Archive for May, 2011



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.
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Investors May Back a Revolution, but It Takes the People to Start One

May 19th, 2011
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A recent article posted by Luke Timmerman of Xconomy.com paints a bleak picture for the state of biotech investment. He explains that the general public no longer views biotech as worthy of the almighty buzz factor, i.e., the magazine cover stories and TV morning shows so important to the elusive independent investor. He suggests that the biotechnology industry may never capture the public’s imagination again, a strong assertion considering the amazing things happening in genomic research, companion diagnostics, medical technology, telemedicine and other parts of the sector. But is the buzz factor the only thing that matters in an age of consumer empowerment? What about the equally powerful phenomenon of simply going viral?
 
In some ways Mr. Timmerman’s article, in which he speaks of investor excitement for TECHnology versus BIOTECHnology, may not present a fair comparison. Facebook and LinkedIn do not have an entity like the Food & Drug Administration (FDA) that sends years of data to the trashcan more frequently than it approves a product for use. Nor do many technologies reckon with the complex reimbursement issues faced by products utilized within the healthcare system.
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Leveraging a Multi-Coastal Point of View of Life Sciences

May 17th, 2011
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Having a pulse on global trends in the biopharmaceutical industry requires a wide range of insights from experience in pharmacological research and technology development through to the core operations of large-scale and startup life science businesses. With this in mind, I’m pleased to welcome Dr. Andreas Muehler as our second strategic advisor. Dr. Muehler’s experience with preclinical and clinical development, major product launches, licensing, business development, and marketing provide him with a unique combination of technical and business perspectives.
 
In the United States, Dr. Muehler developed and managed multiple startup medical device and medical technology companies. Among them were 3TP LLC d/b/a CAD Sciences (White Plains, NY), a medical software company that was sold to iCAD Medical in 2008. Dr. Muehler was also President & CEO of MicroMRI Inc (Langhorne, PA), a medical device company that received FDA clearance for both hardware and software components during his tenure. Dr. Muehler has also been managing director of a German healthcare private equity fund, Palladius Healthcare GmbH in Munich, which acquired distressed medical device companies. Read the rest of Dr. Muehler’s impressive bio here.
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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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Introducing Our First Strategic Advisor: Dr. F. John Mills

May 4th, 2011
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Today’s post is an exciting one for me as I introduce our new strategic advisor, Dr. F. John Mills. With an extensive background that includes more than 25 years at the board and executive levels of major international corporations, Dr. Mills adds profound insights to our expanding operations and provides a new resource of vital information for our clients.
 
It’s difficult to encapsulate his entire career in a few short paragraphs and I encourage you to review his bio in the About section of our website. In brief, Dr. Mills served for three years as corporate senior vice president and president of clinical support services for Covance, Inc., where he was responsible for a $300 million per year clinical services division that employed more than 2,000 staff members globally. Prior to that, he was based in the United Kingdom as corporate vice president for Covance’s European clinical division. Earlier in his career, Dr. Mills held senior positions in Asia and Europe with Janssen Pharmaceutica, a division of Johnson & Johnson, Inc. His expertise includes extensive knowledge of clinical research outsourcing, pharmaceutical development, and global business management. Read the rest of this entry »

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