Posts Tagged ‘companion diagnostics’



Could Orphan Drugs Turn Health Economics on its Ear?

November 21st, 2011
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When is $100,000 a year more expensive than $500,000 a year? The answer: when developing drugs to treat common diseases (e.g., cancer) rather than rare diseases. According to a new article in Forbes magazine, governments and insurers are willing to pay upwards of $200,000 and as much as $500,000 for new orphan drug treatments that attack rare diseases (usually caused by a single gene). Since people suffering from these diseases have a known genetic profile, these targeted treatments are far more effective than most cancer drugs, for which insurers will usually cover up to $100,000 per patient per year.

National Institutes of Health (NIH) Director Francis Collins is urging companies to find more treatments for rare diseases. Of the 7,000 diseases that affect humans worldwide, 6,000 are rare. Traditional drug discovery and development methods for mass populations won’t be effective against these diseases. But more targeted approaches, with specific biologics and companion diagnostics, could be. Read the rest of this entry »

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Through the Murky Slog: Part II—A New Light for Cancer Therapies?

November 9th, 2011
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Last week, we discussed new drug approvals that reflected a paradigm shift for cancer drug development and for treatment of people living with cancer. Finally, we are starting to see a matchup of specific diagnostics with targeted biotherapeutics to address (effectively, we hope) targeted treatments for smaller groups of cancer patients.

Just recently, the American Society for Clinical Oncology (ASCO) urged the use of new biological knowledge to develop treatments faster, design more targeted clinical trials, and use information technology to integrate once-separate translational and clinical research. ASCO even says that targeted therapies can improve clinical trial responses from 8 to 30 percent. Also, just recently, the FDA gave itself a pat on the back as it highlighted its recent innovative drug approvals, with targeted cancer therapies included among those on the list. Read the rest of this entry »

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Companion Diagnostics: More Targeted Medicine on the Horizon

September 12th, 2011
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It’s increasingly clear to anyone who deals with human health – from the bench biologist to the clinical oncologist – that humans are a heterogeneous species. As a result, a drug that works well in one individual may not work at all in another. Thus, the field of targeted (or personalized) medicine came about so doctors could optimize patient care through the use of genetic and biomarker testing. Such tests help identify patients who are (or who are not) most likely to respond to a given therapy. The field is often promoted as a way to get the “right drug to the right patient at the right dose.”

Correct dosing is critical because about 25 percent of all outpatient prescription drugs in the U.S. are taken by patients with genetic variations (specifically, polymorphisms) that affect absorption, metabolism or excretion of those drugs. Again, at risk of stating the obvious, human beings are heterogeneous. Read the rest of this entry »

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What FDA’s Proposed Drug Testing Guidelines May Mean for You

July 15th, 2011
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This week, the FDA issued draft guidance for in vitro companion diagnostics. After a day or so of reflecting about it, here’s what I think it may mean for you:

Overall, while the guidance itself may not be BIG news, it does seem to make good sense for business and to offer life science companies some flexibility. Whether you are a therapeutics company or a diagnostics company, you should see new opportunities as a result.

Following are the key points I took away from my review of the guidance:

  • The FDA acknowledges that not all co-development of diagnostic tests and therapeutic drugs can occur simultaneously. Thus, there is room for you to secure approval of a drug before the test is available and also to seek to modify the drug’s label as new diagnostics information emerges. There is also room for you to potentially market an as yet uncleared or unapproved test, if the marketing of the test is critical in the context of a drug. Read the rest of this entry »

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Marrying Targeted Therapies with Companion Diagnostics: The Novartis MDx Model

May 31st, 2011
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In late 2008, Novartis established its molecular diagnostics unit, to be known as Novartis Molecular Diagnostics (MDx) and to function as an integrated unit within the Novartis Pharmaceuticals Division.  Led by Michael J. Nohaile, Ph.D., Global Head of MDx, the unit is designed to leverage the global pharmaceutical company’s strengths and capabilities in research, development and commercialization to translate identified biomarkers into high-quality diagnostic tests. As Novartis explains via its global website: Novartis MDx strives to become a world leader in developing and commercializing diagnostic tests to optimize patient outcomes and to transform the practice of medicine.

Recently, I spoke to Novartis MDx Global Head of Diagnostics Development Michael C. Little, Ph.D., an old colleague of mine from Becton Dickinson and Company, and to Director of Business Development and Licensing Yves Dubaquie, Ph.D., who presented on behalf of Novartis MDx at the Personalized Medicines Partnerships Conference last month. Both gentleman arrived in their current Novartis MDx roles about two years ago and both have impressive industry experience. Read the rest of this entry »

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