Program

TBA, 2024

* JOIN US FOR THE PRE-EVENT HAPPY HOUR FROM 6:00 PM – 7:00 PM

7:00 am – 7:55 am PST

Delegate Registration and Networking Breakfast

8:00 am – 8:10 am PST

Chair's Welcome and Opening Remarks

Manufacturing and Technology

Coming soon

Quality and Compliance

Coming soon

Supply Chain and Logistics

Coming soon

8:10 am – 8:45 am PST

Opening Keynote

Tackling the Talent Gap

  • What can be done to support the future of biopharmaceutical operations and manufacturing?
  • Addressing capacity limiting issues due to talent retention
  • Uncovering workforce needs today to support tomorrow’s biomanufacturing operations
  • Why a “Reskilling Revolution” is needed and necessary
  • Collaborative approaches to transitioning ‘at-risk’ workers into new roles through targeted re-skilling
  • Why the right training and resources are needed to equip the next-generation biomanufacturing workforce with the tools to drive the industry forward
8:45 am – 9:20 am PST

Plenary

The patient in our hands: Insights into commercial autologous CAR-T manufacturing

  • Enhancing your delivery networks with digitization: How manufacturing and supply chain for cell and gene therapies is different than other modalities
  • Building hub and spoke manufacturing models to achieve economies of scale to ensure product consistency
  • Driving the importance of relentless focus on innovation, quality, safety and agility
  • Re-evaluating technology, systems, processes, people and culture through a new lens
9:20 am – 9:55 am PST

Plenary

Leveraging Digital Twins and Agents to Simplify Your Supply Chain Operations

  • Approaching logistics digitization to overcome current underutilization of data common in logistics
  • Reducing task overload in supply chain personnel and providing consistent solutions and aggregate analysis across a wide variety of shipment types present in today’s pharmaceutical supply chains
  • Leveraging digital twin and agent technologies
10:00 am – 11:40 am PST

Refreshments, Networking, and Pre-Arranged 1-2-1 Meetings

11:45 am – 12:20 pm PST

Sessions

Manufacturing and Technology

Collaborative Approaches to Deploy CMC Technical Operations

  • Developing a robust CMC strategy for late stage gene therapy assets
  • Keeping regulatory and supply chain constraints at bay
  • Overviewing the largest challenges when scaling up or out... What is lacking with the current techniques and approaches?
  • Learnings from Phase 1 and 2 to effectively get to Phase 3
  • Fresh testing your plans, ensuring they work for the U.S. and EU
  • What is needed to advance the future of cell and gene therapy manufacturing to further facilitate the development of cell and gene vector–enabled therapies?

Quality and Compliance

Redefining Care, Quality, and Regulatory Across Emerging Markets

  • Exploring the historical role of quality and what's needed to be successful in the future (Digitalization, smaller batches, new modalities, cell and gene therapies)
  • Transforming quality planning into actionable insights
  • Re-establishing the importance of developing a robust quality management system
  • Driving innovation by harnessing the best talent in the industry and building teams of creative thinkers who work together in a flexible, efficient, and collaborative environment

Supply Chain and Logistics

Building In-House Manufacturing Capability to Supply Gene Therapy to Patients

  • What are the current challenges and trends influencing design considerations for viral vector manufacturing facilities and how can they impact the development of cell and gene therapies?
  • Addressing the global manufacturing bottleneck of viral vectors as a large company vs. small company vs. start-up
  • Using product pipeline and required capacities to dictate the selection between a single product facility or a multi-product concurrent manufacturing facility
  • Highlighting the grand opening of REGENXBIO's Manufacturing Innovation Center to manage production across a full lifecycle, and improve lives through the curative potential of gene therapy
  • Building around cGMP and safe bio disposal themes
  • Adopting technological advances to achieve greater predictability, easier scalability platform to support both developmental and commercial manufacturing scale, and accelerated timeline for manufacturing and release of gene therapies
12:25 pm – 1:00 pm PST

Workshops

Manufacturing and Technology

Optimizing a Scalable pDNA Manufacturing Process

  • Introducing a scalable, innovative, efficient, and cost-effective platform process to purify pharmaceutical grade pDNA
  • Presenting our platform process that employs a low shear mixing process, low shear TFF, and low shear, highly efficient chromatographic separation
  • Leveraging our platform process to deliver high quality supercoiled pDNA
  • Typical yields are ~1 mg of pDNA per g of cell paste

Quality and Compliance

Outsource the compliance, control the manufacturing: A different way of thinking about biomanufacturing

  • Understand biomanufacturing landscape and traditional options available for clinical and commercial manufacturing
  • Provide data and insights on how the industry utilizes those traditional options
  • Introduce a hybrid option that minimizes compliance and capital risk while maximizing flexibility in development and production

Supply Chain and Logistics

Tech Ops Strategies for Complex Biologics and Advanced Medicine

  • Technical operation and manufacturing strategies to optimize manufacturing
  • Best in class practices for facility planning, operational readiness and startup.
  • Strategies for commissioning and qualification, quality, automation & engineering
1:05 pm – 2:05 pm PST

Lunch & Learn Roundtable Discussions

Benefit from additional learning by joining a moderated roundtable discussion on pressing issues in the industry. Registration is required, and attendance for moderated roundtables on Day 1 is limited to attendees and speakers. Choose from:

Empower Your Employees with Automation

ACCELERATE DELIVERY OF COMMERCIALLY VIABLE GENE THERAPIES TO PATIENTS

Viral Vector Manufacturing Strategies: Starting Materials, Process and Analytical Design

Improving Your QMS To Align With Regulatory Requirements

Overhyped or Underrated? Derisking your Biomanufacturing Process

Automating The "Work" In Paperwork: How Documents Of Record Clear The Path To More Efficient Clinical Operations & Assured Regulatory Compliance

Agile and Adaptable Operations Serving Diverse Families of Products

Accelerating Tech Transfer & Modular Manufacturing Through Virtual Processes

Enabling faster development and delivery of therapies to patients through a variable cost model

2:10 pm – 2:45 pm PST

Sessions

Manufacturing and Technology

Defining Your Manufacturing Competitive Edge Through Collaboration and Integration

  • Highlighting future technologies for cell and gene therapy manufacturing: what is the state of capacity for the biotech industry?
  • Showcasing Rocket's pipeline of first-in-class gene therapies that incorporate both adeno-associated viral vector (AAV) and lentiviral vector (LVV) approaches to gene therapy
  • Navigating the use of machine learning and artificial intelligence in the gene therapy market to analyze data, provide insights on immune cell interactions, and provide a more accurate evaluation
  • Championing change through authentic leadership and fostering a culture of trust, curiosity and generosity

Quality and Compliance

Bridging the Gap Between Industry and the FDA to Support Biologics Innovation

  • Update on 2022-2023 biologics and vaccine priorities and preview of 2023-2024
  • Addressing challenges in the manufacturing and regulatory evaluation of biologics products
  • Bringing new innovations and advances faster and more efficiently to patients who need them while providing risk-based oversight on regulatory compliance in keeping with regulatory policy
  • Advancing manufacturing technologies for biologic products
  • Inside CBER: Facilitating the development and availability of safe and effective medical products through the integration of advances in science and technology

Supply Chain and Logistics

OPERATIONAL EXCELLENCE: ACHIEVING INSPECTION READINESS AND HOW THIS IMPACTS SUPPLY CHAIN QUALITY

  • How do you implement consistent quality inspections in supply chain processes to achieve higher performance output?
  • Highlighting the importance of continuous improvement and approaching supply chain leadership with a future-looking mentality
  • Encouraging team innovation and new learning opportunities as an operation to inspire creative strategy development
  • Implementing global; strategies to develop and implement management systems for improved partnerships and product processes
2:50 pm – 3:25 pm PST

Workshops

Manufacturing and Technology

Demystifying Sustainability: How a $2 Billion project with a focus on sustainability transformed the business culture and brought untold benefits

  • What is Sustainability and why should it be more important than it is for you?
  • How to define Sustainability Goals in a sea of options
  • Integration through design and hurdles of educating while executing
  • Execution of transformative programs while not breaking the bank
  • Partnerships: Leading edge without bleeding edge

Quality and Compliance

Navigating the complexity of supply chains in today’s environment while maintaining compliance

  • Exploring the challenges facing life science supply chains
  • Integrating Real-time Excursion Prediction to improve processing applications
  • Addressing the following cases as solutions to combat the life science supply chain issues:
    • Multi-Enterprise Demand Sensing
    • Supply Vulnerability Analytics
    • Inventory Reconciliation
    • Cell & Gene Therapy Supply Chain Control Tower

Supply Chain and Logistics

Implementing Flexible Robotic Aseptic Fill-Finish is the Key to Future Success

  • Mitigate uncertainty by ensuring that your machine is flexible enough to handle future needs
  • Realize quick ROI by implementing flexible equipment in your facility
  • Use robotics to optimize fill-finish operations, reduce costs, and enhance quality
3:30 pm – 4:50 pm PST

Happy Hour, Networking and Pre-Arranged 1-2-1 Meetings

4:50 pm – 5:25 pm PST

Plenary

NAVIGATING THE GLOBAL REGULATORY LANDSCAPE FOR GENE AND CELL THERAPIES DEVELOPMENT AND APPROVAL

  • Overview of regulatory pathways for gene and cell therapies development and approval in US and EU
  • Navigating the regulatory pathway and build a cohesive regulatory strategy
  • Discussing how product comparability between clinical and commercial phases could become a hurdle for regulatory approval
  • Challenges and strategies for gene and cell therapy products development and approval
  • Reviewing CMC aspects to regulatory approval
  • Case studies to support our thinking
5:25 pm – 6:00 pm PST

Panel Discussion

Global Facility Expansion: Diversifying Your Supply Chain and Finding Your Next Leading Biotech Hotspot

  • What steps are required before building a new facility in your current landscape? In a global landscape?
  • Leveraging cross-border collaboration and working with the right partners to ensure reliability
  • Discussing the regulatory and compliance aspects of the approval process to manufacture and commercialize globally
  • Why U.S. biotech and biopharma companies should consider launching in Europe directly
    • Exporting powerhouse
    • Opportunities to collaborate
    • World-class talent
    • Strong compliance record
  • Gaining approval from regional regulatory authorities and health technology assessments
  • Overviewing risk management tactics to ensure frictionless access to the European market
6:00 pm – 6:05 pm PST

Chair's closing remarks

Manufacturing and Technology

Coming soon

Quality and Compliance

Coming soon

Supply Chain and Logistics

Coming soon

6:05 pm – 7:05 pm PST

Networking drinks reception

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