What is Drug Development?
Importance of the Development of New Chemical Entity to Drug Development Cost of the Drug Development Process Biotechnology and Drug Development – A Symbiotic Relationship Biotech/Pharma Industries and Network Economics, Competency and Market Structure Overview Role of Genomics Role of Pharma-Biotech Alliances – Present Day Situation Increasing Collaborative Effort Executive Summary Introduction to the Synergy between Pharma & Biotech Industries Overview Brief History Thaliomid Predicament – Impact in the Form of Industry Consolidation Emergence of Genentech and Evolution of Industry-wide Alliances Introduction to the Biotechnology Industry and Drug Development Defining Biotechnology History of Biotechnology Applications of Biotechnology What is Drug Development? Importance of the Development of New Chemical Entity to Drug Development Cost of the Drug Development Process Biotechnology and Drug Development – A Symbiotic Relationship Biotech/Pharma Industries and Network Economics, Compe
Drug development is a process which takes a drug from initial discovery to the pharmacy shelves. Very few pharmaceutical products actually make it all the way through drug development, and sometimes the process can be an extremely costly and frustrating failure. Drug companies and scientific researchers persist with drug development and research because they are interested in finding new and potentially useful drugs, and because the steady release of new drugs is usually the cornerstone of profits. The stages of drug development begin with the identification of a compound which may have a therapeutic use. This compound could come from a natural source, a random discovery in a lab, or a targeted effort to develop a compound which addresses a particular issue. Once this compound has been identified, tests can be used to determine its precise chemical makeup, and to learn how effective it is, and what it could be used for. If the pharmaceutical company believes at this stage of the drug d
Pfizer Inc discovers, develops, manufactures, and markets leading prescription medicines for humans and animals and many of the world’s best-known consumer brands. Our innovative, value-added products improve the quality of life of people around the world and help them enjoy longer, healthier, and more productive lives. The company has three business segments: health care, animal health and consumer health care. Our products are available in more than 150 countries. Drug discovery begins with chemists and biologists working on new chemical entities or molecules that, based on their research, they hope will be active against (or influence) certain biological targets. Once the molecule reaches rigorous standards or quality guidelines they nominate it for further testing in living organisms. This is the beginning of the pre-clinical phase of drug development. Preclinical research involves testing the candidate molecule in animals, a step required by regulatory agencies around the world to
Idea Biological Target Development Lead Candidate Chemical Compound • From IP to IND Development Discovery Chemistry Chemistry Discovery Development Biology Biology • Development Chemistry, IND Timeline: 9-14 Months to CMC Section • Scalable Process Identified • Analytical Methods Developed • Tentative Specifications Determined • Regulatory Starting Materials Identified • Stability • • DC, IND, Month 2 Process Benchmarking • Demonstration Sample (Preliminary Tox) • AC Method Development and Qualification • Reference Standard Prep and Characterization • Salt Screen Study (Optional) • Polymorph Screen (Optional) • • DC, IND, Month 4 Toxicology Lot Preparation (1-3 Kg) • Analytical Methods Verified (GLP Release) • Tentative Specifications Verified • 28-Day Tox. Studies Start • Regulatory Strategy in Place • • DC, IND, Month 8 GMP-Grade Lot Preparation (5-10 Kg) • Stability-Indicating HPLC Method Developed • Impurity Profile Determined • Residual Solvents Method Developed (ICH) • GMP Analy
