Life Sciences and Pharmaceuticals: Industry Structure and Value Chain
Description
This subject provides a comprehensive understanding of the pharmaceutical and life sciences industry structure, including key segments, players, and the end-to-end value chain from molecule discovery to patient delivery. IT professionals will learn how value is created across research, development, manufacturing, distribution, and post-market activities.
Learning Objectives
Upon completing this subject, IT professionals will be able to: map the complete pharmaceutical value chain from drug discovery through post-market surveillance; identify key industry segments including pharmaceutical, biologics, and medical devices; understand the roles and relationships between Big Pharma, biotech firms, CROs, CDMOs, and other ecosystem players; analyze how value flows through research, development, regulatory approval, manufacturing, distribution, and commercialization stages; recognize the interdependencies between different value chain activities and how IT systems support each stage; and evaluate technology requirements for different segments of the life sciences value chain.
Topics (10)
This topic covers the taxonomy of the life sciences industry, differentiating between pharmaceutical companies focused on small-molecule drugs, biologics manufacturers developing large-molecule therapies, and medical device companies. It examines the unique characteristics, regulatory pathways, and IT infrastructure needs of each segment.
This topic examines the diverse ecosystem of pharmaceutical companies. Big Pharma focuses on blockbuster drugs and global markets. Biotech companies specialize in innovative biologics and precision medicine. Generics manufacturers produce off-patent drugs at lower costs. Specialty pharma targets niche therapeutic areas. Each type has unique technology and data management requirements.
This topic covers the extensive supplier network supporting pharmaceutical companies. API manufacturers produce raw active ingredients. CROs conduct research and clinical trials on behalf of pharma companies. CDMOs provide manufacturing services. Technology vendors supply laboratory, manufacturing, and IT systems. Understanding this ecosystem is critical for designing integrated IT solutions.
This topic examines the critical safety monitoring activities that continue after drug approval. Pharmacovigilance involves collecting, assessing, and reporting adverse drug reactions. Safety databases track side effects globally. Risk management plans mitigate known safety issues. IT systems must support case processing, signal detection, regulatory reporting (FDA FAERS, EMA EudraVigilance), and...
This topic examines the critical safety monitoring activities that continue after drug approval. Pharmacovigilance involves collecting, assessing, and reporting adverse drug reactions. Safety databases track side effects globally. Risk management plans mitigate known safety issues. IT systems must support case processing, signal detection, regulatory reporting (FDA FAERS, EMA EudraVigilance), and literature monitoring.
Show moreThis topic provides a detailed breakdown of the pharmaceutical value chain stages: drug discovery, preclinical research, clinical trials (Phases I-III), regulatory approval, manufacturing, distribution, marketing and sales, post-market surveillance, and lifecycle management. It emphasizes the interdependencies and information flows between stages.
This topic examines the early stages of pharmaceutical R&D. Drug discovery involves identifying disease targets (proteins, genes, receptors) and screening thousands of compounds. Lead optimization refines promising molecules. Preclinical studies test safety and efficacy in laboratory and animal models. IT systems support molecular modeling, laboratory information management, data analytics, and...
This topic examines the early stages of pharmaceutical R&D. Drug discovery involves identifying disease targets (proteins, genes, receptors) and screening thousands of compounds. Lead optimization refines promising molecules. Preclinical studies test safety and efficacy in laboratory and animal models. IT systems support molecular modeling, laboratory information management, data analytics, and electronic lab notebooks.
Show moreThis topic provides detailed knowledge of clinical development phases. Phase I tests safety and dosage in small groups of healthy volunteers. Phase II evaluates efficacy and side effects in patients with the target disease. Phase III involves large-scale trials to confirm effectiveness and monitor adverse reactions. Clinical trial management systems...
This topic provides detailed knowledge of clinical development phases. Phase I tests safety and dosage in small groups of healthy volunteers. Phase II evaluates efficacy and side effects in patients with the target disease. Phase III involves large-scale trials to confirm effectiveness and monitor adverse reactions. Clinical trial management systems (CTMS), electronic data capture (EDC), and randomization systems are essential IT components.
Show moreThis topic covers pharmaceutical manufacturing from API synthesis to final product packaging. It includes batch manufacturing processes, continuous manufacturing approaches, in-process quality controls, final product testing, and release procedures. Manufacturing Execution Systems (MES), Laboratory Information Management Systems (LIMS), and quality management systems are critical IT infrastructure.
This topic examines the distribution of pharmaceutical products from manufacturing sites to patients. It covers wholesaler networks, specialty distributors, retail pharmacies, hospital pharmacies, and direct-to-patient channels. Temperature-controlled (cold chain) distribution for biologics, serialization for anti-counterfeiting, and inventory management are critical IT considerations.
This topic covers the commercial aspects of bringing drugs to market. It includes launch planning, pricing strategies, payer negotiations, formulary access, sales representative deployment, healthcare provider engagement, and patient support programs. Customer Relationship Management (CRM) systems, multichannel marketing platforms, and sales force automation are key IT components.