Variant Pharmaceuticals Has a New Name - ZyVersa Therapeutics, Inc.
Former Vice President, Immunology Research and Development, Janssen Pharmaceutical Companies of Johnson & Johnson
Dr. Baker is an accomplished Clinician Scientist with 20 years’ experience in the Pharmaceutical industry. As former Vice President, Immunology Research and Development at Janssen, he was responsible for the development and global approvals of Remicade and Simponi. He was also responsible for early phase development of Stelara. With his strong background in early research target identification, lead optimization, preclinical evaluation and late stage clinical development, regulatory submissions, and approvals, Dr. Baker was instrumental in developing immunology portfolio programs. Dr. Baker has expertise in both small molecule and biologic development.
Dr. Baker has a strong academic background, with 20 years’ experience in teaching, clinical practice, and research at the University of Pennsylvania School of Medicine. He received a BA in biology from Gettysburg College, and his medical degree at University of Pennsylvania. He completed a residency in medicine at Hershey Medical Center, followed by a fellowship in rheumatology at University of Pennsylvania, and a research fellowship in rheumatology at Mass General Hospital.
Former Global Head and Vice President of Immunology Research and External Innovation at Janssen Research & Development
Dr. Barbosa has over two decades of experience leading drug discovery and development programs at major pharmaceutical and biotechnology companies. Dr. Barbosa was Global Head and Vice President of Immunology Research and External Innovation at Janssen Research & Development, where he oversaw Immunology Research, including approved drugs STELARA and TREMFYA. In addition, Dr. Barbosa held positions of increasing responsibility managing new drug R&D programs at prominent biopharmaceutical firms, including Signal Pharmaceuticals, TRL USA, Chugai Biopharma, Mirna Therapeutics and Assembly Biosciences. Dr. Barbosa received a BS, Genetics degree from the University of California, Davis and a PhD, Microbiology & Immunology from the University of California, Los Angeles. He completed a post-doctoral fellowship at the National Cancer Institute.
Principal, Bioscope Associates
Formerly: Genentech, Sensus Corporation,
Dr. Bennett is a Principal of Bioscope Associates LLC. Until 2009, he was Sr. Director of Regulatory Policy at Genentech, and led the Genentech Biosimilars working group. In 2007-2009, he lectured on the emerging topic of Biosimilars and Follow-on-Biologics on five continents. He was at Genentech for 18 years altogether, having held high-level positions in Research, Bioprocess Development, and Regulatory Affairs. He helped guide Genentech over many years through his participation on the Research Review, Product Development, Process Development Review, and Appointments and Promotions Committees. Scientifically, his work on human growth hormone and tissue-type plasminogen activator has resulted in over 50 peer-reviewed publications and 19 US patents. He led the Research and Development of Activase & TNKase, (first and second generation thrombolytic treatments for Acute Myocardial Infarction, Pulmonary Embolism, and Stroke). During a period away from Genentech, as CSO at Sensus Corporation, he led the research & development of Somavert (a treatment for acromegaly) and was the VP of Research at Cor Therapeutics, and the Sr VP of R&D at Hyseq/Nuvelo. He returned to Genentech in 2003. Dr. Bennett has a B.A. in Chemistry from TCU and a Ph.D. in Biochemistry from the University of Texas Southwestern Medical School. He was named a Distinguished Alumnus of TCU in 2010, and serves on the TCU Science & Engineering Advisory Board.
Professor, Department of Neurological Surgery
The Miami Project to Cure Paralysis
University of Miami Miller School of Medicine
Dr. Bramlett received her bachelor’s degree in Psychology at the University of Texas at Austin, her MS in Psychology at the University of Louisiana at Monroe and her MS and PhD degrees in Behavioral Neuroscience from the University of Miami. She completed her postdoctoral work in Neurotrauma at the University of Miami and she received a postdoctoral fellowship award from the American Heart Association.
Dr. Bramlett is actively involved in undergraduate teaching and serves as Director of the Undergraduate Neuroscience Program at the University of Miami. Dr. Bramlett is an internationally recognized scientist with over 20 years’ experience in the field of CNS injury including the pathophysiology and treatment of traumatic brain and spinal cord injury as well as stroke. Her laboratory focuses on three areas of traumatic research:
Scientific Director, The Miami Project to Cure Paralysis, UM
Kinetic Concepts Distinguished Chair in Neurosurgery
Senior Associate Dean for Discovery Science and Co-Director of the Institute for Neural Engineering, UM
Professor, Neurological Surgery, Neurology, Biomedical Engineering, and Cell Biology
Dr. Dalton Dietrich is the Kinetic Concepts Distinguished Chair in Neurosurgery and Scientific Director at The Miami Project to Cure Paralysis at the University of Miami Miller School of Medicine. He received his Ph.D. in Anatomy from the Medical College of Virginia in 1979 and completed a postdoctoral fellowship in the Department of Pharmacology at Washington University, St. Louis. Since 1981, Dr. Dietrich has been a faculty member at the University of Miami and is currently Professor of Neurosurgery, Neurology, Biomedical Engineering and Cell Biology. He also serves as Senior Associate Dean for Discovery Science and Co-Director of the Institute for Neural Engineering.
Research in Dr. Dietrich’s laboratory is focused on clarifying the pathophysiology of brain and spinal cord injury with the goal of developing new therapies to protect and enhance recovery. His seminal work in therapeutic hypothermia helped change medical practice for treating cardiac arrest, neonatal encephalopathy and other neurological disorders. Dr. Dietrich is a founding member of InflamaCORE, LLC, and collaborates on studies targeting inflammasome signaling to discover novel therapeutic and diagnostic strategies. He has been listed by the Institute of Scientific Information as a “Highly Cited Researcher” placing him in the top 0.5% of all scientists on the impact his research has made on other scientists. He serves on study sections for NIH, Department of Defense and various Foundations. He is Editor-In-Chief of the Journal Therapeutic Hypothermia & Temperature Management and Deputy Editor of the Journal of Neurotrauma.
Research Assistant Professor, Department of Neurological Surgery, UM
The Miami Project to Cure Paralysis
Dr. de Rivero Vaccari is currently a Research Assistant Professor in the Department of Neurological Surgery & The Miami Project to Cure Paralysis at the University of Miami - Miller School of Medicine. He has studied the innate immune response for 14 years and was the first to show the involvement of the inflammasome in vivo in a sterile event, particularly after spinal cord injury. Dr. de Rivero Vaccari has also contributed to studies of the innate immune response following brain injury, stroke, aging, multiple sclerosis, depression, sciatic nerve pain, Alzheimer’s disease, male infertility, male pattern baldness, wound healing, disc degeneration and corneal degeneration. In addition, he has conducted biomarker research on stroke, spinal cord and brain injury, multiple sclerosis, depression and mild cognitive impairment.
Dr. de Rivero Vaccari graduated Summa Cum Laude with a B.S. in Biology from Florida International University where he was inducted into the Phi Beta Kappa honor society (2004). He then pursued his Ph.D. in Physiology & Biophysics at the University of Miami in the laboratory of Dr. Robert Keane (2007) and his post-doctoral fellowship in Neurotrauma at The Miami Project to Cure Paralysis in the laboratory of Dr. Dalton Dietrich (2010). In addition, Dr. de Rivero Vaccari has trained on Biomarker Science at the Harvard Clinical and Translational Science Center and on Computational Immunology at the Santa Fe Institute. He is currently pursuing a Master of Science degree in Business Analytics at the Miami Business School of the University of Miami.
Dr. de Rivero Vaccari is a managing member of InflamaCORE, LLC., an Associate Editor for the Journal Frontiers in Molecular Neuroscience, and he has served as an ad hoc reviewer for over 60 different scientific journals. He has co-authored over 50 peer-reviewed articles, and his work has been cited over 3,000 times.
CEO, Flatirons Biotech, Inc.
Former Cofounder and Chief Technical Officer, Coherus Biosciences
Mr. Farrar has over 30 years of biotech industry experience. He spent 18 of those 30 years with Amgen, starting as a process development engineer in 1987 when the company had 250 employees. Prior to Amgen, he worked for Monsanto in their biotech animal health division, and after Amgen worked as senior vice president of operations for Insmed, and later as chief technical officer of Coherus. Throughout his career, Mr. Farrar has successfully worked with numerous corporate partners in the U.S., Europe and Japan. He has extensive experience in process development, clinical manufacturing and commercial manufacturing. His previous responsibilities include cell-line development, cell banking, fermentation/cell culture, purification, fill/finish, lyophilization, outsourced manufacturing, engineering and logistic operations. Mr. Farrar has been involved in filing 16 Investigational New Drug (IND) Applications and two Biological License Applications (BLAs). He has worked with dozens of products developed by recombinant DNA technology in microbial, yeast and mammalian cells manufactured in-house or at contract manufacturing facilities, and has built a process development pilot plant and multi-product clinical manufacturing plant from the ground up, as well as expanded, renovated and retooled commercial manufacturing facilities with hundreds of kilograms to multi-metric ton output capabilities. Mr. Farrar has hosted numerous US FDA, European and Health Canada prior approval and periodic inspections, and has been involved in many Pre-IND, EOP2, Pre-BLA, Post-Approval Change, Type C, and similar meetings with the FDA, MHRA, EMEA, and other regulatory agencies. He received a Bachelor of Science in chemical engineering from the University of Missouri, Rolla (now known as Missouri University of Science and Technology) in 1986.
Chairman Emeritus, former Chief Scientific Officer at Coherus BioSciences
Formerly: Genentech, Amgen, Merck, Coherus
Dr. Herman has more than 32 years of experience at some of the most significant companies in the biopharmaceutical space. He started his career at Merck, working on recombinant hepatitis B vaccine. Later, at Genentech, he focused on process development and pharmaceutics, contributing to the development of human growth hormone, tissue plasminogen activator, and interferon. At Amgen, he started the Analytical Research and Development Department, which he managed for 11 years. The cutting-edge analytics that emerged from this effort significantly contributed to radical changes in the regulatory review of recombinant products, leading to the “well defined biological products” characterization that enabled more rapid product development. This work helped lay the groundwork for biosimilar products in regulated markets.
During Dr. Herman’s tenure at Amgen, his department contributed to more than 20 INDs and several BLAs. In 2003, he became Senior Director of Quality Control for Tercica, Inc., a start-up that in-licensed a late-stage compound (IGF-1) from Genentech. His group designed a comparability program that would minimize the need for further clinical trials. Dr. Herman also supervised contract laboratories in areas such as product characterization, method development and validation, release testing, and clinical and commercial stability. Dr. Herman served as CSO and Vice President of Product Development at Althea until 2011, when he joined Coherus Biosciences.
Dr. Herman holds B.S. and M.S. degrees in biology from Indiana University of Pennsylvania and a Ph.D. in protein chemistry from Duke University.
Professor, Physiology and Biophysics, Neurological Surgery and Microbiology, and Immunology, UM
The Miami Project to Cure Paralysis
Dr. Keane received his bachelor’s degree in biology from SUNY, College at Buffalo and his MS and Ph.D. degree in Genetics from the University of California, Davis. From 1976-1980 he completed a postdoctoral fellowship in Molecular Biology and Neuroscience at the Massachusetts Institute of Technology and he received a postdoctoral fellowship award from the Leukemia Society of America.
Dr. Keane is Professor of Physiology and Biophysics, Neurological Surgery and Microbiology and Immunology at the University of Miami, Miller School of Medicine. Dr. Keane is actively involved in medical education and is head coordinator of the Neuroscience and Behavioral Science module for MD and MD/MPH students, and is the recipient of the “Teacher of the Year” award. Over the last 30 years his research has focused on understanding the innate immune response in the central nervous system. Dr. Keane is the discoverer of inflammasomes in neurons after central nervous system injury. Dr. Keane currently is the recipient of a fast-track STTR grant from the National Institutes of Health to develop a biologic to treat central nervous system injury, and has published extensively in fields of neuroinflammation and neuroimmunology. He is a founding member of InflamaCORE, LLC, a company dedicated to treating and diagnosing inflammatory injury and disease.