Latrobe, PA Aug 30, 2011 — Classic Industries has named Robert P. Subasic, Jr., its new CEO. Subasic succeeds CEO Joseph (Jay) Policastro, Jr., who will serve in a new role as Company Chairman.
Subasic is a seasoned manufacturing industry veteran who has held several senior executive and board positions. His operating experience from the beverage, metal fabrication and information technology industries, including business operations, marketing and financial management, will help him lead Classic Industries in its next stage of growth.
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U.S. HealthWorks Becomes In-Network Medical Provider for Regence BlueShield/Asuris Members
Seattle, WA Aug 30, 2011 – U.S. HealthWorks Medical Group, the leading operator of urgent care and occupational healthcare centers in Washington, today announced that it will return to being an in-network medical provider for Regence BlueShield members in Puget Sound and Asuris members in Spokane effective Sept. 1.
U.S. HealthWorks Medical Group operates 17 medical centers in Washington – 14 in the Puget Sound area and three in the Spokane area – with many centers open 7 days a week. All centers accept walk-in patients with no appointment necessary.
“U.S. HealthWorks provides quality, convenient medical care when patients need it,” said Dr. Clyde Wilson, President of U.S. HealthWorks Medical Group of Washington. “So, we are pleased to once again be an in-network provider for Regence BlueShield and Asuris members and to deliver high-quality care to those patients.”
Regence BlueShield/Asuris provides insurance to about 780,000 members in Washington.
U.S. HealthWorks provides urgent care services, occupational healthcare services as well as physical therapy, chiropractic care, and massage therapy. The comprehensive occupational healthcare services include injury and illness diagnosis and treatment, pre-placement and post-offer physical exams, drug and alcohol testing, and physical therapy services.
Alterna LLC Launches Kerasal Nail, Fungal Nail Renewal Treatment
Whippany, NJ Aug 22, 2011 — Alterna LLC today announced the launch of Kerasal Nail – Fungal Nail Renewal Treatment, a new addition to the Kerasal® brand. Kerasal Nail is a topical formula that’s clinically proven to rapidly improve appearance of nails damaged or discolored by fungus and psoriasis. The product will be found on store shelves in the foot care aisle in major Walmart stores and Rite Aid stores this fall. Other major drug chains are expected to carry the product soon.
An estimated 30 million Americans suffer from unsightly and embarrassing nail appearance, a market currently underserved by nonprescription products. Kerasal Nail’s unique nail-penetrating formula has been licensed exclusively for the U.S. market from Moberg Derma AB, a leading Swedish pharmaceutical company. The product is already the #1 seller in various European countries where it launched last year.
Kerasal Nail’s patented formula combines the keratolyctic, nail softening, and hydrating effects of propylene glycol, urea and lactic acid to deeply penetrate the nail, and restore healthy appearance by normalizing thickened nails, reducing nail discoloration, and hydrating brittle nails. Kerasal Nail is odorless, preservative free and proven safe in clinical studies. In the most recent clinical study, over ninety percent of users saw improvement in nail appearance after 8 weeks, and more than three fourths saw improvement in appearance in just 2 weeks of use.
Kerasal Nail is easy to use, helping to ensure user compliance. It comes with a unique no-mess pinpoint silicone tip applicator, requires application just once a day, does not require filing of the nail, and dries quickly.
In a consumer research study of 500 fungal nail suffers, 77% said they would definitely or probably buy Kerasal Nail after seeing the concept. Alterna and Moberg are co-funding over $5 million worth of advertising and promotion to launch Kerasal Nail to the U.S. market, with heavy focus on television, print and consumer promotion. They expect to add at least $10 million of incremental retail sales to the category annually.
Tracking Environmental Monitoring Trends Crucial to Regulatory Compliance, OsoBio Expert Says
Albuquerque, NM Jul 28, 2011 – A microbiology laboratory manager at OSO BioPharmaceuticals Manufacturing, LLC, has authored a chapter on environmental monitoring trends for an industry reference manual.
Kim Van Antwerpen wrote a chapter for “Environmental Monitoring: A Comprehensive Handbook (vol. 5)” edited by Jeanne Moldenhauer and being published in September by the Parenteral Drug Association.
Van Antwerpen’s key observation is that aseptic drug manufacturers should closely observe the environmental monitoring trends of their production facilities to ensure regulatory compliance and protect consumer health.
OsoBio, an injectables CMO, manufactures sterile liquid, suspended and lyophilized biologic and pharmaceutical products for the pharmaceutical industry. The company is known for its expertise in difficult–to–manufacture, demanding or highly potent products.
In her chapter, Van Antwerpen wrote that each aseptic drug manufacturer should have a clear understanding of its unique environmental monitoring profile in order to pro–actively execute preventive or corrective steps if an adverse trend is detected.
“The manner in which data are trended influences all stakeholders – both internal and external – and affects resulting opinions of one’s environmental monitoring program, perceptions of control at the production facility, and actions taken to mitigate potential risks,” she stated. “When trends are presented in a concise, thorough and understandable manner, the company gains credibility.”
Van Antwerpen will be a featured speaker at the PDA’s sixth annual Global Conference on Pharmaceutical Microbiology, taking place Oct. 17–19 in Bethesda, Md. She will discuss how to trend environmental data using commonly available software presentation, as well as how best to implement an environmental review board.
Van Antwerpen holds a bachelor’s of science degree in microbiology from the University of Wisconsin–La Crosse and a master’s degree in business administration from the University of Phoenix. A Lean Six Sigma black belt, Van Antwerpen is a member of the Parenteral Drug Association – for which she serves on its program steering committee – and a senior member of the American Society for Quality.
U.S. HealthWorks Acquires Three Minneapolis-area Medical Centers
Minneapolis, MN Jul 27, 2011 – U.S. HealthWorks, a leading operator of occupational healthcare centers nationwide, today announced the acquisition of the NorthWorks Occupational Health centers. The three centers are the company’s first in Minnesota.
The newly acquired centers are all in the Minneapolis-St. Paul area and bring the total number of U.S. HealthWorks medical and worksite centers to 156 nationwide. The centers are located at 7550 34th Ave. South in Minneapolis; 4080 W Broadway, #200 in Robbinsdale; and at 1580 White Oak Drive, Ste 100 in Chaska.
All three facilities offer occupational medicine services, including diagnosis and treatment for injury and illness, preventive services, pre-employment and post-offer exams and screening, and return-to-work rehabilitative care. Terms of the transactions, effective July 27, 2011, were not disclosed.
“In analyzing potential partners for our organizations, U.S. HealthWorks stood out for its commitment to quality and its innovative approaches to providing care and working with clients to minimize workplace injuries and help employees recover and return to work quickly,” said John Capouch, CEO of NorthWorks.
“NorthWorks is well known in the Minneapolis area for providing high-quality care, and we are pleased to have their talented team join us,” said Gregory Marotta, vice president of operations, eastern division, for U.S. HeathWorks. “By extending our network into Minnesota, we will be able to serve our national clients who have operations in the Minneapolis-St. Paul area.”
M2S announces the addition of hemodialysis access to its Clinical Data Pathways registry
West Lebanon, NH Jul 26, 2011 — M2S, Inc., a leading provider of medical image and clinical data analysis services, announces the release of version 1.11 of its Clinical Data Pathways web-based registry. Clinical Data Pathways, utilized by the Vascular Quality Initiative (VQI) is a secure, web-based data collection and analysis system that provides real-time benchmarked reports and facilitates local, regional, national, and international data collaboration.
With version 1.11, hemodialysis access procedure and follow-up forms have been added to the Pathways quality improvement database, enabling the Vascular Quality Initiative to now collect perioperative and one-year follow-up data on nine vascular procedures – carotid endarterectomy, carotid artery stent, open and endovascular repair of abdominal aortic aneurysms, infra-inguinal and supra-inguinal bypass, peripheral vascular intervention, thoracic and complex endovascular aortic repair, and hemodialysis access. VQI currently includes 90 participating centers spread across the United States and Canada. In total, the Initiative has collected data on more than 27,500 procedures. These institutions also participate in regional quality groups through the Society for Vascular® Surgery Patient Safety Organization (SVS PSO), for the sharing and analysis of data through anonymous, benchmarked reports to initiate quality improvement projects in an effort to improve patient care and the quality of vascular health care.
With the latest release of Clinical Data Pathways, M2S has also expanded the Carotid Artery Stent (CAS) procedure form to include the collection of isolated and proximal common carotid stents, giving participating centers the ability to collect data on all CAS procedures in order to meet the requirements of the Centers for Medicare and Medicaid Services’ Carotid Artery Stent Facility Recertification.
Future updates to Pathways include the addition of an amputation procedure module and integration of M2S’s 3D imaging measurement data into VQI to provide customers with a comprehensive patient management system.
Sparta Systems to Present on Future-Proofing CAPA Processes at Medical Device Summit Educational Workshop
Washington, DC Jul 11, 2011 – Sparta Systems, Inc., the maker of TrackWise® quality management software and the market leader in enterprise quality and compliance management solutions, today announced that it will be presenting a session at “CAPA: Corrective Action, Preventive Action, Related Processes and Best Practices,” a two-day interactive workshop presented by the educational division of the Medical Device Summit. Tim Mohn, Industry Principal for Sparta Systems, will speak in an educational session titled “Future-proof Your CAPA Processes,” as he outlines tips, tactics and best practices for implementing and maintaining a quality system strategy in a changing environment.
Medical device organizations are in a state of constant change, whether due to centralization of existing processes or other external factors such as mergers and acquisitions. For these companies, it’s critical to ensure that the ability to initiate corrective and preventive actions (CAPAs) for issues that arise in the manufacturing operation is not affected by any organizational changes that may occur. This presentation from Sparta Systems will provide companies with proven strategies for how to “future-proof” their own CAPA processes, ensuring that existing processes continue to operate in the event of organizational change and that product quality is maintained regardless of any issues that do arise.
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Sparta Systems to Present on Future-Proofing CAPA Processes at Medical Device Summit Educational Workshop
WHAT: Sparta Systems, Inc., the maker of TrackWise® quality management software and the market leader in enterprise quality and compliance management solutions, today announced that it will be presenting a session at “CAPA: Corrective Action, Preventive Action, Related Processes and Best Practices,” a two-day interactive workshop presented by the educational division of the Medical Device Summit. Tim Mohn, Industry Principal for Sparta Systems, will speak in an educational session titled “Future-proof Your CAPA Processes,” as he outlines tips, tactics and best practices for implementing and maintaining a quality system strategy in a changing environment.
Medical device organizations are in a state of constant change, whether due to centralization of existing processes or other external factors such as mergers and acquisitions. For these companies, it’s critical to ensure that the ability to initiate corrective and preventive actions (CAPAs) for issues that arise in the manufacturing operation is not affected by any organizational changes that may occur. This presentation from Sparta Systems will provide companies with proven strategies for how to “future-proof” their own CAPA processes, ensuring that existing processes continue to operate in the event of organizational change and that product quality is maintained regardless of any issues that do arise.
WHO:
Tim Mohn, Industry Principal for Sparta Systems and former Manager, Worldwide Quality Systems for Johnson & Johnson Ortho-Clinical Diagnostics
WHEN:
“Future-proof Your CAPA Process”
Friday, July 15, 2011, 8:30 a.m. – 9:00 a.m.
WHERE:
Georgetown University Hotel and Conference Center
3800 Reservoir Rd. NW
Washington, DC 20057
Seasoned Healthcare Communications Professional Joins Precyse Executive Leadership Team
Wayne, PA and Alpharetta, GA Jul 12, 2011 — Precyse, a leader in health information management (HIM) services and technologies, has announced that Kristen Saponaro has joined the organization’s executive leadership team as Vice President of Marketing. Saponaro, who has extensive experience in marketing for healthcare and healthcare technology, will be responsible for the overall leadership of both internal and external marketing for Precyse.
Saponaro, most recently, was the principal of Saponaro Communications, LLC, the consulting firm that supported Precyse in its recent rebranding and launch of a new corporate identity. Saponaro Communications served a wide range of clients, including Precyse, Siemens Healthcare, NextGen Healthcare, the Department of Homeland Security and others with marketing, public and government relations, corporate communications, branding and advertising programs.
“It gives me great pleasure to welcome Kristen to our executive leadership team,” said Precyse President Chris Powell. “She did a tremendous job in assisting us with our new corporate identity, rebranding and other key marketing communications initiatives, and her appointment as a member of the Precyse team is just a natural extension of the success of those efforts. Her addition to our Marketing group will allow us to focus on educating the market on our new products, promoting our services and ensuring that our message is on track with our mission and values.”
Before founding Saponaro Communications, Saponaro was Director of Marketing for Executive Health Resources, the leading provider of medical necessity compliance solutions to hospitals nationwide. Before that, she was Corporate Affairs Manager for Siemens Medical Solutions, where she was responsible for communicating the company’s corporate messages to enhance image and identity. Other past positions include Public Relations Manager for brand communications firm Brownstein Group, Director of Educational Outreach for Search for Common Ground and a Senior Account Executive for the Fleishman-Hillard public relations firm. Saponaro has won numerous awards on behalf of her clients and employers, including MM&M Gold Awards, Stevie Awards and Marketer of the Year Award for Siemens Medical Solutions, as well as numerous Philadelphia Public Relations Society of America Pepperpot Awards and SABRE Awards, the world’s largest awards competition for the public relations industry, celebrating PR campaigns that demonstrate the highest levels of creativity, integrity and effectiveness.
Saponaro holds a bachelor of arts degree in political science from St. Joseph’s University and a master’s degree in congressional studies from The Catholic University of America. She is a member of the Public Relations Society of America and was a member of the society’s Philadelphia Chapter Agency Leadership Council from 2004 to 2007.
Oso BioPharmaceuticals Receives DEA Approval to Handle Controlled Substances
Albuquerque, NM Jun 22, 2011 – OSO BioPharmaceuticals Manufacturing, LLC, has been granted approval for the Researcher registration by the U.S. Drug Enforcement Administration (DEA) for Schedule II through V controlled substances.
OsoBio, an injectables CMO, manufactures sterile liquid, suspended and lyophilized biologic and pharmaceutical products for the pharmaceutical industry. The new DEA registration allows OsoBio to execute the development of manufacturing processes for controlled substances.
Renowned for its expertise in difficult-to-manufacture, demanding or highly potent products, OsoBio is well suited to handle controlled substances, said Dr. Stuart Rose, president and CEO.
“As a highly disciplined organization, OsoBio is comfortable with the processes, controls and documentation required when working with especially sensitive pharmaceutical materials,” he said. “We do the work that’s difficult to do.”
The DEA places strict guidelines on the research, manufacture and distribution of controlled substances to prevent their diversion into illicit markets. The agency categorizes controlled substances according to each one’s respective use in medical treatment, as well as its potential for abuse or causing dependence.
The agency approved OsoBio’s registration application to conduct research related to the potential manufacture of Schedule II through V controlled substances for clients.
“There aren’t many companies in the United States capable of producing injectable controlled drugs, so we’ve already fielded a number of calls from clients who have that need,” Rose said. “As we broaden OsoBio’s capabilities in handling products that demand special attention, we demonstrate our continued confidence that our company will exceed quality assurance and regulatory compliance expectations.”
U.S. HealthWorks Completes $205 Million Refinancing
Valencia, CA Jun 20, 2011 – U.S. HealthWorks, one of the nation’s largest providers of healthcare for on-the-job injuries and urgent care, today said it has completed a $205 million refinancing initiative.
The refinancing, arranged with the assistance of a lending group led by GE Capital, Healthcare Financial Services consisted of a $140 million first lien credit facility and a $65 million second lien credit facility. The first lien credit facility includes a $20 million revolving line of credit.
“We are pleased with the interest from investors and the financial community,” said Daniel D. Crowley, Chairman and CEO of U.S. HealthWorks. “We were able to achieve this refinancing on favorable terms, which supports our ongoing business and acquisition strategy.”
With over 150 locations consisting of clinics and worksite centers in 13 states and 2,000 employees – including approximately 350 affiliated physicians – U.S. HealthWorks centers serves over 10,000 patients each day throughout the country.
U.S. HealthWorks has acquired 40 clinics in the last four years, 19 of those in the last 18 months.
U.S. HealthWorks focuses on providing quality occupational medical healthcare. Providers specialize in wellness and early return-to-work programs, helping reduce the cost of workers’ compensation claims for both employers and insurance carriers.
Additionally, U.S. HealthWorks provides readily accessible and immediate urgent care services as a better alternative to the emergency room when injuries or illnesses are non life-threatening or when patients are unable to meet with a primary care physician.
The medical group’s mission is to help patients recover quickly and to reduce overall costs by providing the right care, right away.