Pharmaceutical Technologist - May 2008 - (Page 7)

FDA plans to improve safety FDA has published a draft plan for the “enhancement and modernization” of the drug safety system during the next 5 years. The agency will receive approximately $29.29 million (€18.64 million) annually and has been authorized by the US congress to collect additional user fees to broaden the focus of drug safety in the FDA Amendments Act of 2007. The ‘Prescription Drug User Fee Act IV Drug Safety Five-Year Plan’ will involve, among other services, establishing risk evaluation and mitigation strategies, postmarket studies, safety labelling changes and active postmarket risk identification. Throughout 2008 into 2009, FDA will hire additional staff, including more safety evaluators for reviewing reports of adverse effects, medication experts, epidemiologists and regulatory project managers. More risk management experts responsible for reviewing proposed and implemented risk minimization action plans or risk evaluation and mitigation strategies will also be employed. The training of the new staff is expected to take 2–3 years, but FDA is hopeful it will lead to significant improvement of the drug-safety system, including enhancements in technological capabilities and communications. www.fda.gov Spain’s biotech showcase A poster presentation has highlighted a huge portfolio of new healthcare products that are being researched by Spanish biotech companies. The pipeline includes 28 companies contributing a total of 119 projects on drugs and diagnosis systems for use on humans, as well as 12 products for animal healthcare. According to a survey conducted by the Spanish Association of Bioenterprises (ASEBIO), 72 drugs are being researched for 90 different indications. Jorge Barrero, General Secretary of ASEBIO, says: “This presentation initiative forms part of a more ambitious programme of activities that will culminate in Granada (Spain) in September with an international biotechnology convention.” The goal of the presentation and the upcoming BioSpain event is to showcase the capacities of Spanish biotechnology companies and to make the global industry aware of the opportunities that exist for collaboration. Among the Spanish companies, a large proportion are targeting oncology drugs, with 42% of companies already working on the preclinical and clinical development of products. www.asebio.com Global study examines osteoporosis Researchers search for new patient outcomes and treatment patterns. www.ptemagazine.com 7 Digital Vision/Getty Images Nearly 60000 women have enrolled in a multinational study that will focus on the management of osteoporosis across the globe and could lead to an improved treatment. The study, the Global Longitudinal Registry of Osteoporosis in Women (GLOW), will monitor women aged 55 years and older who have visited a primary care physician during the past 2 years. It is believed the study will provide a good representation of ‘typical’ older women and the bone healthcare they receive in the real world as patient recruitment is not linked to osteoporosis and does not alter physician practice. The participants will come from 17 cities in 10 countries on three continents. “We want to understand regional differences in physician and patient behaviour, and how that impacts patient outcomes,” says Professor Pierre Delmas, GLOW Executive Committee Co-Chair and Professor of Medicine and Rheumatology at Université Claude Barnard (France). “Hopefully, armed with that knowledge we will be able to recommend best practices and improve the management of osteoporosis worldwide.” The study will be conducted by The Center for Outcomes research at the University of Massachusetts Medical School (MA, USA), with the support of an unrestricted grant from The Alliance for Better Bone Healthy, which is a collaboration between Sanofi-Aventis and Procter & Gamble Pharmaceuticals. “We know that there are patients at high risk for osteoporosis, sometimes already having suffered a broken bone, who aren’t getting diagnosed and treated. We have to figure out why not,” says Dr Robert Lindsay, GLOW Executive Committee Co-Chair and Chief of International Medicine at Hayes Hospital (NY, USA). “Globally we have an ageing female population that wants to maintain independence and vitality. We can help by finding the key to improving diagnosis and treatment of this debilitating disease.” www.outcomes.org Stockbyte/Getty Images http://www.asebio.com http://www.fda.gov http://www.outcomes.org http://www.ptemagazine.com

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Pharmaceutical Technologist - May 2008 Contents Industry Highlights Morpheus Market Watch Pharma’s Need for Integrated Safety Is Pharma’s Future Mobile? Facing the CRO Behemoths Q&A

Pharmaceutical Technologist - May 2008

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