"Sunshine law" puts cloud of concern over sponsors, sites

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Indiana now has its first commercial Institutional Review Board (IRB). Indiana and its surrounding region, that is. Diana Caldwell and Gretchen Miller Bowker—both Eli Lilly alum and former coworkers at the regulatory compliance consultancy Safis Solutions—have launched Pearl IRB to fill what they say is the commercial IRB gap that stretches north to Minneapolis, east to Philadelphia, south to Cincinnati and west all the way to San Diego.

The goal is that the new IRB will attract more trials to the Hoosier state. According to Caldwell, Pearl’s president and CEO, the idea for the IRB was born out of a meeting of the Indiana Health Industry Forum Task Force, formed last year to help foster growth of the health industry in the state. It quickly became focused on how to remedy the dearth of clinical research there.

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Parexel International of Boston, a global biopharmaceutical services company, has introduced an integrated temperature recording solution for study drug transportation as part of its expanded Clinical Logistics Services. Its temperature control process saves 24 to 48 hours over traditional cold chain methods in which temperature devices shipped out to investigative sites need to be transported back to a hub to be read out and analyzed before study drugs can be released for use. A central hub receives and disseminates confirmations of temperature data in real-time, allowing clinical site investigators to quickly begin using study drugs according to trial protocols. Working in cooperation with Stora Enso, a global paper, packaging and wood products company, and MediXine, specializing in multimodal communication e-services for health care and wellness, Parexel has developed a temperature recording process specifically designed and optimized for the clinical trial supply process. The packaging container for study drugs incorporates a Radio-Frequency Identification (RFID) tag for temperature recording and a dedicated compartment for a mobile phone, providing automatic tracking and remote, high-speed transmission of the complete temperature record. The RFID tag records study drug temperature at pre-defined time points, while a mobile phone application and web-based portal allow secure, controlled data transmission and access to temperature data in real-time between a central hub and an investigative site.

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U.S.-based Medical Device Consultants (MDCI), which provides contract research and regulatory consulting services to the medical device industry, has formed a strategic partnership with a former competitor, U.K.-based contract research organization (CRO)Clinical Development & Support Services (CDSS).

The partnership will allow MDCI and CDSS to support medical device clinical trials in the United States and Europe and help their clients meet both Food and Drug Administration (FDA) and European Union (EU) regulatory requirements.

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        Synexus’ clinical trials activity in Hungary increased by 25% during the first half of 2010. The company’s Dedicated Research Centre has been operating in Hungary since 2006 and has become one of the company’s most successful CEE sites. The Budapest-based operation has been involved in more than 74 trials since being acquired by Synexus, and has randomized over 600 patients. Dr Erika Nemeth, Synexus’ country manager in Hungary, said the trend of more clinical trials being conducted in Hungary is set to continue: “The high standards of medical and research & development expertise in Hungary has resulted in high levels of participation in clinical trials and means that pharma and biotech companies remain keen to include Hungary as part of their global clinical trial programs.” The prevalence of chronic conditions including CVD and COPD among the Hungarian population, together with little preventative healthcare and healthcare education, means the treatment naïve population remains substantial and therefore attractive for clinical trials. Also, the pharmaceutical market in Hungary is set to increase significantly in the coming decade, encouraging the major players to establish a stronger and more proactive presence there before their new drugs come to market. Synexus CEO Michael Fort said the productivity of investigators, the attractive overhead costs and the world-renowned medical expertise and innovation in Hungary make it one of his company’s key areas for future development.

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        Synexus’ clinical trials activity in Hungary increased by 25% during the first half of 2010. The company’s Dedicated Research Centre has been operating in Hungary since 2006 and has become one of the company’s most successful CEE sites. The Budapest-based operation has been involved in more than 74 trials since being acquired by Synexus, and has randomized over 600 patients. Dr Erika Nemeth, Synexus’ country manager in Hungary, said the trend of more clinical trials being conducted in Hungary is set to continue: “The high standards of medical and research & development expertise in Hungary has resulted in high levels of participation in clinical trials and means that pharma and biotech companies remain keen to include Hungary as part of their global clinical trial programs.” The prevalence of chronic conditions including CVD and COPD among the Hungarian population, together with little preventative healthcare and healthcare education, means the treatment naïve population remains substantial and therefore attractive for clinical trials. Also, the pharmaceutical market in Hungary is set to increase significantly in the coming decade, encouraging the major players to establish a stronger and more proactive presence there before their new drugs come to market. Synexus CEO Michael Fort said the productivity of investigators, the attractive overhead costs and the world-renowned medical expertise and innovation in Hungary make it one of his company’s key areas for future development.

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Merck has launched a research partnership with Alectos Therapeutics, a Vancouver-based biopharmaceutical company, to develop drugs to fight Alzheimer’s Disease based on an enzyme believed to be involved in the development of the disease and potentially other disorders.

Under the agreement, Merck paid Alectos an undisclosed sum upfront and will fund research to study the small Canadian company’s existing portfolio of compounds targeting Alzheimer’s Disease. If Merck develops any of the compounds, Alectos is eligible to receive up to $289 million in upfront fees, research, development and regulatory milestones and tiered royalty payments on sales of products from the collaboration.

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United BioSource Corp. (UBC), a pharmaceutical services company that specializes in post-approval drug research, has agreed to be bought byMedco Health Solutions for $730 million in an all-cash deal as part of the pharmacy-benefit management (PBM) company’s strategy to expand beyond its core business and promote medical treatment based on research evidence.

When the deal closes later this year, UBC will become a wholly-owned Medco subsidiary that will operate independently from the core PBM business. UBC’s founders and top executives, CEO Ethan Leder and President and CFO Mark Clein, will continue to run the subsidiary.

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Global CROClinTec Internationalhas announced a financial and strategic partnership with Elephant Capital, an AIM market-listed private equity firm.  With an investment of approximately $12.5 million, Elephant has acquired a significant minority stake in ClinTec, entering the clinical research base. ClinTec operates as a global provider of outsourcing solutions addressing the drug development lifecycle.

Elephant Capital managing partner Gaurav Burman and non-executive director Jim Hauslein have also made personal co-investments and have been elected to the ClinTec board.

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ActivMed Practices & Research , which runs a clinical research center in Northern Massachusetts, has opened a second site in Rochester, N.H., a city where patient access to clinical trials could help raise the level of healthcare in the community by offering higher standards of treatment and access to cutting-edge therapies.

When ActivMed looked at the demographics of the population in Rochester, CEO and President Terry Stubbs decided it was a good area to develop for clinical research. The community, which has one of the lowest per capita incomes in New Hampshire and an unemployment rate higher than the state average, has a large percentage of underserved patients who want access to health treatments. “It’s a blue-collar population. There are a lot of people who have lost their insurance because they have lost their jobs or are self-employed doing clamming or chopping wood to make ends meet,” said Stubbs, who has managed more than 300 clinical trials and has more than 22 years of healthcare management experience. “We believe recruitment will do well because we can offer services to people that they normally wouldn’t get. We figured it might be a good place to run clinical trials and help people get more healthcare.”

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Medco Health Solutions, the largest pharmacy benefits manager by revenue in the U.S., has agreed to buy closely held United BioSource Corp. (UBC) for $730 million in an all-cash deal.

Franklin Lakes, N.J.-based Medco supplies nearly 65 million members. Bethesda, Md.-based UBC conducts safety and effectiveness testing on drugs and devices after they have been approved by federal regulators. The company fits Medco’s strategy to promote medical treatment based on research evidence.

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