PPT-OV101 Phase 2 “STARS” Clinical Trial

Angelman Society of Israel November 29th 2018 דר גרמי לוין יור ומנכל ForwardLooking Statements This presentation contains forwardlooking statements within the meaning of the Private Securities Litigation Reform Act of 1995 Words such as may will expect plan anticipate and similar expressions as well as other words or expressions referencing future events or circumstances are intended to identify forwardlooking statements Forwardlooking statements contained in this presentation include statements about the progress timing clinical development and scope of clinical trials and the reporting of clinical data for the Companys product candidates the potential clinical benefit of the Companys product candidates and the timing and outcome of discussions with regulatory authorities Each of these forwardlooking statements involves risks and uncertainties These statements are based on the Companys current expectations and projections made by management and are not guarantees of future performance Therefore actual events outcomes and results may differ materially from what is expressed or forecast in such forwardlooking statements Factors that may cause actual results to differ materially from these forwardlooking statements are discussed in the Companys filings with the US Securities and Exchange Commission including the Risk Factors sections contained therein Except as otherwise required under federal securities laws we do not have any intention or obligation to update or revise any forwardlooking statements whether as a result of new information future events changes in assumptions or otherwise. Soprano I Hence  stars,  you  daz- zle but the sight,   you teach to Soprano II Hence  stars, \r \r \r Alto Hence  stars, hence   stars too  dim of light,  you  daz-  zle  b Anh Ninh, College of William and Mary. Outline. Introduction. The Inventory Positioning Problem. Description of the problem. Unique features. Basic of inventory management. Site Selection Problem. 2. David N. Assis, MD. Assistant Professor of Medicine. Yale University. I have no disclosures relevant to this presentation.. Clinical Trials in PSC. PSC is a rare disease . 32,000 patients in the US. PSC has no proven and approved treatment. The Balance from . A Medical Communicator’s Perspective. 6th Asia-Pacific . Pharma. Congress. July 11-13, 2016 Kuala Lumpur, Malaysia. Dr.Namrata. Singh. Director - Medical Services. Turcaoz. Health Care Solutions. Tip 16 copper skin tonestars 2105-8507SMnBatWebIs50530qxd 7/12/05 1142 AM Page 1Using Your Decorating Bag and Coupler1Screw ring off coupler to expose series of tiny2Force coupler base as far down x0000x0000 x/Attxachexd /xBottxom x/BBoxx 7x2 21x036x 75 x368x04 x/Subxtypex /Foxoterx /Tyxpe /xPagixnatixon 0x/Attxachexd /xBottxom x/BBoxx 7x2 21x036x 75 x368x04 x/Subxtypex /Foxoterx /Tyxpe /xPagix Christopher S. Coffey. Professor, Department of Biostatistics. Director, Clinical Trials Statistical and Data Management Center. University of Iowa. May 28, 2019. In this webinar, we will:. Discuss the importance of adequate study planning for small clinical trials. Professor Julia . Brown. Leeds Institute of Clinical Trials Research, University of Leeds. Introduction. First clinical trial in 1747, James Lind. Clinical trials are gold standard for the evaluation of new treatments/interventions in health care . T. he . trial sponsor . compiles . a detailed clinical study report (CSR. ) after each clinical trial. . This report follows . a format laid down by the regulatory . authorities.. The CSR can be hundreds of pages long.. “Putting it All Together. ”. 1. Why the changes to NIH-funded studies involving human subjects?. No policies existed to make sure that the public had access to results from unpublished NIH-funded research . Collecting data. 2. Data . Statistics is a way of thinking—thinking about ways to . gather. and analyze data.. Trust data. 3. 3. Resource of Data. Experiment/ clinical trial. Survey. http://www.nhs.uk/Conditions/Clinical-trials/Pages/Healthresearch.aspx. Outline. Review of a phase I trial. What is a phase II trial?. Phase II trial process. Standard trial designs. Innovative trial designs. Phase II trial examples. Guess that trial. Phase II thalidomide study. Karen-Sue Carlson, MD, PhD. Associate Professor of Medicine. Division of Hematology and Oncology. Section Head and Medical Director of Acute Care. Medical College of Wisconsin. Milwaukee, WI. What are clinical trials?. SESSION 8. Handout/Reference sheets:. Study Start-up. NIH guideline-study-start-up document. Study start-up Tips. SOP reference sheet from Session 9. Webinars:. Research 101, session 4. Research 102, session 4.