Digital Pathology and Personalized Medicine News and Discussion

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Big Pharma: Why In-Licensing Is Not the Cure

Posted on Monday, August 30, 2010

From the editor: Jason chew @ Seeking Alpha has a well written article on the issues related to big-pharma in-licensing activity. His article is well referenced, and corresponds with my own personal experience on the matter; that many pharma companies are outsourcing almost all of their research to other sources. Jason goes on to write:

In-licensing allows Pharma to access novel technologies and may have some cost efficiencies for now, but it will only buy time for Big Pharma as costs spiral upwards. While ROI for Pharma compounds is a lowly 5%, the increasing costs combined with increasing failure rates of in-licensed compounds has reduced the ROI of compounds licensed at the Phase III stage from 12% in the 1995-2000 period to just 6% from 2000-2002(3).

Effectively, what he is saying (and what is happening) is in-licensing has reached critical mass, and ROIs are now decreasing. What to do?

I believe as we go forward, it will all come down to understanding biology better via better science, better diagnostics development, and as one commenter on Jason’s article says, “FDA reform” that focuses less on liability and more on facilitating innovation. Translational research seems to be one key leg of the stool going forwards. With respect to oncology, cancer centers are playing an increasing role in not only identifying novel targets and compounds; but also the development of new diagnostics; as well as basic research programs which seek better understand the underlying biology.

Read more of Jason Chew’s article @ Seeking Alpha here:

Flagship Biosciences Creates Scientific Advisory Board

Posted on Friday, August 27, 2010

From the editor: Steve Potts and his team are once again making a significant impact in the digital pathology space, this time with an impressive list of members for their scientific advisory board. I expect to see more good things to come from Flagship Bio.

From Flagshipbio.com

Scientific Advisory Board to help drive pathology innovation in preclinical toxicology and oncology clinical trials

Flagstaff, AZ – August 26, 2010 – Flagship Biosciences LLC, a provider of digital pathology services, has formed a Scientific Advisory Board composed of experienced leaders in the pharmaceutical industry. Flagship is a pathologist-owned company committed to improving the use of digital pathology and tissue assessment in pharmaceutical and medical device development. This team of remarkable individuals will help guide Flagship in the delivery of digital pathology services across discovery, preclinical, and clinical trials in pharmaceutical drug development.

“Flagship Biosciences is committed to using digital pathology techniques and innovations to provide quantitative tissue assessments in research, development and clinical arenas,” said Steve Potts, CEO of Flagship Biosciences. “We are working aggressively on improving applications specifically in preclinical toxicology and oncology clinical trials, two areas where traditional pathology is central to successful outcomes. We are honored to have this remarkable group of distinguished industry leaders to help Flagship better match new technology with current and emerging needs in pharmaceutical drug development. The discipline of pathology is vitally important in effective drug development, and digital pathology is a valuable tool in pathologists’ hands for delivering more quantitative efficacy and toxicology results. The Scientific Advisory Board is composed of both pathologists and scientists who are innovation leaders in the use of digital pathology analysis.”

Read More…

New Cancer Drug Gets Dramatic Results

Posted on Thursday, August 26, 2010

Researchers call the experimental drug a major success for targeted cancer therapies.

From: TechnologyReview.com

Shrinking tumors: A PET scan of one melanoma patient shows a significant decrease in the size and number of tumors (shown in black) 15 days after treatment with an experimental drug. Credit: Peter MacCallum Cancer Centre/Plexxikon

An experimental drug designed to block the effects of a genetic mutation often found in patients with malignant melanoma, a deadly cancer with few existing treatments, significantly shrank tumors in about 80 percent of those who carried the mutation. The findings, published Wednesday in the New England Journal of Medicine, signal a major success for so-called targeted cancer therapies, which are designed to block the effects of genetic mutations that drive the growth of cancer cells.

“This study is a major breakthrough in cancer treatment, and for metastatic melanoma,” says Matthew Meyerson, an oncologist and researcher at the Dana Farber Cancer Institute in Boston. Meyerson was not involved in the study. “It’s a spectacular example of how genome-targeted therapies are beginning to help cancer patients.” The drug in the current study inhibits activity of a protein called BRAF, which is overactive in 50 to 60 percent of malignant melanomas.

Advances in genetic technologies over the last decade have allowed scientists to study the genetic mutations that underlie cancer in much greater detail. The result has been a new approach to drug design. Unlike chemotherapy, which can affect both healthy and cancerous cells and often triggers serious side effects, genetically targeted drugs act selectively on cancer cells that carry the mutation.

Only a handful of such drugs have been approved by the U.S. Food and Drug Administration, and most target rare mutations. The BRAF mutation, in comparison, is common. Discovered in 2002, the mutation disrupts regulation of the BRAF protein, making it continually active. The drug in the current study is under development by pharmaceutical giant Roche and Plexxikon, a startup based in Berkeley, CA. The drug is just one of a number of BRAF inhibitors currently in clinical tests.

Melanoma can be effectively treated with surgery in the early stages, but the prognosis is grim once the cancer has spread beyond the skin. The two currently available drugs work in only about 10 to 20 percent of patients. According to the new findings, 37 of 48 patients with the mutation responded to the new experimental drug, with their tumors shrinking by more than 30 percent. Tumors completely disappeared in three of those patients. About 30 percent of patients who took the drug the longest developed a specific type of squamous cell carcinoma, a tumor that usually doesn’t spread and typically resolves on its own.

Further studies are needed before the drug can be approved by the FDA. But because scientists can use genetic testing to select the patients for whom the drug is most likely to be effective, they require much smaller trials to show the drug works. Keith Flaherty, an oncologist at Massachusetts General Hospital who led the research, says the project reflects a new streamlined approach to clinical testing of cancer drugs that’s quicker and less expensive than traditional methods.

Read More…

Roche Acquires Bioimagene for 100M

Posted on Monday, August 23, 2010

From Roche.com

Acquisition further strengthens Roche’s global leadership in tissue-based cancer diagnostics and research

Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today that it has signed an agreement under which Ventana Medical Systems Inc., a member of the Roche Group, will acquire 100 percent of BioImagene, Inc., a privately held company based in Sunnyvale, California. The purchase price is approximately 100 million US dollars on a debt-free basis. The transaction is subject to customary closing conditions and is expected to close in the coming weeks.

BioImagene is an innovative leader in the field of digital pathology workflow and analysis. Digital pathology is a suite of dynamic, image-based technologies that enable image capture, information management, image analysis and virtual sharing of patients’ tissue samples on glass slides.

“As part of the personalised healthcare approach, pathologists are increasingly involved in generating information with high impact on treatment decisions,” said Daniel O’Day, COO Roche Diagnostics. “The increasing complexity of new tests and technologies creates tremendous need for more sophisticated tools for tissue analysis and diagnosis. BioImagene products will complement and strengthen our current offering in image analysis and information management.”

“With its leadership position in pathology and its global reach, Ventana is the ideal partner for BioImagene,” commented Ajit Singh, CEO of BioImagene, Inc. “Ventana is already a leader in image analysis for breast cancer applications and has a wide range of market-leading diagnostics products used in hospitals and laboratories worldwide. In turn, BioImagene brings to Ventana additional capabilities for scanning and analysing tissue that are not possible in the glass-slide world.”

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Philips and Dako join forces in Digital Pathology

Posted on Sunday, August 22, 2010

From the editor: My apologies for not getting this up sooner – this is a major alliance and shows that digital pathology is here to stay. An interesting point in the press release is how Dr. Clive Taylor notes that digital pathology has been in “gestation” because of old tissue fixation techniques and the fact that digital pathology images are generally larger files than radiology images (implying that computers are now just catching up to handling these types of image files). He also notes that it would be great if “one company” could provide best in class for all digital pathology workflow components.

I would be remiss if I didn’t mention that Philips also has an alliance with Definiens for the development of image analysis algorithms.

From: Dako.com

Eindhoven, the Netherland and Glostrup, Denmark – Royal Philips Electronics (NYSE: PHG, AEX: PHI) and Dako, a Danish company specializing in tissue-based cancer diagnostics, today announced that they have signed an agreement to integrate a selection of Dako’s image analysis applications into Philips’ future digital pathology solutions.

Anatomic pathology is an essential element of virtually every cancer diagnosis and the demand for it is ever-increasing. Our goal is to develop integrated digital solutions that enhance the operational efficiency and productivity of pathology departments, as well as increasing diagnostic confidence,” says Bob van Gemen, General Manager of Philips Digital Pathology. I am convinced that our partnership with Dako, with its leading market position and expert knowledge in detecting and quantifying specific biomarkers in cancer tissue, will significantly accelerate our clinical applications development program.”

We are very pleased to announce this collaboration with Philips, a leading company in the healthcare industry that is committed to entering the digital pathology market,” says Lars Holmkvist, CEO of Dako. By joining forces with Philips, we will be able to deliver highly competitive diagnostic tools based on Philips’ extensive clinical expertise and technology know-how and Dako’s expertise in advanced staining and image analysis in order to benefit pathology laboratories, pathologists and ultimately patients.”

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Olympus VS110™ Virtual Microscopy System Wins Two Awards at European Scanner Competition

Posted on Sunday, August 22, 2010

CENTER VALLEY, PA., August, 2010 – Olympus recently earned two awards at the first European Scanner Contest, which took place in late May in Berlin in conjunction with the 94th Annual Meeting of the German Society of Pathology and the 10th Pathology Federal Meeting. The Olympus VS110 virtual microscopy system competed among a field of five slide scanner systems and earned two of the three top honors in the quality category – scanning slides of a wide variety of specimens at 20x and 40x (0.16 µm). To earn each of the awards, the system had to accurately image three diagnostically relevant regions of interest (ROI) on ten different slides.

The instruments in the competition were used to evaluate the slides, each prepared by an independent institution, and each of different tissue types (skin, breast, kidney, etc.) and staining methods (H&E, PAS, toluidine blue, for example). Each system was used to scan the entire area of all ten slides, and the resulting virtual images were evaluated to identify three pre-determined diagnostically relevant ROIs. The results then were ranked in order of image quality by the pathologists who attended the meeting. Olympus took more quality honors than any other scanner manufacturer.

The awards were announced by Charité – Universitätsmedizin Berlin, a joint institution of the Freie Universität Berlin and the Humboldt-Universität zu Berlin.

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Clarient Announces U.S. And European Patents Allowed For Mammostrat Breast Cancer Prognostic Test

Posted on Sunday, August 22, 2010

Novel Test Classifies Risk of Recurrence of Breast Cancer

Aliso Viejo, CA /PRNewswire-FirstCall/ – Clarient, Inc. (Nasdaq: CLRT), a premier technology and services resource for pathologists, oncologists and the pharmaceutical industry, today announced that the United States Patent and Trademark Office and the European Patent Office have allowed patents covering the technology behind Clarient Insight® Dx Mammostrat®, a test designed to aid in the classification of the risk of recurrence of breast cancer following surgery and initial treatment.

More than 210,000 women in the U.S. develop breast cancer each year. Mammostrat development was targeted to breast tumors which express estrogen receptor, the most commonly seen subtype of breast cancer. The standard of care for most of these patients is surgery to remove the tumor, followed by anti-hormonal therapy (e.g. tamoxifen or aromatase inhibitors).

Mammostrat testing will help pathologists, oncologists and patients decide whether additional aggressive chemotherapy should be added to a patient’s treatment regimen.

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US Breast Cancer Drug Decision ‘Marks Start of Death Panels’

Posted on Tuesday, August 17, 2010

From the editor: As I read this article, I can’t help but wonder if a better companion diagnostic (i.e., via digital pathology) could extend life even more because a more accurate diagnostic would in theory, generate higher response rates. If the drug is no longer covered by insurance as a result of this decision, this will indeed could be a troubling indicator of things to come.

From: Telegraph.co.uk

America’s health watchdog is considering revoking its approval of the drug Avastin for use on women with advanced breast cancer, leading to accusations that it will mark the start of ‘death panel’ drug rationing.

A decision to rescind endorsement of the drug would reignite the highly charged debate over US health care reform and how much the state should spend on new and expensive treatments.

Avastin, the world’s best selling cancer drug, is primarily used to treat colon cancer and was approved by the US Food and Drug Administration in 2008 for use on women with breast cancer that has spread.

It costs $8,000 (£5,000) a month and is given to about 17,500 women in the US a year. The drug was initially approved after a study found that, by preventing blood flow to tumours, it extended the amount of time until the disease worsened by more than five months. However, two new studies have shown that the drug may not even extend life by an extra month.

The FDA advisory panel has now voted 12-1 to drop the endorsement for breast cancer treatment. The panel unusually cited “effectiveness” grounds for the decision. But it has been claimed that “cost effectiveness” was the real reason ahead of reforms in which the government will extend health insurance to the poorest.

If the approval of the drug is revoked then US insurers would be likely to stop paying for Avastin.

Read More…

Don’t Miss Definiens’ First International Symposium, Madrid: Oct 7-8 2010

Posted on Wednesday, August 11, 2010

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

More information:

There is no charge to attend this event. Deadline for registration is September 15th, 2010.

If you have any questions, please send us an email at Academy@Definiens.com

We look forward to seeing you in Madrid!

Regards,

The Definiens Team

Video of FDA/CDRH Public Meeting: Oversight of Laboratory Developed Tests (LDTs)

Posted on Tuesday, August 10, 2010

From the editor: For those interested in the development of multivariate diagnostics, it may be a good idea to view these webcasts regarding laboratory developed tests (LDTs).

To view the archived webcasts please use the following links:

The original website is here:

http://www.fda.gov/MedicalDevices/NewsEvents/WorkshopsConferences/ucm212830.htm

The Genomics and Personalized Medicine Act

Posted on Tuesday, August 10, 2010

From the editor: For those of us in the business of enabling technologies for personalized medicine, the fact that congress is discussing this issue is indeed a good thing. As the population gets older, and healthcare gets more expensive, technologies that deliver the right drug to the right patient at the right time at the right dose will become more and more important.

From the Age of Personalized Medicine Blog:

This summer marked the 10th anniversary of the sequencing of the human genome.  In the course of these ten years, advances in genomic technologies have begun to bring forth the promise of personalized medicine to the clinic.  And as this clinical utility continues to expand, our national legislative priorities will also need to reflect this change in medical practice and create regulatory policies that support creation and adoption of targeted therapeutics and personalized medical programs.

The coming of August starts to signal the close of summer, and with it, the August recess for Congress when our representatives head back to their districts to spend time with their constituencies. However, with the mid-term elections only months away, this August recess also signals a slowdown of legislative efforts and a focus on campaigns. Among the unfinished business that will remain after the 111th Congress closes and the 112th is elected is HR 5440, the Genomics and Personalized Medicine Act of 2010.

The Genomics and Personalized Medicine Act of 2010 is an effort to accelerate research, coordinate federal activities across agencies, and ensure delivery of personalized medicine to the American public.  The bill would help guide this new age of discovery and medicine in the second decade beyond the sequencing of the genome.

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Clarient Can Profit From Rise of Individualized Medicine

Posted on Tuesday, August 10, 2010

From Seeking Alpha

This small-cap company may be poised to be a long-term leader in cancer diagnostics and molecular testing. It combines innovative diagnostic technologies with world-class pathology expertise to assess and characterize cancer. The rise of individualized medicine as the new direction in oncology has created the need for a centralized resource providing leading diagnostic technologies, such as flow cytometry and molecular testing.

Clarient Inc. (CLRT) has a state-of-the-art commercial cancer laboratory, providing the most advanced oncology testing and diagnostic services. It’s also developing new, proprietary “companion” diagnostic markers for therapeutics in breast, prostate, lung and colon cancers, and leukemia/lymphoma. Clarient has a wonderful and comparatively inexpensive series of cancer diagnostic platforms that enables clinicians to determine the most effective therapies available for cancers having various genetic expressions. Its sales have been increasing at up to 20% a year compounded. Much of CLRT’s IP comes from its acquistion of Applied Genomics, Inc in December 2009.

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When a Biopsy Cannot Completely Rule Out Cancer

Posted on Tuesday, August 10, 2010

From the editor: I just caught this article today – very compelling, especially when you consider the emotional component of a patient and their loved ones when they are being diagnosed with cancer. The indirect message is that we need more effective image analysis techniques to make diagnostics more confirmatory.

From MedpageToday, Jeffrey Parks, MD

Pathologists and radiologists don’t have the luxury of spending time with actual patients so they have to render professional judgments and determinations based on indirect data (radiographs, a mashed up slice of breast tissue, etc.).

I don’t envy them; the utter detachment from patient care would make me miserable. But they do have a tough job. They get one shot at getting it right. There’s no patient follow up. They never get the opportunity to explain a missed diagnosis to a patient, to soothe things over. Once they stamp their name on the final report, there’s no turning back. They can’t afford to allow a sliver of a chance that they haven’t “covered” themselves.

And so they hedge. The radiologist will write “cannot rule out possible neoplasm” on an incidentally seen 4mm white blotch on a CXR and recommened “follow up CXR in 6 months advised.” I understand it. I get it.

Read More…

Video Highlights from Definiens Tissue Studio 2.0 Launch Webinar

Posted on Thursday, August 5, 2010

Yesterday, August 4th, 2010, Definiens officially announced the general availability of Definiens Tissue Studio 2.0. More than 100 people registered to view the webinar from around the world from pharmaceutical companies, cancer centers, and platform partners. Dr. Kai Hartmann and myself (Peter Duncan) were the presenters. Dr. Hartmann did a masterful job at presenting the new capabilities of Definiens Tissue Studio 2.0; focusing on immunofluorescence analysis of tissue microarrays. Highlight videos from the webinar are below:

For more details on Definiens Tissue Studio, visit the website at: www.tissuestudio.com

Definiens Introduces New Version of its Digital Pathology Image Analysis Software

Posted on Tuesday, August 3, 2010

Definiens Tissue Studio™ 2.0 Supports Tumor Profiling, Multiplexing and Biomarker Translational Research

MUNICH and PARSIPPANY, N.J., Aug. 3 /PRNewswire/

Definiens today announced the introduction of Definiens Tissue Studio™ 2.0, the latest version of the company’s leading image analysis software for digital pathology.

Along with improved processing speed, the second iteration of Definiens Tissue Studio now includes a full range of functionality for the analysis of immunofluorescence tissue stains. With its “learn-by-example” format, users train the software to identify representative regions of interest, and configure the software to automatically identify cells and sub-cellular objects. Beside the analysis of whole virtual slides, Definiens Tissue Studio 2.0 also provides full support to process tissue micro arrays.  Pathologists do not need prior computer programming, and can develop customized image analysis solutions in as little as 20 minutes.

“The fantastic reception to Definiens Tissue Studio over the last year has demonstrated the growing need among pathologists for accurate biomarker detection and quantification tools,” said Martin Baatz, Ph.D. Vice President of Marketing at Definiens. “With Definiens Tissue Studio 2.0, we are providing an increased level of accuracy and speed while preserving the accessible interface and workflow that has been embraced by our customers.”

Definiens Tissue Studio 2.0 is able to quantify localized biomarker expression as well as more than 50 morphological features. The rapid and accurate results provided by the software reveal underlying biological insights required for successful oncology translational research; supporting retrospective studies, diagnostics development, and early decision support in Phase I and Phase II clinical trials.

Definiens will introduce Definiens Tissue Studio 2.0 during an interactive webinar on Wednesday, August 4 at 11:00am ET. Details and registration are available at www.tissuestudio.com.