David is a co-founder of Vallon and has over 25 years of executive, operational and commercial leadership experience in the biopharmaceutical industry. He has been directly involved with the commercialization of five medications with annual sales in excess of $1 billion each, including Adderall XR® and Vyvanse®, the two most successful ADHD brands based on annual revenue. Previously, David was the Chief Commercial Officer and interim CEO of Alcobra Ltd., a CNS specialty pharmaceutical company that completed a reverse merger with Arcturus Therapeutics in late 2017. Prior to Alcobra, he worked at Shire Plc for 10 years as Vice President of Commercial Strategy and New Business in the Neuroscience Business Unit, Global General Manager for Vyvanse® and Vice President, ADHD Marketing. Prior to Shire, he worked at Merck & Co. in marketing, sales, market research, and business development. Mr. Baker's therapeutic expertise includes ADHD, autism, osteoporosis, migraine, and hyperlipidemia. Mr. Baker earned a bachelor’s degree in Economics and Computer Science from Duke University, and an MBA in Marketing, from Duke’s Fuqua School of Business.
Tim brings over 20 years of experience in the pharmaceutical industry and nearly a decade in academic medicine. His pharmaceutical industry experience involves extensive leadership and management of many global clinical development programs, achieving numerous global regulatory approvals. The majority of his work has been in neuroscience and includes leading the development and approval of multiple ADHD medications. Most recently, Tim served as the Chief Medical Officer at Alder Biopharmaceuticals leading a positive Phase III study in the development of a CGRP antagonist for migraine. Prior to that, Tim worked at Shire for more than 10 years, most recently as VP and Neuroscience Therapeutic Area Head, Global Clinical Development. Prior to Shire, Tim served as a Senior Director – Neuroscience at Wyeth Research with a focus on sleep disorders and life cycle management for Effexor®. Prior to joining the industry, Tim held a variety of clinical and teaching positions at the University of Vermont (UVM) College of Medicine and the Medical Center Hospital of Vermont, including Associate Professor of Psychiatry, Director of the Inpatient Services, Executive Committee of the Vermont Regional Sleep Disorders Center, and Director of the Psychopharmacology Clinic. He earned his bachelor’s degree from Duke University, and his medical degree from Wake Forest University School of Medicine. He completed a residency training program in psychiatry and a fellowship in clinical psychopharmacology at UVM/Medical Center Hospital of Vermont in Burlington.
Penny brings over 25 years of Regulatory and Clinical Development experience in the pharmaceutical industry from Glaxo SmithKline, AstraZeneca, Cephalon, and Teva. At Vallon, Penny heads the Regulatory Affairs & Program Management function, providing regulatory strategies to optimize the most efficient and effective outcomes for Vallon’s drug products as well as ensuring full compliance with FDA and DEA regulations for products in development through post approval. Most recently, Penny developed the Global Regulatory Policy & Intelligence function for Teva’s Specialty, Generic, & Biosimilar portfolio. In this role, Penny participated in several FDA, PhRMA, and BIO cross company working groups to address regulatory policy for abuse deterrent products. Prior to that, Penny led the successful registration of Fentora®, negotiated approval of the first RiskMap for opioids, and was a driver of the initial development of the Fentora® and Actiq® REMS programs. Penny earned her bachelor’s degree in Chemistry and Biology from Florida Atlantic University, an MS in Biostatistics and Epidemiology from New York Medical College.
Ms. Kelly is an accomplished financial executive with over 20 years of experience leading private and publicly traded companies across life science, technology and e-Commerce sectors and a foundation in public accounting. Prior to joining Vallon, she most recently served as the Controller and Executive Director, Global Financial Reporting at OptiNose, Inc. (NASDAQ: OPTN), a $50M revenue specialty pharmaceutical company. Over the course of her career, she has held Senior Vice President of Finance, Controller and Chief Financial Officer positions in private and public companies such as Flower Orthopedics, Iroko Pharmaceuticals, LLC, and Genaera Corporation. Ms. Kelly began her career as an auditor with KPMG LLP. While serving in those roles, Ms. Kelly's work included multi-million dollar financings, M&A diligence and support. She also has experience in financial oversight, internal and external financial reporting, forecasting, and financial analysis, as well as investor and public relations. Ms. Kelly received her Bachelor of Science degree in Business Economics with a concentration in Accounting from Lehigh University, and is a licensed CPA (inactive status) in the state of Pennsylvania.
Ofir is an accomplished biotech entrepreneur with 15 years of experience establishing, managing, and investing in early to late stage life science companies. He was the co-head of research at a major healthcare fund focusing on deep scientific analysis of pharmaceutical and biotechnology companies. Prior to joining the hedge fund industry, Ofir was the founder and CEO at Bioassociate Ltd., an expertise-based consulting, research, and analysis company focused on the pharmaceutical, biotechnology and life science sectors. Until 2011, Ofir was the CEO of Radmor Biocap LLC, a company that invested in and managed pharmaceutical development, clinical diagnostics and medical devices for seed and early stage companies. Led by Dr. Levi Radmor, signed several license agreements with leading universities around the world for novel technologies, and established companies developing these technologies. Ofir completed his Ph.D. studies in Professor Daniel Michaelson’s neurobiology lab at Tel-Aviv University. During the four years of his Ph.D. studies, he led a research group in both in-house research and several international collaborations. Dr. Levi’s Ph.D. thesis focused on neurogenesis processes in Alzheimer's Disease.
Joseph is the President and Chief Executive Officer of Arcturus Therapeutics Ltd. He brings with him an exceptional track record of ushering novel therapeutics to the clinic, including targeted RNA medicines utilizing lipid-mediated delivery technologies. Joseph’s background includes over 20 years of successful drug discovery experience at Merck Research Labs, DuPont Pharmaceuticals, Bristol-Myers Squibb, Kalypsys, and Nitto as evidenced by over 40 publications and patents, and several investigational new drug (IND) clinical candidates. Joseph earned a Bachelor's Degree in Chemistry, magna cum laude, from Brigham Young University, a Master of Science in Synthetic Organic Chemistry from the University of Calgary and Executive Training Certification from MIT Sloan School of Management.
Richard is the Managing Owner and Chief Executive Officer of MEDICE Arzneimittel Pütter GmbH & Co. KG (Medice), a family-owned pharmaceutical company based in Iserlohn, Germany. Medice is the #1 ranked pharmaceutical company in sales of prescription ADHD medications across Europe. Richard has served as Medice’s general manager since 2003, responsible for research & development, medical & regulatory affairs, manufacturing, market access and international marketing & distribution. Richard graduated with a degree in medicine from Technical University, Munich and an internship at Harvard Medical School, Boston. His basic and clinical research on atrial fibrillation for which he obtained his PhD was awarded by the European Society in Cardiology with the Young Investigator Award in Basic Science in 2001. Specializing in cardiac and renal care, Richard pursued his clinical education in internal medicine at Massachusetts General Hospital in Boston (1996-2000), the German Heart Center (2000-2001) and the University Hospital in Muenster (2001). Richard also pursued studies in business administration and economics at University St. Gallen (1992-1996) and Harvard Extension School (1996 -1999), completing his Ph.D. in 2005. Since 2001, Richard has served as an assistant professor at University St. Gallen (Switzerland). Since 2006, Richard has served as a board member and Vice President of the German Pharmaceutical Association with a focus on R&D.
Marella has more than 30 years of accomplishments in finance and operations having successfully led multiple M&A, licensing, and fundraising transactions. She currently serves as the Chief Accounting Officer of Centessa Pharmaceuticals plc (Nasdaq: CNTA) and previously served as Head of Finance. Prior to that, Marella was the Chief Financial Officer of Palladio Biosciences, leading their finance operations and capital strategy and execution. Before joining Palladio, Marella served in various capacities at Realm Therapeutics, PLC, (Nasdaq: RLM), including Chief Financial Officer, Chief Operating Officer and Executive Director. In this role, she led accounting and financial reporting operations and helped transition Realm’s focus to drug development following a strategic overhaul. She was also responsible for divesting domestic and international operating businesses and in-licensing and out-licensing assets. Earlier in her career Marella worked for Campbell Soup Company (NYSE: CPB) in finance and operational roles of increasing responsibility and at Ernst & Young, LLP where she earned a C.P.A. Marella also serves on the Board of Essa Pharm (Nasdaq: EPIX) and on the Board of Living Beyond Breast Cancer (lbbc.org). Marella earned a B.S. in Business from Lehigh University, magna cum laude.
Dr. Faraone is a Distinguished Professor in the Departments of Psychiatry and Neuroscience & Physiology at SUNY Upstate Medical University. He is one of the world's leading authorities on the genetics of psychiatric disorders and an expert on ADHD. He has made substantial contributions to research in psychopharmacology and research methodology having authored over 1000 journal articles, editorials, chapters and books, he was the eighth highest producer of High Impact Papers in Psychiatry from 1990 to 1999 as determined by the Institute for Scientific Information. In 2005, ISI determined him to be the second highest cited author for Attention Deficit Hyperactivity Disorder. From 2014 to 2019 he has been listed as a highly cited researcher by Thomson Reuters/Clarivate Analytics. In 2019 and 2020, his citation metrics placed him in the top 0.01% of scientists across all fields. In 2021, expertscape indicated he was the top-rated expert in ADHD, worldwide.
In 2002, Dr. Faraone was inducted into the CHADD Hall of Fame in recognition of outstanding achievement in medicine and education research on attention disorders. In 2004 and 2008, Faraone was elected Vice President of the International Society of Psychiatric Genetics and in 2019, he received the Paul Hoch Award from the American Psychopathological Association. In 2008, he received the SUNY Upstate President's Award for Excellence and Leadership in Research. In 2019, he was elected President of the World Federation of ADHD. Dr. Faraone also currently serves as the Senior Scientific Advisor to the Research Program Pediatric Psychopharmacology at the Massachusetts General Hospital and a lecturer at Harvard Medical School. Over the course of his career, Dr. Faraone has been principal investigator on several National Institutes of Health funded grants studying the nature and causes of mental disorders in childhood. Additionally, Dr. Faraone heads the adult ADHD education initiative at www.adhdinadults.com and is Biostatistical and Methodology Editor for the Journal of Attention Disorders.
Dr. Newcorn is a Professor of Psychiatry and Pediatrics and Director of the Division of ADHD and Learning Disorders at the Icahn School of Medicine at Mount Sinai. He is a highly regarded researcher in the areas of ADHD, aggression, descriptive psychopathology of child and adolescent disorders, and child and adolescent psychopharmacology, whose work spans both clinical and translational topics. Over the course of his career, he has published over 350 articles and book chapters on these and related subjects. Dr. Newcorn has received numerous awards for his work, including the Hulse Award for lifetime achievement from the New York Council on Child and Adolescent Psychiatry (2002), and the Elaine Schlosser Lewis Award for Research in Attention Deficit Disorder (2018). He was elected to the CHADD Hall of Fame in 2014
Dr. Newcorn is the Principal Investigator or Co-Investigator on several NIH-funded grants that examine the clinical, genetic, neuroanatomic and neurophysiologic basis of ADHD its treatment, as well as the neurobiological basis of substance abuse risk. He also directs an active clinical trials program, and has studied many of the recent medication treatments for ADHD. Dr. Newcorn is an internationally recognized educator and mentor, and is an editorial board member of several leading child psychiatry/psychology and psychopharmacology journals. He was a member of the steering committee of the NIMH-funded multicenter study “Multimodal Treatment of Children with ADHD (MTA)” and the DSM-IV advisory committees on child and adolescent disorders and disruptive behavior disorders. He was a founding member of the board of directors of the American Professional Society for ADHD and Related Disorders (APSARD), and has served as President since 2020.
Dr. Rostain is Chief of Psychiatry and Behavioral Health at Cooper University Healthcare, Chair and Professor of Psychiatry and Pediatrics at Cooper Medical School of Rowan University, and is Emeritus Professor of Psychiatry and Pediatrics at the University of Pennsylvania Perelman School of Medicine. He is a well-established leader in neurodevelopmental psychiatry, ADHD and related disorders, and college student mental health. His clinical focus is lifespan neurodevelopmental psychiatry, which includes caring for patients with ADHD, Autism Spectrum Disorders, Tourette Syndrome, Learning Disabilities (verbal and nonverbal), Neurogenetic Disorders (e.g., Fragile X, Rett) and related social-emotional learning disorders. Dr. Rostain served as Vice Chair of Education for the Department of Psychiatry at Perelman School of Medicine from 1998-2017 and was Co-Chair of the University of Pennsylvania's Task Force on Student Psychological Health and Welfare from 2014-2016. Dr. Rostain was President of APSARD from 2011-2016 and Co-Chair of its Education Committee from 2016-2020. He currently serves on the Medical Advisory Board of the Tourette Association of America. Dr. Rostain is a member of American Academy of Child and Adolescent Psychiatry’s Transitional Age Youth and College Student Mental Health Committee and is one of AACAP’s representatives to the Higher Education Mental Health Alliance (HEMHA).
Dr. Rostain's research is focused on improving clinical outcomes for patients with neurodevelopmental disorders across the lifespan, and on creating effective service systems for these patients and their families. He has co-authored two books on adult ADHD (with J. Russell Ramsay, Ph.D.) entitled The Adult ADHD Tool Kit: Using CBT to Facilitate Coping Inside and Out, and Cognitive-Behavioral Therapy for Adult ADHD: An Integrative Psychosocial and Medical Approach (Routledge, 2015). He is also co-author (with B. Janet Hibbs, Ph.D.) of The Stressed Years of Their Lives: Helping Your Kid Survive and Thrive During Their College Years (St. Martin’s Press, 2019).
Vallon entered into a license agreement with Medice to develop, use, manufacture, market and sell ADAIR throughout Europe. Medice currently markets several ADHD products in Europe and is the ADHD market leader in Europe based on branded prescription market share. Medice is responsible for obtaining regulatory approval of ADAIR in the licensed territory.