We have over 20 years history of customizing 3DNA® for commercial and collaborative purposes.
Genisphere is a nanotechnology company and provider of an innovative DNA-based targeted drug delivery platform called 3DNA®. Genisphere seeks additional partnerships with biotechnology and pharmaceutical companies that could benefit from the company's platform technology, which is IP-protected and fully customizable to deliver small molecules, biologics, and nucleic acids in a highly targeted manner.
For us, this mission is much more than words on a page. We live this mission every day as we develop our innovative platform, establish strong partnerships and implement long-term strategies to give our partners and clients definable competitive advantages.
In 1986, the first patent applications covering the design and use of 3DNA technology were filed. Genisphere was incorporated in 1997 and proudly launched its first 3DNA Expression Array Detection kit, developed in conjunction with Harvard-affiliated researchers, in 1999. Genisphere launched the world’s first microRNA labeling kit in 2005, and an optimized FlashTag microRNA labeling kit in 2007, which was licensed to Invitrogen (2006, 2008) and Affymetrix (2009, 2011).
With an established business in microarrays, Genisphere launched products with unique RNA amplification technology including SenseAMP in 2004, RampUP in 2006, and Sensation in 2011. In 2008, Genisphere’s RNA amplification technology was incorporated into the Pathwork Diagnostics Tissue of Origin Test, which was cleared by the FDA in 2010. The Sensation technology was licensed to Affymetrix in 2011 for microarray applications.
Single-tube 3DNA UltraAmp reagents were first launched in 2005, and have been cited in publications describing improved sensitivity in various immunoassays. Genisphere found particular success in providing custom reagents to improve the limit of detection in lateral flow point-of-care diagnostic tests and licensed 3DNA technology to BBI Solutions for lateral flow assay development for enhanced performance and sensitivity (2014).
In 2009, Genisphere LLC was formed when management partnered with Corporate Fuel Partners to execute a MBO and acquired all its legacy technology and intellectual property from Datascope (Getinge AB). With established success of 3DNA technology in life science and diagnostic applications, the company turned its focus to targeted drug delivery. Since research has shown DNA to be a non-toxic, biocompatible material in vivo, Genisphere aimed to become the first commercial source of highly targeted DNA-based nanocarriers. Genisphere's first task was to re-engineer its DNA strands based on three goals for the final 3DNA construct:
- Redesigning the DNA sequences with the immune system in mind
- Incorporating more crosslinking sites for better stability of the core 3DNA structure
- Scaling up the manufacturing process to achieve routine production of therapeutic quantities of 3DNA
After meeting these objectives, Genisphere expanded its efforts in cellular targeting. Leveraging its experience in antibody-DNA conjugation, the company studied attachment of 3DNA to antibody fragments, peptides, sugars, vitamins and other targeting devices for specific cellular delivery. After producing these data, Genisphere established several key collaborations to generate preclinical data showing the versatility and efficacy of the 3DNA platform in targeted delivery of small drugs, biologics and nucleic acids.
To date, the 3DNA platform has proven to provide cell-specific (cytosolic and nuclear) delivery of drugs with functional intracellular effects without apparent toxicity. The flexibility of the 3DNA platform to deliver hundreds of tracking labels to targeted tissues provides an option to incorporate a companion diagnostic into the drug development process. Genisphere continues to seek partnerships with biotechnology and pharmaceutical companies. The company is also advancing its own lead compounds based on the 3DNA drug delivery platform.
Thomas H. Bliss
Mr. Bliss is the Chief Executive Officer at Genisphere. He is responsible for managing the commercialization of Genisphere's Research and Development with Dr. Getts and his organization. Commercializing successfully also requires him to coordinate with Genisphere Operations led by Jim Kadushin. After spinning out of Datascope with Corporate Fuel Partners and creating a successful, validated diagnostics platform, Genisphere is advancing its 3DNA technology into therapeutics. The initial therapeutic focus is on creating exquisitely controlled, highly targeted medicines, both with biopharmaceutical partners and on its own account.
Mr. Bliss has spent most of his career commercializing technology and research. Prior to Genisphere, he was the founding Chief Executive Officer at TheraKine, a start-up, biophysical matrix, sustained-release, drug delivery technology company. While there, he guided the company through its first evaluative partnerships with two top-5 biopharmaceutical companies and cultivated a CRADA-based partnership with the United States Air Force through its 2nd and 3rd grants. Most recently, Mr. Bliss managed the Business Development function at Kyocera International, the group holding company of the Americas for Kyocera Corporation. Previously, he managed similar licensing, corporate development and business development departments at Amgen and Baxter. At Amgen, Mr. Bliss managed Corporate Development during the acquisition of Abgenix. He went on to manage three departments within the Licensing/R&D organization, International Licensing, Licensing Operations and China/India R&D activities, the latter of which he created under Dr. Roger Perlmutter's direction from concept to include over 200 R&D staff members across five departments. While at Baxter, Mr. Bliss completed over 16 licensing agreements including antibody agreements with Dyax and Protein Design Labs, and a commercialization agreement with InterMune.
Earlier in his career, Mr. Bliss worked in the Treasury, Licensing and Acquisitions Analysis group within Johnson & Johnson to prepare partnering, licensing and acquisition transactions for Executive Committee review. Here, Mr. Bliss completed his first licensing transaction with then start-up company Amylin of San Diego, California. Mr. Bliss also worked in the corporate finance departments of Donaldson, Lufkin & Jenrette, Cowen and Lehman Brothers where he provided financing alternatives and mergers and acquisitions advice to Healthcare and Technology companies. Mr. Bliss has an MBA in Finance and Marketing from The Wharton School, University of Pennsylvania and a BA in English and Asian Studies (Mandarin Chinese) from Dartmouth College.
Robert C. Getts, Ph.D.
Dr. Getts is the Vice President of Research and Development and CSO at Genisphere. Since joining the company 22 years ago as a Senior Research Scientist, he has actively developed outside relationships with project collaborators and potential partners in the biotech research and business communities for work on original and custom products and technologies. Dr. Getts is a chemistry department trained biochemist. During undergraduate and graduate training as a biochemist, his goal was to understand chemically, molecularly and functionally each of the major classes of biomolecules. As an undergraduate, his thesis was focused on vitamins and lipids. As a graduate student his training was focused on proteins, nucleic acids and the interactions between proteins and nucleic acids. As a postdoctoral candidate, Dr. Getts linked his broad training together and studied novel DNA repair mechanisms for double strand break repair. As a biotech professional, Dr. Getts has over 20 years of research and development experience. The majority of this experience has been focused on the development of Genisphere’s 3DNA nanotechnology and IP portfolio as a signal amplification platform for improving sensitivity in life science and diagnostic assays (for microRNA and mRNA) and more recently as a pre-clinically validated targeted delivery platform for cancer, cardiovascular and central nervous system indications. Dr. Getts has over 25 publications and continues to publish peer-reviewed manuscripts and review articles. He has more than 15 issued patents domestically and internationally and more than 35 submitted patent applications internationally. In recent years Dr. Getts has been focused on drug discovery and the pre-clinical development of Genisphere’s 3DNA platform for both Genisphere and partner pharmaceutical company Lead candidates, leading to the development of an extensive dataset in support of this work.
James M. Kadushin
Mr. Kadushin is the Vice President of Operations and COO at Genisphere, a role he has held for more than 11 years, including through the change of ownership from Datascope Corp. to Corporate Fuel Partners. Since joining Genisphere in 1997, he has held increasingly senior operating and product development roles. Along with his strategic and operating management of the company, Mr. Kadushin is also the primary inventor or co-inventor on 14 patents and patent applications, including the application of Genisphere's 3DNA signal amplification technology to "point of care" lateral flow immunoassays. Concurrently with his tenure at Genisphere, Mr. Kadushin started a testing laboratory to conduct molecular research and diagnostic testing for veterinary samples. Among the tests developed were PCR amplification-based assays for infectious diseases and identity determination. Previously, Mr. Kadushin led Operations and R&D for Gen Trak, Inc., manufacturer of a quality line of classical HLA serological typing tests and frozen human lymphocyte cell trays. While there, he developed a HLA PCR-based clinical typing test for matching organ donors and recipients, which became only the second PCR-based product 510(k) cleared by the FDA. Earlier in his career, Mr. Kadushin co-founded HKB Systems, Inc., through which he and his partners licensed the rights from Case Western Reserve University to the clinical laboratory Database Management System (DBMS). He and his partners sold and installed the DBMS system in clinical labs nationwide. Mr. Kadushin holds a B.S. in Zoology from Michigan State University.
Board of Directors
Vijay Aggarwal, Ph.D.
Dr. Aggarwal serves on the Board of Directors of Genisphere. He has over thirty years of experience in both pharmaceutical services and clinical diagnostics. He is currently a Partner of The Channel Group, LLC and its affiliate, BioMed Transition Partners, a New York-based life sciences venture development and management firm, engaging in venture formation and venture transactions. Most recently, Dr. Aggarwal was President and CEO of Aureon Laboratories, Inc., a predictive pathology company offering advanced tissue analysis services to practicing physicians and the pharmaceutical industry. Previously, he was President of AAI Development Services, Inc., a contract research and development services company serving the pharmaceutical and biotech industries. Prior to holding that position, Dr. Aggarwal was President of Quest Diagnostic Ventures, where he had responsibility for new technology, new business models, clinical trials testing, and direct–to-consumer strategies. Earlier in his career, Dr. Aggarwal held many positions with SmithKline Beecham Clinical Laboratories (“SBCL”), the clinical laboratory operations of SmithKline Beecham plc, including direct responsibility for all of SBCL’s U.S.-based laboratories as Executive Vice President of Laboratories, Vice President of Managed Care. Dr. Aggarwal serves on the boards of several privately held diagnostic companies, including: Hycor Biomedical, Inc.; Mitomics Inc.; Targeted Diagnostics and Therapeutics, Inc.; and Viracor-IBT Laboratories; and, serves as Chairman of Lesanne Life Sciences, LLC. He earned a BA in Chemistry from Case Western Reserve University and a Ph.D. in Pharmacology/Toxicology from the Medical College of Virginia.
Alan L. Rubino
Mr. Rubino has served as CEO and President of Emisphere Technologies, Inc. since September, 2012. Previously, Mr. Rubino served as the CEO and President of New American Therapeutics, CEO and President of Akrimax Pharmaceuticals, LLC and President and COO of Pharmos Corporation. Mr. Rubino has continued to expand upon a highly successful and distinguished career which included Hoffmann-LaRoche, Inc. where he was a member of the U.S. Executive and Operating Committees and a Securities and Exchange Commission (SEC) Corporate Officer. During his Roche tenure, he held key executive positions in marketing, sales, business operations, supply chain and human resource management, and was assigned executive committee roles in marketing, project management, and globalization of the worldwide pharmaceuticals business. Mr. Rubino also held senior executive positions at PDI, Inc. and Cardinal Health. He holds a B.A. in economics from Rutgers University with a minor in biology/chemistry and completed his post-graduate educational programs at the University of Lausanne and Harvard Business School. Additionally, he serves on the Boards of Sanuwave, Inc. (SNWV), Vericel, Inc. (VCEL), and Rutgers University School of Business.
S. Arieh Zak
Mr. Zak has 20 years of experience in the life science industry. He is currently Senior Vice President, Regulatory/Clinical/Quality Affairs and General Counsel at PowerVision Inc. in Belmont, California. Prior to that, he held a variety of positions at Datascope Corp. including Vice President, Regulatory Affairs and Corporate Counsel, and was concurrently General Manager of Genisphere Inc., then a Datascope subsidiary, from its inception in 1998 until 2007. Mr. Zak holds a Bachelor of Arts degree in Mathematics from Yeshiva University and a J.D. from Columbia Law School.
John C. Simons
Mr. Simons is a Chairman of Genisphere and a Partner with Corporate Fuel and has spent 27 years as a banker to small and mid-size businesses and the families that own them. Mr. Simons was formerly an Executive Vice President for Bank of America (formerly Fleet National Bank) in the Regional Commercial Services Group, responsible for small business, middle market and corporate banking in New York City, Long Island, New Jersey and the Hudson Valley area. He was also Market Executive for FleetBoston Financial's activities in New York City. Prior to joining Fleet, Mr. Simons was a Senior Vice President with Chase Manhattan Bank. He began his career with Chemical Bank in 1983. Mr. Simons is a Director of The United Hospital Fund, The Foundation for Aids Research, The Greater Jamaica Capital Corporation, and a former Trustee of the Brooklyn Academy of Music. Mr. Simons is also former Chairman of the Lincoln Center Business Council and the Lincoln Center Corporate Fund. Mr. Simons was appointed by Mayor Bloomberg in 2003 to be a member of the Mayor's Fund to Advance New York City. Mr. Simons has a bachelor's degree from Trinity College.
Charles S. Lachman
Mr. Lachman is a Partner with Corporate Fuel and has spent over thirty years in management and financial positions in both large and small business environments, and he has been a principal equity investor and key management participant in a number of middle market operating companies and strategic investments. In addition to his financial background, he served as Chairman of a manufacturing company and a specialty retail chain. Since 1997, Mr. Lachman was the founding partner of Corporate Investment Partners, a middle market investment banking and financial advisory firm that merged with Corporate Fuel in 2005. He was also a Partner and Managing Director of an international consulting firm; a senior executive with American Can Company; and a lending officer at J.P. Morgan. Mr. Lachman received a Bachelor's degree from Amherst College and attended Oxford University in England following his graduation, on a fellowship in history. He also attended the Program for Management Development at the Harvard Business School.
Mr. Fein acts as the CFO of Genisphere and is also actively involved in business development for the Company. He is a Managing Director with Corporate Fuel and began his career in the Mergers and Acquisitions department of Jefferies & Company, Inc. where he worked on numerous complex transactions. He then spent a number of years in the merchant banking field where he negotiated acquisitions and investments both as principal and agent and often stepped in as COO and/or CFO of portfolio companies, leading growth strategies and building professional organizations around entrepreneurial businesses. In 1995, he left the investment banking field to work full time in senior management roles at a number of small and large operating businesses, including a chain of martial art studios, an Internet incubator and most recently as the Vice President, Worldwide Business Operations for Westcon Group, a $2 billion distributor of communications and technology equipment, where he also held the role of General Manager for a $300mm U.S. division. Mr. Fein received his MBA from the University Of Chicago Graduate School Of Business and graduated from Union College with honors in Managerial Economics.