Agenda - Pharma Manufacturing World Summit

Stream One Chair

Charles L. Cooney

Robert T. Haslam Professor of Chemical Engineering, Emeritus, and Faculty Director, Emeritus Deshpande Center for Technological Innovation

MIT

Stream Two Co-Chair

Teresa Gorecki

Practice Lead

Compliance Architects LLC

Stream Three Co-Chair

Jacob Greenwood

Vice President Strategy

Project Farma

5:00pm - 6:00pm

Welcome Day Panel: Planning for Pharmaceutical Manufacturing of the Future: What are the Five Big Things We Need to Talk About?

Paul Testa

EVP Supply Chain and Operations

Kyowa Kirin

Marian Gindy

Vice President, Small Molecule Science and Technology

Merck

Sandra Poole

Chief Operating Officer

Mythic Therapeutics

Alex Cooke

CEO

Phase3

Christine Sheaffer

Vice President of Manufacturing & Supply

Spark Therapeutics

Session Details

Is talent and workforce development in our industry changing? If so how and why?
What are the most important new technologies in manufacturing today?
What current factors are affecting speed of development and efficient manufacturing?
What Regulatory progress has been made and what future opportunities exist?
How can we improve the access of innovative medicines?

6:00pm

7:30am - 8:15am

8:15am - 8:20am

Opening Remarks and Important Announcements

8:20am - 8:30am

Chair’s Welcome Address

Charles L. Cooney

Robert T. Haslam Professor of Chemical Engineering, Emeritus, and Faculty Director, Emeritus Deshpande Center for Technological Innovation

MIT

8:30am - 9:05am

Manufacturing with an Agile and Flexible Mindset

Holger Weintritt

EVP Head Pharmaceuticals Product Supply

Bayer

Session Details

Building a strong manufacturing strategy that can cope with a constant changing environment
Highlighting the importance of flexibility in asset design to better adapt to market fluctuation and reach desired time to market speed
Becoming more agile and flexible in scaling-up new modalities (cell and gene therapies) to bring them at the required speed to patients
Adapting to a new operating model to bring flexibility and agility in resource and capability planning unleashing the full potential of an organization

9:05am - 9:40am

Strategic Expansion Roadmap: Fill & Finish Facilities for Global Growth

Flemming Dahl

SVP Head of Product Supply Fill & Finish Expansions

Novo Nordisk

Session Details

Exploring the strategies and considerations involved in building fill & finish facilities across a global manufacturing network
Discussing the importance of harmonization and global standards in pharmaceutical manufacturing and how we ensure consistency and quality across our facilities
Understanding the challenges and approaches in maintaining regulatory compliance when expanding fill & finish capabilities
Exploring the role of innovation and technology in enhancing efficiency and quality

9:45am - 10:20am

Panel: Optimizing Technical Operations: Best Practices for Manufacturing Next-Gen Medicines

Anshul Mangal

President

Project Farma

Flemming Dahl

SVP Head of Product Supply Fill & Finish Expansions

Novo Nordisk

Ciaran Brady

Vice President, Manufacturing Science and Technology

Vertex Therapeutics

Jason Politi

Chief Technology Officer

Verve Therapeutics

Session Details

Current trends and manufacturing strategies for next-generation medicines
Best in class practices for facility planning, CQV, operational readiness and startup
New innovative technologies on the horizon

9:45am - 10:20am

Data Doesn’t Lie – Digital Manufacturing ROI

Martin Smyth

SVP Go To Market Strategy

MasterControl

Session Details

Why digitizing production records and connecting to other systems is needed to remain competitive
The areas where digital systems have significant impact and how that translates to the bottom line
How digital systems can improve the work experience for operators
How to clearly demonstrate the ROI of a digital system

10:25am - 12:05pm

Pre-Arranged One-to-One Meetings

10:30 am – 10:50 am: Meeting Slot 1/Networking
10:55 am – 11:15 am: Meeting Slot 2/Networking
11:20 am – 11:40 am: Meeting Slot 3/Networking
11:45 am – 12:05 pm: Meeting Slot 4/Networking

These mutually agreed-upon conversations are arranged and facilitated by Executive Platforms staff to ensure attendees have valuable discussions about their top-of-mind questions, challenges, and opportunities.

12:10pm - 12:45pm

Manufacturing as a Strategic Enabler for Serial Innovation

Ciaran Brady

Vice President, Manufacturing Science and Technology

Vertex Therapeutics

Session Details

Sharing Vertex’s track record for serial innovation in manufacturing to create transformative medicines for people with serious diseases and high unmet medical needs
Highlighting Vertex’s success with small molecule continuous manufacturing
Transforming manufacturing in cell and genetic therapies for Sickle Cell Disease, Beta Thalassemia, and Type 1 Diabetes
Describing the specific technical innovations and breakthroughs that have been instrumental in Vertex’s manufacturing success
Emphasizing the importance of cross-functional collaboration to drive manufacturing innovations and deliver transformative medicines

12:10pm - 12:45pm

Proactivity – the Future of Quality

Anthony Mire-Sluis

SVP Head of Global Quality

AstraZeneca

Session Details

Using Human and Organizational Performance (HOP) in designing quality into the end to end supply processes and how to implement effectively
Adopting risk-based approaches to identify and mitigate potential issues, maintaining a focus on critical processes and regulatory compliance
Fostering a culture of continuous improvement, leveraging digital tools to optimize processes and enhance overall quality management
Establish a proactive approach to regulatory compliance and production effectiveness using appropriate problem solving and conducting regular self-assessments

12:10pm - 12:45pm

Navigating the Complexities of Gene Therapy Commercialization and Manufacturing

Ryan Bartock

Head of Engineering, Technical & Digital

Spark Therapeutics

Session Details

Scaling up gene therapy production, the challenges, solutions and real world examples exploring the next frontier of manufacturing and its significance
The future of external gene therapy development, meeting growing demand for advanced therapies
The impact and transformation of advanced technologies on improving efficiency and product quality
Exploring strategies for collaboration and partnerships for large scale gene therapy production
Regulatory challenges in gene therapy manufacturing
Case studies of successful external gene therapy commercialization and manufacturing models and discussing the future outlook of meeting the growing demand

12:45pm - 1:45pm

Executive Lunch Seating

12:45pm - 1:45pm

Explore this year’s themed lunch discussions led by industry leaders, where executives engage in focused conversations over a meal, discussing topics they’re passionate about alongside their peers.

Best Practices for Integrated Business Planning in Pharma: Leveraging Connected Planning to Drive Growth

Robert Honer, PMP CPIM

Senior Director, Supply Chain Practice

Anaplan

Industry Trends, Challenges, and Opportunities in Process and Technology Platforms for the Commercialization of Gene Therapy Products

Christopher Klem

Sr. Director Global Manufacturing

AskBio

Knowledge Retention in a Time of High Turnover

Kari Borroel

Head of Operations Quality Learning & Development

AstraZeneca

Automation Technology to Unlock the Future of Cell Therapy Manufacturing

Paul Kopesky

VP Cell Process Development

Beam Therapeutics

Lessons and Opportunities in Value Stream Mapping

Alok Bhatt

Senior Director, Biologics Value Chain, Global Manufacturing & Supply

BMS

Supply Chain Revolution: Prioritizing Patients in Pharmaceutical Logistics

John Glavas

AVP External Manufacturing

Merck

Creating the Multi-Launch CTOs of the future: Who, How, & When?

Alex Cooke

CEO

Phase3

Modernizing the Pharma Quality System. What is It and Does It Drive Results?

Lisa Winstead

Sr. Director - Site Quality Head

Resilience

Culture Transformation: from Compliance to Performance

Yana Collins

Head of Quality Culture and Transformation

Sanofi

Leveraging Platform Processes for Efficient and Effective Gene Therapy Manufacturing

Christine Sheaffer

Vice President of Manufacturing & Supply

Spark Therapeutics

Rusty Shreve

Director, Manufacturing Operations

Spark Therapeutics

Changing the Compliance Paradigm in Large, Global Companies

Peter Shearstone

VP Global Quality & Regulatory Affairs

Thermo Fisher Scientific

1:45pm - 2:20pm

Driving Transformation in Quality to Meet the Needs of Our Customers

Robin Kumoluyi

VP & Chief Quality Officer, J&J Innovative Medicine

Johnson & Johnson

Session Details

Quality as a business driver by “Flipping the Ratio”
Transforming business growth through Proactive Quality
Preparing our organization for the future of Quality Assurance

2:25pm - 3:00pm

Accelerate Your Bench to Production Timeline by Collocating Research with Process Development and Pilot Scale Production

Peter Genest

Head of Client Solutions

SmartLabs

Craig Beasley

Chief Technical Officer

Blue Rock Therapeutics

Session Details

Facilitate tech transfers between teams
Transition from a PD lab to Pilot lab as business needs change
Ensure quality of pharmaceutical products
Improve your process as it evolves during optimization

2:25pm - 3:00pm

The Value of a Unified Life Sciences Solution in Pharma 4.0

Zillery Fortner

Industry & Business Development Director

Honeywell

April VanDenDriessche

MES Technical Solutions Consultant

Honeywell

Session Details

Manage the production process and quality in real time from order to batch release in one browser-based user interface visualizing real-time and historical data
Streamline collaboration between manufacturing and quality people and processes to maximize throughput and accelerate batch release
Digitize all direct batch execution (EBR) and execution related activities (Logbooks and Digital Procedures) to eliminate paper or unstructured electronic records where data is trapped
Take advantage of configurable functionality
Analyze and report on operational data in one place for a single source of the truth
Achieve measurable results in cost reduction, risk mitigation, and revenue opportunities

2:25pm - 3:00pm

From “Impossible” to Commercialization

Scott DeWire PhD

US Head, Business Development & Licensing

Boehringer Ingelheim

Michael Kraich PhD

Vice President of Global Project & Product Management BioXcellence

Boehringer Ingelheim

Session Details

Boehringer Ingelheim BioXcellence™ demonstrates how effective collaboration in contract manufacturing can expedite the delivery of innovative medicines
Leveraging expertise in microbial development and manufacturing
Toolbox approach for a groundbreaking cancer vaccine platform, that was honored with European Inventor Award in 2022
Showcasing two perspectives from CMO and partner
The session will highlight the power of collaboration and innovation in the pharmaceutical industry

3:05pm - 4:15pm

Pre-Arranged One-to-One Meetings

3:05 pm – 3:25 pm: Meeting Slot 5/Networking
3:30 pm – 3:50 pm: Meeting Slot 6/Networking
3:55 pm – 4:15 pm: Meeting Slot 7/Networking

4:20pm - 4:55pm

Becoming a “Best in Class” Supply Chain Network to Deliver More Medicines to More Patients, Faster

Catalina Vargas

SVP Global Supply Chain

Bristol Myers Squibb

Session Details

Fostering an efficient and agile supply chain network with a quality excellence and continuous improvement mindset
Delivering robust and reliable “patient need” signals to our network with minimal friction
Being seen as a trusted, visible, and resilient partner for our stakeholders
Developing engaged teams who lead with an enterprise mindset and lean into their functional expertise
Resulting in one highly synchronized, transparent and sustainable supply chain network that enables a competitive advantage

4:55pm - 5:30pm

Sanofi Manufacturing Transformation: Turning Science into Reality for Patients

Daniela Ottini

SVP, Manufacturing and Supply Head of Specialty Care

Sanofi

Session Details

Our new purpose: we chase the miracles of science to improve people’s lives
Our race to make available breakthrough treatments & vaccines for patients supported by diverse modalities: accelerate product launches and optimize our asset performance
Our ambition to develop a network of Factories of the Future

5:30pm - 5:35pm

Chair’s Closing Remarks

Charles L. Cooney

Robert T. Haslam Professor of Chemical Engineering, Emeritus, and Faculty Director, Emeritus Deshpande Center for Technological Innovation

MIT

5:35pm

6:30pm

7:30am - 8:20am

7:45am - 8:20am

Pioneering Manufacturing Automation Innovation with AI

Amy Doucette

Head of Business Operations

Applied Materials APG Pharma

Jordan Croteau

Sr. Director, Manufacturing Operational and Engineering Technology

Moderna

Session Details

Leveraging lessons learned from the semiconductor industry for tech-first companies
The journey of defining the high value problems and opportunities for personalized medicine
Optimizing productivity and quality for manufacturing resilience and sustainability
Speed to insights for “Right First Time”
Innovation enabling improvements in key achievement drivers

8:25am - 8:35am

Chair’s Opening Remarks

Charles L. Cooney

Robert T. Haslam Professor of Chemical Engineering, Emeritus, and Faculty Director, Emeritus Deshpande Center for Technological Innovation

MIT

8:35am - 9:10am

A Vision for the Future: Moderna’s Plans for mRNA Technology, Manufacturing and Scale

Jerh Collins

Chief Technical Operations and Quality Officer

Moderna

Session Details

Pivoting fearlessly: How Moderna transitioned from a pandemic to an endemic market
Building for scale: Where the company is investing and partnering as it plans to launch up to 15 products in 5 years
Prioritizing culture: What it took to encode the company’s mindsets and unique culture

9:10am - 9:45am

Integrating Customer Centricity and Innovative Technology into a Forward-Looking Manufacturing & Compliance Strategy

Anil Sawant

SVP Global Quality Compliance

Merck

Session Details

How are biology and patient needs influencing risk-based investment and networking structure in the manufacturing space?
Discussing route and location of administration, including MDCP considerations, components and suppliers, design standards
Exploring flexible facilities, integrated clinical launches, and capital risk avoidance in the quest to get fast to clinical and fast to respond
Understanding the need for early investment in platform changes. How is the emergence of ADCs, modality blurring, and market
How do we ensure quality, risk management and compliance processes are in lock step as our technology and platforms evolve

9:50am - 10:25am

Fireside Chat: Navigating Technological Advancements, Global Operations, and Supply Chain Innovation

Craig Beasley

Chief Technical Officer

Blue Rock Therapeutics

Session Details

Exploring strategies for enhancing efficiency and reliability in the supply chain for cell therapy products, encompassing supply/demand planning, strategic sourcing, GMP purchasing, and external manufacturing
Delving into the evolution of manufacturing methodologies, focusing on cutting-edge technologies, automation, and adaptive processes to meet increasing demands and regulatory requirements
Discussing best practices, challenges, and considerations in establishing and managing facilities on a global scale, addressing regulatory compliance, operational excellence, and localization strategies
Highlighting innovative approaches to managing the drug supply chain, from clinical trials to commercialization, including advancements in logistics, temperature-controlled distribution, and risk mitigation strategies

9:50am - 10:25am

Advanced Manufacturing and Complex Biologic Products

Ingrid Markovic

Senior Science Advisor/CMC Lead

FDA

Session Details

Grasping the significance of FDA-CBER’s oversight in pharma manufacturing, ensuring adherence to strict quality standards, safety measures, and ethical guidelines for global health and patient well-being
Discuss efforts to expedite development of products for small populations through increased use of accelerated approval
Review efforts toward global regulatory convergence
Summarize internal changes and external initiatives at FDA in support of expeditious product development

9:50am - 10:25am

Fireside Chat: Navigating Gene Therapy Commercialization: Trends, Challenges, and Opportunities in Process and Technology Platforms

Christopher Klem

Sr. Director Global Manufacturing

AskBio

Session Details

Exploring leveraging partners and CDMOs for gene therapy commercialization’s focusing on scalability, quality and resilience
Discussing key regulatory hurdles in bringing gene therapy products to market, including FDA requirements, regulatory submission, and manufacturing process
Highlighting emerging technologies and platforms, considering advancements in viral vector manufacturing, gene editing techniques and cell therapy processes
Delving into supply chain complexities and examining strategies for mitigating risks, optimizing logistics and ensuring uninterrupted supply
Opportunities for collaboration and innovation to accelerate advancements in process optimization, technology development and ultimately patient access to life changing therapies

10:25am - 11:15am

Pre-Arranged One-to-One Meetings

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

10:40am - 11:15am

Executive focus groups are informal moderated discussions among peers, held during networking breaks outside the summit agenda. No sign-up is required; delegates and speakers can join any group of interest.

Focus Group Panel: The Evolving Future of Quality – Signals, Trends and Lessons

Karin Ann Payne

Vice President Corporate Quality

Bristol Myers Squibb

Vaishali Shukla

VP Quality

Kite Pharma

Lisa Winstead

Sr. Director - Site Quality Head

Resilience

11:20am - 11:55am

The CDMO of the Future

JR Humbert

VP Quality

INCOG BioPharma Services

Session Details

Learn how a CDMO can be a Customer-Driven Manufacturing Organization
How CDMOs can use digital infrastructure to make the experience from technology transfer all the way through lifecycle management more customer-focused
How CDMOs can partner to integrate the supply chain to simplify processes and increase reliability
How strategic investments by customers with CDMOs can create value for both customer and CDMO

11:20am - 11:55am

Reducing Unplanned Downtime Using Integrated Predictive Maintenance and Operation Teams Management for Steamlined Workflows, Reduced Operational Risk and Optimal Production

Ed Garibian

CEO

LLumin Inc.

Dennis Ladd

Senior Sales Executive

Eschbach North America

Session Details

Learn how using LLumin CMMS+ integrated with eschbach ShiftConnector, not only improve communication for operators in the clean room or control room, quality and maintenance but actually reduces mean time to repair (MTTR) levels: minimizing disruptions and safeguarding critical pharmaceutical operations
Gain keen preventive maintenance insights such as adding machine parameter and condition monitoring for increasing clarity with maintenance work order instructions and parts requirements among other benefits
Discover how to optimize maintenance department processes and elevate your Return on Asset (ROA) investment levels
Uncover how Artificial Intelligence (AI) can bring a new level of intelligence that can easily be adaptable to fit pharmaceutical company’s needs

11:20am - 11:55am

What Traits Should Biopharma Companies Look for When Partnering with Drug Substance CDMOs?

Jin Seok Hur

General Manager and Head of Technical Sales, US

Axplora US

Arul Ramadurai

Chief Commercial Officer (CCO)

Axplora

Session Details

Best traits to look for when partnering with a CDMO, besides just capabilities and capacity
Best practices for discerning which CDMO’s are best for biopharma companies to partner with
Key steps for helping biopharma companies navigate complex sales processes with CDMOs

12:00pm - 12:35pm

Real-Time Release, a Distant Dream or Reality?

Olav Lyngberg

VP Innovation and Technology Deployment, Janssen Supply Chain

The Janssen Pharmaceutical Companies of Johnson & Johnson

Session Details

Insight into J&J’s journey to implement real time multivariate analytics, PAT, modeling and feedback control
Achieving integrated quality objectives, reducing non-conformance, enhancing quality control, and enabling real time release
Integration of digitalization, data, and Quality By Design to intensify processes for flexible and modular manufacturing tailored to customer requirements in quality, price, quantity, and delivery
Exploring the lessons learnt from the real-time release journey and their alignment with J&J’s long-term vision of quality-driven progress

12:00pm - 12:35pm

How Do We “Stay Ahead of the Curve in an Increasingly Complex Regulatory World?”

Søren Thuesen Pedersen

Senior Director External Affairs, Regulatory Policy and Intelligence

Novo Nordisk

Session Details

Discussing the growing regulatory complexity in the world of pharmaceutical quality and manufacturing.
How are new guidelines and regulators’ expectations changing?
Taking a process-based approach to impact assessment, and customizing a setup that identifies and acts on signals proactively
How do we involve the organization in a sustainable way in all of this (Bottom Up approach)Bringing a structured approach to your advocacy within your network of industry and trade organization connections

12:00pm - 12:35pm

A Digital Twin for Integrated mRNA Manufacturing

Dr. Richard Braatz

Edwin R. Gilliland Professor; Associate Faculty Director, MIT Center for Biomedical Innovation

MIT, Massachusetts Institute of Technology

Session Details

Insights into the concept of digital twins and their application in integrated mRNA manufacturing, based on experience in advanced manufacturing and process data analytics
Exploring process modeling and control systems, focusing on their relevance to mRNA manufacturing and how digital twin technology can enhance efficiency and quality in this context
Discussing the potential of digital twins to revolutionize mRNA manufacturing, emerging trends, challenges, and the roadmap for further research and development in this field
Addressing the regulatory landscape surrounding mRNA manufacturing and how digital twin technology can facilitate compliance with regulatory requirements, ensuring product quality, safety and efficacy

12:35pm - 1:35pm

Executive Lunch Seating

12:35pm - 1:35pm

Explore this year’s themed lunch discussions led by industry leaders, where executives engage in focused conversations over a meal, discussing topics they’re passionate about alongside their peers.

CMC Considerations as We Revolutionize Cell Therapy Manufacturing

Matthew Conover

Sr. Director Cell Therapy CMC

BMS

Integrating Sustainability and Quality by Design to Improve Chances of Regulatory Success

Jonathan Tripp

Principal Scientist

Gilead Sciences

Michael O’Keefe

Director

Gilead

Navigating Quality 4.0: Initiating Your Path in Pharmaceutical Manufacturing

JR Humbert

VP Quality

INCOG BioPharma Services

Keeping Pace with the Evolving Quality and Regulatory Trends in Cell Therapy

Scott Nichols

Director Quality

Kite Pharma

Realtime Manufacturing While Stabilizing The Workforce

Dottie Barr

SVP Manufacturing & Technical Operations

Lantheus

Achieving Speed to Market in an Evolving CGT landscape Via Laser Focus on Compliance, Systems and People

Elena Kichula

Sr. Director - Manufacturing, Science, and Technology and Process Engineering

Spark Therapeutics

Vaishal Patel

QA Site Lead

Spark Therapeutics

1:35pm - 2:10pm

Maximizing Quality and Compliance: A Strategic Approach for Pharmaceutical Manufacturing

Nicolas Maldonado

Executive Director, Global Quality Policies and Systems

Gilead Sciences

Session Details

Introduction to the need for quality and compliance transformation and the impact of shifting regulatory landscapes on quality assurance and compliance
The role of advanced technologies in enhancing quality practices, ensuring data integrity and improved product safety and efficacy
Strategies for supplier quality management for maintaining consistency and building a culture of quality and compliance
Case studies highlighting quality driven practices that have led to improved transformation in enhancing quality practices
Real world success stories in transforming quality practices for the modern pharmaceutical landscape

2:15pm - 2:55pm

Panel: Looking Backwards, Looking Forwards: Maximizing Our Impact on the Future of Medicine

Joanne Beck

Chief Technology Officer

Aerium Therapeutics

Carlo de Notaristefani

Former Lead, Manufacturing & Supply Chain Advisor

Operation Warp Speed

Alex Cooke

CEO

Phase3

Pat Yang

Vice Chairman & Co-Founder

Resilience, Inc.

Session Details

How has this changed the CMC ecosystem, and are we overbuilding capacity again?
Avoiding the dangers of fragmentation. How should we better communicate, collaborate, and consolidate our best ideas so we all succeed?
Discussing the reasons to set up a new company today, and imagining how our business ecosystem will continue to grow and evolve
Debating which production platforms will best suit the newer modalities
Exploring the next steps for existing platforms like mAbs, ADC’s, mRNA: How do we efficiently serve giant markets such as Alzheimer’s indications, for example?