Prior to the approval of new drugs, substantial evidence of efficacy is required and safety brought through clinical trials. A massive decline in success rates in Phase II/III of clinical trials has resulted in only 1 in 10 drugs successfully passing  through these trials in the US.

With increasing pressure to bring drugs quickly into the market and reduce the cost of drug development, the paradigms of drug dosage studies in phase II trials and the overall adaptive framework of clinical trials are being increasingly challenged. Thus, strategies such as “Seamless Adaptive Designs” and “Group –Sequential Adaptive Designs” are particular areas that have received a great deal of attention in helping to improve the efficiency of drug development.

This conference will review the drug development process and provide a detailed discussion of how adaptive designs are changing the development process. The main focus of the presentation will be to explore the role of adaptive sample sizing; in particular, why it is important to consider the need to reassess sample sizes during the course of a trial. It is designed for those looking to network and gain the latest knowledge from the academics, industry leaders and regulators.

http://www.smi-online.co.uk/pharmaceuticals/uk/conference/adaptive-designs

The SOT Annual Meeting is the largest meeting of its kind. This annual event features a broad range of scientific sessions and a thematic program that provides partici-pants with a unique opportunity to deepen their knowledge in topical areas and interact with leaders in their respective disciplines. The scientific program includes a plenary session, the MRC Lecture, symposia, work-shops, roundtable discussions, informational sessions, regional sessions, as well as platform and poster sessions. The Society anticipates that more than 6,500 toxicologists from more than 50 countries will attend. The SOT Annual Meeting also features the ToxExpo, which is the largest exhibition dedicated to toxicology and the biomedical sciences. The exhibition features 350 exhibitors, exhibitor-hosted sessions, and the opportunity to debut cutting-edge products, services, and technologies.

nnovative Perspectives

The SOT Annual Meeting provides the most complete and in-depth coverage of toxicology. The Scientific Program Committee’s (SPC) mission is to devise a scientific program that covers the diverse areas of science that toxicology encompasses. The meeting is the venue for toxicologists to learn about the scientific advances that have taken place over the past 12 months. The Scientific Program Committee reviews more than 2,500 abstracts to deliver the most comprehensive and up-to-date program imaginable.

In-Depth Analysis

The Scientific Program Committee has devised a thematic program that encompasses five themes of topical interest. This year, these themes are:

• Advancing Clinical and Translational Toxicology and Application of Biomarkers
• Enhancing Strategies for Risk Assessment
• New Science and Perspectives Surrounding Environmental and Occupational Exposures
• Safety Assessment: Mechanisms and Novel Methods
• Stem Cell Models for Integrated Biology

Countless Networking Opportunities

With more than 6,500 toxicologists from more than 50 countries in attendance, this five-day event allows everyone the opportu-nity to network with colleagues and leading scientists from around the world.

A Global Audience

More than 20 percent of the attendees come from countries as far away as Australia, Egypt, China, Latin America, and Africa. Toxicologists can explore lessons learned, share scientific findings, and novel approaches with other toxicologists at this annual event, which is designed to showcase the year’s latest in research.

 

Value

The SOT Annual Meeting is one of the most cost-effective meetings you can attend. For example, you pay $300 for early-bird registration, compared to an average cost of $461 for similar toxicology society meetings. Also, SOT has arranged air carrier dicounts and has reserved SOT Annual Meeting attendee discounted rates rooms at various hotels in the Phoenix area through the SOT hotel room block. If you need to provide your employer with additional justification for attending the SOT Annual Meeting, to the SOT Annual Meeting website to find more information about the importance of this annual five-day event and why it should be the one meeting you attend.

ToxExpo Attendees Are Engaged in One or More of the Following Areas of Research

http://www.toxicology.org/AI/MEET/AM2014

The failure of experimental liver cancer therapies directed specifically against the EGFR protein is presumably the result of insufficiently specific patient selection. This is the conclusion that can be drawn from data that were obtained within the framework of a project carried out by an Austrian Science Fund FWF doctoral programme, and that have now been published in NATURE Cell Biology. The data prove that the tumour-promoting effect of EGFR originates, not directly from its expression in the tumour cells, but rather from its presence in the surrounding cells (macrophages) of the immune system. This predicts that experimental anti-EGFR therapeutic agents will prove effective only in patients who exhibit EGFR in the immune cells. This expanded understanding of the occurrence of EGFR in macrophages now offers, however, potential new approaches for the treatment of liver cancer.

Liver cancer is one of the most common malignant tumours. As treatment options are limited, the prognosis is very poor. Hopes were therefore high when, a few years ago, it was shown that a special protein – the epidermal growth factor receptor (EGFR) – accumulates in up to 70 percent of all liver tumours and promotes tumour development. It was believed that a target had been found for targeted therapies. However, the use of therapeutic agents to inhibit EGFR proved unsuccessful and the expected effect remained largely absent. Too little was known about the function of EGFR in liver cancer development. This is precisely what a research project at the Medical University of Vienna has now clarified.

SURPRISING FINDING

At the core of the work carried out at the Institute of Cancer Research were mouse models in which the presence of EGFR was suppressed in various different cell types of the liver. This made it possible to also grow liver tumours whose tumour cells were completely lacking EGFR. According to the previous knowledge, this would have been expected to result in decreased tumour growth. However, during the analysis a surprise emerged, as Prof. Maria Sibilia, coordinator of the FWF doctoral programme "Inflammation and Immunity", explains: "We found just the opposite – tumour growth increased. This was not the case for tumours in which EGFR was lacking only in the surrounding macrophages. There, tumour growth was considerably decreased." In fact, until now, it wasn't known that EGFR is even expressed in these immune cells. These liver macrophages, or Kupffer cells, become active particularly when inflammations and infections occur as a means to protect the body – the fact that EGFR has a tumour-promoting effect in these cells was not known.

To gain a better understanding of how the activity of EGFR on the Kupffer cells influences tumour growth, the team headed by Prof. Sibilia further analysed its functional mechanism. The group thereby succeeded in decoding a complex chain of cellular signalling pathways that actually leads to increased growth of liver cells. According to project team member Karin Komposch, "We were able to show that injuries to hepatocytes trigger the release of the messenger substance, interleukin-1beta. This, via diverse intermediate stages, causes EGFR in Kupffer cells to stimulate the production of interleukin-6 (IL-6), which causes liver cells to proliferate. In principle, the release of IL-6 should stimulate the proliferation of hepatocytes thus aiding in the repair of damaged tissue – but can also lead to uncontrolled hepatocyte proliferation, and thus to tumour formation."

TREATMENT & DIAGNOSIS

In the team's view, this fresh understanding now offers a new opportunity to use EGFR inhibitors in the treatment of liver cancer. These inhibitors would actually have to be used only in patients with EGFR expression in the Kupffer cells, and not in patients with EGFR expression exclusively in the tumour cells/hepatocytes. If these inhibitors were to act only in Kupffer cells, maximum reduction of tumour growth could be achieved. However, Ms. Komposch believes this work also offers another key finding for cancer diagnosis: "The presence of EGFR in the Kupffer cells could provide crucial information on the future course of tumour development, making it an important prognostic marker."

On the whole, the FWF doctoral programme findings thus provide both fundamental insight into complex cellular signalling pathways and concrete starting points for new developments in treatment and diagnosis.

Original publication: EGFR has a tumour-promoting role in liver macrophages during hepatocellular carcinoma formation. H. Lanaya, A. Natarajan, K. Komposch, L. Li, N. Amberg, L. Chen, S. K.Wculek, M. Hammer, R. Zenz, M. Peck-Radosavljevic, W. Sieghart, M. Trauner, H. Wang und M. Sibilia. Nature Cell Biology 16, 972–981 (2014) doi:10.1038/ncb3031

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Gaithersburg, Maryland and SEOUL, Korea, November 19, 2014 - Seegene Inc. (096530.KQ), a leading developer of multiplex PCR technologies, today announced that it has been issued a United States Patent, No. 8,809,239, for its tagging oligonucleotide capture and extension (TOCE™) technology, which enables highly multiplexed target amplification and detection in a single tube.

TOCE™ technology is now IP protected in the U.S., Korea, Singapore, and the Republic of South Africa, with a European patent expected in early 2015. The receipt of this U.S. patent is a significant milestone ahead of Seegene's planned entry into the United States, the largest molecular diagnostic market in the world.

"Our expanded patent portfolio provides critical support to our planned FDA submissions and potential collaborations with global in-vitro diagnostics companies," said Dr. Jong-Yoon Chun, founder, CTO and CEO of Seegene. "We expect our first U.S. FDA clearance for a TOCE™-based herpes simplex virus (HSV) I and II assay in 2015. In addition, we intend to further accelerate corporate growth by collaborating with global IVD players, such as Beckman Coulter Diagnostics, with whom we closed a long-term global ODM supply agreement last week."

Since TOCE™ technology was introduced in 2012 Seegene has commercialized seven TOCE™-based Anyplex II™ assays and obtained Korea FDA approvals and CE Marks for those tests. Furthermore, Seegene is actively expanding its global presence by distributing Anyplex II™ assays to molecular laboratories worldwide through distributors in 56 countries.

"In support of our mission to support the good health of humanity, Seegene is committed to the ongoing development of novel PCR chemistry technologies that enable faster, more accurate and cost-effective molecular diagnostics," added Dr. Chun.

About Seegene

Seegene is the world's leading developer of multiplex molecular technologies and multiplex clinical molecular diagnostics (M-MoDx). Seegene's core enabling technologies - ACP™, DPO™, READ™, TOCE™, mTOCE™ and MuDT™ - are the foundation for M-MoDx tests that can simultaneously detect multiple targets with high sensitivity, specificity and reproducibility.  Seegene's products detect multi-pathogens with great reliability and throughput, ultimately providing the most economical basis for saving time, labor and cost. Seegene's mission is to maintain leadership in molecular diagnostics for infectious diseases, genetics, pharmacogenomics, and oncology using innovative proprietary technologies.

For more information please visit www.seegene.com or call +301-762-9066.

GTC’s 11th Anti-infectives Partnering and Deal-Making Conference, taking place on July 10-11, 2014 in Boston, MA, will contribute to the on-going battle against the ever-changing infectious threats by having experts with direct experiences in the field discuss a wide variety of topics on infectious diseases. The agenda also allows time for networking and opportunities to interface with speakers and fellow delegates in a collegial setting. Previous GTC conferences have been catalytic to several successful partnerships and in 2014 we expect this trend to continue.

GTC’s Anti-Infectives Partnering & Deal Making is an infectious disease partnering and business development conference that gives global biotechnology and pharmaceutical companies an opportunity to network with high-level executives from top pharma and various biotech/pharmaceutical companies, explore potential collaborations, and learn about relevant anti-infective issues and deals that will affect the industry. This event also provides a unique venue for attendees to learn about the anti-infective business development trends, the infectious disease markets, and novel technologies that shape up the industry.

Conference Dates: July 10-11, 2014

Conference Link: http://www.gtcbio.com/conference/anti-infectives-partnering-and-deal-making-overview