Journal of Commercial Biotechnology Vol 18, Issue 3 (2012)
Could personalized medicine be the driver for widespread price controls?
Yali Friedman
Everyone should agree that the benefits of personalized medicine — prescription of drugs most likely to benefit and least likely to harm individual or groups of patients — are are positive. However, one must consider the potential practical challenges of increased implementation of personalized medicine, if the current healthcare delivery system is compatible with personalized medicine, and what regulatory/policy changes may be needed to accomodate personalized medicine…
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Innovating in the New Austerity
G. Steven Burrill
We are in the midst of dramatic changes in the way life sciences companies are funded. The model of funding a company with venture capital leading to an IPO is now the exception rather than the rule for life sciences companies. Venture investors are no longer willing or able to fund companies with an indefinite exit…
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Innovative biotechnology industry strategies in the U.S.’ rapidly evolving payer environment
Sarah Stanton Collins, Will Collins
In 2010 healthcare represented 17.9% of GDP; its cost is growing significantly faster (~5%) than economic growth (~ 2%). This growth presents a challenge to all payers, whether they are governments, employers, or individuals. Within healthcare, one of the most rapidly growing areas is “specialty drugs” which are frequently biotechnology agents, or drugs for cancer or orphan conditions…
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Biotechnology in Argentina: Development and Resources
Claudia Zylberberg, Asli Ceylan Oner, Ezequiel Zylberberg
Biotechnology related developments in Argentina have gained momentum in the past few years. The creation of the Ministry of Science, Technology and Innovative Production in 2007 that focuses on high-tech growth in technology related fields including biotechnology, demonstrates the public sector commitment to a field with a thriving business sector and promising improvements in research and development…
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Creating systemic oral transmucosal drug delivery strategies: Case study of APL-130277
Anthony Giovinazzo, Nathan Bryson, Timothy Tankosic
This article addresses the strategic application of systemic oral transmucosal* (i.e., sublingual and buccal) drug delivery. Circumvention of first-pass hepatic metabolism in the gut, rapid onset of action, easy access via the oral cavity, easy administration for patients with dysphagia and a high level of patient acceptance are the principal advantages of the oral transmucosal route…
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What do hospital labs really need to streamline diagnostic testing: Apple vs. Microsoft environment?
Doug Millar, John Melki
Molecular diagnostic (MDx) tests are now commonplace in virtually every hospital and pathology laboratory, however many questions have arisen, such as “What do diagnostic laboratories require from the MDx revolution in order to better improve patient care?” and “Is a fully integrated ‘black-box’ device the answer to simple rapid diagnostic testing or do mainstream laboratories require more in terms of available testing menu and streamlined workflow?” With more and more ‘black-box’ devices available on the market, laboratories need to first decide if they need to make such an investment, and if so, in which to make the most appropriate investment, whilst also considering the cost of consumables…
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A general model for training the next generation of Biotechnology entrepreneurs based on recent experience of USA-UK-South Africa collaborations
Karl J. Kunert, Blessed Okole, Barend J. Vorster, Nicholas J. Brewin, Christopher A. Cullis
Preparing students for future entrepreneurial activity in the biotechnology industry is an important issue in many parts of the world because most countries seek to reap the benefits of investments in university-based teaching and research through the development of a knowledge-based economy driven by a highly skilled work force…
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Biomarketing strategy and tactics 101 PART II of III
Dimitris Dogramatzis
The American Marketing Association defines marketing as the activity, set of institutions, and processes for creating, communicating, delivering, and exchanging offerings that have value for customers, clients, partners, and society at large. According to the Pharmaceutical Research and Manufacturers of America appropriate marketing of medicines ensures that patients have access to the products they need and that the products are used correctly for maximum patient benefit…
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Disaster Planning for Biotechnology Companies
Frank Goudsmit
An earthquake in Japan cuts off the supply of key equipment and/or pharmaceutical ingredients to a biotechnology company with facilities in the U.S. High winds and flooding from a hurricane along the East coast—home to a notable number of biotechnology facilities—causes catastrophic property damage…
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Are laboratory notebooks necessary in a first inventor to file world?
Deborah L. Lu, Thomas Kowalski, Smitha Uthaman
The importance of laboratory notebooks was long touted in the US to prove a date of invention. With the dawning of a first-to-file era in the US, the importance of laboratory notebooks has been questioned. A perspective on the importance of laboratory notebooks is provided as well as an answer to the question whether laboratory notebooks are necessary in a first-to-file regime…
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Mayo “nays”: The Supreme Court says no to patenting laws of nature
Jennifer A. Camacho
On March 20, 2012, the U.S. Supreme Court handed down its decision in Mayo Collaborative Services, et al v. Prometheus Laboratories, Inc (“Mayo”) and ended an eight-year legal battle over patents covering processes for determining patient-specific dosing for a thiopurine drug to treat autoimmune diseases…
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EU Legal & Regulatory Update
Ewan Grist
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Drug discovery & Development Landscape: New Trends in Academia-Industry Partnerships
Vasu Pestonjamasp
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