CURTANA - Key Persons
Job Titles:
- Professor and Director of the Neural Stem Cell Lab, Department of Neurosurgery, University of Florida
Job Titles:
- Consultant, Clinical Development
Dr. Pertschuk has spent the last 30 years working in positions of increasing responsibility in small to medium-size biotechnology companies. During this period Dr. Pertschuk has conducted Phase 1 through Phase 3 studies for a diverse group of clinical candidates that includes small molecules, monoclonal antibodies, vaccines and gene therapies. For the past 14 years Dr. Pertschuk has been closely involved in the adult, primary malignant brain tumor space; most recently at Tocagen (NASDAQ: TOCA), where he led the early-stage clinical development of the company's treatment for glioblastoma.
Job Titles:
- Chief Medical Officer
- Member of the Management Team
Dr. Weiner most recently served as the Chief Executive Officer at Amathus Therapeutics. He has over 25 years of experience in the discovery and clinical development of novel therapeutics for neurological and rare diseases. He started his career at ACADIA Pharmaceuticals, where, over a ten-year period, he held a series of discovery research and clinical development roles working on multiple CNS therapeutics, most notably pimavanserin which is approved for the treatment of Parkinson's disease psychosis. He subsequently joined EMD Serono in a late clinical development role, ultimately leading early clinical development activities in neurology globally. Dr. Weiner has extensive experience in rare disease drug development, serving as Chief Medical Officer and Interim CEO for Proteostasis Therapeutics, and as CMO at aTyr Pharma and Lumos Pharma.
Dr. Weiner received his M.D. from the School of Medicine and Biomedical Sciences, SUNY at Buffalo, and was a Howard Hughes Medical Institute Research Scholar at the NIH in Bethesda. He trained in clinical neurology at New York Hospital, Memorial Sloan Kettering, Cornell Medical Center, and did a post-doctoral fellowship in neuropharmacology at the University of Vermont. Dr. Weiner has authored over 30 scientific publications and multiple patents and serves on multiple clinical and scientific advisory boards, including the Michael J. Fox Foundation for Parkinsons Research.
Job Titles:
- Member of the Board of Directors
- Fellow of the Australian Academy of Technological Sciences
Dr. Gary W Pace has more than 40 years of experience in the development and commercialization of advanced life sciences and related technologies, spanning biotechnology, pharmaceuticals, medical devices, and food industries. He is a serial entrepreneur and has held senior positions in small- and large-scale life sciences ventures and companies in the USA, Canada, Europe, Australia and New Zealand. He has long-term board level experience with multi-billion and small cap companies with an in-depth knowledge of all aspects of technical operations, compensation and corporate governance. Currently, he is a Director of Pacira Pharmaceuticals (NASDAQ: PCRX), Simavita Ltd. (ASX: SVA), Antisense Therapeutics (ASX: ANP) and Invitrocue (ASX: IVQ) as well as several private companies.
Dr. Pace is an elected Fellow of the Australian Academy of Technological Sciences and Engineering, as well as author or co-author of over 70 research papers and patents. In 2003, Dr. Pace was awarded a Centenary Medal by the Australian Government for service to Australian society in research and development. Dr. Pace holds a Ph.D. from MIT, where he was a Fulbright Scholar.
Job Titles:
- Member of the Management Team
- Vice President, Regulatory Affairs
Dr. Michelle Rose established Michelle Rose, Inc. after 20 years of working in the pharmaceutical and biotech industry as both in-house Regulatory support for Sponsor companies and as a consultant in all phases of the drug development process from discovery through clinical research to licensing. She endeavors to serve as a trusted, experienced partner when bringing strategic regulatory advice to clients. Dr. Rose has extensive experience with Orphan Drug and Rare Disease Development Programs as well as FDA's Expedited Programs for Serious Diseases and Conditions including Fast Track Designation, Accelerated Approval, Breakthrough Therapy Designations, and Priority Review. She also has extensive experience with other unique regulatory pathways, such as NDA Approval under the Animal Efficacy Rule. She has worked with FDA on Expanded Access programs, including Emergency INDs and Intermediate Size Expanded Access Programs and has led and participated in FDA Advisory Committees.
Prior to becoming a consultant, Dr. Rose served as Vice President of Regulatory Affairs for Chimerix, Inc, an antiviral focused drug development company, where she built the Regulatory Affairs and Operations functions. Over the course of 8 years, her department of one overseeing a single FIH clinical program grew to encompass both US and EU based employees conducting global Phase 3 clinical trials and preparing for simultaneous NDA and MAA submissions. Prior to her time with Chimerix, Dr. Rose served as a Regulatory Authority Liaison at Biolex Therapeutics and EMD Pharmaceuticals, where she was the regulatory lead for global development projects in antiviral and oncology therapeutic areas and led US submissions for small molecule NCEs for treatment of Type 2 diabetes and for one of the first products approved by the FDA under the Animal Efficacy Rule.
Dr. Rose earned a BS in biochemistry from Case Western Reserve University and PhD in toxicology from the University of North Carolina at Chapel Hill.
Job Titles:
- Professor, Department of Pathology, University of California at San Diego
Professor of Neurosurgery in the Department of Surgery and Professor in the Department of Molecular Genetics at The University of Toronto, Principal Investigator at The Arthur and Sonia Labatt Brain Tumour Research Centre, at Staff Neurosurgeon at The Hospital for Sick Children
Job Titles:
- Chief Executive Officer
- Member of the Board of Directors
- Member of the Management Team
Dr. Stein co-founded Curtana Pharmaceuticals and became the company's Chief Executive Officer in April, 2013. During his professional career of over 30 years, he has been a clinician and a life sciences executive with experience in the areas of diagnostics, medical devices, pharmaceuticals and biotechnology.
Prior to co-founding Curtana, Dr. Stein served as the Vice President, Operations and Medical Affairs at Sova Pharmaceuticals, Inc., a venture-backed company he co-founded in March, 2010. The company is focused on the development of novel therapeutic drugs for the treatment of inflammatory and neuropathic pain. Prior to Sova, he was the Senior Director of Product Marketing at Genoptix, which was recently acquired by Novartis. Genoptix is a specialized laboratory service provider focused on delivering personalized and comprehensive diagnostic services to community-based hematologists and oncologists. Prior to joining Genoptix, Dr. Stein was an entrepreneur with a focus on identifying innovative technology for commercial development in the medical therapeutic, device and diagnostic areas. He has been the founder of two other early-stage drug development companies, Opus Pharmaceuticals and Uzima Bioscience.
Before pursuing a career in the business world, Dr. Stein practiced Emergency Medicine in a busy urban hospital on the west side of Chicago where he served as the Assistant Medical Director of the department and Associate Emergency Medical Services Director for the regional EMS system.
Dr. Stein is formerly board certified in Emergency Medicine. He completed his residency at the University of Illinois Affiliated Hospitals in Chicago and is a graduate of the 3-year accelerated Independent Study Program at the Ohio State University School of Medicine. Dr. Stein received a B.A. in Psychology from UC San Diego and an M.B.A. from The Rady School of Management at UC San Diego.
Job Titles:
- Professor of Radiation Oncology, Head of the Translational Neuro - Oncology Laboratory, Mayo Clinic
Dr. Trost has 23 years nonclinical operations and development experience within the CRO, Sponsor and Consultant settings. Previous companies at which he has worked include Cato Research, Triangle Pharmaceuticals, Gilead Sciences, and Chimerix. Dr. Trost's focus is nonclinical strategy development and implementation including study design, management and reporting across all phases of development of drugs and biologics from pre-IND through approval via 505(b)(1), 505(b)(2) and Animal Rule pathways. He has a wide range of experience and expertise, including developing drugs, biologics, devices and combination products delivered orally and by implantation, inhalation, topically, ocular, intra-articular, subcutaneous, intravenous and other parenteral routes for infectious, cardiovascular, genetic, oncology, ocular, autoimmune, respiratory, liver, CNS, bone, pain/analgesics, contraception (male and female), CBERN, endocrinology, neonatal, skin, addiction (opiate and nicotine), storage disorders and gastrointestinal diseases and indications. He has contributed to the progression of over 100 pharmaceutical candidates and 6 marketed products, including the nucleoside analogs Emtricitabine (Truvada) for the treatment of HIV and Adefovir (Hepsera) for treatment of Hepatitis B.
Dr. Trost is a Diplomat of the American Board of Toxicology. He received a Doctor of Philosophy in Toxicology from the University of North Carolina, Chapel Hill; a Master of Science Degree in Pharmacology from the University of Minnesota; and a Bachelor of Science Degree in Chemistry from the University of Minnesota.
Job Titles:
- Head of CMC Development at Curtana Pharmaceuticals
- Head, CMC Development
Dr. Sorenson is Head of CMC Development at Curtana Pharmaceuticals. He brings over 25 years of experience in the pharmaceutical industry to Curtana. Dr. Sorenson has extensive experience consulting for pharmaceutical companies where he provides Chemistry, Manufacturing and Controls (CMC) leadership associated with the development of small molecule new chemical entities. His areas of expertise include analytical method development/validation and transfers, stability programs and data assessment, chemical process development, formulation and process development, API and drug product manufacturing and CMC regulatory document preparation. He previously held positions of increasing responsibility at Agouron Pharmaceuticals, Warner Lambert, Pfizer, and MGI Pharma. Dr. Sorenson earned his Ph.D. in Pharmaceutics and B.S. in Pharmacy at the University of Minnesota.
Job Titles:
- Member of the Board of Directors
- COO of Mist Pharmaceuticals
Mr. Simonetti is currently the COO of Mist Pharmaceuticals. Prior to that, Mr. Simonetti served as VLST's President and CEO from 2005 to 2013. From 1999 to 2005, he was employed at Dendreon Corp., most recently serving as the CFO, Senior Vice President Finance and Treasurer. From 1991 to 1998, he was employed at Amgen Inc., serving as the VP of Operations and Finance of Amgen BioPharma and its Director of Colorado Operations. From 1984 to 1991, he worked at Genentech, Inc., first as a scientist in its Medicinal and Analytical Chemistry Department and later as a financial analyst and group controller.
Besides Curtana Pharmaceuticals, Mr. Simonetti serves on the Board of Directors of Nexgenia, EpiThany and VLST Corp., Inc. He served on the Boards of Directors of Alexandria Real Estate Equities (NYSE: ARE), from 2005 - 2013 and Icagen, Inc., a Nasdaq company, from 2005 until its sale to Pfizer in 2011. He was also a past member of the Dean's executive advisory board for the Albers School of Business and Economics at Seattle University and former chairman of the board of Life Sciences Washington. He received an M.S. and B.S. from the University of California, Davis and an M.B.A. from the University of Santa Clara.
Job Titles:
- Professor of Neurosurgery in the Department
Professor of Neurosurgery in the Department of Surgery and Professor in the Department of Molecular Genetics at The University of Toronto, Principal Investigator at The Arthur and Sonia Labatt Brain Tumour Research Centre, at Staff Neurosurgeon at The Hospital for Sick Children
Job Titles:
- Member of the Board of Directors
- Director of Neuro
- Director of Neuro - Oncology
Director of Neuro-oncology, Professor of Neurosciences, and Chairman of the Department of Translational Neuro-oncology and Neuro-therapeutics, John Wayne Cancer Institute
Dr. Kesari is currently the Director of Neuro-oncology, Professor of Neurosciences, and Chairman of the Department of Translational Neuro-oncology and Neuro-therapeutics at the John Wayne Cancer Institute. From 2009 through 2015, he was the Director of the Neuro-Oncology Program, Director of the Neurotoxicity Treatment Center, and Director of the Translational Neuro-Oncology Laboratories at Moores Cancer Center and a Professor of Neurosciences at the UC San Diego School of Medicine. Prior to coming to UC San Diego in 2009, he was an Assistant Professor of Neurology at the Dana-Farber Cancer Institute and Brigham and Women's Hospital in Boston from 2003 to 2009.
Dr. Kesari was determined to be among the top 1% neuro-oncologists and neurologists in the nation, according to Castle Connolly Medical Ltd., which reports its findings as the U.S. News & World Report Top Doctor list. He is a winner of an Innovation Award by the San Diego Business Journal. He is on the advisory board of American Brain Tumor Association, San Diego Brain Tumor Foundation, Chris Elliott Fund, Nicolas Conor Institute, Voices Against Brain Cancer, and Philippine Brain Tumor Alliance. He has been the author of over 200 scientific publications and is the inventor on several patents and patent applications.
Dr. Kesari is board certified in Medical Oncology and Neurology. He completed his residency at Massachusetts General Hospital/Brigham and Women's Hospital in Boston and his fellowship at the Dana-Farber Cancer Institute in Boston. He earned a Ph.D. degree in molecular biology and a medical degree from the University of Pennsylvania School of Medicine. He is a member of the Society of Neuro-Oncology, American Society of Clinical Oncology, Indian Society of Neuro-Oncology, and American Academy of Neurology.
Professor, Research Group Head, Oncogenic Signaling, Hudson Institute of Medical Research. Associate Professor of Cancer Biology, Monash University, Director, Brain Cancer Discovery Collaborative
Job Titles:
- Associate Professor, Department of Pediatrics, Section of Hematology - Oncology, Baylor College of Medicine, Houston, TX