Explore the Agenda
7:00 am Check In, Coffee & Light Breakfast
7:55 am Chair’s Opening Remarks
From Start-Up to Scale-Up: Building Accountable, Learning, & Leadership-Driven EHS Cultures
8:00 am Moving Beyond Blame, Uncovering Root Causes, & Embedding Learning Across Global Biopharma Operations
- How are biopharma organisations aligning on a common framework for managing serious incidents, and where do models like SIFs or Life Events add real value?
- What best practices exist for conducting investigations that move beyond individual blame to uncover systemic causes and drive meaningful change?
- How can EHS leaders ensure that insights from incident investigations are effectively shared, tracked, and embedded across global sites to prevent recurrence?
8:30 am Panel Discussion & Extended Q&A
- Explore how the Swiss Cheese Model applies to layered EHS defences in biopharma, from engineering controls to human behaviour and management systems
- Identify where new “holes” are emerging as modalities evolve and operations grow more complex, from potent compounds to digital workflows
- In what ways can human factors, digital monitoring, and behavioural data be used to close the “holes” between procedural intent and real-world practice?
9:00 am Roundtable Discussion: Building Stage-Appropriate EHS Programs from Start-Up to Global Scale
- How do early-stage companies prioritise essential EHS functions without overengineering their systems?
- What indicators signal it’s time to scale up processes, automation, or documentation?
- How can growing organizations maintain safety culture and leadership engagement through each stage of expansion?
9:30 am Morning Break & Refreshments
Turning Uncertainty into Action by Advancing Risk Assessment, Documentation & Collaboration for Emerging Biopharma Modalities
10:00 am From Unknowns to Controls: Quantifying Risk for Radiopharma, ADCs, & Novel Biologics
- Modelling exposure and consequences across radiological, biological, and highpotency modalities to identify when BSCs, isolators, or engineered enclosures are essential, preventing the removal of critical controls and reducing costly incidents
- Mapping gaps in SDS and hazard communication for gene and cell therapies to expose where traditional 16-section formats fall short, and introducing a supplemental “BioRisk Communication Sheet” to enhance compliance and worker protection
- Measuring validation and contractor performance metrics, such as leak tests and rework rates, to demonstrate how manufacturer-led validation windows cut leaks, stress, and lifecycle risk while strengthening the business case for early investment
- Using AI for enhanced EHS biological safety data sheets to save resources needed for this task
10:30 am Lost in Translation: How the Lack of Standardized Banding & Qualified Safety Talent Risks Biopharma Integrity
- Examine the growing shortage of safety professionals with deep understanding of potent compound handling and occupational exposure banding (OEB) systems, in a landscape where every company uses its own classification and language
- Highlight how inconsistent banding frameworks and limited cross-training between organisations lead to confusion, misaligned expectations, and inflated risk or cost when contracting and collaborating
- Learn strategies to build internal expertise, align communication across partners, and close the skills gap through standardisation, education, and industry collaboration, strengthening both workforce capability and scientific safety assurance
11:00 am Roundtable Discussion: The New Frontiers of Risk: Potency, Toxicology, & Occupational Safety in Emerging Biopharma Modalities
- How can we modernise risk assessment frameworks to manage uncertainty in potency and toxicology for novel compounds, where data are sparse or still evolving?
- What methodologies, from flexible banding systems to pre-approved dynamic risk assessments, best support safe, agile decision-making in R&D environments?
- How can toxicologists, EHS professionals, and process scientists collaborate to close data gaps and translate incomplete toxicology findings into practical workplace safeguards?
11:30 am Lunch & Networking Break
Building Safe & Sustainable Biopharma Operations Through Smarter Lab Design, Environmental Responsibility, & Contractor Collaboration
12:30 pm Designing for the Unknown: Building Flexible, Safe, & Sustainable Biopharma Labs
- Address how lab and facility design must evolve to accommodate novel compounds, potent materials, and rapidly shifting modalities, from peptides to gene therapies, and highlight real-world approaches to containment, disposable systems, ergonomic design, and staged investment strategies
- Explore how adaptive design principles and data-driven risk assessment can reduce unnecessary capital expenditure, prevent contamination, and ensure safety and comfort within cleanroom constraints
- Gain actionable insights on balancing safety, scalability, and human factors in lab design, learning how to future-proof facilities for scientific innovation without compromising on ergonomics, containment, or cost efficiency
1:00 pm Panel Discussion: Building a Unified Approach to Contractor & Supply Chain Safety in Biopharma
- Explore how fragmented standards, inconsistent oversight, and cost-driven pressures across contractors and suppliers create vulnerabilities in EHS performance, addressing prequalification, third-party assurance, and the opportunity for industrywide alignment on safety expectations and ethical contracting
- Demonstrate how collaboration across biopharma companies can establish shared standards, reduce duplication, and strengthen cultural consistency across complex global supply chains
- Gain strategies to implement unified contractor management frameworks, balance cost and safety incentives, and foster long-term partnerships that enhance both compliance and worker wellbeing
1:30 pm Roundtable Discussion: Closing the Loop Between Banding, Training, & Real-World Competence
- How can biopharma organisations ensure that exposure banding knowledge translates into practical containment behaviour on the lab floor, not just compliance on paper?
- What collaborative models between EHS, toxicology, and operations can align risk communication, training, and validation to create a shared language of safety across global teams?
- How can training data, incident feedback, and OEB reclassifications be looped back into continuous learning frameworks to sustain competency as modalities evolve?
2:00 pm Afternoon Break & Refreshments
2:30 pm Climate Action: Reducing Biopharma’s Environmental Footprint Despite 24/7 Energy-Intensive Operations
- Explore practical site-level strategies for energy efficiency and sustainability reporting, whilst supporting HVAC and contamination control demands, connecting carbon emissions, climate risk, and regulatory expectations
- How EHS leaders can bridge corporate sustainability goals with plant operations, translating Scope 1–3 emissions, climate risk scenarios, and ISO frameworks into actionable business cases and operational priorities
- Communicating sustainability as a strategic advantage, identify emission reduction opportunities in high-energy environments, and build alignment across EHS, engineering, and corporate sustainability teams
3:00 pm Roundtable Discussion: Competence, Culture, & Communication for New Biopharma Frontiers
- How can EHS and operations teams build competency pipelines and use AI-assisted knowledge retrieval to accelerate readiness when programmes pivot rapidly to new modalities like vaccines, radiopharma, or gene therapy?
- In an environment of clinical uncertainty, staffing churn, and contractor variability, what practical rituals or leadership behaviours help sustain a consistent safety culture and psychological stability across teams?
- How can early-stage EHS engagement de-risk environmental and permitting challenges, particularly for waste, water, and infrastructure, to ensure smoother tech transfer and operational continuity across sites?