Membership Update — December 2012

BioNJ welcomes Kissei America, Inc., OrthogenRx, Inc., and RXi Pharmaceuticals Corp. as Core Members for 2012.

Kissei America, Inc.
Kissei America, Inc., is the U.S. subsidiary of Kissei Pharma, a medium-sized pharma company based in Japan. Kissei is actively seeking in-licensing, out-licensing, and other business development opportunities for new drugs.

OrthogenRx, Inc.
OrthogenRx, Inc., is a late-stage development company focused on the development of Class III generic orthopedic medical devices. The business model is to identify products being sold ex-U.S. that are identical to currently marketed U.S. products and license them for commercialization in the United States.

Of particular interest are Class III medical devices that presently have limited competition in the U.S. marketplace and no patent protection. The initial focus is on a class of products that had $714 million in U.S. sales in 2011. Several suppliers of targeted products have been identified and licensing/supply agreements have been executed. Testing of equivalence of licensed products and U.S. marketed products is under way, and a novel abbreviated regulatory strategy should permit commercialization within 12 months. With three product approvals anticipated by the end of 2013, sales exceeding $100 million are achievable within 5 years. Additional pipeline products are also being developed to expand the orthopedic franchise.

RXi Pharmaceuticals Corp.
RXi Pharmaceuticals Corp. (OTC: RXII) is a biotechnology company focused on discovering, developing, and commercializing innovative therapies based on its proprietary, next-generation RNAi platform. Therapeutics that use RNA interference, or “RNAi,” have great promise because of their ability to “silence,” or down-regulate, the expression of a specific gene that may be overexpressed in a disease condition. Building on the pioneering work of scientific founder and Nobel Laureate Dr. Craig Mello, RXi’s first RNAi product candidate, RXI-109, entered into RXi’s first human clinical trial in 2012. RXI-109 targets connective tissue growth factor (CTGF), a key regulatory of fibrosis and scar formation, and is initially being developed to reduce or inhibit scar formation in the skin following surgery.

 

BioNJ welcomes American Industrial Supply, Finn Partners Health, Global Prairie Integrated Marketing Communications, Medix Staffing Solutions, Prescient Drug Delivery Consulting, and RCM Technologies Inc. as new Associate Members for 2012.

American Industrial Supply
American Industrial Supply (AIS) is a leading provider of pipe, valves, and fittings located in Perth Amboy, NJ, and serving the pharmaceutical and biotech industry in the Northeast region. Since 1978, AIS has worked tirelessly to help our clients minimize their downtime and reduce total costs by providing effective solutions and on-time delivery. All products offered are delivered with our own fleet of trucks, with most orders being shipped the same or next day as required. To learn more about how our value-added services can help your project or business, please visit our website.

Finn Partners Health
Finn Partners Health is a diversified practice with expertise and experience across a wide range of industry sectors, including consumer health, health policy and public affairs, health services, non-profit, and health information technology. Finn Partners Health also has a focus on the life sciences and specialty pharma industries, with particular emphasis on helping clients navigate the world of investor and corporate communications.

Global Prairie Integrated Marketing Communications
Global Prairie Integrated Marketing Communications is a different kind of integrated marketing and communications consultancy, recognized for providing senior-level strategic counsel and creative solutions to meet our clients’ needs. We take a comprehensive view of communications to ensure our clients succeed in an era of mass communication and media fragmentation. Whether it is scientific communications, issues management, public relations, advertising, public affairs, or product marketing, we leverage the digital touchpoints that are revolutionizing how we communicate as individuals and organizations.

Founded in March 2008 by a handful of big agency émigrés, the Global Prairie team now includes more than 60 communications and marketing professionals across the country, in New Jersey, New York, Cleveland, Kansas City, and Dallas/Fort Worth. Although we have a broad range of industry experience, our focus and passion is for the life sciences, which we broadly define to include biotech, healthcare, food, and energy, all of which we view as being important to improving the health and well-being of consumers around the world.

Medix Staffing Solutions
Medix Staffing Solutions’ Life Sciences division recruits the most seasoned talent in a wide range of healthcare, science, and laboratory related organizations. Medix’s Life Science, Laboratory and Quality Assurance sector has experience recruiting in many industries, including food and beverage, pharmaceutical, biotechnology, medical device, oil and gas, and environmental sciences. Within these industries, we place myriad professionals, such as chemists, biologists,, and lab techs, in a variety of settings including QA/QC laboratories, research and development, and regulatory. Additionally, Medix’s staffing verticals include placing professionals within the professional services and information technology industries as well.

Prescient Drug Delivery Consultants
The mission of Prescient Drug Delivery Consulting is to accelerate small-molecule translational drug discovery programs by providing expert consultation services to:

  • Improve drug candidate biopharmaceutical and physicochemical attributes
  • Develop formulations that enable in vitro, ex vivo, or in vivo preclinical studies
  • Critically review drug candidate developability
  • Implement advanced drug delivery technologies when appropriate
  • Enhance and strengthen intellectual property profiles
  • Repurpose, reformulate, or reposition existing drugs
  • Perform unbiased due diligence exercises for licensing or partnering situations.

Prescient Drug Delivery Consulting serves both public (academic and government) and private research sectors. Detailed information is available at our website.

RCM Technologies Inc.
RCM’s Life Science division specializes in delivering life science and technology expertise to our client base through either a flexible staffing model or practice-based solution offerings tailored to meet global regulations, enterprise compliance, and quality objectives. RCM’s tenured team of “hands-on” industry experts are uniquely qualified to perform and execute on the outputs of risk assessments and compliance audits by conducting process and validation services, addressing preventative, investigational, and corrective actions, and helping our clients ensure customer safety and satisfaction through the delivery of product quality.

 

BioNJ thanks Conner Strong & Buckelew, ImClone Systems, and Sanofi for renewing as Diamond Members for 2012.

Conner Strong & Buckelew
Conner Strong & Buckelew are innovative leaders in risk management, insurance, and employee benefits with a dedicated team of professionals exclusively servicing the complex insurance brokerage needs of the life sciences community locally and globally. We know science, and just as importantly, we know your process. Our approach is part experience, part process, and all partnership.

ImClone Systems Incorporated
ImClone Systems is dedicated to developing and commercializing novel therapeutic products in the field of oncology. Our efforts have resulted in a commercially available novel therapy, ERBITUX® (cetuximab), as well as a broad spectrum of innovative product candidates with potential application in multiple tumor types. As a member of the oncology community, we are committed to providing treatments to meet the unmet needs of cancer patients. To fulfill this commitment, ImClone Systems fosters integration of the principles of teamwork and scientific integrity into all facets of the company’s activities. We believe that these values will benefit patients, physicians, and our employees while creating value for our shareholders.

Sanofi
Focused on patients’ needs, Sanofi-Aventis offers a range of essential healthcare assets, including a broad-based product portfolio and a presence worldwide. Our ambition is to become a diversified global healthcare leader. Our strategy is built around three priorities to reach our goals and ensure sustainable growth: Innovation in Research and Development, Adaptation of Group Structures, and External growth opportunities.

 

BioNJ thanks Bristol-Myers Squibb, Fisher Scientific, McGladrey, PricewaterhouseCoopers, and SNR Denton for renewing as Platinum Members for 2012.

Bristol-Myers Squibb Company
Bristol-Myers Squibb Company develops and markets pharmaceuticals, health and personal care products, nutritionals, and medical devices. Around the world, our innovative medicines help millions of people in their fight against serious diseases such as cancer, heart disease, diabetes, HIV/AIDS, rheumatoid arthritis, hepatitis B, and psychiatric disorders.

Fisher Scientific
Fisher Scientific specializes in scientific research, laboratory testing, and life science research, providing the latest equipment and instrumentation, finest chemicals, and highest-quality supplies. We are also a full-service provider of leading-edge safety products, training, equipment maintenance, and procurement solutions for industrial, laboratory safety, and first responder customers. We service the nation’s diagnostic testing needs in hospitals, reference labs, and physicians’ office laboratories with more offerings, more solutions, and more value. Fisher Scientific also provides resources for educators to create scientific excitement in elementary, secondary, and college classrooms with essential products and invaluable information.

McGladrey
McGladrey is a leading professional services firm providing accounting, tax, and business consulting. McGladrey operates in an alternative practice structure with McGladrey & Pullen LLP, a partner-owned CPA firm that delivers audit and attest services. Through separate and independent legal entities, they work together to serve clients’ business needs. Together, the companies rank as the fifth largest U.S. provider of accounting, tax, and business consulting services (source: Accounting Today), with 8,000 professionals and associates in nearly 100 offices. McGladrey Inc. and McGladrey & Pullen LLP are member firms of RSM International, an affiliation of independent accounting and consulting firms. McGladrey is the official accounting, tax, and business consulting firm of The PGA of America.

PricewaterhouseCoopers LLP
PricewaterhouseCoopers LLP (PwC), the world’s largest professional services organization, helps its clients build value, manage risk, and improve their performance. Drawing on the talents of nearly 8,000 partners in 148 countries, PwC provides a full range of business advisory services.

SNR Denton
SNR Denton’s Venture Technology practice, a top 10 law practice for venture capital transactions in the United States, provides nimble, fast-paced counsel to cutting-edge emerging growth companies and venture capital firms — from Silicon Valley to New York to London and around the globe. Our multidisciplinary team of lawyers operates at the convergence of innovation, strategy, finance, and law. We leverage deep expertise in life sciences, medical devices, media and entertainment, telecommunications, cleantech, and health information technology, along with a global network of venture capital and investment banking relationships, to remove hurdles to our clients’ success.

 

BioNJ thanks Argyle Therapeutics, Celldex Therapeutics, Helsinn Therapeutics, Novartis Pharmaceutical Corp., PTC Therapeutics, and Unigene Laboratories for renewing as Core Members for 2012.

Argyle Therapeutics, Inc.
Argyle Therapeutics, Inc. (Argyle) is a biopharmaceutical company focused on the discovery and development of innovative products to address major medical needs in the field of dermatology. Argyle develops synthetic compounds that are mimetics of natural lipid ligands crucial to cellular regulation and signaling. The novel mechanism of action and superior safety profiles makes them highly promising drug candidates. These proprietary New Chemical Entities (NCEs) have significant pharmaceutical potential for treating regulatory dysfunctions underlying inflammatory skin diseases. The worldwide prescription market that is being targeted amounts to over $14 billion and includes major inflammatory diseases such as acne, atopic dermatitis, psoriasis, and rosacea as well as the rapidly expanding area of prescription aesthetics. The company has also identified compounds that will be out-licensed for use in a diverse array of cosmetic applications. Argyle has strategically selected these industry segments that have had annual growth rates of 6% to 8% and should continue for the foreseeable future.

Celldex Therapeutics, Inc.
Celldex Therapeutics is the first antibody-based combination immunotherapy company. Celldex has a pipeline of drug candidates in development for the treatment of cancer and other difficult-to-treat diseases based on its antibody focused Precision Targeted Immunotherapy (PTI) Platform. The PTI Platform is a complementary portfolio of monoclonal antibodies, antibody-targeted vaccines, and immunomodulators used in optimal combinations to create novel disease-specific drug candidates.

Helsinn Therapeutics, USA
Helsinn Therapeutics USA is a privately held biopharmaceutical development company whose management has leadership experience with major pharmaceutical companies such as Roche, Merck, Aventis, and Novartis. The team’s experience ranges through all aspects of drug development — from research, safety assessment, and manufacturing through regulatory affairs and commercialization. Our pipeline consists of first-in-class, composition-of-matter protected compounds acting within the ghrelin pathway.

Novartis Pharmaceuticals Corp.
Novartis Pharmaceuticals Corp. (NPC) researches, develops, manufactures, and markets leading innovative prescription drugs used to treat a number of diseases and conditions, including central nervous system disorders, organ transplantation, cardiovascular diseases, dermatological disorders, respiratory disorders, cancer, and arthritis.

PTC Therapeutics
PTC Therapeutics, Inc. (PTC) is a biopharmaceutical company focused on the discovery, development, and commercialization of orally administered, proprietary small-molecule drugs that target post-transcriptional control processes. Post-transcriptional control processes regulate the rate and timing of protein production and are of central importance to proper cellular function. PTC has assembled proprietary technologies and extensive knowledge of post-transcriptional control processes that it applies in its drug discovery and development activities. PTC’s current pipeline of clinical and preclinical product candidates addresses multiple indications, including genetic disorders, oncology, and infectious diseases.

Unigene Laboratories, Inc.
Unigene Laboratories, Inc. is a biopharmaceutical company engaged in the research, production, and delivery of valuable therapeutic peptide hormones for pharmaceutical purposes.

 

BioNJ thanks Alchimia Partners, LLC, Biologics Consulting Group, Inc., BioRepository Resources, JBK Associates, LeClairRyan, and William Gallagher for renewing as Associate Members for 2012.

Alchimia Partners, LLC
Alchimia Partners offers consulting services to biotechnology and pharmaceutical companies, to investors in those companies, and to other organizations requiring insight or expertise related to the biopharmaceutical industry. Our principle, Tony Fiorino, MD, PhD, brings a unique background and skill set to this consulting practice. Tony founded, and served as President and CEO, of EnzymeRx, LLC, where he led the clinical development of pegylated uricase through Phase I and successfully executed the sale of the program. Before founding EnzymeRx, Tony spent 10 years on Wall Street as a biotechnology and pharmaceutical analyst and portfolio manager. Tony trained in medicine and dermatology at the Hospital of the University of Pennsylvania after completing the MD-PhD program at the Albert Einstein College of Medicine, and received a BS in Biology from MIT. With the experiences and skills built across his career, Tony is equally conversant in basic science, clinical medicine, drug development, financial modeling, and healthcare investing, and he applies this unique, multidisciplined and strategic vision to each engagement.

Biologics Consulting Group, Inc.
Biologics Consulting Group, Inc. specializes in the preparation and review of CBER regulatory applications (INDs and BLAs) as well as the inspection/audit of biologics manufacturing facilities but also in similar regulatory activities for drugs, devices, and combination products.

BioRepository Resources, LLC
BioRepository Resources (BRR) is a privately held life science service provider located in northern New Jersey. It is owned and operated by Ms. Catherine Chin and Mr. Glenn Bullett. The principals have a combined 35-plus years in the pharmaceutical and contract research environments in Canada and the United States. This experience has laid the groundwork for a client-focused approach to the contract pharmaceutical service business. Our sole objective is to provide life science companies with a reliable, secure, and economical alternative for all of their offsite biological sample storage requirements.

All biorepository activities are conducted under Good Laboratory Practices (GLP) and are governed by standard operating procedures and regular quality-control reviews. Internal backup systems are in place for all aspects of the business. Repositories of biological samples and their inventory databases are critical and important components of pharmaceutical research. This is highly respected at BRR, and our facility is managed with the utmost regard for “The Best Practices for Repositories.”

JBK Associates, Inc.
JBK Associates, Inc., is a retainer-based, award-winning, and woman-owned certified executive search firm with a strong focus on the life science and healthcare industries. Placing superstar talent in a wide array of functional specialties, JBK Associates, an AESC member, takes a fully integrated talent management approach to help all size organizations achieve major growth by providing best-in-class solutions for search, staffing, and organizational development. The firm has been recognized by Forbes, The American Business Awards, Diversity Business, Working Mother, Pharma Voice, and New Jersey Business for its achievements and track record of success.

LeClairRyan
LeClairRyan is a national law firm that provides comprehensive legal representation to the biopharma and life sciences industry across the entire legal spectrum. We have 75 professionals, including attorneys and technical specialists who devote their practices to the representation of life science and healthcare related companies and institutions in all phases of product development, from start-up entities with emerging technologies to large branded companies. We have over 30 attorneys and professionals focused specifically on complex patent and FDA-related matters. Our attorneys are also nationally and internationally involved in mergers and acquisitions, joint ventures, corporate partnering, and drafting manufacturing supply, outsourcing, and co-development agreements. In the regulatory approval area, our attorneys provide guidance on regulatory pathway strategies.

On the operational side, our attorneys handle labor and employment matters and immigration matters, and they have extensive litigation experience with product liability matters. In fact, we are national coordinating counsel for one of the largest branded companies. Additionally, our attorneys have extensive experience in e-commerce and intellectual property issues and regularly counsel clients on complex compliance matters, including issues concerning the Foreign Corrupt Practices Act and state and federal false claims matters. Our industry team also regularly represents clients in a variety of patent litigations, including Hatch Waxman, Section IV matters.

William Gallagher Associates
William Gallagher Associates (WGA) is a leading provider of insurance brokerage, risk management, and employee benefits services to companies with complex risks and dynamic needs, including the life sciences. Founded in 1983, WGA has offices in Boston, MA; New York, NY; Hartford, CT; Princeton; Columbia, MD; Atlanta, GA; and Paris, France.

 

BioNJ thanks UMDNJ for renewing as an Institutional Member for 2012.

UMDNJ
The University of Medicine and Dentistry of New Jersey (UMDNJ) is the nation’s largest free-standing public health sciences university, with more than 5,600 students attending the state’s three medical schools, its only dental school, a graduate school of biomedical sciences, a school of health-related professions, a school of nursing, and its only school of public health on five campuses. Annually, there are more than 2 million patient visits at UMDNJ facilities, and faculty practices at campuses in Newark, New Brunswick/Piscataway, Scotch Plains, Camden, and Stratford. UMDNJ operates University Hospital, a Level I Trauma Center in Newark, and University Behavioral HealthCare, a statewide mental health and addiction services network.