Strategic Transformation: Leading Pharma's Future
The three days that point your next capital, regulatory, and network decisions in the right direction, before you're locked in.
Senior Leadership Agenda
Why This Agenda is Built for You: As a senior leader, you're setting strategy, owning capital and regulatory decisions, and shaping where your organization goes next, often with incomplete information and no time to spare. This agenda pulls the strategic thread through a program of sixty-plus sessions so you don't have to. It concentrates on the conversations that move your decisions: standardized manufacturing networks and the regulatory frameworks forming around them, AI governance in GxP, the direction global regulators are signaling, and how peer organizations like AstraZeneca, Lilly, GSK, and Lonza are actually executing at scale.
Your Monday Morning Impact: Return with a defensible point of view on your network and facility strategy, a regulatory-direction brief that shapes your next submission cycle, a shortlist of partners evaluated against a real capital program, and a handful of peer contacts wrestling with the same decisions you are. Three days here is how you de-risk the bets you're about to make.
Is This You?
This agenda is built for you if you're a:
- VP or SVP of Manufacturing, Operations, or Engineering
- Site Director or Head of Technical Operations
- Head of Quality, Chief Engineer, or Director of Capital Projects
- Senior leader who approves budgets and capital rather than requesting them
- Decision-maker who needs strategic intelligence, not implementation detail, and whose scarcest resource is time, not budget
If you're implementing the strategy rather than setting it, the Mid-Career Leaders Agenda may fit you better.
What You'll Walk Away With
- A board-ready position on standardized manufacturing networks (modular, copy-paste, sister-site, and fleet models), informed by how Novo Nordisk, Roche, Merck, and FUJIFILM are doing it, plus the regulatory framework taking shape around them.
- A regulatory-foresight brief from the Global Regulatory Town Hall and AI-governance sessions that lets you shape your next submission and compliance strategy proactively.
- A vetted partner shortlist: A&E firms and technology platforms evaluated against a specific capital program already on your roadmap.
- Peer intelligence you can't get from a report: direct conversations with leaders at comparable organizations confronting the same scale, sustainability, and AI-governance decisions.
SUNDAY SCHEDULE
| Time | Session | Type |
|---|---|---|
| 0700 – 1800 | Registration Open Registration is also open Saturday, 17 October, 1300 – 1800. | Registration |
| 1300 – 1600 | Choose Your Focus: Option A: From Single Sites to Standardized Manufacturing Network Choose this for network strategy, the emerging regulatory framework for distributed manufacturing, and ICH Q12 tools, with Novo Nordisk, Roche, Merck, and FUJIFILM. The strongest session of the day if you are shaping your own network model. Option B: Accelerating Innovation in Sustainable Sourcing & Ops Choose this if sustainable-sourcing strategy and lifecycle data sit closer to your remit. Option C: Annex 1 in Action: Designing Facilities That Reduce Risk Choose this if you are setting contamination-control and facility-design direction across your sites. | Workshop |
| 1600 – 1800 | Sunday Social First-night peer contact at your altitude before the crowds. Find the other site and network leaders facing the same scale decisions. | Networking |
| 1900 – 2230 | 2026 ISPE FOYA Banquet & Awards Celebration Please note that separate registration is required. Where the industry recognizes excellence in facility delivery. Visibility and benchmarking in one evening. | Special Event |
MONDAY SCHEDULE
| Time | Session | Type |
|---|---|---|
| 0700 – 0800 | Continental Breakfast | Meal |
| 0800 – 0930 | Opening General Sessions
The strategic tone-setter, and the one moment the whole industry is in one room. The Patient Speaker is your reminder of the stakes behind the capital decisions you will weigh this week. | General Session |
| 0930 – 1030 | Networking Break in Expo Hall First expo pass. Scout the A&E and technology partners you will want deeper conversations with. | Networking |
| 1030 – 1100 | Choose Your Focus: Option A: Implement and Manage Risks for AI solutions in cGMP Choose this for regulatory-compliance governance and engineering-validation readiness at the strategic level, framed by a Pfizer validation director. The readiness posture you are accountable for. Option B: Ambition Zero Carbon at an AstraZeneca Biologics Flagship Choose this for a decade-long corporate carbon strategy and its execution, if sustainability is board-level for you. Option C: Early Regulatory Alignment to Implement NGS at GMP Scale Choose this if novel-modality regulatory strategy is live for your organization. | Governance, Risk, and Readiness |
| 1130 – 1200 | Successful Business Cases for Sustainability Initiatives Choose this for how to build the leadership-facing business case and beat decision-maker objections. Useful from the other side of the table, since you are often the one being pitched. | Systems That Deliver Reliably |
| 1200 – 1230 | A Structured Path to Sustainable Pharma Manufacturing Choose this for a maturity-based improvement framework and decarbonization roadmaps aligned to capital cycles. | Systems That Deliver Reliably |
| 1200 – 1330 | Networking Lunch in Expo Hall Find your peers, the other VPs and directors. Lunch is where the unstructured strategic conversations happen. | Meal/Networking |
| 1330 – 1400 | Choose Your Focus: Option A: Quality Advantage: Advance Your Quality System Maturity Choose this for the continued strategic-readiness thread. The Governance, Risk, and Readiness track reliably carries the governance and strategy content you are here for. Option B: Sustainability Modeling Through EcoDesign (GSK) Choose this if lifecycle and EcoDesign strategy is your focus. | Multiple Tracks |
| 1400 – 1430 | Designing Reliable & Sustainable Pharma Systems A leadership panel on integrated systems, Sustainability by Design, and AI in network decision-making. | Systems That Deliver Reliably |
| 1500 – 1600 | Networking Break in Expo Hall Second expo window. With morning context, narrow to the two or three vendors worth a real meeting. | Networking |
| 1400 – 1430 | Introduction of Risk Management Maturity Model The late-afternoon strategic-readiness session. | Governance, Risk, and Readiness |
| 1630 – 1700 | Choose Your Focus: Option A: Water, Water Nowhere, Not a Drop to Waste Choose this if you approve utility capital. Front-end water strategy with hard ROI: $4.0M capex, $1.9M opex, 220M L over ten years. Option B: Progressive QA in AI-Enabled GxP Environments Choose this for digital-governance strategy. | Multiple Tracks |
| 1700 – 1730 | Isotope to Animal: Radiopharma Design Considerations Choose this if radiopharmaceutical or aseptic facility design is on your plate—a case study on the manufacturing, supply chain, and short-half-life logistics challenges of radioisotope therapies, built with flexibility to scale from veterinary to human indications. | From Breakthrough to Bedside |
| 1745 – 1915 | Welcome Reception in Expo Hall | Networking |
TUESDAY SCHEDULE
| Time | Session | Type |
|---|---|---|
| 0700 – 0800 | Continental Breakfast | Meal |
| 0800 – 0930 | Morning General Sessions
A Lilly SVP keynote, strategic industry direction from someone operating at your scale. The peer-altitude content you flew in for. | General Session |
| 0930 – 1030 | Networking Break in Expo Hall | Networking |
| 1030 – 1100 | Choose Your Focus: Option A: Beyond Standardization: GMP Facility Delivery at Scale (Lonza) Choose this for the move to platform-based facility delivery across capital programs. The program-strategy view that compounds value across every build you sponsor. Option B: ISPE Drug Shortages Assessment Tool Update Choose this for continued strategic governance and readiness content. Option C: Automated ATMP Manufacturing, Consistency & Quality Choose this if advanced-therapy scale-up is in your portfolio. | Systems That Deliver Reliably |
| 1100 – 1130 | Integrated Systems for Reliable GMP Operations The enterprise-ecosystem view: harmonizing EAM, QMS, and ERP across functions, aligned to Pharma 4.0. Governance and measurable results, for someone who owns the systems strategy. | Systems That Deliver Reliably |
| 1200 – 1415 | Membership Meeting and Awards Lunch - Open to All Attendees The state-of-the-society address and recognition. Worth your presence for the industry-direction signal and the room. | Meal/Awards |
| 1415 – 1545 | Dessert Reception in the Expo Hall Final expo-floor window. Close out the vendor conversations you opened Monday before the hall closes at 1530. | Networking |
| 1545 – 1630 | Optimizing Facility Performance Through LEED Design Choose this if facility performance and reliability are your focus, applying LEED-driven design within a live GxP environment through a real laboratory retrofit case study (VRF, DOAS with energy recovery, enhanced commissioning, advanced metering). | Systems That Deliver Reliably |
| 1630 – 1745 | Advanced Kinetic Modelling: New Era of Stability Analysis Choose this if stability and shelf-life work is on your plate, a model-informed approach aligned to the updated ICH Q1 draft that speeds development timelines and catches stability failures earlier. | Digital, Data, and Decision Integrity |
| 1900 – 2300 | Tuesday Night Celebration at Topgolf National Harbor Included with the In-Person All Access Pass, the add-on fee for the Tuesday Night Celebration is $225 for all other registration passes. The relationships you build here are the ones you will call on next year. The informal counterpart to the boardroom. | Special Event |
WEDNESDAY SCHEDULE
| Time | Session | Type |
|---|---|---|
| 0800 – 0900 | Continental Breakfast | Meal |
| 0900 – 1215 | Closing General Sessions
The Global Regulatory Town Hall is the single strongest forward-looking session of the conference for you. Global regulator direction in one room, the foresight that shapes next year's submission and facility strategy. | General Session |