January 2016

C-Trials, the Israeli Association for Research and the Advancement of the Biomedical Community, has conducted a discussion group to  form a response to the proposed updates of the draft ICH E6 (R2) Step 2b released by ICH for comments on 2015. The discussion group included  local clinical trials community (e.g. the Ministry of Health, Ethic Committees, sponsors, CROs, investigators, site team personnel, etc.), hosted approximately 100 participants. The suggested changes were presented and an open discussion on the different topics was conducted, allowing the various parties to express their opinions. CTrials sent the summary of the discussion and the issues CTrials would like ICH to consider for the upcoming addendum.
 
Israel BIO Convention 2016: Winners of Contest for Life Science Companies. IATI – Israel Advanced Technology Industries,  announced the results of the recent contest for Israeli Life Science companies, sponsored by MATIMOP with the Office of the Israeli Chief Scientist at the Ministry of Economy, and the IATI. The winners will join the Israeli delegation to Bio Convention 2016, which will take place this year in San Francisco from June 06-09, 2016. 20 companies were selected this year to present in the Israeli National Pavilion at Bio Exhibition 2016.
 
Israeli startup Regentis Biomaterials has closed a $15 million Series D financing round led by Chinese pharmaceutical group Haisco. The company, which is developing products to treat damaged cartilage, has raised $35 million to date including the latest financing round.
 
Adicet buys Israeli co Applied Immune TechnologiesUS biopharmaceutical company Adicet Bio, Inc. has acquired Israeli company Applied Immune Technologies (AIT), which develops immunotherapies. AIT specializes in generating and developing T-Cell Receptor-Like antibodies with high affinity and specificity to disease-specific intracellular peptides presented on the cell surface by the major histocompatibility complex. AIT also established Epitarget, a proprietary technology to identify and validate novel disease-specific peptide targets.
 
Results generated by point-of-care diagnostics are increasingly being used in trials as decision-makers prior to administering treatments or to generate actual trial data. Clinical Jorge Villacian, chief medical officer at Janssen Research and Development, describes the progress being made and how far there is to go.
 
The innovative recruitment and retention strategies being used by a new Europe-wide Alzheimer's study could be applied to other disease areas, improving clinical trial efficiency. New adaptive trial design being tested by a major European consortium has the potential to ease the recruitment process for AD, while lessons learnt from the project's innovative recruitment and  retention strategies could be applied to other diseases areas too.
 
BioLineRx Announces Collaboration with MSDknown as Merck, to support a phase 2 study investigating BioLineRx’s BL-8040 in combination with KEYTRUDA® (pembrolizumab), MSD’s anti-PD-1 therapy, in patients with metastatic pancreatic cancer. The study is an open-label, multicenter, single-arm trial designed to evaluate the safety and efficacy of this combination in patients with metastatic pancreatic adenocarcinoma. 
 
MEDICAL Expo held its national conference for clinical research in Israel, on February 8, 2016 at the David Intercontinental Hotel in Tel Aviv . The speakers at the conference presented updates in the field of clinical research in Israel, in its various aspects: planning and management studies, GCP updates, descriptions of studies with important implications and report on what is happening in this field in Israel and abroad (Hebrew).
 
IMP held its official launch event on February 11, 2016 at the David Intercontinental Hotel in Tel Aviv. IMP established clinical trials supply services.
 
Save the date: Ctrials Annual Meeting will be held on April 11th 2016 at the David Intercontinental Tel Aviv. Ctrails is the Israeli Association for the advancement of the biomedical research community.
                       
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