Journal of Commercial Biotechnology Vol 18, Issue 1 (2012)

Exciting changes

Yali Friedman — Sun, 01 Jan 2012 00:00:00 -0500

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Bacterial proteins: A new class of cancer therapeutics

Ananda Mohan Chakrabarty — Sun, 01 Jan 2012 00:00:00 -0500

Cancer is a complex disease with a network of multiple metabolic pathways that are interlinked to promote growth and resist immune surveillance. Such a network is efficiently maintained through acquisition of multiple mutations in the human genome that result in the escape from normal cellular growth regulation and formation of lumps of fast growing cells known as tumors. The varied pathways through which cancer cells grow and inhibit their own cell death have made it difficult to develop effective drugs either to prevent the emergence of tumors or to check their rapid growth. Current anticancer drugs are either small molecules or monoclonal antibodies that target and inhibit a key important step in cancer progression pathway, thereby significantly inhibiting their proliferation. No effective drug or vaccine exists to prevent cancer initiation and drug resistance and toxicity are major problems in cancer chemotherapy. This article describes recent attempts to develop bacterial proteins that are used as weapons by certain pathogenic bacteria with long term residence in human bodies to prevent invasion of their habitat by invaders such as cancers, viruses or parasites. In one instance, such a protein, termed azurin, has been shown not only to have entry specificity in cancer cells and prevent cancer cell growth by interfering in multiple pathways by which cancer cells grow, but also to prevent induction of pre-cancerous lesion formation triggered by a potent carcinogen. A 28 amino acid peptide derived from azurin, p28, also shows similar anticancer and cancer preventive activity. In phase I human clinical trials, chemically-synthesized p28 has shown very little toxicity but significant beneficial effects, including partial and sometimes complete regression of metastatic refractory solid tumors in 15 advanced stage (stage IV) cancer patients where no conventional drugs were working. A second such protein, termed ATP-01, very different from azurin and obtained from a different bacterium, has shown similar anticancer and anti-HIV/AIDS activity and a 30 amino acid peptide derived from it has anticancer activity similar to p28. It would be of great interest to test these two proteins, should they prove to be non-toxic and non-immunogenic in humans, and the peptides derived from them, for their efficacy in cancer therapy and prevention. Such efficacies can be tested, singly or in combination, in vulnerable people such as people with predisposition to cancer (women with BRCA1/2 mutations, for example) or in HIV/AIDS patients with Kaposi’s sarcoma or other forms of cancer.

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Industrial biotechnology – Markets and industry structure

Gunter Festel, Christian Detzel, Ruth Maas — Sun, 01 Jan 2012 00:00:00 -0500

An increasing number of chemicals and materials, like base chemicals and polymers, as well as high value products, such as consumer chemicals and specialty chemicals, are produced using biotechnology in one or more of the process steps. In 2010, the sale volume of biotechnology products was around 92 billion Euro worldwide. Sales are estimated to increase to around 228 billion Euro in 2015 and to around 515 billion Euro in 2020. On a sector level, the largest market potential lies in the production of biopolymers and active pharmaceutical ingredients. As a rule, commercial development is mainly driven by multinational enterprises, whereas small and medium enterprises contribute primarily to the technological development. Especially the latter group faces several challenges during their development. These mainly concern business models and growth strategies as well as financing strategies and resources. Investors have not yet fully identified the area of industrial biotechnology as an attractive investment field but they could become a major capital source as they start to understand more the potential of industrial biotechnology. Full details at the Journal of Commercial Biotechnology

Options to change Medicare payment for outpatient prescription drugs and biotechnology products

Thomas Barker, Maia Larsson — Sun, 01 Jan 2012 00:00:00 -0500

The debates over the Obama Administration’s health care reform law, and, more recently, the federal budget deficit and national debt have focused attention on the growth in costs of the Medicare program. Three approaches to reducing Medicare expenditures command the most attention. Under the first, changes to the Medicare delivery system – such as accountable care organizations (ACOs) and medical homes – are believed to have the potential to reduce the growth in costs in the program over time. Under the second, tinkering with the reimbursement formulae in the Medicare program – pejoratively, government “price fixing” – will reduce the price that Medicare pays for an item or service, thereby reducing the growth in costs. A third approach – converting Medicare to a premium support or defined contribution model – has been passed by the House of Representatives, but has failed in the United States Senate.

This article addresses the effect of these various approaches on Medicare payment for outpatient prescription drugs and biotechnology products. It begins by analyzing the Administration’s ACO regulation and the effect that this regulation may have on reimbursement for outpatient prescription drugs and biotechnology products. It then addresses legislative proposals to alter the Medicare reimbursement formulae for these products. It concludes by speculating on how the Medicare reform legislation passed by the House of Representatives might affect reimbursement for outpatient prescription drugs and biotechnology products.

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The emergence of bio-clusters in Egypt and South Africa

Ramazan Uctu, Nirvana Shanalee Pillay — Sun, 01 Jan 2012 00:00:00 -0500

There is a wide body of literature on biotechnology clusters. However, most of the works has been focused on the description of the clusters as well as the development of biotechnology clusters in USA, Europe and other developed countries. Much less attention has been paid to the development of biotechnology clusters in developing countries. The aim of this paper is to gain a better understanding of the emergence of biotechnology clusters in Egypt and South Africa.

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Patent litigation in India and interim injunctions — An evolving jurisprudence

Rajashree Sharma, Dinesh Kumar Sharma — Sun, 01 Jan 2012 00:00:00 -0500

This paper attempts to summarize and analyze the judicial trend towards granting or denying interim injunctive relief in patent litigation arena. Full details at the Journal of Commercial Biotechnology

Digital health investment opportunities abound, but standouts deliver disruptive change

G. Steven Burrill — Sun, 01 Jan 2012 00:00:00 -0500

The convergence of ubiquitous smartphones, wireless Internet, and low-cost monitoring devices, is driving the emergence of a new world of digital health. At the same time, cost pressures on healthcare are creating demand for new ways to not just improve the way patients receive information and care and the way doctors provide it, but fundamentally change the way they interact with each other. The article discusses a venture capitalist's approach to investing in the sector.

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Strategies for collaboration agreements focusing on innovation

Pamela Cox — Sun, 01 Jan 2012 00:00:00 -0500

Collaborations focusing on innovation are often born with the conception of a technology, typically as a result of one side’s research effort. Collaborations for innovation can also be made through a deliberate process of identifying strategic synergies that should, with appropriate incentives, lead to jointly created technology in the selected area of interest.
The predominant factors motivating the parties to collaborate will heavily influence the agreement structure selected to support the collaboration. If a specific technology was “born” prior to the collaboration, the parties will most likely memorialize their collaboration in an agreement specific to the joint development and commercialization for that technology. In contrast, when the parties are entering the collaboration to stimulate innovation, the agreement is often structured as a master agreement.
Regardless of the agreement structure, there are two keys to a successful collaboration for innovation: (1) effective communication; and (2) balancing incentives. Full details at the Journal of Commercial Biotechnology

Biomarketing strategy and tactics 101 PART I of III

Dimitris Dogramatzis — Sun, 01 Jan 2012 00:00:00 -0500

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.¹ 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.² The most important promotional tools for biopharmaceutical firms are 1) personal selling, 2) advertising, 3) public relations and publicity, and 4) web promotion. Part I of this three-part article focuses on the nature of the biopharmaceutical marketing’s four P’s, the importance of marketing strategy, the conduct of environmental analysis, and maket segmentation. Part II delves into the processes of targeting and positioning, marketing planning, as well as biopharmaceutical branding. Part III completes the series by focusing on the push and pull promotional strategies, advertising, selling, and biopharmaceutical web and social marketing.

biopharmaceutical, marketing, targeting, positioning, branding, advertising

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The University of Colorado Certificate Program in Bioinnovation and Entrepreneurship: An interdisciplinary, cross-campus model

Madhavan Parthasarathy, David Forlani, Arlen Meyers — Sun, 01 Jan 2012 00:00:00 -0500

In keeping with an emerging literature on the role of business education in the development of entrepreneurially-intentioned biotechnologists, this paper describes the actions and experiences of an entrepreneurship program that began in the late 1990’s. Along the way it illustrates how a business-centric approach can shift the budding entrepreneur’s perspective from a product to a market orientation when considering an innovation’s commercialization. While the developmental timeline and specific stages of the adoption process for biotechnology-based products vary from traditional consumer or industrial products, there many similarities, foremost is the notion that to be successful the market must perceive significant advantage to the new offering. Lastly, this paper provides thoughts on potentially profitable areas for program expansion and new foci, especially regarding the globalization of biotechnology innovation and international opportunities.

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EU Legal & Regulatory Update

Ewan Grist — Sun, 01 Jan 2012 00:00:00 -0500

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Post-Grant Review: The Good, the Bad and the Ugly for Biotechnology Companies

Smitha Uthaman, Deborah Lu, Thomas Kowalski — Sun, 01 Jan 2012 00:00:00 -0500

This paper summarizes the Post-Grant Review process, one of the many interesting aspects of patent reform brought about by the enactment of the America Invents Act, and the effect it may have on how Biotechnology companies conduct business and manage their intellectual property. Full details at the Journal of Commercial Biotechnology

Book Review: Constructing and Deconstructing Patents by Irah H. Donner

David B. Orange — Sun, 01 Jan 2012 00:00:00 -0500

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Book Review: Plunkett's Biotech & Genetics Industry Almanac 2012

Barry J. Marenberg — Sun, 01 Jan 2012 00:00:00 -0500

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