When: October 7-8, 2010

Where: CNIC – Melchor Fernández Almagro, 3, 28029 Madrid, España.

The annual Definiens Symposium serves as the premier forum for developers and users of the Definiens image analysis platform and applications from around the world to present their latest techniques and research in life science image analysis. Speakers and attendees will attend from international institutions, bio-pharmaceutical companies, industry partners, and the healthcare industry.

The Definiens Symposium 2010 will be the place to exchange the latest ideas related to state of the art image analysis and to meet international experts from the Definiens community. It will be hosted by Dr. María Montoya, CNIC.

Sessions will include:

• Digital Pathology Image Analysis
• Cell, Confocal, and Small Animal Image Analysis
• The Developer Perspective: Life Science Image Analysis Solution Strategies

Definiens is now accepting applications for speakers. Participate in the Definiens Symposium 2010 in Madrid alongside image analysis thought leaders from industry and academia; and Prof. Gerd Binnig, Nobel Laureate and Founder of Definiens.

Speaking slots are limited. Talks will be 20 minutes in length, followed by a question / answer period. Speakers are encouraged to submit papers for the conference proceedings.

Due Dates:

Speaker Titles and Abstracts Due: June 30th, 2010

Submit Title, Abstract, and .PDF of slide deck to:

The Definiens Academy

Email: academy@definiens.com

Definiens Tissue Studio™ and Definiens Developer XD Help Quantify Changes in Apoptosis in the Liver Following Chemical Exposure

Parsippany, New Jersey / Research Triangle Park, North Carolina – May 26, 2010 – Definiens, the number one Enterprise Image Intelligence® company, today announced that The Hamner Institutes for Health Sciences is utilizing Definiens image analysis software in a comprehensive liver toxicology study. The Hamner Institutes will utilize Definiens Tissue Studio™ and Definiens Developer XD to develop an application that automatically analyzes images of liver tissue slides. The application will identify and quantify apoptotic nuclei in hundreds of whole-slide liver tissue section images, expediting the image analysis process.

“The use of automated image acquisition and analysis technologies greatly expands our ability to identify and quantify low-frequency adverse events resulting from chemical exposure,” said Dr. Russell Thomas, Senior Investigator and Director of Genomic Biology and Bioinformatics at The Hamner Institutes. “We are using Definiens digital pathology software to measure small changes in the background rate of apoptosis. This capability allows us to assess the effects of chemicals at environmentally-relevant doses. Initial studies demonstrated that Definiens’ software delivers highly accurate and reproducible analysis results.”

Read More…

From ScienceDaily.com

Researchers at the University of Alabama at Birmingham (UAB) Department of Pathology have discovered a set of four biomarkers that will help predict which patients are more likely to develop aggressive colorectal cancer and which are not. The findings also shed light on the genetics that result in worse colorectal cancer-treatment outcomes for African-Americans, compared with Caucasians, the researchers said.

In data presented April 19 at the American Association of Cancer Research annual meeting in Washington, D.C., Liselle Bovell, a graduate student working in the laboratory of UAB Associate Professor of Pathology Upender Manne, Ph.D., discovered that patients who tested positive for higher levels of a genetic biomarker called microRNA (miRNA) had increased risk of death after being treated for colorectal cancer.

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While I find this an interesting survey, it fails in one respect. There will be constant and increased innovation coming out of the academic research centers, and life science technology providers that will in my view INCREASE the intellectual property that venture capital firms will want to snatch up (and hence start more biotech companies). This IP will take the form of new targets and / or biomarkers for diagnostics. So at the very least, while we will see some B and C level biotechs get absorbed into Pharma (or go out of business) we will also observe  new companies taking their spot.

From Yahoo Finance

A recently released survey from consulting firm Deloitte Touche Tohmatsu, in collaboration with the Economist Intelligence Unit, paints a dire picture for the future of many biotech companies.

Between 20% and 40% of biotech companies won’t exist within five years, according to almost half the 281 participants in the Deloitte-Economist worldwide survey of senior biopharma sector executives and board members. Even more of biotech executives, 68%, share that view.

The survey’s goal was to assess the effect of the worldwide recession on life science companies. For many biotechs, if the pessimists are right, the fallout from the recession will be fatal, says John Rhodes, U.S. & global life sciences managing partner for Deloitte.

“Some will just disappear,” he said. “Others will disappear through acquisition.”

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Date: June 10^th, 2010

Time: 11am EDT / 4pm GMT

Join us for a webinar: SOX2 Evaluation in Non-small Cell Lung Cancer using Definiens Tissue Studio.

In this talk, a study on SOX2 amplification in non-small cell lung cancer with a special focus on IHC assessment using Definiens Tissue Studio image analysis software will be presented.

The aim of the study was to verify SOX2 amplification and protein over-expression in non-small cell lung cancers (NSCLC) and to compare these results with patient and tumor characteristics. A total of 940 NSCLCs from two independent population-based cohorts containing predominantly adenocarcinomas of the lung and squamous cell lung carcinomas, were assessed by fluorescence in-situ hybridization (FISH) and immunohistochemistry (IHC) to study SOX2 amplification and expression level. For protein expression analysis, the expression level was explored by utilizing Definiens Tissue Studio.

Speakers:

• Sven Perner: Assistant Professor – Institute of Pathology, Comprehensive Cancer Center, University Hospital Tuebingen
• Theresia Wilbertz: PhD Candidate – Institute of Pathology, Comprehensive Cancer Center, University Hospital Tuebingen
• Peter Duncan: Director of Marketing and Business Development – Definiens

Space is limited. Reserve your webinar seat now at:

https://www2.gotomeeting.com/register/654854170

Looks to be a fantastic show for Digital Pathology Informatics. Definiens will  be a sponsor, speaker, and have an exhibit. Stop in and say hello to the Definiens Team.

Who Should Attend?

Pathology Informatics 2010 is an annual educational conference designed for world-wide collaboration, technology and learning together to come together in one meeting place.

PI2010 offers direct interaction with physicians, researchers, residents and graduate students, Industry-related developers, engineers, imaging informatics professionals, vendor representatives and many others interested in how informatics and imaging are transforming pathology, oncology and radiology. Prior knowledge of informatics is not required and courses are offered for individuals new to this field.

Conference Highlights

• Three pre-conference workshops and three tracks to choose from over the course of the four conference days
• An eminent faculty consisting of most of the national experts in the field of pathology informatics in the country and from abroad.
• Dawn-to-dusk programming over the course of four days including a gala welcoming reception on the first night of the conference and formal lecture-demonstrations by a selection of exhibitors.
• Elegant conference space and room accommodations at the Westin Copley Place, one of the finest hotels in Boston.

Overall Conference Objectives

• Present practical and emerging solutions for automated information and image management in pathology and the clinical laboratories.
• Describe how workflow in the clinical laboratories and pathology can be supported and enhanced by new software and hardware solutions.
• Understand the various software and hardware products available in the clinical laboratory and pathology market by interacting with a large number of exhibitors.
• Present new research in pathology informatics on the basis of submitted competitive scientific abstracts.
• Provide a forum for basic pathology informatics instruction for house officers and fellows in pathology training programs.

From Medpagetoday.com

Interesting study results for Tarceva. Of note is that in this study, the drug seemed to do just as well with EGFR over-expressors as with the rest of the patients in this clinical study.

Maintenance therapy with erlotinib (Tarceva) immediately after successful first-line chemotherapy improves outcomes in non-small cell lung cancer (NSCLC), researchers affirmed.

Erlotinib was associated with a 19% relative overall survival advantage compared with placebo (12 months versus 11, P=0.0088), Federico Cappuzzo, MD, of the Ospedale Civile di Livorno in Livorno, Italy, and colleagues reported online in The Lancet Oncology.

This benefit in the SATURN study appeared equally good regardless of overexpression of the epidermal growth factor receptor (EGFR) targeted by the drug.

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Pfizer Inc. and the Washington University School of Medicine have reached an agreement aimed at finding new uses for existing drugs.

Another indicator that large drug companies are increasingly seeking the aid of the academic research institutions to help prioritize drug development programs. I am seeing a trend in that it is academia who are becoming the center of the universe with respect to drug development. From efforts mentioned in the article below; to government sponsored clinical trials; to increased federal funding for research to cutting edge translational research studies revealing new validated biomarkers and / or targets; it is academia now leading the way towards the drugs of tomorrow. Many academic institutions are now establishing their own biomarker / diagnostics groups to accompany these programs.

From: RDMag.com

STLtoday.com, the Web site for the St. Louis Post-Dispatch, reported Monday that Pfizer has pledged $22.5 million to fund research projects between Washington University scientists and the drug maker.

The agreement provides Washington University researchers with confidential access to more than 500 chemical compounds that Pfizer has investigated, or that are being tested on humans.

Some of the compounds will be drugs currently on the market. Others are new or are part of Pfizer’s internal clinical investigations on humans, or were previously tested by Pfizer but the research was discontinued.

Another indicator that personalized medicine is here to stay. I agree with the article below in that especially with respect to cancer diagnostics, there is no substitute for the tissue as the source for the most accurate diagnostics, as it contains both biomarker and morpholigical information. Digital pathology (image analysis) will further enable more accurate tissue-based diagnostics.

From GEN:

Long-Term Health of Sector Dependent on Changes in Approval and Reimbursement

Tissue-based diagnostic testing continues to serve as one of the gold standards for cancer diagnosis. There is no other technology that can capture the biological context of the disease and the critical parameters that factor into patient outcomes. From a biopsy, a pathologist can determine the type of cancer, the stage, and the degree to which the cancer has invaded healthy tissue.

As the rate of cancer incidence grows steadily each year, tissue diagnostics will be in high demand and produce a robust market with many high growth opportunities. The total U.S tissue diagnostics market generated revenues totaling $1,029.7 million in 2009 and is forecasted to reach $2,278.2 million in 2016.

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Courtesy of the medical imaging group at Definiens, a new video that discusses Definiens Lymph Expert is now uploaded on our Definiens Life TV channel on YouTube. Definiens Lymph Expert detects lymph nodes and lesions, and quantifies them volumetrically. Another breakthrough in image analysis for the medical field from Definiens.

Watch the video:

Digital Pathology Insights Comment:

Another article describing the positive impact of biomarkers for personalized medicine. Two points that I note:

1. Dr. Stephen Little, VP Personalized Healthcare from Qiagen mentions the negative economics of co-developing a companion diagnostic as part of a PIII trial. I agree 100% that at the moment, this is somewhat prohibitive in the current construct of clinical development. MD Anderson recently showed us that there is a better way and that is through studies like BATTLE which are adaptive, and seek to quickly determine which patients will have a better chance at favorable response. So, the current clinical development dynamic really needs to become less linear, and more adaptive in order for the promise of biomarkers to finally lift off. Additionally, the FDA really needs to finally come to some sort of streamlined approval process where expectations are clearly set, and where diagnostic or drug developers can work with one point of contact as a partner to help manage expectations and the process towards approval.

2. More strategic use of biobanks! I have often wondered: In a PII trial, why is it not more prevalent to create a higher “N” by supplementing patient numbers with FFPE tissue samples from past trials that have similar patient inclusion criteria? This would serve to bolster statistical confidence in the results for whatever biomarker studies are being performed, leading to more confidence for prospective trials going forwards. This approach could very well make PIII clinical trials SMALLER, and LESS EXPENSIVE, which would help the issue that Dr. Little mentions above. Once again, digital pathology image analysis to the rescue! Not only could we supplement smaller clinical trials with annotated FFPE patient tissue materials from past trials, but the ability to data mine these tissue samples comprehensively for biomarker localized expression and cellular morphology (for example with Definiens Tissue Studio) would certainly yield important insights which have clinical utility.

From GEN

At the “BIO International Convention” in Chicago, there were ten breakout sessions on biomarkers; intellectual property, commercialization, reimbursement, drug development, and diagnostics were among the topics discussed. This explosive new technology niche, which requires the co-development of diagnostics and drugs, has tremendous potential to exploit breakthroughs in the molecular basis of disease. Genomics has transformed biology, and as biomarker research advances we will likely see a similar impact on drug development.

Cancer Markers on a Fast Track

Cancer and Alzheimer disease are two disease areas that can be significantly advanced by biomarker research. Cancer is a priority because targeted drugs like Herceptin (trastuzumab), Gleevec (imatinib), and Iressa (gefitinib) are already on the market and can benefit from a more targeted therapy utilizing biomarkers.

In a session chaired by Bernward Garthoff, Ph.D., chair of cluster biotechnology of the Federal State of North Rhine-Westphalia, Germany, the use of biomarkers in the diagnosis and treatment of breast cancer and other tumors was explored. Breast cancer was highlighted because it is believed that biomarkers could help reduce the use of chemotherapy after surgery. As an example, it was noted that in the treatment of node-negative breast cancer, research has shown that only 30% of patients benefit from chemotherapy treatment.

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Doesn’t distinguish aggressive tumors from slow-moving malignancies

A technique that urologists had hoped would make it possible to distinguish men with prostate cancer who need treatment from those who would only need watchful waiting didn’t work well, researchers report.

The technique, called PSA kinetics, measures changes in the rate at which the prostate gland produces a protein called prostate-specific antigen. A significant increase in PSA kinetics, measured by the time during which PSA production doubles or increases at a rapid rate, is supposed to indicate the need for treatment, by radiation therapy or surgery.

PSA kinetics has long been used to measure the effectiveness of treatment. A number of cancer centers have started to use it as a possible method of distinguishing aggressive cancers that require treatment from those that are so slow-growing that they can safely be left alone.

Recent studies indicating that many men with slow-growing prostate cancers undergo unnecessary treatment have given urgency to the search for such a tool, especially considering that side effects of treatment can include incontinence and impotence.

But the study indicates that “PSA kinetics doesn’t seem to be enough to show you who you should follow and who you should treat,” said Dr. Ashley E. Ross, a urology resident at the Johns Hopkins University Brady Urological Institute, and lead author of a report on the technique published online May 3 in the Journal of Clinical Oncology.

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New methods of targeting certain treatments to smaller patient populations could drastically change the sales patterns of well-known drugs—for better or worse

In the game of pharma, companies may have to give up on the home run known as the blockbuster drug—products like Lipitor and Avastin that were marketed to large swaths of the population and generated billions in sales—and hope that well-timed singles and doubles can carry the day.

Drug manufacturers have been loath to surrender broad markets and efficient marketing campaigns for more targeted patient populations and, presumably, higher marketing costs. But the number of prospective blockbusters has dwindled—and some drug companies are slowly coming around to the potential benefits of targeting certain treatments to smaller patient populations who genetic tests show will be most receptive to them. The hope is that increased safety and quality assurance—and the possibility of moving drugs up into earlier phases of treatment—could bolster sales and help make up for narrower markets for each drug.

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More of the “ripple effect” of the MD Anderson BATTLE study: Bloomberg news picks up the story below:

April 18 (Bloomberg) — Lung cancer patients given drugs such as Roche Holding AG’s Tarceva or Bayer AG’s Nexavar fare better when their tumors are first tested for certain genetic traits and then matched with the corresponding treatment.

The drugs, called targeted therapies because they home in on specific biological pathways involved in tumor growth, were significantly more effective in keeping cancer from worsening when prescribed based on the biomarkers, a study found. The findings, from researchers at the University of Texas M.D. Anderson Cancer Center in Houston, were presented today at the American Association for Cancer Research meeting in Washington.

It isn’t standard practice for lung cancer patients to be biopsied for their genotypes, said M.D. Anderson thoracic oncologist Edward Kim, the study’s lead author. Most treatment decisions are based on cancer type, he said. That is likely to change as more studies show the benefit of tailoring treatment to the individual, said Anil Potti, an associate professor of medicine at Duke University.

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The biopharmaceutical industry is adapting to shrinking pipelines, increased market access barriers, significant financial strains and advances in technology. Companies must employ certain tools to bring life-saving medicines to market sooner and remain competitive in the rapidly changing arena of drug development.

Among the technological advances that can shorten drug development timelines and reduce the overall complexity of conducting clinical research, digital pathology and advanced biomarker development stand out. These areas hold the potential to not only reduce costs and timelines, but also deliver more targeted, and more effective therapies to patients.

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Ever since Philips announced their entry into the digital pathology market there has been countless articles like the one below. Note: Philips and Definiens have established an alliance for the development of breast cancer biomarker algorithms which will run in the Philips environment.

May 3, 2010

A work-in-progress pathology slide scanner and associated image management system is being developed to overcome one of the major hurdles for mainstream introduction of digital pathology–the availability of a scanning technology that combines ease of use, speed, and high image quality.

Philips Healthcare’s (Best, The Netherlands) ambitions in digital pathology fit its integrated care cycle approach to cancer care. These prototype systems will form the basis of the company’s future integrated digital pathology solutions.

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(Click to Enlarge)

Dear Colleague,

At the beginning of every month, Digital Pathology Insights will be hosting an “Image of the Month” contest!  This is a great opportunity to not only see Definiens Tissue Studio in action on your digital slides, but also earn a chance to win a free FLIP ULTRA HD portable video recorder!

We will process the images for the specified parameters (i.e., nuclear markers, tumor vs. non-tumor, membrane markers, etc.) with Definiens Tissue Studio, and post the results on this blog. Winners will be announced at the end of the month, and your new FLIP will be mailed to your specified address upon announcement (limit, 1 per person).

Images must be of solid tissue (i.e., breast, colon, prostate, liver, lung) and be stained with IF, H&E or IHC (blue or brown), 20X preferred. For additional image requirements, and uploading instructions please contact me for details: pduncan@definiens.com.

Our first Image of the Month comes from Dr. Kai Hartmann at Definiens. This is a screen shot of Her2 stained breast tissue that has been analyzed with Definiens Tissue Studio. Low intensity cells, yellow; medium intensity, orange;  high intensity, red.

Biomarkers may help identify which women treated with lumpectomy for ductal carcinoma in situ (DCIS) are most at risk for subsequent invasive cancer, researchers found.

Women who had lesions positive for p16, COX-2, and Ki67 were twice as likely as those with masses of other phenotypes to develop invasive cancer within about eight years (HR 2.2, 95% CI 1.1 to 4.5), according to Karla Kerlikowske, MD, of the University of California San Francisco, and colleagues.

In addition, those whose DCIS was detected by palpation were nearly three times as likely to develop invasive cancer as those whose mass was detected by mammography (HR 2.7, 95% CI 1.4 to 5.5), the researchers reported online in the Journal of the National Cancer Institute.

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This is an article from April 16th from the New York Times, but if you haven’t seen it already, it is well worth reading. The bottom line: Targeted therapies are only as good as the diagnostic that can determine if a patient should get the treatment or not. Digital pathology image analysis approaches will certainly play a major role in this going forwards, and I expect to the use of digital pathology applied to companion diagnostics to increase in the years to come.

Dr. Linda Griffith was at a conference in Singapore in early January when she felt a lump in her breast. She assumed it was nothing — a cyst. And anyway, she had no time for it. She was returning on a Sunday night and the next Tuesday morning was leaving for a conference in Florida.

But she had a mammogram, ultrasound and biopsy within hours of getting off the plane. The news was not good: she had cancer.

Then the complications began. Dr. Griffith, director of the Center for Gynepathology Research at M.I.T., had a test to see whether her tumor had extra copies of a protein, HER2. If it did, it would respond to a drug, Herceptin, which blocks the protein and stymies the tumor’s growth.

Drugs aimed at disabling proteins that spur cancer are, many oncologists say, the future of cancer therapies. Only a few are available now but almost every new drug under study is designed to disable cancer-fueling proteins.

But these so-called targeted therapies are only as good as tests to find their protein targets. And while most patients do not yet know it, those tests can be surprisingly unreliable.

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