DAY ONE - WEDNESDAY, MARCH 26

7:00 am Check In

7:55 am Chair’s Opening Remarks

8:00 am Panel Discussion: Overcoming Resistance to Change to Accelerate Safety Implementation

  • Monty Stollar Director HSE External Mfg. Americas & LATAM Affiliates, Elanco
  • Chanell Alaniz Head of Enviromental Health & Safety, Cytovance Biologics
  • Patricia Tsang Associate Director, Environment, Health & Safety Management Systems, Novavax
  • Deepa Ramachandra Associate Director EHS, Cytokinetics Inc

Synopsis

  • Fostering buy-in across all levels of the organization drives faster adoption of new safety practices
  • Evolving lagging KPIs to leading KPIs
  • Keeping up with emerging technological developments in the pharmaceutical industry

Streamlining New Processes to Drive Faster Access of Transformative EHS Tools

8:30 am Getting Leaders to Own the Risk to Achieve Operational Excellence

  • Patricia Tsang Associate Director, Environment, Health & Safety Management Systems, Novavax

Synopsis

  • Encouraging biopharma leaders to understand, define, and take responsibility for risk tolerability
  • Ensuring consistency in risk assessments across laboratory and manufacturing sites
  • Optimizing risk communication between biopharma departments

9:00 am Elevating EHS Risk Management & Process Design

Synopsis

  • The importance of integrating safe and sustainable design concepts early in commercial biopharmaceutical manufacturing
  • Incorporating EHS into the design for manufacturing (DFM) program
  • The benefits of incorporating EHS risk assessments in process development

9:30 am Speed Networking

Synopsis

A prime chance to make the most of in-person networking with a niche community of EHS professionals working within the biopharma space. Designed to maximize your introduction to numerous new individuals and serve as a catalyst for ongoing discussions during the summit.

10:00 am Morning Break

10:30 am Session Reserved for SafetyStratus

Striving for Zero Harm: Modality-Specific Challenges

11:00 am Ensuring Employee Safety in Gene Editing, Cell Therapy & Gene Silencing Technologies

  • Kim Caserta Director, Environmental Health & Safety, Intellia Therapeutics

Synopsis

  • Analyzing potential hazards related to AAV vectors and extensive testing in human cell lines
  • Discussing the classification of cell lines in terms of risk and the challenges of establishing acceptable exposure limits for viral vectors
  • Presenting practical strategies to minimize exposure to viral vectors and mutagenic compounds

11:30 am Roundtable: Exploring Modality Specific EHS Challenges

  • Kim Caserta Director, Environmental Health & Safety, Intellia Therapeutics
  • Debby Santiago Senior Manager - Environmental, Health & Safety, Amgen Inc.
  • Maureen OLeary Associate Vice Provost - Research Environmental Health & Radiation Safety, University of Pennsylvania

Synopsis

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

  • Gene Therapy Manufacturing & AAV Containment: Discuss the appropriate levels of containment AAV during gene therapy manufacturing and best practices for minimizing exposure risks to personnel and the environment
  • Handling ADCs Safely: Explore effective strategies for managing antibody-drug conjugates, focusing on safety protocols, containment measures, and cross-contamination prevention
  • mRNA: Managing the risks of mRNA technologies, focusing on biosafety, challenges with traditional exposure banding, and strategies for managing risks in development and deployment

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.

Delving into Future Technologies, AI & Robotic Automation to Revolutionize EHS Activities

12:00 pm Utilizing AI for Predictive Analysis to Create Proactive EHS Systems

  • Chioma Bekwelem Associate Director - Safety, Health & Environment, AstraZeneca

Synopsis

  • Why Proactive Incident Reporting Matters?
  • What is Predictive Analytics?
  • Challenges in Adopting AI-Driven Systems

12:30 pm Networking Lunch

1:30 pm Spearheading Challenges with Containment Systems for Robotics

  • Linda Jackowiak Associate Director , Chemical Safety, Industrial Hygiene & Ergonomics, AstraZeneca

Synopsis

  • Justifying the need for containment systems in robotics, emphasizing protection and safety
  • Balancing footprint with effective containment
  • Comparing individual containment methods to integrated system containment for enhanced protection

2:00 pm Developing a Global Harmonized Digital Tool for Biological Shipments to Increase Efficiency & Ensure Regulatory Compliance

Synopsis

  • Exploring a case study of automating the process of shipment classifications to reduce shipping times from the US to Europe from one month to about a week
  • Ensuring adherence to all compliance standards and regulations
  • Overcoming confusion with gene therapy shipments

2:30 pm Roundtable: Analyzing the Potential Impact of AI, Automation & Robotics to Create Proactive Systems

Synopsis

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

  • Enhancing EHS with Automation: Discuss how EHS automation can streamline auditing processes, improve efficiency, and reduce human error, ultimately leading to more accurate compliance assessments
  • Proactive Incident Reporting & Management through AI: Explore the potential of AI-driven insights to create proactive incident reporting systems, focusing on how predictive analytics can help identify risks before they result in incidents and improve overall safety culture
  • Leveraging Robotics for Safety & Efficiency in: EHS Operations Discuss the role of robotics in enhancing safety and efficiency within EHS operations, including the use of automated systems for monitoring hazardous environments, conducting inspections, and performing routine maintenance tasks to minimize human exposure to risks

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.

3:00 pm Afternoon Break & Poster Session

Synopsis

Immerse yourself in an engaging and informal session, join your peers in a relaxed atmosphere that encourages meaningful conversions and relationship building. Explore a range of exciting poster presentations of the latest EHS strategies and showcase your own innovations in EHS management.

Optimizing Biosafety to Safeguard Employees

3:30 pm Minimizing Exposure to Hazardous Gases to Reduce Respiratory Hazards

  • Debby Santiago Senior Manager - Environmental, Health & Safety, Amgen Inc.

Synopsis

  • Identifying the risks and types of hazardous gases commonly encountered in biopharma environments
  • Implementing effective safety measures and containment strategies to protect personnel
  • Complying with EHS regulations and best practices to minimize exposure

4:00 pm Protecting Lab Technicians from Risks with Animal in Vivarium to Minimize Pathogen Exposure

  • Jason Burrill Sr. Director, Global EHS&S, Charles River Laboratories

Synopsis

  • Conducting comprehensive bio-risk assessments with animal handling
  • Managing Isoflurane explore in animal anesthesia
  • Implementing safety protocols for animal handling and care

4:30 pm Implementing Biosafety Best Practices in BSL-3 Laboratories to Mitigate Microbial Risk

  • Maureen OLeary Associate Vice Provost - Research Environmental Health & Radiation Safety, University of Pennsylvania

Synopsis

  • Discussing the essential design features and operational protocols of BSL-3 laboratories
  • Exploring methodologies for conducting comprehensive risk assessments in BSL-3 settings
  • Detailing best practices for emergency preparedness

5:00 pm End of Day 1