american biomanufacturing summit 2019...• defining the capabilities you need for success •...
TRANSCRIPT
AMERICAN BIOMANUFACTURING SUMMIT 2019
JUNE 18-19, 2019
HYATT REGENCY SAN FRANCISCO AIRPORT • SAN FRANCISCO, CA
biomanamerica.com
+1-416-298-7005
TOMORROW’S CONNECTION TODAY
Designing a new future for manufacturing, quality and supply chain leaders
PROGRAM
American Biomanufacturing Summit 2019 Program • Page 1
DELEGATE REGISTRATION AND BREAKFAST
CHAIR’S WELCOME AND OPENING REMARKS
HERMANN ALLGAIER, PH.D.
Managing Director and Executive Board Member
PLENARY LEVERAGING GLOBAL CHANGE TO TRANSFORM OPERATIONS AND DESIGN A NEW FUTURE
• Designing a new future for manufacturing and supply chain leaders
• Examining the state of the bioproduction industry and its impact on global operations:
• Evolution of medicines
• CMO/CDMO consolidation
• Capacity and complexity
• Cost Pressures
• How is Teva is taking a leading role in shaping this new future?
• Discussing capabilities needed to drive business performance
6:00 am – 7:00 am
7:05 am – 7:10 am
7:45 am – 8:20 am
PROGRAM DAY ONE
PAUL DALY, PH.D.
Corporate VP and Head,
Global Quality
MANUFACTURING AND TECHNOLOGY CHAIR
7:10 am – 7:45 am
* JOIN US FOR THE PRE-EVENT HAPPY HOUR ON JUNE 17, 2019 AT 6:00 PM – 7:00 PM
KEYNOTE HOW READY IS THE INDUSTRY FOR THE TIDAL WAVE OF BIOPHARMA DEMAND?
• Addressing strengths and weaknesses in the supply chain to create better planning for the future
• Building internal capabilities to prepare for a wave of potential new product launches in the coming years
• Bringing innovation to life: CRISPR/Cas-9, CAR-T, niche and novel therapies
• Collaborating to gain access to specialized knowledge and cutting-edge technologies
• From clinical to launch: How to best deal with demand planning
• Increasing visibility during a product’s lifecycle the ensure the readiness of supply chains
RON BRANNING
SVP, Quality
QUALITY AND COMPLIANCE CHAIR SUPPLY CHAIN AND LOGISTICS CHAIR
Sponsored By:
WOLFRAM CARIUS, PH.D.
EVP and Head, Pharmaceuticals Product Supply
VIMAL GANDHI
Director, Global BioVentures
Supply Operations and Strategy
American Biomanufacturing Summit 2019 Program • Page 2
PLENARY ATTRIBUTES OF GREAT LEADERS TO CREATE A GAME CHANGING CULTURE
• Setting clear expectations of where we need to be in one, five, 10 years from now
• Ability to connect with others and motivate people to do what is important
• Engaging and empowering teammates to help address the skills gap
• Discussing how culture informs new products and process from R&D to the patient
• Examining the right mindset and culture needed to drive productivity and ingenuity
• Focusing on the future: What’s next to drive continuous improvement and innovation in the industry?
TIM MOORE
EVP, Technical Operations
9:35 am – 11:15 am
PRE-ARRANGED 1-2-1 BUSINESS MEETINGS AND REFRESHMENTS
8:20 am – 8:55 am
PLENARY ADVANCING MANUFACTURING FOR ADVANCED THERAPIES
• Examining examples of cell and gene therapies
• Discussing the need for consistent manufacturing and characterization processes
• Reviewing the challenges of logistics and manufacturing for autologous cells
• Solutions on the horizon for cell and gene therapy manufacturing
• Simplifying agency interactions for gene therapy products
• Plans for CBER laboratory research programs and collaborations with academic and public-private partners to advance the field
RAJ K. PURI, M.D., PH.D.
Director, Division of Cellular and Gene Therapies Office of Tissues and Advanced Therapies
8:55 am – 9:30 am
American Biomanufacturing Summit 2019 Program • Page 3
MANUFACTURING AND TECHNOLOGY INDUSTRY 4.0: TAKING THE STEPS TO CREATE A
“DIGITAL FACTORY” AND SHAPING THE FUTURE OF
VACCINE MANUFACTURING
• Discussing the impact of digitization on people,
process and production
• Defining the capabilities you need for success
• Understanding the technology landscape and
your digital maturity
• Focusing on the projects that will bring the most
value AI and Machine Learning: Further
integrating these into your operations
• Getting started on a digital journey with small
pilot projects
• Case study: Implementing a digital strategy at
Takeda
• Providing truly revolutionary differentiation for
vaccine manufacturers
QUALITY AND COMPLIANCE QUALITY CULTURE AND QUALITY LEADERSHIP:
WHERE ARE WE NOW AND WHERE ARE WE HEADED
IN THE NEXT 5 YEARS?
• Exploring three crucial questions we need to ask:
• What are we trying to achieve with Quality
Metrics?
• What would we want Quality Culture in our
industry to look like?
• How effective is your process capability program
in driving product quality?
• Examining different approaches to create a
quality culture within an organization
• Creating a Quality Ecosystem as an agent of
change
• Engaging and motivating teams to strive for
Continuous Improvement
SUPPLY CHAIN AND LOGISTICS UTILIZING JOINT AUDIT PROGRAMS TO ENSURE THE
QUALITY OF RAW MATERIALS USED IN PRODUCTION
• Establishing strong operational control and
quality processes to drive supply chain
transparency
• Mitigating supply chain risk through the
application of regulatory guidance and
independent best practices
• Building a better culture of quality across
complex global supply chains
• Case study: Improving supply chain reliability
through the standards and mechanisms of Rx-
360 in conjunction with the regulatory guidance
ANDERS VINTHER, PH.D.
VP, Global Quality
and Engagement
12:00 pm – 12:35 am
ROOM 2 USING SYSTEMATIC TOOLS TO EXPEDITE PROCESS
CHARACTERIZATION AND MAXIMIZE RELIABILITY OF
PROCESS VALIDATION CAMPAIGNS
• Using a suite of tools, standard practice and
depth of experience in Process Performance
Qualification protocol
• Effectively focusing attention on critical process
understanding and control
• Scoping and completing the ideal scope and
range of characterization studies to support
reliable operations in manufacturing
• Maximizing reliability during PPQ and
commercial manufacturing
• Enabling full preparedness for Pre-Approval
Inspection (PAI) and regulatory review
ROOM 1 CASE STUDY: SIGNIFICANT TECHNOLOGY ADVANCES
ENABLING INTEGRATED CONTINUOUS
BIOPROCESSING
• Developing a strategy for continuous
bioprocessing
• Increasing the use of innovative single-use
technologies
• Applying Lean thinking from batch to continuous
bioprocessing
• Delivering better quality and productivity in a
smaller footprint with shorter lead times
• Reviewing the journey to continuous
bioprocessing
• Enabling unit operations platforms
• Delivering a robust platform process
SPEAKER TBA
ROOM 3 ENSURING SAFE AND SECURE HANDLING OF
BIOLOGICS IN YOUR SUPPLY CHAIN
• Why talent and innovation should be at the
heart of a supply chain and logistics strategy
• Understanding the needs of specific, time-critical
shipping requirements
• Examining the proper storage and management
of inventory
• Delivering on an unmatched level of customer
service and superior handling
• Ensuring just-in-time delivery of products
SPEAKER TBA
11:20 am – 11:55 am
JIM FRIES
CEO
RAHUL SINGHVI, PH.D.
Chief Operating Officer, Takeda
Vaccines
ERIC BERG
Director, Quality
SPEAKER TBA
American Biomanufacturing Summit 2019 Program • Page 4
1:20 pm – 2:20 pm
ENSURING A SUCCESSFUL COMPANY-CMO
RELATIONSHIP THOUGH GOAL ALIGNMENT,
COLLABORATION AND COMMUNICATION
MANAGING COMMERCIAL MANUFACTURING
LIFECYCLE STRATEGIES THAT LOWER THE COST OF
GOODS
LUNCH AND LEARN ROUNDTABLE DISCUSSIONS
Benefit from additional learning by joining a moderated roundtable discussion on pressing issues in the industry. Choose from:
TAD THOMAS, PH.D.
Director and Global Lead,
Biologics Process Transfer
and Launch
PAUL HANSON, PH.D.
Director, Technical Operations,
Global Manufacturing
and Supply
Seating is limited, so please sign up early. Sessions start at 1:20 PM and run for one hour. More seating will be provided if you would prefer to discuss other topics.
PLENARY YOUR SUPPLY CHAIN IS NO STRONGER THAN ITS WEAKEST LINK: IMPROVING PRODUCTIVITY ACROSS YOUR ENTIRE SUPPLY CHAIN
• Propelling communication and collaboration with CMOs to a new level
• Leveraging AI and business intelligence to deploy automated systems to detect abnormal performance
• Deploying automated management alarms and escalation systems
• Using emails and text messages to accelerate response to performance-impacting events
• Creating real-time management dashboards and alerts, tailored for each role
• Connecting and integrating data across multiple platforms, such as PLCs, ERPs, QMS, LIMS, etc.
12:40 pm – 1:15 pm
JAIME VELEZ
Partner
API PLANT MANAGEMENT AND QUALITY
OPERATIONS: ENHANCING YOUR EH&S AUDITS TO
ENSURE QUALITY AND REGULATORY COMPLIANCE
NIAMH MALONEY
Senior Director, Chemical
Development and
Manufacturing
ENHANCING YOUR SUPPLIER RELATION
MANAGEMENT (SRM) PROGRAM TO CREATE
MOMENTUM FOR TECHNOLOGY INNOVATION AND
NATHALIE FRAU, PH.D.
Head, Biologics Technology
Innovation and Strategy,
Downstream Processing
BEST PRACTICES FOR CREATING WELL-DEFINED
MASTER SERVICE AND QUALITY AGREEMENTS WITH
CMOS
HOPE MUELLER
VP, Quality
American Biomanufacturing Summit 2019 Program • Page 5
2:25 pm – 3:00 pm
ROOM 3 DRIVING MODERN DAY QUALITY THINKING AND
OPERATIONAL APPROACHES
• Exploring the historical role of quality and what's
needed to be successful in the future
• How can quality be of greater benefit to an
organization beyond compliance?
• What motivation do both quality and operations
teams need to modernize?
• Discussing examples of how quality is helping
take organizations to a new modern state
• How should quality be taking advantage of AI
and AR?
• Learning from successful quality activities that
propel change
ROOM 1 PROJECTING QUALITY: ASSURING CULTURE AND
COMPLIANCE IN THE BIOMANUFACTURING SUPPLY
CHAIN
• Examining common supply chain challenges that
require a sharper, deeper view of the global
supply landscape
• Understanding the current environment of
emerging standards, corporate churn, new risks
and finite resources
• Three key areas of supply chain evaluation and
monitoring that represent best practice, and
maximize the effectiveness of internal and
external resources
• Identifying and addressing supply chain
vulnerabilities. Staging for success – the pre- and
post-audit process
• Following-up, closing the loop, and adapting the
process
• Using data analytics to make your team and
your supply chain better
SPEAKER TBA
ROOM 2 LEGAL AND REGULATORY ISSUES IMPACTING THE
SUPPLY CHAIN AND COMMERCIAL TRANSACTIONS,
RISK MANAGEMENT AND BEST PRACTICES
• Discussing the importance of experts in litigation
and government investigations
• Lowering litigation risk
• Conducting risk assessments and counseling
clients on risk mitigation
JOHN W. JONES, JR.
Partner and Chair, Health Care
3:05 pm – 3:40 pm
QUALITY AND COMPLIANCE BUILDING A QUALITY CULTURE: KEY ELEMENTS IN
IDENTIFYING GAPS AND BUILDING A PLATFORM
FOR CONTINUOUS IMPROVEMENT
• Reviewing universal key elements to ensure a
quality culture
• Discussing ICH Q10 Pharmaceutical Quality
System (QS) Elements
• What are the FDA’s current Quality Metrics and
what you need to be aware of?
• Identifying gaps and implement a platform for
continuous improvement
MANUFACTURING AND TECHNOLOGY DISCUSSING THE IMPORTANCE OF ARTIFICIAL
INTELLIGENCE AND MACHINE LEARNING IN
BIOMANUFACTURING INFRASTRUCTURE PLANNING,
FACILITIES OPERATIONS AND STRATEGY
• What are the top leaders in global industries
doing to improve efficiencies in their product
supply chain?
• Examining where technology is in the
biomanufacturing industry and projecting where
we're headed
• Exploring tools and approaches that greatly
increase your ability to create value faster and
within the most difficult situations
• Driving technology in your supply chain: AI and
machine learning
• Using data-driven techniques to ensure on-time,
on-quality biologics
• Creating a results-oriented global supply chain
and operations workforce
• What's next?: Making a roadmap ready for the
Age of Disruption
SUPPLY CHAIN AND LOGISTICS ENSURING SAFE AND SECURE HANDLING OF
BIOLOGICS IN YOUR SUPPLY CHAIN
• Managing network complexities of multiple state
-of-the-art production sites
• Leading the expansion of manufacturing
capability with a key focus on Operational
Excellence
• Discussing the latest tools to improve
operational efficiency
• Combining Lean Six Sigma, digital and
innovation to transform operations towards
OpEx
• Launching continuous improvement initiatives to
help aid in the success
• Demonstrating a continuous improvement
mindset with problem-solving and root cause
analysis
JÉRÔME REPITON
Global Head, Product Supply
Operational Excellence
RON BRANNING
SVP, Quality
JOYDEEP GANGULY
SVP, Operations
GERARD PEARCE
Executive Vice President
American Biomanufacturing Summit 2019 Program • Page 6
FIRESIDE CHAT EVOLVING EXTERNAL COLLABORATION MODELS: HOW OUR INDUSTRY’S BUSINESS PARTNERSHIPS HAVE CHANGED OVER TIME AND HOW TRENDS WILL CONTINUE
IN THE FUTURE
• Assessing and address issues of over- or under-capacity in today’s industry
• Examining how our industry’s business partnerships have changed over time\
• What does the current state of partnerships say about the future? Having an external partner that can absorb projects in times of internal under-capacity Utilizing
a combination of internal and external expertise and technology to propel innovation What's next: Where are we headed and what collaboration models will help
KELVIN H. LEE
Director, National Institute for Innovation in Manufacturing
Biopharmaceuticals (NIIMBL)
5:45 pm – 6:20 pm
3:45 pm – 4:20 pm
ROOM 1 BEST PRACTICES AND IMPORTANT
CONSIDERATIONS IN THE PROCUREMENT OF
UPSTREAM BIOPROCESS EQUIPMENT
• How does the total cost of ownership of
upstream equipment tie into with the complexity
of a system?
• Maintaining a high level of flexibility of
equipment while still dealing with many process
unknowns
• Reviewing control systems and their implications
on different scale equipment
• Looking forward: Increasing robustness and
reliability of systems
ROOM 3 THREE CRITICAL DRIVERS OF DIGITAL
TRANSFORMATION: LEADERSHIP, BEHAVIOR AND
CULTURE
• How is digital transformation is one of the most
complex and disruptive initiatives organizations
experience?
• Examining five leadership behaviors every leader
must role model
• Why behavior change is required at all levels of
the organization
• Achieving digital transformation success through
culture change
SPEAKER TBA
KIM HUGGINS
Partner
ROOM 2 CASE STUDY: IMPROVING EFFICIENCY IN MEDIA AND
BUFFER PRODUCTION TO ENABLE YOU TO GET TO
MARKET RAPIDLY
• Ensuring single-use powder containment in
today’s safety-focused manufacturing
environment
• Preventing product from cross-contamination
and reducing airborne particulates
• Understanding how modern bag designs can
increase safety and speed
• Examining the ease of filling along with
dispensing times and product loss
SPEAKER TBA
JOANNE BECK, PH.D.
EVP, Global Pharmaceutical Development and Operations
4:25 pm – 5:45 pm
HAPPY HOUR AND PRE-ARRANGED 1-2-1 BUSINESS MEETINGS
American Biomanufacturing Summit 2019 Program • Page 7
RAMY KHALIL
Managing Director
NETWORKING DRINKS RECEPTION
7:15 pm – 8:15 pm
Sponsored By:
6:20 pm – 7:05 pm
PANEL DISCUSSION DRIVING MODERN DAY QUALITY THINKING AND OPERATIONAL APPROACHES
• Exploring the historical role of quality and what's needed to be successful in the future
• How can quality be of greater benefit to an organization beyond compliance?
• What motivations do both quality and operations teams need have to modernize?
• Discussing examples of how quality is helping take organizations to a new modern state
• Learning from successful quality activities that propel change
CHAIR’S SUMMARY AND CLOSING REMARKS
7:05 pm – 7:10 pm
CHRISTOPHER BELL
VP, Quality Systems and
Compliance
BRYAN BALL
SVP, Quality and Environmental
Health & Safety
TINA SELF
VP, Quality, Supply Center
Berkeley
ANDY RAMELMEIER, PH.D.
SVP, Chief Manufacturing and
Quality Officer
PAUL DALY, PH.D.
Corporate VP and Head,
Global Quality
MANUFACTURING AND TECHNOLOGY CHAIR
RON BRANNING
SVP, Quality
QUALITY AND COMPLIANCE CHAIR SUPPLY CHAIN AND LOGISTICS CHAIR
VIMAL GANDHI
Director, Global BioVentures
Supply Operations and Strategy
American Biomanufacturing Summit 2019 Program • Page 8
CHAIR’S OPENING REMARKS
KEYNOTE DEVELOPING FUTURE-FOCUSED STRATEGIES TO INCREASE PROCESS PRODUCTIVITY AND FLEXIBILITY
• What will the future of the bio-production look like in the next 5-10 years?
• Creating production strategies to fit the growing need for biologics around the world
• Understanding the impact and opportunity of personalized therapeutics, and new modalities
• Considerations for creating flexible manufacturing models to accommodate advanced therapy production
• How to plan for new modalities and technologies amidst the uncertainty of needs
• Looking at speed-to-market and how to best introduce a product to market
• Seeing launch capacity as an enabler of speed-to-market
• Understanding the growing importance of data management and analytical tools for efficiency and real-time release
• Simplifying supply chain: Mitigating risks and eliminating bottlenecks
8:10 am – 8:45 am
PROGRAM DAY TWO
JUDY CHOU, PH.D
SVP and Global Head, Biotech; Site Head, Bayer Berkeley
NETWORKING BREAKFAST
WOMEN IN LEADERSHIP ROUNDTABLE
Enjoy breakfast refreshments and informal networking in the Exhibition Hall. We also invite our attendees to network at a Women in Leadership Roundtable with
discussion from inspirational leaders in manufacturing, quality and supply chain. Seating is limited, so please sign up early.
8:05 am – 8:10 am
7:00 am – 8:00 am
DIANE BLUMENTHAL
Head, Technical Operations
NEVADA BLAIR
Director, Supply Chain
RAN ZHENG
Chief Technical Officer JASPREET GILL
EVP, Global Quality Compliance
PAUL DALY, PH.D.
Corporate VP and Head,
Global Quality
MANUFACTURING AND TECHNOLOGY CHAIR
RON BRANNING
SVP, Quality
QUALITY AND COMPLIANCE CHAIR SUPPLY CHAIN AND LOGISTICS CHAIR
VIMAL GANDHI
Director, Global BioVentures
Supply Operations and Strategy
GARGI MAHESHWARI, PH.D.
AVP, Biologics Process Develop-
ment and Commercialization
JILL ZUNSHINE
SVP and Head, Global Real
Estate, Facilities,
and Procurement
American Biomanufacturing Summit 2019 Program • Page 9
9:55 am – 10:30 am
PLENARY CONTINUOUS PROCESS VERIFICATION OF NEXT GENERATION PROCESSES UTILIZING ADVANCED PROCESS CONTROL
• Minimizing process input variability through better raw material control
• Achieving greater process understanding and control through real-time analytics
• Reviewing examples of robust process design and advanced process control
• Applying tools to assure process and product quality consistency
• Discussing elements of a predictive model development strategy:
• Data acquisition and population
• Data pre-treatment and exploratory analysis
• Model optimization and validation
• Seeing adaptive control as a critical element of process consistency
ROHIN MHATRE, PH.D.
SVP, Pharmaceutical Development, Engineering and Technology
PLENARY TECHNICAL OPERATIONS: FOCUSED ON THE FUTURE
• How does the industry best plan for the future of personalized therapeutics and new modalities?
• Discussing the right mindset to drive strategy product development success
• Keys to driving productivity:
• Manufacturing: Building a flexible manufacturing environment
• Quality: Improving capabilities for CMC and analytical chemistry
• Logistics: Disruptive supply chain models
• What's next?: Discussing the next generation of biomanufacturing on the horizon
• Bringing down the cost of goods and creating a second revolution in bioprocessing
• Increased competitiveness by reducing cost and increasing market access
8:45 am – 9:20 am
ROBERT A. BAFFI, PH.D.
EVP, Technical Operations
PLENARY NAVIGATING THE UNIQUE MANUFACTURING CHALLENGES IN CELL AND GENE THERAPY AND WHAT WE CAN LEARN FROM OUR PAST EXPERIENCES
• What are the unique challenges to the gene and cell therapy manufacturing processes?
• Why supply chain needs a lot of attention, from starting materials, vector banking, frozen vial to chain of custody and how to build it robustly
• How does cell and gene therapy capacity planning compare to products in the past?
• Re-thinking the capacity dilemma: CDMO, build our own facilities or partnership strategies for facility build, space sharing and co-control?
• Highlighting Sangamo’s approach to addressing these challenges
ANDY RAMELMEIER, PH.D.
SVP, Chief Manufacturing and Quality Officer
9:20 am – 9:55 am
American Biomanufacturing Summit 2019 Program • Page 10
ROOM 2 CAPACITY ANALYSIS AND PROCESS IMPROVEMENT
USING A REAL-TIME MODELING SYSTEM
• Understanding the complexity of upstream and
downstream processes
• Examining drivers behind using simulation
• Bridging the gap between production vs. lab
scales
• Identifying bottlenecks and improving process
steps
11:40 am – 12:15 pm
ROOM 1 NDUSTRY 4.0: BIO-PROCESSING DIGITAL
TRANSFORMATION
• Moving beyond automation to leverage data
across biomanufacturing
• Why the next industrial revolution is digital
• Utilizing systems to control and monitor activity
through computer-based algorithms
• Embracing digital transformation to trigger a
quantum leap in productivity
• Minimizing maintenance downtime and spare
part inventory for process equipment
ROOM 3 PROJECT DELIVERY FOR THE PACE OF INNOVATION
• What are the best ways to enhance your project
delivery approach?
• Delivering complex, compliance-driven projects
that exceed expectations for speed and
efficiency
• Leveraging Design-Build™ to unlock efficiencies
between design and construction
• Compressing time-to-occupancy and therefore
time-to-innovation by up to 40%
SPEAKER TBA
10:35 am – 11:35 am
PRE-ARRANGED 1-2-1 BUSINESS MEETINGS AND REFRESHMENTS
SPEAKER TBA
12:20 pm – 12:55 pm
QUALITY AND COMPLIANCE ACCELERATING DEVELOPMENT AND INNOVATION:
MANAGING INCREASED QUALITY DEMANDS, TIME
TO MARKET AND THE NEED FOR FLEXIBILITY
• Discussing the constraints and complexities of
vaccine product development and manufacture
• Examining the evolution of bioprocess and
analytics technologies to accelerate and
overcome these challenges
• Leveraging innovation and technology for rapid
product development to shorten time to clinical
trials
• Case study: Accelerating process and analytical
development
• Exploring potential technologies that could play
a role in accelerating product development in
the future
SUPPLY CHAIN AND LOGISTICS APPLYING LEAN CONCEPTS TO DRIVE INNOVATION
IN BIOPHARMACEUTICAL DEVELOPMENT AND
MANUFACTURING
• How is Roche/Genentech applying lean concepts
to pilot manufacturing operations and facilities?
• Determining the best way to make medicines
faster and at larger scales
• Overcoming challenges in going from small-scale
to large-scale production
• Examining processes and equipment that can
help improve cost savings and efficiencies
MANUFACTURING AND TECHNOLOGY CASE STUDY: CREATING A FUTURE-FOCUSED
BIOMANUFACTURING FACILITY AND PORTFOLIO
• What does the current clinical and commercial
capacity look like at Chugai, and what's next?
• Examining the importance of creating a modular
facility for commercial biologics manufacturing
• Exploring recent design and technology trends
new directions in modular manufacturing
• Using enabling technologies and innovative
thinking to ensure the right strategy for the
future
HIROSHI MURATA, PH.D.
VP and General Manager,
Pharmaceutical Technology
JEFF DAVIS
Head, Operations and
Engineering, US Biologics
Process Development
JEAN MARIE BOUVIER
Director, Supply Chain
and Digitalization
TONY D'AMORE, PH.D.
VP, Product R&D
American Biomanufacturing Summit 2019 Program • Page 11
1:00 pm – 1:35 pm
1:40 pm – 2:40 pm
COMPARATIVE ANALYSIS OF BOTTLES AND
CARBOYS VS. BAGS IN SINGLE-USE
UTILIZING DIAGNOSTIC TOOLS THAT ACCELERATES
MEDICAL DISCOVERIES THROUGH A NOVEL
APPROACH TO CELL ANALYSIS AND SORTING
IMPROVING COST SAVINGS IN YOUR COLD CHAIN
OPERATIONS THROUGH THE REUSE OF
TEMPERATURE ASSURANCE PACKAGING
LUNCH AND LEARN ROUNDTABLE DISCUSSIONS
Benefit from additional learning by joining a moderated roundtable discussion on pressing issues in the industry. Choose from:
Seating is limited, so please sign up early. Sessions start at 1:40 PM and run for one hour. More seating will be provided if you would prefer to discuss other topics.
OPTIMIZATION OF A COMMERCIALIZED DRUG
SUBSTANCE MANUFACTURING PROCESS HELPFUL STRATEGIES FOR A SUCCESSFUL
RELATIONSHIP WITH YOUR CDMO
STORAGE AND DISTRIBUTION OF TEMPERATURE
SENSITIVE BIOLOGICS: HOW DO YOU KNOW WHAT’S
HAPPENING TO YOUR PRODUCT AFTER IT’S LEFT
YOUR FACILITY?
JEFFREY GUTKIND
Senior Business Development
Manager
PANEL DISCUSSION BUILDING A GLOBAL CELL THERAPY MANUFACTURING NETWORK
• What are the technological improvements required to democratize access to cell therapies?
• Discussing supply chain considerations for delivering therapies globally
• Building regional cell therapy manufacturing hubs: What works, what doesn't?
• Exploring the evolving regulatory landscape for cell therapies
• Creating a global manufacturing strategy that works for the size and maturity of the company
SPEAKER TBA
SPEAKER TBA
SPEAKER TBA
ZHI XU TAN
Regional Director,
New York Office
SPEAKER TBA ANDREW SINNEN
Director, Sales
READY TO FILL PACKAGING MATERIALS: CONCEPTS
FOR CLINICAL OR COMMERCIAL ASEPTIC
SPEAKER TBA
EXPLORING INNOVATIVE TECHNOLOGIES HELPING
TO BRING ABOUT THE NEXT GENERATION OF
PROTEIN THERAPEUTICS AND PRODUCTS
SPEAKER TBA
FINDING YOUR ORGANIZATION’S ROADMAP TO
SUCCESS FOR QUALITY AND REGULATORY MATTERS
SPEAKER TBA
DELIVERING SUCCESSFUL PLANNING, PROCESS AND
FACILITY DESIGN
SPEAKER TBA
EXAMINING PROCESSES MANUFACTURERS WILL
HAVE TO UNDERTAKE TO ONBOARD AND LEVERAGE
THE 3PO MODEL
SPEAKER TBA
ADVANCING QUALITY BIOTHERAPEUTICS FROM
CONCEPT TO COMMERCIALIZATION
SPEAKER TBA
American Biomanufacturing Summit 2019 Program • Page 12
2:45 pm – 3:20 pm
INNOVATION SPOTLIGHT MAKING GENE THERAPY A REALITY – CMC CONSIDERATIONS FOR FAST-PACED
PRODUCT DEVELOPMENT AND SPEED-TO-MARKET
• What are the challenges of taking a product from clinical to commercial?
• Conducting a technology transfer to external partners, and getting it right the
first time
• Developing a robust CMC program that meets regulatory requirements
• Ensuring the rapid delivery of quality product to the patients
INNOVATION SPOTLIGHT INCREASING EFFICIENCY THROUGH AUGMENTED REALITY IN REAL SHOP FLOOR
• Examining new technology that helps reduce setup times and increase both
efficiency and viability
• Case study: Vifor Pharma AG's first realized shop floor application of a
system using
• Augmented Reality: Gamification brought to the pharma shop floor
• First insights from Proof-of-Concept to a prototype
• Discussing improvements to performance, quality and employee
engagement
• What's next?: Packaging line and other applications
DIRK SCHRADER, PH.D.
EVP and Head, Global Technical Operations
4:00 pm – 4:45 pm
3:25 am – 4:00 am
PLENARY VISIONARY PLANNING AND INNOVATIVE THINKING PAY OFF
• Examining technology and facility investments for creating a dynamic flexible network
• Exploring Boehringer Ingelheim's future bioproduction network plans
• Discussing progress on the new cell culture facility in Europe operational in 2021
• Examining state-of-the-art analytical methods for characterization and quality testing
• Progress and continuous improvement on a multiproduct facility - Oasis - in Asia
• Integrating data management into production network and system plans
• Ensuring the reliability of supply and high quality and compliance standards are the basis of our daily work
JENS H. VOGEL, PH.D.
President and CEO, Boehringer Ingelheim Fremont Inc.
DIANE BLUMENTHAL
Head, Technical Operations
MANINDER HORA, PH.D.
Chief Technical Operations
Officer and SVP,
Pharmaceutical Development
and Manufacturing
PANEL DISCUSSION ADDRESSING CHALLENGES IN MEETING GLOBAL CAPACITY
• What are companies thinking about when building new capacities?
• How to best invest in capacity, contract manufacturers, emerging markets and technology
• Seeking partnerships and alliance models to help overcome production challenges
• Increasing the agility of your organization in a global markets
TOMMY FANNING
Head, Biopharmaceuticals
and Food
American Biomanufacturing Summit 2019 Program • Page 13
CHAIR’S REMARKS AND DELEGATE SURVEY PRIZE DRAW
4:45 pm – 5:00 pm
PAUL DALY, PH.D.
Corporate VP and Head,
Global Quality
MANUFACTURING AND TECHNOLOGY CHAIR
RON BRANNING
SVP, Quality
QUALITY AND COMPLIANCE CHAIR SUPPLY CHAIN AND LOGISTICS CHAIR
VIMAL GANDHI
Director, Global BioVentures
Supply Operations and Strategy