A Medical Device Daily

Phase Forward (Waltham, Massachusetts), a provider of data management solutions for clinical trials and drug safety, said it has established a wholly owned subsidiary, Phase Forward Software Services India, based in Hyderabad, India.

In developing the new subsidiary, Phase Forward said it will be working with current partner Virtusa (Westborough, Massachusetts), a global information technology services company. Phase Forward’s Hyderabad center will be situated within Virtusa’s facilities there.

Phase Forward said it has had “a long and successful track record” in the Indian market, having worked with several partners and sponsors in the region for the past seven years to support several hundred hosted clinical trials.

Its expansion in India will involve leveraging its model of staffing global projects with in-country and external resources. The company said that approach gives both it and its customers “optimal flexibility and scalability in supporting rapid enterprise-wide adoption of Phase Forward solutions.”

“The Indian market is strategic to Phase Forward’s continued growth,” said Phase Forward CEO and President Bob Weiler. “The formation of a Phase Forward subsidiary [there] is a natural extension of our long-established strategy to give our customers access to the most advantageous and cost-effective mix of offshore and onshore resources available.”

“We are pleased with the high-quality partnership we have built with Phase Forward,” said Virtusa Chairman and CEO Kris Canekeratne. “We are delighted to extend ourselves beyond engineering services to include professional services as well. This is an important step in the evolution of our practice, as it expands the range of services that we offer our pharmaceutical clients.”

Phase Forward and Virtusa have previously worked together on a number of projects, combining resources as appropriate from their professional services and engineering organizations.

Phase Forward’s activity in India will be led by Steve Powell, senior vice president of worldwide sales.

New diagnostic j-v in Singapore

Qiagen (Venlo, the Netherlands), a provider of sample and assay technologies, and Bio*One Capital (Singapore), a biomedical investment management company, said they have entered into a joint venture to establish Dx Assays in Singapore.

Dx Assays is expected to be one of the first centers in Singapore for assay development in which molecular diagnostics for infectious and genetic diseases will be developed. The center is expected to be fully operational by early 2008, employing more than 30 scientists.

“The in-depth expertise and talent pool in biomedical research makes Singapore an ideal location for a centre for assay development”, said Peer Schatz, CEO of Qiagen. “This joint venture brings to Qiagen further resources to contribute to our goal to further broaden our global portfolio of molecular-testing solutions, to further accelerate our development speed and to expand our market and technology leadership in this fastest-growing segment of diagnostics.”

He added: “Together with Bio*One, we will support this new venture’s expansion into what we expect to be one of the world’s premier suppliers of molecular diagnostic assay development solutions to major pharmaceutical and biotech companies.

Qiagen already has assay development teams in Hamburg, Germany; Gaithersburg, Maryland; and Shenzhen, China.

Bio*One Capital is pleased to enter into this venture with Qiagen to establish Singapore’s first commercial entity that focuses on the development of molecular diagnostics,” said Bio*One CEO Swee-Yeok Chu. “Dx Assays will benefit tremendously from Qiagen’s technological expertise and market presence in this sector.”

Chu said the company also will collaborate with research institutes and hospitals in this field and “bring a strong commercial perspective to the ongoing research activities here. This combination of resources will enable Dx Assays to be a leading player in the field of molecular diagnostics.”

Qiagen said Asia today is its fastest-growing sector, with Singapore taking significant market share. Its strategic expansion into the region began in 2005, and today the company maintains 12 Asian offices with some 300 employees.

Beijing j-v facility gets ISO certification

Calypte Biomedical (Lake Oswego, Oregon), a manufacturer of HIV diagnostic tests, said today that its Beijing, China, manufacturing subsidiary, Beijing Marr Bio-pharmaceutical, a joint venture between Calypte and a Marr Group subsidiary, has passed its quality system audit and obtained certification of that quality system to the international standard, ISO 13485:2003.

Certification was provided by TÜV SÜD Management Service (Munich Germany).

The ISO 13485:2003 standard specifically addresses the application of quality system principles to medical device products and is based on the ISO 9001:2000 quality management standard, with many requirements specific to the medical device industry.

Calypte noted that regulatory authorities in several countries around the world, including the U.S. FDA, Health Canada, China, the European Union and elsewhere base their requirements for good manufacturing practices (GMP) on the ISO quality standards.

Beijing Marr Bio-pharmaceutical was established by Calypte and its joint venture partner, Marr, to manufacture the Aware line of rapid HIV tests, including the Aware HIV-1/2 OMT product for both the Chinese and international markets.

The product is a rapid test that uses oral fluid for a diagnosis of HIV-1 or 2 infection in as little as 20 minutes, with an accuracy comparable to FDA-approved, blood-based laboratory HIV EIA tests.

Beijing Marr Bio-pharmaceutical is currently manufacturing the Aware HIV-1/2 OMT product for export from China and this ISO certification expands the number of countries to which the facility can export product. Beijing Marr is awaiting approval from the China State Food and Drug Administration to sell the product within China.

Japanese certification for Axiom Worldwide

Axiom Worldwide (Tampa, Florida) said it has received Japanese certification as a medical device manufacturer, meeting quality management system requirements and other regulations for the manufacture and sale of medical devices.

The company said Japan’s Pharmaceutical Affairs Law harmonizes requirements and reduces some of the conflicting demands by incorporating the guidance documents of the Global Harmonization Task Force, including quality management systems requirements based on ISO 13485:2003.

Axiom Worldwide manufactures its flagship products, the DRX9000 True Non-Surgical Spinal Decompression System, DRX9000C and DRX9500, in medical markets around the world. It also manufactures an all-digital “electroceutical” device, the EPS8000, for use in relieving pain and in muscular rehabilitation.