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| 2 min read
The late March announcement that Cambridge, U.K.-based Cytomix would acquire Ardais Corp.’s biorepository of more than 130,000 biospecimens was much more than a simple transaction for Ardais. It marked the completion of a year-long strategic remaking of Ardais that moved the company from a provider of biospecimens for the research community, to a consultant whose services help research centers manager their internal tissue collection and biospecimen management systems.

| 2 min read
Vaccine specialist VaxGen recently announced a collaborative effort with privately held biotechnology company EndoBiologics International to pursue research into a vaccine that targets meningitis B, a bacterial disease that targets children and can lead to mental retardation, loss of limbs, and even death. According to Atlanta’s Centers for Disease Control and Prevention, meningitis attacks approximately 1 in every 100,000 people worldwide, but regional epidemics can kill tens of thousands of people.

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Newly designated FDA Commissioner Lester Crawford will deliver a keynote address at the 10th Annual Drug Discovery Technology & Development World Congress, scheduled for August 8-11 at the Boston Convention & Exhibition Center here. Dr. Crawford’s speech, “New Regulatory Directions for the 21st Century,” will explore the theme of the conference “Optimizing the Discovery and Development Interface to Improve Productivity.” His remarks will focus on new regulatory and scientific steps to make the introduction of novel drugs more predictable and less time-consuming. He will also elaborate on the FDA’s reforms designed to facilitate the modernization of drug manufacturing and to strengthen the safety of marketed medicines.

| 3 min read
Developments this past month surrounding stem cell research have been nothing short of astounding. First came news from South Korea that researchers there have successfully cloned patient-specific stem cells, cell lines that were genetic matches to donor patients. This advance is a fundamental step if stems cells are ever going to be used for the vast array of potential therapies researchers envision.
While scientists from research institutions

| 3 min read
Will translational medicine alter the discovery landscape?
Anyone who has been involved in the drug discovery and biotech arenas for any time knows, there is a simple paradigm that holds the universe together: basic research begets drug development begets clinical research begets healthcare. The mantra is as fundamental—nay, visceral—as DNA begets RNA begets protein.
And yet, even as modern biology has shown us that RNA can form DNA and proteins can “replicate” themselves (think prions), so too are we facing the possibility of another paradigm lost; that the healthcare process may not be unidirectional afterall. If explored to its fullest potential, this new paradigm—translational medicine or translational research—will have a significant impact on how we explore human health at all levels.

| 2 min read
In March, the FDA’s Center for Drug Evaluation and Research (CDER) released the long-awaited report “Guidance for Industry: Pharmacogenomic Data Submissions”, which offers the regulatory agency’s thoughts on voluntary genomic data submission as a component of the drug and biologics review process.
















