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![]() Biotechnology Opportunities In Southwestern PennsylvaniaMarch 2002Report prepared by the Market Research Centre Market Support Division (TCM) The Market Research Centre produces a wide range of market reports by region and sector for Canadian exporters. These reports are available from: - The FaxLink Domestic service (613-944-4500); and - DFAIT's InfoExport Internet site (http://www.infoexport.gc.ca). The Government of Canada has prepared this report based on primary and secondary sources of information. Readers should take note that the Government of Canada does not guarantee the accuracy of any of the information contained in this report, nor does it necessarily endorse the organizations listed herein. Readers should independently verify the accuracy and reliability of the information. Executive SummaryWhat is biotechnology?" Biotechnology is the use of living organisms to produce engineered products that can modify health or the environment; it is a set of biological techniques developed through basic research (molecular, cell and structural biology) and now applied to product development. Examples include: recombinant DNA-based drugs, gene therapy, monoclonal antibodies, engineered proteins and tissues, liposomes and other drug delivery systems, and agricultural as well as industrial products." Source: Dr. Arthur Levine, Senior Vice Chancellor for the Health Sciences, University of Pittsburgh. The biotechnology market in the Southwestern Region of Pennsylvania is in its infancy. While this stage provides many opportunities to invest, guide and nurture these emerging companies, it is fraught with risk due to the current level of support and lack of critical infrastructure within the region. More specifically venture capital, wet lab space and experienced biomedical business management are all in short supply. Initiatives have developed and are ready to move forward to mitigate the risks in the biotechnology market. The Pittsburgh Life Sciences Greenhouse is a focal point where the efforts and resources of many regional organizations will be coordinated and directed to where they will be most effective. The Greenhouse has a ten-year, $600 million plan. The success of getting this plan off the ground is dependent upon receiving $40 million from the state of Pennsylvania's tobacco settlement fund. Today, there is a group of approximately 60 core biotechnology companies in the region. The largest group, 77% of the core, is instrument and device companies with pharmaceutical companies making up the remaining 13%. There is a supporting subcluster of biomedical research support and health services companies. There are approximately 250 biomedical research support companies and over 3,000 health services providers in the Southwestern Pennsylvania region. The biomedical research support companies provide tools that speed and automate the analysis and evaluation of bioscience information. The health services providers include clinics, doctors' offices, hospitals, medical laboratories, ophthalmic goods, kidney dialysis centers, special outpatient facilities, and companies providing diagnostic and analytical services to doctors and hospitals. Biotechnology Market OverviewBiotechnology refers to the application of biological and biochemical science to large-scale production, for the purpose of modifying human health, food supplies or the environment. The biotechnology industry is comprised of many different practices including those involving the alteration of genetic material. To understand the context in which the biotechnology sector is developing in Southwestern Pennsylvania, a brief overview of the biotechnology sector in the United States and Pennsylvania has been provided. United StatesCenters of biotechnology development are becoming more defined in the United States. These centers are growing around existing colleges and universities specializing in medical research, information science and technology and large hospitals and health care organizations. These institutions attract critical federal funding, provide access to labs and other required space, and supply the talent, skill and knowledge needed to perform in the biotechnology sector. There are six leading biotechnology centers in the U.S.: San Diego and San Francisco, California; Seattle, Washington; Boston, Massachusetts; Research Triangle Park, North Carolina, and suburban Maryland.1 With the rapid growth of this sector, additional centers of biotechnology growth will soon emerge. Market Size and Growth RateSince the inception of the biotechnology industry, in the mid 1970's, there have been close to 100 biologic drugs approved. In 2000, five biotech drugs generated sales of over one billion dollars. Standard & Poor's (S & P) estimates up to ten biotech drugs will be generating annual sales in excess of one billion dollars by 2006. According to Ernst & Young, revenues for 339 public biotech companies totaled $22 billion in 2000, up from $18.8 billion in 1999.2 Standard & Poor's expects industry wide revenues for public biotech firms to increase to approximately $25 billion in 2001 and $31 billion in 2002. S & P also estimates the aggregate earnings growth rate of today's profitable large-capitalization biotech firms will be approximately 24% a year for the next three to four years. In 2001, the U.S. biotechnology market entered a stage of rapid growth in product sales fueled by a wave of new biologic drugs on schedule for approval by the Food & Drug Administration (FDA). There were over 400 biotechnology drugs in human clinical trials in 2000.3 This figure is expected to increase sharply over the next several years. Battelle Memorial Institute found that there were 38,466 biotechnology firms in the U.S., employing over 1,444,469 persons (an average of 37.6 employees per firm). Key Factors Affecting Market GrowthResearch & Development SpendingAs a percentage of revenues, research and development (R&D) spending in the biotech industry is among the highest of any U.S. industry group According to Ernst & Young, R&D expenditures by public biotech firms was $9.9 billion in 2000, up from $6.9 billion in 1999 and $6.7 billion in 1998.5 S & P estimates R&D spending will approximate $13 billion in 2001. Although R&D in biotech firms has traditionally been over 50% of revenues, S & P expects this percentage to decrease over time due to the strong revenue growth of existing products coupled with additional revenues generated by new product launches. Based on a PhRMA report for the Healthcare industry, R&D spending was 12.8% of product sales in 2000, which is significantly higher than the 3.9% average for non-health related industries. Availability of CapitalCompanies in the biotech industry range from small start-ups to multibillion-dollar firms. One of the key requirements in a small biotech company is access to capital. According to the private merchant bank Burrill & Company, the biotechnology industry raised $6.9 billion from venture capital and private investment sources in 2000, up from $2.5 billion in 1999. An important source of funding for some biotech firms has been the National Institutes of Health (NIH), a division of the Department of Health and Human Services (HHS). The NIH plays a critical role in drug discovery by funding basic research on the fundamentals of disease. The NIH is comprised of 27 separate institutes and centers. The federally funded budget in 2000 was $17.9 billion. The budget grew to $20.3 billion in 2001 and was expected to be $23 billion in 2002. Approximately 82 percent of the budget is invested through grants and contracts supporting research and training in more than 2,000 research institutions throughout the U.S. and abroad.6 Once a biotech firm has a promising new product, it may be lucky enough to team up with a major pharmaceutical or biotech company. These valuable partners will generally supply up-front funding and additional payments as milestones are reached. In addition, the partnership may yield production facilities, sales forces, marketing expertise, and access to distribution channels in exchange for marketing rights under licensing arrangements. PennsylvaniaThe state of Pennsylvania has three regions that are poised to become biotechnology centers: Philadelphia, Central Pennsylvania and Southwest (or Pittsburgh Region). In 2001, Pennsylvania Governor Tom Ridge announced a plan to allocate $100 million of the state's tobacco settlement funds to build three Life Sciences Greenhouses modeled after Pittsburgh's successful Digital Greenhouse. Each region, while vying for funding to build these biotech research centers, has vowed to cooperate and bring their own unique strengths together in an effort to become a recognized world leader in the biotech industry. PhiladelphiaOf the three regions in Pennsylvania, Philadelphia's private biotech sector is the most advanced when it comes to biopharmaceuticals. Leading the Philadelphia Life Sciences Greenhouse effort is Cephalon, Inc., a biopharmaceutical company. Other major drug companies stimulating biotech growth in the area are Wyeth-Ayerst Pharmaceuticals, AstraZeneca Pharmaceuticals LP, Merck & Co. Inc. and GlaxoSmithKline. The University of Pennsylvania and Thomas Jefferson University provide an educated workforce to these companies. Other universities involved in the project are Temple, Drexel and LaSalle. The Philadelphia Region has not focused on any specific areas of bioscience or technology. Instead, the bulk of the state tobacco funds will be used to make pre-seed stage investments in companies that have the most promising commercialization prospects. The major barrier to success in this region could be political fiefdom. Philadelphia doesn't have a history of working together, but indications of cooperation on the Greenhouse project are positive thus far. Central PennsylvaniaThe biotechnology market in Central Pennsylvania is a mixture of universities, hospitals and private companies. Leading the region are Penn State University, Lehigh University, and Hershey Medical Center. The Central Penn Greenhouse will focus on drug discovery, biomedical devices, bioinformatics and nanofabrication. Nanofabrication may have the highest overall potential for this region. Nanofabrication is the design and manufacture of devices such as super high-density microprocessors and memory chips, with dimensions measured in nanometers. One nanometer is a millionth of a millimeter. Nanofabricated devices could include biochips whose components would simulate the division of cells in a living being. The major barrier to success in the Central Region is geography. Some of the research centers and campuses are separated by as many as 80 miles. Other barriers sited are lack of gap funding, venture capital and lab space. Southwest RegionEconomic BaseThere are approximately 545 bioscience establishments, representing 130 - 150 firms, employing more than 76,000 workers, and representing 5.8% of the workforce in the Pittsburgh Region. Hospitals account for over 87% of the region's bioscience employment; 13% is in the remaining categories of medical devices and instruments, medical labs, drugs and pharmaceuticals, research and testing, and agricultural chemicals.7 Hospitals are the largest bioscience subsector in the region. The concentration of hospitals in the Pittsburgh Region is 43% higher than the rest of the U.S.. Through consolidation, there has been a 21% decrease in hospital employment since 1995, however, hospitals remain the basic driver of the bioscience sector. Contributions from area hospitals can be seen in spin-off activity, collaborative efforts, localized supply chains, and regional employment.8 The number of non-hospital bioscience sector establishments grew 35% and employment in this sector grew 16.2% from 1995 - 2001. Pittsburgh is 27% less concentrated in the non-hospital bioscience sectors than the nation. Although the growth rate of bioscience firms is comparable to the state of Pennsylvania and the U.S., the region lags behind in employment growth. Pittsburgh bioscience employment totals approximately 10,000.9 The medical device and instrument manufacturing subsectors have grown 18.5% since 1995 and accounts for over half of Pittsburgh's non-hospital bioscience employment. Drugs and pharmaceuticals and research and testing subsectors account for less than 1,200 employees. Growth has been flat in these subsectors since 1995. Medical Laboratories have experienced decreased specialization as a result of hospital downsizing. Strategic FocusThe current biotechnology initiative in Pittsburgh is mainly rooted in academia. Early in 2001, the University of Pittsburgh and Carnegie Mellon University formed an alliance called Pittsburgh BioVenture in an effort to position the region as a major player in biosciences. Later, in that same year, following Governor Ridge's announcement of the formation of Life Science Greenhouses, the Universities met with the Pittsburgh Regional Alliance (PRA) and other leadership organizations in the region and determined that a single concerted initiative would better serve the community. Therefore, the Pittsburgh BioVenture became the Life Sciences Greenhouse to position the region as a bioscience leader. The Pittsburgh Region can be positioned as a leader in biotechnology through a two-fold focus on:
To drive these initiatives, the Pittsburgh Life Sciences Greenhouse will concentrate on four core research areas:
These research initiatives emerged as the result of three facilitating factors:
The University of Pittsburgh's prominent work in biosciences, Carnegie Mellon University's expertise in computer science and robotics and the network of hospitals and health organizations are critical factors in accomplishing the core research initiatives. Key Factors Shaping Market GrowthThe key factors impacting the growth rate of the biotech economy in the Pittsburgh Region are:
Venture capital is the most important funding source for a biotech firm. While other sources contribute to the growth of these companies, the level of funding is not enough to sustain and ensure their survival. Pittsburgh lacks venture funding, at all stages of investment, which is targeted toward biotechnology. Technology commercialization is the process of identifying, funding, developing, mentoring, marketing and managing an emerging biotechnology. There is no smooth process for bioscience technology commercialization in the region today. In an effort to address this issue the universities have been adding staff to their technology transfer offices. The universities will work with the Life Sciences Greenhouse to try and institute a process. Wet labs and other specialized space needed by bioscience companies are in short supply in Pittsburgh today. Civic leaders, working together with economic development organizations, will need to devise plans to attract private developers to tackle this issue. A lack of seasoned, experienced, entrepreneurial managers, sales, marketing and regulatory personnel was sited as one of the largest gaps in the region by Battelle Memorial Institute, in a recent study. There are several underlying issues here. First, Pittsburgh must be able to attract talented, skilled, biomedical managers. Second, workforce development efforts need to focus on bioscience career development. A lack of strategic industry partners in close proximity has been sited as an issue that may potentially affect the growth of the biotech economy in Pittsburgh. As biotech firms develop products that attract the attention of large industry partners, the firms may find it easier to operate by relocating out of the region to the partner's location. Business resources and climate refers to the investment that must be made by local government, economic development organizations and industry trade organizations. These investments cover developing an image for the region, marketing the region, addressing tax policy issues, gaining knowledge of bioscience issues in packaging economic development deals and how these initiatives will continue to be funded until a return on investment is realized in the regional economy. The infrastructure related issues must be addressed through the cooperation of industry, civic and academic leadership organizations in the Pittsburgh Region. The Life Sciences Greenhouse will act as a conduit facilitating collaboration between industry, organizations and institutions. It will assist the different entities to operate in an entrepreneurial fashion to achieve the growth of the biotech economy. See Appendix A for Key Regional Contacts - Board Members and participants in the Pittsburgh Life Sciences Greenhouse. Pittsburgh Biotechnology Market SegmentationDespite the obstacles that must be overcome to grow the biotechnology business sector in Southwestern Pennsylvania, a core cluster of approximately 60 biotechnology companies have emerged. A subcluster of over 3,200 supporting establishments also exists in the region. The core cluster of biotech companies can be divided into two groups: instruments/devices and pharmaceuticals. There are 46 companies that make up the instruments devices group and 13 companies in the pharmaceutical group. A further breakdown of each group by SIC code is provided in the following illustrations. Instrument and Device CompaniesThe five largest instrument and device companies, as measured by number of employees in the region, are Medrad, DynaVox Systems, Respironics, NOMOS, and Berkley Surgical Corporation. Medrad Medrad was founded in 1964, when M. Stephen Heilman, M.D., an emergency room physician, created the first angiographic injector. Dr. Heilman saw tremendous potential in angiography, a revolutionary X-ray technology that made it possible to visualize blood vessels inside the body. Injecting a contrast agent into the vessels enhances the image and makes it possible to diagnose heart disease and stroke patients. Medrad later introduced the first injector technology for computed tomography and magnetic resonance imaging. Medrad products are sold to hospitals and medical imaging centers in over 85 countries. Total annual sales are over $200 million. Their product line includes Vascular Injection, Magnetic Resonance, and Service. Medrad is headquartered in Indianola, Pennsylvania, 15 miles northeast of Pittsburgh. The major location of 285,000-sq. ft. includes headquarters, administration functions, and production units. A smaller facility nearby, of about 15,000-sq. ft., houses a circuit board assembly operation. Medrad employs more than 1,000 people in the Pittsburgh Region. Recent News3/5/02 PBT "The medical imaging industry is discovering better ways to detect and treat disease earlier and more accurately, and our employees and products are entirely focused on that goal," said John Friel, president and CEO. DynaVox Systems DynaVox Systems LLC is a leading provider of advanced augmentative communication (AAC) products. The AAC products are sold to individuals with speech disabilities. AAC products are tools that enable these individuals to express themselves and communicate more fully. These speech-output devices combine state-of-the art technology with natural language formation processes, allowing people of all ages to communicate quickly and easily. Anyone with speech that is unintelligible and has the desire to communicate is a good candidate for DynaVox products. Customers include people with conditions such as Amytrophic Lateral Sclerosis (ALS or Lou Gehrig's Disease), stroke, traumatic brain injury and cerebral palsy. DynaVox was established in 1983 as Sentient Systems Technology and is now a division of Sunrise Medical Inc. DynaVox employs 150 in the Pittsburgh Region and continues to grow rapidly as the need for their products increases in the U.S. and abroad. Respironics Respironics (RESP) is a recognized resource in the medical device market. The company provides unique programs designed to assist health care providers with the management of sleep disordered breathing, chronic obstructive pulmonary disease, asthma and infant care. Respiratory care is a $3.1 billion market. The company is focused on home care, hospital and international markets. The company's goal is to continue to grow its revenues and earnings by further penetrating the largely untapped sleep disorders market as well as the chronic obstructive pulmonary disease, asthma/allergy and infant care markets around the world. Additional medical conditions and patient populations targeted by the company include congestive heart failure and stroke victims. Respironics employs 446 in the Pittsburgh Region. Recent News02/02/02 Pittsburgh Business Times NOMOS NOMOS Corporation provides advanced radiation therapy solutions for cancer patients. The Company offers a broad range of oncology options capable of meeting all of the treatment planning and delivery requirements of a radiation therapy department or clinic, including Intensity Modulated Radiation Therapy (IMRT) planning and delivery, conventional treatment planning, and unique support devices for radiation therapy practice. NOMOS introduced its flagship product, PEACOCK, in 1992. In clinical use since 1994, PEACOCK is the only 510-K cleared inverse treatment planning system for delivering both rotational and fixed angle IMRT. In 1998, the Company introduced BAT, a product that utilizes ultrasound to more precisely locate an organ or target before a radiation therapy treatment. In July of 1999, NOMOS was granted an exclusive license by Lawrence Livermore National Laboratory (LLNL) to commercialize its Monte Carlo-based PEREGRINE™ technology. Based on the Laboratory's decades of research into radiation physics, PEREGRINE employs Monte Carlo statistical techniques to accurately predict the radiation dose to tumors and other structures within the patient's body during a radiation treatment. Current dose calculation methods approximate the radiation dose distribution in the patient based on dose distributions in water. With the refined PEREGRINE calculations, doctors and clinicians will improve the treatment to concentrate curative radiation doses on tumors with less damage to surrounding healthy tissue. On February 1, 2000, NOMOS Corporation and Marconi Medical Systems entered into a distribution agreement whereby Marconi would distribute NOMOS' IMRT, Monte Carlo and ultrasound radiation oncology products to Marconi's worldwide customer base. In addition, the two companies' oncology systems will be aligned to provide the core of advanced technology required in today's radiation oncology suites. NOMOS' strategy is to make Monte Carlo-based PEREGRINE a part of routine clinical practice and the system of choice for clinical applications. Partnerships with Marconi Medical Systems and other radiation therapy product providers will allow them to provide customers with a one-stop-shop for all of their radiation therapy planning and treatment needs. Their headquarters are located in Sewickley, Pennsylvania, and houses marketing and sales, engineering, manufacturing, clinical and regulatory affairs and a prototype development shop. Nomos employs 85 people. Berkley Surgical Corporation Berkley Surgical Corporation (BSC) started business more than a century ago making pajamas for Sears & Roebuck. By embracing advanced technology and close customer partnerships, BSC has successfully withstood the dynamic change in the apparel market to emerge as a strong contract manufacturer specializing in medical products. BSC's medical product line includes surgical facemasks that provide a wide range of barrier protection for air-borne and blood-borne pathogens. Its manufacturing facilities are located in Uniontown and are registered with the FDA for Class 1 and Class 2 medical devices. BSC Vice President of Manufacturing Ted Michaelis, explained that Berkley Surgical, through manufacturing innovations and the use of advanced technology, has stayed on the cutting edge of manufacturing its product line. The company has been able to produce better products more efficiently through innovative techniques such as making products that normally require sewing with needle and thread on woven material to specializing in non-woven materials using alternative fastening techniques. Michaelis further explained that much of BSC's success has come from forming strategic partnerships, including Medline, Johnson & Johnson, Kimberly-Clark, and PGI. BSC is primarily a private label supplier for medical distribution. Pharmaceutical CompaniesThe two largest companies in the pharmaceutical group, as measured by number of employees in the region, are SmithKline Beecham Corporation, and HVL Inc./Douglas Laboratories. It should be noted that the headquarters for Mylan Laboratories is also located in Pittsburgh, however, there are only eight employees consisting of the senior level executive staff in this office. Other pharmaceutical companies, such as Eli Lily and Company and Baxter Healthcare Corporation, have small sales and distribution offices located in the Pittsburgh Region with 15 people or less. SmithKline Beecham Corporation Through a merger with Glaxo Wellcome on December 27, 2000, SmithKline Beecham Corporation became GlaxoSmithKline Beecham. GlaxoSmithKline (GSK) is a world leading research-based pharmaceutical company. GSK's mission is to improve the quality of human life by enabling people to do more, feel better and live longer. Headquartered in the UK and with operations based in the US, the new company is one of the industry leaders, with an estimated seven per cent of the world's pharmaceutical market. GSK also has leadership in four major therapeutic areas - anti-infectives, central nervous system, respiratory and gastro-intestinal/metabolic. In addition, it is a leader in vaccines and has a growing portfolio of oncology products. GSK has a Consumer Healthcare portfolio comprising over-the-counter medicines, oral care products and nutritional healthcare drinks, all of which are among the market leaders. Based on 2001 annual results, GSK had sales of $29.5 billion and profit before tax of $8.8 billion. Pharmaceutical sales accounted for $24.8 billion with new products representing 22% of total pharmaceutical sales. GSK had four products with sales of over $1 billion and a total of 16 products with sales in excess of $500 million. GSK has over 100,000 employees worldwide. Of these, over 40,000 are in sales and marketing, the largest sales force in the industry. Over 40,000 employees work at 107 manufacturing sites in 40 countries and over 16,000 are in R&D. A Consumer Healthcare R&D Center and shipping operation is located in Pittsburgh at 100 Beecham Drive Pittsburgh, PA 15205. Phone: 1-800-456-6670 or 1-412-928-1000. Brand names such as Panadol the analgesic, Aquafresh toothpaste, Lucozade the nutritional and Nicorette/ Niquitin smoking cessation products are household names around the world. In one year GSK Consumer Healthcare produces - among many others - nine billion tablets to relieve stomach upsets, six billion tablets for pain relief tablets and 600 million tubes of toothpaste. The Consumer Healthcare center in Pittsburgh employs over 500 people. HVL Inc./Douglas Laboratories Douglas Laboratories is a manufacturer of dietary supplements employing more than 250 people in a 70,000 square foot, manufacturing and distribution facility. The facility houses three laboratories outfitted with the latest high-tech analytical equipment. There is also a chemical testing lab that carefully checks bioavailability with USP dissolution tests and pH testing, while verifying potency with HPLC (High Pressure Liquid Chromatography). The production process of nearly 1000 products is constantly monitored to ensure that rigorous USP, G.M.P., and other worldwide standards are met. The manufacturing facility houses thirteen state-of-the-art encapsulation machines that can each run batches of over 40,000 capsules per hour. There are seven tablet presses that can cold process millions of tablets daily. In addition, Douglas has built in manufacturing flexibility enabling custom formulations, private labeling, and packaging for customers marketing their own brand of natural products. In addition to the US and European distribution offices, Douglas has a Canadian distribution office located in Ontario at: Douglas Laboratories of Canada Mylan Labs Mylan Laboratories Inc., headquartered in Pittsburgh, Pennsylvania, is a leading pharmaceutical company specializing in the development, manufacture and marketing of generic and branded pharmaceutical products. When Mylan Pharmaceuticals was founded in 1961, its mission was to help make quality medicines more affordable for patients who need them. Today, Mylan is a leader in the generic pharmaceutical industry. Mylan markets its extensive line of generic products through three business units: Mylan Pharmaceuticals Inc., Mylan Technologies Inc. and UDL Laboratories, Inc. The generic product portfolio covers a variety of dosage forms including immediate and extendedrelease oral tablets and capsules and transdermal patches, as well as repackaging and marketing multisource and single-source products in unit dose form for the institutional marketplace. Mylan markets its branded pharmaceuticals through Bertek Pharmaceuticals Inc. Bertek operates as a stand-alone proprietary pharmaceutical company with independent clinical development, business development and sales and marketing efforts. Bertek is a transitional pharmaceutical company that will enable Mylan to grow from a traditional generic company to a proprietary based company. Bertek's goal is to expand the branded business to 50% of total company revenues. The Company's strategy is to optimize marketing and sales through a targeted therapeutic focus on neurology, dermatology and cardiology, thereby enabling field sales representatives to concentrate on a narrow physician call base. Mylan's facilities, in Morgantown, W.V., consist of over 550,000 square feet of research, laboratory, manufacturing, and office space. The main manufacturing plant occupies over 300,000 square feet, and routinely produces over 15 tons of product each day. More than one hundred different products, of multiple strengths and package sizes are produced, in full compliance with all FDA mandated Good Manufacturing Practice regulations. Stringent QA/QC procedures, backed by innovative manufacturing methods and equipment, ensure Mylan's products are safe and effective. R&D Research and Development Operations located in Morgantown, W.V., assure a continual flow of new products. From research and development through packaging and shipping, Mylan employs more than 1200 people in the Morgantown facility. Mylan's cutting edge R & D and pharmacokinetics labs feature the sophistication and technology of a world-class facility. Mylan makes numerous FDA submissions per year, and boasts one of the shortest times between FDA submission and approval in the industry. The product development area features 20 development suites, thus allowing many products to be developed simultaneously. The construction in this area fully meets GMP standards. The potent substance containment development suite has three air-locked chambers and negative air pressure to ensure that potent substances are safely contained in a secure zone. The R&D laboratories also feature high tech equipment, such as an extensive and modern HPLC lab, DSC/TGA instrumentation, tandem mass spectrometers, and a robotics lab. The result of this technology, in the robotics lab for example, is that samples that used to take 8 hours to process manually, can now be processed in under 30 minutes. Recent News3/6/02 Pittsburgh Business Times A detailed list of the 60 biotechnology companies in the instruments and devices and pharmaceutical groups is provided in Appendix C. Biomedical Research CompaniesThe supporting subcluster is comprised of biomedical research support and health services companies. There are approximately 250 biomedical research support companies and over 3,000 health services providers in the Southwestern Pennsylvania region. The five largest biomedical research companies, as measured by number of employees in the region, are Cellomics, BioTronics, Novum Pharmaceutical Research Services, Lifecor, and TissueInformatics. Cellomics Cellomics is a privately held company, located in Pittsburgh, Pennsylvania employing approximately 140. Cellomics' cell-based products and services are designed to enable drug discovery firms to rapidly narrow their search to include only the compounds that are most likely to succeed in clinical trials. Cellomics predicts that understanding cellular processes will mirror the understanding of genomic information, but with far greater impact. The company has combined automated intracellular and intercellular measurements with searchable databases of cellular information to build on the success of the genomic revolution, which has combined automated DNA sequencers with searchable DNA sequence databases for gene discovery. Cellomics is the only company that provides information on multiple interacting or independent components within or between living cells. This high content information enables more qualified new chemical entities to come out of the early drug discovery pipeline. Cellomics has the technology that combines high throughput primary screening with high content cellular screening, including reagents and kits, cell lines, automated cell analysis instrumentation, assays with proprietary cell analysis software, informatics, cellular bioinformatics and assay development services. R & D High Content Screening is multiplexed, functional screening based on high-resolution fluorescence imaging of multiple targets in the context of intact cells. The goal is to draw from expertise in the fields of fluorescent microscopy and cell biology to create a new set of screening tools aimed at the bottlenecks in drug discovery. Cellomics, Inc., has successfully combined fluorescent reagents and cell lines, automated imaging instrumentation, informatics and bioinformatics tools to create a turnkey system that:
Recent NewsDecember 19, 2001 Pittsburgh Business Times BioTronics Founded in 1984, BioTronics specializes in medical technology management services. Its goal is to provide technology management services that result in cost effective, safe and reliable equipment that meet the demands of quality patient care and improve the organization's bottom line. BioTronics' customers are hospitals, clinics and physician offices located in Western Pennsylvania and Eastern Ohio. They currently manage over $500 million in medical equipment assets. They offer medical equipment, perfusion and sterilizer services Medical Equipment Service BioTronics Inc. can significantly reduce the maintenance costs of many high-tech medical instruments. They monitor the quality and cost of medical and radiology equipment and services. They offer repair service, quality assurance, and preventive maintenance programs. Perfusion Services The Perfusion Division was formed in 1994 to provide clinical services and equipment required for openheart procedures, intra-aortic balloon pumping and auto-transfusion. Under a contractual arrangement, BioTronics Inc. provides all equipment, supplies, and personnel necessary to deliver safe and costeffective cardiovascular services. Individual service combinations also are available under lease or rental agreements. BioTronics also provides in-service programs that meet JCAHO standards that can train staffs to operate auto-transfusion equipment and intra-aortic balloon pumps. Sterilizer Services BioTronics offers a sterilizer service program to hospitals, clinics, and physicians offices on a demand labor or service contract basis. Services include:
BioTronics employs 135 people in the Pittsburgh Region. Novum Pharmaceutical Research Services For over 25 years, Novum has been a leading provider of Phase I clinical research services to the generic, pharmaceutical, and biotechnology industries. They have completed over 2,000 studies with over 36,000 participants for more than 200 pharmaceutical companies. In the past year, Novum has paid over $1.4 million to individuals who have participated in studies. There are two locations that offer clinical studies - Pittsburgh, PA and Houston, TX. Novum operates screening locations at State College, PA and Morgantown, WV. Novum Pharmaceutical Research Services announced in May, 1999 that the Food and Drug Administration (FDA) approved the eighth Abbreviated New Drug Application (ANDA) for a generic topical corticosteroid where the clinical conduct and analysis was conducted by Novum. Since the issuance in 1995 of the FDA Guidance on bioequivalence studies for the generic topical corticosteroids, twelve such products have received marketing approval. Eight of these approvals have resulted from data and analysis from Novum. The FDA has conducted numerous pre-approval inspections of these studies at Novum and accepted their methodology. Data generated from studies conducted at Novum has also been used to support marketing applications in Canada, Europe, and Israel. Since 1995, Novum has conducted sixty-eight vasoconstrictor studies with topical corticosteroids, covering twenty-four different products and formulations. Novum has also conducted potency classification studies for several investigational corticosteroid products and formulations currently under evaluation by the FDA. Novum's experienced scientists and operational staff, supported by their automated data capture system and quality control procedures, has allowed them to provide study results to sponsors within hours of completion of the clinical conduct. Their unique formulation screening protocols and rapid data analysis procedures significantly shorten the time needed for sponsors to make informed decisions on the quality of their formulations which accelerates products to market. Lifecor Lifecor was founded by a team of former Intec System employees who were responsible for developing and introducing the world's first Implantable Cardioverter Defibrillator (ICD). The current market for ICD is estimated at more than $2 billion annually. ICDs have reduced the sudden cardiac arrest (SCA) rate from an expected 30% to approximately 1% per year, thus saving thousands of lives. Medrad/Intec received the NASA Outstanding Achievement Recognition Award for its development of the ICD and was inducted into the Space Technology Hall of Fame in 1991. The Medrad/Intec's ICD technology and related assets were sold to Eli Lilly and Company in 1986. R & D Lifecor is currently developing a solution to address the high mortality associated with high-risk SCA. The LifeVest™, the world's first automatic wearable cardioverter defibrillator, is designed to be a costeffective, noninvasive, non-surgical treatment option that will guard against arrhythmias or rapid heart rates in patients at high risk for SCA. It is designed to automatically intervene at the first sign of lifethreatening cardiac distress. The FDA has given LIFECOR approval to begin limited clinical trials in the United States. The LifeVest system consists of:
The Garment holds the Electrode Belt next to the patient's skin, allowing the device to constantly monitor the patient's heart, and in case of a life-threatening arrhythmia, deliver a series of up to five defibrillating shocks. The Holster can be worn like a belt, and holds the Monitor against the patient's body. The Battery Pack provides the power to the device, and the Alarm Module allows the patient to respond to messages and alarms. The system also comes with modem so that the patient may send device and heart-related information to doctor's office via the telephone. TissueInformatics TissueInformatics, Inc., founded in Pittsburgh in 1997, provides tissue imaging, image analysis and image information management solutions to the tissue engineering, pharmaceutical, genomics and related industries. They specialize in the extraction of information from tissue using imaging technologies and related biological methods. They provide management of tissue-derived information, including database development, secure storage of images and associated information and development of internet-based access and retrieval systems. TissueInformatics, Inc. is launching Tissue Information Solution™, the first process to automatically capture, analyze and mine the vast data found in human, animal and plant tissues. Tissue Information Solution helps pharmaceutical, tissue engineering and other biotechnology companies speed their research and product development by providing quantitative tissue data faster and more accurately than currently possible using any other analytical method. This new platform for understanding disease and drug effects should help shorten the amount of time it takes to bring new drugs and therapies to patients. Recent News01/24/02 Pittsburgh Post Gazette Health Services CompaniesThe health services providers include clinics, doctors' offices, hospitals, medical laboratories, ophthalmic goods, kidney dialysis centers, special outpatient facilities, and companies who provide diagnostic and analytical services to doctors and hospitals. There are three Health Services companies that have gained size and recognition in the region: Main Medical, NeoGen Screening and Precision Therapeutics. Main Medical Main Medical, Inc. is a Pittsburgh-based company founded in 1985. Main has evolved from a manager of Cardiac Care Centers to a multi-million dollar integrated healthcare company, specializing in diagnostic imaging. Main's business approach uses a balance of mobile services with fixed-site operations to provide a cost-effective delivery system. Main's service line includes nuclear medicine, radiopharmaceuticals, mobile ultrasound and diagnostic imaging facilities. Employing 140 people, Main Medical is listed as the fifth largest biotechnology company in the Pittsburgh Region according to the Pittsburgh Business Times. Recent NewsNovember 2000 - Named for the second consecutive year as one of the 500 fastest growing companies in the United States by INC. Magazine. October 2000 - Mobile Imaging Services receives accreditation in ultrasound by the American College of Radiology. Neo-Gen Screening Neo Gen Screening began independent operations on October 1, 1994 as a spin- off from Magee-Women's Hospital and the University of Pittsburgh. It was founded with three main purposes in mind: 1. to provide state-of-the-art metabolic screening to newborns for conditions not included in mandated state screening programs; 2. to provide an alternative to state health department based newborn screening laboratories; and 3. to carry out research into new methodologies for the detection of inherited metabolic disorders in newborns. Neo Gen Screening offers programs for newborn and high risk clinical screening. Neo Gen Screening uses patented laboratory, quality assurance, and interpretive methodologies and cutting edge technology, such as tandem mass spectrometry and molecular confirmation, to screen for more than 50 clinically significant and manageable disorders that affect newborns. Neo Gen Screening is a CAP, CLIA, Pennsylvania, and New York certified laboratory Neo Gen Screening participates in The Center for Disease Control (CDC), New Zealand, and French Cystic Fibrosis proficiency screening programs and exchanges Quality Assurance materials with other expert metabolic laboratories throughout the United States. Neo Gen Screening currently supplies the state mandated screening for both Pennsylvania and Washington DC. Neo Gen Screening also provides supplemental screening programs to more than 600 submitters in 45 states as well as hospitals in Latin America, Europe and Asia. In addition to the screening programs, Neo Gen Screening is actively involved in research and development. Recent News09/09/2001 Virtual Health Maternity Services: "7000 Babies Can't
be Wrong" - An overview of the maternity services at the Virtual
Health Systems Hospitals in South Jersey. 05/07/2001 ABC News: "Unequal Baby Testing" - A two-part series on inadequate newborn screening for over 30 serious and/or life-threatening metabolic disorders. Precision Therapeutics Precision Therapeutics, Inc. is a cancer management services company founded in 1995 to help physicians determine the most appropriate cancer treatments for their individual patients. Precision Therapeutics has developed a patented technique for successfully growing human tumorderived cells in culture and testing the cultivated cells for drug sensitivity and/or resistance. The company's ChemoFx® Assay is the first application of this technology. The results provide medical and surgical oncologists with patient-specific tumor information that may provide additional insight when determining the appropriate course of treatment for a patient. Physicians can use Precision Therapeutics' ChemoFx® Assay to assist them in evaluating optimal therapy options for individual patients. The biopharmaceutical industry may be able to use these services to improve the selection of effective drugs and responsive tumors to decrease drug development costs significantly. Precision Therapeutics' scientific staff has extensive experience in clinical testing and cancer research, and provides services to physicians and biopharmaceutical companies from their headquarters in Pittsburgh, where they employ 36 people. Recent News11/13/01 Pittsburgh Post Gazette Precision Therapeutics plans to use the capital to pursue key management hires, conduct additional research and clinical studies, build a direct sales distribution channel and streamline lab operations. The company also plans to move into a new office on the South Side by the end of January. The new facility will feature 9,000 square feet of dedicated lab space. "The success of the $17.5 million fund-raising initiative, given recent market trends, is indicative of the strength of Precision Therapeutics' science and our strong commercial potential," said Sean McDonald, Precision Therapeutics' president and CEO. Appendix A - Key Regional Contacts and Board Members of Pittsburgh Life Sciences GreenhouseDr. Jared L. Cohon, President Mark A. Nordenberg, Esq., Chancellor Dennis Yablonsky, CEO William S. Dietrich II, Chairman Arthur S. Levine, M.D., Senior Vice Sean McDonald, President and CEO C.J. "Chuck" Queenan, Esq. Jeffery Romoff, President David S. Shapira, Chairman and CEO D.Lansing Taylor, Ph.D., President and CEO Bernie McShea Appendix B
Source: Pittsburgh Business Times survey of over 80 companies identified by the Pittsburgh Tissue Engineering Initiative as directly or indirectly involved in biotechnology in Allegheny, Beaver, Fayette, Washington and Westmoreland counties. Appendix C - 60 Core Biotechnology Companies in the Pittsburgh RegionPharmaceuticalsH V L Inc/Douglas Labs Baxter Healthcare Corporation Johnsons Pharmaceutical Lilly, Eli And Company Inc Mylan Laboratories Inc Three River's Pharmaceutical, LLC SmithKline Beecham Corporation Unipack, Inc. Bayer Corporation Organic ChemicalsAshland Inc Chemfirst Fine Chemicals, Inc Earth Sources Ltd Pressure Chemical Co. Inc Pressure Chemical Co. Inc Cq Inc Instruments and DevicesAlvord Systems Inc Applied Test Systems, Inc Aspex LLC Berkley Medical Resources Inc Berkley Surgical Corporation Berkowitz, Michael Company Inc Bico, Inc Bico, Inc Bodymedia, Inc. Cardiac Assist Technologies Inc Central Orthotic & Prosthetic Co Inc ChemIcon Inc Chiron Diagnostics Cianflone Scientific Instruments Corporation Cook Vascular Corp Inc Diebold, Incorporated Dymax Corporation Excel Technology Inc Extrel Mass Spectrometry Fischione, E. A., Instruments, Inc Foerster Instruments Inc Gatan Incorporated Haemonetics Corporation Instrumentation Industries Inc International Interscope Technologies Inc John Robert Enterprises Inc Lake Region Manufacturing Company Inc Laurel Mountain Whirlpools, Inc Medical Center Brace Co Inc Medrad, Inc Medtronic, Inc Mine Safety Appliances Company Inc Neo-Solutions Inc Neuro Kinetics Inc Nomos Corporation Pittsburgh Medical Device Respironics, Inc Semtek Systems, Inc Sunrise Medical Inc Thar Design, Inc Thermo-Electric Co, Inc Ultraoptics, Inc. UPMC Lee Regional MRI Visible Genetics Corp Xodus Medical, Inc. Appendix D - Recent DealsBiotechnology Investors who have made past investments in the region:
Company: TissueInformatics Company: TissueInformatics Company: Precision Therapeutics Company: Cellomics Company: LaunchCyte Company: Flourous Technologies, Inc. Appendix E - Useful WebsitesBioPoint - Pittsburgh Biotechnology, Biomedical and Medical Industry Resource "This site seeks to offer a clear picture of the Pittsburgh biomedical community - what it has to offer, where it is headed, and what opportunities exist for employment/ investment and licensing." http://www.biopoint.org Pittsburgh Technology Council - Visit the Pittsburgh Technology Council's site to view the "State of the Industry Report" which contains facts and figures on the Biomedical and Biotechnology sectors. http://www.pghtech.org/pittsburgh/report_bio.html Pittsburgh Regional Alliance - The Pittsburgh Regional Alliance is an economic development organization whose mission is to "sell the region" to attract businesses, talent, and investment in the region. Visit their website to view reports like Pittsburgh's Biomedical Centers of Excellence Identification and Validation, and BioVenture/Life Sciences Greenhouse Prospectus. http://www.pittsburgh-region.org World Trade Center Pittsburgh - The World Trade Center Pittsburgh is an economic development organization that offers businesses educational services, publications, and consulting. A directory of biotechnology firms in Pittsburgh is accessible through their website. http://www.wtcpa.org University of Pittsburgh Center for Biotechnology and Bioengineering - Visit the university site to get the latest update on biotech studies and programs. http://www.pitt.edu/~biotech/ GSIA Biotech Club Carnegie Mellon University - Their mission is to link members of the club with opportunities in the biotech arena, enhance biotechnology awareness, and host biotech activities at CMU and in the greater Pittsburgh area. http://www.gsia.cmu.edu/afs/andrew/gsia/biotech/ 1 Ernst &Young, Focus on Fundamentals: The Biotechnology Report, October 2001 2 Ernst &Young, Focus on Fundamentals: The Biotechnology Report, October 2001 3 Biotechnology Industry Survey, December 20, 2001, pp. 8 4 Battelle Memorial Institute, Pittsburgh Bioventure Phase I Report: Core Competency, Economic, Market, and Benchmarking Analyses, Cleveland, OH, July 2001, 3-12 5 Ernst &Young, Focus on Fundamentals: The Biotechnology Report, October 2001 6 Http://grants.nih.gov/grants/award/index.htm 7 Battelle Memorial Institute, Pittsburgh Bioventure/Life Sciences Greenhouse Prospectus Phase III Report, Cleveland, OH, October 2001, 5-11 8 Battelle Memorial Institute, Pittsburgh Bioventure/Life Sciences Greenhouse Prospectus Phase III Report, Cleveland, OH, October 2001, 5-11 9 Battelle Memorial Institute, Pittsburgh Bioventure/Life Sciences Greenhouse Prospectus Phase III Report, Cleveland, OH, October 2001, 5-11 10 Battelle Memorial Institute, Pittsburgh Bioventure/Life Sciences Greenhouse Prospectus Phase III Report, Cleveland, OH, October 2001, 5-11
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