8:15 am Registration & Morning Coffee

8:50 am Chair’s Opening Remarks

Discussing the Factory of the Future: Evaluating Where the Manufacturing Field will be in Five Years & How to Get a Head Start

9:00 am Strategy to Action – Transforming into a Multi-Model Biopharma Launch Site

  • Drew Johnston Vice President Site Engineering Berkeley, Bayer Pharma, Biotech, Bayer

Synopsis

  • Connecting the corporate vision and strategy with the needed capabilities
  • Assessing the current state, flexible long-term transition planning, and managing implementation
  • Attaching the talent and building the organization needed to fully deliver for the business and patients

9:30 am Our Modular Facility Concepts and Platform Technology Approach

  • Jim Green Senior Director, Platform Engineering & Automation, Bayer

Synopsis

  • Sharing lessons learned on single-use facilities and hybrid stainless steel/single-use facilities.
  • Our modular facility approach and how it translates to cell therapy, gene therapy, and monoclonal antibodies.
  • Advantages of deploying platform technology across a global organization and our efforts to platform cell therapy.

10:00 am Establishing Continuous Manufacturing in a Relevant Production Scale

  • Morten Munk Director, Alliance Management, FUJIFILM Diosynth Biotechnologies

Synopsis

  • Development of a multi-functional Continuous Manufacturing process system
  • Quality advantages of Continuous Manufacturing
  • Optimal column loading case study

10:30 am Discussing the Advantages of Transitioning to Continuous Bioprocess Design & Manufacturing

Synopsis

  • Discussing how iterative approaches can be used to convert from batch to continuous processing. Addressing general design considerations touching on typical bioprocess unit operations and impacts to critical utility systems
  • Outlining how continuous processing increases facility throughput with decreased equipment sizing, lending itself toward modular designs

11:00 am Life Science Integrated Facility Management – Progressing from Provider to Partner

Synopsis

  • LSIFM – Life Science Integrated Facility management model
  • Validation and Commissioning Services
  • Calibration and Metrology Services

11:15 am Morning Networking & Refreshments

11:15 am Adapting to Hybrid & Remote Working as it Becomes the “New Normal”

  • John Gardner Manager/TL, Construction Services, Pharmaceutical Manufacturing Industry, Pfizer

Synopsis

  • Discussing methods to enhance collaboration and communication where face-to-face interaction is not possible
  • Embracing technology and tools that will aid your hybrid working team
  • Motivating members of the team to become more comfortable with Zoom, Google Meets, Teams etc
  • Discussing further technology innovations that can help with this transition
  • Enhancing communication between CDMOs and pharma/biotechs

12:15 pm Optimizing Outcomes across the Pharma Value Chain Network

Synopsis

Speed to market for high-efficacy pharmaceuticals remains a top business imperative. Join this session to learn how to:

  • Realize ISPE’s Pharma 4.0 vision with the implementation of digital technologies that enhance traceability and on-time delivery of medicines to the patients that need them
  • Move forward on your digital transformation journey regardless of your company’s digital maturity today
  • Build agility and resiliency into the traditional supply chain by modernizing to a Value Chain Network

12:45 pm Networking Lunch

1:45 pm Discussion Panel: Putting the Workplace at the Heart of Organisational Trust

Synopsis

  • Reconnecting those who’ve been working on-site with those coming back to hybrid working
  • Refocusing our teams on our stakeholders’ new ways of working
  • ‘Live it, don’t laminate it’ – we know as leaders we should role model desired behaviors but what are they and how do we do that?

Increasing Productivity, Reliability & Capital Efficiency

Optimizing Facility Design for Cell-Based Therapies

  • Matthew Treon Vice President, Corporate Facilities, Engineering & Capital Projects, Co-Founder, Lykan Bioscience

Synopsis

  • Optimizing cleanroom layout to minimize risk to product and personnel including discussion flow considerations and cleanroom design considerations
  • Engineering controls to enhance compliance and cleanroom status, including access control and cleanroom monitoring

3:00 pm Chair’s Closing Remarks