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GEN Online posts articles and columns from the print edition of Genetic Engineering & Biotechnology News. Read our acclaimed columns, including Wall Street BioBeat, FDA News & Analysis, Point of View articles by industry experts, and the ever popular Best of the Web bioscience website reviews, and learn about the new products that are fueling the industry.

Current Issue - Feb 1, 2010 (Vol. 30, No. 3 )


BIOBUSINESS

Point of View

  • Board Composition Planning
  • Peter C. Johnson, M.D.
  • A corporate board should be composed of members having high character and the proper collective skill set to guide corporate strategy successfully. Achieving this end through the initial selection of board members or by adjusting the membership of an existing board is nevertheless a high achievement.

    ... more

Legal Affairs

  • Court Ruling Could Lengthen Patent Term
  • Courtenay C. Brinckerhoff
  • The Federal Circuit started 2010 on a positive note for patent holders by affirming the district court decision in Wyeth v. Dudas (affirmed as Wyeth v. Kappos) on the proper interpretation of the patent term adjustment (PTA) statute. The court determined that the U.S. Patent and Trademark Office (PTO) has erroneously interpreted the statute in a manner that shortchanges patentees by undercalculating PTA in certain circumstances.

    ... more

Wall Street BioBeat

  • Antidepressant Efficacy Called into Question
  • Patricia F. Dimond, Ph.D.
  • Antidepressants have provided huge profits for pharmaceutical companies. Drug sales reached almost $11 billion in 2008, with Wyeth’s Effexor representing almost 36% of the market at about $3.93 billion. According to IMS Health, 164 million antidepressant prescriptions were written in 2008, an increase of 4 million over 2007.

    ... more

Corporate Profile

  • Savara Breathes Life into Inhaled Therapeutics
  • Carol Potera
  • Inhalable therapeutics offer a new formulation option and delivery route for existing drugs that are losing patent protection or need to become more efficient. Inhaled drugs should ideally be one to three microns in diameter, the best size for delivery into the deep lung for local and systemic absorption.

    ... more

BioMarket Trends

  • Epigenetic Research Surges on Many Fronts
  • Christianne Bird
  • The discovery that epigenetics plays a pivotal role in the regulation of gene expression sparked tremendous interest among researchers to further study these processes. Epigenetic research has experienced a tremendous surge in recent years, as researchers discovered the major role DNA methylation, chromatin and histone modification, and other epigenetic mechanisms play in various biological processes.

    ... more

DRUG DISCOVERY

Feature Article

  • In Vivo Imaging Accelerates Development
  • Nina Flanagan
  • In vivo imaging technology is advancing rapidly and expanding to include not only drug discovery and development but also diagnostics. Current efforts range from developing novel brain-imaging agents to further understanding the molecular basis of human behavior to engineering antibody fragments for cancer imaging biomarkers.

    ... more

Tutorial

  • Obtaining Pluripotency Biomarker Signatures
  • Kathryn Sciabica, Ph.D.
    Knut Woltjen, Ph.D.
    Akitsu Hotta, Ph.D.
  • Recent methods to reprogram human somatic cells in order to create induced pluripotent stem cells (iPSCs) are intended to provide important tools for drug discovery and models for the study of disease. The ultimate goal is to create an alternative to controversial embryonic stem cells (ESCs) and eventually generate patient-specific pluripotent cells for autologous cell therapy. 

    ... more

OMICS

Feature Article

  • Epigenetics Offers Strategies for New Drugs
  • Susan Aldridge, Ph.D.
  • Increasing numbers of scientists are focusing their studies on epigenetics to get a better handle on how internal and external factors lead to cellular malfunctioning and impact the progression of various human diseases.

    ... more
  • Expanding the Usefulness of qPCR
  • Vicki Glaser
  • The scope of real-time quantitative (qPCR) assays for gene-expression analysis in research applications and for sequence-specific nucleic acid detection for diagnostic purposes continues to grow. Driving this growth are increasingly robust, automated, and high-throughput technologies and multiplexed analytical strategies.

    ... more
  • Insights Accrue on Epigenetic Modification
  • Richard A. Stein, M.D., Ph.D.
  • The biomedical literature provides many examples when medical conditions that were classically viewed as a paradigm for genetic inheritance appear to be shaped by additional factors, which cannot be explained by DNA sequence variation alone. For example, there are several reports of monozygotic twins with Huntington disease who, despite harboring identical numbers of the CAG trinucleotide repeats, differ in their age at onset and in clinical presentation and progression.

    ... more

Assay Tutorial

  • Minimizing Protein-Detection Expenses
  • Todd Watterson
  • The protein-detection landscape has seen a number of advances in the last decade. Much of our knowledge of proteins has come from using ELISA, Western immunoblot, immunoprecipitation, and two-hybrid systems. Of those advances, the ability to simultaneously detect multiple proteins in a single sample has greatly enhanced our understanding of some of the complex protein interactions that occur in normal and disease states. The manifold benefits of multiplex protein detection are increasingly being appreciated by researchers.

    ... more

Tech Update


BIOPROCESSING

Feature Article

  • Microbioreactors Carve Out Growing Niche
  • Angelo DePalma, Ph.D.
  • With volumes ranging from the low tens of milliliters to nanoliters, microbioreactors (MBRs) have become one of the more interesting engineering stories in biotech. At the high-end, MBRs serve as versatile scaledown systems for process development, whose utility is limited only by control capabilities. Capabilities vary significantly below 30 mL or so, but this is where much of the exciting work is going on.

    ... more

Tutorial

  • In-Line Process Analytics for Fractionation
  • Kurt Hiltbrunner
  • The starting material for virtually all pharmaceuticals and biologics is a synthetic or chemical. Human plasma-derived therapies are one of the few exceptions. A number of fragile proteins can be extracted from human plasma. Indeed, no other single starting material can be utilized for producing such a diverse range of therapies as is possible from human plasma.

    ... more

CLINICAL RESEARCH & DIAGNOSTICS

Feature Article

  • Emerging Label-Free Technologies
  • K. John Morrow Jr., Ph.D.
  • Cell-based assays are powerful tools for monitoring response to external activation signals in living cells. Recognition of this fact has been responsible for roughly 40% growth in the industry in 2008, according to SMI Conferences, which recently sponsored a symposium on the topic. The meeting showcased new developments, including many different automated platforms, new assays for hepatotoxicity, and assays based on the application of transient gene expression, transmembrane receptors, and pluripotent stem cells.

    ... more
  • Innovative Drug R&D on the Rise in China
  • Jim J. Zhang, Ph.D.
    Qunjie Man
  • As the Chinese pharmaceutical industry expands rapidly, Chinese pharma and biotech companies—and even outsourcing service providers—are increasingly paying attention to and investing in innovative drug R&D. A flotilla of returnees and venture capital firms are aiding in these endeavors.

    ... more

Tutorial

  • Cryopreserved PBMCs and Cell-Based Assays
  • Deepa Patke, Ph.D.
    Anis H. Khimani, Ph.D.
    Christine Marking
    Renee M. Howell, Ph.D.
    Mark Manak, Ph.D.
  • The advent of new and precise high-throughput screening technologies has opened up a vast resource for understanding the molecular mechanisms underlying disease, genetic disorders, and immune dysfunction. It is estimated that each year 100 or more cellular targets of disease are discovered, making it critical to develop and optimize appropriate screening and evaluation approaches to accelerate the development of successful drug therapies or potent vaccines.

    ... more

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