american biomanufacturing summit 2019...• defining the capabilities you need for success •...

AMERICAN BIOMANUFACTURING SUMMIT 2019

JUNE 18-19, 2019

HYATT REGENCY SAN FRANCISCO AIRPORT • SAN FRANCISCO, CA

biomanamerica.com

+1-416-298-7005

[email protected]

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


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


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


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


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


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


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.


Global Quality


RON BRANNING

SVP, Quality


VIMAL GANDHI




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.


Global Quality


RON BRANNING

SVP, Quality


VIMAL GANDHI



GARGI MAHESHWARI, PH.D.

AVP, Biologics Process Develop-

ment and Commercialization

JILL ZUNSHINE

SVP and Head, Global Real

Estate, Facilities,

and Procurement


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


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


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


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


CHAIR’S REMARKS AND DELEGATE SURVEY PRIZE DRAW

4:45 pm – 5:00 pm

PAUL DALY, PH.D.


Global Quality


RON BRANNING

SVP, Quality


VIMAL GANDHI



american biomanufacturing summit 2019...• defining the capabilities you need for success •...

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