6:00 pm - 7:00 pm

Welcome Drinks Reception for the Evening of November 14th

7:00 am - 7:45 am

Registration & Breakfast

7:45 am - 7:50 am

Opening Remarks and Important Announcements

7:50 am - 8:00 am

Co-Chairs’ Welcome Address

Pat Yang
Vice Chairman & Co-Founder
National Resilience, Inc.

Alison Moore
Chief Technology Officer
Allogene Therapeutics

9:15 am - 9:50 am

Progress on the Industrialization of Autologous Ex Vivo Genetically Modified Cell Therapies

• Product milestones achieved
• Impact BACCELERATE^tm can have on industrial scale viral vector manufacturing and their costs
• Cell processing improvements that can impact patients’ dose
• Progress in rapid analytics and digital ecosystems

Joseph Tarnowski
SVP, Cell & Gene Therapy, R&D Medicinal Science and Technology
GSK

9:15 am - 9:50 am

Global Quality in Takeda: Integration, Transformation and Innovation

• Overview of Takeda
• Learnings from Integration of two large pharma companies
• Global Quality roadmap and transformation of Quality Management Systems
• Innovation through digitalization
• Quality Culture

Gerard Greco
Global Quality Officer
Takeda

9:15 am - 9:50 am

Taking Commercial Cell Therapy Supply to the Next Level

• How should our industry build upon current cell therapy advances to create even more advanced and complex biopharmaceutical treatments
• Understanding how facility and process validation considerations change and become even more important when dealing with cell therapies
• Illustrating how investing in the relevant science directly informs product knowledge
• Demonstrating that this hard-won internal expertise can be harnessed into developing a successful new modality for cell therapies
• How to manage and maximize internal and external capacity to overcome product supply challenges

Chris McDonald
SVP & Global Head, Manufacturing
Kite Pharma

9:55 am - 11:35 am

Pre-Arranged One-to-One Meetings

• 10:00 am – 10:20 am: Meeting Slot 1/Networking
• 10:25 am – 10:45 am: Meeting Slot 2/Networking
• 10:50 am – 11:10 am: Meeting Slot 3/Networking
• 11:15 am – 11:35 am: Meeting Slot 4/Networking

11:40 am - 12:15 pm

Quality 4.0: Where Do I Start?

• Discussing the current Quality 4.0 environment and addressing the most common challenge of how to get started
• Applying what we’ve learned to help companies begin their quality and compliance digital initiatives by leveraging behavioral and predictive analytics
• Ensuring quick results and getting the most value out of your investments in Quality 4.0 initiatives

Jaime Velez
Co-founder
Operations & Quality Systems Improvement Experts (OQSIE)

11:40 am - 12:15 pm

Building a Safe World When It’s Falling Apart

On January 9^th, 2020, the WHO announced a mysterious coronavirus-related pneumonia in Wuhan, China. We have come to know this virus as COVID-19 in the years since. COVID-19 vaccines became available after a series of quarantines shut down the global economy and overwhelmed healthcare services. This presentation discusses the fundamental steps required to prepare, implement, and sustain exponential vaccine growth during global chaos:

• Creating, and sharing the vision
• Identifying the fundamentals
• Dealing with changes in the ever-changing regulatory landscape
• Implementing and sustaining near impossible growth

Robert Beall, PMP
Director, Product Lifecycle Management
ProPharma Group

11:40 am - 12:15 pm

Are We There Yet? The Digital Transformation Journey

• The buzzwords abound: digital transformation…..Industry X.0….Industry 4.0……but what are some practical approaches to achieving the promised benefits?
• What does digitalization actually mean in terms of transforming the biopharma product lifecycle?
• What are best practices to accurately assess and benchmark the capabilities of my organization and develop a transformation plan?
• Hear some recent experiences of successful digitalization initiatives in biopharma R&D and manufacturing
• Learn from a variety of diverse perspectives for quantifying real benefits and what pitfalls to avoid (hint: don’t focus just on technology)

Sean Buckley
Sr. Industry Consultant, Life Sciences
Emerson Automation Solutions

12:20 pm - 12:55 pm

From Big Pharma to Specialty Manufacturers: The Future is About Innovation

• Comparing and contrasting how large and small organizations approach their biopharmaceutical manufacturing processes
• How do the best practices of large companies translate into smaller and more specialized organizations?
• Discussing some of the new ideas and opportunities emerging in the cell therapy arena
• Leveraging the knowledge and processes of industry leaders to improve competitiveness in younger companies
• Sharing lessons learned so far and discussing next steps

Greg Guyer
EVP and Chief Technical Officer
BioMarin Pharmaceuticals

12:20 pm - 12:55 pm

Staying at the Cutting Edge of Quality by Investing in Your People, Processes, and Technology

• What makes biopharmaceutical workforce development challenges fundamentally different from other industries?
• Challenges of maintaining Quality Culture through the pandemic and shifting culture as we move back to the “new normal”
• Cross-pollinating new ideas and innovations throughout the company and up and down our supply chain.
• Talking about Quality Culture as a constant work-in-progress. How do we continue to innovate and improve and evolve?

Melissa Seymour
Head of Global Quality and Chief Quality Officer
Biogen

12:20 pm - 12:55 pm

Cell Therapy Manufacturing Commercialization – Strategy and Challenges

• Understanding the unique manufacturing challenges for Autologous Cell Therapy, including the paradigm shift from IND to Commercial
• How does Development By Design, Quality By Design, and Cell Therapy COGs optimization engage with one another in this newly emerging space?
• Creating a Cell Therapy Technology Road Map Vision to address scale-out challenges
• Recognizing the current weaknesses in the Technology landscape and seeking ways to overcome these challenges moving forward
• Offering final thoughts on where we are as an industry today, and what we need to be doing right now to get ready for tomorrow

Harry Lam
Chief Technology Officer
JW Therapeutics

12:54 pm - 1:55 pm

Executive Lunch

12:55 pm - 1:55 pm

Industry Trends, Challenges, and Opportunities in Process and Technology Platforms for the Industrialization of Cell Therapy Products

Nuno Fontes
SVP, Global Head of Development
Bayer

12:55 pm - 1:55 pm

Accelerating Development Timelines and Reducing Risk with Flexible GxP Solutions

Ravi Samavedam
President and COO
Azzur Cleanrooms on Demand™

12:55 pm - 1:55 pm

Building a Resilient Supply Chain and Robust Manufacturing Platform to Accelerate Cell and Gene Therapy Commercialization

12:56 pm - 1:55 pm

Analytical Considerations/Challenges for Cell & Gene Therapeutics

Babita Parekh
VP, Analytical Sciences and Global Bioassay Steward
Eli Lilly

12:56 pm - 1:55 pm

Strategies and Opportunities for Enabling and Accelerating Patient-Centric Flexible Care Solutions

Gargi Seth
Director, Global Technical Development Project and Portfolio Management
Genentech

12:56 pm - 1:55 pm

Strategies in Effective Tech Transfer

Sid Advant
VP GMP Operations
GSK

12:57 pm - 1:55 pm

Experiences in Building Virtual Networks for Start Ups

Eileen Higham
SVP Technical Operations
Intergalactic Therapeutics

12:57 pm - 1:55 pm

Manufacturing Digital Twin

Reza Sadeghi
CSO
BIOVIA, Dassault Systèmes

12:57 pm - 1:55 pm

Using Cloud Technology in CMO Networks To Ensure Data Integrity and Timely Process Monitoring and Reporting

Mark Isaacs
VP
Skyland Analytics

12:58 pm - 1:55 pm

Pharma 4.0: Unlocking Rapid Tech Transfer

Eric Hacherl
VP of Manufacturing
Spark Therapeutics

12:58 pm - 1:55 pm

Lessons Learned for Effective Process Development and Technology Transfer When Using an Outsourcing Model

Bikash Chatterjee
Chief Executive Officer
Pharmatech Associates

12:58 pm - 1:55 pm

Maximizing Diversity to Build High-Performing Teams

Stan Russell
VP, Quality
TCR2 Therapeutics

2:35 pm - 3:10 pm

Becoming Patient-Centric, Do You Have What it Takes?

• Today’s biopharma companies are energized by the unprecedented progress and speed in manufacturing COVID vaccines and therapeutics, advancements in personalized therapies and breakthrough treatments
• How can we keep up with the intricate manufacturing, supply chain and quality control processes necessary to bring them to patients who need them?
• We highlight how scaling-up technologies like Cloud, AI, and Machine learning develop a digital thread that will connect siloed teams and datasets that allow companies to meet the challenges of shortened timelines and increasing product complexity
• We share examples of industry leaders who are engaged in near-term and long-term transformation efforts using data to accelerate pipelines and optimizing their supply chains and operations to become more patient-centric

Anne Marie O’Halloran
Global Supply Chain/X.0 Life Sciences Lead
Accenture

2:35 pm - 3:10 pm

The Therapeutic Diabetes Vaccine Diamyd® – Precision Medicine to Navigate Complexity

• Diamyd Medical and Diamyd®; the company and the diabetes vaccine
• Precision medicine approach to develop an antigen-specific disease-modifying therapy
• How internal and external events have shaped clinical development and manufacturing strategy

Ulf Hannelius
President & CEO
Cytiva

2:35 pm - 3:10 pm

Digital Twin Applications for Quality by Design in Bioprocess Development and Manufacturing

• The integrated process model (IPM) is the engine that drives to a digital twin in manufacturing
• QbD and CPV applications can be easily run from a working digital twin
• FMEA rankings can be algorithmically established
• Control Strategies can be determined based on impact on final drug product
• Process monitoring improved as it compares results not against a full process variation (e.g. 3SD), but within the context of the full model RMSE given concrete process settings

Christopher Taylor
Head of Consulting at Körber Pharma Software PAS-X Savvy
Körber Pharma Software

3:15 pm - 4:25 pm

Pre-Arranged One-to-One Meetings

• 3:15 pm – 3:35 pm: Meeting Slot 5/Networking
• 3:40 pm – 4:00 pm: Meeting Slot 6/Networking
• 4:05 pm – 4:25 pm: Meeting Slot 7/Networking

5:05 pm - 5:50 pm

The Transformational Potential of the Advanced Manufacturing of Biologics

• Describe the potential for advanced manufacturing
• Review case studies illustrating the potential of advantages advanced manufacturing
• Provide resources for product developers

Peter Marks
Director – Center for Biologics Evaluation and Research (CBER)
FDA

5:50 pm - 6:00 pm

Co-Chairs’ Closing Remarks

Pat Yang
Vice Chairman & Co-Founder
National Resilience, Inc.

Alison Moore
Chief Technology Officer
Allogene Therapeutics

6:00 pm

Drinks Reception

6:01 pm

HANGOUTS

From 6:00 pm onwards there will be three different ‘Hangout’ areas set up in the Exhibition Hall, each beside a bar. These are unmoderated opt-in networking opportunities for attendees to engage with their peers about the content and issues they enjoyed during the day’s sessions. Choose the topic that interests you most and congregate at the appropriate Hangout.

6:02 pm

At Bar 1 in the Exhibition Hall

6:02 pm

At Bar 2 in the Exhibition Hall

6:02 pm

At Bar 3 in the Exhibition Hall

7:30 am - 8:25 am

Registration & Breakfast

8:25 am - 8:35 am

Co-Chairs’ Welcome Remarks

Pat Yang
Vice Chairman & Co-Founder
National Resilience, Inc.

Alison Moore
Chief Technology Officer
Allogene Therapeutics

9:50 am - 10:25 am

Fast End to End, Then and Now!

• There is a clear need for rapid scale up, launch and tech transfer to meet global demand
• The regulatory, quality and compliance, and technical environment is evolving through key triggers
• Discussion of various quality and regulatory approaches and technical advances to support strategic acceleration

Andrea Goddard
SVP, Global Head of Quality and Compliance for Pharma Technical Operations
Roche

9:50 am - 10:25 am

Staying Ahead of the Curve in an Increasingly Complex Regulatory World

• Discussing the growing regulatory complexity in the world of pharmaceutical manufacturing. How are new guidelines and regulators’ expectations during inspections changing?
• Taking a process-based approach to impact assessment, and customizing a setup that identifies and acts on signals proactively
• Bringing a structured approach to your advocacy within you network of industry and trade organization connections
• Embracing the idea that keeping things simple even in a complex environment generates the best outcomes

Søren Thuesen Pedersen
Sr. Director, External Affairs Quality Intelligence and Inspection
Novo Nordisk

9:50 am - 10:25 am

Navigating the Unique Manufacturing and Supply Chain Challenges in Commercializing Cell and Gene Therapy

• Highlighting the 3 pillars of the Sangamo manufacturing strategy
• Achieving a balanced investment in manufacturing capacity and how to build a strong supply chain
• Identifying the key challenges and areas for improvement in 3 case studies
• Options to increasing AAV yield and scalability
• Achieving scale and COGs in allogeneic cell therapy products
• Streamlining cold chain and delivery to patients for AAV and cell therapy products
• How to lead a CMC team in an emerging and growing industry

Andy Ramelmeier
EVP Technical Operations
Sangamo Therapeutics

10:25 am - 11:15 am

Pre-Arranged One-to-One Meetings

• 10:30 am – 10:50 am: Meeting Slot 8/Networking
• 10:55 am – 11:15 am: Meeting Slot 9/Networking

11:20 am - 11:55 am

The Rise of mRNA Vaccines and Therapeutics – CMC Development During a Once-in-a-Lifetime Pandemic

• The push for a COVID-19 vaccine – from a CMC perspective
• The challenges of rapid vaccine scale-up to meet world-wide demand
• The next chapter: the future of mRNA vaccines and therapeutics development and manufacturing

Jason Murphy
VP, Nucleic Acid Process Development and Applied Technologies
Moderna

12:00 pm - 12:35 pm

Building Capacity and Capabilities to Realize the Promise of Cell and Gene Therapies

• Challenges and opportunities with bringing cell and gene therapies to market
• The importance of building capacity and capabilities to enable successful commercialization of therapies
• Criticality of high quality raw materials to ensure a seamless transition from early development to late phase

Lawrence (Larry) Pitcher
General Manager, Microbial Manufacturing Services, Part of Thermo Fisher Scientific
Thermo Fisher Scientific

12:00 pm - 12:35 pm

Leading Through Change: Adjusting your Leadership and Talent Strategy During an Unforeseen Crisis

• Global talent trends in biopharma operations – an updated view
• The knee-jerk reaction to the pandemic and initial solutions planned
• Driving leadership performance & development in a crisis
• The three critical dimensions of resilience: individual resilience, team resilience and organizational resilience

Pascal Bécotte
Global Executive Committee, Global Sector Leader – Functional Practices, Country Manager – Canada & Managing Director
Russell Reynolds Associates

12:00 pm - 12:35 pm

J.POD 1 US: Delivering Low-Cost, Flexible and Deployable Manufacturing

• Applying a fully integrated biologics platform from discovery through cGMP manufacturing – J.DESIGN – to deliver upon a mission to expand global access to biotherapeutics
• Incorporating the most advanced, innovative technologies into a simpler facility design to reduce the cost of manufacturing, improve speed to clinic/market, while maintaining the highest quality
• Building a cost-effective plant that has capacity flexibility to adjust to demand fluctuations
• Designing a geographically deployable platform approach throughout a global biologics manufacturing network

Renae Dill
VP, Manufacturing Operations
Just – Evotec Biologics

12:34 pm - 1:35 pm

Executive Lunch

12:35 pm - 1:35 pm

Rise to the Challenge: How to Find and Keep Your Next Successor

Ruby Casareno
SVP Technical Operations
Allakos

12:35 pm - 1:35 pm

Building Quality in Small Clinical Stage Biotech Companies

Claus Weisemann
VP Quality
NGM Biopharmaceuticals

12:35 pm - 1:55 pm

Raw Material Constraints and Opportunities for the Production of mRNA-Based Vaccines and Therapeutics

Murali Muralidhara
Chief Manufacturing Officer
RVAC Medicines

12:36 pm - 1:35 pm

COVID-19 Disruptions in the Ecosystem of Materials and Components Supply— Challenges and Opportunities

Mihaela Simianu
Executive Director Global Vaccines Technical Operations
Merck

12:36 pm - 1:35 pm

12:36 pm - 1:55 pm

1:35 pm - 2:10 pm

Rethinking Our Supply Chains to Serve Patients Better

• Discussing the challenge of supplying large patient populations: What makes sense now, and what does the future hold?
• How are cell-line improvements, fed-batch cell culture technology, and high-performance purification allowing our industry to increase output?
• Creating modular, scalable production facilities that will give our organizations the capacity to respond to changing global demand
• How have these steps informed how we built and rolled out the supply chain supporting the fight against COVID-19?

Dennis Nsenkyire
VP, Strategy & Deployment Janssen Supply Chain
Johnson & Johnson

1:35 pm - 2:10 pm

Improving Global Medicines Supply with Science, Trust, an Effective Quality System and Leadership

• It usually takes a minimum of 3-5 years for global health authority approval of a single post approval change even when the change reduces risk to patients. The global regulatory complexity disincentivizes companies to continually improve and it’s a threat to the medicines supply
• This problem has been known for more than two decades and no solution has fixed the problem, which has only become bigger
• Chief Quality Officers of the top Pharma companies have come together to speak with One Voice of Quality on Post Approval Changes and are suggesting a path to reduce drug shortages and enhance continual improvement
• No single stakeholder can fix the OAC problem alone. Only when leaders in the industry and at regulatory agencies come together will this decade long problem be solved. Now is the time!

Anders Vinther
VP Quality
Kronos Bio

1:35 pm - 2:10 pm

Commercialization and Technology Transfer of mRNA Therapeutics and Lyophilized Vaccines

• The novel development and manufacturing technologies for mRNA therapeutics and lyophilized vaccines
• Current challenges and success in large-scale production of the latest mRNA vaccines
• Global technology transfer, process validation rapid commercialization, and supply strategies

Dushyant Varshney
EVP & Chief Technology Officer
Arcturus Therapeutics

3:15 pm - 3:25 pm

Co-Chairs’ Closing Remarks

Pat Yang
Vice Chairman & Co-Founder
National Resilience, Inc.

Alison Moore
Chief Technology Officer
Allogene Therapeutics