NOVEMBER 13, 2016 Welcome Drinks Reception NOVEMBER 14, 2016 Registration and Breakfast Chair s Welcome Address Patrick Yang Genentech

Transcription

1 ren NOVEMBER 13, :00 pm - 7:00 pm Welcome Drinks Reception NOVEMBER 14, :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

2 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 The Role of Next Generation Quality Systems in the Advancement of Biomanufacturing Innovation 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 sciencebased and technologyenabled 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 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

3 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 New Construction, Facility Expansion, and Debottlenecking Understanding The Benefits and ROI of Modeling and Simulation Navigating The Challenges of a Global Temperature Controlled Supply Chain 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 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 approaches to process optimization David Zhang Principal Bioproduction Group 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.

4 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 Meeting Regulatory and Compliance Requirements in Your Operation's Manufacturing Processes Discussing building blocks to patient protection Understanding value realization Showcasing future opportunities Angela Card Executive Director, Supply Chain Amgen 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 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

5 Tech Transfer Quality, Cost & Speed Solving For All Three Building Flexibility into Manufacturing Processes Challenges of Quality Control in Biologics Owen Murray Head of Technical Operations Recordati Rare Diseases Erik Fouts VP Novato Manufacturing BioMarin 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 The Importance of Quality and Compliance When Managing CMOs Technology Transfer to Fill/Finish CMO & Considerations for High- Value 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

6 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 Digitization of BioManufacturing Get a CMO s Perspective on Contracts, Risk and Metrics for Success 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 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 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

7 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

8 Patrick Yang Former EVP, Technical Operations Genentech 5:55 pm Drinks Reception NOVEMBER 15, :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.

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

10 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 Developing a World-Class Quality Management and Compliance System 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 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

11 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 Managing Raw Material Risk for Cell and Gene Therapies 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. 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

12 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