BioStat Solutions, Inc. of Frederick, MD at MEDICA 2017 in Düsseldorf -- MEDICA Trade Fair
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BioStat Solutions, Inc.

5280 Corporate Drive, Suite C200, 21703 Frederick, MD
United States of America

Telephone +1 301 829-4001
Fax +1 301 829-4166
info@biostatsolutions.com

This company is co-exhibitor of
Maryland Department of Commerce

Hall map

MEDICA 2017 hall map (Hall 16): stand C18

Fairground map

MEDICA 2017 fairground map: Hall 16

Our range of products

Product categories

  • 07  Medical Services and Publications
  • 07.01  Reports and analyses
  • 07  Medical Services and Publications
  • 07.01  Reports and analyses
  • 07.01.02  Laboratory planning
  • 07  Medical Services and Publications
  • 07.01  Reports and analyses
  • 07.01.03  Evaluations

Our products

Product category: Reports and analyses, Laboratory planning, Evaluations

BIOMARKER ANALYSIS

Biomarkers play a crucial role in the era of precision medicine.  Applications of biomarkers are being increasingly utilized in basic biomedical research and medical product development. Measurement of physiologic processes from biochemical, cellular, or molecular alterations are utilized to better understand disease etiology, prodrome, or drug response.

BSSI has been offering biomarker consulting and analytical services to the pharmaceutical and biotechnology industry for more than fifteen years. From the beginning, BSSI has been a pioneer in the field of translational sciences, specializing in biomarker analytics. BSSI serves clients from industry, academic and research institutions, and government agencies, and has become a preferred service provider of biomarker statistics for several major pharmaceutical companies.

Experienced translational team:
  • Biostatisticians
  • Bioinformaticists
  • Epidemiologists
  • Geneticists
Support from discovery through clinical development and application:
  • Identification and validation of disease state biomarkers
  • Measurement of pharmacokinetic (PK) markers to determine dosing
  • Linking pharmacodynamic (PD) biomarkers to the mechanism of action (MOA) of a therapeutic intervention
  • Analysis of relationship between predictive or prognostic biomarkers and drug effectiveness and safety
  • Utilization of biomarkers to identify and stratify patients with improved efficacy and safety profiles
  • Assist the development and validation of diagnostic tools (e.g. companion diagnostics)
Experienced in analyzing different types of biomarker data:
  • Next generation sequencing (NGS) for DNA and RNA: whole genome or exome sequencing, RNA sequencing
  • Microarrays for DNA and RNA: whole genome genotyping, candidate genes, methylation arrays, and gene expression arrays
  • Immunoassays: enzyme-linked immunosorbent assay (ELISA) for proteins, and microsphere-based immuno-multiplexing for cytokines and chemokines, and others
  • Imaging data
  • Data from other techniques such as immunohistochemistry (IHC), mass spectrometry, and flow cytometry

Complex data structure requires specialized approaches:
  • Analytical expertise for genetic and expression studies including variant, gene protein, and pathway level analyses
  • Computing capabilities to handle large amounts of data (such as proteomic and image data)
  • Predictive modeling
  • Resampling and machine learning approaches
  • Identification and stratification of patient subgroups
  • Systems biology approaches for pathway and network analyses
  • Effective illustration and exploration of biomarker data through static and interactive visualization

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Product category: Reports and analyses, Laboratory planning, Evaluations

MEDICAL COUNTERMEASURES

What are Medical Countermeasures?

“Medical countermeasures, or MCMs, are FDA-regulated products (biologics, drugs, devices) that may be used in the event of a potential public health emergency stemming from a terrorist attack with a biological, chemical, or radiological/nuclear material, a naturally occurring emerging disease, or a natural disaster.” (From the FDA website)

Product Development Under the Animal Rule

When developing a medical countermeasure, testing for efficacy in humans would not be ethical or feasible.  The FDA therefore developed regulations for approval of these products based on well-controlled animal studies. Results from those animal studies have to show that the drug or biologic is reasonably likely to produce a clinical benefit in humans. These regulations are commonly referred to as the Animal Rule.

Since the establishment of the Animal Rule in May 2002, statistical methodologies have been developed to bridge the gap between animal models and predicting efficacy in humans. BSSI has many years of experience supporting clients in the development of MCMs (drugs, biologics and medical devices) and has been developing new analytical strategies to support the approval process under the Animal Rule. The challenges are numerous and include:

  • Development of well-characterized animal models:Study design and power analysis
  • Median lethal dose estimation
  • Toxicokinetics studies
  • Validation for assays measuring correlative of protection, potency, and toxicity
  • Endpoints established in the animal studies have to be clearly tied to the desired benefit in humans
  • Kinetic and pharmacodynamic analyses in animals and humans are necessary to determine a “humanized” dose
  • Pharmacokinetics/Pharmacodynamics analyses
  • Non-inferiority evaluation of effective doses

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Product category: Reports and analyses, Laboratory planning, Evaluations

MEDICAL DEVICE SUPPORT

BSSI has successfully supported the development and clearance for numerous medical devices.  Whether it is an in vitro diagnostic or an imaging tool, our staff has deep expertise in analytical and clinical validation, including multiplex assays employing advanced technologies such as NGS. Our strategic consultants help with study conceptualization and design as well as with supporting regulatory communications. Our statistical staff has extensive experience in assay validation and methods comparison from R&D validation, through Laboratory Developed Tests (LDT), 510k (Class I through de novo), and PMA clearances for simple and advanced technologies.

Study Conceptualization and Design
  • Analytical and clinical design considerations
  • Protocol development
  • Power and sample size determination
Statistical Analyses
  • Analytical assay/methodology validationSpecificity, accuracy, precision, limits of detection, limits of quantification, linearity and range, ruggedness (reproducibility) and robustness
  • Device comparisonNon-inferiority, superiority, equivalence
  • AUC, ROC, LROC, FROC, SSPN
  • Quality assurance and controlQuality management system and processes to support regulatory submissions
  • Statistical packages and software for analysis in a regulated environment
Reporting and Regulatory Communications
  • Experience with many regulatory bodies: CAP, CLIA, ISO, FDA, EMA
  • Comprehensive packages in support of PMA, 510(k) (Class I, II, III and de novo), CE mark, LDT, IDE applications

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About us

Company details

ABOUT BSSI
BioStat Solutions, Inc. (BSSI) provides innovative expert-level statistical analysis and strategic consulting to the pharmaceutical and biotech industries as well as to the US Government. BSSI has its roots in the National Cancer Institute, where its President and CSO did her post-doctoral training. BSSI was established in 2001 based on the need for statisticians and clinical investigators to be able to communicate effectively in order to make smart decisions in the analyses and interpretation of clinical studies.

BSSI’s Precision Statistics® approach provides the client with an individualized approach where statistical analyses tools are carefully matched to the research needs and business objectives of the client. In this approach, our statisticians function as a team to provide relevant information to our clients and assist in the interpretation of statistical findings that helps answer the “so-what” question. Unlike typical Clinical Research Organizations (CROs), BSSI provides access to a pool of highly experienced statisticians, geneticists and epidemiologists, using a composite FTE (Full Time Equivalent) model, thereby making sure the right expertise is available for each individual project. Statistics by itself is merely a tool. Thorough background knowledge in most disease areas and experience with virtually every data type guarantees for a quick project start and no time wasted with “getting the statistician up to speed”.

Whether a client is working with novel data (e.g. Next-Generation Sequencing data) in the precision medicine arena or entering new regulatory terrain (e.g. licensure under the FDA Animal Rule), innovative strategies are required to help navigate these challenges. BSSI’s Precision Statistics® approach supports clients towards developing the right study design, and implementing the appropriate analytical approach, with validated analyses appropriate for regulatory submission. In other words, The Right Analysis using the Right Tools for the Right Data.

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