutical development and operations executive with more than 30 years experience in advancing complex, technology-based products from proof of concept through commercialization.
David A. Czekai, Vice President Manufacturing
Dave is a global pharmaceutical development and operations executive with more than 30 years experience in advancing complex, technology-based products from proof of concept through commercialization. He is a pioneer in the areas of developing and advancing nanotechnology to commercial success for multiple FDA-approved drug products. At Marinus, Dave leads drug product development and manufacturing initiatives for all clinical programs. Dave started his career at Eastman Kodak where he was co-inventor of Kodak’s NanoCrystal® technology platform, and co-founder of Kodak’s pharmaceutical subsidiary NanoSystems LLC (later acquired by Elan Corporation). While at Elan (later acquired by Alkermes), Dave led the NanoCrystal® business, including responsibility for drug delivery product development and commercialization within the global pharmaceutical industry. After his tenure at Alkermes, Dave founded and served as president of NanoCentrix LLC, a technology start-up engaged in development and commercialization of the next generation of nanotechnology materials and manufacturing processes.
Dave holds B.S. and M.S. degrees in chemical engineering from Clarkson University and has been inducted to Omega Chi Epsilon and Tau Beta PI National Engineering Honor Societies.
Julia has more than 15 years of experience in clinical and drug development and global clinical operations from Phase 1 through Phase 3, in multiple indications within Neurology and Psychiatry.
Julia Tsai, PhD, Vice President Clinical Development
Julia has more than 15 years of experience in clinical and drug development and global clinical operations from Phase 1 through Phase 3, in multiple indications within Neurology and Psychiatry including general epilepsy, posttraumatic stress disorder, Alzheimer’s disease and orphan diseases such as Fragile X Syndrome, Status Epilepticus, and epileptic encephalopathies (infantile spasms, PCDH19 Pediatric Epilepsy, CDKL5 Deficiency Disorder). As Vice President of Clinical Development, Julia is responsible for clinical protocol and program development, participating in advisory boards and FDA and EMA meetings, and presenting at numerous scientific meetings and conferences. She also oversees NDA- supporting clinical and nonclinical studies and regulatory submissions from pre-IND through End of Phase 2, including orphan drug applications and Pediatric Study Plans. Julia is experienced in strategic development planning, pipeline expansion analysis, preclinical IND-enabling studies, and management of clinical supply operations. Prior to joining Marinus, Julia conducted research in synaptic pathology in Alzheimer’s disease at New York University School of Medicine, Cornell Weill Medical College of Cornell University, and Rockefeller University.
Julia is an author of over 50 scientific abstracts and journal publications in neuroscience and psychiatry. She holds a Ph.D. in Physiology and Biophysics from New York University School of Medicine and received her B.A. from Cornell University.
Dr. Gutíerrez-Esteinou has more than 20 years of experience in the clinical development of neuropsychiatric and CNS therapies.
Rolando Gutíerrez-Esteinou, M.D., Vice President of Clinical Development and Pharmacovigilance
Dr. Gutíerrez-Esteinou has more than 20 years of experience in the clinical development of neuropsychiatric and CNS therapies. As Vice President of Clinical Development and Pharmacovigilance at Marinus, he will primarily be responsible for the medical leadership of the postpartum depression programs and drug safety. Dr. Gutíerrez-Esteinou was previously Executive Director and Global Clinical Leader, Psychiatry, at Takeda Pharmaceuticals, and Vice President and Global Therapeutic Area Head at Covance Clinical Development Services. He has also held positions at Prostrakan, Inc.; Bristol-Myers Squibb; Novartis Pharmaceuticals; and the Janssen Research Foundation.
Dr. Gutíerrez-Esteinou holds an M.D. from the National Autonomous University of Mexico Medical School, Mexico City, and was a resident and research fellow at Harvard Medical School.