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PubMed2005

EPIDAUROS Biotechnologie AG.

EPIDAUROS Biotechnologie AG is a leading provider of pharmacogenetic consulting, genotyping and research services to the international pharmaceutical and biotechnology industries, contract research organizations and healthcare providers. The company's mission is to improve safety, efficacy and predictability in drug development and drug therapy. EPIDAUROS determines its customers' needs in the field of pharmacogenetics using an in-depth consultancy process. The development and conduct of genotyping assays for drug-metabolizing enzymes, drug transporters and drug targets (for example, receptors)--all performed under stringent quality standards--are a major activity at EPIDAUROS. The company offers its research services to academic and industrial partners for the development of innovative diagnostic solutions by using its intellectual property.

Biotechnology↗
PubMed2002

Who owns the data in clinical trial?

Data gathered by investigators are used to test the validity of a specific scientific hypothesis. When the hypothesis relates to the biology of a disease or its treatment, then data sets may contain specific and identifiable medical information. Since the information in a clinical data set was gathered to test a specific hypothesis and there is usually a sponsor interested in the outcome, the issue of who owns the data is a critical one. In my opinion, data from both publicly and privately funded research should be made available, in a format that protects confidentiality and intellectual property rights, to interested and responsible parties within a reasonable period of time after publication.

Clinical Protocols↗
PubMed2001

Biotechnology and research: promise and problems.

Biotechnology has expanded greatly during the last two decades. This expansion is due to worldwide investment in basic biomedical research. The new knowledge generated by this investment has led to a bounty of potential applications for improvement of health, which are being explored for commercial purposes by the biotechnology industry. Private investment is thus ever present in development of these biotechnological products. All these factors raise important questions, including increasing concerns about intellectual property and conflict of interest. As this expansion continues, the established processes of peer review should be strengthened.

Biotechnology↗
PubMed1999

Medicolegal aspects of imaging and Internet communications.

Many facial plastic surgeons have set up their own personal World Wide Web (WWW) pages with an electronic mail link to communicate with and educate prospective patients. The possible dilemma is in that these services are provided without actually meeting patients face to face. Also, despite the growing popularity of computer imaging systems, it is not clear whether the medical and legal advantages of using such a system outweigh the disadvantages. The purpose of this article is to evaluate these aspects and to provide some protective guidelines. An examination of possible causes of actions arising from computer imaging suggests that surgeons who follow a few simple guidelines, and who use computer imaging responsibly and cautiously, minimize their legal liability. Issues surrounding Internet discussion groups, posted medical advice, intellectual property, and the use of an electronic mail link are also discussed.

Humans↗
PubMed2003

The extended pharmaceutical enterprise.

The availability of widespread contractual services led to the birth of the virtual company in the 1990s. As the concept has matured, and the biotechnology sector diversified, interchange of intellectual property in the form of collaborative and license arrangements opens up still further the opportunities for outsourced forms of pharmaceutical R&D.

Contracts↗
PubMed1999

Careful telemedicine planning limits costly liability exposure.

Recent Federal and state legislation and new payment opportunities from Medicare, Medicaid, and private payers may make it possible to offer telemedicine as a viable, cost-effective alternative to traditional care delivery in communities where access to health care is limited. Originally, nonexistent payment and expensive technology held back telemedicine but, these barriers are giving way to specific applications that can yield dramatic cost savings for group practices in the delivery of medical care while adding features and benefits not typically available in traditional delivery settings. Before joining a telemedicine network, group practices need to negotiate a variety of legal issues related to the corporate practice of medicine, patient confidentiality and privacy, malpractice, informed consent, licensure and credentialing, intellectual property, Medicare and Medicaid payment, fraud and abuse, medical device regulation, and antitrust.

Antitrust Laws↗
PubMed2005

Genetic patent protection in the pharmaceutical and biotechnology industries.

Without patent protection, biomedical progress would be severely diminished. Conditions under the current patent regime are characterized by rapid advancement made possible by cooperative licensing, collaboration and partnerships between and among various entities, and the drive to bring successful products to market both in order to make profits and to further the cause of humanity. The financial advantages associated with patent-driven corporate participation are the lifeline of innovation. While granting limited periods of exclusivity under the patent system necessary to entice innovation is a calculated sacrifice, the enormous benefits of fully-disclosed pharmaceutical and genetic discoveries result in a handsome net benefit over the alternative of resource-limited research clouded by a shroud of secrecy as a substitute for patent protection. By examining characteristics of the pharmaceutical and biotechnology industries and the critical role the patent regime plays in driving investment in these areas, a clearer picture of the necessity of strong intellectual property rights in the context of genetics will emerge.

Biotechnology↗
PubMed1995

The case for genomic patenting.

Opposition to the patenting of genomic inventions threatens to erode the foundation of intellectual property rights needed to convert innovative research into new drugs, vaccines and diagnostic tests.

Base Sequence↗
PubMed2006

You have an idea, now what?

The innovation process is often more important than the original idea, particularly when the ultimate goal is to improve patient care through technologically advanced products. Many physicians have great ideas; unfortunately, many of these great ideas are never translated to patient care improvements because of a misunderstanding of "the next step." In many cases, the next step is a step backward to understand the real clinical problem: "the clinical need." With the clinical need in hand, the most efficient path to a product for improved patient care can then be derived. Often, the most efficient pathway involves an appreciation of many issues, including intellectual property, regulatory pathways, finance, and clinical trial strategies. The integration of these issues underlies innovation in biomedical technology.

Commerce↗
PubMed2004

BioAsia Licensing and Deal-Making Summit-SRI Conference. Life science partnering and investment on the Pacific Rim 2-3 August, 2004, Coronado, CA, USA..

The Strategic Research Institute's inaugural BioAsia Licensing and Deal-Making Summit, co-organized by the BioMinerva Group, attracted industrial leaders in biotechnology and pharmaceuticals from both sides of the Pacific Ocean. Topics discussed at the 2-day conference spanned from trans-Pacific licensing and partnering trends led by Japan-US deals, the changing landscape of the Japanese pharmaceutical industry, and trans-Pacific partnering strategies to perspectives of Asia-Pacific markets and successful investment strategies. The emerging Chinese biotechnology and pharmaceutical industry was also covered prominently, including assessments of the Chinese market, discussions on intellectual property, regulatory and tax issues, as well as case studies of Sino-US collaborations and technology showcases from Chinese biotech companies.

Biotechnology↗
PubMed2000

Agricultural biotechnology. Monsanto donates its share of golden rice.

Monsanto Co. has agreed to provide royalty-free licenses to speed up work on a genetically modified rice that could alleviate vitamin A deficiency around the world. Researchers welcomed last week's announcement, but warn that a thicket of intellectual property claims surrounds the technology and that significant legal hurdles remain before the rice can become widely available to farmers in developing countries.

Biotechnology↗
PubMed2004

Overview of geriatric distance education for academic courses and continuing education.

Distance education technologies may be applied to academic settings, continuing education/continuing medical education settings or in combination to both. This article provides an overview of what we have learned about academic and continuing education/continuing medical education in geriatrics and gerontology. It includes information on the scope of distance education, the strengths and challenges of distance education, and discusses issues related to technology, intellectual property, instructional design and curriculum development, collaborative effort, marketing, evaluation, and research.

Certification↗
PubMedDate not supplied

Licensing web-based nursing programs, courses, and course materials.

With the advent of the digital information age, schools of nursing are developing and using web-based programs, courses, and course materials to meet students' needs for access and high-quality learning experiences. In an attempt to maximize scant resources, including faculty, many schools are seeking grant funding, joining consortia, or forming partnerships that require sharing of web-based course materials. Entering such collaborative arrangements usually requires licensing agreements to transfer intellectual capital. This article explains licensing and the related concepts of intellectual property, copyright, and technology transfer. It also identifies the advantages and disadvantages of licensing and describes a licensing process.

Computer-Assisted Instruction↗
PubMed1998

Research and trade in genetics: how countries should structure for the future.

This article discusses the international trade issues that will underlie the institution of genetic research and technological regimes. As the biotechnology industry grows trade considerations will become paramount in structuring domestic regimes designed to limit or emphasise certain aspects of genetic research. As such, many countries will wish to maintain or enhance their comparative economic and strategic advantages vis-à-vis their trading partners. The international biotechnology climate will mature within the next fifteen to twenty years. Consequently, there will be an impetus towards conducting a multilateral trade round on genetic research and technology. The supposition is that this future trade round will be similar to the intellectual property negotiations at the Uruguay Round of the GATT. Countries that are willing to adopt regimes that are very conducive to genetic research will be better placed for the future.

Biotechnology↗
PubMed2006

Removing barriers to global pandemic influenza vaccination.

This article clarifies the regulatory issues surrounding influenza pandemic vaccine for the larger policy community and describes the need for regulatory harmonization. Vaccination would save lives in an influenza pandemic, but a lack of global manufacturing capacity will leave most of the world without access to vaccine. Capacity can be expanded if governments harmonize their regulatory policies. This article details the regulatory approaches taken by the United States, the European Union, and Japan for pandemic vaccine development, three regions that produce the majority of the world's seasonal influenza vaccine. They should quickly converge on regulatory requirements, intellectual property considerations, the use of recombinant DNA techniques for vaccine production, and technical issues about the composition of pandemic vaccine.

European Union↗
PubMedDate not supplied

An ethics framework for nursing education on the Internet.

An ethics framework for the use of the Internet for nursing education, consultation, research, and practice is proposed. The proposed framework, discussed in terms of structure, process, and outcome, would guide policy for confidentiality, privacy issues, professionalism, ownership of intellectual property, accountability, and control of access. A goal would be to encourage creative problem solving without constant reference to authority.

Codes of Ethics↗