The Drug Discovery Infographic
A Tough Pill to Swallow - illustrated guide to drug discovery Infographic demonstrating the mega-investments required to discover a new drug (or biologic, biopharmaceutical, therapeutic, etc). by JP Science Marketing jpsciencemarketing.com Incentives for Innovation Companies weigh profit potential vs risk factors. Immediate and long-term incentives help to spur innovation. Grants & Loans, Tax Credits, Proprietary Patent, Profit Potential, Stock Value, Brand Equity Background Research Collaboration in research by industry, academia, & government provides the basis for drug discovery strategies. Choose a Target Confirm Role in Disease The target is validated (shown to be critical to the disease) by research, and screening assays are developed. Pharmaceutical Agents Chemical: drug design methods: (3D models to fit target) Direct (mimic target binders) Indirect types of bonds: (reversible) Ionic, Hydrogen (irreversible) Covalent Biological: biopharmaceuticals/biologics: Nucleic acids (DNA, RNA) Proteins (enzymes, antibodies) Microorganism (virus, bacteria) Cell therapy (stem cells) Tissue therapy (transplant) Type of lead developed depends on the unique characteristics of the target. Not all targets can be reached with a pill. Discover Potential Leads Safe molecules that modify the target are found via nature, 3D modeling, high- throughput screening, & biotechnology. Optimize with Analogues Variations of ‘hits’ are tested for improved strength and specificity of interaction with the target. Pre-Clinical Testing Optimize Pharmacokinetics Leads are tested in animals & modified for optimal absorption, distribution, metabolism, and excretion properties. Safety & Pharmacodynamics Efficacy, dosing, and negative effects are tested. Strict safety requirements must be met before testing in humans. IND Application Investigation New Drug application is filed with the FDA, outlining drug safety, known risks, and plans for clinical trials. Phase 1 & 2 Clinical Trials Phase I Clinical Trials Pharmacokinetics and safety data are collected from a small group of healthy volunteers. Phase II Clinical Trials Efficacy, dosage, safety, and side effects are measured in diseased patients. Sometimes combined with Phase I. Phase 3 Clinical Trials Large, time-consuming, expensive trials determine efficacy, safety, side effects, & comparison to existing treatments. New Drug Application NDA All data, research, information, and manufacturing & labeling plans are compiled and submitted to the FDA. FDA Approval The FDA weighs the benefits & risks, determines appropriate label content, and approves manufacturing plans. Pre-Market Scale-Up Each drug has unique production & safety concerns, often requiring construction of new equipment & facilities. Scientific marketing materials written & designed by JP Science Marketing jpsciencemarketing.com
