Scientific Advisory Board
Charles A. Dinarello, MD | SAB Chairman, co-Chief Scientific Officer
Charles A. Dinarello, MD serves as Chairman of Olatec's Scientific Advisory Board and Chief Scientific Officer. Dr. Dinarello joined Olatec’s Drug Development Team in January 2014 and became a member of the Scientific Advisory Board in May 2014. Dr. Dinarello elucidated the mechanism of action of dapansutrile (OLT1177) as an NLRP3 inhibitor that prevents the formation of the NLRP3 inflammasome, which in turn inhibits the production of bioactive IL-1β and IL-18. Dr. Dinarello’s ongoing translational research for Olatec is on the molecular mechanism and pharmacology of dapansutrile and the OLT Analogues. Dr. Dinarello is considered one of the world’s leading experts on cytokine biology, with a focus on interleukin IL-1 and IL-18 as mediators of inflammation. Dr. Dinarello is considered one of the founding fathers of cytokines. Dr. Dinarello was the first to identify IL‑1α in 1974 and completed the purification of IL-1β in 1977. His group reported the first cDNA for IL-1β in 1984. He has published over 1000 original research articles and 250 reviews and book chapters on inflammatory cytokines, particularly on IL-1, the IL-1 family and related cytokines. He has trained over 50 investigators, many of whom are recognized experts in their fields. The Institute for Scientific Information listed Dinarello as the world’s 4th most-cited scientist during the 20 years 1983 to 2002; and from 1996 to 2011 he was listed as one of 400 of the world’s most influential biomedical researchers. In 1998, Dr. Dinarello was elected to the United States National Academy of Sciences, and in 2010, he was made a foreign member of the Royal Netherlands Academy of Sciences. Dr. Dinarello received his medical degree from Yale University, clinical training at the Massachusetts General Hospital and from 1971 to 1977, he was senior investigator at the National Institutes of Health in Bethesda. Dr. Dinarello is presently Distinguished Professor at the University of Colorado’s School of Medicine, where he is Professor of Medicine and Immunology; he is also Professor of Experimental Medicine at Radboud University in the Netherlands. Dr. Dinarello has received numerous honorary degrees, awards and medals from among the most prestigious universities and research institutes around the world. He is a member of the Board of Governors of the Weizmann Institute (Israel) and Ben Gurion University (Israel) and former Vice President of the American Society of Clinical Investigation and President of the International Cytokine Society. Dr. Dinarello has received honorary degrees from the University of Marseille (France), the Weizmann Institute (Israel), the University of Frankfurt (Germany), Roosevelt University (USA), Albany Medical College (USA), Radboud University (Netherlands), Trinity College (Ireland), the University of Bonn (Germany) and Aarhus University (Denmark). For his contributions to the field of cytokines and medicine, he received the Squibb Award (USA), Ernst Jung Prize in Medicine (Germany), Gold Medal of the Heilmeyer Society for Internal Medicine (Germany), Chirone Prize (Italian National Academy of Medicine), Carol Nachman Prize (Germany), Sheikh Hamdan bin Rashdid al Maktoum Award (United Arab Emirates), Beering Prize (USA), Albany Prize in Medical Research (USA), Crafoord Prize of the Royal Swedish Academy of Sciences (Sweden), Paul Ehrlich Prize (Germany), Bonfils-Stanton Prize (USA), the Novartis Prize in Clinical Immunology (Switzerland), the Bonazinga Award (USA) and Drexel Prize in Immunology (USA). Dr. Dinarello received the Lifetime Achievement Award of the Eicosanoid Foundation for his pioneering studies on the role of lipids in cytokine-mediated inflammation. In 2017, Dr. Dinarello was awarded the Meinhard von Pflaundler Medal, Ludwig Maximillan University (Germany) and the Cerami Prize (USA). Dr. Dinarello donates the monies from his awards and prizes to The Interleukin Foundation, a charitable foundation he established in 2009, which supports research on cytokines, particularly to young investigators.
Joseph P. St. Laurent | co-Chief Scientific Officer
Joseph P. St. Laurent serves as the Olatec’s co-Chief Scientific Officer. Since July 2005, Mr. Laurent has been responsible for all aspects of the chemical drug development and analysis of dapansutrile and the OLT Analogues. Mr. St. Laurent is President and Chief Scientific Officer of Chemic Laboratories Inc., which he co-founded in 1998. Prior to establishing Chemic, Mr. St. Laurent served for 10 years in various technical and management roles at several New England contract research organizations. Mr. St. Laurent served as a research associate at the Eunice Kennedy Shriver Center, where his research surrounded the area of childhood genetic disorders (specifically those caused by abhorrent levels of lysosomal enzymes) and implications of outside influences on the causation of such disorders. Mr. St. Laurent’s educational credentials include a BS degree in Biology-Biochemistry from Bridgewater State College (now Bridgewater State University) in 1988; advanced postgraduate organic and physical chemistry studies at Bridgewater State College from 1988-1989; advanced studies in mass spectral data interpretation in 1991 at Analytical Education Center, Atlanta, Georgia; and management development studies at Suffolk University in 1991.
Curtis L. Scribner, MD | Chief Medical Officer
In December 2006, Curtis L. Scribner, MD, joined Olatec’s Drug Development Team. Dr. Scribner, who serves as Chief Medical Officer, was appointed to Olatec’s Scientific Advisory Board in November 2014. Dr. Scribner has been contributing leading expertise to the clinical development of dapansutrile in the design and conduct of Olatec’s human clinical trials, and acts as a member of the Safety Committee for Olatec’s clinical trials. Dr. Scribner is an independent consultant and was previously Senior Vice President of Medical and Regulatory Affairs at RRD International, LLC. Dr. Scribner is a board certified physician in internal medicine and has direct experience running large clinical programs. He joined RRD from Intarcia Therapeutics, where he was the Vice President of Regulatory and Quality Affairs and Chief Regulatory Officer. Previously, Dr. Scribner was Chief Regulatory Consultant for Quintiles Consulting, where he developed and wrote numerous NDA, BLA, IND, IDE, 510(k), PMA and MAA applications. Prior to Quintiles Consulting, Dr. Scribner spent 10 years at FDA, where he held a variety of positions and was involved in reviewing products regulated by the Center for Biologics. Dr. Scribner holds an MD from the University of Colorado College of Medicine, an MBA from the University of Maryland College of Business and Management and a BA in Biology from Grinnell College.
Antonio Abbate, PhD, MD | Cardiology
In 2016, Antonio Abbate, MD, PhD, a prominent leader in the field of heart disease, joined Olatec’s Drug Development Team and became a member of the Scientific Advisory Board in March 2017. For Olatec, Dr. Abbate has been contributing to the development of dapansutrile in the design and conduct of Olatec’s preclinical programs in cardiovascular disease, as a result of his deep knowledge and expertise in the research of NLRP3 inflammasome and its inhibition of the release of IL-1β and IL-18. In 2018, Dr. Abbate served as Principal Investigator in a Phase 1b trial with dapansutrile in subjects with stable systolic heart failure. During the COVID-19 pandemic, Dr. Abbate has been serving as a member of VCU’s COVID-19 Clinical Trials committee and principal investigator or co-investigator on phase 2/3 trials with anti-viral and anti-inflammatory treatments, including IL-1β biologics to treat moderate to late stage COVID-19 patients. Dr. Abbate is board certified in Internal Medicine and Cardiovascular Medicine. Dr. Abbate currently holds the endowed James C. Roberts, Esq. Professor of Cardiology of the Virginia Commonwealth University (VCU) Pauley Heart Center and serves as an attending physician in the General Cardiology, and the Coronary Intensive Care Unit, and as Medical Director of Clinical Research Services Unit of the Center for Clinical and Translational Research. Dr. Abbate leads a multidisciplinary team in the VCU Pauley Heart Center and the Johnson Research Laboratories, examining the role of inflammation in cardiac diseases. Dr. Abbate is also principal investigator on several preclinical research studies and pilot clinical studies funded by, among others, the National Institute of Health, and the American Heart Association, aimed at identifying novel anti-inflammatory therapies for patients with acute myocardial infarction or heart failure. Dr. Abbate also performs clinical duties in the Coronary Intensive Care Unit, the General Cardiology Practice and the Ambulatory Care Center at VCU Medical Center. Dr. Abbate is a Fellow of the American College of Cardiology, Fellow of American Heart Association, and Fellow of the European Society of Cardiology. Dr. Abbate has authored or co-authored over 300 articles, reviews and editorials that have been published in professional journals. In addition, he has participated in more than 350 oral and poster presentations to national and international meetings. Dr. Abbate is a member of the editorial board of the American Journal of Cardiology, the Journal of Cardiovascular Pharmacology, PLOS ONE, and Translational Medicine and is a peer reviewer for more than twenty international journals. Dr. Abbate received his Medical Degree from University Campus Bio-Medico of Rome, Italy and completed a Clinical Fellowship in Adult Cardiovascular Medicine and a PhD in Molecular and Cellular Cardiology at the Catholic University of the Sacred Heart, Rome, Italy. In Rome, Dr. Abbate trained under Drs. Attilio Maseri and Filippo Crea. Dr. Maseri’s group pioneered the understanding of the role of inflammation in heart disease and proposed the use of the IL-1 biologic, anakinra, to treat acute myocardial infarction. Dr. Abbate then completed an additional Internal Medicine Residency program at VCU Hospitals in Richmond, Virginia.
Roy D. Altman, MD | Rheumatology & Radiology
In June 2010, Roy D. Altman, MD, world-renowned KOL in the fields of Analgesics, Immunology, and Rheumatology joined Olatec’s Drug Development Team and Scientific Advisory Board. He is a recognized pioneer in the field of Osteoarthritis, with his longstanding success in the clinical development of topical and oral therapies to treat arthritic patients. Dr. Altman has been contributing leading expertise to the clinical development of dapansutrile in the design and conduct of Olatec’s human clinical trials. Dr. Altman has over 40 years of clinical experience in Rheumatology with a special interest in Osteoarthritis. He is Professor of Medicine, at the Division of Rheumatology and Immunology at the University of California, Los Angeles. He is Professor Emeritus at the University of Miami Miller School of Medicine, where he was Chief of Rheumatology and Immunology as Professor of Medicine, with a secondary appointment as Professor of Orthopedics. He is retired from the Miami Veterans Administration Medical Center, where he was chief of rheumatology and clinical director of the Geriatric Research, Education, and Clinical Center (GRECC). Dr. Altman is a founding board member and past President of the Osteoarthritis Research Society International. He started and for 16 years was Editor-in-Chief of that organization’s official journal, Osteoarthritis and Cartilage. He was co-editor of Seminars in Arthritis and Rheumatism for over 20 years. In addition, Dr. Altman has contributed to the medical literature with over 200 juried manuscripts and over 60 book chapters. With Dr. Roland Moskowitz, he edited the fourth edition of the text Osteoarthritis: Diagnosis and Management. He initiated the journal Cartilage for the International Cartilage Repair Society, where he continues as Associate Editor. Dr. Altman is a member and Master of the American College of Rheumatology (ACR), in addition to membership in several other medical societies. He is a former delegate to the American Medical Association, and board member of the Paget’s Disease Foundation. The Osteoarthritis Research Society awarded him the Clinical Science Award in 2001 and the Lifetime Achievement Award in Osteoarthritis in 2007. Dr. Altman holds an MD from the University of Miami Miller School of Medicine.
William J. Cunningham, MD | Dermatology & Clinical Design
William J. Cunningham, MD joined Olatec’s Drug Development Team in August 2011 and became a member of the Scientific Advisory Board in November 2012. Dr. Cunningham has been contributing leading expertise to the clinical development of dapansutrile in the design and conduct of Olatec’s human clinical trials, also serving as Medical Monitor in several of Olatec’s clinical trials. Dr. Cunningham has over 30 years of experience in clinical research. He is the founder and president of Cu-Tech, LLC, a CRO, and is a board certified dermatologist and lead drug development consultant to many pharmaceutical companies in the U.S. and abroad. Formerly the Assistant Vice President and Director of Medical Affairs at Roche Dermatologics, a division of Hoffman-La-Roche, he acquired broad clinical development experience as director of the dermatological and infectious disease programs, where he initiated and supervised dozens of individual programs in the development, licensing, and strategic alliance areas. Following his long association with Hoffmann La-Roche, Dr. Cunningham founded Cu-Tech, LLC, in 1993. He was on the faculty at Columbia University for over a decade. Dr. Cunningham remains active as a fellow of the American Academy of Dermatology, a member of the Society for Investigative Dermatology and a member of the Drug Information Association. Dr. Cunningham holds an MD from the State University of New York at Buffalo School of Medicine and a BS from Niagara University. He trained in dermatology in the U.S. Public Health Service and Columbia-Presbyterian Medical Center.
Robert H. Dworkin, PhD | Clinical Design & Assay Sensitivity
In December 2013, Robert H. Dworkin, PhD joined Olatec’s Drug Development Team and became a member of the Scientific Advisory Board in April 2016. Dr. Dworkin is contributing leading expertise to the development of OLT1177™ Gel in the design of Olatec’s Clinical Trials Program, specifically with regards to assay sensitivity. Dr. Dworkin currently serves at the University of Rochester School of Medicine and Dentistry as Professor of Anesthesiology, Neurology, and Psychiatry and also as Professor in the Center for Human Experimental Therapeutics. Dr. Dworkin is also the Director of the Analgesic, Anesthetic, and Addiction Clinical Trial Translations, Innovations, Opportunities, and Networks (ACTTION) public-private partnership with FDA; a member of the U.S. Centers for Disease Control and Prevention Zoster Working Group; and a Special Government Employee of FDA Center for Drug Evaluation and Research. Dr. Dworkin received the American Pain Society’s Fordyce Clinical Investigator Award in 2005 and Bonica Public Service Award in 2014, the Eastern Pain Association’s Bonica Award in 2011, and the American Academy of Neurology’s Max Award for Neuropathic Pain in 2015. Dr. Dworkin received his doctorate from Harvard University in 1977 and his BA from University of Pennsylvania in 1971.In December 2013, Robert H. Dworkin, PhD joined Olatec’s Drug Development Team and became a member of the Scientific Advisory Board in April 2016. Dr. Dworkin is contributing leading expertise to the development of OLT1177™ Gel in the design of Olatec’s Clinical Trials Program, specifically with regards to assay sensitivity. Dr. Dworkin currently serves at the University of Rochester School of Medicine and Dentistry as Professor of Anesthesiology, Neurology, and Psychiatry and also as Professor in the Center for Human Experimental Therapeutics. Dr. Dworkin is also the Director of the Analgesic, Anesthetic, and Addiction Clinical Trial Translations, Innovations, Opportunities, and Networks (ACTTION) public-private partnership with FDA; a member of the U.S. Centers for Disease Control and Prevention Zoster Working Group; and a Special Government Employee of FDA Center for Drug Evaluation and Research. Dr. Dworkin received the American Pain Society’s Fordyce Clinical Investigator Award in 2005 and Bonica Public Service Award in 2014, the Eastern Pain Association’s Bonica Award in 2011, and the American Academy of Neurology’s Max Award for Neuropathic Pain in 2015. Dr. Dworkin received his doctorate from Harvard University in 1977 and his BA from University of Pennsylvania in 1971.
Robert M. Fielding, MS | Preclinical & Clinical Pharmacology and Pharmacokinetics
Robert M. Fielding joined Olatec’s Drug Development Team in September 2013 and became a member of the Scientific Advisory Board in November 2018, contributing leading expertise in the design and conduct of Olatec’s pharmacology programs. Mr. Fielding has over 30 years of experience in the pharmaceutical and biotech industries, including formulation evaluation, preclinical pharmacokinetics/toxicokinetics, pharmacology and clinical pharmacokinetic studies for more than 30 products now approved or in clinical trials. He has contributed over 90 articles, abstracts and reviews on the subjects of liposomal antibiotics, bronchodilators and antineoplastics, hemoglobin-based oxygen carriers, oligonucleotides, inhalation delivery, sustained release formulations and drug delivery systems. Prior to founding Biologistic Services in 1998, Mr.Fielding held positions at Liposome Technology, Somatogen, Nexagen and NeXstar Pharmaceuticals, Inc. He is a member of the American Association of Pharmaceutical Scientists, the American Society for Microbiology and the Society of Toxicology. Mr. Fielding received his BS in Chemistry and his MS in Organic Chemistry from University of California, Riverside, and studied Physiology at the University of California, San Francisco.
Shayne C. Gad, PhD, DABT | Toxicology
Shayne C. Gad, PhD, world-renowned KOL in the field of Nonclinical toxicology and safety, joined Olatec’s Drug Development Team in November 2011 and became a member of the Scientific Advisory Board in November 2012. Dr. Gad has been contributing leading expertise to the development of dapansutrile and the OLT Analogues in the design and conduct of Olatec’s Nonclinical program. Dr. Gad has over 38 years of broad based experience in toxicology, drug and device development, statistics and risk assessment. He has specific expertise in neurotoxicology, in vitro methods, cardiovascular toxicology, inhalation toxicology, immunotoxicology and genotoxicology. Dr. Gad is the principal of Gad Consulting Services, a 23 year old consulting firm with 8 employees and more than 500 clients (including 120 pharmaceutical companies in the U.S. and 50 overseas). Prior to this, he served in director-level and above positions at Searle, Synergen and Becton Dickinson. Dr. Gad has direct involvement in the preparation of INDs (over 100 successfully to date), NDAs, PLAs, ANDAs, 510(k)s, IDEs, CTDs, clinical databases for Phase 1 and Phase 2 studies, and PMAs. He has consulted for FDA, EPA and NIH, and has trained reviewers and been an expert witness for FDA. He has also conducted the triennial toxicology salary survey as a service to the profession for the over 25 years. Dr. Gad has authored or edited more than 47 published books and more than 350 chapters, articles and abstracts in the fields of toxicology, statistics, pharmacology, drug development and safety assessment. He is a past President of the American College of Toxicology, the Roundtable of Toxicology Consultants and three of Society of Toxicology’s specialty sections, and recipient of the American College of Toxicology Lifetime Contribution Award. Dr. Gad received his BS from Whittier College in Chemistry and Biology and his PhD in Pharmacology/Toxicology at The University of Texas at Austin.
Leo A. B. Joosten, PhD | Immunology & Cellular Biology
In August 2014, Leo A. B. Joosten, PhD, world-renowned KOL in the field of degenerative and inflammatory arthritis, joined Olatec’s Drug Development Team and joined Olatec’s Scientific Advisory Board in September 2015. For Olatec, Dr. Joosten is collaborating with Dr. Dinarello on in vitro, in vivo and ex vivo studies that target specific cytokines to better understand the MOA of dapansutrile and the OLT Analogues. Dr. Joosten is Professor of Mechanisms of Inflammatory Diseases, Department of Internal Medicine, at Radboud University in the Netherlands where he is also head of the Research Laboratory of Experimental Medicine. In addition, he is a visiting professor at the University of Colorado School of Medicine. During the past five years, his research has focused on the role of cytokines in the pathogenesis of chronic inflammation and was aimed to find novel inhibitors to treat patients with these inflammatory diseases. His research group demonstrated for the first time that the novel cytokine IL-32 is an important pro-inflammatory mediator in arthritis and has investigated the function of the protein complex called the “inflammasome” in gouty arthritis and Lyme disease. Dr. Joosten’s recent research is focused on gout and uric acid. He has published over 400 original research articles in the areas of rheumatology, infectious diseases, immunology and endocrinology and metabolism. In 2008, the article of Joosten LAB et al. “Anticytokine treatment of established type II collagen-induced arthritis in DBA/1 mice: A comparative study using anti-TNF alpha, anti-IL-1alpha/beta, and IL1-Ra”. Arthritis Rheum 1996;39:797-809” was selected as one of the ten best articles of the last fifty years for the 50th anniversary of the Arthritis & Rheumatism journal. Dr. Joosten holds several patents including US 61/890,354: Gout diagnosis in whole blood samples (2013). He is board member of the following committees: selection committee of the Radboud UMC PhD competition; European Gout consortium (EuroGout); and scientific committee of the first international Crystal Network Meeting in Paris. Dr. Joosten holds Master’s degrees from HMLS, Oss, Netherlands and HAN, Nijmegen, Netherlands. He was awarded a doctorate degree from Radboud University Medical Centre, Nijmegen, Netherlands in 1999 with his thesis titled “Targeting of cytokines in experimental arthritis.”
Viola T. Kung, PhD, JD | Intellectual Property
In September 2013, Viola T. Kung, PhD, JD joined Olatec’s Scientific Advisory Board. Dr. Kung has been assisting Olatec in the creation and management of Olatec’s Intellectual Property portfolio since the filing of Olatec’s first patent application in September 2005. Dr. Kung is a Partner in Perkins Coie’s Patent Procurement practice focusing on patent prosecution and patent counseling in the chemical, pharmaceutical, diagnostics, biotechnology and small molecule arenas. She is experienced in reexamination, appeal and interference proceedings before the U.S. Patent and Trademark Office. Her other client counseling activities include opinion work, freedom-to-operate and due diligence evaluation. Through her extensive research and industrial training as a development director and as a research scientist, Dr. Kung has broad R&D experience in formulation, assay development, in vitro diagnostics, protein and DNA interaction, lipid bilayer membrane, conjugation chemistry and molecular biology and is an inventor of a total of 21 U.S. patents. Dr. Kung also has numerous publications in scientific journals. Dr. Kung is ranked by Chambers USA, as "America's Leading Life Sciences; IP/Patent Litigation Lawyers, in 2016, and listed in the Best Lawyers in America in patent law in 2016. Dr. Kung is recognized by Managing Intellectual Property as an IP Star in 2013, 2014, and 2016. Dr. Kung is also named by the Daily Journal as a "Top 25 Intellectual Property Portfolio Managers" in 2010, 2012. She is a member of the American Bar Association. Dr. Kung received a BS in Chemistry from National Taiwan University, a PhD in Chemistry-Biochemistry from University of California, Berkeley, and a JD from Santa Clara University School of Law.
Peter Libby, MD | Cardiology
In December 2014, Peter Libby, MD, world-renowned KOL in the field of cardiology, joined Olatec’s Scientific Advisory Board and Drug Development Team. For Olatec, Dr. Libby is focusing his efforts on conducting in vivo studies seeking to establish the Lead Compound’s ability to treat cardiovascular disease. Dr. Libby was the Chief of Cardiovascular Medicine at Brigham and Women’s Hospital in Boston, Massachusetts for over 15 years. He also serves as the Mallinckrodt Professor of Medicine at Harvard Medical School. His current major research focus is the role of inflammation in vascular diseases such as atherosclerosis. Dr. Libby has received numerous awards and recognitions for his accomplishments, most recently including the Gold Medal of the European Society of Cardiology (2011), the Basic Research Prize of the American Heart Association (2011), Award for Lifetime Achievements in Cardiology from the Austrian Society of Cardiology (2012), Anitschkow Prize in Atherosclerosis Research from the European Atherosclerosis Society (2013), the Lifetime Achievement Award from the Heart Failure Association of the European Society of Cardiology (2014), and the Jung Foundation Gold Medal for Medicine in 2016. His areas of clinical expertise include general and preventive cardiology. Dr. Libby’s professional memberships include the Association of American Physicians, the American Society for Clinical Investigation, and elected honorary memberships in the British Atherosclerosis Society, the Japan Circulation Society, and the Japanese College of Cardiology. He has served as the President of the Association of University Cardiologists. He also has served in many roles as a volunteer for the American Heart Association, including chairman of several research committees and member of the executive committees of the Councils on Arteriosclerosis, Circulation, and Basic Science. He has served two terms as Chairperson of the American College of Cardiology’s Research Allocations Peer Review Committee. He directed the DW Reynolds Cardiovascular Clinical Research Center and two cycles of Leducq Foundation Awards, and has received continuous funding from the National Heart, Lung, and Blood Institute for several decades. An author and lecturer on cardiovascular medicine and atherosclerosis, Dr. Libby has published extensively in medical journals including Circulation, Journal of Clinical Investigation, Proceedings of the National Academy of Sciences, New England Journal of Medicine, and Nature. He is one of the Editors of Braunwald’s Heart Disease, having served as the Editor-in Chief of the 8th Edition. Dr. Libby has also contributed chapters on the pathogenesis, treatment, and prevention of atherosclerosis to Harrison’s Principles of Internal Medicine. He has held numerous visiting professorships and has been selected to deliver some 90 named or keynote lectures throughout the world. Dr. Libby earned his medical degree at the University of California, San Diego, and completed his training in internal medicine and cardiology at the Peter Bent Brigham Hospital (now Brigham and Women’s Hospital). He also holds an honorary MA degree from Harvard University, and an honorary doctorate from the University of Lille, France.
Howard I. Maibach, MD | Dermatology & Dermatotoxicology
In January 2010, Howard I. Maibach, MD, KOL in the field of Dermatology and Dermatopharmacology, joined Olatec’s Scientific Advisory Board and Drug Development Team. Dr. Maibach has been contributing leading strategic expertise to clinical development and market positioning of dapansutrile, as well as in the areas of topical drug development and dermal toxicology. Dr. Maibach is a board certified physician with over 50 years of experience in dermatology in medical practice, academic and commercial settings. Dr. Maibach is a Professor of Dermatology at the University of California, San Francisco School of Medicine. He has vast experience with drug development programs, with a specific focus on preclinical and clinical protocol development for topical products. He has written and lectured extensively on dermatotoxicology (the toxicity to man from skin exposure) and dermatopharmacology (the treatment of skin diseases). During his career Dr. Maibach has held positions in the field of dermatology and pioneered research in the area of dermatotoxicology. He is a member of American College of Physicians, American Academy of Dermatology and American Dermatological Association. He is on the editorial board of journals including International Journal of Dermatology, Recent Advances in Dermatology, Journal of Clinical Research and Pharmacoepidemiology, Journal of European Academy of Dermatology and Venereology, Journal of Applied Toxicology and Clinical Therapeutic. He has published over 2,400 articles dealing with dermatological topics. Dr. Maibach holds an MD from Tulane University, two honorary PhDs from L’Universite de Paris-Sud and Université Claude Bernard Lyon and an AB completed at Tulane University.
Steven B. Newhard | Manufacturing
Steven B. Newhard joined Olatec’s Drug Development Team in July 2014 and became a member of the Scientific Advisory Board in November 2018. He is responsible for development and manufacturing of dapansutrile at CMOs undertaking with cGMP production of the active drug substance and drug product. Mr. Newhard has over 40 years of experience in the pharmaceutical and regulatory industry, including over 20 years as a senior executive responsible for quality operations and multiple years as a senior executive responsible for supply chain, technical operations, and product development. Prior to entering the industry, Mr. Newhard served as an employee of FDA for over 10 years. His pharmaceutical experience includes the development, submission and approval of multiple NDAs and ANDAs encompassing multiple dosage forms including tablet, parenteral and topical drug products. Mr. Newhard received his BS degree in Biology from Washington College in Chestertown, MD.
Marc J. Philippon, MD | Orthopedics
In September 2013, Marc J. Philippon, MD joined Olatec’s Scientific Advisory Board and Drug Development Team, and Dr. Philippon is contributing leading expertise to the development of topical dapansutrile in the design of Olatec’s Clinical Trials Program. Dr. Philippon is currently managing partner at The Steadman Clinic and serves as co-chairman of the Steadman Philippon Research Institute. Dr. Philippon is Board member of Vail Health Services and a Board member of the United States Ski and Snowboard Foundation. He is an Adjunct Associate Professor of Orthopaedic Surgery, University of Pittsburgh School of Medicine. Dr. Philippon is internationally known for performing joint preservation techniques utilizing arthroscopic hip surgery to treat painful joint injury in high-level athletes who constantly use powerful hip rotation. Dr. Philippon is board certified by the American Board of Orthopaedic Surgery, is an Active member with the American Orthopaedic Society for Sports Medicine and the Arthroscopy Association of North America. He is also a Fellow with the American Academy of Orthopedic Surgeons and is a Master Instructor with the Arthroscopy Association of North America. He is an elected member of the Herodicus Society and is a Founding member of the International Society of Hip Arthroscopy (ISHA). Dr. Philippon earned his medical degree from McMaster University Medical School in Ontario, Canada.
Amy K. Poshusta, PhD | Regulatory
Amy Poshusta, PhD joined Olatec’s Drug Development Team in December 2012 and became a member of the Scientific Advisory Board in December 2019. Dr. Poshusta is Olatec’s liaison to FDA and relevant European regional regulatory bodies. Dr. Poshusta has lead responsibility for all submissions to regulatory agencies as well as compliance requirements of the Company’s open regulatory applications, e.g., IND’s and IMPDs. Dr. Poshusta has over 15 years of pharmaceutical experience and involvement in all aspects of pharmaceutical development including clinical, nonclinical, and Chemistry, Manufacturing and Controls (CMC), for the major regulatory markets including the USA, EU, Australia and Canada. Her pharmaceutical experience encompasses proprietary drugs and new indications and/or dosage forms for existing drugs. Dr. Poshusta received her BA degree in Mathematics/Physics from Whitman College and her MS and PhD in Chemical Engineering from the University of Colorado at Boulder.
Lucio C. Rovati, MD | Rheumatology
In September 2015, Lucio C. Rovati, MD, joined Olatec’s Scientific Advisory Board and in July 2016 joined the Olatec Board of Directors. For Olatec, Dr. Rovati brings extensive experience in drug development and clinical programs. Dr. Rovati is CEO and CSO of Rottapharm Biotech S.r.l., the R&D spin-off of the former Rottapharm pharmaceutical company. Rottapharm Biotech is a company of biotechnologies committed to the discovery, research and development of new innovative drugs, both chemical and biological in nature. Dr. Rovati has held numerous academic positions and he currently is Visiting Professor of Clinical Pharmacology at the University of Milano-Bicocca, School of Medicine. Dr. Rovati is a member of several international scientific societies. Dr. Rovati’s research focuses on pharmacology and clinical pharmacology in different therapeutic areas, with a predominance in Rheumatology. He has authored or co-authored over 190 full papers published in peer reviewed international scientific journals and 15 book chapters. Related scientific activity includes authorship of over 400 abstracts and selected/invited presentations in international congresses. Dr. Rovati holds a degree in Medicine and Surgery from the University of Milano, Italy, with specialization in Clinical Pharmacology.
F. Kip Vought | Global R&D Strategy & Regulatory Development
Kip Vought joined Olatec’s Drug Development Team in October 2009 and became a member of the Scientific Advisory Board in November 2012. Mr. Vought is Olatec’s advisor on strategies in connection with 1) development programs leading to market approvals for the product pipeline, as well as 2) regulatory communications to FDA and other regulatory agencies. Mr. Vought has over 20 years of pharmaceutical experience and involvement in all aspects of pharmaceutical development including clinical; nonclinical; in addition to Chemistry, Manufacturing and Controls (CMC) for the major regulatory markets including the U.S., EU, and Canada. His pharmaceutical experience encompasses proprietary drugs, new indications and/or dosage forms for existing drugs, and generic drugs. Mr. Vought has taken multiple products successfully from early development through the submission of market applications and onto post-approval activities. Along with providing strategic expertise for these pharmaceutical development programs, Mr. Vought has written and coordinated the preparation of multiple clinical trial applications and market applications. He was one of the founders of Regulus Pharmaceutical Consulting, Inc., which became the Regulatory and Strategic Development Group at Clinipace Worldwide, consultants to the pharmaceutical industry on strategy development and managing development programs. Mr. Vought also led M&A due diligence on the behalf of private equity, venture capital, investment banks, and pharma companies evaluating development programs. He also represented clients during and after partnering with larger pharmaceutical partners. Mr. Vought is currently the Vice President of Development at Scilex Pharmaceuticals, Inc. a pharmaceutical company focused on acquiring and commercializing prescription products with more efficient and effective delivery solutions for the treatment of pain. Mr. Vought received his BS degree in Chemistry from the University of Miami.
J. Richard Steadman, MD | Orthopedics, ex officio
Olatec’s co-founder, J. Richard Steadman, MD, is a world-renowned KOL in the fields of Orthopaedics and Sports Medicine. Dr. Steadman is the Founder of the internationally known Steadman Clinic in Colorado. He has over 40 years of experience in the field of orthopaedics and is recognized worldwide for his innovative surgical procedures developed over time and employed today by orthopaedic surgeons practicing throughout the world. The Steadman Philippon Research Institute (SPRI) has one of the largest patient databases in existence, and its research supports the evidence-based practice of Orthopaedics at the Steadman Clinic. Dr. Steadman and the Institute have published over 70 research articles and have presented over 150 research papers at national and international conferences. In 2015, Dr. Steadman was inducted into the American Orthopaedic Society for Sports Medicine’s (AOSSM) Hall of Fame, honoring individuals in the sports medicine community who have contributed immensely and set themselves apart from others in the field. Dr. Steadman has also received a number of some of the most prestigious international medical awards and honors, including: the American Orthopedic Society for Sports Medicine, the Cabaud Award, the International Knee Society Albert Trillat Award, the Gots-Beiersdorf Research Award of Germany and the American Orthopaedic Society for Sports Medicine 2005 Award, among others. Following his internship at Charity Hospital in New Orleans, Dr. Steadman and his family spent two years in Germany, where he served as the Commander of an Armored Medical Company in the U.S. Army. He returned to Charity Hospital for his orthopaedics residency, which he completed in 1970. Dr. Steadman graduated from Texas A&M University in 1959 and then the Medical School at the University of Texas, Southwestern Medical School in 1963.