Life Sciences and Pharmaceuticals: Core Business Processes

This topic examines market access workflows that secure reimbursement and patient access. Payer dossiers compile clinical, economic, and budget impact data. Health technology assessments (HTAs) evaluate comparative effectiveness and cost-effectiveness. Formulary submissions request inclusion on payer lists. Negotiations address pricing, rebates, and utilization management. Outcomes-based contracts link payment to clinical...

This topic examines market access workflows that secure reimbursement and patient access. Payer dossiers compile clinical, economic, and budget impact data. Health technology assessments (HTAs) evaluate comparative effectiveness and cost-effectiveness. Formulary submissions request inclusion on payer lists. Negotiations address pricing, rebates, and utilization management. Outcomes-based contracts link payment to clinical results. Prior authorization support helps prescribers obtain approval. Market access systems manage payer intelligence, submissions, contracts, and performance tracking.

This topic covers R&D workflows spanning drug discovery and development. Discovery phase includes target identification, high-throughput screening, hit-to-lead optimization, and lead compound selection. Preclinical development involves synthesis scale-up, formulation development, and safety/toxicology studies under GLP. Go/No-go decisions occur at stage gates based on efficacy, safety, and commercial potential. IT systems...

This topic covers R&D workflows spanning drug discovery and development. Discovery phase includes target identification, high-throughput screening, hit-to-lead optimization, and lead compound selection. Preclinical development involves synthesis scale-up, formulation development, and safety/toxicology studies under GLP. Go/No-go decisions occur at stage gates based on efficacy, safety, and commercial potential. IT systems supporting R&D include electronic lab notebooks (ELN), laboratory information management systems (LIMS), compound registration systems, and R&D portfolio management platforms.

This topic examines clinical trial operational workflows. Study startup includes protocol finalization, IRB submissions, site selection, budgeting, and site initiation visits. Patient recruitment uses various channels (clinics, registries, advertising). Enrollment involves informed consent, eligibility screening, and randomization. Ongoing monitoring ensures protocol compliance, data quality, and safety reporting. Data management includes...

This topic examines clinical trial operational workflows. Study startup includes protocol finalization, IRB submissions, site selection, budgeting, and site initiation visits. Patient recruitment uses various channels (clinics, registries, advertising). Enrollment involves informed consent, eligibility screening, and randomization. Ongoing monitoring ensures protocol compliance, data quality, and safety reporting. Data management includes electronic data capture (EDC), query resolution, and database lock. Closeout involves site closure visits, final data reconciliation, and archiving. Clinical Trial Management Systems (CTMS) orchestrate these workflows.

This topic covers regulatory submission processes. Submission planning begins early in development, defining regulatory strategy and filing timelines. Document compilation aggregates clinical, nonclinical, CMC (chemistry, manufacturing, controls), and supporting data. Electronic Common Technical Document (eCTD) format standardizes submissions globally. Pre-submission meetings with FDA/EMA align expectations. Submission review involves responding to...

This topic covers regulatory submission processes. Submission planning begins early in development, defining regulatory strategy and filing timelines. Document compilation aggregates clinical, nonclinical, CMC (chemistry, manufacturing, controls), and supporting data. Electronic Common Technical Document (eCTD) format standardizes submissions globally. Pre-submission meetings with FDA/EMA align expectations. Submission review involves responding to agency questions and providing additional data. Approval results in marketing authorization. Regulatory Information Management (RIM) systems manage the submission lifecycle and document repository.

This topic examines manufacturing operations. Batch planning schedules production based on demand forecasts and material availability. Master batch records define all manufacturing steps, critical parameters, and specifications. Material dispensing accurately measures raw materials. Production execution follows validated procedures with in-process controls (temperature, pH, mixing time). Environmental monitoring ensures clean room...

This topic examines manufacturing operations. Batch planning schedules production based on demand forecasts and material availability. Master batch records define all manufacturing steps, critical parameters, and specifications. Material dispensing accurately measures raw materials. Production execution follows validated procedures with in-process controls (temperature, pH, mixing time). Environmental monitoring ensures clean room compliance. Batch record review verifies all steps completed correctly before lot release. Manufacturing Execution Systems (MES) digitize batch records and integrate with equipment, ensuring GMP compliance and data integrity.

This topic covers quality control (QC) operations. Sample collection follows sampling plans to ensure representative testing. Analytical testing includes identity (is it the right compound?), assay (correct amount?), impurities (within limits?), dissolution (releases properly?), and microbial testing. Out-of-specification (OOS) results trigger investigations to identify root causes. Stability testing monitors product...

This topic covers quality control (QC) operations. Sample collection follows sampling plans to ensure representative testing. Analytical testing includes identity (is it the right compound?), assay (correct amount?), impurities (within limits?), dissolution (releases properly?), and microbial testing. Out-of-specification (OOS) results trigger investigations to identify root causes. Stability testing monitors product over shelf life. Certificate of Analysis (CoA) documents all test results. Quality release decision approves or rejects batches. Laboratory Information Management Systems (LIMS) manage samples, testing, data, and CoA generation.

This topic examines pharmacovigilance operations. Adverse event (AE) reports come from clinical trials, spontaneous reports, literature, and regulatory queries. Case intake captures reporter and patient information, event description, and suspect drug details. Medical review assesses seriousness (death, hospitalization, disability). Causality assessment determines relationship to drug. Expectedness compares to known safety...

This topic examines pharmacovigilance operations. Adverse event (AE) reports come from clinical trials, spontaneous reports, literature, and regulatory queries. Case intake captures reporter and patient information, event description, and suspect drug details. Medical review assesses seriousness (death, hospitalization, disability). Causality assessment determines relationship to drug. Expectedness compares to known safety profile. Serious unexpected AEs require expedited reporting (15-day alerts). Periodic reports (PSURs/PBRERs) summarize safety data. Signal detection identifies new safety concerns. Safety database systems (Argus, Vault Safety) manage case workflows and regulatory submissions.

This topic covers medical affairs operations that provide scientific support distinct from commercial promotion. Medical information responds to unsolicited inquiries from healthcare providers with evidence-based answers. Publication planning coordinates dissemination of clinical data in peer-reviewed journals and conferences. Advisory boards gather expert clinical input. Investigator-initiated studies support independent research. Medical...

This topic covers medical affairs operations that provide scientific support distinct from commercial promotion. Medical information responds to unsolicited inquiries from healthcare providers with evidence-based answers. Publication planning coordinates dissemination of clinical data in peer-reviewed journals and conferences. Advisory boards gather expert clinical input. Investigator-initiated studies support independent research. Medical science liaisons (MSLs) engage key opinion leaders with scientific dialogue. Congress medical affairs teams staff booths and present data. Medical affairs platforms manage inquiries, publications, and field activities.

This topic examines commercial launch processes. Launch planning begins 12-18 months pre-approval with cross-functional teams. Brand strategy defines positioning, messaging, and target customers. Promotional materials (sales aids, websites, ads) undergo medical-legal-regulatory review. Sales force receives product training. Market access secures payer coverage. Patient services establish support programs. Launch execution coordinates...

This topic examines commercial launch processes. Launch planning begins 12-18 months pre-approval with cross-functional teams. Brand strategy defines positioning, messaging, and target customers. Promotional materials (sales aids, websites, ads) undergo medical-legal-regulatory review. Sales force receives product training. Market access secures payer coverage. Patient services establish support programs. Launch execution coordinates activities across channels. Post-launch monitoring tracks prescriptions, market share, and customer feedback. Commercial platforms integrate CRM, content management, and analytics.

This topic covers pharmaceutical sales operations. Territory management assigns representatives to geographic areas and target healthcare providers. Call planning prioritizes high-value prescribers. Sample management tracks distribution of product samples with signed receipts. Speaker programs train physicians to present clinical data. Customer interactions are documented in CRM with call notes. Compliance...

This topic covers pharmaceutical sales operations. Territory management assigns representatives to geographic areas and target healthcare providers. Call planning prioritizes high-value prescribers. Sample management tracks distribution of product samples with signed receipts. Speaker programs train physicians to present clinical data. Customer interactions are documented in CRM with call notes. Compliance monitoring ensures adherence to promotional guidelines and spending limits. Sales force automation systems provide mobile access to promotional content, sample tracking, and call reporting capabilities.

This topic covers supply chain operations. Demand forecasting predicts future product needs based on sales trends, market intelligence, and seasonal patterns. Production planning schedules manufacturing to meet forecasts while maintaining inventory targets. Inventory management balances stock levels across manufacturing sites, distribution centers, and the channel. Distribution logistics coordinate shipments via...

This topic covers supply chain operations. Demand forecasting predicts future product needs based on sales trends, market intelligence, and seasonal patterns. Production planning schedules manufacturing to meet forecasts while maintaining inventory targets. Inventory management balances stock levels across manufacturing sites, distribution centers, and the channel. Distribution logistics coordinate shipments via wholesalers, direct delivery, and specialty distributors. Cold chain products require temperature monitoring throughout. Supply-demand balancing addresses shortages or excess inventory. Enterprise Resource Planning (ERP) and supply chain systems integrate planning, execution, and tracking.

This topic examines product lifecycle management across the commercial lifespan. Launch phase focuses on uptake and market penetration. Growth phase maximizes market share. Maturity phase maintains revenue as competition enters. Patent cliff preparation includes lifecycle extensions (new formulations, delivery systems, indications), authorized generics, and next-generation products. Generic entry requires supply...

This topic examines product lifecycle management across the commercial lifespan. Launch phase focuses on uptake and market penetration. Growth phase maximizes market share. Maturity phase maintains revenue as competition enters. Patent cliff preparation includes lifecycle extensions (new formulations, delivery systems, indications), authorized generics, and next-generation products. Generic entry requires supply adjustments and brand defense strategies. Product discontinuation involves inventory rundown, customer notification, and regulatory submissions. Lifecycle management systems track patents, sales, competition, and strategic initiatives.