GUEST EDITORIAL
	The Massachusetts Clean Energy Agenda: Creating Jobs & Powering The New Economy Nick D'Arbeloff
	FEATURES
	Joint Ventures and Collaborations: Best Practices and Red Flags David J. Dykeman and Catherine A. Ferrigno
	Mergers & Aquisitions (M&A): Accounting Changes on the Horizon Richard Ramko
	The Negotiation of a Series A Preferred Stock Term Sheet: Building for Success Peter B. Finn and Marc Goldberg
	Standardizing the Decision Process to Personalize a Therapy with a Theranostic: The Options for Test Index (OFTi) Mollie Roth, Dave Smart and Patrick Considine
	Biotechnology Business and Revenue Models Stephen M. Sammut
	FDA and the Critical Path to 21st Century Medicine Peter J. Pitts
	The Case For Personalized Medicine Personalized Medicine Coalition
	Lucky Orphans: Adoption as a Strategic Option Syamala Ariyanchira
	The Genetic Disease Burden and the Molecular Diagnostic Industry in India Arvind Rup Singh, Jai Rup Singh, and Vanita Vanita
	RECENT DEVELOPMENTS
	Science and Safety Bryan A. Liang
	Abigail Alliance Legal Battle Comes to an End Cameron Rhudy
	Over-The-Counter Adverse Drug Event Reporting Pamela Willis
	Lyrica Approved: The First Drug to Treat Fibromyalgia Kale Heiman
	MRSA in the Gay and MSM Communities: An Emerging Health Threat Matthew Izu
	Beating Heart Created In the Laboratory Kathleen Sweeney
	Government Health Officials Began Cracking Down On Internet Sales of Custom-mixed Hormones for Menopausal Women Nicole Wells
	BIOCOLUMNS
	Tech Transfer/The Secret Engine Behind Israel's Innovations Nava Swersky Sofer
	International/How Multinational Corporations Can Benefit from Israel's Innovation in R&D: New Initiatives Open to Foreign Investors and Strategic Partners Robin JR Blatt
	Stem Cells/ Stem Cells and Cancer Brock C. Reeve
	BioWorkforce/Overseeing Innovation: The Role of the Corporate Science and Technology Committee Paul Earle and Tom Robinson

Abstract: The new energy economy is coming whether we like it or not. In the next 50 years our economy will almost certainly be powered by something other than fossil fuels. This article highlights the Massachusetts Clean Energy Agenda and discusses its role in economic development. 2 pages

©2008 by The Journal of BioLaw & Business. All Rights Reserved.

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Abstract: Joint ventures and collaborations are driving innovation in life sciences. The growing trend in life sciences is for large established companies to collaborate with early stage companies to develop a new product or drug. Similar to the honeymoon stage of a marriage, parties enter into collaborative relationships trusting each other with confidential information and pooling patent rights they had prior to the partnership. Unfortunately, collaborative relationships often end unexpectedly in divorce, leaving the parties in a vulnerable position unless they protected their rights beforehand through a written agreement, akin to a pre-nuptial agreement. When teaming up, parties should execute a written collaboration agreement to ensure the parties have protected their rights and the parties are clear on the details of their relationship. 5 pages

©2008 by The Journal of BioLaw & Business. All Rights Reserved.

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Abstract: In late 2007, the US Financial Accounting Standards Board issued Statement No. 141(R), Business Combinations, which will be effective for most companies in 2009. Statement 141(R) represents a significant change from current practice and will cause biotech companies to reconsider the way business combinations are structured. For instance, items that have historically been immediately expensed, such as in-process research and development, will now be capitalized, and costs that have been capitalized, such as acquisition-related costs, will now be expensed as incurred. In addition, entities that previously did not qualify for business combinations accounting, such as development stage companies, may now be treated as such under certain circumstances. These changes are likely to have a significant effect on an acquirer's future earnings volatility, financial metrics, and possibly debt covenants. This article discusses these changes and provides insights for companies thinking about entering into business combinations. 5 pages

©2008 by The Journal of BioLaw & Business. All Rights Reserved.

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Abstract: This article examines, from a company and investor perspective, the principal sections of a standard Series A term sheet where most of the economic and control conflicts exist, with proposed solutions and a view towards advocating a balanced approach. 6 pages

©2008 by The Journal of BioLaw & Business. All Rights Reserved.

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Abstract: While the top pharmaceutical companies have all made investments at an R&D stage in biomarkers and genetics to aid drug selection and clinical trials, only a few have taken targeted therapies all the way through the development pathway and onto the market. A key question for those companies who have not yet acquired this level of experience is, "What exactly are the decision processes essential to guide early commercial commitment, i.e. the commitment to market a therapy alongside a theranostic, in Personalized Medicine?" Although not all "personalized medicines" may require diagnostics, most targeted therapies are likely to depend upon new or existing diagnostic testing methods to determine their appropriateness in terms of prescribing and/or dosing decisions. To address this overall issue, we have used a Case Based Reasoning ("CBR") methodology to help define and build the Options for Testing Index ("OFTi") to learn from and improve upon the 7-8 year experience of the first movers and new entrants into the PM market. 8 pages

©2008 by The Journal of BioLaw & Business. All Rights Reserved.

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Abstract: This article provides an overview of accounting of the macro conditions in the biotechnology and pharmaceutical industry and identify the factors that drive change in business and revenue models. 3 pages

©2008 by The Journal of BioLaw & Business. All Rights Reserved.

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Abstract: One of the most pressing issues that confronts the FDA is learning how to better address and assist in medical product development. FDA needs to prepare today so the agency can efficiently evaluate the technologies of tomorrow. Clearly this is an area that impacts not only health care consumers, but also our economies and financial markets. If the FDA can be a more aggressive part of the solution, they can help not only ease some of the pressures that are driving up healthcare costs, but also help all of us to maximize the value of medical innovations. This article highlights key issues associated with the FDA's Critical Path Initiative. 4 pages

©2008 by The Journal of BioLaw & Business. All Rights Reserved.

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Abstract: By using molecular analysis to achieve optimum medical outcomes in the management of a patient's disease or disease predisposition, personalized medicine promises to introduce a new standard of healthcare. The molecular methods that make personalized medicine possible include testing for variations in genes, gene expression, proteins, and metabolites, as well as new treatments that target molecular mechanisms. Test results are correlated with clinical factors - such as disease state, prediction of future disease states, drug response, and treatment prognosis - to help physicians individualize treatment for each patient. This article highlights developments in this emerging sector. 6 pages

©2008 by The Journal of BioLaw & Business. All Rights Reserved.

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Abstract: Orphan drugs market is estimated to be around $59 billion in 2006 and is growing at a CAGR of 7%. The changing outlook of the pharmaceutical industry towards orphan drugs is a key factor driving this growth. Big pharma is finally acknowledging the potential of the favorable regulatory environment offered by the Orphan Drugs Act (ODA) and is getting ready to take advantage of the opportunity. Currently, big pharma account for over 60% of the orphan drugs market, the development of which was championed by the biotech companies. The fact that big pharma companies currently form the top 5 companies with highest numbers of orphan designations and orphan drug approvals also indicates their emerging interest in the sector. This article analyses the main factors responsible for this new trend and the strategies adopted by multinational pharma giants to have successful orphan drug development programs. 3 pages

©2008 by The Journal of BioLaw & Business. All Rights Reserved.

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Abstract: India with its diverse ethnic gene pool, and its ever increasing quantity and quality of available clinical data has the potential to become a world's "gold mine" in functional genomics. However, collaborative action is needed between healthcare personnel, academicians, physicians, researchers and the pharmaceutical companies, to fully utilize this potential for genetic diagnostics. It is necessary to have these public-private-partnerships (ppp) among various partners so that the impact assessment of the new type of diseases can be anticipated and suitable preventive measures taken to tackle various genetic and multifactorial factors. Further, prevention of genetic diseases has to be achieved through research and diagnostics and the development of new breed of vaccines and pharmaceuticals will certainly play a crucial role. There is an urgent need for developing and producing cost effective treatment regimens for the genetic disorder through advances in gene therapy, development of gene chips, stem cell research and nano-biotechnology. The recent advances in biotechnology and bioinformatics have shifted the focus of pharmaceutical companies from the trial and error process of drug discovery to a rational structure based drug design. The growing understanding of molecular basis of cancer and other chronic diseases is opening up new vistas and possibilities of molecular diagnostic testing. The completion of human genome project signaled a paradigm shift for the pharmaceutical industry towards molecular diagnosis of the diseases and for designing molecular medicines with the help of "targeted biomarkers" during clinical trials. Taken together, these latest developments will provide tremendous opportunities as well as shift the treatment modalities options from "post-symptomatic" to "preventive/palliative." 5 pages

©2008 by The Journal of BioLaw & Business. All Rights Reserved.

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Abstract: No Abstract 2 pages

©2008 by The Journal of BioLaw & Business. All Rights Reserved.

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Abstract: The United States Supreme Court declined to hear arguments involving the question of whether terminally ill patients have a constitutional right to experimental drugs that have not been approved by the Food and Drug Administration (FDA). Current FDA policy prohibits drug makers from selling unapproved drugs to a patient. 2 pages

©2008 by The Journal of BioLaw & Business. All Rights Reserved.

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Over-The-Counter Adverse Drug Event Reporting

Pamela Willis