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BioJournal - Insight Pharma Reports
http://www.bioportfolio.com/cgi-bin/acatalog/Insight_Pharma_Reports.html
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Recent developments reflect the explosion in the number of kinase
inhibitors that have entered clinical development in the past few years: *
By the end of 2006 seven kinase inhibitors had reached the market, three in
the period December 2005-December 2006.
* Their collective sales exceeded $4 billion.* Three more kinase
inhibitors have been approved in 2007.
* In addition to ongoing studies of approved kinase inhibitors seeking line
extensions, a further 11 are in Phase III studies.* More than 130 kinase
inhibitors are reported to be in either Phase I or Phase II clinical
development, with 47 reported to be in Phase II studies. |
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Molecular diagnostic tests are now used for a wide range of
applications, including: * Human clinical molecular diagnostic testing
* Veterinary molecular diagnostic testing* Identity testing
* Forensic testing* Histocompatibility testing |
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In the more than 30 years since the first process for creating
monoclonal antibodies, or mAbs, was introduced, they have remained a
centerpiece of the growing biotechnology industry. Twenty-four therapeutic
mAbs have been approved, several of which have attained blockbuster status,
with sales reaching the coveted billion-dollar mark and well beyond. Two
drugs, Remicade and Rituxan, generated sales of about $4 billion each in
2006, and global sales for this entire portfolio approached $20 billion in
that year. |
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Backup compound planning has risen in importance as the percentage of
R&D projects focused on unprecedented targets has skyrocketed. Heads of R&D
and chemistry, therapeutic area heads, portfolio analysts, and project
managers all recognize that there is no surer way to minimize Phase II risk
than a well thought-out backup plan. |
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The pharma industry is gradually coming to realize that the classically
structured clinical trial does not offer enough flexibility to make use of
continuously emerging knowledge that is generated as the trial progresses.
This report is a comprehensive assessment of the benefits, challenges, and
accumulated industry experience with regard to adaptive clinical trials. It
includes: * A critique of the structural, conceptual, and ethical issues
inherent in the traditional clinical trial.
* An in-depth review, based on actual case studies (e.g., Napo, Genaera,
Pfizer, Lilly, Millennium, and various academic institutions) of the use of
adaptive and Bayesian approaches in Phases I, II, and III* An assessment
of various hybrid and seamless designs in which the line between trial
stages is blurred
* Evolving regulatory positions of FDA, EMEA, and ICH on adaptive designs;
industry response and initiatives
* A review of specialized software vendors (e.g., Cytel, Tourtellotte,
Pharsight, CTriSoft) and their applications that have emerged to support
adaptive designs.
* A CHI Insight Pharma survey of the views and experiences of individuals
involved with adaptive designs* Three future scenarios for the
integration of adaptive designs in clinical trials by 2015: (1) United
States Leads the Way, (2) Globally Integrated Midphase Revamping, and (3)
the Late Phoenix Scenario
* Roundtable interviews with senior executives in industry and consulting
who bring decades of combined experience in adaptive and Bayesian clinical
trial designs |
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Current trends and future directions in genome sequencing A growing
number of companies and academic groups are reporting impressive progress in
commercializing new sequencing platforms that offer orders of magnitude of
improved throughput and cost. The prospect of routine, personalized genome
sequencing is suddenly within reach, not to mention spectacular advances in
a host of related fields. This new report from CHI Insight Pharma Reports
describes and assesses these developing technologies and their applications:
* Pyrosequencing* Sequencing by synthesis
* Supported oligonucleotide detection (SOLiD)* Single-molecule sequencing
* Nanopore sequencing* Optical trapping |
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In recent years, there has been an explosion in predictive technologies
to help researchers select only the most promising candidates for clinical
development. The need for such tools is driven by the disastrous economic
consequences of late-stage failures, which account for over 60% of all drug
terminations. This report describes a powerful and novel predictive tool
called Bayesian network modeling and demonstrates its application in
clinical forecasting. Among its many potential benefits, clinical
forecasting can: * Reduce drug development costs
* Increase median cumulative 7-year revenue per Phase III trial* Redirect
capital and human resources to development programs with the greatest
likelihood of success
* Expose clinical trial subjects to fewer unsafe or ineffective drugs*
Improve the accuracy and decision-making utility of market forecasts (which
currently assume that all drugs in the projection period will achieve NDA
approval)
* Increase industry’s and society’s confidence in including pediatric
subjects in clinical trials |
http://www.bioportfolio.com/cgi-bin/acatalog/Insight_Pharma_Reports.html
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