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Ravi Kumar, Ph.D.
Scientific Director
Dr. Ravi Kumar has served as the Scientific Director since 2014. His passion for bringing innovative medicine to Type II diabetes patients and the need for innovative drugs that differentiate mechanistically and clinically from the currently marketed drugs are the motivating force behind ARKAY Therapeutics. Dr. Kumar has a unique combination of expertise in metabolic, cardiovascular and chronic inflammatory diseases. Type II diabetes runs in Dr. Kumar's family; he knows first-hand, the challenges of Type II diabetes patients, the limitations of currently marketed drugs and the devastating consequences of diabetes-related complications. He developed the scientific rationale, product concept, methods and clinical strategies for ARKAY's anti-inflammatory beta-cell centric product platform to develop personalized medicines for treating patient specific comorbidities.
Dr. Kumar is the inventor of the U.S. and PCT patent applications titled "Formulations and Methods for Treating Metabolic Syndrome."
Dr. Kumar has distinguished experience in academia as well as in the pharmaceutical industry. As a recipient of research grants from the American Heart Association, he cloned and characterized the Angiotensin-converting enzyme (ACE) gene at The Cleveland Clinic [(Kumar, R.S. et al. (1989) J. Biol. Chem. 264: 16754-16758; Kumar, R.S. et al. (1991) J. Biol. Chem. 266: 3854-3862)]. ACE is the rate-limiting enzyme of the Renin-Angiotensin System (RAS) which controls blood pressure. It converts the hormone Angiotensin I to the active vasoconstrictor, Angiotensin II. ACE inhibitors are widely used for the clinical management of high blood pressure and hypertension. Dr. Kumar also cloned and characterized the mRNA for the alpha subunit of stimulatory GTP binding protein (G Protein), Gs as a protein differentially regulated during the development of the nervous system at New York University (NYU). Over 40% of the currently marketed drugs are modulators of G-protein coupled receptors (GPCRs).
He obtained M.S. and Ph.D. in Molecular and Cell Biology from New York University, an executive Mini-MBA in Bio-Pharma Innovation from Rutgers University, and a certification for GCP (Good Clinical Practice) from ACRP (Association of Clinical Research Professionals). Dr. Kumar obtained B.Sc. in Biology and Chemistry from National College. Prior to his 25 year career in the pharmaceutical industry, Dr. Kumar was a Research Fellow at The Cleveland Clinic Foundation, Cleveland, OH.
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During the course of his career, Dr. Kumar has held roles of increasing responsibility in small-to-medium-to-large pharmaceutical companies including Pfizer, Pharmacia Corporation and OSI Pharmaceuticals. He has relentlessly pursued excellence in proposing new ideas and developing new hypotheses to discover and develop innovative drugs for metabolic diseases and chronic inflammatory diseases. Dr. Kumar has served as either a project leader or co-project leader of several drug discovery and development projects in Type II Diabetes, Atherosclerosis, Obesity, and Chronic Inflammatory Diseases. Some of the projects include: 'beta-cell centric' therapies, inhibitors of insulin-dependent hepatic gluconeogenesis, incretin mimetics, PPAR agonists, CRF-2R activators, activators of ApoA1, inhibitors of apo(a), inhibitors of Scavenger receptor, inhibitors of TNF-alpha, inhibitors of mPGES-1 (safer Celebrex™), TLR4 blockers, inhibitors of iNOS, FXR activators etc.
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Stanley Schwartz, M.D., FACP, FACE
Emeritus Associate Professor of Medicine at the University of Pennsylvania, currently in a private practice in Ardmore, PA.
Dr. Stanley Schwartz is a renowned endocrinologist, an expert and a key opinion leader in diabetes and cardiometabolic syndrome. Dr. Schwartz actively lectures nationally, as well as internationally, about diabetes and its treatment. In the past 4 years he has been a speaker in Turks/Caicos, Istanbul, Switzerland , Belgium, Tunisia, Spain, 11 cities in China, Phillipines (AACE), Israel, Singapore and AACE 2011/2014, ADA 2014-(2015) and in October 2016 at Korean Diabetes Assoc. meeting. He has authored numerous articles in peer-reviewed scientific journals and has been a lead or co-investigator for many clinical trials (DCCT-EDIC, LOOK AHEAD). He has created a call for minimizing insulin use in ‘Type 2‘ DM and proposed a New Classification for All Diabetes and presented it in Jerusalem, at ADA 2014 and ADA/JDRF symposium 2015 and now published in Diabetes Care, which has garnered much attention.
Since leaving Penn, he has received an R-01 from the NIH for studying the Genes related to LADA (with 2 articles published), written 3 book chapters, had posters at 2012 AACE, ADA and EASD in 2014 and 2015), has had 25 peer-reviewed article’s published (incretins in Hospital, hypoglycemia, a critique of ADA DM guideline, incretins in NODAT, weight reduction in DM, and the incretin story). He is an author of the Self-Assessment Program of the American Diabetes Assoc (2007 and 2008), the 2009/2010 AACE Diabetes Guidelines, and slide modules for primary care for AACE, 2011 and 2013, and Diabetes in Control 2013-2016. He is a member or fellow of international, national, and local professional societies including an Overseas Fellow of the Royal Society of Medicine (London), European Association for the Study of Diabetes (EASD), the International Diabetes Federation (IDF), the American Diabetes Association (ADA), the American Endocrine Society (ES), College of Physicians in Philadelphia, and the American College of Physicians (ACP). He’s been elected by his peers for inclusion in Best Doctors in America® from 1996 to 2015. Though he does some research and teaches a great deal, most of his time is spent caring for patients.
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| Dr. Schwartz received his MD in 1973 from the University of Chicago in Chicago, Illinois. He then completed his residency at the University of Pennsylvania, followed by a fellowship in endocrinology and metabolism at the University of Chicago. |
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Ishwarlal Jialal, M.D., Ph.D.
Distinguished Professor of Pathology and Laboratory Medicine
Endocrinology, Diabetes and Metabolism (Retired)
Director of Laboratory for Atherosclerosis and Metabolic Research
Director, Special Chemistry and Toxicology
University of California Davis Medical. Currently in private practice.
Editor-in-chief of Metabolic Syndrome and Related Disorders (2007-17)
Dr. Jialal has published over 380 original papers and invited reviews in the areas of diabetes, atherosclerosis, lipid metabolism, nutrition and vascular biology. He has received numerous awards for his research, and has served on the editorial boards of numerous journals, including: American Journal of Clinical Nutrition, Journal of Molecular and Cellular Cardiology and Atherosclerosis. Currently, Dr. Jialal serves as section editor of the American Journal of Clinical Pathology for Clinical Chemistry and editor-in-chief of Metabolic Syndrome and Related Disorders.
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His major research interests are in the role of oxidative stress and inflammation in atherosclerosis, understanding the cellular dysfunction and the role of inflammation in metabolic syndrome, and understanding the pathobiology of diabetic vasculopathies. He also has a long-standing interest in hyperlipidemia and diabetes. His research has been funded over the years by the National Institutes of Health (NIH), the American Diabetes Association, the Juvenile Diabetes Research Foundation and the American Heart Association.
He serves on the grant review panels of the American Diabetes Association and Juvenile Diabetes Research Foundation, as well as the National Institutes of Health, including the Mentored Clinical Scientist Development Award Grant Review Panel for the K-8 awards study section and other special-emphasis panels for the National Heart, Lung and Blood Institute.
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Martin Ogletree, Ph.D.
Former Distinguished Research Fellow and Director of Thrombosis
Research, Metabolic and Cardiovascular Drug Discovery, Bristol-Myers Squibb
Dr. Ogletree led thrombosis research in Cardiovascular Drug Discovery at Merck Research Labs and at Bristol-Myers Squibb. At Merck he also led target identification and validation for the cardiovascular franchise. As Distinguished Research Fellow and Director of thrombosis research in Metabolic and Cardiovascular Drug Discovery at Bristol-Myers Squibb, he led thrombosis biology research as well as early clinical development teams, including the teams that advanced ELIQUIS (apixaban) in drug discovery, preclinical development and early clinical development.
He participated in the partnering, registration, research, and strategic positioning of PLAVIX (clopidogrel) and led the evaluation and integration of coagulation assets, including COUMADIN and the factor Xa inhibitor program, upon acquisition of DuPont Pharmaceuticals.
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Prior to joining Merck, he worked as Director of Development at Cumberland Pharmaceuticals in Nashville where he prepared an IND for ACETADOTE (acetylcysteine for injection) and contributed to an sNDA for its use in acute liver failure. At Cumberland he also led work to repurpose the thromboxane receptor antagonist, HEPATOREN (ifetroban), including manufacture of drug substance for clinical trials, planning clinical development, and preparing the IND and other regulatory documents.
Dr. Ogletree earned a B.A. in biology from Swarthmore College and a Ph.D. in Physiology from Thomas Jefferson University. He received post-doctoral training in pulmonary medicine and pharmacology at Vanderbilt University School of Medicine. He has published more than 100 articles in peer-reviewed journals. He currently serves as Adjunct Professor of Pharmacology at Vanderbilt University and on the Temple University Health System Board's Quality and Patient Safety Committee and on the Jeanes Hospital Board as chair of the Professional Affairs Committee.
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Clifford M. Davidson
Intellectual Property Attorney, Founding Partner, Davidson, Davidson &
Kappel, LLC
Clifford is a founding partner at Davidson, Davidson & Kappel, LLC, an Intellectual Property law firm with offices in New York. He counsels pharmaceutical clients in pharmaceutical patent-related matters, including patent prosecution, freedom to operate and infringement opinions, due diligence and techtransfer, and litigation. He has assisted pharmaceutical and biotech companies in creating significant and valuable patent portfolios covering their proprietary technologies. He has pioneered strategic patent focus on the pharmacokinetic profiles and the pharmacologic activity of drugs/drug formulations, and drafted and/or prosecuted patents which have protected blockbuster drugs such as Oxycontin® (oxycodone HCl extended release tablets), Ryzolt® (tramadol HCl extended release tablets), and Opana® ER (oxymorphone HCl extended release tablets). He has also drafted the patents which are the basis of protection for newer products Butrans® (buprenorphine transdermal system), Subsys® (fentanyl sublingual spray), Caldolor® (intravenous ibuprofen), Kristalose® (dry powder crystalline formulation of lactulose), among others.
Mr. Davidson received his BS in Pharmacy and his JD from Rutgers University, and is a member of the New York and New Jersey Intellectual Property Law Associations, the American Association of Pharmaceutical Scientists (AAPS) and The Controlled Release Society (Pharmaceuticals). He has been awarded MartindaleHubbell’s® AV® Preeminent rating by his peers in his field (recognizing him as having the highest legal ability and ethical standards awardable). In 2010, Mr. Davidson was given the honor of making the Commencement Speech at the Ernest Mario College of Pharmacy at Rutgers University.
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Nancy C. Motola, PhD, RAC
Former Senior Vice President of
Regulatory & Quality,
Alexion Pharmaceuticals Inc.
Nancy C. Motola, PhD, RAC, has over 30 years' experience in the Pharmaceutical Industry, encompassing both small molecules, biologics, and many therapeutic areas, in regulatory affairs and quality assurance, as well as chemical development/manufacturing. Through her consulting company, Pharma Regulatory Connection, she provides strategic Regulatory expertise for small/start-up, as well as large pharma companies.
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Nancy was previously Senior Vice President of Regulatory and Quality for Alexion Pharmaceuticals Inc. and VP Regulatory Affairs for New Haven Pharmaceuticals Inc. In these roles, she was a member of the company’s Management Team, built and managed the product compliance organization, and was responsible for the approvals of both company's first products, Soliris, a monoclonal antibody for a rare hematological condition (Alexion), and Durlaza, a controlled release aspirin product for secondary prevention of acute cardiac events (New Haven).
She also served as Senior Vice President of Regulatory Affairs for Rib-X Pharmaceuticals, a development stage anti-infective company. Prior to joining Alexion, Nancy held positions of increasing responsibility in Regulatory Affairs, and achieved approvals of several marketed products at Bayer Corp., Abbott Laboratories, and E.R. Squibb & Sons, Inc., where she also started her career as a process chemist. Nancy received her PhD and MS degrees in Medicinal Chemistry from University of Rhode Island College of Pharmacy; her B.A. degree in chemistry from Central CT. State University; and is Regulatory Affairs Certified (RAC).
She is a member of Connecticut United for Research Excellence (CURE); the Dean’s Advisory, GMP Manufacturing Facility and External BS Pharmacy Program Advisory Boards for URI College of Pharmacy; Board of Directors for the Southeastern CT Womens Network (SECTWN); a member of the Scientific Advisory Board of TaiRx (Taiwan); a founder and past chair of the Regulatory Sciences Section of the American Association of Pharmaceutical Scientists (AAPS), a steering committee member of the South Eastern CT Entrepreneurs Network (SECTen); and a frequent contributor to industry programs. |
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Hemant N. Joshi, Ph.D., MBA
Founder, TARA Innovations, LLC.
Dr. Hemant Joshi is the founder of Tara Innovations LLC, a Pharmaceutical product development Contract Research Organization (CRO). He has over 27 years' experience as a Pharmaceutical Scientist. Tara is involved in product development, analysis and technology management. Tara has a history of providing effective solutions to complex pharmaceutical development problems in a timely manner. Prior to starting Tara, Dr. Joshi worked for pharmaceutical companies such as Glaxo (India), Bristol-Myers Squibb, Forest Labs, Barr Labs, and Spectrum Pharmaceuticals in the areas formulation development, development of analytical assays and finished products. He was involved in the formulation development and scale-up of various types of dosage forms. Dr. Joshi has worked on many name brand products such as Stadol Nasal Spray (Butorphenol), Questran powder (Cholestyramine), Celexa tablets (Citalopram), Pravachol tablet (Pravastatin), Viagra nasal spray (Sildenafil), Retinoic acid capsules (Tretinoin), Fusilev Injection (Levoleucovorin), Serzone tablets (Nefazodone) etc. He has a passion for developing formulations with a desired rate of drug release and targeting the drugs to the site of action. Dr. Joshi has a particular interest in understanding in-vitro/in-vivo correlation.
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TARA Innovations has developed two Ayurvedic products which have been approved by the Indian counterpart of the FDA, Drugs Controller General of India (DCGI). They are expected to be launched in 2016.
Dr. Joshi obtained B.Pharm. and M.Pharm. from Bombay College of Pharmacy, India and a Ph.D. in Pharmaceutical Chemistry from University of Kansas. He received his MBA from Fairleigh Dickinson University. He is the author of many research articles. He writes columns on a regular basis in journals such as the Pharmaceutical Outsourcing (on NDAs) and American Pharmaceutical Review (on patents).
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