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Moving Beyond The Whack-a-Mole Style of Cancer Treatment

September 26th, 2011
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In his latest Wall Street Journal column (“Drugs That Are as Smart as Our Diseases”), biologist/author Matt Ridley bemoans the plummeting efficiency of drug discovery in the pharmaceutical industry. He points to a disturbing paradox: while identifying and sequencing genes of pathogens and cancer cells has become much cheaper in a short period of time, the number of new drug candidates (based at least in part on our knowledge of those genes) has dropped. According to Ridley, new molecule approvals per billions of dollars of inflation-adjusted R&D amounts to no more than one percent of the number of approvals in 1950. And as we’re all aware, this decline in innovation is all the more dire because the pharmaceutical industry needs to replace so-called “blockbuster” drugs that are about to lose their patent protections if it is to continue to keep investors satisfied and fuel future innovation.
 
So, why hasn’t the same industry that gave us statins, Herceptin®, and vaccines come up with a new generation of treatments? The biggest problem might lie in its success. Researchers today confront an enormous—and growing—amount of genetic and biochemical information as the search continues for newer, more effective drugs.  As we generate more data, we are increasing our understanding of the complexity of biological processes underlying disease states.  While this better understanding can lead to innovation, it also has uncovered obstacles. For example, scientists have found that signaling pathways leading to cancers are replete with redundancy, shortcuts and other molecular detours that block the activity of cancer drugs. Sometimes, these pathways can help eliminate or prevent cancer; at other times they can exacerbate it.
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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.

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Negative Headlines, Scientific Vulnerability and the Future of Genetic Tests

July 19th, 2011
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Though the life sciences industry is making great progress with genetic tests and targeted therapies, a recent article in the New York Times (“How Bright Promise in Cancer Testing Fell Apart”) exposes disturbing and cautionary insights into the application of this technology. The article revealed that research on the application of complex genetic tests to match cancer patients to the best available therapy may not be as promising as it seems.
 
The article describes a situation that emerged just over a year ago that raised serious doubts about a test developed by researchers at Duke University. The test used gene expression signatures to characterize tumors and to identify those most likely to respond to different drugs.
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#BIO2011: After the Party is Over

June 30th, 2011
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For the thousands of  life science industry representatives who attend the Biotechnology Industry Organization Annual Convention each year, the last few days have been similar to a favorite holiday: exciting, long-awaited, and too quickly over. As we wrap up our #BIO2011 experience and say good-bye to Washington, DC, I took a few moments to look back on many inspiring networking and learning opportunities only available at this kind of international event.
 
Within the span of a few days, my colleague Caroline Popper and I have been able to meet with clients, colleagues and new contacts from states such as Michigan, California, Texas, and Massachusetts.  Furthermore, a large exhibit hall showcasing different regions of the world’s biotech industry has been an extraordinary venue to network with international visitors. I traveled to DC from my office in Toronto, and was able to meet with life science representatives from Australia, New Zealand, Spain, and Italy, sharing with them ideas and guidance for how to establish a presence in North America.
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Biodegradable Nanostructures – A Novel Means of Combating Antibiotic Resistance

May 10th, 2011
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Antibiotic resistance: Two words that strike fear in physicians, hospital workers, and patients and which increasingly grab the attention of media outlets throughout the world.
 
Nanotechnology, the branch of engineering that deals with things smaller than 100 nanometers (especially with the manipulation of individual molecules), continues to make inroads in various areas of medicine and life sciences. Over the past several years we have seen advances in nanomaterials that provide the basis for diagnostic tests, improved vehicles for drug delivery, and novel therapeutics. Among those advances, applications related to the development of novel drugs are especially interesting, particularly where hope in the fight against highly drug-resistant bacteria may be offered.  The ability to carefully engineer nanomaterials to specifically interact with biomolecules suggests that further developments in the therapeutic use of nanomaterials are likely to emerge. Engineered nanomaterials that have ideal drug properties – namely, high selectivity (an ability to hit very specific molecular targets), well understood mechanisms of action that provide high efficacy, and limited side effects – are now on the horizon. So the potential for nanomaterials to replace existing biologics, including monoclonal antibodies and recombinant proteins, is a possibility.
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Benlysta: Long & Winding Road to Genomics’ Payoff

March 16th, 2011
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On March 9, 2011, the U.S. Food & Drug Administration approved Benlysta® (benlimumab) for the treatment of systemic lupus erythematosus. Benlysta is the first new drug approved for the treatment of lupus in more than 50 years: a triumph of genomic medicine. The drug was born of a partnership, dating back some 18 years, between biotech Human Genome Sciences and multinational pharma GSK. The Benlysta story is an interesting example of how molecular biology and genomic technologies can be applied to create new treatments for challenging diseases, even though the timeline extended well beyond what was anticipated by the lofty projections made in the earliest days of genomic medicine some 20 years ago.
 
Benlysta is a monoclonal antibody that was developed by HGS and GSK from antibodies that were provided by Cambridge Antibody Technology (which was acquired by AstraZeneca and is now part of AZ’s biologics arm, MedImmune). It acts against B-lymphocyte stimulator (BLyS), which is believed to increase the production of white cells that attack healthy tissue in lupus patients.
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After the Conference Ends: Thoughts Following Tri-Con 2011

March 3rd, 2011
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Now that the Molecular Med Tri-Con 2011 has ended and attendees are back at their offices, labs, practices, and/or hospitals – or perhaps have landed at their next business meeting or conference destination – it’s a good time to reflect on some of my general observations from the event.
 
The conference covered so much information that it would be impossible to review every topic. Following are a few areas that captured my attention and remain in my thoughts:

     

  • STEM CELLS – There was a lot of focus on induced pluripotent stem cells (iPSC), in particular how to better characterize and understand those cells. Pluripotent stem cells can differentiate, or change, to become any one of the many types of cells that make up an organism. These cells are already being used for applications such as drug testing and drug screening. Once they are induced to re-differentiate, iPSC can provide good models for disease: what some conference speakers referred to as a “disease in a dish.” Some discussion among presenters focused on the idea of isolating cells from patients, producing iPSC, and then reintroducing the produced cells into the patient to replace cells that have been damaged or lost as a result of disease – an elegant form of cell-based therapy. Although widespread use of this approach is likely a ways off, I’m both optimistic of the therapeutic potential and somewhat cautious because of regulatory hurdles and potential safety issues (including some data showing tumor production in animals). Read the rest of this entry »

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TRI-CON – Diagnostics, Drug Discovery & Biologics: Oh My!

February 21st, 2011
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Sometimes, between the hotel room, the lectures, the networking, the power lunches and the data consumption at a conference, you’re on the plane home before you have time to reflect upon why you attended in the first place. I’m excited to be heading to the 18th International Molecular Medicine Tri-Conference in San Francisco this week—and I’m setting out my reasons for going this year beforehand.
 
I always look forward to this conference because of its balanced range of life science topics, including those with technical, scientific, business, strategy, regulatory and reimbursement slants. Within this balanced range of topics, the Tri-Con uses a channel structure to help attendees “tune in” where they can get the biggest bang for their buck. I’m excited to learn more about the following specifics within each channel: Read the rest of this entry »

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DNA Sequencing – Now It’s Getting (Even More) Personal!

January 31st, 2011
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“We said that once we had finished sequencing the genome we would make it available to the scientific community for free. …And we will be doing that on Monday morning at 10am.” – J. Craig Venter, February, 2001
 
It’s been ten years since the famous unveiling of the first human genome sequence. Since then, we’ve developed the ability to sequence large numbers of individual human genomes thanks to rapidly changing technology that translates into ever lower costs per genome and higher throughput sequencing capabilities. The $10,000 genome has arrived – even sooner than anticipated – and now the challenge is to figure out what to do with all of the information that is starting to accumulate.
 
The past year has seen a number of key developments and there are no signs that things will slow down over the coming months:
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Synthetic Biology: Onward and Upward

December 17th, 2010
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A recent article in The New York Times sheds light on concerns about synthetic biology, a field thus christened as the result of advances in DNA synthesis, bioinformatics, and protein engineering. In the article, journalist Andrew Pollack reports that President Obama’s bioethics commission found no need to temporarily halt research or impose new regulations on synthetic biology.
 
Synthetic biology – a new area of biological research that combines science and engineering in order to design and build novel biological functions and systems – has already been subject to much controversy and hype. Nevertheless, it is an area that holds great long-term promise for the creation of many novel human healthcare products: It is the ultimate realization of genetic engineering.
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