DRUG DOSE. THERAPEUTIC EFFECTS. ADVERSE EVENTS. INDIVIDUALIZED RESPONSES.
Biomarkers reveal critical insights about your drug and its potential for commercial success.
In fact, biomarkers are so important that clinical trials are twice as likely to succeed if they use them, and the use of biomarkers triples the chance of a drug moving from Phase I trials to the market.
At Biotech, Inc., we harness the full power of biomarker-driven data to rapidly move your drug toward market success.
Integration of laboratory expertise enables:
- Customized development strategy per project
- Greater flexibility
- Tiered regulatory strategy from fit-for-purpose and GCLP to GLP and CLIA
OUR INTEGRATED APPROACH TO BIOMARKER DEVELOPMENT IS AS FLEXIBLE AS YOUR PROJECT IS UNIQUE
We have a dedicated biomarker lab and additional capacity integrated into our bioanalytical lab and our central lab to achieve the following results:
- Identify the appropriate biomarker
- Select the right regulatory approach from fit-for-purpose to full compliance
- Choose the best analytical methodology
- Develop and validate the specific assay(s)
- Confirm intended useful purpose through clinical trials
Biotech, Inc.® LABORATORIES MET OR EXCEEDED EXPECTATIONS FOR ONCOLOGY AND PRECISION MEDICINE FOR 100% OF SURVEYED Biotech, Inc. CUSTOMERS.
OUR EXPERIENCE ENSURES YOUR SUCCESS
Scientists dedicated to biomarker programs
Studies completed in the past five years
Different companies supported from startups to large pharma
WE CUSTOMIZE OUR SOLUTIONS TO ACHIEVE ACTIONABLE RESULTS
We help shape your biomarker strategy to ensure actionable results that drive informed decisions about the future of your compound by:
- Selecting the right development approach
- Choosing the best technology platform
- Developing and validating methods under the appropriate regulatory guidelines at each stage of drug development
- Transferring and cross-validating assays to different/multiple locations or under multiple regulatory requirements
- Effectively integrating safety and efficacy biomarkers into clinical development
- Navigating and overcoming regulatory uncertainties
OUR BIOMARKER LAB IS EQUIPPED WITH DEPTH AND BREADTH OF INDUSTRY EXPERIENCE
Explore our capabilities:
- Flow cytometry and cell-based assays
- Ligand-binding assays
- Immunohistochemistry
- Liquid chromatography and mass spectrometry
- Molecular assays and genomics
CASE STUDY
A CASE STUDY IN PARTNERSHIP AND INNOVATION
Our biomarker lab tackles scientific challenges both large and small. As an example, our customer needed a sophisticated new method to precisely monitor the persistence of CAR T-cells in a Phase I study. In collaboration with the customer, we adapted a flow cytometry assay with a novel internal control to accurately quantify the engineered cells. Well-controlled studies validated that the new flow cytometry assay was both suitable and repeatable.
