The nonprofit Institute for OneWorld Health started a post-approval study with a large safety component. Odyssey Research, a CRO based in India (with a North Dakota headquarters) won the work. “We welcome Odyssey Research as part of our team to further develop Paromomycin IM Injection as a safe, affordable and effective treatment for a major public health problem in India,” said Dr. Ahvie Herskowitz, OneWorld Health’s chief medical officer. “Odyssey’s clinical trial management capabilities and depth of experience in India make them a good fit for this important post-approval Phase IV study.”

Cardium Therapeutics of San Diego, CA, selected the TrialMaster EDC solution from OmniComm Systems for a Phase III study in women to evaluate Generx as a treatment for myocardial ischemia. An excerpt from the news release: “The TrialMaster EDC solution provides us with an intuitive and easy to use export tool that simplifies the process. Integration is also very important to us and with the TrialMaster solution we’ve been able to easily integrate with our IVRS solution to manage enrollment and randomization,” said Anthony Andrasfay, VP of clinical operations for Cardium.

German software house SAP unveiled a product tracking and authentication (PTA) process with radio frequency identification (RFID) and other auto-identification technologies, enabling companies, especially in the pharmaceutical sector, to apply the technology to solve pressing business challenges. In the pharmaceutical sector, PTA processes will help secure distribution and combat drug counterfeiting and diversion.

Synchron Research Services based in Ahmedabad, India, has taken over Innovance, a local start-up contract research organization (CRO). The deal will help Synchron hike its bed capacity to nearly 200 from 90.

United Pharma, a nutraceutical/supplement contract manufacturing community, recently opened its new factory in Fullerton, California, with Enteprise Resource Planning (ERP) solutions from BatchMaster Enterprise, that is designed to support the manufacture of chemistry or nutritional based products, and also supports regulatory compliance requirements.

Verticals onDemand, a provider of industry-specific CRM solutions delivered on the Salesforce Platform, and C3i, an IT services provider serving the life sciences industry, have partnered to provide life sciences customers with comprehensive service offerings for their onDemand CRM deployments.

eMolecules, the provider of an online chemistry database, and Advanced Chemistry Development (ACD/Labs), announced a collaboration that will allow predicted logP data to be displayed in eMolecules freely accessible online database of 5.6 million unique chemical structures.

Cerep announces the extension of its pharmaco-informatics alliance with Pfizer for up to three years (through 2009). As part of the alliance, Pfizer and Cerep will collaborate on the enhancement of BioPrint and the derived pharmaco-informatic methods with Pfizer compounds. The goal of the collaboration is to provide early tools for in vitro safety evaluation of lead compounds.

The Canadian electronic data capture (EDC) company TrialStat named Peter Hunter to the position of chief financial officer and chief operating officer. Hunter brings more than 20 years of experience in corporate finance, corporate governance, strategic negotiations and general management. Prior to TrialStat, he managed an independent consulting practice specializing in business financings, mergers and acquisitions and licensing agreements.

Cyprotex announces that it has enhanced its Cloe Screen Mechanism-Based Inhibition service to include four additional cytochrome P450 (CYP450) isoforms. These new assays compliment the CYP3A4 isoform assay which was launched last year, and provide information on 5 of the major CYP450 isoforms.

PBS interviewed Janet Woodcock, chief medical officer at the FDA. Biomarkers and imaging are discussed as elements of the Critical Path agenda. The level of funding for the Critical Path is not discussed. We do not know what percentage of the dialogue recorded in this transcript actually aired. Still, we had to pinch ourselves. The reporter asked surprisingly detailed questions about clinical trials today and in the future. Woodcock’s answers seemed sensible.