BioStat Solutions, Inc.
BioStat Solutions, Inc.
Blog Post
  • Currently, the pharmaceutical and scientific communities are highly interested in the functional role of “-omics” data in clinical research. Omics data (e.g. DNA, mRNA, microRNA) help to understand pathways and biological processes along with identifying genetic variation or differentially expressed genes as potential biomarkers for drug target discovery and patient stratification. Omics data, par...

BioStat Solutions, Inc.
BioStat Solutions, Inc.
Blog Post
  • Clinical trials are inarguably the most expensive part of drug development, and the most risky to study subjects. Thus, it is only sensible to promote maximal usage of already available data, through data sharing. However, some stakeholders are hesitant to share data, stating concerns for patient confidentiality and vulnerability of intellectual property in pharmaceutical and biotechnology industr...

BioStat Solutions, Inc.
BioStat Solutions, Inc.
Blog Post
  • Because of various genetic and/or environmental factors, treatment response may vary across patient populations. As a result, increased focus on targeted therapies has led to great interest in subgroup analysis. Therefore, proactive planning is imperative for subgroup analysis. Here, I focus on trial designs that foster subgroup analysis, and on analysis methods that can be explored further to opt...

BioStat Solutions, Inc.
BioStat Solutions, Inc.
Blog Post
  • Statisticians are often categorized into two groups: clinical and nonclinical. The nonclinical statistician encompasses most areas where studies were not involved in a clinic. This wide variety of work means that nonclinical biostatisticians have a wide variety of challenges to face. Of all these challenges, three main ones were discussed at the 2015 Nonclinical Biostatistics Conference (NBC) at V...

BioStat Solutions, Inc.
BioStat Solutions, Inc.
Blog Post
  • Most people grimace when I tell them I am a consulting statistical analyst for pharmaceutical, biotechnology and biodefense industries. That or they stare at me blankly trying to remember half of the words I just told them. For me, the amount of words in my job description depicts the variety and excitement I experience every day. While a student, it is common to work on the same project for month...

BioStat Solutions, Inc.
BioStat Solutions, Inc.
Blog Post
  • To appreciate the need for advancement in pharmacogenomics (PGx), let’s start by taking an inventory of the success in this space since the approval of Herceptin (the first drug with PGx / biomarker information in its label). A review of the FDA’s Pharmacogenomic Biomarkers in Drug Labeling Table revealed only 12% of drugs since Herceptin had PGx / biomarker information in their label and only 14 ...

BioStat Solutions, Inc.
BioStat Solutions, Inc.
Blog Post
  • The promise of personalized medicine is becoming a reality in the space of oncology with a noticeable shift in the past decade from targeting the largest possible population to targeting cancer subtypes with smaller patient populations or biomarker-defined subgroups of a patient population with enhanced response. Approximately 60% of US drug sales related to anti-cancer drugs are targeted therapie...

BioStat Solutions, Inc.
BioStat Solutions, Inc.
Blog Post

New blog articles detected.

  • Experiences from NCBI’s Biomedical Data Science Hackathon 2016

    Data sharing is critical to advance genomic research because it reduces the demand to collect new data by reusing and combining existing data, while upholding transparency in research, promoting reproducible research.  As of January 2015, the National Institutes of Health (NIH) has implemented a Genomic Data Sharing (GDS) Policy that applies to all large scale genomic data generated with NIH fundi...

  • Analytical Challenges and Opportunities Associated with the Analysis and Interpretation of Clinical Studies in Precision Medicine

    Recent advances in technology have led to a proliferation of data and in genomic testing alternatives for complex diseases as more treatment options are developed to target genomic and/or proteomic alterations in subsets of the overall population. Due to these recent advances in the capturing of genomic variables (Kalf et al., 2015; Marzuillo et al., 2014), there has been an increased clinical, an...

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