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registry of biomedical companies

May 24, 2022

promoting the transfer of scientific know-how between industry and academia

Registry of biomedical companies:

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BioStat Solutions, Inc.

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

Phone: 301.829.4001
Fax: 301.829.4166
Please notice: This entry hasn't been updated by the submitting company for more than 2 years. It could be possible that this company doesn't longer exists.

Description:

BioStat Solutions, Inc. (BSSI) is a statistical consulting corporation providing services in biomarker statistics, medical & diagnostic device studies and vaccine development.

Biomarker Statistics:

We offer statistical expertise, from SAP development to reporting, and analytical support, from program creation to validation, on the PGx / biomarker component of studies:

Across Phase I-IV clinical trials as well as exploratory studies
Across therapeutic areas: Oncology, Diabetes, Neuroscience, Cardiovascular, Autoimmune, Infectious Diseases, Musculoskeletal, and ADME
Across commercial assay platforms: SNP genotyping (whole-genome or candidate gene), next generation sequencing (NGS), gene expression (chips and qPCR), immunohistochemistry (IHC) and a wide array of protein assays
And we are experienced and adept at dealing with data from novel assay platforms

Biomarker Discovery & Evaluation

Analysis of Targeted or High‐Dimensional Biological Data
Empirical Evidence to Support Marketable Differentiation Strategies

Patient Stratification

Identification of Treatment‐Specific Subgroups
Estimation of Disease Subtypes

Integration of Biomarker Programs with Your Portfolio

Drug Target Identification
Characterization of Mechanism of Action
Using Late‐Phase Studies to Inform Early‐Phase Decisions

Medical Countermeasures

The development of medical countermeasures (i.e. drugs, devices, or biologics) for use in biodefense presents unique challenges due to the ethical implications of actively exposing humans to known lethal agents and low frequency of natural occurrence limiting the ability to perform efficacy evaluations in observational studies. Alternative solutions such as the use of animal models or surrogate biomarkers must be developed to predict likely clinical benefits in humans, and these new scientific challenges necessitate tailored analytical strategies.

Challenges of Gaining Licensure

Engagement with a cross-functional team of experts
Understanding of the requirements set forth in 21 CFR Parts 314 and 601 (FDA Animal Rule)
Ability to interact with cross governmental agencies (e.g. FDA, NIAID, DSTL)
Selection of appropriate design and methods to demonstrate performance

The Complete Analytical Solution

Strategic planning
Statistical Analysis Plan (SAP) development
Program creation and validation
High quality reporting (SARs, regulatory documents, presentations)
Representation for interactions with collaborators and governmental agencies

Medical Devices

Medical devices span many spaces and applications, ranging from radiology (e.g., multi-reader multi-case studies) to pathology (e.g., in vitro companion diagnostics built on IHC data). In this complex landscape, it is critical to understand concepts from pre-analytical development through analytical and clinical validation.