Bruno BESSELIEVRE
Manage the strategy of an organization

Manage the strategy of an organization

Manage the strategy of an organization

1. Foundation: Build a Solid Industrial Base

  • Regulatory Compliance First:
    • GMP (Good Manufacturing Practices), FDA/EMA standards, ISO certifications.
    • Build a robust Quality Management System (QMS).
  • Operational Excellence:
    • Lean manufacturing & Six Sigma to reduce waste.
    • Digitalization of plant operations (MES, SCADA, predictive maintenance).
  • Supply Chain Resilience:
    • Multi-sourcing of critical APIs.
    • Regionalized supply hubs to mitigate geopolitical risks.
  • Talent & Culture:
    • Recruit engineers, pharmacists, data scientists.
    • Build a culture of compliance, safety, and innovation.

2. Growth & Market Positioning

  • Choose Your Industrial Strategy:
    • Generics → compete on cost efficiency and volume.
    • Biosimilars → long-term investment with high entry barriers.
    • Niche / Orphan Drugs → lower competition, higher margins.
    • Contract Manufacturing (CDMO/CMO) → produce for big pharma.
  • Invest in R&D / Tech Transfer:
    • Partnerships with universities, biotech startups, and research labs.
    • Build capacity for rapid tech transfer (from lab → pilot → industrial scale).

3. Performance Levers (Operational + Financial)

  • Digital Pharma 4.0:
    • Use AI for demand forecasting, process optimization, and predictive QC.
    • Implement real-time analytics to reduce batch release times.
  • Sustainability & ESG:
    • Reduce carbon footprint, optimize water/energy usage.
    • “Green chemistry” approaches → can become a differentiation factor.
  • Cost Leadership vs. Value Leadership:
    • If cost-driven → focus on efficiency, automation, low-cost geographies.
    • If value-driven → emphasize innovation, patient-centric products, rapid-to-market.

4. Differentiation & Competitive Edge

  • Speed-to-Market:
    • Build flexible production lines (multi-product facilities).
    • Leverage continuous manufacturing vs. batch (faster, cheaper, higher quality).
  • Regulatory Intelligence:
    • Anticipate changes in pharma laws (FDA, EMA, ANSM, etc.).
    • Build internal compliance expertise → avoid costly delays.
  • Strategic Alliances:
    • Collaborate with biotech firms for pipeline expansion.
    • Licensing deals with universities / startups.
  • Customer Trust:
    • Transparency on quality & safety.
    • Digital traceability (blockchain for supply chain integrity).

5. KPIs to Track Industrial Performance

  • Operational: OEE (Overall Equipment Effectiveness), batch release time, yield, deviation rate.
  • Quality: number of recalls, regulatory inspection scores.
  • Financial: cost per batch, EBITDA margin, ROI on R&D.
  • Strategic: market share in target segment, speed of tech transfer, pipeline strength.

Organisation Strategy

Enterprise Strategy: Strengthening IT & Architecture Like the Army

1. Objective

  • Build a robust, resilient, and agile IT organization.
  • Ensure clear separation of responsibilities between IT operations and architecture (hardware & software).
  • Adopt a model inspired by the military structure: discipline, resilience, and readiness for change.

2. Strategic Rationale

  • Today’s IT organizations face cybersecurity threats, rapid technological changes, and scalability challenges.
  • A split structure—like specialized army divisions—enhances resilience, clarity, and efficiency.
  • Each division focuses on its mission but works together under a central command.

3. Organisational Model

Command Headquarters (CIO / CTO Office)

  • Defines global strategy, priorities, and rules of engagement.
  • Acts as the General Staff ensuring alignment with business goals.

Division 1: IT Operations (“The Infantry”)

  • Responsible for day-to-day stability.
  • Manages infrastructure, networks, security monitoring, helpdesk.
  • KPIs: availability, reliability, rapid response.

Division 2: Architecture & Engineering (“The Special Forces”)

  • Designs and deploys future-proof systems (hardware & software).
  • Focus on innovation, integration, and long-term scalability.
  • KPIs: performance, modularity, cost efficiency, agility.

Division 3: Cybersecurity (“The Defense Force”)

  • Ensures protection and resilience against external and internal threats.
  • Works as an independent, specialized unit reporting to top command.
  • KPIs: compliance, incident response time, zero major breaches.

4. Benefits of the Army-Inspired Model

  • Resilience: if one division is under attack (IT issues), others remain operational.
  • Clarity of mission: no overlap, no confusion of roles.
  • Rapid response: clear chain of command accelerates decisions.
  • Future readiness: architecture team free to innovate while IT ensures stability.

5. Implementation Roadmap

  1. Assessment phase – map current IT organization and architecture.
  2. Redefine governance – establish clear command hierarchy.
  3. Division of forces – separate IT Ops, Architecture, and Cybersecurity.
  4. Training & doctrine – set processes, playbooks, and KPIs.
  5. Continuous drills – test robustness through simulations (cyberattacks, outages).