August 2014

Q-Trials representatives will participate at CenterWatch's 2nd Annual Forum on Optimizing Clinical Research Performance to be held September 15-16, 2014, at the Sheraton Hotel in Boston.The conference will present a very unique selection of topics most impacting clinical research performance today and led by thought leaders at the forefront of driving change across the global clinical research landscape.
 
Ctrials, the Israeli association for the advencement of the biomedical research community, will hold a Risk Based Monitoring conference on September 9, 2014 at the The-Aviv Sourasky Medical Center.The conference will present the rational and practical aspects of risk based monitoring clinical trials.
 
The Food and Drug Administration (FDA) posted a final guidance document, “Evaluation of Sex-Specific Data in Medical Device Clinical Studies.” in combination with the FDASIA Section 907 Action Plan. The FDA’s final guidance outlines specific recommendations for considering sex and other variables during the study design stage, to improve consistency of analysis and reporting of information on demographics in labeling and other public documents. The action plan focuses on three over-arching priorities: Data Quality, Subgroup Participation, and Data Transparency.
 
The Food and Drug Administration (FDA) has recently issued a final guidance document, “FDA Decisions for Investigational Device Exemption (IDE) Clinical Investigations.”The FDA is committed to improving US patient access to new devices by strengthening and streamlining the clinical trial enterprise so that clinical trials are conducted in the US in an efficient, cost-effective manner while maintaining appropriate patient protections.
 
Statistics show: multinationals central to Israel's business R&D. Israel's Central Bureau of Statistics has released data suggesting that the 290 multinational R&D centers operating in Israel compose a significant proportion of Israel's business R&D. In 2012, 42.7% of Israel's business R&D originated in multinational R&D centers. In total, Israeli expenditure on R&D as a percentage of GDP is the highest in the world, standing at 4.38% in 2013 according to the OECD Science, Technology and Industry Scoreboard 2013.
 
Japan & Israel deepen R&D ties. Japan and Israel recently concluded a bi-lateral agreement to advance joint R&D research between the two countries. The agreement is one of some 40 bi-lateral and multi-lateral R&D agreements between Israel and partner countries, but is Japan's first such arrangement. The agreement was signed in the framework of a senior economic delegation to Israel, headed by Japanese Minister of Economy, Trade and Industry, Toshimitsu Motegi.
 
Israel's NASDAQ presence grows. The first half of 2014 saw a spike in the number of Israeli IPOs on the Nasdaq Exchange, with six companies facilitating initial public offerings totaling $590 million. Projections expect 2014 to break a seven-year record, with 9 additional Israeli biomed companies poised to make IPOs later this year. The largest IPO in Israeli history was further registered in July, with road safety technology play, Mobileye raising over $1 billion. Israel remains a major foreign player on the Nasdaq, second only to China in the number of companies traded.
 
Q2 sees spike in fundraising rounds for Israeli startups. IVC Research Center has released Quarter 2 reports, which show a 38% increase in Israeli startup fundraising rounds over Q1 and a 109% hike over Q2/ 2013. In total, 175 Israeli startups raised $930 million during that period, making it the most successful quarter since Q2 of 2000. The first half of 2014 saw 335 Israeli hi-tech companies raise $1.6 billion, an 81% increase over H1/2013.
 
EU and Israel sign Horizon 2020. The State of Israel and the European Union recently signed the Horizon 2020 association agreement, according Israel full access to EU research and innovation for the next seven years. With a total budget of nearly 80 billion euros over seven years, Horizon 2020 is the largest-ever EU research and innovation program and one of the biggest in the world. Israeli public and private institutions participated in over 1,500 joint projects during the previous program round, which ended in 2013.
 
U.S. tech giant snatches Israeli Wilocity. San Diego-based mobile chipmaker, Qualcomm, confirmed that it has acquired Wilocity, an Israeli startup that develops high-speed wireless chipsets. Although terms of the deal were not disclosed, sources estimate the deal at around $400 million.
 
New incentives to encourage investment in early-stage start-ups. The Israeli Ministries of Economy and Finance are jointly advancing legislative reform designed to encourage investment in early-stage Israeli start-up companies. The reform, slated for review by a governmental task-force, aims to help transform seed-stage startup ventures into commercially viable companies by offering tax breaks to investors who support them in the initial stages of their development. Israel is highly regarded for its entrepreneurial innovation, and the legislation aims to capitalize on its attractiveness to international investors by offering incentives that ultimately stimulate continued economic growth.