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Oct. 15, Vol. 29, No. 18

BioBusiness
- Point of View
  - DTC Genomics & Leading-Edge Ethics
  - Chris MacDonald, Ph.D.
  - Direct-to-consumer (DTC) personal genomics services such as those currently marketed by 23andMe, Navigenics, and deCode, among others, occupy a small place in today’s biotech industry, but an enormously important position on the trajectory of the in ... more »
- Corporate Profiles
  - Merrion Strives to Turn IV Drugs into Tablets
  - Carol Potera
  - The drugs in the pipeline at Merrion Pharmaceuticals are not new chemical entities poised to become blockbuster drugs. Instead, the company specializes in designing oral formulations for existing drugs that must be given intravenously or by injectio ... more »
- BioMarket Trends
  - Firms Seek to Prove Cancer Stem Cell Hypothesis
  - Keith Markey, Ph.D.
  - The pharmaceutical and biotech industries have begun to develop targeted inhibitors of pathways that contribute to tumorigenesis and metastasis. These new medicines offer the promise of treating many types of cancer with greater efficacy and fewer u ... more »
- Spotlight on the FDA
  - Update on Evolving Regulatory Guidance
  - Bruce Mackler, Ph.D., J.D.
  - The FDA’s position on a myriad of issues is constantly evolving. Companies need to be aware of these pending and implemented changes and adjust their practices accordingly. This month’s column will focus on ghost writing of medical journal articles, ... more »
Drug Discovery
- Feature Articles
  - High-Content Screening Surges Ahead
  - Vicki Glaser
  - High-content screening (HCS) and the technology to do it faster, on more compounds in a shorter period of time, and to generate quantitative, multiparametric data took center stage at CHI’s “High Content East” meeting held in Boston last month. Pres ... more »
- Tutorials
  - Automated Cell Culture with 3-D Substrate
  - Nadia Badr
  - Brad Justice
  - Robin Felder, Ph.D.
  - In recent years, there has been a significant decline in the success rate of drug candidates in clinical trials. This situation has put pharmaceutical companies under immense pressure to reduce expenses and increase productivity. As a result, drug r ... more »
- Tech Notes
  - Assessment of Drug Interaction Potential
  - Igor Mezine, Ph.D.
  - Chris Bode, Ph.D.
  - Sid Bhoopathy, Ph.D.
  - For at least a dozen years since the publication of a 1997 FDA guidance on in vitro metabolism studies, drug developers have been required to perform in vitro tests of drug interaction potential prior to clinical trials. The 1997 guidance has been u ... more »
OMICS
- Feature Articles
  - qPCR Faces Growing Pains Head-On
  - Kathy Liszewski
  - Quantitative PCR (qPCR) technologies have exploded in the last decade. Commonly used for both diagnostics and basic research, new and exciting advances are being made in such areas as biomarker discovery and treatment monitoring. This rapid growth h ... more »
- - Use of Microarrays Increasing Rapidly
  - Sophia Fox
  - A team from the Technical University of Denmark and the Copenhagen University Hospital recently published research results obtained with a microfluidic device known as a Multi-Stringency Array Washer (MSAW). According to the researchers, the MSAW fa ... more »
- Assay Tutorials
  - High-Resolution Melt Analysis Applications
  - Viresh Patel, Ph.D.
  - Genomics is rapidly expanding beyond merely identifying the genetic makeup of organisms to encompass studies of how variations in genotype impact physiological function. Applications involving analysis of the genome include mutation discovery, SNP g ... more »
- Tech Notes
  - Assessment of Drug Interaction Potential
  - Igor Mezine, Ph.D.
  - Chris Bode, Ph.D.
  - Sid Bhoopathy, Ph.D.
  - For at least a dozen years since the publication of a 1997 FDA guidance on in vitro metabolism studies, drug developers have been required to perform in vitro tests of drug interaction potential prior to clinical trials. The 1997 guidance has been u ... more »
Bioprocessing
- Feature Articles
  - Enhancement of Cell Culture Techniques
  - Angelo DePalma, Ph.D.
  - The CHI conference “Optimizing Cell Culture Technology,” which was held in Boston recently, featured several speakers whose work directly affects the biopharmaceutical industry. Yubing Xie, Ph.D., assistant professor at the College of Nanoscale Sc ... more »
- - Novel Tools Streamline Purification Process
  - K. John Morrow Jr., Ph.D.
  - Participants at a recent downstream processing meeting sponsored by Sartorius Stedim Biotech considered a host of new technologies to speed and streamline protein purification, including membrane chromatography, nanofiltration, ultraviolet irradiati ... more »
- Tutorials
  - Simulated Moving Bed Chromatography
  - Anthony Grabski, Ph.D.
  - Robert Mierendorf, Ph.D.
  - The number of protein-based pharmaceuticals reaching the marketplace has dramatically increased over the past few years. New developments in protein expression and bioprocessing technologies have led to significant advancements in protein manufactur ... more »
- Sidebars
  - Cells That Get No Respect
  - Plant cell culture has not received the attention it deserves from biopharmaceutical companies, but that may change as research-level developments reach the corporate level. One reason, said Karen McDonald, Ph.D., professor of chemical engineering a ... more »
Translational Medicine
- Feature Articles
  - Fighting Pancreatic Cancer's Intractable Nature
  - Patricia Fitzpatrick Dimond, Ph.D.
  - This year has been disappointing for physicians and patients hoping for new treatment options for pancreatic cancer. Pfizer terminated its Phase III development of axitinib in pancreatic cancer in January. Sanofi-Aventis and Regeneron Pharmaceutical ... more »
- - GEN's Cryptogram Challenge Solved
  - Two scientists from Canada have figured out the answer to the Genetic Engineering & Biotechnology News Cryptogram Challenge. Adrienne Halupa, Ph.D., serves as project manager/research associate in the department of chemistry at the University of ... more »
- - Stem Cell Technologies Boost Regenerative Medicine
  - James Netterwald, Ph.D.
  - Akin to the transition from winter to spring, stem cells regenerate life. Their regenerative role in the human body is the subject of intensive research aimed at producing the next generation of effective cell-based cures for various human diseases. ... more »
- Corporate Profiles
  - Merrion Strives to Turn IV Drugs into Tablets
  - Carol Potera
  - The drugs in the pipeline at Merrion Pharmaceuticals are not new chemical entities poised to become blockbuster drugs. Instead, the company specializes in designing oral formulations for existing drugs that must be given intravenously or by injectio ... more »
- BioMarket Trends
  - Firms Seek to Prove Cancer Stem Cell Hypothesis
  - Keith Markey, Ph.D.
  - The pharmaceutical and biotech industries have begun to develop targeted inhibitors of pathways that contribute to tumorigenesis and metastasis. These new medicines offer the promise of treating many types of cancer with greater efficacy and fewer u ... more »