Program
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American Pharma Outsourcing Summit 2022 - Program (770.3 KiB)
September 20, 2022
* JOIN US FOR THE PRE-EVENT HAPPY HOUR on September 19th, 2022 FROM 6:10 PM – 7:10 PM EST
Delegate Registration and Networking Breakfast
Chair's Welcome and Opening Remarks
EXTERNAL MANUFACTURING
Cedric Dubois
Head, Biologics External Manufacturing
Sanofi
EXTERNAL QUALITY
Francis Dumont
Senior Director, External Drug Product Supply Strategy
Pfizer
EXTERNAL SUPPLY
Kris Hall
Procurement Lead, External Supply Operations Americas
Novartis
Opening Keynote
Kevin Cook
VP and Head, Supply Chain, Demand Planning and Customer Service
Sandoz, a Novartis Division
Trust, Relationships and Data: Important Considerations for Supplier Integration Both Upstream and Downstream
- What is the new value driver in outsourcing?
- Examining some of the unique challenges brought about by the pandemic
- Better integrating CDMOs/CMOs into your network
- Keys to building trust and relationships
- Achieving deeper levels of supply chain transparency both upstream and downstream
available: Video
Plenary
Ramesh Panchagnula, Ph.D.
Managing Director
Nektar Therapeutics India Pvt Ltd
Leading Internal and External Teams to Success Across a Global Manufacturing Network
- Developing a winning team of external manufacturing, quality and supply chain experts
- Best techniques for collaborating with expert teams to develop, launch and supply therapies
- Ensuring quality oversight in contract manufacturing and outsourced activities
- Building external expertise and capabilities
- Sourcing and selecting partners with technical capabilities and mutually aligned goals
- Case studies of outsourcing success
available: Video
Plenary
Shabbir Dahod
President and Chief Executive Officer
TraceLink
Digitalizing Supplier Management Operations to Improve Visibility and Collaboration with CMOs and Direct Suppliers
- What key challenges drive supplier management leaders to digital transformation in the pharmaceutical industry?
- Achieving more agility with CMOs and direct suppliers
- Linking systems, processes, people and enterprises into a collective information network to support intelligent business execution
- Improving visibility and collaboration in supplier management operations
- How a digital network platform enables data sharing with a network of CMOs/suppliers through a single link
- Enabling supplier management teams to engage CMOs/suppliers through collaborative work management
available: Video
Refreshments, Networking, and Pre-Arranged 1-2-1 Meetings
Sessions
EXTERNAL MANUFACTURING
Siân Jones-MacPhail
Director, Contract Development and Manufacturing
Amgen
Scale-Up and Tech Transfer Best Practices
- Keys to executing a successful technology transfer
- Discussing the importance of synergy with contractors
- Utilizing good communication to drive project success
- Develop long-term strategies and product timelines
- Reviewing the tech transfer success with Amgen's Synthetic DS portfolio
- Enabling quick and seamless technology transfers
available: Video
EXTERNAL QUALITY
Jaye Greene
Director, Quality and Process Optimization
Rx-360
David Cady
Senior Director, Strategic Sourcing
TCR² Therapeutics Inc.
Achieving Supplier Quality Excellence
- What are key considerations for supplier auditing?
- Ensuring audit readiness
- Best practices for audits of material and service providers
- Tools and techniques for enhancing audit programs
available: Video
EXTERNAL SUPPLY
Luiz Alberto Barberini
Head, External Manufacturing, Latin America
Bayer
Leveraging Technology to Optimize Supply Chain Visibility and Enhance Service Levels
- What does the Strategy House look like within the global supply chain at Bayer Consumer Care?
- Overcoming external network operations amidst widespread supply chain challenges posed by COVID-19
- Navigating the complexities from supplier to customer in challenging geographical environments
- Case study: How do some of the complexities operating in South America vary from other regions
- Optimizing pharmaceutical and biotech supply chains relationships for the next generation
available: Video
Workshops
EXTERNAL MANUFACTURING
Amy Manning
Head, Commissioning, Qualification and Validation
FUJIFILM Diosynth Biotechnologies
FUJIFILM Diosynth Biotechnologies: A Partner for Life, Today and Beyond
- Building the largest end-to-end biopharmaceutical manufacturing facility in North America
- Implementing highly automated operational processes
- Cloning established operational and business processes used at our sister site
- Providing end-to-end manufacturing in a single facility
- Providing clients with supply chain efficiencies, and consistent high-quality results
available: Video
EXTERNAL QUALITY
Haider Kamal
Senior Process Specialist
Basetwo AI
Kiefer Eaton
Head, Product
Basetwo AI
Unlocking Pharma 4.0: Model-Based Optimization of Pharmaceutical Process Development and Manufacturing Using Collaborative AI
- What's stopping manufacturers from unlocking the full potential of their data?
- Exploring how process modeling and data scientists can easily collaborate and empower engineering end-users with modern software solutions
- Examining how hybrid modeling approaches can allow manufacturers to expedite process scale-up and tech transfer
- Fostering intelligent manufacturing collaboration and lifecycle management across the organization
- Building and sharing libraries of process models
available: Video
EXTERNAL SUPPLY
Amy Trotch
Business Development Director, Commercial/Technical Transfer
Societal™ CDMO
80/20 Risk Mitigator: A Smart Approach to Preparedness
- Discussing global supply chain vulnerabilities and the COVID-19 era
- The value and misconceptions of secondary sourcing
- Achieving more significant risk mitigation via a backup supply model
- Saving time and cost while ensuring supply continuity
available: Video
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 is limited. Choose from:
Dana Toops
President
Avéma Pharma Solutions
Benefits of Integrated Small-Volume Manufacturing Capabilities
Gregory Slack, Ph.D.
Senior Director, Scientific Technical Services
Boston Analytical
CONSIDERATIONS WHEN SELECTING AN OUTSOURCED TESTING ORGANIZATION PARTNER FOR ANALYTICAL, MICROBIOLOGY AND STABILITY TESTING SUPPORT
Kurt Hoeprich
VP and Global Head, Strategic Partnerships
Curia
Optimizing CDMO-Sponsor Collaborations to Accelerate Special Designation
Alessandro Agosti
Senior Director, Scientific Operations
Olon Ricerca Bioscience
Techniques for Selecting a Highly Reliable Partner for the Development and Production of Active Pharmaceutical Ingredients (APIs)
Andrew Morbey
Associate Director, Process Development
PCI Pharma Services
ENSURING SCALABLE, REPRODUCIBLE AND COMMERCIALLY ROBUST STERILE FILL-FINISH AND LYOPHILIZATION MANUFACTURING
Corbett French
Laboratory Director
Nova Biologicals, A Tentamus Company
Utilizing a Risk-Based Approach to Quality and Selecting a Third-Party Lab
Timo Taghizadeh, PH.D.
Head, Marketing and Business Development
tesa Labtec
Important Tools for the Collaboration Between Sponsors and CDMOs
Ashley Wentworth
Senior Director, Vault Quality
Veeva Systems
Modernizing Quality by Improving Collaboration with Your Customers and Partners
Sessions
External Manufacturing
Cedric Dubois
Head, Biologics External Manufacturing
Sanofi
Leading Internal and External Team Success Across a Global Manufacturing Network
- Best techniques for collaborating with expert teams to develop, launch and supply biologics therapies
- Developing a winning team of external manufacturing, quality and supply chain experts
- Sourcing and selecting partners with technical capabilities and mutually aligned goals
- Case studies of outsourcing success at Sanofi Genzyme
available: Video
External Quality
Maria Avoujageli
Head, External Quality, Americas
GSK
Ensuring Quality in the Management of Outsourced Activities
- Exploring the historical role of quality and what's needed to be successful in the future
- Establishing and sustaining a quality culture with partners in your network
- Best techniques for establishing Quality Agreements with contract manufacturers
- Enhancing Quality System compliance oversight
- Conducting quality audits during technical transfers
- Driving modern-day quality thinking and approaches to stay current and compliant
available: Video
EXTERNAL SUPPLY
Prem Ramiya, Ph.D.
SVP, Manufacturing and Supply Chain
Aurinia Pharmaceuticals Inc.
Building a Lean, Efficient and Robust Outsourced Supply Chain
- Developing a network of worldwide vendors, contract suppliers and CMOs
- Best practices for selecting partners for starting materials, APIs and drug products
- The keys to outsourced supply chain management
- Helping contract suppliers and CMOs consistently achieve outstanding results
available: Video
Workshops
External Manufacturing
Mary Lou Glotzbach
Director, Business Development
Grand River Aseptic Manufacturing
Lessons Learned from COVID-19: Successes, Changes and Opportunities for Improvement in the Outsourcing Landscape
- Exploring how companies responded to the COVID-19 crisis and their outcomes
- What changed regarding supply, manufacturing, quality, collaboration/partnering, outsourcing, R&D, etc.?
- What were some of the industry's biggest successes in responding to the crisis?
- What can we do to be prepared for or mitigate the risk of future disruption?
available: Video
External Quality
Raghvendra Sahai, Ph.D.
Founder and CEO
ARL-EuTech, A Tentamus Company
How and When Extractable/Leachable Decisions Should be Taken for Pharma Packaging
- What is the definition of an extractable/leachable?
- Decision trends for generic vs. brand-name drugs
- What information should be requested from vendors?
- Reviewing regulatory landscape/guidance available
- How ARL-EuTech can help
available: Video
Happy Hour, Networking and Pre-Arranged 1-2-1 Meetings
Sessions
External Manufacturing
Firelli Alonso, Ph.D.
Senior Director, External Supply, BioTherapeutics and Vaccines Outsourcing
Pfizer
Reviewing Best Practices for Pre-Qualifying and Executing a Partnership with a CMO
- Guiding principles for externalization
- Weighing make vs. buy options
- How to eliminate peaks and valleys of resource demands
- Ensuring maximum flexibility and adaptability in your partnerships
- Preparing for rapid scale-up and hand-off to a commercial organization
- Maintaining alignment between partners to ensure a seamless transition in the future
available: Video
External Quality
Nanna Andersen
Principal, QP, External Manufacturing and Supplier Quality,
LEO Pharma
How to Assure Quality When Engaging in External Partnerships
- Understanding the complexity of ensuring supplier quality in today's supply chains
- Identifying what approaches can be taken to ensure quality when working with an external manufacturer
- Discussing the cost of quality assurance vs. future costs of rectification
- Implementing change in the manufacturing process to ensure quality levels
- Making smart infrastructure investment decisions
- Best practices for inspections and audits
- Seeing quality as the responsibility of everyone to ensure a good partnership
available: Video
EXTERNAL SUPPLY
Adriana Sardella
Associate Director, Global External Supply Operations
Apotex
Key Elements of a Successful Technology Transfer to a CMO and CPO
- Discussing project management strategies for effective and successful tech transfers
- Why technical due diligence is key
- Setting out cost and scope to determine the path forward
- Enabling a core team to support and implement projects
- Managing the product lifecycle after the transfer
- Conducting reviews to strengthen partnerships
available: Video
PANEL DISCUSSION
Luiz Alberto Barberini
Head, External Manufacturing, Latin America
Bayer
Vildan Kortan
Head and Senior Director, External Analytical Strategy
Bristol Myers Squibb
Luckner Ulysse, Ph.D.
Director, Plant Management, External Manufacturing Operations
Merck
Jay Hall
Director, External Manufacturing Operations
NovavaxFirelli Alonso, Ph.D.
Senior Director, External Supply, BioTherapeutics and Vaccines Outsourcing
Pfizer
Glenn Killingworth
VP, Business Development US East
Raffles PharmaTech
OUTSOURCING SUCCESS IN THE POST-PANDEMIC ERA
- How has the COVID-19 pandemic radically reshaped the world of outsourcing?
- Ushering in new customer demands and expectations from CMOs/CDMOs
- Best practices that outsourcing companies will need to adapt
- Surviving and thriving in this new landscape
- Weighing outsource vs. in-house manufacturing decisions
- Securing critical raw materials amidst shipping delays and port congestion
- Cutting unnecessary costs and minimizing risks
available: Video
Chair's closing remarks
EXTERNAL MANUFACTURING
Cedric Dubois
Head, Biologics External Manufacturing
Sanofi
EXTERNAL QUALITY
Francis Dumont
Senior Director, External Drug Product Supply Strategy
Pfizer
EXTERNAL SUPPLY
Kris Hall
Procurement Lead, External Supply Operations Americas
Novartis
