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PubMed2005

Central nervous system drug development: an integrative biomarker approach toward individualized medicine.

Drug development for CNS disorders faces the same formidable hurdles as other therapeutic areas: escalating development costs; novel drug targets with unproven therapeutic potential; and health care systems and regulatory agencies demanding more compelling demonstrations of the value of new drug products. Extensive clinical testing remains the core of registration of new compounds; however, traditional clinical trial methods are falling short in overcoming these development hurdles. The most common CNS disorders targeted for drug treatment are chronic, slowly vitiating processes manifested by highly subjective and context dependent signs and symptoms. With the exception of a few rare familial degenerative disorders, they have ill-defined or undefined pathophysiology. Samples selected for treatment trials using clinical criteria are inevitably heterogeneous, and dependence on traditional endpoints results in early proof-of-concept trials being long and large, with very poor signal to noise. It is no wonder that pharmaceutical and biotechnology companies are looking to biomarkers as an integral part of decision-making process supported by new technologies such as genetics, genomics, proteomics, and imaging as a mean of rationalizing CNS drug development. The present review represent an effort to illustrate the integration of such technologies in drug development supporting the path of individualized medicine.

Animals↗
PubMed1999

Drug development for neurodegenerative diseases: role of PET.

There are few relevant animal models for neurodegenerative diseases to be used for human drug development. Most current drugs for neurodegenerative diseases act through different neurotransmitter systems. Positron emission tomography (PET) is a unique tool in the study of neurodegenerative diseases as it enables quantitative measurements of oxygen consumption, blood flow, energy metabolism and functioning of various neurotransmitter systems. There are several possibilities in the use of PET in drug development. It is possible to radiolabel the drug itself or to study the effect of an unlabelled drug on blood flow, energy metabolism or function of neurotransmitter systems. All these approaches have been used in drug development for neurodegenerative diseases. However, in spite of the important role of PET in pathophysiological studies of neurodegenerative diseases, thus far the versatile possibilities of PET in drug development for neurodegenerative diseases have not been fully exploited.

Animals↗
PubMed2005

Drug resistance and antiretroviral drug development.

As more drugs for treating HIV have become available, drug resistance profiles within antiretroviral drug classes have become increasingly important for researchers developing new drugs and for clinicians integrating new drugs into their clinical practice. In vitro passage experiments and comprehensive phenotypic susceptibility testing are used for the pre-clinical evaluation of drug resistance. Clinical studies are required, however, to delineate the full spectrum of mutations responsible for resistance to a new drug and to identify the settings in which a new drug is likely to be most useful for salvage therapy.

Anti-HIV Agents↗
PubMed1999

[The trends of new drug development in the 21st century].

The trends of new drug development in the 21st century were described. First, the history of drug development including that of the drug delivery system (DDS) was shown. Then, the recent drugs and therapeutic technology were discussed in detail. These topics are biomedicine, gene related technology, vaccine, hybrid artificial organ, chemical and phage library, fetal growth hormone, cell therapy, humanized anti-body and Viagra. In addition, some natural products were introduced, emphasizing the relationship between food and human health. Finally, I stated my opinion about the new drug development in the 21st century in Japan.

Biopharmaceutics↗
PubMed1994

The new drug approvals of 1990, 1991, and 1992: trends in drug development.

Efforts to speed the development and review of new drugs have increased sharply in recent years. This report, which is the third in a series on trends in drug development, examines the new drug approvals of 1990, 1991, and 1992. During the 3-year study period, the Food and Drug Administration (FDA) approved 79 new drugs, 74 of which met the Center for the Study of Drug Development's definition of a new chemical entity (NCE). Of the 74 NCEs, 36 (49%) were considered by the FDA to represent notable therapeutic gains and were selected for "priority" review (i.e., drugs rated 1P, 1A, 1AA, and 1B), and 38 (51%) were considered to represent little or no gain and received "standard" reviews (i.e., drugs rated 1S and 1C). Investigational new drug application (IND) filing and new drug application (NDA) submission dates on all 74 drugs were obtained from responses to our manufacturer surveys as well as from FDA and public sources. The mean length of the clinical phase (IND filing to NDA submission) was 6.1 years and that of the review phase (NDA submission to approval) was 2.6 years. Of the 74 NCEs, 43 (58%) were available in foreign markets at least 1 year before U.S. approval, with a mean of 5.6 years of foreign marketing. In general, 1990 to 1992 figures are similar to those in the last half of the 1980s.

Drug Approval↗
PubMed2004

A cost-related approach for evaluating drug development programs.

Most pharmaceutical statisticians make a contribution to drug development at the study level by designing and analysing clinical studies. There is less involvement at the drug project level, especially when it comes to making a strategic decision for a drug development program. Motivated by the assessment of drug safety, this paper presents a new decision rule on whether or not to continue developing a new drug based on a cost function. The cost function takes into account both type I and type II errors in a decision making problem. It also incorporates both the cost and benefit from a drug development program. This cost-benefit approach enables company senior management to evaluate a drug program objectively and make decisions in a quantitative and rational manner. The probabilities of making correct decisions are illustrated by using a real data example.

Clinical Trials as Topic↗
PubMed1990

The role of ethnopharmacology in drug development.

There are 119 drugs of known structure that are still extracted from higher plants and used globally in allopathic medicine. About 74% of these were discovered by chemists who were attempting to identify the chemical substances in the plants that were responsible for their medical uses by humans. These 119 plant-derived drugs are produced commercially from less than 90 species of higher plants. Since there are at least 250,000 species of higher plants on earth, it is logical to presume that many more useful drugs will be found in the plant kingdom if the search for these entities is carried out in a logical and systematic manner. The first and most important stage in a drug development programme using plants as the starting material should be the collection and analysis of information on the use(s) of the plant(s) by various indigenous cultures. Ethnobotany, ethnomedicine, folk medicine and traditional medicine can provide information that is useful as a 'pre-screen' to select plants for experimental pharmacological studies. Examples are given to illustrate how data from ethnomedicine can be analysed with the aim of selecting a reasonable number of plants to be tested in bioassay systems that are believed to predict the action of these drugs in humans. The ultimate goal of ethnopharmacology should be to identify drugs to alleviate human illness via a thorough analysis of plants alleged to be useful in human cultures throughout the world. Problems and prospects involved in attaining this goal are discussed.

Drug Evaluation, Preclinical↗
PubMed2001

Laboratory surrogates for anti-atherosclerotic drug development.

Anti-atherosclerotic drug development includes the need for biochemical surrogate markers, because clinical parameters of efficacy are of very limited use early in the development process. Surrogate biochemical markers may provide a basis in Phase II for dose selections for Phase III trials. They may also help to improve selection of the most suitable population for entry to clinical endpoint trials. There is still a great deal of confusion as to the epidemiologic relation of biochemical markers and risk of coronary artery disease and whether altering these markers results in clinical benefit. The primary biochemical surrogate currently used and well accepted by regulatory agencies is low-density lipoprotein (LDL) cholesterol. Apolipoprotein B (apo B) is not as well accepted but, based on clinical trials, may be a better surrogate, because it simultaneously evaluates other atherogenic lipoproteins. Other potential surrogates include various lipid and lipoprotein subpopulations, apolipoproteins, procoagulants, fibrinolytics, inflammatory proteins, adhesion molecules, and lesion lytic enzymes. All of these parameters are involved in either the causation or propagation of the atherothrombotic process.

Biomarkers↗
PubMedDate not supplied

Emerging and recurrent issues in drug development.

This paper reviews several emerging and recurrent issues relating to the drug development process. These emerging issues include changes to the FDA regulatory environment, internationalization of drug development, advances in computer technology and visualization tools, and efforts to incorporate meta-analysis methodology. Recurrent issues include: renewed interest in statistical methods for handling subgroups in the design and analysis of clinical trials; renewed interest in alternatives to the 'intention-to-treat' analysis in the presence of non-compliance in randomized clinical trials; renewed interest in methodology to address the multiplicities resulting from a variety of sources inherent in the drug development process, and renewed interest in methods to assure data integrity. These emerging and recurrent issues provide a continuing challenge to the international community of statisticians involved in drug development. Moreover, the involvement of statisticians with different perspectives continues to enrich the field and contributes to improvement in the public health.

Computer-Aided Design↗
PubMed2005

Understanding the drug development process.

In the United States, new drug development is a complex, highly regulated process that often involves academic institutions, the pharmaceutical industry, and government agencies. Much of the primary and clinical research conducted in the United States is funded by the National Institutes of Health. The Food and Drug Administration (FDA) provides regulatory review and oversight of the drug development process. The Investigational New Drug application is the primary mechanism that the FDA uses to regulate clinical testing in humans. A New Drug Application summarizing all of the data necessary to perform risk/benefit analysis of the new drug is submitted to the FDA for review and approval once sufficient testing has been completed. Recent research into the pathogenesis of inflammatory bowel disease has yielded numerous drug targets resulting in a multitude of molecules and biologic agents under varying stages of development and a consequent need for clinical testing. A thorough understanding of the regulatory development process and the National Institutes of Health funding process is necessary for any investigator involved in clinical trials.

Clinical Trials as Topic↗
PubMed2005

How will RNAi facilitate drug development?

Development of effective drugs for treatment of human disease relies on identification of therapeutic molecular targets. The identification of targets to treat human disease has previously relied on genetic screens in model organisms, and less robust or lower throughput approaches in mammalian systems. RNA interference (RNAi) makes possible, for the first time, the use of large-scale functional genomics approaches for target identification in human cells. This remarkable breakthrough has the potential to influence every facet of the drug discovery process, and is poised to revolutionize drug development. Reports of RNAi screens for the identification of novel genes implicated in apoptosis, cell division, and drug resistance support the enormous promise of this technology. Here, we discuss the potential impact of RNAi screens on target identification and validation and consider issues that warrant caution when interpreting RNAi screening results.

Animals↗