Life Sciences Industry Knowledge Document

1. Industry Overview

Market Landscape

• Global life sciences market: $2+ trillion value
• Key segments: Pharmaceuticals, Biotechnology, Medical Devices, Research Services
• Major players: Traditional Pharma (Pfizer, Novartis), Biotech (Amgen, Biogen), Contract Research Organizations (IQVIA, Charles River)
• Rise of precision medicine and digital therapeutics
• Platform-based research and Development-as-a-Service trends

Regulatory Environment

• FDA/EMA requirements for drug approval
• Regional regulations (FDA in US, EMA in EU)
• GxP requirements (GMP, GCP, GLP)
• Clinical trial regulations
• Data integrity requirements (21 CFR Part 11)

Industry Challenges

• Long development cycles (10-15 years)
• High R&D costs and failure rates
• Regulatory compliance complexity
• Patent cliff pressures
• Data management and integration
• Supply chain complexity
• Access to specialized talent

2. Business Architecture

Value Chain

Primary Activities:

• Research & Discovery
• Pre-clinical Development
• Clinical Development
• Manufacturing & Supply Chain
• Commercial Operations
• Medical Affairs

Support Activities:

• Quality Management
• Regulatory Affairs
• Technology Infrastructure
• Research Operations
• Portfolio Management

Business Capabilities

L1 Capabilities:

1. Research Management

   • Target Discovery
   • Lead Optimization
   • Pre-clinical Studies

2. Development Management

   • Clinical Operations
   • Regulatory Affairs
   • Medical Writing
   • Bio-statistics

3. Operations Management

   • Manufacturing
   • Quality Control
   • Supply Chain
   • Technical Services

4. Commercial Operations

   • Market Access
   • Sales & Marketing
   • Medical Affairs
   • Patient Services

Operating Model

Typical Structures:

• Therapeutic Area-based
• Development Phase-based
• Geography-based
• Function-based (R&D, Commercial, Manufacturing)
• Matrix combinations

3. Technology Landscape

Core Systems

1. Research & Development Systems

   • Laboratory Information Management Systems (LIMS)
   • Clinical Trial Management Systems (CTMS)
   • Electronic Data Capture (EDC)
   • Electronic Trial Master File (eTMF)

2. Quality & Manufacturing Systems

   • Quality Management Systems (QMS)
   • Manufacturing Execution Systems (MES)
   • Enterprise Resource Planning (ERP)
   • Laboratory Information Systems (LIS)

3. Common Platforms

   • R&D: Benchling, PerkinElmer
   • Clinical: Medidata, Veeva Vault
   • Quality: TrackWise, MasterControl
   • Commercial: Veeva CRM, IQVIA

Technology Trends

• AI/ML in drug discovery
• Digital clinical trials
• Real-world evidence platforms
• Blockchain for supply chain
• Cloud-first platforms
• Digital therapeutics
• Advanced analytics

IT Operating Model

Structure:

• Research IT teams
• Clinical IT teams
• Manufacturing IT teams
• Digital & Analytics
• Compliance & Validation
• Innovation Labs

4. Value Streams & Processes

Core Value Streams

1. Drug Development

   • Target identification
   • Lead optimization
   • Pre-clinical testing
   • Clinical trials
   • Regulatory submission

2. Clinical Operations

   • Protocol development
   • Site selection
   • Patient recruitment
   • Study conduct
   • Data management

3. Manufacturing Operations

   • Process development
   • Technology transfer
   • Production
   • Quality control
   • Distribution

Support Value Streams

1. Regulatory Affairs

   • Submission planning
   • Documentation
   • Agency interactions
   • Post-market surveillance

2. Quality Management

   • Quality control
   • Compliance monitoring
   • Audit management
   • CAPA management

5. Agile Transformation Context

Transformation Drivers

• Speed to market
• R&D productivity
• Digital innovation
• Cost optimization
• Regulatory compliance
• Patient centricity

Common Patterns

1. Transformation Approach

   • Digital R&D initiatives
   • Agile clinical development
   • Digital manufacturing
   • Data-driven decisions
   • DevSecOps adoption

2. Organization Structure

   • Product-aligned teams
   • Development squads
   • Platform teams
   • Scientific CoEs

6. Change Management Considerations

Cultural Aspects

• Scientific rigor mindset
• Regulatory compliance focus
• Quality-first approach
• Innovation barriers
• Siloed operations
• Risk-averse culture

Stakeholder Management

Key Groups:

1. Internal

   • Scientific Leadership
   • R&D Teams
   • Manufacturing Teams
   • Quality Teams
   • Commercial Teams

2. External

   • Regulatory Agencies
   • Healthcare Providers
   • Patients
   • Research Partners
   • Contract Organizations

7. Reference Information

Industry Standards

• ICH Guidelines
• GxP Standards
• ISO Standards (13485, 9001)
• Quality System Regulations
• Pharmacopeia Standards

Key Frameworks

• Target Product Profile
• Quality by Design
• Clinical Development Framework
• Technology Transfer Framework
• Risk Management (ICH Q9)

Metrics & KPIs

1. Research & Development

   • Pipeline Progress
   • Clinical Trial Success Rate
   • Time to Market
   • Patent Life
   • R&D ROI

2. Operations

   • Manufacturing Yield
   • Right First Time
   • Batch Success Rate
   • Inventory Turns
   • CAPA Metrics

3. Digital

   • Digital Trial Adoption
   • Data Integration Level
   • Automation Rate
   • Digital Engagement

Glossary

• Scientific Terms
• Regulatory Terms
• Technical Terms
• Industry Acronyms