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Gregory Stein, M.D., M.B.A.
Chief Executive Officer
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 was 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 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.
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David M. Weiner, M.D.
Chief Medical Officer
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.
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Michelle Rose, Ph.D.
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.
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Lawrence J. Trost, Ph.D., DABT
Vice President, Toxicology & Nonclinical Development
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.
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Mark Sorenson, Ph.D.
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.
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Daniel Pertschuk, M.D.
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.
