GVKBIO Online Biomarker Database
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GVK BIO Online Biomarker Database - GOBIOM

GVK BIO Online Biomarker Database (GOBIOM) is a comprehensive biomarker database that provides information on Biochemical, Genomic, Imaging, Metabolite, Clinical Scoring scales and Cellular markers for 18 different therapeutic areas, covering 1700+ therapeutic indications with its reported utilities like diagnosis, prognosis, monitoring disease progression, treatment response, surrogate, efficacy and toxicity. Information is gathered from over 200,000 sources which include clinical trials, scientific conferences, regulatory-approved documents, literature databases, patents etc.

new

What's new on GOBIOM

  • Companion diagnostics approved by regulatory agencies
  • 'In development' companion diagnostics
  • Drug resistance biomarkers
  • Novel biomarkers reported in last 6 months
  • PMDA, Japan approved diagnostics

Choose the best biomarker to diagnose disease, monitor disease progression, treatment selection, predicting treatment outcome, monitor treatment efficacy and safety using GOBIOM


Target Discovery/Identification:

Enables discovery biologists working on an indication to gain insights into proteins/genes targeted by drugs. Genes/proteins activated in the disease condition i.e. diagnostic biomarkers can serve as a therapeutic target enabling discovery of new drugs


Drug Repositioning:

Enables companies involved in new drugs development to gain insights into probable use of the drug in other indications. Analysis of Top 10 indications vis-a-vis number of biomarkers can provide insights into drug repositioning in indications other than which the drug is intended to use.


Competitive Intelligence:

Provides critical information on ongoing and completed clinical trials in addition to companies involved in drug discovery and development. It also provides insights into the competitive landscape in a given therapeutic area or a specific indication


Clinical Decision Support:

Helps identify/stratify patients who will respond to the treatment and also identify efficacy biomarkers which aids in designing effective clinical trials


Clinical Trial Insights:

Provides insights into clinical trial landscape vis-a-vis ethnicity, sample size and different specimens evaluated for measuring the biomarker. It also provides information about evaluated end points in different studies which could assist researchers in incorporating the most relevant endpoints in the clinical trials


Safety/Toxicity Profiling:

Enables safety/toxicity profiling of a drug by assessing the biomarkers reported for toxicity and safety application. Researchers working on a compound can gain insights into the biomarkers of toxicity, response and resistance


Biomarker Classification:

Biomarkers are classified based on the nature and technique used to measure a biomarker. ex: biochemical, genomic, imaging, metabolite, physiological, scoring scale, cellular etc. or by the chemical nature of the biomarker ex: DNA, RNA, epigenetics, microRNA, polymorphism, non-coding RNA, lipid, antibody etc.


Biomarker Utility:

Each biomarker is assigned with the following utilities as reported by the investigator.


Diagnosis:


Biomarkers which indicate the presence or likelihood of a particular disease in patients or in animal models.


Prognosis:


Biomarkers which can discriminate between patients at high and low risk of a clinical outcome.


Progression of Disease:


Biomarkers which can indicate the progression of disease.


Efficacy:


Biomarkers which correlate with the desired effect of a treatment.


Response to Therapy:


Biomarkers predictive of response to a treatment.


Surrogate:


Markers which substitute a desired clinical outcome and which can be measured months or even years before meaningful clinical endpoints like mortality or morbidity.


Safety:


Biomarkers suggestive of potential harmful effects of a drug in clinical population.


Toxicity:


Biomarkers suggestive of potential harmful effects of a drug in cell-based or preclinical studies.


Pharmacokinetic:


Biomarkers which can be used to indicate the pharmacokinetic properties of the drug.


Clinical Scoring Scales:


Scoring scale biomarkers are standard rating scales used by the clinicians to detect the severity or relapse of the disease.


Drug Resistance:


Predictive of resistance to a particular therapy or treatment failure.


Biomarker Qualification:

Evidence based FDA/EMEA/PMDA approved biomarker qualification information associating biomarker to specific biological process or clinical end point.


Experimental Qualification:

Biomarker specific information including biological specimens evaluated, experimental technique used, FDA/EMEA/PMDA approved diagnostic kits, approved companion diagnostics, assay provider information and assay analytical qualification details.


Statistical Evaluation of Biomarkers:

Information on statistical relationship of the biomarker with clinical endpoints and other variables with details including statistical significance, confidence intervals, odds ratio, relative risk, hazards ratio etc.


Clinical Meta Data:

Information on clinical trial design, biomarkers evaluated, clinical endpoints, sponsors and collaborators, phase of the study, study population, ethnicity details etc.


Drugs/Intervention:

Information on drugs/intervention synonyms, drug target pathways, drug targets, end points, efficacy and safety characteristics, drug induced toxicity and drug resistance.


Preclinical Qualification:

Information of putative biomarkers of human diseases in animal models and cellular models.


Intuitive user interface:

Web-enabled search application with basic search, advance search and batch query option for quick and easy access of biomarker data.


Manual curation of biomarker data:

Manual curation of each data field ensuring accuracy of the data


Standard nomenclature/ontology followed throughout the database

Biweekly updates with auto alert function for all users

GOBIOM analytics platform helps you visualize and analyze huge and discrete biomarker datasets and gain insights on how biomarkers are used and developed. The robust analytics platform aids in evidence based development of diagnostics, effective decision making in drug discovery and development, identification of research gaps, gain competitive advantage,and to enable clinical decision support.

GOBIOM heat map visualization allows you to visualize biomarker trends in an indication or evaluate biomarkers common between different indications. It helps understand the role of common diagnostic biomarkers reported in multiple indications aiding in understanding the complex biological system and cellular networks in disease development.

Data can be exported into Excel, PDF or XML files with an option to provide oracle dump which can be integrated with client proprietary data

Training and support:

24/7 online support and on demand training sessions

Pharma/Biotech companies:

Helps you to
  • Identify disease mechanism and validate drug target
  • Build PK/PD models to understand safety and efficacy in preclinical setting
  • Study dose response in early clinical trials
  • Define target population in late clinical studies
  • Monitor therapeutic response and side effects in post marketing setting

Diagnostic companies:

Helps you to
  • Predict response to therapy in a population
  • Assess safety profile of any given drug
  • Check disease progression and monitoring of disease
  • Estimate patient's prognosis and determining treatment options

R&D Centers:

Helps you to
  • Broaden patent scope so as to identify other biomarkers and drugs not within the ambit of the patent
  • Assess competitor landscape
  • Develop known drugs in new therapeutic areas

Benefits:

Target Discovery/Identification:


GOBIOM enables discovery biologists working on an indication to gain insights into proteins/genes targeted by drugs. Genes/proteins activated in the disease condition i.e. diagnostic biomarkers can serve as a therapeutic target enabling discovery of new drugs

Drug Repositioning:


GOBIOM can help companies involved in new drugs development to gain insights into probable use of the drug in other indications. Analysis of Top 10 indications vis-a-vis number of biomarkers can provide insights into drug repositioning in indications other than which the drug is intended to use.

Competitive Intelligence:


GOBIOM provides critical information on ongoing and completed clinical trials in addition to companies involved in drug discovery and development. It also provides insights into the competitive landscape in a given therapeutic area or a specific indication

Clinical Decision Support:


GOBIOM can help identify/stratify patients who will respond to the treatment and also identify efficacy biomarkers which aids in designing effective clinical trials

Clinical Trial Insights:


GOBIOM provides insights into clinical trial landscape vis-a-vis ethnicity, sample size and different specimens evaluated for measuring the biomarker. It also provides information about evaluated end points in different studies which could assist researchers in incorporating the most relevant endpoints in the clinical trials

Safety/Toxicity Profiling:


GOBIOM enables safety/toxicity profiling of a drug by assessing the biomarkers reported for toxicity and safety application. Researchers working on a compound can gain insights into the biomarkers of toxicity, response and resistance

Questions Addressed By GOBIOM

  • Are there any diagnostic biomarkers?
  • Are there any biomarkers to identify disease progression and prognosis?
  • What are the markers linked to efficacy/toxicity of a drug?
  • Are there any biomarkers approved by regulatory authorities?
  • Is the biomarker translating from preclinical to clinical models?
  • What are the clinical endpoints to which a biomarker is significantly correlated?
  • What is the study population who would be most benefitted by a therapy?
  • How many clinical trials are associated with a given biomarker? What is the biomarker outcome in each trial?
  • What are the approved diagnostics for a given biomarker and who are the assay vendors?
  • What are the available companion diagnostics and is there any scope for development of new CDx?
  • What are the drug resistance biomarkers reported for a given therapy?

Press Releases:

  • US FDA Extends License of the GVK BIO Biomarker database


    February 04th, 2013; Hyderabad, India: GVK Biosciences (GVK BIO) today announced that it is extending its Clinical Biomarker Database (GOBIOM) license to the Biomarker Qualification Group of the US Food and Drug Administration (USFDA). The GOBIOM database, which has the latest and recently updated information on all the biomarkers reported in various clinical and preclinical studies, will be beneficial to the USFDA in its Biomarker Qualification Process.
  • GVK Biosciences licenses its Biomarker Database to The Division of Cancer Prevention, National Cancer Institute


    September 4th, 2012; Hyderabad, India: GVK Biosciences (GVK BIO), Asia's leading contract research organization announced today that it has licensed its popular clinical biomarker database (GOBIOM) to the prestigious Division of Cancer Prevention (DCP), National Cancer Institute (NCI).
  • Indiana CTSI partners with GVK Biosciences to provide national access to biomarkers database


    June 08, 2011, Hyderabad: In an agreement facilitated by the Indiana Economic Development Corporation (IEDC) during a February economic mission to India, the Indiana Clinical and Translational Sciences Institute (CTSI) has partnered with GVK Biosciences, Asia's leading Contract Research Organization, to provide researchers across the United States access to GVK BIO's Clinical Biomarker Database that will advance research on wide range of diseases. The Indiana CTSI Bioinformatics Core and Indiana Institute for Personalized Medicine will work together to manage the process by which researchers access this new resource.
  • GVK Biosciences Partners with the PROOF Centre of Excellence, University of British Columbia in Biomarker Development and Commercialization


    November 15th, 2011; Hyderabad, India: GVK Biosciences (GVK BIO), Asia's leading drug discovery research and development organization, announced today a new partnership with the PROOF Centre of Excellence, focusing on biomarker development for heart, lung and kidney failure.

Posters:

Interpretation of common diagnostic markers reported for Colorectal cancer and other indications for the development of multiplex biomarker panels; Analysis using GOBIOM Biomarker Database


Madhukar P, Nikhil T, Vijaya Rao P, Pavan B, Srikanth Y, Suman C, Ramadevi S

Heat map visualization of the diagnostic biomarkers that overlap between Pancreatic cancer and other indications; Analysis using GOBIOM Database


Sreeni Devidas, Ramadevi Sanam, Sreenivasa Rao Guggilla, Vijaya Rao Pidugu,Pavan Kumar Bhatta, Madhukar Reddy Patlolla, Srikanth Yinala, Rajkumar Kommalapati, Suman Challa, Ayyappa Chaturvedula

Drug-induced nephrotoxicity analysis in HIV therapy;case study using creatinine biomarker data from GOBIOM database


Madhukar Reddy Patlolla, Vijaya Rao Pidugu, Pavan Kumar Bhatta, Sreenivasa Rao Guggilla, Rama Devi Sanam, Sreeni Devidas

Clinical Utility of Circulating Tumor Cells Enumeration in Breast Cancer Prognosis


Sreeni Devidas, Ramadevi Sanam, Sreenivasa Rao Guggilla, Vijaya Rao Pidugu,Pavan Kumar Bhatta, Madhukar Reddy Patlolla

Osteopontin as a Diagnostic biomarker in cancer research - Analysis using GOBIOM database


Sreeni Devidas, Ramadevi Sanam, Sreenivasa Rao Guggilla, Vijaya Rao Pidugu,Sarma Jagarlapudi

BIOMARKERS IN CLINICAL DRUG DEVELOPMENT


Sreeni Devidas, Ramadevi Sanam, Sunita Tajne, Sarma Jagarlapudi

Publications:

Challenges and opportunities for oncology biomarker discovery


Deyati A, Younesi E, Hofmann-Apitius M, Novac N Merck Serono

13,000-biomarker deal


Killugudi Jayaraman Indiana CTSI

Differentially expressed RNA from public microarray data identifies
serum protein biomarkers for cross-organ transplant rejection and other conditions


Chen R, Sigdel TK, Li L, Kambham N, Dudley JT, Hsieh SC, Klassen RB, Chen A,Caohuu T, Morgan AA, Valantine HA, Khush KK, Sarwal MM, Butte AJ Stanford University

Methods for monitoring allograft rejection


BUTTE, Atul, J, CHEN, Rong. The Board Of Trustees Of The Leland Stanford Junior University

The Handbook of Biomarkers


Jain, Kewal K.

Literature Sources:

  • Clinical trial registries

  • Clinical trial results published by pharmaceutical and Biotech companies

  • Published journal articles

  • Patents

  • Scientific meetings

  • FDA/EMA/PMDA Regulatory websites

  • 510K and PMA databases

  • News alerts and Press releases