Mar 2012

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Over One Third of Clinical Trials Outsourced by Pharmaceutical Companies, reports Kalorama Information. The portion of global R&D expenses outsourced to contract drug developers reached $36.6 billion in 2011, up 6.6% from $31.8 billion in 2009.
http://www.kaloramainformation.com/about/release.asp?id=2491
 
After a long coma, the drug market is waking up: breakthrough clinical trials are paving the way for severe diseases and common symptoms treatment, and opening the door for trillion dollars huge markets (Hebrew).
http://www.calcalist.co.il/markets/articles/0,7340,L-3564065,00.html
 
FDA public hearing is scheduled for April 23 & 24, 2012, entitled: Modernizing the Regulation of Clinical Trials and Approaches to Good Clinical Practice.
http://www.fda.gov/Drugs/NewsEvents/ucm284118.htm
 
FDA has issued the final guidance, "IRB Continuing Review after Clinical Investigation Approval."  This guidance is intended to assist institutional review boards (IRBs) in carrying out their continuing review responsibility under 21 CFR 56.108(a) and 56.109(f) by providing recommendations regarding the criteria, process, and frequency of continuing review to assure the protection of the rights and welfare of human subjects enrolled in clinical investigations.
http://www.fda.gov/downloads/RegulatoryInformation/Guidances/UCM294558.pdf
 
FDA has issued the guidance, "FDA Acceptance of Foreign Clinical Studies Not Conducted Under an IND, Frequently Asked Questions."  This guidance document is intended to clarify for sponsors and applicants how they can demonstrate compliance with the requirements of 21 CFR 312.120.
http://www.fda.gov/downloads/RegulatoryInformation/Guidances/UCM294729.pdf
 
Business people from 20 countries attended the first BioInvest conference held in Haifa at the beginning of March. According to conference founder Sigal Weisswasser about 450 one-on-one business meetings took place at the conference with Israeli biomed technology developers. Companies presenting included Rapidx, Lung Guard, Enterolab, Dali Medical Devices, NI Medical, PixCell, UC-Care, BMR Solutions and P-Cure.
http://www.bioisrael.com/?carous=450-meetings-at-bioinvest
 
The ILSI-Biomed 2012 Conference will be held May 21-23, 2012 in Tel-Aviv. This is the leading international conference covering the fast-growing field of innovation in the biomedical, health care and life sciences industries, where industry and academia join hands to learn about the latest and future developments, explore opportunities for new business ventures, meet up with old colleagues and make new contacts.
http://www2.kenes.com/biomed/Pages/Home.aspx