All Recent GLG News Analyses by Leading Experts at BioRankings, LLC

William ShannonFounder and PresidentBioRankings, LLC

The data and news behind the FDA decison

January 31, 2010

Analysis of:FDA to Re-evaluate Use of Erythropoiesis-Stimulating Agents in Chronic Kidney Disease | www.parenteaubc.com

The FDA announced plans for an advisory review board in 2010 to re-evaluate erythropoiesis-stimulating agents (ESAs) usage and dosing for the treatment of anemia in chronic kidney disease. This decision followed publication of a report indicating ESAs provide no benefit in outcome compared to placebo, and increases stroke rates.

William ShannonFounder and PresidentBioRankings, LLC

Cancer Immunotherapy Explained

January 31, 2010

Analysis of:Immunotherapy Demystified: Investing In High Risk, High Reward Opportunities In Cancer Therapeutics | www.parenteaubc.com

The Parenteau BioConsultants and BioRankings Alliance, both GLG consultants, have released a free ebook for investors and biotech executives -- "Immunotherapy Demystified: Investing In High Risk, High Reward Opportunities In Cancer Therapeutics".This ebook presents the necessary background of the biology and statistics of this field to help the investor avoid the hype and spin behind cancer immunotherapies, and reduce the risk of their investment decisions. 

William ShannonFounder and PresidentBioRankings, LLC

Meta-analysis of probiotics in atopic dermatitis

April 16, 2009

Analysis of:Probiotics for the treatment or prevention of atopic dermatitis: a review of the evidence from randomized controlled trials. | www.ncbi.nlm.nih.gov

The use of meta-analysis to evaluate probiotics in this condition is commendable.  The abstract suggests that improvement may be real, but the evidence presented indicates that probiotics may be ineffective on careful reading.  The abstract is lacking information needed to determine the quality of the meta-analysis and whether its results/suggestions should be considered in investment decisions.

William ShannonFounder and PresidentBioRankings, LLC

New FDA effort takes aim at genomics: Inherent risk to investors

February 6, 2009

Analysis of:New FDA Effort to Take Aim at Genomics | www.genomeweb.com

The risk to an investor in genomic or personalized medicine is significant and a clear understanding of the low power and high risk of false-positives needs to be kept in mind.  The establishment at the FDA of a senior scientist to oversee and coordinate genomic activities is necessary but not necessarily sufficient to insure that future genomic treatments are effective. 

William ShannonFounder and PresidentBioRankings, LLC

Eli Lilly's Personal Medicine Goal

November 27, 2008

Analysis of:Personal medicine is goal of Eli Lilly & Co. | www.azcentral.com

The Chairman of Eli Lilly announcing that personalized medicine (e.g., pharmacogenetics) is a major shift in strategy for big pharma could impact in a significant way the market share for new drugs and the amount of money for research needed to bring a targeted therapy to market. If this strategy is widely accepted the likely impact on small biotech firms will be a significant increase in their value and more acquisitions.

William ShannonFounder and PresidentBioRankings, LLC

Dealing with publication bias using the 'file drawer' scenario.

October 28, 2008

Analysis of:Many Trial Reports on FDA-Approved Drugs Go Unpublished | www.washingtonpost.com

In this meta-analysis, the authors looked at the number of studies, if any, per new drug application with the FDA that got published, at what time, and how much information they released. They concluded that there is strong evidence of publication bias in what the drug companies will make public, with only 76% of pivotal trials and 24% of non-pivotal trials making publication. We looked at how this publication bias can affect investors when making investment decisions about pharmaceutical companies, due to limited or incomplete public information.

William ShannonFounder and PresidentBioRankings, LLC

Is Biodel's argument to drop the India data from analysis valid?

October 9, 2008

Analysis of:Biodel Releases Preliminary Phase III Clinical Trials for VIAject | www.fiercebiotech.com

Biodel’s September 8th announcement of the Phase III non-inferiority trial results for VIAject at the 44th Annual Meeting of the European Association for the Study of Diabetes (EASD) in Rome left many investors wary of the legitimacy of the data that was presented. The study, which was originally conducted in the US, Germany, and India, did not include the data from the Type 1 study in India in its final results due to the company’s claims of data anomalies that question the validity of the data for determining non-inferiority. We analyzed the study design and subgroup analyses to understand the impact of eliminating the India subgroup on the final trial results.

William ShannonFounder and PresidentBioRankings, LLC

Review of Statistical Conclusions of National Trends in Psychotherapy by Office-Based Psychiatrists

August 20, 2008

Analysis of:National Trends in Psychotherapy by Office-Based Psychiatrists | archpsyc.ama-assn.org

An August 2008 study analyzing the National Ambulatory Medical Care Survey (NAMCA) database shows a significant decrease in the amount of psychotherapy that psychiatrists are providing for their patients, while at the same time possibly showing an increase in medications prescribed. This correlation implies an emerging trend away from the traditional role of the psychiatrist as providing therapy to control common psychiatric disorders. We looked at the study design and statistical analyses to determine what impact this study should have as a commentary on possible changes in prescription rates.

William ShannonFounder and PresidentBioRankings, LLC

Biostatistical and Experimental Design Assessment of Research on Tau Tangle Targeting for Alzheimer’s Disease

August 5, 2008

Analysis of:New Treatment Halts Progress of Alzheimer's Disease | www.abdn.ac.uk

Slowing the progression of Alzheimer's disease by attacking tau tangles is a novel idea that should be considered a viable treatment alternative, especially in light of the failings of some recent beta-amyloid treatment strategies (e.g., Flurizan).   At the 2008 International Conference on Alzheimer's Disease (ICAD 2008), Dr. Claude Wischik (Univ. of Aberdeen and TauRx Pharmaceuticals) and colleagues gave positive research reports on treatments developed to target and dissolve the tau tangle protein complex, including the first report of an international randomized Phase II clinical trial of Rember™.   We performed a comprehensive biostatistical and experimental design assessment of the pre-clinical and clinical research reported by Dr. Wischik and colleagues at ICAD 2008, to see if the evidence for tau tangle targeting has early scientific validity.

William ShannonFounder and PresidentBioRankings, LLC

Biostatistics: Subgroup Analysis in Clinical Trials

December 28, 2007

Analysis of:Statistics in Medicine – Reporting of Subgroup Analyses in Clinical Trials | content.nejm.org

The authors of this NEJM Special Report define subgroup analysis as “any evaluation of treatment effects for a specific end point in subgroups of patients defined by baseline characteristics.” When done appropriately, subgroup analysis are valuable. However, when done post hoc they can lead to incorrect conclusions. Understanding how subgroup analysis should be done can help when making decisions as to whether a company has correctly analyzed their clinical trials data or whether the results they are reporting have a high chance of being wrong.

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