FDA Duke Launch Collaboration to Modernize Clinical Trials

The News Review:

- FDA Duke Launch Collaboration to Modernize Clinical Trials
- Dream of local medical school inches closer to reality
- Gene Express Announces Scientific Advisory Board
- Lixte Biotechnology Holdings Announces New Appointment To Board f…
- InSightec Ltd. Announces US$30 Million Investment Round.

FDA Duke Launch Collaboration to Modernize Clinical Trials
WRAL.com – Nov 29, 2007
Under an agreement between the organizations Duke will host a Public-Private Partnership that will include broad representation from government industry patient advocacy groups professional societies and academia. The participants will work together to develop new standards and identify new methods and technologies that improve safety boost the quality of information derived from clinical trials and make the research process more efficient. "To ensure the safety of clinical trial participants and to improve the health of the public the clinical research enterprise needs to evolve" said Janet Woodcock M. deputy commissioner and chief medical officer. "It needs to be much more streamlined and efficient and at the same time it needs to be better equipped to answer the pressing questions that confront both patients and health care professionals. Through this collaboration between FDA and Duke we are going to work with many stakeholders to lay the foundation for achieving these goals.

Dream of local medical school inches closer to reality
Brownsville Herald – Nov 29, 2007
Researchers announced last month that Hidalgo County will be one of 100 sites nationwide participating in the children’s study which will follow 1000 local children from before birth until their 21st birthdays. The investigators will gather data on the impact of a variety of factors from diet to water quality to poverty on a child’s health and development. Some of the clinical research for that study will take place in Harlingen while genetics and statistics research will take place at the RAHC medical research building in Edinburg Vela said. The research facility in Edinburg is used for laboratory research genetics research and animal-based studies Vela said. The new Harlingen building will be used for studies involving human subjects he said. The presence of these research facilities will help to bring more medical residents to programs at the RAHC and set the stage for more doctors to practice here officials said. “(The RAHC) is developing a reputation as a top-notch facility” said Sen.

Gene Express Announces Scientific Advisory Board
Genetic Engineering News – Genetic Engineering News (press release) – Nov 29, 2007
Gerald Vardzel CE of Gene Express stated “We are honored to haverecruited such an outstanding team of internationally recognizedexperts in the study of cancer genetics and molecular medicine. Thewealth of experience and expertise of this board will be invaluableto ensure a solid development plan is in place for Gene Express’sStaRT-PCR(TM) technology. From a strategic point of view this groupprovides us with strong clinical research and practice perspectivesboth for our current and future products intended for enhancing andaccelerating the delivery of molecular diagnostics. renowned oncologist and a consultant to anumber of leading biotechnology companies is the Director of theHead and Neck Cancer Research Division at Johns Hopkins UniversitySchool of Medicine. In addition he is Professor of ncologytolaryngology Cellular & Molecular Medicine Urology Genetics andPathology at Johns Hopkins University and Hospital.

Lixte Biotechnology Holdings Announces New Appointment To Board f…
Free with registration – PR Newswire – AccessMyLibrary.com – Nov 29, 2007
For 13 years he was associated with Bristol-Meyers Co. and Bristol-Meyers Squibb Co. holding successively the positions of Senior Vice President Anti-Cancer Research; President Division of Pharmaceutical Research and Development and ultimately Senior Vice President Worldwide Clinical Research and Development Pharmaceutical Research Institute. Carter was Senior Vice President of Clinical and Regulatory Affairs at Sugen Inc. after serving as Senior Vice President for Research and Development at Boehringer Ingelheim Pharmaceuticals Inc.

InSightec Ltd. Announces US$30 Million Investment Round.
Free with registration – PR Newswire – AccessMyLibrary.com – Nov 29, 2007
GE Capital Equity Holdings Inc. a subsidiary of General Electric Company MediTech Advisors LLC (“MTA”) a private firm specializing in the healthcare marketplace and directors and managers of the company. The investment will take the form of Preferred Shares which are convertible to InSightec’s ordinary shares subject to the. CPYRIGHT 2007 PR Newswire Association LLC.

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