Bio Screening Industry News

The obstacles to successful drug discovery and development are numerous and well appreciated. In discovery, from target identification through lead optimization and validation, and in development, from first-in-man studies through large registration trials, inefficiencies and uncertainties complicate even well-funded efforts by sophisticated and industrious scientists and clinicians. Despite huge outlays by the worldwide pharmaceutical research enterprise, the number of new chemical entities brought to market has actually declined in recent years, even as the cost of developing them has increased significantly.

Against this backdrop, biomedical imaging is poised to play an increasingly powerful role in enhancing the efficiency of the drug discovery and development process. Multiple modalities, including optical imaging, ultrasound, nuclear imaging (both positron and single photon tomography), x-ray computed tomography, and the many flavors of magnetic resonance imaging are all being integrated ever more fundamentally in the various phases of drug discovery and development. In CNS, oncology, rheumatology/inflammation, and many other clinical settings, imaging is proving invaluable.

The 3rd Imaging in Pre-clinical & Clinical Drug Development Conference will be held March 17-18, 2008, in San Diego, CA. This conference will survey a wide range of topics in the field, from the latest advances in the modalities themselves to their application to cutting-edge preclinical and clinical problems. Presentations will be made from numerous distinguished contributors to the field’s advancement on both scientific topics and subjects of interest to the regulatory, data management and investment communities.

Topics include:

- Novel Imaging Methods & Technology
+ Novel Imaging Tools for Inflammation and Arthritis Drug Development
+ Dynamic Contrast MRI
+ Optical Imaging

- Imaging in Drug Development and Therapy
+ Molecular Imaging Approaches to In Vivo Pharmacokinetic and Pharmacodynamic Studies: A Pharmaceutical Prospective
+ PET for In-Vivo Distribution and Pharmacokinetics, Including Novel Dosage Forms
+ Translational Nuclear Molecular Imaging in Drug Development
+ Using MRI to Monitor Cellular Therapy

- Imaging Applications in CNS, Oncology, and the Cardiovascular System
+ Novel Imaging Applications in CNS Drug Development
+ PET Imaging for Efficacy of Anticancer Drugs
+ Non-invasive Imaging of Atherosclerosis: MRI versus CT
+ Atheroma: Developments in Imaging Surrogates of Risk with MRI

Click here for a FULL AGENDA

Register today to reserve your spot! Team Registration: Register 2, the 3rd goes free! For more information call 626-256-6405 or visit www.gtcbio.com.

PRESENTERS
Marc Berridge, President, 3-D Imaging
Janet Eary, Director, Nuclear Medicine Program, University of Washington Medical Center
Joseph Frank, Chief, Laboratory of Diagnostic Radiology Research, NIH
Jonathan Gillard, Department of Radiology, University of Cambridge
Hisataka Kobayashi, Chief Scientist, Molecular Imaging Program, NCI
Richard Margolin, Vice President & Global Head, CNS, i3 Research [Chair]
Raymond Nunnally, Vice President, InvivoMetrics
Michael Paulus, VP, Product Management, Siemens Preclinical Solutions
Roderic Pettigrew, Director, National Institute of Biomedical Imaging and Bioengineering, NIH
Paul Picot, Chief Scientist, Pre-clinical Imaging, GE Healthcare
Simon Robinson, Bristol Myers-Squibb
Stefan Ruehm, Director, Diagnostic Cardiovascular Imaging, CT, UCLA
Susanta Sarkar, Molecular Imaging Center of Excellence, GlaxoSmithKline
Werner Scheuer, Research Leader, Preclinical Imaging, Roche Diagnostics GmbH
Jan Schnitzer, Sci. Dir., Prof., Cellular & Molecular Bio, Kimmel Cancer Center
David Shalinsky, Associate Director, Translational Medicine, Pfizer
Mark Tengowski, Director, Clinical Affairs, VirtualScopics Inc.
David Vera, Professor, Radiology, UCSD
Jingsong Wang, Director, Bristol Myers-Squibb
Yumin Zhang, Research Investigator, Abbott Laboratories

Select Biosciences is proud to announce their first conference devoted to Advances in Synthetic Chemistry. The meeting will focus primarily on Flow Chemistry and Microwave-Assisted Organic Synthesis.

Alongside an exhibition of selected scientific posters and service providers, Select Biosciences is organizing a two day conference gathering some of the most influential researchers in the field including :

• Oliver Kappe, Associate Professor of Chemistry, University of Graz
• Ferenc Darvas, President, Thales Nanotechnology
• Fredrik Almqvist, Research Director, Biological Chemistry, Umeå University
• Mark Bagley, Senior Lecturer, University of Cardiff
• Ian Baxendale, Research Fellow, University of Cambridge
• Carsten Bolm, Professor, RWTH Aachen
• Maurizio Botta, Professor, University of Siena
• Marcus Koppitz, Senior Scientist, Bayer Schering Pharma
• Fernando Langa, Professor, University Castilla-La Mancha
• Vincenzo Santagada, Professor of Medicinal Chemistry, University of Naples
• Peter Seeberger, Professor, ETH Zurich
• Brian Warrington, Director, BB Consultants Ltd
• Catherine Smith, University of Cambridge
• Mark Bagley, Senior Lecturer, University of Cardiff
• Sven Schroeder, Professor, University of Manchester
• And many more…

To guarantee a high attendance Select Biosciences will maintain their traditional low registration fees and group booking discounts. Furthermore, to encourage educational development, special priced passes are available to students as are one-day passes for the busy researcher who can’t spare time for the full two days.

About Select Conferences http://www.selectconferences.com

The conferences division of Select Biosciences Ltd. is focused on organizing specialist biomedical meetings each year. Experts from both academia and commerce are invited to present timely information from current research through to commercial implementation of new technologies. These events also provide a unique networking facility and the opportunity to reach a highly targeted scientific audience.

New line of DNA and serum samples for Type II diabetes, hypertension and hyperlipidemia provide researchers access to clinically defined controls to validate biomedical research results

Beltsville, MD, December 4, 2007 – BioServe today introduced ControlMATCH, a new line of fully annotated control DNA and serum samples designed to help biomedical researchers efficiently validate new biomarkers and early stage clinical trial drug candidates. Leveraging BioServe’s Global Repository of 600,000 human biological samples, ControlMATCH allows researchers to select and match control samples to the specific needs of their own DNA and/or serum-based studies.

ControlMATCH DNA and serum controls will initially cover type II diabetes, hypertension and hyperlipidemia, and extend to other disease states in early 2008.

ControlMATCH normal samples for type II diabetes, hypertension and hyperlipidemia are annotated with body mass index (BMI), confirmed normal blood glucose levels, confirmed normal blood pressure and cholesterol levels, and a family history of health status and ethnicity determined by data collected on three generations. ControlMATCH therefore permits researchers to identify one-to-one matched controls for extended criteria such as age, gender, ethnicity, BMI, diet and a host of lifestyle factors. Furthermore, ControlMATCH includes clinically confirmed negative results enabling researchers to further confirm that their markers are valued against the correct set of controls.

Xin Li Wang, a professor and director in the cardiothoracic research laboratory in the division of cardiothoracic surgery of the Michael E. DeBakey Department of Surgery at Baylor College of Medicine, commented, “We are engaged in landmark cardiothoracic studies that we hope will reveal the DNA aberrations in a few target genes responsible for thoracic aortic disease. Like any large epidemiological study, time is money and generating valid results as quickly as possible is a prerequisite for success.”

“The faster a study is able to generate validated results, the higher the probability of achieving longer term program milestones. By providing us with ready made DNA samples stratified by age, ethnicity and smoking status, BioServe’s ControlMATCH has proven to be an indispensable tool in accelerating our research,” he added.

“ControlMATCH was developed to be a powerful validation tool for epidemiologists and researchers investigating a variety of major diseases,” said Kevin Krenitsky, Chief Executive Officer, BioServe.  “DNA and serum control sets linked to extensive clinical, demographic and lifestyle data will enable researchers to both rapidly validate which markers are valuable and worth pursuing, and generally contribute to the genetic understanding of debilitating disease.”

About BioServe

BioServe is a leader in the processing, development, and validation of diagnostic tests for the practice of personalized, predictive and preventive medicine. Leading pharma, biotech and diagnostic firms collaborate with BioServe to identify and validate markers that cause disease while correlating clinical and molecular data to develop new diagnostic tests promoting wellness around the world. BioServe offers the Global Repository®, a growing library of over 600,000 human DNA, tissue and serum samples linked to detailed clinical and demographic data from 140,000 consented and anonymized patients from four continents. Leveraging BioServe’s robust genomic analytical services, technology, Global Repository and CLIA-certified laboratory, collaborators gain a complete, highly efficient platform for processing diagnostic test results and identifying genomic markers for powerful new assays. BioServe has headquarters in Beltsville, MD and Hyderabad, India. For more information please visit www.bioserve.com or call 301-470-3362.

The essence of synthetic biology is that techniques used to build non-biological systems in the engineering and computational sciences could potentially be used to build novel synthetic biosystems. The sessions will develop the following topics:

• Regulatory, IP, Ethical and Business Issues
• Protein, Metabolic & Therapeutic Engineering
• Design & Fabrication of Parts: Devices and Systems
• Cell & Tissue Engineering

Advances in Synthetic Biology, will be held on 6-7 March, at the Wellcome Trust Genome Campus, home to the Sanger and European Bioinformatics Institutes in Cambridge suburb. Both historically and today, the beautiful city of Cambridge is positioned at the forefront of scientific advancement and appears to be an ideal venue for such a meeting.

Alongside an exhibition of selected scientific posters and service providers, Select Biosciences is organising a two day event gathering world players in the field.

• Peter Ghazal, Director of Division of Pathway Medicine, Edinburgh University, UK
• Andreas Herrmann, Professor for Polymer Chemistry and Bioengineering, University of Groningen, NL
• Alfonso Jaramillo, Assistant Professor, Ecole Polytechnique, FR
• Juan Poyatos, Associate Professor, Spanish National Research Council, ES
• Laurie Zoloth, Professor, Northwestern University, US
• And many more…

To guarantee a high attendance at Europe’s largest conference dedicated to synthetic biology, Select Biosciences will maintain their traditional low registration fees and group booking discounts. Students will also benefit from special rates.

All conference passes include entrance to the sessions, the exhibition, as well as conference documentation, lunch and refreshments

To further increase the value of their trip, delegates can opt to attend a free guided tour of the Sanger Institute, the largest sequencing facilities in Europe! Early booking is necessary as numbers are strictly limited.

SyntheticBiologyAdvances.com

About Select Conferences http://www.selectconferences.com

The conferences division of Select Biosciences Ltd. is focused on organising specialist biomedical meetings each year. Experts from both academia and commerce are invited to present timely information from current research through to commercial implementation of new technologies. These events also provide a unique networking facility and the opportunity to reach a highly targeted scientific audience.

(Amherst, NH) - The success of recombinant protein drugs such as Enbrel, Remicade, and Herceptin in treating refractory conditions is fueling the search for protein and peptide-based therapeutic agents in oncology, inflammation and a host of other disease classes. Led by the proliferation of antibody-based drug candidates, biological drugs as a class continue to outpace all other NCEs in development pipelines and clinical trials. This shift away from small molecule drugs is creating opportunities for drug developers, device designers, packagers and - ultimately - pharmaceutical marketers.

Because biological drugs most often target chronic conditions, dosing strategies and treatment protocols must be developed for long-term use, often for self-administration by patients who may have limitations directly related to their condition. The powerful physiological effects of antibodies, hormones and other biological drugs also increase the need for safety and compliance.

Compliance with drug therapy and disease management protocols has been and is a primary concern within the healthcare and pharmaceutical industries. Efforts to enhance compliance are having a non-negligible effect on drug formulations and delivery decisions, and can be a significant factor in the prescribing decisions of most physicians. Compliance concerns have driven and continue to drive investment in new drug delivery technologies.

As patients live longer and are diagnosed with chronic and often debilitating ailments, the result will be a dramatic increase in self-administration of drug therapies in non-traditional settings for a number of conditions. This trend is creating an increased interest in routes of administration that are patient-friendly and cost-effective. Pharma company decision makers have come to the realization that new drug product success no longer only depends on the medication itself but also on achieving a patient-friendly form of application.

New injectable delivery device designs currently being developed will create new opportunities for alternative injection methods. Reusable injectors designed to accept prefilled syringes or drug cartridges will improve ease-of-use and increase alternative device share of the growing self-injection market. Partnerships between device suppliers and pharmaceutical companies will foster market acceptance of new injection devices for a host of new therapies such as therapeutic vaccines, DNA-based drugs, and protein-derived biologics.

These findings are contained in a comprehensive report, Injectable Drug Delivery: Evolving Markets, Emerging Opportunities. More information is available at www.greystoneassociates.org .

About Greystone
Greystone Associates is a medical and healthcare technology consulting firm providing services in strategic planning, venture development, product commercialization, and technology and market assessment.

In Quest for a Cure, Peter Day reports on whether the US Food and Drug Administration will licence the HIV/AIDS drug Maraviroc.

Maraviroc, a new HIV/AIDS drug was developed by Pfizer - the world’s largest pharmaceutical company - at its vast research and development center located at Sandwich in Kent, on the southeastern tip of England.

In the first two episodes (broadcast last year), the series examined how the drug was discovered - by screening millions of compounds in search of just one with the right efficacy and tested at vast cost, on thousands of volunteers.

In the final episode, the story reaches a climax with the public hearing into maraviroc organised by the US Food and Drug Administration in Washington DC in April this year.

At this extraordinary event, a panel of independent experts hear evidence for and against the drug in question. At the end of the day the panel vote, in public. For the Pfizer scientists it was the climax of years and years of work, involving thousands of people and millions of dollars.

When the result was announced - a unanimous yes vote - the team watching on CCTV back in Sandwich cheered and clapped ; some even shed a tear or two. As one researcher remarked “this doesn’t happen very often…”

The next step should have been a formality, with the expectation that the FDA would ratify the panel’s recommendation a few weeks later, but - surprisingly - it did not.

It seems even tumour cells can get lonely; scientists have discovered that by cutting off a key gene, lung cancer tumour cells are left ‘homeless’ and they can’t survive on their own.
The gene in question is called 14-3-3zeta and it can now be considered a potential target for selective anticancer drugs, according to Professor Haian Fu at the Emory University School of Medicine. These latest research results were published in the 24 December edition of the Proceedings of the National Academy of Sciences (PNAS).

Lung cancer kills more Americans annually than any other type of cancer, according to the National Cancer Institute. Yet treatment options are very limited.

“The recent trend towards targeted therapies requires us to understand the altered signalling pathways in the cell that allow cancer to develop,” said Prof. Fu.

“If you think about genes that are deregulated in cancer as drivers or passengers, we want to find the drivers and then, aim for these drivers during drug discovery.”

Prof. Fu and his collaborator, Dr Fadlo Khuri, deputy director of clinical and translational research at Emory Winship Cancer Institute, chose to focus on the gene 14-3-3zeta because it is activated in many lung tumours. In addition, recent research elsewhere shows that lung cancer patients are less likely to survive if the gene is on overdrive in their tumours, Dr. Fu explained.

There are seven 14-3-3 genes, each designated with a Greek letter. Their protein products act as adaptors that can clamp onto other proteins, depending on whether the target protein has been phosphorylated or not. One of the pathways 14-3-3 helps control is epidermal growth factor receptor (EGFR) signalling, which drives the growth of lung cancer.

The team of scientists, including lead author Dr Zenggang Li, used RNA interference (RNAi) to selectively silence the 14-3-3zeta gene. They found that when 14-3-3zeta is turned off, lung cancer cells become less able to form new tumour colonies in a laboratory test.

One of the most important properties of cancer cells is their ability to grow and survive without touching other cells or the polymers that connect them. The researchers found that if they turned 14-3-3zeta off, the tumour cells once again become vulnerable to anoikis (Greek for homelessness), a form of cell death that occurs when cells that are accustomed to growing in layers find themselves alone.

“You can see how control of anoikis means 14-3-3zeta could play a critical role in cancer invasion and metastasis,” Dr. Fu says. “The mechanistic question we still haven’t answered is: what makes zeta unique so that it can’t be replaced by the others.”

Further experiments also showed that 14-3-3zeta regulates the Bcl2 protein family, which is a popular target for cancer drug developers thanks to its role in cell death. If 14-3-3zeta is absent, it upsets the balance within the Bcl2 family.

The finding has implications beyond lung cancer, in that 14-3-3zeta is also activated in other forms of cancer such as breast and oral, he notes.

“Targeting this critical molecule could lead to meaningful therapeutic progress,” said Dr Khuri.

Dr Fu and his co-workers are using a robot-driven screening programme at the Emory Chemical Biology Discovery Center to sort through thousands of chemicals that may disrupt its interactions specifically. They hope to identify these compounds rapidly and move them from bench into clinic testing to benefit patients.