ren

NOVEMBER 13, 2016

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

NOVEMBER 14, 2016

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

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 9:45 am - 10:20 am 9:45 am - 10:20 am CASE STUDY STREAM 1 CASE STUDY STREAM 2 CASE STUDY STREAM 3 STRATEGIC MANUFACTURING QUALITY SUPPLY CHAIN MANAGEMENT Embracing Manufacturing Complexity to Build Manufacturing Capability and Competitive Advantage

• 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

The Role of Next Generation Quality Systems in the Advancement of Biomanufacturing Innovation

• Developing science-

based and technology-enabled Quality oversight

• Leveraging advanced process controls to enhance process robustness and predictable outcomes

• Exploring novel approaches to commissioning, qualification, and validation of facilities, utilities, and equipment systems for optimal compliance

• Replacing the paradigm of drug substance release testing with modern in-line analytical approaches

• Maximizing efficiency, streamline processes and dynamically scale

BMS BioPharma Evolution and Managing Rapid Global Growth in Biologics Manufacturing and Supply

• 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

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

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

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 probability of success

We will introduce a new biomanufacturing solution that leverages 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

New Construction, Facility Expansion, and Debottlenecking – Understanding The Benefits and ROI of Modeling and Simulation

Validation and

verification of capital expenditures through modeling and simulation

Customer based case studies on the impact of variability on debottlenecking in large-scale facilities – batch and perfusion processes

Reducing risk and increasing reliability using model-driven approaches to process optimization

David Zhang Principal Bioproduction Group

Navigating The Challenges of a Global Temperature Controlled Supply Chain

Investigating the inherent

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

Keegan Moore Director of Business Development World Courier Inc.

David Radspinner General Manager GE Healthcare BioPark

12:20 pm - 12:55 pm 12:20 pm - 12:55 pm CASE STUDY STREAM 1 CASE STUDY STREAM 2 STRATEGIC MANUFACTURING QUALITY Serialization and Traceability

• Discussing building blocks to patient

protection • Understanding value realization • Showcasing future opportunities

Angela Card Executive Director, Supply Chain Amgen

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

12:55 pm -1:55 pm 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

Heidi Hoffmann Senior Director, Manufacturing Sutro Biopharma

Bringing a Quality Focus to CMO Management

Walter Cespedes Executive Director Commercial Quality TEVA

Making Metrics Mean Something

Jeffrey Trost

SVP Operations

Myriad Genetic Labs

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

Owen Murray Head of Technical Operations Recordati Rare Diseases

Building Flexibility into Manufacturing Processes

Erik Fouts VP Novato Manufacturing BioMarin

Challenges of Quality

Control in Biologics

Mark Galbraith

Head of Quality Control

Spark Therapeutics Inc.

Opportunities and Challenges of Continuous Manufacturing of Biopharmaceuticals

Shou-Bai Chao SVP, BioVentures Medimmune

1:55 pm - 2:30 pm 1:55 pm - 2:30 pm 1:55 pm - 2:30 pm CASE STUDY STREAM 1 CASE STUDY STREAM 2 CASE STUDY STREAM 3 STRATEGIC MANUFACTURING QUALITY SUPPLY CHAIN MANAGEMENT Maintaining an Effective Quality Focus in Operations During Mergers and Acquisitions

• 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

The Importance of Quality and Compliance When Managing CMOs

• 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

Technology Transfer to Fill/Finish CMO & Considerations for High-Value Biologic API

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

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

Rami Mitri CEO & Founder

Digitization of BioManufacturing

• Improving

environmental control for yield and reduced waste with asset monitoring and visibility on the manufacturing floor

• Driving better data and analytics for faster decision making up and down the supply chain

• Creating high impact collaboration for R&D and production teams to speed up 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

Randal Kenworthy Practice Director, Manufacturing Digital Transformation Group Cisco

Get a CMO’s Perspective on Contracts, Risk and Metrics for Success

• Challenges CMOs face

regarding contract negotiations, liability and risk assessment – and why that matters to you

• Why conforming to a CMO’s quality system helps safeguard your medicine

• How mutual metrics for success can reduce risk and increase quality

Lisa Thimmesch Sr. Quality Manager Pfizer CentreOne

One Hill Solutions 3:15 pm - 4:25 pm Pre-Arranged One-to-One Meetings

4:25 pm - 4:35 pm GE Virtual Reality Showcase Taking Place in the Delegate Lounge

4:40 pm - 5:15 pm The AbbVie Journey to Perfect Performance: “The Now, The Vision, The Path”

Building a toolkit to generate and sustain change in cGMP and quality performance initiatives

Discussing the role of leadership in the implementation of an engaged workforce

Illustrating tools, tactics, techniques, and technologies that make a positive impact

Reviewing real-world examples: What do the successful initiatives all have in common? Daniela Ottini VP, Manufacturing Operations Biologics AbbVie 5:15 pm - 5:50 pm Encouraging Ambition: What Does the Future of Quality Management Look Like?

What is the next “Big Idea” for biopharmaceutical quality management? Where should we go from

here?

Transforming what quality management contributes to your organization

Setting far-reaching goals that challenge you about people, sustainability, innovation, and marketshare

Building bridges between the quality management team and other facets of the company

Taking local innovations and initiatives and translating them up into the global culture of your company Anil Sawant Vice President, Global Quality Management Systems and External Affairs Merck

5:50 pm - 5:55 pm Chair’s Closing Address

Patrick Yang Former EVP, Technical Operations Genentech

5:55 pm Drinks Reception

NOVEMBER 15, 2016

7:30 am - 8:00 am Registration and Breakfast 8:00 am - 8:10 am Chair’s welcome address

Patrick Yang Former EVP, Technical Operations Genentech 8:10 am - 8:45 am The Role of Process Development in Next Generation Biologics Manufacturing

Multiple product modalities need a flexible and adaptable manufacturing network

Process Development needs to ensure robust processes regardless of modality or manufacturing technology

Process Development focuses on delivering target product attributes and a robust control strategy

Amgen targets six sigma performance using PpK measurement; we will discuss pros and cons Alison Moore Senior Vice President, Process Development Amgen Inc.

8:45 am - 9:20 am

The Role of Manufacturing in a Successful Biosimilar Strategy

The biosimilars market includes a diverse set of competitors with a range of manufacturing capabilities

What are the main cost considerations for manufacturers looking to compete in this space?

Buy versus build - when is contract manufacturing the right strategic option?

Can single-use bioreactors provide an advantage over stainless steel reactors?

Peter Moesta CEO Therapeutic Proteins International 9:25 am - 10:00 am 9:25 am - 10:00 am CASE STUDY STREAM 1 CASE STUDY STREAM 2 STRATEGIC MANUFACTURING QUALITY Case Study: CSL Behring – Innovating Our Way to Success in the Plasma Protein Biotherapeutics Industry

• The BioPharma business revolves around people –

our life saving products are manufactured by people for people. What are the implications for our operations?

• Discussing some of the differences between plasma product manufacturing and other more conventional product lines

• Illustrating the challenges and opportunities plasma therapeutics face while working to benefit small, specialized patient populations

• What have we learned so far, and where do we go from here?

Val Romberg EVP Manufacturing, Operations & Planning CSL Behring

Partnering Across the Development Lifecycle to Ensure the Delivery of Quality Products

• Meeting and exceeding GMP requirements to

maintain a continually improved process performance and product quality

• Instilling a collaborative approach with R&D, Manufacturing, Supply Chain groups towards successful technical transfer

• Optimizing risk-based post-approval change processes to maximize benefits from new technologies and innovation

Andrew McKillop Vice President, Pharmaceutical Sciences Quality Assurance Pfizer

10:05 am - 10:25 am Town Hall Q&A in the Exhibition Hall This 20-minute moderated Q&A session will take place in the Exhibition Hall. Questions will be gathered from the audience throughout the course of the summit and discussed in an open forum among speakers, delegates, and sponsors.

10:25 am - 11:15 am

Pre Arranged One-to-One Meetings

11:20 am - 11:55 am Panel: Developing the Biomanufacturing Organization of the Future

• Discussing trends in new builds and facility expansions: What makes sense now, and how are the pros and cons

changing over time? • Where are the people going to come from? Strategies to attract, retain, and develop the workforce our industry

needs to succeed • How can the experience of the first generation of biopharmaceutical manufacturers be translated and built upon

by younger enterprises and startups? • How should today’s senior executives mentor and guide their future successors?

Tina Larson Vice President, Technical Operations Achaogen Andy Ramelmeier SVP, Biologics Technical Operations Portola Pharmaceuticals, Inc George Avgerinos SVP Operations Fortress Biotechnology

12:00 pm - 12:35 pm 12:00 pm - 12:35 pm WORKSHOP WORKSHOP STRATEGIC MANUFACTURING QUALITY Digital Transformation with Business Impact for Biopharmaceutical Manufacturers

• Proving that the most valuable data in

manufacturing is from production itself • Choosing the right goals and outcomes to

make a difference • Connecting disparate IT systems together

into a unified whole • Building a scalable approach for the

enterprise, step-by-step: Start small to go big

• Understanding why data lakes and bespoke projects don’t scale

• Illustrating successful projects with concrete examples

Developing a World-Class Quality Management and Compliance System

• Identifying and managing instances of noncompliance

with GMPs • Developing a quality system infrastructure to ensure

compliance in a fast growing company • Placing quality and compliance as the core strength of

your organization and the industry • Identifying, mitigating and preventing high-risk events

through integration, automation and collaboration • Ensuring a strong quality and compliance focus with

CMOs, partners and suppliers Tony Parise Product Strategist-Life Sciences EtQ

Chris Dobbrow SVP Sight Machine

12:35 pm - 1:35 pm 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.

Leveraging Data to Solve Your Biggest Quality and Productivity Challenges

Optimizing and Streamlining the Data Collection that Powers Smart Factories

Quality as a Strategy for Pharma Manufacturing

1:35 pm - 2:10 pm 1:35 pm - 2:10 pm CASE STUDY STREAM 1 CASE STUDY STREAM 2 STRATEGIC MANUFACTURING QUALITY Global Outlook – Addressing the Challenges of Supply Chain Sourcing and Manufacturing in Emerging Markets

• Understanding the stark contrast between outsourcing for biologics and small molecule drugs

• Examining options to safeguard manufacturing processes against deliberate violation of SOPs

• Strategies for tech transfer and IP protection in emerging markets

• Ensuring quality oversight before investing in CMOs

• Discussing import/export challenges of microbial products

Mayo Pujols VP Manufacturing Advaxis, Inc.

Managing Raw Material Risk for Cell and Gene Therapies

• Identifying and handling principal challenges faced

with ATMPs • Exploring challenges for managing raw material

attributes and risks • Ensuring chain of identity from collection to

administration • Managing variability in raw materials • Investigating approaches and best practices to fix

compliance issues and mitigate risk

Karen Walker Global Head Cell and Gene Therapies Technical Development and Manufacturing

Novartis

2:15 pm - 2:50 pm PANEL – Looking Forward: Where are Biopharmaceutical Manufacturers Going, and How Should We Get There?

• Talking about the state of the biotech industry today: Which emerging trend will see the most growth? • People and technology: How are these forces working together to grow and mature our industry? • Discussing challenges in capacity planning, make-buy decisions, and supply chain management • What is the next big challenge and the next big opportunity facing our community? Are we ready for it?

Joanne Beck EVP Global Pharmaceutical Development & Operations Celgene Corporation Sally Dyer Director of Manufacturing for the Boulder Manufacturing Center MedImmune Andrew Mica Sr. Director, Global Supply Chain, NA Commercial Supply Biogen Ken Green Head of Manufacturing Science and Technology Shire

2:50 pm - 3:00 pm Chair’s Closing Address

Patrick Yang Former EVP, Technical Operations Genentech