SUSTAINED NANO SYSTEMS, LLC

small answers to big problems

Sustained Nano Systems, LLC (SNS) is a privately held drug delivery technology company whose research facility is located on the campus of Stony Brook University as part of the Center for Biotechnology.

The company utilizes its expertise in small particle behavior to produce short and long term sustained drug delivery with applications for a variety of fields, including chronic disease states, where repetitive dosing is required.

The SNS program is the result of a comprehensive research effort that has demonstrated its ability to administer drugs via short or long term micro-dosing. This allows for the continuous release of drugs to targeted tissues from weeks to years, as prescribed.  Its resorbable drug-loaded nano and microparticles offer both enhanced drug release kinetics and high dose capacity. In-vitro and in-vivo studies   demonstrate that the SNS system can be used across a wide spectrum of drugs, utilizing multiple delivery modalities and a sustained drug release as prescribed.  Such parameters assure that full dosing compliance is achieved without the inherent difficulties of patient self-medication.

The Company has two divisions:

  1. SNS Applied Delivery: Established to partner its delivery mechanism with companies wishing to adapt SNS technology for their own drugs.
  2. SNS Ophthalmology: Developing SNS drug candidates for FDA approval.  This   includes drugs to treat the major causes of blindness, of which SNS is preparing to initiate Phase II clinical trials.

PRODUCTS UNDER DEVELOPMENT

POST- CATARACT SURGERY: DEX-SA, (beginning pivotal clinical trials)

Cataract surgery is the most common operation performed in the United States, with approximately four million annual procedures (nearly 30 million worldwide). Anti-inflammatory eye drops are typically self-administered by the patient for one month postoperatively. DEX-SA, designed to last approximately one month and treat postoperative inflammation and pain, would deliver dexamethasone to the subconjunctival space, eliminating the need for patient dosing of medication after surgery. FDA-required PK and toxicology studies have been completed and planning to begin Phase II-III clinical studies is underway.

GLAUCOMA: LAT-LA

Glaucoma is the most common cause of irreversible blindness in the world, often requiring a lifetime of eye drop treatment to reduce intraocular pressure. LAT-LA is a single extraocular injectable administration of a six-month release prostaglandin analog for glaucoma treatment, replacing the currently prescribed multiple daily eye drops.

RETINAL DISEASE: RET-LA

Age-related macular degeneration and macular edema are major causes of vision loss in people over 50. In these cases, damage occurs to the macula, a small spot in the center of the retina responsible for seeing objects directly ahead of us. As a result, patients with AMD have difficulty performing various activities. Current treatment consists of monthly or bimonthly injections of monoclonal antibodies designed to eliminate angiogenesis. Animal studies have demonstrated that a single administration of SNS RET-LA is capable of preventing such blood vessel growth for over a year in a standard rabbit model of corneal angiogenesis.

Protein Therapeutics:

SNS technology, initially designed for small molecules, is now being adapted to allow delivery of protein therapeutics. This includes such important macromolecules as anti-angiogenic antibodies, oligonucleotides, trans-gene expression products and growth factors, all of which have immense therapeutic value. An example is in delivering monoclonal antibodies (anti-vegf) drugs to the back of the eye to treat serious visual impairment, including age-related macular degeneration and macular edema, leading causes of blindness affecting over eight million people in the United States.

 

SNS Technology shows ONE YEAR In-Vivo bioactivity OF MACROMOLECULES FOLLOWING A SINGLE ADMINISTRATION.

Using a rabbit model, studies utilizing a corneal model in rabbits indicate one year bioactivity in preventing angiogenesis in Avastin, and similar in-vitro results in other macromolecules.

WHO WE ARE

Leadership

Barry Libin, DDS, MSD, MS

Dr. Libin is an experienced researcher and businessman in taking companies from inception through the development stages. He was Founder, Chairman and CEO of BML Pharmaceuticals Inc., a pharmaceutical research and development company in inflammatory and infectious diseases. Dr. Libin identified, formulated and directed clinical studies on a series of drugs having anti-inflammatory (Cox 2), anti-microbial and analgesic properties. BML’s lead drug in cancer therapy for prevention of chemotherapy and radiation induced mucositis was granted fast track status by the FDA and advanced through phase three clinical testing before BML was sold to Endo Pharmaceuticals in July of 2002. Following that Dr. Libin founded BML MedRecords Alert, LLC, an electronic medical records company that provides hospitals and physicians with “paperless” venues, and provides individual consumers with secure personal medical vaults. Dr. Libin received his DDS and his Masters (MSD) in Periodontics and Oral Medicine from NYU College of Dentistry, and his MS in Management and Policy from the Harriman School of Business at the State University at Stony Brook.

Jeffrey M. Liebmann, MD

Dr. Liebmann is Professor of Ophthalmology, Glaucoma Service Director, and Vice-Chair for the Department of Ophthalmology at Columbia University Medical Center. Dr. Liebmann graduated from Boston University’s Combined Six-Year Medical Education Program in 1983, completed his ophthalmology residency at the State University of New York/Downstate Medical Center, and glaucoma fellowship training at the New York Eye and Ear Infirmary. Dr. Liebmann was previously Clinical Professor of Ophthalmology at New York University School of Medicine and Director of Glaucoma Services at Manhattan Eye, Ear, and Throat Hospital and New York University Langone Medical Center. Dr. Liebmann is the immediate past-President of the World Glaucoma Association, past-President of the American Glaucoma Society, Secretary-Treasurer of the New York Glaucoma Society, and co-editor of Journal of Glaucoma and is a member of the Board of Governors of the World Glaucoma Association and Boards of Directors of The Glaucoma Foundation and the American Glaucoma Society Foundation. In addition to having one of the nation’s busiest tertiary-care glaucoma practices, Dr. Liebmann is also the Principal Investigator of the African Descent and Glaucoma Evaluation Study and is the author and/or co-author of more than 1,000 medical and scientific papers, book chapters, and abstracts. He has lectured widely in the United States and abroad on glaucoma diagnosis and management. His current main areas of research interest include the causes of glaucoma, glaucoma progression, glaucoma surgery, ocular imaging, and neuroprotection.

Uri R. Shabto, MD

Uri R. Shabto, M.D., Chief Medical Officer, is a leading specialist in retinal disease. Dr. Shabto graduated Cum Laude from Columbia University and received his M.D. from the Harvard Medical School. He completed an internship in Internal Medicine at The Lenox Hill Hospital, and a residency in Ophthalmology at the New York Eye and Ear Infirmary where he also served as Chief resident. He is fellowship trained in Retina-Vitreous diseases completing that training at Montefiore Medical Center in New York. Dr. Shabto is a past Associate Professor of Ophthalmology at New York Medical College, and senior attending on the Retina and Trauma service at the New York Eye & Ear Infirmary. He has authored numerous publications in ophthalmology and retinal disease. Prior to joining SNS, Dr. Shabto was founder, president and CEO of the Retina Consultants of New York, one of the largest retinal practices in the U.S. Dr. Shabto is a member of the American Academy of Ophthalmology and a diplomate of the American Board of Ophthalmology.

Weiliam Chen B.S., M.S., Ph.D.

Dr. Chen is a leading expert in biodegradable polymer matrices for drug and gene delivery and tissue engineering. Dr. Chen received his B.S. in Pharmacy from the University of Wisconsin, and his M.S. and Ph.D. from the University of Michigan in Pharmaceutics. Dr. Chen was Associate Professor of BioMedical Engineering in the Department of Surgery at New York University and past Associate Professor in the Department of Biomedical Engineering at the State University of New York at Stony Brook, where he jointly Co-founded EndoMedix, Inc., in the Long Island High Technology Incubator. Prior to that he was Manager of Drug/Gene Delivery Technologies at Clear Solutions (2001-2003). He has been awarded numerous grants from the NIH in the fields of biodegradable drug delivery devices and tissue engineering. He has written numerous peer reviewed articles and has lectured throughout the world.

David Beach, B.S., Ph.D.

Dr. Beach received his BS in Pharmacy at Union University-Albany College of Pharmacy and his Ph.D. at the University of Maryland. He is past President and COO of Synovics Pharmaceuticals where he was responsible for overall operations, including Prescription and Business Development. Previously he was Senior Consultant to VCG&A in Toronto where he managed the Phase II Clinical Program, and at Genpharm where he was Director of Research and Development. Dr. Beach was Associate Director of Pharmaceutical Process Improvement at Schering-Plough and Solids Development Senior Scientist/Group Leader at DuPont Pharmaceuticals.

Jan Peterson, MS

Jan Peterson, MS, as Senior Regulatory Affairs Director, will be responsible for overall relationships with the FDA. For the past 18 years, Jan worked at the Emmes Corporation, and has over 40 years of experience in clinical research trial design and management as well as preclinical laboratory research, data management, scientific writing, quality assurance (QA) and regulatory affairs. At Emmes, he was Director of Regulatory Affairs for numerous clinical trials sponsored by Government and commercial concerns, conducting clinical trial audit operations in 15 countries and providing strategic advice on regulatory affairs for drug and medical device development, writing clinical study reports, conducting quality assurance audits, supervising process development, and preparing regulatory documents for submission to FDA. He directed regulatory affairs for intramural and extramural clinical research trials performed under contract for the National Eye Institute (NEI), as well as commercially sponsored trials in ophthalmology.
Mr. Peterson’s earlier career was based in academic settings at the University of Minnesota and the University of California at San Francisco, supporting both nonclinical and clinical neuro-physiology and ocular pharmacology research. He has published or presented over 50 research papers on diverse topics including ocular pharmacology and physiology, surgical treatments for glaucoma and ocular refractive errors, retinal degenerative disorders, and uveitis, as well as urology, clinical research quality auditing, regulatory affairs and good clinical practices. Mr. Peterson is the 2018 Chair of the Association of Clinical Research Professionals (ACRP) Regulatory Affairs Committee, and a participant on industry-FDA standards development committees since 2004, including an American National Standards Institute (ANSI) Z80 subcommittee for ophthalmic medical devices. He has directed and monitored multi-national trials for the successful FDA approval of ophthalmic laser products for both refractive surgery and glaucoma. Mr. Peterson received his BA in Biomedical Sciences from St. Cloud State University (MN) and his MS in Pharmacology and Experimental Therapeutics from the University of California at San Francisco.

Morton Coleman, B.A., M.D.

Director, Medical Oncology Advisory Board.

Dr. Coleman is Clinical Professor of Medicine at New York Presbyterian Hospital and Diplomate in Hematology and Oncology of the American Board of Internal Medicine. He is Associate Director of the Division of Hematology-Oncology and Director of the Center for Lymphoma and Myeloma, at New York Presbyterian-Weill Cornell Medical Center. Dr. Coleman is Associate Editor of the Journal of Clinical Lymphoma, Myeloma & Leukemia, and authored nearly 300 scientific articles, books, and reviews. He received his B.A. from Johns Hopkins University, M.D. from the Medical College of Virginia School of Medicine, and a Fellowship in Hematology at the National Institutes of Health. Dr. Coleman’s expertise is in the treatment of lymphoma, myeloma, Waldenstrom’s macroglobulinemia, and associated diseases. He is a leader in the innovative applications of monoclonal antibodies in lymphoma and has played an instrumental role in devising the standard treatment for Hodgkin’s disease, the use of infusional chemotherapy in lymphoma, the concept of dose intensity and its use in myeloma and lymphoma, the combined use of thalidomide in myeloma, and the role of PET scanning in lymphoma.

Corporate Leadership

Robert I. Goldfarb, B.A., J.D.

Mr. Goldfarb, a member of the Board of Directors, has over twenty-five years of legal experience. Before joining SNS in December, 2011, Mr. Goldfarb was Senior Vice-President, General Counsel and Secretary of Andrx Corporation. Prior to that he was a partner with the law firm of Hughes, Hubbard and Reed. Mr. Goldfarb is presently President and General Counsel of Accu-Break Pharmaceuticals. He obtained his Bachelor’s degree from the University of Connecticut and his law degree from the University of Florida.

Michael Goodman, CPA

Michael Goodman, CPA, as Chief Financial Officer, is a former Janover LLC, Managing Partner where he provided corporate structure services for over 35 years. Known throughout the public accounting community for his creativity, Michael’ s depth of knowledge has translated into effective corporate strategies. In assuming overall responsibility for managing the company’s finances, he will assume direct involvement with financial planning, management of financial risks, and assist in all strategic and tactical matters relating to budget management, cost–benefit analysis, forecasting needs and securing of new funding. Michael is a member of the American Institute of CPAs and the New York State Society of CPAs. He has lectured widely throughout the country on taxation issues, and has been interviewed in a number of industry-related articles in leading publications. Prior to joining Janover, Michael practiced engineering in the aerospace industry, joining the development team at Grumman in designing the propulsion system of the lunar module. Michael earned his BS in Mechanical Engineering from Lehigh University, an MS in Mechanical Engineering from The City University of New York, and an MBA from Pace University.

Len Schutzman

Len Schutzman, a member of the Board of Directors, retired from Pepsico in 2011, after serving as part of Pepsico’s leadership team for more than thirty years.

He served as Senior Vice President & Treasurer of Pepsico, where he directed global financing, tax strategies  and Mergers & Acquisitions . He was Chief Financial Officer of Pepsi Cola International, Frito Lay and Taco Bell. He has served as a member of the Boards of Directors and Audit Committee Chair of five Fortune 500 Companies.

His career and accomplishments are the subject of Amazon best seller, “Fast Track Up The Corporate Ladder: The 8 Step Guide To Turbo Charge Your Career”.

He is the founder and Chairman of the Advisory Board of the Schutzman Center For Entrepreneurship At Queens College.

He holds a Bachelor of Arts degree from Queens College and a Masters  of Business Administration degree from  the University of Rochester and is a CPA

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Sustained Nano Systems, LLC. A New York LImited Liability Company