April 2015

IATI Biomed May 12-14 Tel Aviv. IATI Biomed will be held May-14 in Tel Aviv. The conference is a meeting place for healthcare’s industry players from Israel and abroad. Exuberance is felt everywhere; lectures, exhibition halls and partnership meetings. International visitors come to witness the various innovations, and experience firsthand the entrepreneurial spirit so strongly exhibited within the vibrant Israeli life science community.
The FDA announced the availability of a draft guidance for industry, clinical investigators, and institutional review boards entitled “Use of Electronic Informed Consent in Clinical Investigations: Questions and Answers.” The guidance provides recommendations for clinical investigators, sponsors, and institutional review boards (IRBs) on the use of electronic media and processes to obtain informed consent for FDA-regulated clinical investigations of medical products, including human drug and biological products, medical devices, and combinations thereof. Comments due by May 8, 2015.
The FDA posted draft guidance on the Acceptance of Medical Device Clinical Data from Studies Conducted Outside the United States (OUS). This draft guidance focuses on FDA’s policy of accepting scientifically valid clinical data from foreign clinical studies in support of premarket submissions for devices. The guidance describes special considerations that apply when using such data, including applicability of the data to intended patient populations within the United States and study design issues, and also provides recommendations to assist sponsors in developing data that are adequate under applicable FDA standards to support approval or clearance of the device in the United States.

Israeli Biomed Companies Raised $2B in 2014. The Israeli life science industry is healthier than ever, thanks to a record year of investments in 2014, according to Benny Zeevi, co-chairman of the Israel Advanced Technology Industry (IATI). The industry, Zeevi said, “is rapidly and exuberantly growing, while playing an important role in the world healthcare market. Following a decade of significant growth, the Israeli life sciences industry is continually demonstrating encouraging parameters of maturity and promising signs towards a breakthrough decade.”
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The annual meeting of the clinical trials community in Israel held on April 28 2015 in Tel Aviv. More than 500 participants attended the event. The Keynote speaker was Prof. Zelig Eshhar, Head of Immunological Research Center from Sourasky Medical Center, and 2015 Israel Prize laureate in Life Sciences Research, with his lecture "From the Mouse Cage to the Patient's Health". Among the discussed topics: Pharmacogenetics, Behind The Scenes of the Investigational Product, Attracting Companies  to Conduct Clinical Trials in Israel, and more.Photo gallery