DAY TWO - THURSDAY, MARCH 27

7:30 am Check In

8:25 am Chair’s Opening Remarks

Mastering EHS Biopharma Regulations to Enhance Safety & Operational Efficiency

8:30 am Outlining OSHA Expectations to Ensure EHS Compliance

  • Lisa Puckett Senior Manager - Environment Health & Safety, Natera

Synopsis

  • Understanding OSHA compliance requirements for biopharma
  • Implementing ISO 14001 for environmental management
  • Navigating new governance in EHS compliance

9:00 am Evolution of Biorisk Management Standards: From CWA 15793 to ISO 35001

  • J. Craig Reed Chief of Staff and Director, EHS, Texcell North America

Synopsis

  • Understand the relationship of CEN Workshop Agreement (CWA) 15793 to ISO 35001
  • Discussion of the critical differences between a biosafety program and a biorisk management system
  • Benefits to your organization of having an effective biorisk management system

9:30 am Panel Discussion: Ensuring Compliance in a Diverse Regulatory Landscape to Reduce Legal & Financial Risks

  • J. Craig Reed Chief of Staff and Director, EHS, Texcell North America
  • Lisa Puckett Senior Manager - Environment Health & Safety, Natera
  • Maureen OLeary Associate Vice Provost - Research Environmental Health & Radiation Safety, University of Pennsylvania

Synopsis

  • Understanding permits and chemical procurement requirements
  • Examining best practises for incident reporting and data management
  • Challenges of shipping biological materials between territories with different regulations

10:00 am Morning Break

Catalyzing Sustainable Innovation in EHS Management & Corporate Strategy in Industry to Enhance Long-Term Operational Efficiency

10:30 am Navigating Sustainable Waste Disposal for Biopharma to Promote Environmental Protection

Synopsis

  • Examining the common denominators in waste management, including their effectiveness and potential compliance challenges. This includes biological waste, chemical waste and potent compound waste
  • Discuss best practices for ensuring adherence to local, state, and federal regulations to avoid penalties
  • Highlight the importance of adopting sustainable materials in waste disposal processes

11:00 am Roundtable: Discussing Sustainable Solutions for Chemical Disposal, Emissions Reduction & Energy Efficiency in Labs & Manufacturing to Increase Long-Term Viability

  • Lisa Puckett Senior Manager - Environment Health & Safety, Natera
  • Arif Peshimam Director & Global Head of Biosafety, Health, Safety & Environment, Sanofi
  • Thomas Fenton Senior Specialist - Environment, Health & Safety, Alkermes

Synopsis

Practical and highly interactive breakout roundtables where attendees can crowd-source solutions and share opinions around preassigned topic areas:

  • Minimizing Chemical Disposal: Reducing hazardous chemical waste in labs and best practice
  • Reducing Air & Water Emissions: Discussing compliance strategies, filtration techniques and monitoring systems
  • Energy Efficiency to Cut Consumption: Discussing energy lab recycling and energy saving initiatives

Moderator Feedback and Audience Debate: Moderators will be assigned to each roundtable to facilitate discussion and collate the findings. Following the roundtable discussions, they will present back to the entire delegation and open wider audience debate.

Protecting & Motivating Your Biopharma Workforce to Elevate Safety Culture

11:30 am Embedding EHS Programs with Your Workforce to Create a Lasting Impact

Synopsis

  • Exploring evidence-based strategies to create trust and accountability
  • Convincing business leaders to buy-in to EHS programs
  • Creating a unified message to effectively communicate across departments and bridge cultural differences

12:00 pm Networking Lunch

1:00 pm Optimizing Frameworks for Human & Organization Performance to Secure Senior Leadership Support

  • Victor D’Amato Sr Director & Head of Operations Safety, Health & Environment (SHE), AstraZeneca

Synopsis

  • Utilizing HOP to unearth challenges in implementation
  • Improve equipment and processes in R&D and manufacturing settings
  • Empowering employees to prevent burning out and promoting psychological wellbeing

1:30 pm Implementing EHS Culture in Assembly Line-Like Work Environments• Launching quick, easy, effective, routine, EHS systems that include the involvement by management and employees • Programs that ensure cross collaboration and communication with management

  • Tim Hellem Head of Environment, Health & Safety Manager, B.Braun Medical Kft.

Synopsis

  • Launching quick, easy, effective, routine, EHS systems that include the involvement by management and employees
  • Programs that ensure cross collaboration and communication with management and employees
  • Tracking, fixing and communicating issues through to completion in assembly line work environments

2:00 pm Roundtable: Balancing Growth, Budget & Culture in EHS for Biopharma to Foster a Safety Focused Environment

Synopsis

A more practical and highly interactive breakout roundtables where attendees can crowd-source solutions and share opinions around preassigned topic areas:

  • Maximizing Efficiency with Limited Staff & Budget: Discussing growing operational capabilities without increasing
  • Building Safety into the Science by Gaining Buy-in: How to implement and reinforce behavioral-based safety in labs, overcoming slow adoption and ingrained habits
  • Bridging Departmental Culture Gaps: Discuss strategies for fostering collaboration and understanding between teams with varying safety mindsets and operational goals headcount by leveraging budgets across departments

Moderator Feedback and Audience Debate: Moderators will be assigned to each roundtable to facilitate discussion and collate the findings. Following the roundtable discussions, they will present back to the entire delegation and open wider audience debate.

2:30 pm Afternoon Break

3:00 pm Navigating Radation Safety A Critical Component of a Biopharma EHS&S Program

  • Ronald Amoling Associate Director - Environment, Health & Safety, Bristol Myers Squibb

Synopsis

  • Biopharma R&D: Does your EHS&S program include a radiation safety component?
  • Regulatory requirements for x-ray equipment and radionuclides
  • Appointing a radiation safety officer

3:30 pm Cost-Effective EHS Training to Breaking the Cycle of Incidents & Ensure Standardization

Synopsis

  • Techniques for keeping EHS training fresh and relevant
  • Leveraging new technologies such as VR simulations to increase engagement
  • Measuring impact and tracking the effectiveness of training programs

4:00 pm Chairs’ Closing Remarks & End of Conference