Ren NOVEMBER 13, 2016 NOVEMBER 14, 2016

6:00 pm - 7:00 pm Welcome Drinks Reception

ren

NOVEMBER 13, 2016

7:15 am - 8:15 am Registration and Breakfast 8:15 am - 8:30 am Chair's Welcome Address

NOVEMBER 14, 2016

Patrick Yang Former EVP, Technical Operations Genentech

8:30 am - 9:05 am From Big Pharma to Specialty Manufacturers: The Future is About Innovation

Comparing and contrasting how large and small organizations approach their biopharmaceutical manufacturing processes

How do the best practices of large companies translate into smaller and more specialized organizations?

Discussing some of the new ideas and opportunities emerging in the cell therapy arena Leveraging the knowledge and processes of industry leaders to improve competitiveness in younger

companies Sharing lessons learned so far and discussing next steps

Tim Moore EVP Technical Operations Kite Pharma

9:05 am - 9:40 am Opening Keynote: Quality Culture and the Living Quality Ecosystem

What are we trying to achieve with quality metrics? Comparing and contrasting lean thinking with living systems Creating a quality ecosystem: It begins with what motivates people Building and sustaining a cultural change towards continual improvement Discussing our journey so far and where we go from here

Anders Vinther Chief Quality Officer Sanofi Pasteur

9:45 am - 10:20 am CASE STUDY STREAM 1 STRATEGIC MANUFACTURING Embracing Manufacturing Complexity to Build Manufacturing Capability and Competitive Advantage

9:45 am - 10:20 am CASE STUDY STREAM 2 QUALITY The Role of Next Generation Quality Systems in the Advancement of Biomanufacturing Innovation

9:45 am - 10:20 am CASE STUDY STREAM 3 SUPPLY CHAIN MANAGEMENT BMS BioPharma Evolution and Managing Rapid Global Growth in Biologics Manufacturing and Supply

? Introducing a systems framework to manage manufacturing complexity and drive performance improvements

? Highlighting the evolution of a manufacturing system through an industry case study

? Relying on rapid analytics to drive product and process development

? Translating lessons learned at the manufacturing network level

? Optimizing manufacturing network, reducing inventory and improving financial performance with the help of advanced planning systems

? Adapting supply chain capabilities in order to meet emerging market demand

? Developing science-

based and technologyenabled Quality oversight ? Leveraging advanced process controls to enhance process robustness and predictable outcomes ? Exploring novel approaches to commissioning, qualification, and

? BMS and the biologics portfolio

? Biologics global network expansion

? Targeted initiatives for process and operations productivity

? Integrated product teams for end to end coordination

? Controlling execution through PMO

validation of facilities, utilities, and equipment systems for optimal compliance ? Replacing the paradigm of drug substance

Paul J. Staid VP, Biologics Product Strategy & Operations, Global Manufacturing & Supply Bristol-Myers Squibb

release testing with

modern in-line analytical

approaches

? Maximizing efficiency,

streamline processes

and dynamically scale

Kimball Hall SVP and Head of Biologics Drug Substance Genentech

productivity in laboratories through innovative technologies

Juan Torres SVP, Global Quality Biogen Idec

10:20 am - 11:35 am

Pre Arranged One-to-One Meetings

11:40 am - 12:15 pm WORKSHOP STRATEGIC MANUFACTURING A New Way to Rapidly Develop Biomanufacturing Capacity and Add Greater Value to the Decision to Build

11:40 am - 12:15 pm WORKSHOP QUALITY New Construction, Facility Expansion, and Debottlenecking ? Understanding The Benefits and ROI of Modeling and Simulation

11:40 am - 12:15 pm WORKSHOP SUPPLY CHAIN MANAGEMENT Navigating The Challenges of a Global Temperature Controlled Supply Chain

Investigating the inherent

The decision to invest capital in capacity expansion when a drug is early in development is challenging. There are new manufacturing models that reduce risk and add value to your decisions through a concept called optionality

When options to build decision are critically evaluated risk can be balanced against

Validation and verification of capital expenditures through modeling and simulation

Customer based case studies on the impact of variability on debottlenecking in largescale facilities ? batch and perfusion processes

Reducing risk and increasing reliability using model-driven

dangers in shipping between international markets Exploring what options are available for safe and secure international transport of clinical and commercial product Establishing how to ensure security in line with regulatory requirements as it relates to the GDP directive

approaches to process optimization

Keegan Moore Director of Business Development

probability of success

We will introduce a new biomanufacturing solution that leverages

David Zhang Principal Bioproduction Group

World Courier Inc.

manufacturing ecosystems

to reduce the need to

build infrastructure. You

can effectively transfer

non-value added work

from the manufacturing

site to service providers

with this new

manufacturing model

David Radspinner General Manager GE Healthcare BioPark 12:20 pm - 12:55 pm CASE STUDY STREAM 1 STRATEGIC MANUFACTURING Serialization and Traceability

? Discussing building blocks to patient protection

? Understanding value realization ? Showcasing future opportunities Angela Card Executive Director, Supply Chain Amgen

12:55 pm -1:55 pm

12:20 pm - 12:55 pm CASE STUDY STREAM 2 QUALITY Meeting Regulatory and Compliance Requirements in Your Operation's Manufacturing Processes

? Anticipating what FDA inspections are seeking through conducting your own internal inspections

? Offering key steps and best practices to improve your validation program

? Ensuring timely approval of FDA submissions: What does the extra mile look like?

? Lessons learned from the most recent regulatory warning letters

Pierre-Alain Ruffieux Head of Quality and Compliance Roche

Themed lunches are roundtable discussions amongst industry leaders where you will have the opportunity to discuss the most pressing issues. Each roundtable will be led by an expert in the field. Limited seating available. Select from:

Adjusting Production and Supply Chain Strategies for ADCs

Bringing a Quality Focus to CMO Management

Making Metrics Mean Something

Heidi Hoffmann Senior Director, Manufacturing Sutro Biopharma

Walter Cespedes Executive Director Commercial Quality TEVA

Jeffrey Trost SVP Operations Myriad Genetic Labs

Tech Transfer ? Quality, Cost & Speed ? Solving For All Three

Building Flexibility into Manufacturing Processes

Owen Murray Head of Technical Operations Recordati Rare Diseases

Erik Fouts VP Novato Manufacturing BioMarin

Opportunities and Challenges of Continuous Manufacturing of Biopharmaceuticals

Challenges of Quality Control in Biologics

Mark Galbraith Head of Quality Control Spark Therapeutics Inc.

Shou-Bai Chao SVP, BioVentures Medimmune

1:55 pm - 2:30 pm CASE STUDY STREAM 1 STRATEGIC MANUFACTURING Maintaining an Effective Quality Focus in Operations During Mergers and Acquisitions

1:55 pm - 2:30 pm CASE STUDY STREAM 2 QUALITY The Importance of Quality and Compliance When Managing CMOs

1:55 pm - 2:30 pm CASE STUDY STREAM 3 SUPPLY CHAIN MANAGEMENT Technology Transfer to Fill/Finish CMO & Considerations for HighValue Biologic API

? Discussing best practices to establish and maintain a quality focus on each product lifecycle during M&A activity

? Clarifying who is responsible for what and opening up lines of communication, coordination, and collaboration between teams in transition

? Balancing phase appropriate applications of: o Quality systems o Knowledge and risk management o Product control

? Tips on ensuring successful regulatory inspections at CMOs

? Importance of collaboration between sponsor and CMO

? Determining the appropriate level of CMO oversight

? What should we be measuring?

Bob Miller Vice President Quality Gilead Sciences, Inc

? Understanding the key and unique considerations for CMO selection

? Organizing for success ? Managing complexity for

flawless execution

Eric Niebling Vice President, External Supply Integration Janssen Pharmaceutical Companies of Johnson & Johnson

? Offering examples of positive outcomes and explaining what made these stories a success

Charlene Banard Senior Vice President of Global Quality Shire Pharmaceuticals

2:35 pm - 3:10 pm WORKSHOP STRATEGIC MANUFACTURING Data Automation Will Transform All Stages of Process Development, from DoE to Manufacturing

2:35 pm - 3:10 pm WORKSHOP QUALITY Digitization of BioManufacturing

2:35 pm - 3:10 pm WORKSHOP SUPPLY CHAIN MANAGEMENT Get a CMO's Perspective on Contracts, Risk and Metrics for Success

? Improving

environmental control

? Challenges CMOs face

? By leveraging smart automation systems, process development experts can more efficiently design, run, monitor, collect, analyze and report all bioprocess information

? Data from bioreactors and analyzers can now be automatically and seamlessly connected, collected and organized in one location for process control and monitoring

? Knowledge about multiple areas of the drug development process is gathered into one interface, where scientists can analyze the data and make better decisions -- faster

? All of this increased

for yield and reduced

regarding contract

waste with asset

negotiations, liability and

monitoring and visibility

risk assessment ? and why

on the manufacturing

that matters to you

floor

? Why conforming to a CMO's

? Driving better data and

quality system helps

analytics for faster

safeguard your medicine

decision making up and

? How mutual metrics for

down the supply chain

success can reduce risk and

? Creating high impact

increase quality

collaboration for R&D

Lisa Thimmesch

and production teams to Sr. Quality Manager

speed up

Pfizer CentreOne

communication

? Increasing safety, quality

and compliance in the

manufacturing and

supply chain processes

? Reducing obstacles for

3rd party

contractors/partners

while adhering to

security policy in the

factory environment

efficiency yields reduced time and expense in the development of new biologics and in support of the FDA PAT initiative

Randal Kenworthy Practice Director, Manufacturing Digital Transformation Group Cisco

Rami Mitri CEO & Founder

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