Renowned Endocrinologist, Dr. Stan Schwartz, Regulatory Strategies Expert Dr. Nancy Motola And Formulations Expert, Dr. Hemant Joshi Join ARKAY Therapeutics’ Scientific Advisory Board

East Windsor, NJ — ARKAY Therapeutics, LLC announces the appointment of Dr. Stanley Schwartz, a renowned diabetes expert and key opinion leader, Dr. Nancy Motola, a regulatory strategies veteran and Dr. Hemant Joshi, formulations development expert to ARKAY Therapeutics’ scientific advisory board. “We are delighted to have these exceptional individuals join ARKAY’s team. We are confident that with these new additions to our existing scientific advisory board and the current members of the board, ARKAY has assembled the team it needs to advance its innovative pancreatic beta-cell centric combination product, RK-01 to the clinic and to the market by the year 2020” said Ravi Kumar, Ph.D., President and CEO of ARKAY Therapeutics.

Dr. Stanley Schwartz, MD, FACP, FACE is a renowned endocrinologist, an expert and a key opinion leader in diabetes and cardio-metabolic syndrome. He is an emeritus Associate Professor of Medicine at the University of Pennsylvania, currently in a private practice in Ardmore, PA. 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, Philippines (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 II‘ 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 Association (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.

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. Nancy C. Motola, PhD, RAC, has over 30 years of 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. 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 companys’ 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.

Dr. Hemant Joshi, Ph.D, MBA is the founder of Tara Innovations LLC, a Pharmaceutical product development Contract Research Organization (CRO). He has over 27 years of 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.

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).

####

About ARKAY Therapeutics

ARKAY Therapeutics is a privately-held pre-IND stage biopharmaceutical company located in East Windsor, NJ. We are dedicated to developing and commercializing personalized medicines for Type II diabetes, Prediabetes and metabolic disease-related disorders. Type II diabetes is characterized by progressive deterioration of pancreatic beta cell dysfunction and insulin resistance. In spite of intense therapies with the modalities used for the currently marketed therapies patients, experience deterioration of metabolic control of glucose homeostasis which is indicative of progressive deterioration of pancreatic beta-cell dysfunction. Lack of adequate glycemic control prevents almost 50% of the patients from reaching their target goals for blood glucose (A1c), blood pressure and cholesterol levels. Inflammation-mediated pancreatic beta-cell dysfunction triggers insulin resistance. ARKAY was founded with a mission to develop an orally-active combination product that would target maximum number of clinically relevant pathways that contribute to deterioration of pancreatic beta-cell function with a minimum number of drugs to provide long-term sustainable glycemic control, treat patient-specific comorbidities and more importantly prevent or reduce the severity of diabetes-related complications. ARKAY is currently advancing an orally-active combination product, RK-01 to the clinic. RK-01 fills clinically the most important gap that exists in the modalities by blocking multiple distinct yet overlapping signaling pathways along immune dysregulation-inflammation-insulin resistance axis. Based on the preclinical and the clinical data, treating the underlying inflammatory component of the complex pathophysiology of Type II diabetes with an anti-inflammatory beta-cell centric therapy represents a new shift in the paradigm of clinically managing type diabetes efficiently. Currently, there are no beta-cell centric therapies on the market for treating either Type II diabetes or prediabetes. RK-01 was efficacious and safe in C57BL/6J DIO (Diet-induced Obesity) translational mouse model with insulin resistance and pancreatic beta cell dysfunction. Study results were presented at the 76th Scientific Sessions of the American Diabetes Association, June 10-14, 2016, New Orleans, LA. ARKAY Therapeutics is on track to bring RK-01 to market by the year 2020 to treat a pandemic with an enormous market potential. We invite you to visit our web site: www.arkaytherapeutics.com to find out why now is the best time to invest, collaborate and partner with us and learn more about how our products differentiate clinically and mechanistically from the drugs that are on the market for treating Type II diabetes.

Back to news