Please note all times are local, Eastern Daylight Time

13 May, 2024


5:00 pm - 6:00 pm

WELCOME DAY SPECIAL CONTENT

ROOM 2

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

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

6:00 pm - 7:00 pm

Welcome Drinks Reception

14 May, 2024


7:30 am - 8:15 am

Registration and Breakfast

8:15 am - 8:20 am

Opening Remarks and Important Announcements

8:20 am - 8:30 am

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

8:30 am - 9:05 am

Manufacturing with An Agile and Flexible Mindset
  • 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

Holger Weintritt
EVP Head Pharmaceuticals Product Supply
Bayer

9:05 am - 9:40 am

Strategic Expansion Roadmap: Fill & Finish Facilities for Global Growth
  • 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.

Flemming Dahl
SVP Head of Product Supply Fill & Finish Expansions
Novo Nordisk

STREAM 1 CHAIR

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

compliance insights

STREAM 2 CHAIR

Teresa Gorecki
Practice Lead
Compliance Architects LLC

compliance insights

STREAM 3 CHAIR

Jacob Greenwood
Vice President Strategy
Project Farma

compliance insights

9:45 am - 10:20 am

WORKSHOP

ROOM 1

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

Anshul Mangal
President
Project Farma

Flemming Dahl
Senior Vice President, Fill & Finish Expansions Management
Novo Nordisk

Ciaran Brady
Vice President MS&T
Vertex Therapeutics

Jason Politi
Chief Technology Officer
Verve Therapeutics

9:45 am - 10:20 am

WORKSHOP

ROOM 2

Data Doesn’t Lie – Digital Manufacturing ROI
  • 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

Martin Smyth
SVP Go To Market Strategy
MasterControl

10:25 am - 12:05 pm

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 am: Meeting Slot 4/Networking

12:10 pm - 12:45 pm

CASE STUDY STREAM 1

STRATEGIC MANUFACTURING

Manufacturing as a Strategic Enabler for Serial Innovation
  • 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

Ciaran Brady
Vice President, Manufacturing Science and Technology
Vertex Therapeutics

12:10 pm - 12:45 pm

CASE STUDY STREAM 2

QUALITY

Proactivity – the Future of Quality
  • 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

Anthony Mire-Sluis
SVP Head of Global Quality
AstraZeneca

12:10 pm - 12:45 pm

CASE STUDY STREAM 3

SUPPLY CHAIN

Navigating the Complexities of Gene Therapy Commercialization and Manufacturing
  • 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

Ryan Bartock
Head of Engineering, Technical & Digital
Spark Therapeutics

12:45 pm - 1:45 pm

Executive Lunch Seating

12:45 pm - 1:45 pm

THEMED LUNCH DISCUSSION

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

Robert Honer
PMP CPIM
Anaplan

12:45 pm - 1:45 pm

THEMED LUNCH DISCUSSION

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

Christopher Klem
Sr. Director Global Manufacturing
AskBio

12:45 pm - 1:45 pm

THEMED LUNCH DISCUSSION

Knowledge Retention in a Time of High Turnover

Kari Borroel
Head of Operations Quality Learning & Development
AstraZeneca

12:46 pm - 1:45 pm

THEMED LUNCH DISCUSSION

Automation Technology to Unlock the Future of Cell Therapy Manufacturing

Paul Kopesky
VP Cell Process Development
Beam Therapeutics

12:46 pm - 1:45 pm

THEMED LUNCH DISCUSSION

Lessons and Opportunities in Value Stream Mapping

Alok Bhatt
Senior Director, Biologics Value Chain, Global Manufacturing & Supply
BMS

12:46 pm - 1:45 pm

THEMED LUNCH DISCUSSION

Supply Chain Revolution: Prioritizing Patients in Pharmaceutical Logistics

John Glavas
AVP External Manufacturing
Merck

12:47 pm - 1:45 pm

THEMED LUNCH DISCUSSION

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

Alex Cooke
CEO
Phase3

12:47 pm - 1:45 pm

THEMED LUNCH DISCUSSION

Modernizing the Pharma Quality System. What is it and does it drive results?

Lisa Winstead
Sr. Director – Site Quality Head
Resilience

12:47 pm - 1:45 pm

THEMED LUNCH DISCUSSION

Culture Transformation: from Compliance to Performance

Yana Collins
Head of Quality Culture and Transformation
Sanofi

12:48 pm - 1:45 pm

THEMED LUNCH DISCUSSION

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

12:48 pm - 1:45 pm

THEMED LUNCH DISCUSSION

Changing the Compliance Paradigm in Large, Global Companies

Peter Shearstone
VP Global Quality & Regulatory Affairs
Thermo Fisher Scientific

12:48 pm - 1:45 pm

THEMED LUNCH DISCUSSION


1:45 pm - 2:20 pm

Driving Transformation in Quality to Meet the Needs of Our Customers
  • Quality as a business driver by “Flipping the Ratio”
  • Transforming business growth through Proactive Quality
  • Preparing our organization for the future of Quality Assurance

Robin Kumoluyi
VP & Chief Quality Officer, J&J Innovative Medicine
Johnson & Johnson

2:25 pm - 3:00 pm

WORKSHOP

ROOM 1

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

Peter Genest
Head of Client Solutions
SmartLabs

Craig Beasley
Chief Technical Officer
BlueRock Therapeutics

2:25 pm - 3:00 pm

WORKSHOP

ROOM 2

The Value of a Unified Life Sciences Solution in Pharma 4.0
  • 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

Zillery Fortner
Industry & Business Development Director
Honeywell

April VanDenDriessche
MES Technical Solutions Consultant
Honeywell

2:25 pm - 3:00 pm

WORKSHOP

ROOM 3

From “Impossible” to Commercialization
  • 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

Scott DeWire PhD
US Head, Business Development & Licensing
Boehringer Ingelheim

Michael Kraich PhD
Vice President of Global Project & Product Management BioXcellence
Boehringer Ingelheim

3:05 pm - 4:15 pm

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

4:20 pm - 4:55 pm

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

Catalina Vargas
SVP Global Supply Chain
Bristol Myers Squibb

4:55 pm - 5:30 pm

Sanofi Manufacturing Transformation: Turning Science into Reality for Patients
  • 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

Daniela Ottini
SVP, Manufacturing and Supply Head of Specialty Care
Sanofi

5:30 pm - 5:35 pm

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

5:35 pm - 6:35 pm

Drinks Reception

6:30 pm

Executive Dinner

15 May, 2024


7:30 am - 8:20 am

Registration and Breakfast

7:45 am - 8:20 am

BREAKFAST WORKSHOP

ROOM 2

Pioneering Manufacturing Automation Innovation with AI
  • 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

Amy Doucette
Head of Business Operations
Applied Materials APG Pharma

Jordan Croteau
Sr. Director, Manufacturing Operational and Engineering Technology
Moderna

8:25 am - 8:35 am

Chair’s Welcome Remarks

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

8:35 am - 9:10 am

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

Jerh Collins
Chief Technical Operations and Quality Officer
Moderna

9:10 am - 9:45 am

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

Anil Sawant
SVP Global Quality Compliance
Merck

STREAM 1 CHAIR

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

compliance insights

STREAM 2 CHAIR

Teresa Gorecki
Practice Lead
Compliance Architects LLC

compliance insights

STREAM 3 CHAIR

Jacob Greenwood
Vice President Strategy
Project Farma

compliance insights

9:50 am - 10:25 am

CASE STUDY STREAM 1

STRATEGIC MANUFACTURING

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

Craig Beasley
Chief Technical Officer
BlueRock Therapeutics

9:50 am - 10:25 am

CASE STUDY STREAM 2

QUALITY

Advanced Manufacturing and Complex Biologic Products
  • 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

Ingrid Markovic
Senior Science Advisor/CMC Lead
FDA

9:50 am - 10:25 am

CASE STUDY STREAM 3

SUPPLY CHAIN

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

Christopher Klem
Sr. Director Global Manufacturing
AskBio

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

10:30 am - 11:15 am

EXHIBITION HALL

FOCUS GROUP

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

11:20 am - 11:55 am

WORKSHOP

ROOM 1

The CDMO of the Future
  • 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

JR Humbert
VP, Quality
INCOG BioPharma Services

11:20 am - 11:55 am

WORKSHOP

ROOM 2

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

Ed Garibian
CEO of LLumin
LLumin Inc.

Dennis Ladd
Senior Sales Executive
Eschbach North America

11:20 am - 11:55 am

WORKSHOP

ROOM 3

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

Jin Seok Hur
General Manager and Head of Technical Sales, US
Axplora US

Arul Ramadurai
Chief Commercial Officer (CCO)
Axplora

12:00 pm - 12:35 pm

CASE STUDY STREAM 1

STRATEGIC MANUFACTURING

Real-Time Release, A Distant Dream or Reality?
  • 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

Olav Lyngberg
VP Innovation and Technology Deployment, Janssen Supply Chain
The Janssen Pharmaceutical Companies of Johnson & Johnson

12:00 pm - 12:35 pm

CASE STUDY STREAM 2

QUALITY

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

Søren Thuesen Pedersen
Senior Director External Affairs, Regulatory Policy and Intelligence
Novo Nordisk

12:00 pm - 12:35 pm

CASE STUDY STREAM 3

SUPPLY CHAIN

A Digital Twin for Integrated mRNA Manufacturing
  • 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

Dr. Richard Braatz
Edwin R. Gilliland Professor; Associate Faculty Director, MIT Center for Biomedical Innovation
MIT, Massachusetts Institute of Technology

12:35 pm - 1:35 pm

Executive Lunch Seating

12:36 pm - 1:35 pm

THEMED LUNCH DISCUSSION

CMC Considerations as We Revolutionize Cell Therapy Manufacturing

Matthew Conover
Sr. Director Cell Therapy CMC
BMS

12:36 pm - 1:35 pm

THEMED LUNCH DISCUSSION

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

Jonathan Tripp
Principal Scientist
Gilead Sciences

Michael O’Keefe
Director
Gilead

12:36 pm - 1:35 pm

THEMED LUNCH DISCUSSION

Navigating Quality 4.0: Initiating Your Path in Pharmaceutical Manufacturing

JR Humbert
VP Quality
INCOG BioPharma Services

12:37 pm - 1:35 pm

THEMED LUNCH DISCUSSION

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

Scott Nichols
Director Quality
Kite Pharma

12:37 pm - 1:35 pm

THEMED LUNCH DISCUSSION

Realtime Manufacturing While Stabilizing The Workforce

Dottie Barr
SVP Manufacturing & Technical Operations
Lantheus

12:37 pm - 1:35 pm

THEMED LUNCH DISCUSSION

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

1:35 pm - 2:10 pm

Maximizing Quality and Compliance: A Strategic Approach for Pharmaceutical Manufacturing
  • 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

Nicolas Maldonado
Executive Director, Global Quality Policies and Systems
Gilead Sciences

2:10 pm - 2:55 pm

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

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.

2:55 pm - 3:00 pm

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