Conference Day Two - Thursday October 9, 2025

8:00 am Check In, Coffee & Light Breakfast

8:55 am Chair’s Opening Remarks

EXPLORING THE BEST PRACTICES IN WASTE MANAGEMENT TO ACHIEVE REGULATORY READINESS OF EHS PROGRAMS

9:00 am Modernizing Waste Neutralization: Transitioning from Bleach to Sodium Hydroxide in Biologics EHS Programs

  • Eric Knight Global Head of Environment, Health, Safety & Sustainability, Ultragenyx Pharmaceutical Inc.

Synopsis

  • Discussing the growing shift in biologics operations from traditional bleach-based neutralization to the more effective and compliant use of sodium hydroxide
  • Analyzing a real-world case study of how to mitigate formaldehyde exceedances, protect permits and align with best practices in lab and pilot plant waste management
  • Take away practical steps and data needed to guide a successful transition

9:30 am Navigating the Challenges of Zero Landfill Goals in Biopharma to Prepare Data for Sustainable Waste Management

Synopsis

  • The challenge of categorizing and managing multiple waste streams, including biological, chemical, and recyclable materials
  • Techniques for sorting and identifying waste from labs including plastics and single-use PPE, tracking them accurately for landfill diversion efforts
  • How to ensure vendor qualification, manage waste streams, and meet compliance requirements

10:00 am Roundtable Discussion: Best Practices in Hazardous Waste Management for Biopharma EHS Leaders

  • Regina Donaldson Site Engineering & Sustainability VACC and Energy Manager, Bayer

Synopsis

  • Exploring innovative strategies for handling hazardous waste, compare best practices, and discuss real-world case studies from leading companies in the industry
  • Share real-world experiences, strategies, and lessons learned in managing hazardous and biohazardous waste
  • Benchmarks for waste volume, cost, and treatment options from peer companies
  • Explore how to effectively vet waste vendors and maintain compliance with complex EPA, RCRA, and local hazardous waste regulations

10:45 am Morning Break & Refreshments

LEVERAGING ISO STANDARDS TO MANAGE RISK & STRENGTHEN COMPLIANCE FOR 2025

11:15 am Implementing ISO Standards in Pharma & Biopharma to Enhance EHS Performance & Global Compliance

  • Martha Lara Associate Director - Global Environment, Health & Safety, Illumina, Inc.

Synopsis

  • Investigating how following ISO 14001 AND ISO 45001 can offer key benefits for EHS professionals in biopharma, especially during periods of regulatory uncertainty
  • Demonstrating ISO certification shows regulators, partners, investors, and employees that the organization prioritizes safety and environmental responsibility
  • Exploring the risk assessments needed to implement ISO Standards in pharma and biopharma organizations

11:30 am Roundtable Discussion: Driving Operational Excellence: The Strategy for ISO 14001 & ISO 45001 in Biopharma EHS

Synopsis

  • Evaluating the Strategic Value of ISO 14001 and ISO 45001: Exploring how aligning with these international standards can strengthen EHS performance and resilience
  • Highlighting how achieving ISO certification signals a strong commitment to environmental stewardship and workplace safety
  • Outlining the critical risk assessments and gap analyses required to effectively adopt ISO standards within a pharmaceutical or CDMO environment

12:15 pm Lunch & Networking Break

STRENGTHENING EHS RESILIENCE THROUGH COMMUNICATION, COORDINATION, & CONTROL

1:15 pm Managing Natural & Man-Made Disasters for Emergency Preparedness in Pharma & Biopharma EHS

  • Will Hernandez Senior Manager - Environmental, Health & Safety, Gilead Sciences

Synopsis

  • Highlighting the importance of clear communication, coordination, and safety protocols in emergency responses
  • Discussing how to overcome complex communication and decision chains
  • Developing strategies to make teams proactive by implementing structured approaches and utilizing the right technology to navigate crises effectively

1:45 pm Navigating EHS Risks of Third-Party IFMs in Pharma to Make Informed Decisions for Safety

  • Blair Michael Head of Environment, Health & Safety , Lonza Biologics, Lonza

Synopsis

  • Evaluate the EHS trade-offs of using third-party Integrated Facilities Management (IFM) providers, including impacts on safety culture, compliance, and operational control
  • Explore best practices for risk assessment and oversight when managing IFM teams on-site
  • Learn how to align safety standards, communication protocols, and accountability structures between in-house teams and outsourced providers to maintain regulatory integrity and site safety

2:15 pm Contractor Safety & Work Permits: Aligning Responsibility, Risk, & Regulatory Compliance

Synopsis

  • Clarifying where the responsibilities lie between internal teams and external contractors to ensure alignment and accountability from project initiation to completion
  • Identifying, assessing, and mitigating high-risk activities commonly associated with contracted work
  • Ensuring efficiency without compromising safety or regulatory compliance

2:45 pm Afternoon Break & Refreshments

BUILDING TRUST-DRIVEN SAFETY CULTURES THROUGH LEADERSHIP & COMMUNICATION

3:15 pm Embedding Safety Culture Through Coaching, Gemba, & Decision-Making

  • Obed Varela Senior Director & Head Of Global Environment, Health, Safety & Plasma Derived Therapies, Takeda Pharmaceutical

Synopsis

  • Revitalizing safety leadership across global sites through updated coaching modules focused on serious injury and fatality (SIF) prevention
  • Emphasizing the importance of leadership presence through gemba, being physically present where work happens to build trust, understand risks, and influence safety culture authentically
  • Driving cultural change through intentional leadership actions to reinforce safety as a shared value and strategic priority

3:45 pm Roundtable Discussion: Implementing HOP in Biopharma to Enhance Safety Culture & Reduce Incident Frequency

Synopsis

  • Developing phased approaches to successful HOP adoption, beginning with leadership buy-in, piloting small-scale programs, and scaling with structured training and metrics to track progress
  • Shifting communication and leadership mindsets, focusing on empathetic, non-accusatory language and realistic expectations to maintain trust and reinforce safety priorities
  • Understanding how implementation strategies must be tailored to organizations by sharing practical experiences, roadmaps, and lessons learned in HOP adoption

4:30 pm Chair’s Closing Remarks & End of Conference