|
| |
BioReports
-
Drug and Market Development
http://www.bioportfolio.com/cgi-bin/acatalog/Drug_and_Market_Development.html
| |
The pharma industry loses about $20 billion annually to
counterfeiters.
Artesunate, a major weapon against malaria, is widely counterfeited.
Researchers have found that up to 33 percent of the artesunate sold in
Thailand, Cambodia and Vietnam contained no active ingredients. Of 30
medicines named in a list of drugs especially susceptible to
counterfeiting, 23 are used in treating HIV/AIDS and cancer. |
|
| |
Regulatory bodies in the US, Canada, EU and Japan accept the CTD
document format when applying for IND and NDA approval. This multiparty
agreement, led by the ICH Harmonization, facilitates the application
process when multi-nation regulatory approvals are being sought. The
ground work and preparation of the CTD is critical since it serves as
the platform for regulatory filings. Module 3 of the CTD focuses on
Chemistry, Manufacturing and Controls (CMC) documentation relating to
substance and product quality. Providing the correct information in
sufficient detail in this section will reduce delays and costs. |
|
| |
D&MD's Transdermal & Transmucosal Delivery of Therapeutics, 2nd
Edition market analysis report estimates the transdermal/transmucosal
drug delivery market is poised for growth through 2010.
Delivering drugs non-invasively through the skin, and particularly
through the mucosa in the oral cavity or nose, has grown from a
specialized application field to a formulation option that is not only
convenient for the patient but also combines sustained or flash delivery
with improved metabolic profile. While transdermal and transmucosal drug
delivery had mainly focused on smoking cessation and cancer pain a few
years ago, the therapeutic scope has since dramatically expanded to
include contraception, sexual dysfunction, alcohol abuse, attention
deficit disorder, and Parkinson's disease, among others. In addition,
new chemical entities are now being specifically tailored for this route
of administration as a competitive marketing strategy. |
|
| |
G-protein coupled receptors (GPCRs) have proven to be a highly
amenable target class to successful therapeutic intervention via
small-molecule drugs. There are 324 distinct molecular drug targets for
all classes of approved pharmaceuticals of which 25 percent modulate
GPCRs. |
|
| |
D&MD's Current Drug Development Market for Cytokines, Chemokines and
Growth Factors focuses primarily on the cytokine market, company
pipelines and trials in the field of cytokine research. This report
succinctly details all the latest advances in the push to market of
cytokine-based therapeutics: which products have evolved, which have
failed and new players on the field. Primary readers will have
comprehensive updates on relevant company pipelines. |
|
| |
The Discovery to IND process currently takes an average of 6.5 years
and consumes over 40% of the total R&D budget for a new drug. This
critical, initial phase yields a drug candidate that, with FDA approval
of an IND, will enter Phase 1 clinical trials in healthy human
volunteers. The stakes are high because the initiation of human clinical
trials commits a company to significant additional R&D investment.
Consequently, the process of drug candidate discovery through to IND
submission which consists of a series linear and parallel, steps,
procedures and outcomes critical to reducing the risk of further
investment. This initial phase is also governed by the need to present a
cogent case before the FDA in order to gain approval to move the
candidate into clinical trials. |
|
| |
Next-generation molecular diagnostics utilize multiplexing platforms
(such as DNA and protein microarrays, or bead-based technologies), to
perform parallel biomarker analyses in order to obtain more
comprehensive clinical information. During 2005 and 2006, the FDA
approved the first DNA microarray instrumentation system for IVD use (Affymetrix's
GeneChip System 3000Dx), and the first highly multiplexed diagnostic
microarrays: Roche's AmpliChip CYP450 test, and two cystic fibrosis
tests - Tm Bioscience's Tag-It and Osmetech's eSensor. Although they
have not yet been approved by the FDA, tests based on transcriptomic and
proteomic profiling have also debuted successfully on the market. |
|
| |
While the bulk of the business for enzymes is still serving the
industrial market, the growth areas are increasing utilizing
biotechnology. Revolutionary changes in molecular biology are churning
out thousands of new uses of enzyme technology, fueling major growth in
this multi-billion-dollar field.
D&MD's Commercial Opportunities in Enzyme Technologies, 3rd Edition
examines the many current opportunities for enzymes as well as areas
targeted for future growth. Specific attention is paid to the growing
and various uses of enzymes over several industries from industrial uses
to therapeutic targets. In addition, this Report profiles companies
designing and producing enzymes, detailing their technologies and
product pipelines. |
|
| |
Unprecedented levels of funding reaching tens of billions of dollars
from governments, large corporations and private venture capital during
the last decade, has yet to bear the fruits on the ROI. Optimistic
predictions have slowly given way to the painful reality that the impact
of nanotechnological applications may take one or two decades before
anticipated pay offs become apparent. However, a recent analysis of more
than 200 commercially available products that use nano-based
technological enhancements in the pharmaceutical, medical or healthcare
field is reinforcing the notion that "incremental" modifications of
existing drugs, drug delivery devices and tissue engineering products
enhanced by nano innovations is actually profitable and beginning to
harvest revenue. |
|
| |
Several new developments have taken place in the Antibody
Therapeutics in the last two years. These developments are primarily in
the antibody market place and in clinical development areas as opposed
to in the antibody discovery field as was observed in the early part of
this decade. That the emphasis in the field has shifted from the
discovery area towards product development is obvious by the fact that
many of the companies are now involved in building product based
collaborations and in some cases major antibody discovery companies have
become attractive enough that some of those have been acquired by large
pharma organizations. |
|
| |
The kinase-targeted drug market is forecast to reach $58.6 billion
in 2010.
D&MD's Kinases: Advanced Strategies for Drug Discovery market
analysis report comprehensively reviews protein kinases and assesses
their importance as drug targets. Approaches to kinase drug discovery
are evolving. Small molecule inhibitors now encompass
rationally-designed single-target inhibitors and multi-target inhibitors
developed with the aid of new screening and profiling assays. Innovative
biopharmaceuticals are making inroads into the market. The range of
indications for kinase-targeted drugs is expanding. |
|
| |
This Guide thoroughly evaluates the capabilities, strengths,
weaknesses, and expectations of leading assays and assay technologies.
Assay development is often time consuming and frustrating. But
reliable, robust assays are key to every phase of pharmaceutical
development. D&MD's Assay Development & Technology, 2nd Edition provides
critical information to speed and simplify the development and
optimization of most technologies. This Guide eliminates the tendency to
"reinvent the wheel" by providing valuable tips that incorporate the
author's many years of hands-on experience in the field.
|
|
| |
About $70 million (20%) of the total R&D costs per drug are spent on
ADME/Tox failures.
Preclinical toxicity is one of the major bottlenecks in drug
development. In particular, the ability to predict the safety of a drug
in the preclinical stage, prior to human testing, has been one of the
major bottlenecks in drug development. Current approaches have serious
limitations in their ability to predict toxicity in humans, and thus
invite substantial risk not only in terms of patient welfare, but also
in terms of the cost of late-stage clinical trial failure. The
integration of novel and traditional approaches to preclinical toxicity
assessment will have a major impact on the ability to predict compound
behavior in humans, reduce clinical trial failure, and cut both risk and
cost in drug development. |
|
| |
This report focuses on two key pharmaceutical target classes-GPCRs
and Ion Channels. GPCRs and Ion Channels are important targets. They are
associated with a number of disease areas and are currently associated
with blockbuster pharmaceutical sales status. Identifying future
direction of industry growth opportunities in these spaces can be
challenging. |
|
 |
Recent projections predict a serious shortfall in manufacturing
capacity in the next 3 years.
The biotechnology industry has been growing at a rapid rate,
currently topping $35 billion worldwide. The industry most affected by
this impressive growth is the bioprocessing industry, which provides the
means for the fabrication, and testing of biopharmaceutical products.
The bioprocessing industry is under constant pressure to increase
efficiency, reduce production costs, and speed time to market. To meet
these heavy demands, bioprocessing companies are adapting and innovating
faster than ever. |
|
| |
D&MD's updated Good Manufacturing Practices professional development
guide provides pharmaceutical and biological companies of all sizes with
assistance in regulatory compliance. The guide examines the new FDA
Guidance for Industry documents and a new amendment covering an
exemption for investigational drugs in Phase 1 studies. The guide is
addressed particularly to smaller sized companies, perhaps those with
their first new drug, working on this extra challenge to their
capabilities.
|
|
| |
D&MD’s High-Growth Diagnostics: Technology and Market Analyses of
Segments experiencing Robust Growth in the Various Diagnostics Spaces
market analysis report focuses on the market segments within the
diagnostics industry that are currently experiencing robust growth. This
also analyzes the technologies, markets (both qualitatively and
quantitatively), and key companies within this space. |
|
| |
D&MD’s new Pain Therapeutics market analysis report focuses on new
advances in drug discovery and development. The report provides a
background on pain, current therapies and research and development in
the area. Profiles of companies with major pain programs include Abbott
Laboratories, AstraZeneca, GlaxoSmithKline, GW Pharmaceuticals, Johnson
& Johnson, Merck & Co., Neuromed Pharmaceuticals, Novartis, Pfizer,
Vernalis, VistaGen Therapeutics, Xenome and more. In-depth interviews
with industry leaders provide specific case studies from both biotech
and academia that give a sense of what’s really going on in the
trenches. |
|
| |
The transporter-targeted drug market is forecast to reach $153.8
billion in 2010 and more than 100 transporter drug targets are under
commercial investigation.
Transporters represent a highly druggable class of targets and are
addressed by many successful drugs on the market. Of the 957 or so human
transporter genes, around 10 percent are being targeted for therapeutic
effects, which leaves a large number of potential targets unexplored. As
additional transporters are characterized and their structures are
elucidated competition in this field is likely to increase. |
|
| |
Five years after the historic completion of the Human Genome
Sequencing Project, personalized nutrition and medicine are fields
evolving with an emphasis on discovering and researching biomarkers to
aid diagnoses. Specifically, clinical pharmacogenomics, theranostics,
and nutrigenomics are all examples of areas where diagnostic have
entered the arena of being used in conjunction with drug treatments and
nutrition recommendations. The availability of genome sequences and
biotechnology developments, such as clinical microarrays during the last
year, are driving the development of diagnostics. At the same time, the
technology is progressing, regulatory issues have to keep up with the
changes. The FDA approval of Affymetrix's AmpliChip at the end of 2004
and beginning of 2005 as a 510K device rather than analyte specific
reagents reflects the changing landscape of genetic testing regulation.
Therefore, having examples and cases studies of business strategies,
business models, regulatory, and reimbursement issues are extremely
useful for learning and understanding the commercialization process of
diagnostics that are to be used in conjunction with therapeutics. |
|
| |
D&MD's Growth and Technological Advances of the Biodisposables
Market is valuable tool. The report details and reviews the
implementation, cost-effectiveness, utility and applications, including
advances in specific apparatus, for disposable biotechnology equipment
including filters, mixers, dispensers, connectors, storage bags and
bioreactors. |
|
| |
Chronic Obstructive Pulmonary Disease (COPD) has been a much
neglected area in drug development for several decades but now is the
fifth leading cause of death worldwide.
Widely recognized as self-inflicted by smoking, COPD has often had
low priority in respiratory programs. It is now realized that at least
600 million people, worldwide, suffer from COPD-numbers indicative of
epidemic proportions. Governments, healthcare workers and pharmaceutical
companies have recently prioritized and raised awareness of this disease
area as one of major unmet medical need. Indicative of prioritization of
this disease is the widespread occurrence of COPD-specific drug
discovery in respiratory R&D in pharmaceutical companies. It is evident
that a paradigm shift is taking place in COPD drug discovery. Rather
than the traditional approach of symptom relief; new generation
pharmaceuticals are beginning to target underlying disease.
|
|
| |
To date, three types of molecules have been developed for the
treatment of human diseases. These major classes of molecules are 1)
small molecules, 2) antibodies, and 3) peptides. Currently, the majority
of the therapeutic molecules developed and marketed are small molecules.
However, with the recent development in several technologies in the
areas of peptide synthesis, screening, stability, and modifications,
peptides are now recognized as lead molecules for therapeutics. |
|
| |
Securing FDA approval or clearance is not a guarantee of payer
coverage or payment for your novel drug or device. D&MD's Guide to US
Reimbursement for Drugs, Medical Devices, and Diagnostics is a
comprehensive review of how medical technologies secure payment from
private and public payers. The Guide examines coverage, coding, and
payment issues from private payer (HMO, PPO) and public payer (Medicare,
Medicaid) perspectives. The Guide is indispensable for life science
technology executives who are responsible for reimbursement strategy,
securing reimbursement, or assessing the value of a new technology with
reimbursement in mind. D&MD's Guide to US Reimbursement for Drugs,
Medical Devices, and Diagnostics will provide insight to a wide audience
of product managers, reimbursement planners, business development
executives, and CEOs. |
|
| |
D&MD’s Life Sciences Mergers & Acquisitions (M&A): A Reference Guide
Illustrating Recent Trends in Life Science M&A market analysis report
focuses on mergers & acquisitions (M&A) in the general life sciences
space.
This report is an excellent reference guide for the life sciences
audience engaged primarily in drug discovery and development. The report
includes information on the latest industry statistics on recent life
sciences merger and acquisition transactions in biotechnology and
medical devices, latest industry statistics on initial public offerings
(IPOs) and venture capital investing. Specifically, key merger and
acquisition transactions within the last 18 months in the life sciences
tools space are presented and characterized in this report to help
readers spot growth trends or define exit strategies.
|
|
| |
High-content Screening (HCS) is a focused term referring to the
re-screening process-referred to sometimes as secondary
screening-whereby the use of different types of assays enables a number
of different parameters of a system to be assessed, in the presence of
given lead compounds (in this manner, the effect of lead compounds on
the biological system can be studied and those leads that display
significant toxicity, for instance, can be eliminated early in the
process-thereby enabling triage of the sub-optimal leads).
|
|
| |
The bio-outsourcing trend is being influenced by recent developments
such as dwindling biopharmaceutical financial support, increasing costs
associated with building biomanufacturing facilities, increasing
regulatory complexity surrounding biomanufacturing, shortages of
qualified manufacturing and technical personnel, and the advent of
disposable technologies. |
|
| |
Breast Cancer treatment is undergoing major transition. New targeted
therapies are emerging that target cancer cells and spare healthy cells,
resulting in reduced side effects. These developments have arisen
following at least two decades of research into the molecular mechanisms
that underlie cancer phenotypes. |
|
| |
Traditionally, treatment of human diseases is carried out by small
or large molecules that modulate specific cell types. In the majority of
the cases, such as cancer, the aim of the treatment is to kill cancer
cells, leading to the physiological benefit of the organism. In other
circumstances, the disease cells are manipulated to perform a specific
function that they normally do not. A variety of therapeutic molecules
have been utilized to carry out for treatment leading to therapeutic
benefit. These include small molecules, peptides, proteins, antibodies,
anti-sense RNAs, and ribozymes. In the case of cell therapy, as the name
indicates, treatment is carried out with cells instead of small
molecules, as mentioned above. In cell therapy, cells are given to the
patient as the therapeutic delivery system for a specific disease to
achieve therapeutic benefit. |
|
| |
The application of pharmacogenomics in drug development is
widespread today in differing degrees of intensity. Pharmacogenomics has
recently seen an inflection point that pharmaceutical and biotechnology
companies need and want to understand. Given recent issues with Cox-2
inhibitors and anti-depressants, the FDA is increasingly focused on
bringing personalized medicine to this area. Advances in patents and
technology are occurring at a faster rate than ever before. The first
FDA approved test in this area was for the Roche and Affymetrix 2D6
GeneChip. |
|
| |
D&MD's Protein Therapeutics Production: Large-scale Mammalian Cell
Culture provides an introduction and overview of current manufacturing
practices associated with large scale mammalian cell culture. The focus
is on the use of large scale mammalian cell culture systems. The
industry, which began in the late 1980s from the utilization of
recombinant DNA technology and cell hybridization, is now a significant
production process of the biopharmaceutical industry. |
|
| |
During the past two decades, biopharmaceuticals have advanced the
prevention and treatment of many serious diseases, and also contributed
to the continued success of the pharmaceutical industry.
Biopharmaceuticals have shorter development times than chemically
synthesized drugs NCEs and the ability to clone, manipulate and express
proteins in high concentrations has facilitated the development of
biotechnology based drugs. |
|
| |
More than 100 companies are developing or have developed antibody
array and/or bead platforms. The competition is fierce, but the progress
in the field has been slow. The problem has been a disconnect between
the capabilities of the available technologies and the demands of the
market place.
|
|
| |
Since the publication of the first edition, pharmaceutical and
biotechnology companies have broadened from a primary focus on biomarker
discovery to greater emphasis on assay development and implementation of
biomarker applications. Drug developers have also demonstrated increased
interest in imaging-based based biomarkers. The second edition,
Post-Genomic Biomarkers: From Discovery to Implementation covers these
and other new developments |
|
| |
GPCRs represent the largest pharmaceutical target class, and account
for approximately 50% of all currently
G Protein-Coupled Receptors (GPCRs) account for 50% of the current
drug targets, and remain about one-third of the drug discovery effort in
the drug discovery-development community. As a result of the sequencing
of the human genome, more than 150 orphan and non-chemosensory GPCRs
have been identified for which their cognate ligands or biological
functions are unknown. De-orphanization of those receptors could bring
novel therapeutic targets to the industry against which novel
therapeutics could be designed. In addition, current GPCR-based drugs
only target ~30% of the approximately 200 known GPCRs in the genome.
This is a rich target class that is highly-druggable. |
|
| |
Transmissible spongiform encephalopathy (TSE) agents, or prions as
they are commonly referred to, are a significant concern to the
biologicals and biotechnology industries. With the BSE epidemic in the
UK in the nineteen eighties and the subsequent demonstration that the
BSE prion has crossed the species barrier and manifested itself in
humans as variant Creutzfeldt-Jakob Disease (vCJD), risk assessment when
ruminant and specifically, bovine-sourced materials are used in the
manufacture of biopharmaceuticals is imperative. The altered tissue
tropism of vCJD (localized in the lymphoid tissues rather than the
central nervous system), combined with the resilience of prions to most
inactivating agents, the extended incubation period (measured in years
and decades rather than days and months) and lack of validated prion
detection assays for detection during the subclinical phase of the
disease have escalated the stakes for biotherapeutics from a TSE-safety
standpoint. |
|
| |
There has been an "omics" explosion. With the advent of genomics,
proteomics, transcriptomics, there is also now metabolomics and
metabonomics. These terms are the newest sibling to genomics and
proteomics and are supposed to embody metabolic profiling. Metabonomics
is defined as measurement of the complete metabolic response of an
organism to an environmental stimulus or genetic modification. Some
people use the term metabolomics to refer to metabonomics at the level
of a single cell type, rather than a larger system. In this report we
will use both terms interchangeably. |
|
| |
RNAi is the hottest topic in biotechnology and is positioned to
revolutionize research and drug discovery. The drug discovery market
based on RNAi is projected to be $650 million in 2005 and $1 billion by
2010. Don't miss out on your share of this growing market! The
increasing demand for target validation and the large number of new
potential targets has augmented the need and importance of RNAi in
sorting through the possibilities. The future is bright for this
technology in that it may supplant or complement crucial existing
technologies such as antisense and knockout models. As the first drugs
are commercialized there will be an even greater interest in this
exciting new technology. |
|
| |
This Report reviews current thinking about when life actually
begins. Practical issues relating to the use of stem cells are
overviewed as well as the topics associated with clinical research in
children. The Report also deals with the appropriateness of withholding
treatment in the case of terminally ill patients. In addition, it
profiles the unfortunate occurrence of fraud in clinical research and
the ways in which those involved in clinical research can be prepared to
prevent its recurrence. |
|
| |
Proteases are a superfamily of enzymes with important roles in the
regulation of cellular protein activity. There are at least 475 known
and putative proteases and 103 homologs to known proteases in humans,
and it is estimated that up to 1,200 human genes encode proteases.
Successful established protease inhibitor drugs on the market act by
inhibiting key proteases. Their success has led to proteases being
increasingly viewed as valuable drug targets in disease treatment and a
range of protease inhibitors are in various stages of commercial
development. |
|
| |
The area of protein-protein interaction has been growing at a
tremendous rate. The market is expected to reach over $50 billion by
year 2010. Protein-protein interaction targeting activities are
increasing and are expected to bring success in the near future.
Protein-protein interactions are critical for normal and tumor cells
signal transduction pathways, making them attractive targets for
developing therapeutic molecules.Targeting protein-protein interactions
has been challenging due to the diversity and complexity of proteins
involved and the structures they form. However, the number of
therapeutic molecules that have been developed against signal
transduction proteins that are involved in protein-protein interactions
is increasing at a steady rate. |
|
BioPortfolio's BioReports catalogue is one of the most comprehensive sources of
specialized life science management reports on the internet. You can search our database by using the
links below:
If you
represent a publisher who wishes to market via BioPortfolio's BioReports service
please contact
Peter Barfoot.
| |
|
