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Management
Randall L. Carpenter, MD Dr. Carpenter has over 25 years of experience in medicine, basic science and clinical research and pharmaceutical drug development including leading several research and development teams to submit successful INDs, NDAs and sNDAs. He has held a number of leadership positions in the pharmaceutical and biotechnology industries including President and Chief Executive Officer of Sention, Vice-President of Clinical Research & Development and Regulatory Affairs at Adolor Corporation, Director of Clinical Research at Astra USA and member of the Global Therapeutic Area Team at Astra Pain Control Sweden. Prior to joining industry, Dr. Carpenter held academic faculty appointments at the University of Washington and Wake Forest University. Dr. Carpenter has co-authored 65 journal articles, holds several patents and has served as editor-in-chief or on the editorial boards of four medical journals. He has frequently been an invited speaker at national and international meetings and symposia and has been an invited visiting professor to numerous domestic and international universities and medical schools. Dr. Carpenter completed a fellowship in pharmacokinetics at the University of California San Francisco and a sabbatical in molecular biology at the University of Washington and is Board Certified in anesthesiology and pain management. Dr. Carpenter earned his MD at The University of Michigan Medical School and completed his residency at the Virginia Mason Medical Center.
John C. Amedio, Jr., PhD Dr. Amedio has twenty years of experience in major and start-up pharmaceutical companies. He has extensive experience in all aspects of chemistry, manufacturing and controls (CMC), including regulatory agency document preparation, quality assurance, active pharmaceutical ingredient synthesis, drug product pre-formulation and formulation, analytical methods development and the preparation of clinical trial material for the appropriate developmental stage worldwide. Dr. Amedio has delivered numerous profitable and patented manufacturing processes for active pharmaceutical ingredients and finished drug product (injectable and oral dosage forms). He is the author and co-author of several peer-reviewed articles, publications and patents and has given numerous invited presentations. Prior to joining Seaside Therapeutics Dr. Amedio was Vice President, Manufacturing & Process Development, ZIOPHARM Oncology, Inc., Executive Director, Analytical and Chemical R&D, EPIX Pharmaceuticals Inc. and Unit Leader, Chemical Research and Development Department, Sandoz Research Institute (currently Novartis Pharmaceuticals). Dr. Amedio completed his PhD in Organic Chemistry from the University of Delaware and completed post-doctoral research at Oregon State University.
Daniel E. Geffken Mr. Geffken brings more than 25 years of financial and operational management experience to Seaside, 16 of which have been in the life sciences industry. He has been the chief financial officer of seven companies, ranging from venture-backed start-ups to publicly-held corporations. Mr. Geffken has played a critical role in building infrastructure, managing fundraising and investor relations and leading organizations in several high growth life science companies, including Transkaryotic Therapies, Inc. (later acquired by Shire plc), CytoTherapeutics, Inc. and Omnisonics Medical Technologies, Inc. During his career, he has raised more than $700 million through debt and equity financings. He joins Seaside from Codon Devices, Inc., where he was Senior Vice President and Chief Financial Officer. Mr. Geffken has a BS in Economics from The Wharton School, University of Pennsylvania and an MBA from Harvard Business School.
Aileen M. Healy, PhD Dr. Healy has over 15 years of experience in disease biology, leading independent research efforts in the areas of neuroscience, cardiovascular pathophysiology, oncology and inflammation. From 2001 until 2008, Dr. Healy held positions of increasing responsibility at Momenta Pharmaceuticals and Millennium Pharmaceuticals. Her prior preclinical research in drug discovery and development included significant contributions to target identification, lead optimization, in vivo pharmacology and biomarker discovery for small molecules and biologics. Before taking those positions, Dr. Healy was a faculty member at Boston University School of Medicine, where her research focused on cellular and molecular mechanisms of pulmonary development and disease. Dr. Healy holds patents and has published in peer-reviewed journals on a wide range of topics including biomarkers and the molecular mechanisms of disease. Dr. Healy received her PhD in cellular biology at Tufts University Medical School and completed her postdoctoral training in the molecular biology of the blood vessel wall at the Massachusetts Institute of Technology.
Tanya N. Lewis Ms. Lewis has over 15 years in the biotechnology field, 12 of which have been in regulatory affairs. She has experience in all phases of drug development and across varied therapeutic areas, including oncology, cardiovascular, pulmonology, rheumatology and metabolism. She has played a critical role in developing the strategy and leading the interactions with the U.S. Food and Drug Administration on Investigational New Drug Applications, New Drug Applications and key labeling supplements. Ms. Lewis joins Seaside Therapeutics from Vion Pharmaceuticals, Inc., where she was Vice President, Regulatory Affairs and Quality Assurance. Prior positions include leadership roles at Millennium Pharmaceuticals Inc. (later acquired by Takeda Pharmaceutical Company Limited) and Genzyme Corporation. At Millenium, she had regulatory oversight for the company’s oncology pipeline and played a leading role in the strategy development for the regulatory approval and launch of Velcade®, Millenium's lead anticancer product. While at Genzyme, she held increasing roles of responsibilities in both quality and regulatory affairs. Ms. Lewis has a MS from the Massachusetts College of Pharmacy and Allied Health Sciences, with a concentration in regulatory affairs and health policy.
Jack Morgan Mr. Morgan brings over 30 years of broad general management, marketing, planning, finance and business development experience at life science companies, including Baxter, Genetics Institute, Wyeth, Dyax and Syntonix. He has led product out-licensing and partnering efforts generating over $200 million in collaborative R&D revenues from partners in the U.S., Europe and Japan. In addition, he has in-licensing efforts for products ranging from pre-clinical through Phase 3 and marketed products. He has also managed commercial organizations as large as $400 million in annual revenues. Much of his experience was with novel products to treat orphan diseases. Mr. Morgan has a BA in Economics from Yale University and an MBA from the Stanford Graduate School of Business.
W. Roger Rush, PhD Dr. Rush brings thirty years of international experience in pharmaceutical research and development to Seaside. His major career focus has been on preclinical research and development, particularly the transition of discovery research candidates into clinical development where he has provided drug metabolism, pharmacokinetics and preclinical drug safety evaluation expertise. Throughout his career he has contributed to numerous drug registration dossiers including Investigational New Drug Applications, Clinical Trial Authorizations, New Drug Applications and Marketing Authorization Applications. He joins Seaside Therapeutics from Wolfe Laboratories, Inc., where he was Vice President, Preclinical Development. His prior experience also includes senior management positions at Critical Therapeutics, Inc., Roche Palo Alto LLC, Scotia Pharmaceuticals (acquired by QuantaNova Ltd) and Quintiles Scotland Ltd. Dr. Rush holds a BSc and a PhD both in Biochemistry from the University of Surrey in the UK.
Mike Walsh Mr. Walsh is the Human Resources Consultant to Seaside. He has over 18 years of experience in human resources in life sciences. He has consulted to early stage biotechnology, diagnostic tools and medical device companies. His experience cover all areas of human resources including employment, compensation, equity, benefits, management development, organizational development, mergers/acquisitions and HR information systems. Prior to his work as a consultant, he was Vice President, Human Resources at Vertex Pharmaceuticals in Cambridge, Massachusetts. His experience includes roles as Vice President, Human Resources of both Genzyme Corporation and BioSurface Technology. Mr. Walsh earned a BS degree from the University of Vermont in Education and has completed advanced course work in Counseling.
Paul P. Wang, MD Dr. Wang brings more than 15 years of experience in pediatric neurodevelopmental disorders and pediatric drug development to Seaside. Prior to joining Seaside, Dr. Wang was a Senior Director in Clinical Development for Pfizer Global Research & Development where he provided clinical leadership for multiple pediatric drug development projects spanning epilepsy, migraine, bipolar disorder, schizophrenia and ADHD. Prior to Pfizer, Dr. Wang was a member of the faculty at the University of Pennsylvania and Children's Hospital of Philadelphia where his research and clinical work focused on children with developmental disabilities, especially those resulting from genetic syndromes. Dr. Wang has authored more than 25 peer-reviewed publications in the field of developmental-behavioral pediatrics and has provided consultation to the Food and Drug Administration and the National Institute of Health related to his research and to pediatric drug development. Dr. Wang holds leadership roles in the Society for Developmental-Behavioral Pediatrics and the American Academy of Pediatrics and has served on the editorial board of the Journal of Developmental-Behavioral Pediatrics and the Board of Developmental-Behavioral Pediatrics. He has also served on advisory boards of support organizations for families of children with special needs. Dr. Wang earned his undergraduate degree at Harvard College, his MD at Yale University School of Medicine and served his residency and chief residency in Pediatrics at the University of Michigan. He completed a research fellowship in developmental cognitive neuroscience at the Salk Institute and a clinical fellowship in developmental-behavioral pediatrics at the Children's Hospital of Philadelphia.
Peter Zarevics Mr. Zarevics brings more than 30 years of domestic and international drug development experience and a diverse, multi-disciplinary background spanning preclinical neuropharmacology, medical writing, clinical research operations and infrastructure engineering/re-engineering. During his career, Mr. Zaverics has worked in diverse environments including large pharmaceutical companies (SmithKline Beecham, Merck), a rapidly expanding new company (Astra Merck), a contract research organization (G.H. Besselaar, now Covance), biotechnology (Stressgen Biotechnologies, Sention) and as an independent consultant. Mr. Zarevics has participated in more than 10 NDA, sNDA and MAA engagements over multiple therapeutic areas including CNS. Mr. Zarevics is a graduate of the University of Pennsylvania. |
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