BioNJ welcomes Savient Pharmaceuticals as a new Diamond Member.
Savient Pharmaceuticals, Inc., is a specialty biopharmaceutical company focused on developing and commercializing KRYSTEXXA (pegloticase) for the treatment of chronic gout in adult patients refractory to conventional therapy. Savient has exclusively licensed worldwide rights to the technology related to KRYSTEXXA and its uses from Duke University (“Duke”) and Mountain View Pharmaceuticals, Inc. (“MVP”). Duke developed the recombinant uricase enzyme and MVP developed the PEGylation technology used in the manufacture of KRYSTEXXA. MVP and Duke have been granted U.S. and foreign patents disclosing and claiming the licensed technology and, in addition, Savient owns or co-owns U.S. and foreign patents and patent applications, which collectively form a broad portfolio of patents covering the composition, manufacture, and methods of use and administration of KRYSTEXXA. Savient also manufactures and supplies Oxandrin (oxandrolone tablets, USP) CIII in the United States.
BioNJ welcomes Hay Group, Teva Pharmaceuticals, and The Mega Group as new Platinum Members for 2012.
Hay Group is a global management consulting firm that works with leaders to make strategy a reality and drive performance. We help our clients to improve the way they organize, lead, develop, and reward their people. Our global life sciences team works with biopharmaceutical clients large and small to create innovative organizational practices, plan and implement effective leadership in R&D, build new commercial organizations, and manage the challenges that come with growth.
Teva Pharmaceutical Industries Ltd. (NASDAQ:TEVA) is a leading global pharmaceutical company, committed to increasing access to high-quality healthcare by developing, producing, and marketing affordable generic drugs as well as innovative and specialty pharmaceuticals and active pharmaceutical ingredients. Headquartered in Israel, Teva is the world’s largest generic drug maker, with a global product portfolio of more than 1,300 molecules and a direct presence in about 60 countries. Teva’s branded businesses focus on central nervous system, oncology, pain, respiratory, and women’s health therapeutic areas as well as biologics. Teva currently employs approximately 47,000 people around the world and reached $16.1 billion in net sales in 2012.
The Mega Group creates brands from the inside out. It’s Their process. Their Passion. Their Religion. Their communications executions are solid and effective works because they take the steps necessary to understand, be smart, targeted, and meaningful. They add significant value to their clients’ business.
BioNJ welcomes Oncobiologics, PendoTECH, and Validus Pharmaceuticals as new Core Members for 2012.
Oncobiologics is an early-stage biotechnology company that is advancing novel and improved biotherapeutics to treat serious diseases, including cancer and immune disorders by leveraging proprietary technologies and expert science and engineering. Oncobiologics was formed by a team of eminent scientists and engineers from leading global biopharm and pharmaceutical organizations, including Amgen, Genentech, Eli Lilly, Bristol-Myers Squibb, Bayer, Merck, Johnson & Johnson, Schering-Plough, and Medarex. The company is developing a pipeline of oncology and immunology candidates built on a proprietary discovery platform that features a modular antibody scaffold that can be adapted to address a variety of targets.
PendoTECH offers technology for manufacturing and process development of biopharmaceuticals with a focus on unique single use in-line sensing technologies designed specifically for the biotechnology Industry. Along with the sensors are complementary product lines of software and hardware products that collect data from the sensors for analysis. Sensors include pressure, temperature, UV absorbance, flow, and conductivity. These products assist users in meeting the FDA’s initiative in the area of process analytical technology (PAT) for quality by design (QbD) for manufacture of their products. Software/hardware expansion options are available to create a complete process control system for all unit operations in a biotech process. These options facilitate the integration of the sensors and other devices, such as pumps, scales, detectors, and many more for both critical lab operations and for GMP production.
Validus Pharmaceuticals LLC is focused on acquisition and commercialization of effective, branded, and underutilized products in specialty therapeutic areas. Validus seeks out and acquires FDA-approved products with well-established safety and clinical benefits. We enhance this process by providing materials that will assist physicians in managing disease, and information that helps patients understand their illnesses. We also create new, interactive programs that enable doctors to guide their patients to learn more about their disease. During the past five years, the company has successfully acquired four products with specific therapeutic advantages in several specialty pharmaceutical areas.
BioNJ welcomes our new Associate Members for 2012.
6 Degrees Communications has that unique combination, as a results-oriented, full-service public relations firm that serves clients across the healthcare spectrum. We deliver experiences that are meaningful, tangible, quotable, distinguishable, and indelible, setting our work apart from our competition. Our offering is unique in three ways. First, our plans focus on your business objectives. A signature media placement is of little use if it doesn’t move an organization closer to its goals. Second, we are defined by our relationships. No other healthcare firm is more skilled at forging relationships. Finally, we execute. Plans are only as good as the people implementing them, and our nimble, senior-based model means we deliver business-changing results.
At 6 Degrees, we are uniquely positioned to help transmit messages through that web by leveraging our unparalleled experiences gained and relationships earned inside the world’s most powerful media institutions, regulatory bodies, and corporations. Our team brings distinctive perspectives, specifically that of public relations professionals, corporate communicators, federal regulators, policy and news media. We move seamlessly among services, including FDA panel preparation, issues management, media platform creation and execution, executive positioning, thought-leadership, and communications. It is this insider’s knowledge of how different systems work that distinguishes our approach.
Alert Scientific, Inc., provides specialized service on hundreds of different types of laboratory equipment to those who demand that their laboratory equipment functions at peak performance and efficiency.
Alert Scientific, an ISO-9001 certified company, provides factory-authorized repair service, preventive maintenance, and calibration and validation service in the form of IQ/Oq/PQ. In addition, we offer repairs and NSF Accredited Certification on bio-safety cabinets, chemical fume hoods, laminar flow hoods, and clean rooms.
With strategic locations in Boston, MA, East Hartford, CT, and Princeton, NJ, Alert Scientific is able to provide our clients with both on-site service and emergency service that is available 24/7/365. For further details, visit their website.
Bridge Tech and Capital Corp. (BTCC) is a leader in providing comprehensive value-based solutions to Chinese and U.S. businesses that desire to build strategic partnership. With a presence in the United States and China, BTCC offers professional services in merger, acquisition, joint venture, technology cooperation, industrial expert solutions, and provides business expertise to develop solutions to difficult industry problems. As a proud BioNJ member, BTCC is dedicated to help U.S. biotechnology and pharmaceutical companies to attract Chinese investors, penetrate Chinese markets, or conduct cost-effective clinical trials in China, by utilizing its extensive business network and governmental ties.
Catalyx Group is a retained executive search firm specializing in healthcare and the life sciences. Headquartered in Verona, NJ, and organized in 1982, Catalyx Group serves the biotechnology, pharmaceutical, medical device, diagnostics, tools, and healthcare IT sectors as well as university, venture capital, private equity, and other investment and service communities supporting healthcare. Searches are for CEO and board of director members, C-level, and other senior and middle management executive, scientific, engineering, clinical, regulatory, financial, manufacturing, and commercial positions. Catalyx Group has also been called upon to assist its clients in additional strategic ways and builds entire teams for venture-backed start-ups.
Since its founding, Catalyx Group has been led by Lawrence D. Poster, managing director, who earned his BS in Management Science from MIT.
Hays Life Sciences provide comprehensive talent management and acquisition solutions for life sciences/technology-based organizations. Our core service offerings include mid- to senior-level executive search, exclusive contingency search, recruitment process outsourcing, and contract/contract to hire management recruitment solutions.
Hays consultants function as cross-functional vertical specialists within the life sciences market. Utilizing a niche focus model along with a branded proprietary inhouse technology robust active networks, and best-in-class customer service standards has resulted in effectively meeting our clients’ talent-acquisition requirements. Service offerings and capabilities include access and utilization at all levels/phases of the recruitment life-cycle process.
MarketVision Research is a custom marketing-research consulting firm. We uncover/deliver insight through qualitative and quantitative research to pharmaceutical, biotechnology, medical device, and medical diagnostics clients around the world. We design research in consultation with our clients based on their specific business needs and strategic direction. Insight is provided across the entire asset life cycle from discovery through brand-to-generic transition. Examples of the range of expertise include portfolio optimization, forecasting, market landscape assessment, materials development, and materials testing. Our philosophy is to apply the most appropriate methodology to each of our clients’ unique questions. We support this philosophy with a variety of inhouse data collection and analytical tools, including advanced modeling, online capabilities, qualitative specialists, and global resources.
Sordoni Construction Company is a full-service, privately owned and operated construction management firm based in Chester, NJ. Sordoni is a leading expert in providing construction services to the pharmaceutical and biotechnology markets. We have a reputation that’s second to none for completing projects ahead of schedule, under budget, and with ultimate client satisfaction. Sordoni’s staff is extremely motivated and highly talented construction professionals who strive to be recognized industry-wide for delivering extraordinary service, creative thinking, and breakthrough results. As a mission-based organization, we fully understand that we must always go beyond business as usual to ensure customer satisfaction and to exceed expectations. For more information, please visit their website.
Steven Katz & Associates, Inc.
Steven Katz is President of Steven Katz & Associates, Inc., a life sciences and technology-based management consulting firm specializing in strategic planning, technology licensing, and structuring and securing various forms of financing. Steve has also been a turnaround CEO/COO, is a board member of various publicly held and private companies, and has advised and participated in proxy contests.
ToxPharm Consulting LLC provides consulting services in toxicology and pharmacokinetics (PK). Louise Latriano, PhD, a board-certified toxicologist, is the owner and principal scientist. Dr. Latriano provides clients technical and regulatory expertise in all phases of drug development, ranging from compound selection and conduct of IND-enabling programs, to the preparation and filing of documents (CTDs/NDA/BLAs) for marketing worldwide. Services include the design and execution of the nonclinical regulatory strategy and preparation of the project plan; the placement, monitoring, and reporting of individual toxicology and PK studies; and then preparation of integrated safety assessments, including evaluation of drug impurities.
World Courier is a provider of premium logistics services and the leading global specialty supplier of transportation, storage, and distribution services for multinational biopharmaceutical clinical trials.
Our service offerings include temperature-controlled and time-critical handling and transportation, temperature-controlled storage and distribution, specialized packaging, and customs brokerage services. Our services are utilized by over 500 biopharmaceutical companies, including each of the top 50 global players, as well as all major contract research organizations, clinical trial suppliers, and central labs.
WorldWide Medical Products, Inc. (WWMP) is a technologically advanced, quality-driven provider of essential laboratory wares and services to the scientific community, and is dedicated to exceeding the wants and needs of our clients. We are both a New Jersey–based laboratory company and a manufacturer, which gives us excellent insight into the needs of our clients and the ability to provide our products quickly and efficiently. Our mission is to utilize our unique comprehension and understanding of the research and development market, while maintaining the ability to respond and adapt to our clients’ needs. The personal attention and custom-tailored solutions our clients deserve are ultimately achieved through the collaboration of our team of technical and professional consultative representatives and delivery of our high-quality BioExcell product line.
BioNJ welcomes InspireMD as a new International Member for 2012.
InspireMD, Inc., is a high-growth medical-device company focusing on the development and commercialization of its proprietary stent platform technology: MGuard. InspireMD has created a unique, patent-pending mesh net technology that wraps a stent, providing embolic protection (preventing major adverse cardiac events [MACE] by filtering debris) and reducing vessel injury by spreading strut pressure. MGuard is delivered with no change to the current procedure and is well accepted by physicians. MGuard has been implanted in thousands of patients, and in clinical trials it has shown a more than 50 percent reduction in MACE compared with traditional bare metal stents.
MGuard is the only complete solution for high-risk acute coronary syndrome (heart attack) patients — a market of over 2 million patients per year. This market is the fastest-growing segment of the stent market, currently estimated to exceed $2.3 billion annually with limited competition for InspireMD. MGuard and the next-generation MGuard Prime have distribution agreements in more than 40 territories, including Europe, Asia, Australia, Brazil, the Far East, India, and South America. In 2 years, InspireMD has ramped from $0 in revenue to $5 million annually and is experiencing ongoing rapid growth.
The company is seeking FDA approval to sell in the United States and is collaborating with the Harvard Clinical Research Institute (HCRI), an international leader in design and conduct of coronary device trials, for U.S. FDA trials.
BioNJ thanks Ernst & Young for renewing as a Diamond Member 2012.
Ernst & Young is a global leader in assurance, tax, transaction, and advisory services aiming to have a positive impact on businesses and markets, as well as on society as a whole. The company works hard to gain a clear understanding of the client’s organization, assemble the right multidisciplinary team, and then strives to identify issues before they become problems.
BioNJ thanks BDO USA for renewing its Platinum Membership for 2012.
BDO provides assurance, tax, financial advisory, and consulting services to a wide range of publicly traded and privately held companies. We offer a sophisticated array of services and the global capabilities of the world’s fifth-largest accounting and consulting network, combined with the personal attention of experienced professionals. Our life sciences practice serves pharmaceutical, biotech, and medical-device manufacturers of all sizes at every stage of development through 40 offices and more than 400 independent alliance firm locations nationwide. As an independent member firm of BDO International Limited, BDO serves multinational clients through a global network of 1,082 offices in 119 countries. For more information please visit their website.
Dedicated to quality service for 100 years… People who know, know BDO.
BioNJ thanks our Core Members who have renewed their memberships for 2012.
Aramis Pharma is a healthcare company that retains North American marketing and distribution rights to a variety of products in the drug, device, cosmeceutical, and nutraceutical arenas. These products belong mostly to foreign companies without affiliates or distribution partners in North America (Canada, United States, and Mexico). The products are positioned primarily in the therapeutic areas of dermatology, women’s health, infections, and wound healing. Aramis brings these products to the markets through agreements with contract sales organizations, or by placing the products in existing small specialty pharma companies with a commercial activity relevant for those products, in exchange for equity in that company or cash.
Cornerstone Pharmaceuticals is a privately held pharmaceutical company dedicated to the discovery and development of innovative cancer therapies that exploit cancer-specific metabolic pathways. Our novel and singular focus on cancer metabolism springs from our passionate commitment to making a positive and significant difference in the lives of cancer patients and their families.
Edge Therapeutics is a biopharmaceutical drug development company focused on the products used within the hospital acute care market. The company focuses on improving the current routes of delivery of both existing and emerging drugs that will reduce development risk and increase the speed to market.
ExSar is a development-stage company dedicated to identifying, developing, and commercializing small molecule therapeutics for protein misfolding diseases. The company is a leader in the application of hydrogen/deuterium exchange and utilizes the platform technology to screen lead compounds for the ability to prevent protein misfolding and restore protein function.
Gedeon Richter USA, Inc., located in Ridgewood, NJ, is the local affiliate of Gedeon Richter Plc, a leading Central-Eastern European pharmaceutical company located in Hungary. Gedeon Richter is engaged in research and development as well as the manufacture and sales of products. Two of the primary areas of focus are women’s healthcare and central nervous system disorders. In addition, significant work is being done in the area of biosimilars, both mammalian and microbial. Gedeon Richter USA, Inc., has a total of three employees who are focused on existing sales as well as the development of new strategic alliances with U.S. and global companies.
Genmab is a leading international biotechnology company focused on developing fully human antibody therapeutics for the potential treatment of cancer. Genmab’s world-class discovery and development teams are using cutting-edge technology to create and develop products to address unmet medical needs. Our primary goal is to improve the lives of patients who are in urgent need of new treatment options. For more information on Genmab’s products and technology, visit their website.
Immunomedics is committed to being a leading, innovative biopharmaceutical company, dedicated to improving health and quality of life with novel immunotherapeutics for the treatment of cancer, autoimmune, and other serious diseases. The company’s work is driven by scientific excellence and the highest standards, in a culture of integrity, pride, and dedication.
INSMED, Inc., is a biopharmaceutical company focused on developing innovative, inhaled pharmaceuticals for the site-specific treatment of serious lung diseases, such as pulmonary infections in cystic fibrosis patients and cancers affecting the lung. The company is committed to significantly improving the quality of life and healthcare of patients suffering from these life-threatening diseases.
Lundbeck Research USA is engaged in drug discovery aimed at treating central nervous system diseases by designing small molecule therapeutics. Lundbeck Research USA is a world leader in G Protein-Coupled Receptor discovery research.
Lux Bioscience is a clinical stage biotechnology company specialized in the field of ophthalmic diseases. Lux is developing novel medications to treat the underlying causes of ophthalmic diseases and alleviate their symptoms, and if approved by regulatory authorities, plans to commercialize these products.
NeoloMed BioSciences is a consultative biotechnology company based in central New Jersey. The company develops and commercializes new diagnostic products, in a GLP environment, to support innovative bioscience research in oncology, immunology, and stem-cell technology. Company services include preclinical research applications as well as clinical services.
Onconova Therapeutics creates novel solutions for oncology by combining conventional pharmaceutical science (a small molecule approach) with the latest genomic and genetic technologies for drug discovery and development.
Palatin Technologies is a biopharmaceutical company focused on discovering and developing targeted, receptor-specific small molecule and peptide therapeutics. The company’s strategy is to develop products and then form marketing collaborations with industry leaders in order to maximize their commercial potential.
BioNJ thanks our Associate Members who have renewed their memberships for 2012.
Ashton Tweed is a robust professional force of highly experienced life sciences industry experts who are deployed throughout the company’s diverse range of service offerings to solve clients’ human capital and commercialization management needs. The company excels in finding the right candidates for clients’ workforces at all points of growth and across all specialized staffing needs.
BioSciences Expansion specializes in helping French and European companies introduce and develop their businesses in the United States. Focusing on small to midsized companies in the life sciences industry, BioSciences Expansion designs customized programs and manages their successful implementation so that European companies can optimally establish and grow their businesses. The company provides comprehensive services and solutions from strategic planning to operational development and execution. Taking full advantage of BioSciences Expansion’s transatlantic expertise, companies achieve their goals in shorter timeframes while avoiding costly delays and mistakes. With its network and partners, BioSciences Expansion provides a unique combination of scientific and business expertise.
Edwards Wildman has been at the forefront of life sciences for 30 years. We have grown with the industry and have more than 70 lawyers supporting life sciences companies, investors, universities, medical centers, and research foundations in their efforts to bring life-saving discoveries to market. Forty of our team members have life sciences degrees, 16 of those are PhDs. We work with over 200 clients in biotechnology, pharmaceuticals, medical devices, and healthcare technologies. Some clients are early stage, researching new therapies for cancer, and others distribute branded drugs to the world’s markets. Whatever the legal issue, Edwards Wildman can provide the guidance, depth, and experience to help achieve your commercialization goals. Edwards Wildman is an international law firm with 15 offices in the United Kingdom, Asia, and the United States, including Madison, NJ.
Greenberg Traurig (GT) is an international law firm with more than 1,800 attorneys and governmental affairs professionals in 32 commercial and government centers across the United States and in Europe and Asia. The firm was selected as the 2007 USSA Law Firm of the Year by Chambers and Partners. GT provides integrated, business-focused legal services for clients ranging from innovative start-ups to Fortune 500 corporations. Our multidisciplinary team includes senior lawyers who have been the chief legal officers at major multinational companies and have spent years solving real-world problems in the business, political, and legal arenas.
Integrium is a full-service Phase I-IV CRO specializing in cardiovascular, metabolic, renal, wound healing, and dermatology therapeutic drug development. Along with our full-service CRO, we have two fully integrated Phase I-IV clinical research units with access to various patient populations. Our greatest strength (besides our experienced and passionate team) is the ability to rapidly enroll studies within cardiovascular, metabolic, renal, wound healing, and dermatology.
Physician-founded and operated since 1998, Integrium works closely with you to advance your clinical research programs. Our fully integrated clinical services and technology platform offer a streamlined, single-source solution. Although we have run trials in a variety of regions around the world, Integrium is considered “Best in Class” within North and South Africa. Integrium combines clinical expertise with trusted study methods, which consistently produces reliable results to inform drug and medical-device development decisions.
Integrium is dedicated to delivering clinical results fast. But we’re also proud of our proven track record of delivering results that are consistently accurate, reliable, and communicated with clarity and precision.
Mancino Burfield Edgerton has over 25 years of experience successfully conducting retained searches. We are results oriented and have a track record of providing quality and timely professional recruitment and business advisory services to our life sciences client. We are engaged routinely by Fortune 500 companies, midsize as well as emerging, venture-backed start ups.
The Charles Group, Inc., is a full-service domestic and international meeting planning and consulting firm. We offer clients a comprehensive range of services spanning a wide spectrum – from retreats for small groups of executives to educational conferences and advisory board client entertainment events with thousands in attendance – and everything in between. We welcome working either in place of your internal staff or as an extension of their capabilities. Regardless of the scope of the assignment, we are committed to providing our clients with the highest quality service.
Unforgettable meetings and special events…anywhere in the world.
YourEncore is a U.S.-based innovation services company that taps into our country’s under-utilized asset: the growing number of veteran/retired scientists, engineers and life sciences professionals. We connect our member companies with experienced experts from all aspects of scientific disciplines to leverage their expertise and accelerate innovation. YourEncore Experts specialize in the life sciences, consumer sciences, food sciences, as well as the aerospace and defense industries. These experts come from over 1,000 different companies and organizations.
BioNJ thanks our Institutional Members who have renewed their memberships for 2012.
The School of Science houses four departments: Biology; Chemistry, Medical Technology, and Physics; Mathematics; and Computer Science and Software Engineering. The school is also the home for two Centers of Distinction, the Urban Coast Institute (UCI) and Rapid Response Institute (RRI).
The Economic Development Authority (EDA) is a state financing and development agency that works to strengthen New Jersey’s economy by retaining and growing businesses through financial assistance, by renewing communities, and by promoting the state’s strategic advantages to attract domestic and international business.
The Jackson Laboratory is an independent, nonprofit organization focused on mammalian genetics research to advance human health. The organization produces and distributes millions of genetically defined inbred mice from a repository of over 5,000 strains to laboratories around the world. The organization also offers breeding, cryopreservation, genome science, and in vivo preclinical efficacy and phenotyping services to external clients.