Category Archives: Pharmacogenomics

By Turna Ray

Based on promising Phase II results, Generex Biotechnology is planning to meet with the US Food and Drug Administration about its investigational cancer immunotherapy for breast patients who have tumors that express low to intermediate levels of the HER2 protein, the company said this week.

Generex's HER-2/neu peptide vaccine, called AE37, is being developed as an adjuvant therapy for the 50 percent of breast cancer patients who express low to intermediate levels of HER2, and as a result, don't have HER2 expression levels high enough to be eligible for Roche/Genentech's Herceptin, according to the company.

However, although the AE37 immunotherapeutic is for a molecularly defined patient population, Generex is not currently planning to develop the drug with a new companion diagnostic to gauge HER2 expression in the intent-to-treat patient population.

"At the moment we are not working to set up a separate diagnostic test" for AE37, Eric von Hofe, CEO of Generex subsidiary Antigen Express, told PGx Reporter. AE37 is the first product Generex is developing using Antigen Express's Ii-Key Hybrid technology platform.

"There is currently the Dako HercepTest that can be used for scoring tumor tissue HER2 1+, 2+ or 3+; with low to intermediate expressing tissue being 1+ or 2+," Von Hofe said. "There are other tests, as well, that are available that claim to be more quantitative."

Patients who end up receiving AE37 will likely be those who were initially being considered for Herceptin treatment and, as such, were already tested with one of several FDA-cleared HER2 tests and found to have low to intermediate HER2 expression. This may be one reason why Generex expects it will not have to develop a companion test for its product.

The FDA has indicated that when a drug requires the aid of a molecular diagnostic to determine which patients should receive it, the test, in most cases, must be approved by the agency. "An IVD companion diagnostic device is an in vitro diagnostic device that provides information that is essential for the safe and effective use of a corresponding therapeutic product," the FDA states in its draft companion diagnostics guidance, released last year.

The FDA-approved labeling for HercepTest notes that it is indicated "as an aid in the assessment of patients for whom Herceptin treatment is being considered." Given the rationale for how a breast cancer patient might become eligible to receive AE37, it is unclear whether the agency will require a separate FDA-cleared companion diagnostic to market the drug for a subset of the HER2 population.

Meanwhile, Dako and other firms marketing FDA-cleared HER2 tests that are supporting an additional indication for Herceptin or that are intended to be used with a new HER2-targeted therapy have had to seek approval for their tests in these new settings (PGx Reporter 6/2/2010; 2/8/2012).

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Generex to Meet with FDA about AE37 HER2 Peptide Vaccine; Companion Dx Path Still Unclear

By Turna Ray

After the Patient-Centered Outcomes Research Institute held a meeting this week to gather public input on its comparative effectiveness research priorities, personalized medicine stakeholders are still uncertain to what degree the institute will fund studies that aim to define how well drugs work in molecularly distinct patient groups or if it will mostly fund research to gauge how interventions work in the general population.

Another unknown as PCORI further defines its CER framework is whether "patient-centered research" a term the institute has been working to define with public input will explicitly mention personalized medicine principles. Whether it does or not could signal whether comparisons of genomic medicine to the standard of care will be a major focus of PCORI's CER efforts.

PCORI, a non-profit organization formed by the 2010 Patient Protection and Affordable Care Act, has issued a draft document outlining the research areas in which it wants to conduct studies comparing the safety and efficacy of medical interventions, healthcare delivery models, and infrastructure. The findings from such CER, PCORI hopes, will help drive informed healthcare decision making, improve patient outcomes, and reduce unnecessary spending in healthcare.

The public was invited to discuss the preliminary research agenda with PCORI and key stakeholders at a meeting this week. PCORI is also accepting written comments on its draft research agenda until March 15.

PCORI is planning to spend $122 million for research activities in 2012, and it's possible that some of this money may go toward funding CER on molecularly targeted personalized medicine products. According to PCORIs statutory purpose, the research the institute supports must consider how disease can be prevented, diagnosed, and treated in patient subpopulations, which could include groups defined by molecular subtypes.

Regardless, some believe that the focus areas outlined in PCORI's draft research agenda are too broad, and personalized medicine principles, which are still new and evolving, can very easily get lost in the mix.

"PCORI was designed to address specific, practical questions of national importance," Amy Miller, vice president of public policy for the advocacy organization Personalized Medicine Coalition, said at the meeting according to prepared comments provided to PGx Reporter. "However, the broad and vague drafting of the research priorities is more appropriate for traditional, investigator-driven research, which may or may not address the types of questions PCORI must answer."

In addition, "since broad drafting does not allow for an examination of individual research proposals, topics, or research questions, it is not possible to say whether PCORIs work will support personalized medicine or not," Miller said.

Since PCORI was formed, the PMC has been trying to remind the institute's leaders that their charge isn't just to look at whether most people respond better to one drug over another, but to investigate how and why treatments work best in some people with a unique set of characteristics. "It is not enough, in the PMCs opinion, to say that one therapy works for most people in the aggregate," Miller said. "To enable personalized medicine, research must explain why a therapy works and for what types of patients."

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Will PCORI's Patient-Centered Comparative Effectiveness Research Track with Personalized Rx?

CHICAGO--(BUSINESS WIRE)--

Fitch Ratings today published 'Navigating the Drug Channel - Pharmaceutical Manufacturers: At the Source,' the second of seven reports analyzing the U.S. drug channel. This newest report focuses on headwinds and tailwinds faced by drug makers, as well as their role in the U.S. drug channel and Fitch's take on certain considerations on the horizon.

Drug makers are plagued by unprecedented and now-accelerating drug patent expirations, which will continue through 2015. Fitch believes the impact of the so-called 'patent cliff' apply to each pharma manufacturer on an individual basis, with issuers such as Bristol-Myers Squibb Co.; Eli Lilly & Co., Inc.; and Pfizer Inc. most affected.

The industry's R&D pipelines were productive in 2011, positioning several drug makers to benefit from a solid recovery of a portion of lost revenues and profits; albeit delayed from the greatest impact of patent expiries. Due to their position at the beginning of the drug channel, pharmaceutical manufacturers' productivity is directly related to the longer-term viability of the channel as a whole.

Labor conditions in the U.S. are not expected to materially improve over the next few years, likely leading to continued treatment avoidance and a further pressuring of prescription drug trends. Nevertheless, Fitch expects the effects from an aging U.S. population and the expansion of Medicaid coverage in 2014 from the Patient Protection and Affordable Care Act to backstop the dampening effect on overall prescription demand from prolonged poor macroeconomic conditions.

Fitch believes that stubbornly high unemployment, constrained third-party reimbursement growth, and very large drug patent expiries will clash with favorable demographic trends and an anticipated one-time addition of about 30 million potential new patients to result in annual U.S. drug spending growth of 3% or less over the next couple of years.

Considerations on the horizon include the introduction of biosimilars into the U.S. drug channel, the rapid growth of specialty pharmaceuticals, and the growing importance of pharmacogenomics. The report discusses Fitch's take on each of these very vital issues.

The full report, 'Navigating the Drug Channel - Pharmaceutical Manufacturers: At the Source,' is available at 'www.fitchratings.com.' This is the second in a series of seven reports that Fitch will publish during the first half of 2012. The expected schedule for future reports can be found on the first page of previously published reports, including this one.

Additional information is available at 'www.fitchratings.com'.

Applicable Criteria and Related Research: Navigating the Drug Channel Pharmaceutical Manufacturers: At the Source

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Fitch: Drug Makers Continue to Face Challenges at the Beginning of the Drug Channel

ROCHESTER, N.Y.--(BUSINESS WIRE)--

ACM Global Central Lab, the central laboratory that continually defines the customer-service standard with its flexible approach, today announced the launch of its complimentary workshop series, Navigating Global Clinical Trials with Your Central Lab, designed for global pharmaceutical and biotechnology companies and contract research organizations (CROs) interested in managing global clinical trials testing. The first workshop, Ensuring Patient Safety through Efficient Specimen Lifecycle Management, will take place Thursday, March 15, 2012, from 2:00 5:00 p.m. PST at Hotel Vitale in San Francisco.

In many clinical trial scenarios, there may only be one chance to collect, ship, test and analyze a patients specimen. These often time-sensitive snapshots into a patients progression in a study are critical not only to the overall study results, but ultimately the safety of patients undergoing treatment. The lifecycle of a specimen, which starts at collection and ends at database lock, can be prone to human error along each step of the testing process, particularly when conducting global clinical trials in more remote ends of the world. Sponsors need to ensure the integrity of the specimen throughout this process, while balancing the relative cost of logistics.

There are many considerations when it comes to conducting global studies, said Tracy Hendershott, vice president of clinical trials at ACM Global Central Lab. As a central lab devoted to clinical trials testing, we wanted to develop a workshop series to support the clinical trials community by helping them navigate the many hurdles and offer some new approaches that can improve efficiencies along the way.

Executives from ACM Global Central Lab, Cryoport and Dorevitch Pathology will be discussing the scientific, financial and logistical factors that should be considered to ensure patient safety and will offer innovative, yet cost-effective methodologies and solutions for maintaining specimen integrity. During interactive presentations and a networking reception, attendees will have the opportunity to hear from ACM Global Lab and its partners on their insights on monitoring and oversight on patient safety, safeguarding sample integrity, and good business sense, based on lessons learned from managing global clinical trials testing.

To register for ACM Global Central Labs complimentary workshop, please click here. Registrants will automatically qualify to be entered into a drawing for a Sunset Sailing Experience for Two around the San Francisco Bay.

About ACM Global Central Lab ACM Global Central Lab offers a flexible approach and a focus on precision to keep clinical research studies on schedule. ACMs services extend to more than 60 countries with all tests conducted and managed from central lab facilities with seamless data management providing a single database. The organization performs 13 million tests each year, featuring more than 1,500 individual tests spanning all medical disciplines, including pathology, microbiology, flow cytometry and pharmacogenomics. Combining comprehensive safety, efficacy and pathology testing from a single lab ensures clients receive consistent, analyzable test results with faster and cleaner reporting.

For more information, visit http://www.acmgloballab.com and our Central Labs in Focus blog atwww.acmgloballab.com/blog.

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ACM Global Central Lab Launches Workshop Series to Share Expert Insights on Navigating Global Clinical Trials with a ...

New research report Future US Hematology and Flow Cytometry Market Outlook prepared by Venture Planning Group has been recently published by Market Publishers Ltd. The report reveals that commercialization of innovative products is likely to drive the future growth in the market, and the US will remain the biggest market for hematology.

London, UK (PRWEB) February 28, 2012

The world hematology market is likely to grow over the forecast period, driven by the development in bench-top high throughput hematology analyzers and in high sensitivity point-of-care (POC) tests. Commercialization of innovative products is also likely to drive the future growth in the market. The US is the biggest market for hematology, contributing around 50% towards the global market share.

New research report Future US Hematology and Flow Cytometry Market Outlook prepared by Venture Planning Group has been recently published by Market Publishers Ltd.

Report Details:

Title: Future US Hematology and Flow Cytometry Market Outlook

Published: February, 2012

Pages: 275

Price: US$ 9,500

http://marketpublishers.com/report/medicine_pharmaceuticals_biotechnology/healthcare_equipment_services/future_us_hematology_n_flow_cytometry_market_outlook.html

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US Hematology & Flow Cytometry Market Future Discussed in New Report Published at MarketPublishers.com

Last Updated on Sunday, February 26, 2012 10:27 PM Written by The Darien Times
Monday, February 27, 2012 06:00 AM

Darien High School students took home first place honors in five out of eight categories at the 12th Annual Southern Connecticut Invitational Science & Engineering Fair in Woodbridge on Feb. 4.

More than 600 students, judges and community members were joined by Dr. Dan Riskin, host of Animal Planet's Monsters Inside Me, at the fair, which was held at Amity Regional High School. Completed projects and research proposals were presented by students from Darien, Amity, Convent of the Sacred Heart, Joel Barlow High School, Hamden High School, Newtown High School and Staples High School.

Each student was required to create an exhibit, make a presentation, and participate in a question and answer session. Volunteer judges evaluated entries — both completed projects and research proposals — in four categories: behavioral sciences, environmental sciences, health sciences and physical sciences.

Darien student Reed Morgan took first place for his behavioral science proposal called, "Ethnogenesis and State Formation in the Mycenaean Hither State of Pylos: A-pu2/Iklaina as a Diagnostic for Expansion of the Core Zone." Katherine Ferguson won first place for her environmental science proposal, "Quantifying the Effect of Lionfish and Other Stressors on Coral Reef Ecosystems off the Coast of Southern Mexico." Jeffrey Sload tied for first place in the health science proposal category his work, "Elucidating Warfarin Pharmacogenomics in African Americans: A Genome-Wide Association Study on Warfarin Dose Response in a Cohort of African American Individuals." Brooke Davis won first place for her completed behavioral science project, "Use of Formant Values in Classifying Vocalizations of Beluga Whales (Delphinapterus leucas)," and Amanda Sommi took first place for her completed environmental science project, "The Effect of Rising Sea Level on the Elevation of Salt Marshes Throughout Long Island, NY."

Darien students Oscar Barbour, Leah Hotchkiss, Caroline Wetterauw, Grace Brandon, Mark Kaminski and Andrew Fletcher also earned awards for their science projects. Sacred Heart junior Lauren Wood also lives in Darien and was awarded a second place prize for her project.

State Rep. Tony Hwang, a Democrat who represents Fairfield and Trumbull, was a first time judge at the event. "The quality of each exhibit was impressive and the enthusiastic and energetic presentation by each young science/engineering scholar gave hope that our community and country will ably compete in the global marketplace into the future," Hwang said. "The tireless work of board members and volunteers made this event an incredible success. They are the true heroes in advocating science/engineering education for our kids."

Celebrity scientist Riskin delivered a speech called, "Should I Really Consider a Career in Science?" An internationally known evolutionary biologist, Riskin told the story of his own career path, how it led him to become an expert on bat locomotion and then a TV host. Among his many lessons, he urged the students to question what they see and what others have told them, and then to question themselves before drawing any conclusions. He said science is about following one's passion, and that it's an intellectual pursuit but "cool and awesome," too.

The science foundation is actively encouraging future participation by additional schools for the science fair competition, part of this effort being to subsidize participation by science teachers in a program on teaching science research at the high school level offered by the State University of New York.

The Sexauer Foundation is a major funding source of the fair and this year's prizes were sponsored by Laticrete International of Bethany. The fair is sponsored by the Southern Connecticut Science & Engineering Foundation.

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Darien High Schoolers fare well at science fair