| Volume 9, Number 3 (2006)
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| ABSTRACTS |
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| Volume Index |
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Feature
5 pages
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Global Perspectives on the Life Sciences Industry
Frank Goudsmit, Christine Fernandez, Li Shan Yeo, Chris Tait, Travis McIntosh and Javier Garcia
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Abstract:
By the mid-1990s, the United States could claim that it was home to nearly two-thirds of the biotechnology companies in the world. But that's changed dramatically in the past 10 years with the industry's robust global growth.
This article highlights the latest trends and developments in litigation, regulation, risk management and insurance that are affecting biotech companies world-wide; in addition, it observations about the insurance needs of biotechnology companies in the United States, Canada, Europe, Australia, Asia and Latin America.
©2006
by The Journal of BioLaw & Business. All Rights Reserved.
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(4 pages)
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Boosting Biomedical Research and Biomanufacturing in Singapore
Steve K.W. Oh and Miranda G.S. Yap
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Abstract:
Singapore has embarked on a long term, determined and detailed plan to build a biomedical research hub and to attract a biomanufacturing industry to its shores. The Agency for Science, Technology and Research (A*STAR) has already invested S$500 million to establish a strong biomedical research and development presence at the Biopolis. Recognizing that research talent is a vital component, A*STAR has awarded numerous scholarships to train Singaporean graduates at prestigious universities and biologics companies around the world, who upon their return are populating the Biopolis. The Bioprocessing Technology Institute (BTI) is one of these research institutes at Biopolis, which currently has over 100 staff carrying out research in the areas of Expression Engineering, Animal Cell Technology, Stem Cells, and Microbial Fermentation with strong support from Analytics, Proteomics, and Microarray platforms. These cross disciplinary capabilities are brought together to tackle important issues related to industrial production of biotherapeutics from microbes, animal cells and cell expansion technologies for regenerative medicine. As a result of these investments, two new companies have recently established operations in Singapore. A-BIO, a contract manufacturing organization, has major contracts with multi-nationals to produce clinical Phase I and II biologics. In February 2006, Lonza Biologics, a major chemical and biotechnology company, also broke ground on their US$250 million biopharmaceutical plant. With a pro-active policy of investments in people and infrastructure, and initial commercialization success, the future looks bright for boosting biomedical research and biomanufacturing in Singapore.
©2006
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Ethical Questions To Ponder in the European Stem Cell Patent Debate
Duncan Curley and Andrew Sharples
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Abstract:
Patents may be refused in Europe on ethical grounds. Whereas in the past this issue has arisen only infrequently, recent developments in human embryonic stem cell research have given rise to conflicting opinions in Europe as to the approach that should be adopted in relation to patents. The United Kingdom Patent Office has adopted a positive policy towards inventions involving human embryonic stem cells, but the European Patent Office has to date refused to grant patent applications involving similar subject-matter. A series of legal questions on the role of ethics in granting European patents is now to be considered for clarification by the European Patent Office. The answers to these questions should eventually resolve the debate on the patenting of human embryonic stem cells throughout Europe.
©2006
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(4 pages)
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Human Papilloma Virus Vaccine: Addressing Policy Issues to Fulfill Social Potential
Meghan D. Morris and Bryan A. Liang
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Abstract:
The human papilloma virus causes significant morbidity and mortality around the world as a known precursor of cervical cancer. However, advances in formulation of an effective vaccine against its precancerous forms is on the horizon, providing great hope for potentially ending the social and financial costs associated with this disease. However, because of the sensitive nature of the transmission of the disease, policies advancing the use of these vaccines must take into account social and political concerns. Only through addressing these issues directly will the potential of these vaccines to improve public health be fulfilled.
©2006
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Special Segment:India
(5 pages)
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India's Life Sciences Sector: Leading the Way for Science & Society
Kulvinder Singh Saini & Kedar Purnapatre
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Abstract:
In terms of future growth potential, only the Indian Biotech (BT) industry could rival its "rich cousin" from the Information Technology (IT) sector. However, BT is a highly regulated and patent protected industry with a much longer gestation period. How can academia-government-industry partnerships help in overcoming some of these hurdles faced by BT? One possible route could be through the establishment of a critical mass with respect to R&D, manufacturing and commercialization via the development of incubators, clusters and networks. A team effort and niche positioning by the Indian Biotech will be required to make differentiation on the competitive world stage. With low capital and operational costs for bio-manufacturing, along with a highly skilled and competitive human resource power, Indian BT could certainly be the next big thing after IT. How bio-pharmaceutical industry is helping to turn this dream into reality along with the challenges that lie ahead will be discussed.
©2006
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Special Segment:India
(3 pages)
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Audits of Clinical Trials in India: A Step in the Right Direction
Viveka Roychowdhury
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Abstract:
Random audits of clinical trial sites in India are due to start any time now. These regulatory measures come at a very crucial time when India's relatively young clinical research industry is poised for exponential growth. Can the industry scale up fast enough? Viveka Roychowdhury spoke to a cross section of industry experts to get their views.
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Special Segment:India
(1 page)
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Clinical Trials and Regulatory Affairs in India
An Interview with Ashwini Kumar, Drug Controller General of India
Viveka Roychowdhury
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Abstract:
Mr. Ashwini Kumar, present Drug Controller General of India (DCGI), has been closely involved with drug control and regulation since the mid-1970s. In the past he has also acted as an international advisor to the World Health Organization (WHO). In this interview with Viveka Roychowdhury, Mr. Kumar addresses the latest initiatives to bring qualitative changes to India's drug regulatory environment.
©2006
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Good Clinical Practice (Gcp) Standards: Clinical Trials in India
An Interview with Dr. Urmila Thatte, Head of Clinical Pharmacology, TN Medical College & BYL Nair Hospital
Viveka Roychowdhury
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Abstract:
Dr. Urmila Thatte, Head of Clinical Pharmacology, TN Medical College & BYL Nair Hospital, Mumbai serves on several medical ethics committees. Viveka Roychowdhury interviews Dr. Thatte to get her views on the importance of ethics and adherence to Good Clinical Practice (GCP) standards.
©2006
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First Impressions: Clinical Trials in India
An Interview with Dr. David Lepay, Senior Advisor for Clinical Science and Director, Good Clinical Practice Program of the US Food and Drug Administration (FDA)
Viveka Roychowdhury
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Abstract:
In this interview, Dr. David Lepay, Senior Advisor for Clinical Science and Director, Good Clinical Practice Program of the US Food and Drug Administration, speaks with with Viveka Roychowdhur about his first impressions of India and what he thinks will be the critical links in the clinical trial process.
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Law Making Under the International Liability Regime for the Transboundary Movement of Living Modified Organisms (Lmos) Under the Cartagena Protocol on Biosafety
KD Raju
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Abstract:
Environmental protection is an age old problem in the evolution of human history. Industrialization in the modern world has affected the globe and environment in many ways. The human effort to control the damage came in the form of international agreements in the 20th century. The development of new technologies and their applications to the living organisms pose new challenges and threat to the environment. Biotechnology is only one of them.
This paper reviews the issue of environmental protection, state responsibility and liability positions under the existing general principles of international law jurisprudence and its applicability to Article 27 of the Cartagena Protocol on Biosafety dealing with the movement of living modified organisms. The second section analyses the available international legal jurisprudence and Conventions, which can be applied to the protocol in accordance with the mandate contained in Article 27. The conflict between various WTO agreements is analyzed closely. The third part discusses the emerging scenarios and options in the light of past experience. The final section offers some brief conclusions.
©2006
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Building Synergies between Business and BioDiversity: Constructing Ecological Balance Sheets
Chandrashekar Hariharan
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Abstract:
India enjoys a landmass that's about a sixth of the United States. Until 1850, India was a country known for the wealth of the nations' biomass. The years of colonizing by the British saw large-scale felling to feed the emerging timber markets that was emerging worldwide. Such depletion has continued in the fifty odd years since India gained political independence. The fortunes of these forests didn't change for the better with the change of helm. Depletion continued, to a point where India has lost, in all, over 78 per cent of our natural forests in less than 150 years. Enmeshed with the destiny of these forests is the lot of those people whose survival has depended on these forests, and who have traditionally had rights and control over natural resources. This article addresses the traditional rights that natural ecosystems have had over millennia, and the rights and control over these natural resources that they, and the local, indigenous communities have lost, and are losing.
3 pages
©2006
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Accountability: Rough Roads for the Scientific and Business Community
Bryan A. Liang
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Abstract:
No Abstract
2 pages
©2006
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Dogs to Aid in Cancer Treatment
Tim Flanagan
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Abstract:
Recent studies show that dogs may be trained to smell chemical reactions emitted from cancer cells.
2 pages
©2006
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Biotech Firm Civilly and Criminally Liable for Illegal Promotion of AIDS Drug
Julie Hall
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Abstract:
Swiss biotechnology firm Serono committed healthcare fraud by illegally promoting, marketing, and selling its drug, Serostim.
2 pages
©2006
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Congress Probes Drug Company Grants
Bart Parsley
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Abstract:
The Senate Finance Committee is investigating whether drug makers award educational grants to further educational purposes or to satisfy
marketing goals.
2 pages
©2006
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Advances in Sight Prosthetic May be Limited by Medical Coverage Issues
Daniel A. Porras
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Abstract:
Recent advances in retinal implant technology will help people with extreme degenerative vision to see, but the high cost of medical technology may limit broad use.
2 pages
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Legislation Encourages Donation of Umbilical Cord Blood to Provide Non-controversial Stem Cells
Aline Gaba
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Abstract:
New legislation encourages the donation and collection of stem cells from umbilical cord blood for treatment and research, establishing the first nationwide stem cell transplantation system and providing a non-controversial way to advance regenerative medicine.
2 pages
©2006
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Enrollment in International HIV/AIDS Study Terminated
Leslie J. Shields
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Abstract:
The "SMART" trials, designed to determine which of two different HIV treatment strategies would result in greater overall clinical benefit to patients, have been terminated due to negative effects on participants.
2 pages
©2006
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Pandemics in the Twenty-first Century: China and U.S. Approaches to Quarantine and Isolation
Aurora Elizabeth Bewicke
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Abstract:
With their large populations and regional influences, China and the United States are necessary partners in twenty-first century efforts to address pandemics.
2 pages
©2006
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Venture Capital Thought Leadership
BioInterview with Michael Greeley
Robin JR Blatt
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Abstract:
In this BioInterview, Robin JR Blatt speaks with VC thought leader Michael A. Greeley. Michael Greeley is Founder and Managing General Partner of IDG Ventures-a global network of venture capital funds with approximately $1.25 billion under management and a portfolio of over 150 companies built over the last 15 years. Prior to joining IDG Ventures, Michael was with Polaris Venture Partners, where he focused on both early and later stage financings for emerging growth companies. Prior to Polaris, Michael served for over five years as Senior Vice President and Founding Partner of GCC Investments, a successful $200 million private equity fund. He previously worked at GCC Investment as a Vice President and was one of the early professionals at Wasserstein Perella & Co., an international merchant bank with a $1.0 billion private equity fund. Michael currently serves on the Board of Directors for the New England Venture Capital Association and is a member of the Executive Business Advisory Council for Mass General Hospital for Children. With partnerships in Boston, San Francisco, and multiple locations throughout China and Vietnam, the IDG Ventures network offers the international perspective and the local market expertise to help companies grow from start-ups to global success stories.
3 pages
©2006
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Patents/ Patent Protection in the Biotechnology Industry-A Unique Approach to Obtaining Fast Patent Rights
Scott A. Burow
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Strong intellectual property protection is as essential in the biotechnology field as in any other cutting-edge field. Biotechnology patents can serve to promote the advancement of new medicines, diagnostic equipment and agricultural products. Biotechnology patents not only reward inventors for their inventions through market exclusivity, they can stimulate research and the flow of scientific and technological knowledge on a global basis. Biotechnology patents further encourage companies to invest in developing new drugs, therapies and equipment. This development often takes many years and is a very expensive and risky process. Without patent protection, competitors could copy the developed drugs, for example, and sell these drugs at a substantially lower price because they have not expended the resources necessary to develop the drugs. In this situation, the competitor could capture the market with its lower priced drug and the innovating company would be required to lower its price to compete and, as a result, may never recoup its substantial development costs. Thus, it becomes critical to obtain patent protection and to do so as expeditiously as possible. This article addresses a unique approach to obtaining fast patent protection to help companies capture or maintain market share and exclusivity and prevent would-be copiers from undercutting the substantial investment expended by these companies.
3 pages
©2006
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BioCase Study/ ENDEPUSresearch Spin Out: A Cost Sensitivity Simulator for Health Care Decision-Making
Christine C. Huttin
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This article presents the creation of an emerging Research and Development organization called ENDEPUSresearch, Inc. It is an academic spinout for a technology transfer of Professor Huttin's inventions resulting from fifteen years of academic experience in European institutions and collaborations with US and Asian universities. The technology in development is a methodology and system for decision makers in health care. The new type of health care software will integrate cognitive economic data that may restrain cost sensitive physicians from rational decision making and use of evidence based medicine or patients compliance to their choices. Linked to macro level data, such individual level data can be useful not only for education outreach but also for health care budget forecasts, especially in the context of health care financing reforms. Endepusresearch Inc's Technology is currently under patent filing under business method and system.
5 pages
©2006
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