Consumers across the world benefit from having access to the safest and most advanced drug discovery system. Every country has its own regulatory authority responsible for enforcing the guidelines in the drug development process of pharmaceutical products. Regulatory agencies such as the FDA in the USA, MHRA in the UK, TGA in Australia, SFDA in China, HEALTH CANADA and more. The FDA regulated drug discovery process is as follows-
Step 1: Discovery and Development
Step 2: Preclinical Research
Step 3: Clinical Research
Step 4: FDA Review
Step 5: FDA Post-Market Safety Monitoring.
This process ensures the most efficient and safest pharmaceutical system in America. With the growing demand of new and improved drugs, evolving technology and methods are needed to further the advancement of drug discovery techniques, such multiplex labeling.
Visikol has developed a proprietary multiplex slide imaging approach which allows for the visualization of over ten markers per slide by conducting sequential rounds of 3-5 marker labeling and imaging. Complex labeling using multiple rounds of immunofluorescence comes with a thorough optimization and validation for each antibody and panel prior to use in our platform. Multiplex technology and Visikol’s advanced labeling, imaging, and image analysis offers advancements in the first 3 steps of the drug development process, exceling and strengthening drug candidacy for review and marketing.
First 3 steps of the Drug Development Process
Step 1: Discovery and Development. Researchers discover new drugs through insights into a disease process, allowing researchers to design a product to stop/reverse the effects or test a library of molecular compounds to find possible beneficial effects against an array of diseases. Once a promising compound is chosen for development, experiments are conducted to gather information on absorption, distribution, proper dosage, benefits, and mechanism of action. Many of these attributions are determined during the second step of the drug discovery process.
Step 2: Preclinical Research. Two types of preclinical research are utilized in drug development- in vitro and in vivo methods. Preclinical studies provide some detailed information on dosing, toxicity levels, mechanism of action, and more. Multiplex technology and Visikol, together, help to maximize the information obtained from these studies and ensure that the most detailed report can be utilized to support further development. The ability to label tissue, cell pellets, and smears with multiple targets and overlay those images opens the door for image analysis and big data mining to observe multiple data points from target intensity, localization, population number, and co-localization. This allows for multiple endpoints to be determined and statistically evaluated using less time and resources streamlining the preclinical research process.
Step 3: Clinical Research. Utilizing detailed reports and large data mining with multiple statistical and bioinformatics analysis, researchers can better select targeted patients for clinical research as well as efficiently evaluate study endpoints. In the changing medical age of personalized medicine and targeted treatments, focus has switched to treating specific groups for optimal results instead of assuming everyone should be treated with the same medication across the board. Drug discovery can become more efficient than ever by combining multiplexing and advanced imaging analysis techniques, giving insight throughout the entire process and pushing more successful, lifesaving drugs onto the market to help save more patients and better the lives of consumers.
Learn More
Visikol and its cutting-edge Multiplex technology and image analysis offers a new paradigm in the drug discovery process and opens a whole new door to personalized medicine and targeted treatment. If you’d like to learn more, visit our Multiplex Technology Page, our Overview Page, or our recent blog post about the Clinical Applications of Multiplex Imaging.
Please check out our new webpage detailing each of the panels in more detail, and stay tuned for more panels coming in the near future! If you’re interested in finding out more about Visikol’s Multiplex technology, contact us today.