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Pharmaceutical perspectives of nonviral gene therapy.

The use of nonviral plasmid-based gene medicines represents an attractive in vivo gene transfer strategy that is simple and lacks many risks that are inherent to viral systems. Commercialization of gene medicines requires a thorough analysis of business opportunities, unmet clinical needs, competitive products under development, and issues related to intellectual property. Synthetic gene delivery systems are designed to control the location of a gene within the body by affecting distribution and access of a gene expression system to the target cell, and/or recognition by a cell surface receptor and uptake followed by intracellular and nuclear translocation. Plasmid-based gene expression systems are designed to control the level, fidelity, and duration of in vivo production of a therapeutic gene product. This review will provide insights into the potentials of plasmid-based gene therapy and critical evaluation of gene delivery sciences and clinical applications of gene medicines.

Animals↗

Commercialization of animal biotechnology.

Commercialization of animal biotechnology is a wide-ranging topic for discussion. In this paper, we will attempt to review embryo transfer (ET) and related technologies that relate to food-producing mammals. A brief review of the history of advances in biotechnology will provide a glimpse to present and future applications. Commercialization of animal biotechnology is presently taking two pathways. The first application involves the use of animals for biomedical purposes. Very few companies have developed all of the core competencies and intellectual properties to complete the bridge from lab bench to product. The second pathway of application is for the production of animals used for food. Artificial insemination (AI), embryo transfer, in vitro fertilization (IVF), cloning, transgenics, and genomics all are components of the toolbox for present and future applications. Individually, these are powerful tools capable of providing significant improvements in productivity. Combinations of these technologies coupled with information systems and data analysis, will provide even more significant change in the next decade. Any strategies for the commercial application of animal biotechnology must include a careful review of regulatory and social concerns. Careful review of industry infrastructure is also important. Our colleagues in plant biotechnology have helped highlight some of these pitfalls and provide us with a retrospective review. In summary, today we have core competencies that provide a wealth of opportunities for the members of this society, commercial companies, producers, and the general population. Successful commercialization will benefit all of the above stakeholders.

Animals↗

The pharmaceutical industry as an informant.

The pharmaceutical industry spends more time and resources on generation, collation, and dissemination of medical information than it does on production of medicines. This information is essential as a resource for development of medicines, but is also needed to satisfy licensing requirements, protect patents, promote sales, and advise patients, prescribers, and dispensers. Such information is of great commercial value, and most of it is confidential, protected by regulations about intellectual property rights. Through their generation and dissemination of information, transnational companies can greatly influence clinical practice. Sometimes, their commercially determined goals represent genuine advances in health-care provision, but most often they are implicated in excessive and costly production of information that is largely kept secret, often duplicated, and can risk undermining the best interests of patients and society.

Drug Industry↗

Influence of disease burden, public perception, and other factors on new vaccine development, implementation, and continued use.

The development, implementation, and continued use of new vaccines depends on several factors. Although disease burden seems like an obvious quantitative measure for setting priorities for new vaccine development and use, resources are not always allocated proportionately. This is particularly evident for diseases that are unique (or largely limited) to people in developing countries. Public pressure based on perceptions of the risks associated with a disease or vaccine, the cost of new vaccines, and the ability to incorporate them into existing vaccination programmes also need to be considered in the decision to introduce new vaccines. Vaccine manufacturers play an important part in development of new vaccines, and therefore, the issues that are important to them, namely, production, intellectual property rights, and product liability, must be addressed. By advocating rational decisions, supported by accurate information, scientists and public-health professionals can have an important role in transforming the potential of new vaccines into the reality of new vaccine-preventable diseases.

Animals↗

Towards in-vitro prediction of an in-vivo cytostatic response of human tumor cells with a fast chemosensitivity assay.

The objective of this study is to evaluate a novel approach to chemosensitivity testing with respect to its predictive value in the selection of clinically effective cytostatic drugs to optimize the therapeutic treatment of cancer. The chemosensitivity assay, which we used in this study, has its roots in pharmaceutical drug screening and the surrounding intellectual property is protected by various patent applications and trademarks. Therefore, we will refer to this test in the following pages as ChemoSelect. ChemoSelect is a sensor-chip based diagnostic test, which permits the functional and continuous real-time measurement of induced tumor cell cytotoxicity following the administration of chemotherapeutic drugs. Chemosensitivity is measured through the reduction of the excretion of lactic and carbonic acids--by-products of the metabolic processes of glycolysis and respiration and a parameter for cell vitality--generated specifically by ATP hydrolysis and lactic acid production. We used this test to study the applicability of this assay for tumor cells based on the analysis of tumor cell lines and tumor specimens. In this preliminary study, this test was studied in predicting chemoresistance and chemosensitivity in cell lines and tumor specimens for which the result was already predetermined by the properties of the cell line or the tumor specimen used in the experiment. The applicability in a clinical setting was studied by confirming the trends on selected drug sensitivity and drug resistance with an interim analysis of an ongoing clinical study in selected patients with breast cancer undergoing neoadjuvant chemotherapy. The minimum detection limit of cells and biologic cell responses, an important variable determining the applicability of the test in routine clinical use, was also assessed. ChemoSelect avoids many of the limitations of existing chemoresistance assays and provides more comprehensive information and output, as it has a 24-h turnaround time, is applicable to the majority of solid tumors and available cytostatic drugs, does not need more than 10(5) cells in total, cultivated tumor cells, provides dynamic monitoring of cellular responses through on-line data read-out during the perfusion with drugs and can be extended to the analysis of novel therapeutic modalities such as biologics.

Antineoplastic Agents↗

Sexing mammalian sperm--intertwining of commerce, technology, and biology.

Sperm from many mammalian species can be sexed by flow cytometry/cell sorting at about 90% accuracy without damaging them unduly. However, because sperm are evaluated one at a time, in series, the number of sexed sperm produced per unit time is limited. Furthermore, the equipment required currently is expensive, in the order of 300,000 US dollars per machine. Despite these limitations, commercialization of this technology has begun with bovine semen, in part by inseminating cattle with relatively low number of sperms. No other approach to sexing sperm in any practical way is likely to be available within the next few years. The constraints for commercial application of sexed sperm in cattle can be somewhat lowered fertility, the high costs of equipment and skilled personnel, and costs of intellectual property such as licensing fees and royalty payments. Most economic analyses indicate that farmers can afford to pay 10-20 US dollars more per dose of sexed sperm than unsexed sperm if costs must be recouped by selling milk or meat. When the product is breeding stock or for certain niche applications, a higher price for sexed semen may be justified. Sexed sperm will be used more broadly in cattle only when improved production and/or efficiency can compensate for the extra costs of purchasing sexed sperm.

Animals↗

Predictive DNA testing for glaucoma: reality in 2003.

As new genes and common mutations are identified, DNA testing can be offered. Like clinical testing used in glaucoma, such as IOP, tonography, disc measurements, nerve fiber layer analysis, and the various methods of visual field analysis, well-designed studies are needed to be able to interpret clearly the meaning of abnormal results. To use DNA testing to identify individuals at high risk for glaucoma, it is necessary to have solid evidence with sensitivity and specificity parameters, genotype-phenotype correlations, and information on prevalence and penetrance. These data will have to be replicated in several studies using large, population-matched control groups. Mass screening of glaucoma patients for Myocilin mutations may be worthwhile if 3% to 5% of glaucoma patients will be positive. For comparison, screening all cases of colon cancer for gene mutations involved in hereditary nonpolyposis colorectal cancer is considered feasible and desirable with a yield of only 3%. Recent research has shown the value of early treatment of glaucoma. The cost effectiveness of genetics screening will need to be weighed against the cost of conventional screening and the benefits of early treatment considered. Within glaucoma pedigrees with known mutations, DNA mutation-positive individuals will need more frequent clinical screening, whereas DNA mutation-negative individuals will need less frequent follow-up. It is likely that, for every positive-mutation glaucoma case identified, there will be on average two siblings and two children to test. In addition to the laboratory costs, the costs of counseling, and, in particular, the availability of suitably trained individuals who can correctly interpret these test results, must be considered. The risk and benefits of these measures must be calculated and then balanced with the long-term visual outcome of such a strategy. How could genetic testing alter management in glaucoma? If a family member in a Myocilin pedigree with a severe mutation is negative for the mutation, that individual's risk changes from 50% to that of the general population (ie, -2%), and the frequency of clinical screening can be reduced. There are ethical issues involved in testing, particularly in children, but testing would seem justified in congenital, developmental, and juvenile glaucoma. Issues related to insurance may affect the decision making of some patients. A further consideration, which may regrettably become important in the future, is that of intellectual property and patent issues pertaining to glaucoma gene discovery. In addition to clinical evidence of the value of predictive DNA testing, it is incumbent on those working in the field to evaluate the acceptability of testing to patients and their family members. The authors' experience to date is that predictive DNA testing in glaucoma is well supported in suitable families. As with predictive DNA screening in other ophthalmic conditions, issues relating to insurance, ethics, and confidentiality need to be taken into consideration. Although many of the more recently described genetic associations of POAG require more thorough evaluation, Myocilin gene testing can and should be offered for young-onset severe glaucoma cases with a positive family history.

DNA↗

Industry-sponsored research in minimally invasive surgery.

In many disciplines, including minimally invasive surgery, pharmaceutical and instrument companies are major sources of industry-sponsored research. There are two types of such research, industry-initiated and investigator-initiated. Distinction between them is sometimes blurred. In industry-sponsored research a conflict may occur between clinicians and sponsor. In all cases, a clinical trial should be done properly and ethically, and results, whether negative or positive, should be published. Disposition of intellectual property and authorship should be established before starting the trial.

Humans↗

A patent strategy for genomic and research tool patents: are there any differences between the USA, Europe and Japan?

The patenting of genomics and research tools, and its effects on the development of therapeutics are attracting considerable attention. Regardless of whether one is in favor of patents for this technology, it is not specifically excluded from patenting in most countries. Accordingly, it is imperative that a suitable global patent strategy be developed and followed to maximize both intellectual property rights and returns on R&D investment.

Journal Article↗

Chemistry challenges in lead optimization: silicon isosteres in drug discovery.

During the lead optimization phase of drug discovery projects, the factors contributing to subsequent failure might include poor portfolio decision-making and a sub-optimal intellectual property (IP) position. The pharmaceutical industry has an ongoing need for new, safe medicines with a genuine biomedical benefit, a clean IP position and commercial viability. Inherent drug-like properties and chemical tractability are also essential for the smooth development of such agents. The introduction of bioisosteres, to improve the properties of a molecule and obtain new classes of compounds without prior art in the patent literature, is a key strategy used by medicinal chemists during the lead optimization process. Sila-substitution (C/Si exchange) of existing drugs is an approach to search for new drug-like candidates that have beneficial biological properties and a clear IP position. Some of the fundamental differences between carbon and silicon can lead to marked alterations in the physicochemical and biological properties of the silicon-containing analogues and the resulting benefits can be exploited in the drug design process.

Chemistry, Pharmaceutical↗

Solid-state analysis of the active pharmaceutical ingredient in drug products.

The solid form of a drug substance is important when developing a new chemical entity. The crystalline form used in development is significant based on possible manufacturability, solubility, bioavailability and stability differences between the solid forms. Regulatory issues require that the form present in a solid dosage form or liquids containing undissolved drug substance be identified. Drug product samples can be analyzed by a variety of techniques to determine the crystal form present or changes that occur during the manufacture of a drug product. The form present will affect development, regulatory and intellectual property issues.

Chemistry, Pharmaceutical↗

High-throughput approaches to catalyst discovery.

High-throughput synthesis and screening approaches to catalyst discovery and optimization are systematically changing the way in which catalyst research is conducted. Increased rates of innovation, cost effectiveness, improved intellectual property, reduced time to market and an improved probability of success are some of the attractive features that demand consideration. Advances made over the past few years reveal that any initial skepticism is waning, and high-throughput approaches to catalyst discovery are now being implemented broadly in industrial and academic laboratories.

Catalysis↗

Agricultural biotechnology in developing countries.

After a slow start many developing countries are now investing in agricultural biotechnology. Although these countries face several constraints, efforts are being made to promote biotechnology that requires high investment with long term returns. A number of donor agencies are providing incentives to stimulate biotechnology in the developing countries. There is however a major debate towards the development of biotechnology, especially genetically modified organisms, in the developing countries and there is a need for them to address biosafety issues and proper monitoring systems. The concern of intellectual property rights is a major issue in the developing countries in order to have access to the technologies that are often owned by multinational corporations in the industrialized countries.

Agriculture↗

Trade secrets and other R&D capital preservation techniques.

In today's age of ballooning R&D expenses, it is critical to preserve and make the most cost-effective use of discoveries and expertise. Business and marketing plans make positive use of such discoveries and expertise through creating and selling products based upon this intellectual property. Legal protections preserve the discoveries and expertise, by preventing competitors from profiting from the efforts of innovative companies.

Journal Article↗

Molecular diagnostics: hurdles for clinical implementation.

In the coming years, molecular diagnostics will continue to be of critical importance to public health worldwide. It will facilitate the detection and characterization of disease, as well as monitoring of the drug response, and will assist in the identification of genetic modifiers and disease susceptibility. A wide range of molecular-based tests is available to assess DNA variation and changes in gene expression. However, there are major hurdles to overcome before the implementation of these tests in clinical laboratories, such as which test to employ, the choice of technology and equipment, and issues such as cost-effectiveness, accuracy, reproducibility, personnel training, reimbursement by third-party payers and intellectual property. At present, PCR-based testing predominates; however, alternative technologies aimed at reducing genome complexity without PCR are anticipated to gain momentum in the coming years. Furthermore, development of integrated chip devices ("lab-on-a-chip") should allow point-of-care testing and facilitate genetic readouts from single cells and molecules. Together with proteomic-based testing, these advances will improve molecular diagnostic testing and will present additional challenges for implementing such testing in health care settings.

Animals↗

Varieties of secrets and secret varieties: the case of biotechnology.

This article examines several trends that have combined to veil the new field of biotechnology in secrecy: the transformation of biotechnology from an essentially academic field characterized by strong norms of openness to a field with extensive corporate connections that have reached even to research in leading universities; the establishment of intellectual property rights for life-forms initiated by the landmark Supreme Court decision, Diamond v. Chakrabarty; and the limiting of public access to information about the genetically altered organisms whose use in agriculture, industry, and medicine falls under government controls. The article also examines the effects of the U.S. biotechnology industry's demand for secrecy on the negotiations for a protocol to the 1972 Biological Weapons Convention, particularly the turn from requirements for transparency to protection of opacity with respect to biotechnology and other biological processes, equipment, and production.

Access to Information↗

Discovery of enzymatic activity using stable isotope metabolite labeling and liquid chromatography-mass spectrometry.

Stable isotope labeling of an intracellular chemical precursor or metabolite allows direct detection of downstream metabolites of that precursor, arising from novel enzymatic activity of interest, using metabolite profiling liquid chromatography-mass spectrometry. This approach allows the discrimination of downstream metabolites produced from novel enzymatic activity from the unlabeled form of the metabolite arising from native metabolic processes within the cell. Even for the case in which a given product of novel enzymatic activity is a transient, the novel enzymatic activity that produced it can be demonstrated to exist indirectly by identification of product-specific downstream metabolites. Therefore, direct or indirect discovery of novel enzymatic machinery engineered within a cell can be accomplished without a requirement for direct product purification or identification. The application of this approach to confirm the presence of a novel metabolic activity, alanine 2,3-aminomutase, obtained by mutagenesis and selection are discussed. The advantages of metabolite profiling approaches to metabolic engineering in terms of accelerating enzyme discovery and development of intellectual property will also be highlighted.

Chromatography, High Pressure Liquid↗

HIV-1 vaccine development: constrained peptide immunogens show improved binding to the anti-HIV-1 gp41 MAb.

The human immunodeficiency virus type I (HIV-1) transmembrane glycoprotein gp41 mediates viral entry through fusion of the target cellular and viral membranes. A segment of gp41 containing the sequence Glu-Leu-Asp-Lys-Trp-Ala has previously been identified as the epitope of the HIV-1 neutralizing human monoclonal antibody 2F5 (MAb 2F5). The 2F5 epitope is highly conserved among HIV-1 envelope glycoproteins. Antibodies directed at the 2F5 epitope have neutralizing effects on a broad range of laboratory-adapted HIV-1 variants and primary isolates. Recently, a crystal structure of the epitope bound to the Fab fragment of MAb 2F5 has shown that the 2F5 peptide adopts a beta-turn conformation [Pai, E. F., Klein, M. H., Chong, P., and Pedyczak, A. (2000) World Intellectual Property Organization Patent WO-00/61618]. We have designed cyclic peptides to adopt beta-turn conformations by the incorporation of a side-chain to side-chain lactam bridge between the i and i + 4 residues containing the Asp-Lys-Trp segment. Synthesis of extended, nonconstrained peptides encompassing the 2F5 epitope revealed that the 13 amino acid sequence, Glu-Leu-Leu-Glu-Leu-Asp-Lys-Trp-Ala-Ser-Leu-Trp-Asn, maximized MAb 2F5 binding. Constrained analogues of this sequence were explored to optimize 2F5 binding affinity. The solution conformations of the constrained peptides have been characterized by NMR spectroscopy and molecular modeling techniques. The results presented here demonstrate that both inclusion of the lactam constraint and extension of the 2F5 segment are necessary to elicit optimal antibody binding activity. The ability of these peptide immunogens to stimulate a high titer, peptide-specific immune response incapable of viral neutralization is discussed in regard to developing an HIV-1 vaccine designed to elicit a 2F5-like immune response.

AIDS Vaccines↗