American Biomanufacturing Summit 2021

AMERICAN BIOMANUFACTURING SUMMIT 2021

APRIL 27-29, 2021 biomanamerica.com

TOMORROW'S CONNECTION TODAY Designing a new future for manufacturing, quality and supply chain leaders

 +1-416-298-7005  [email protected]

PROGRAM Generis • American Biomanufacturing Summit • Page 1 PROGRAM · DAY 1 APRIL 27, 2021

10:00 am – 10:30 am EST LOG-IN AND WELCOME

10:35 am – 10:45 am EST CHAIR'S OPENING REMARKS

CHRIS MCDONALD SVP and Global Head, Manufacturing Kite Pharma

10:45 am – 11:20 am EST OPENING KEYNOTES

LARS DREESMANN, PH.D. JEFFREY BAKER President and Site Head Deputy Director, Oce of Biotechnology Products, CDER, FDA at CDER Boehringer Ingelheim Fremont, Inc. FDA

LEVERAGING FLEXIBLE NETWORKS, QUALITY CULTURE AND CUTTING DISCUSS, DEPLOY, OR DEFER: NEW TECHNOLOGIES IN REAL WORLD EDGE INNOVATION BIOPHARMACEUTICAL MANUFACTURING How biomanufacturing can address the dichotomy of small volume precision Examining the landscape for new technologies in domestic biotech medicines and high volume blockbuster drugs Unravelling the science behind regulatory CMC challenges associated with new Building exible global manufacturing networks to meet our industry’s evolving needs product development and approval Leveraging cutting-edge innovation to maximize process intensication and augment Maintaining a commitment to continuous improvement in biopharmaceutical exibility manufacturing Creating high-performance teams and building and maintaining a culture of quality, reliability and innovation as key dierentiator and foundation for continued success

11:25 am – 12:00 pm EST PLENARY

ANGELO STRACQUATANIO CEO and Co-Founder Apprentice.io

THE RAPID ADOPTION OF INTELLIGENT MANUFACTURING AND PHARMA 4.0 DURING COVID How Apprentice solutions helped the world's leading life science organizations navigate through the COVID-19 pandemic Incorporating AI, AR and Pharma 4.0 principles to help you scale faster Small/large molecule and cell & gene therapy use cases How to easily leverage the content you already have to make deployment fast and easy

12:05 pm – 12:45 pm EST PRE-ARRANGED 1-2-1 BUSINESS MEETINGS AND NETWORKING

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12:50 pm – 1:30 pm EST LUNCH & LEARN ROUNDTABLE DISCUSSIONS

Benet from additional learning by joining a moderated roundtable discussion on pressing issues in the industry. Registration is required, and attendance is limited. Choose from:

CARL RADOSEVICH CAROLINA VALOYES BRENT LIEFFERS Senior Manager, Scientic Applications Head, Corporate Quality Systems Senior Director, Operations and Collaborations Boehringer Ingelheim, Inc. Singota PHC Corporation of North America

DRIVING DATA INTEGRITY ACROSS MULTIPLE SCALING UP YOUR CELL CULTURE AVOIDING DELAYS CAUSED BY THE ORGANIZATIONS FILL/FINISH BOTTLENECK WHEN GETTING YOUR PRODUCT INTO THE CLINIC RAHUL KAUSHIK VP and Head, Antibody/Protein Process PÄR ALMHEM Development and Manufacturing Director, Business Development SCOTT WHYTE FibroGen KeyPlants Chief Digital Ocer AeroSafe EMBRACING TECHNOLOGY TO IMPROVE THE RAPID AND COST EFFECTIVE DEPLOYMENT WAY YOU GATHER, ANALYZE, REPORT AND OF MODULAR BIOMANUFACTURING SHARE PROCESS DATA ACROSS TRENDS IN SUPPLY CHAIN ACCELERATED BY FACILITIES MANUFACTURING NETWORKS COVID-19 AND IMPLICATIONS BEYOND

1:35 pm – 2:10 pm EST WORKSHOPS

MANUFACTURING AND TECHNOLOGY QUALITY AND COMPLIANCE SUPPLY CHAIN AND LOGISTICS

THOMAS GERVAIS ANH VO, M.A., ACC MICHAEL DELLORTO Head, Manufacturing, Science, and Senior Principal VP, Business Development Technology (MSAT) ALULA MNX Global Logistics Samsung Biologics

CONTINUOUS MANUFACTURING LEVERAGING YOUR CLINICAL SHIPMENT “BIG DANIELLE GEISSLER, PH.D. TECHNOLOGY TO EXISTING PROCESS: DATA” TO IMPROVE DECISION MAKING CHALLENGES AND ADVANTAGES OF Senior Principal ALULA Why simplicity and visibility on every piece of the end- IMPLEMENTING N-1 PERFUSION to-end logistics process is the key TECHNOLOGY to success Impact of continuous technology on tech transfer and HOW TO COMBAT UNCERTAINTY FATIGUE How collaborative partnerships and a laser focus on process scale-up AND DRIVE ENGAGEMENT quality ensures trial and commercial Key considerations and challenges in N-1 perfusion to success Sharing strategies to help teams overcome meet reduced cell culture duration and higher protein MNX technology showcase “uncertainty” fatigue titers in the overall product yield Identifying how uncertainty fatigue impacts Real case: Before vs After implementing N-1 engagement technology Highlighting steps to take to shape a high- Preparing for next plan for continuous process performance culture intensication

2:15 pm – 2:55 pm EST PRE-ARRANGED 1-2-1 BUSINESS MEETINGS AND NETWORKING

Generis • American Biomanufacturing Summit • Page 3

3:00 pm – 3:35 pm EST SESSIONS

MANUFACTURING AND TECHNOLOGY QUALITY AND COMPLIANCE SUPPLY CHAIN AND LOGISTICS

ROHINI DESHPANDE, PH.D. KIM BURSON, PH.D. CRAIG MALZAHN VP, Drug Substance Technologies, Head, Quality Assurance and Quality VP, Manufacturing and Supply Chain Process Development and Control REGENXBIO Massachusetts Site Head Denali Therapeutics Amgen

ESTABLISHING A QUALITY PARTNERSHIP BUILDING A FLEXIBLE GENE THERAPY NEXT GENERATION BIOMANUFACTURING: A WITH YOUR SUPPLIERS AND OUTSOURCED SUPPLY CHAIN TO ACCELERATE DRUG JOURNEY CONTRACT MANUFACTURING/TESTING SITES DEVELOPMENT Discussing the advent of immuno-oncology targets, Sharing your quality vision and responsibilities with Strategic principles to guide decision making lower volume high potency molecules and multi your outsourced partners Manufacturing optionality for a broad pipeline specics Establishing and negotiating quality agreements with Scalable technology right-sized with customer demand Sharing the role new manufacturing technology in partners in your network Accelerating drug development with platform overcoming the ongoing challenges currently facing Navigating the challenges of auditing outsourced processes the sector (cornerstone technologies for MoF-ATF, partners during a pandemic single use, media, harvest and downstream becoming Analyzing the performance of outsourced partners: critical to next generation manufacturing) What tools and processes can be applied? Why biomanufacturing needs will be dierent and challenges the adaptation of manufacturing capabilities to meet the needs of the diverse pipeline Future considerations on manufacturing innovation

3:35 pm – 4:35 pm EST EXPO HALL NETWORKING

Generis • American Biomanufacturing Summit • Page 4 PROGRAM · DAY 2 APRIL 28, 2021

9:45 am – 9:55 am EST LOG-IN AND WELCOME

10:00 am – 10:50 am EST EMPOWER HOUR

TERESA RODÓ GAYLE GIRONDA ROBERT BOTTOME EVP and Head, Global Healthcare VP, Human Resources VP, Global Supply Chain Operations Bristol-Myers Squibb BioMarin Pharmaceuticals Inc. Merck KGaA, Darmstadt, Germany

GISSELLE PEREZ VICKY VERONNEAU JORDYNE BLAISE Head, Global Diversity, Equity & SVP, Quality, Novartis Gene Director, Diversity, Equity and Inclusion, and People Relations Therapies Inclusion Biogen Novartis bluebird bio

DIVERSITY AND INCLUSION ROUNDTABLE

We invite attendees to network at the Diversity and Inclusion Roundtable with discussions from inspirational leaders in manufacturing, supply chain, quality and more.

10:55 am – 11:05 am EST CHAIR'S OPENING REMARKS

CHRIS MCDONALD SVP and Global Head, Manufacturing Kite Pharma

11:05 am – 11:40 am EST OPENING KEYNOTES

PATRICK Y. YANG, PH.D. JENS VOGEL Executive Vice Chairman and Co-Founder, National Resilience, Inc., SVP and Global Head, Biotech Chairman/Co-Founder, Acepodia, Inc., Executive Chairman, AltruBio, Inc., Bayer Pharmaceuticals Former EVP Juno, Roche and Genentech

PLANNING FOR THE FUTURE OF BIOMANUFACTURING: PAVING THE WAY FOR SUCCESSFUL INDUSTRIALIZATION OF NEW THERAPEUTIC BIOMANUFACTURING 2031: REFLECTING ON THE PAST AND SETTING MODALITIES GOALS FOR THE NEXT DECADE OF INNOVATION How mRNA technology as well as cell and gene therapies promise to revolutionize What does biomanufacturing innovation look like in the post-COVID economy? medicine and may enable curative approaches for hard to treat diseases Discussing an industry in transition and what's on the horizon Why open innovation and external partnering in discovery and product innovation Being a patient-focused business leader that embraces technology works – for both innovators and mature biopharma companies Placing an emphasis on Operational Excellence and sustainable growth What are the biggest challenge of bringing these therapies to patients globally – Investing in our science, facilities and commercial capabilities to deliver better stepping up the pace of adoption of new technologies, current industry limitations in outcomes CMC capabilities and capacity bottlenecks Creating innovative medicines to treat patients and protect public health around the Delivering success in industrializing cell and gene therapies requires vision, world leadership, diverse talent, the right organizational set-up and the right culture Case study: Discussing how Bayer is leveraging its core strengths in advanced manufacturing of dicult to make biologics in dening its technological approaches, including process integration, intensication, automation and digitalization which form the basis for creating our next generation cell and gene manufacturing platforms

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11:45 am – 12:20 pm EST PLENARY

TERESA RODÓ EVP and Head, Global Healthcare Operations Merck KGaA, Darmstadt, Germany

INVESTING IN AGILITY, RESILIENCY, AND COLLABORATION DURING THE COVID-19 PANDEMIC Prioritizing the health, safety and well-being of employees Ensuring the continuity of operations and continuing to build for the future Contributing to the ght against COVID-19 Building on the learnings from the COVID-19 crisis

12:25 pm – 1:05 pm EST PRE-ARRANGED 1-2-1 BUSINESS MEETINGS AND NETWORKING

1:10 pm – 1:50 pm EST LUNCH & LEARN ROUNDTABLE DISCUSSIONS

Benet from additional learning by joining a moderated roundtable discussion on pressing issues in the industry. Registration is required, and attendance is limited. Choose from:

NATHAN TEMPLE ANDY ALASSO MIKE MOLLOY C&Q Global Business Area Lead SVP, Product Management Technical Director CAI Aizon Boston Analytical

RAPID RESPONSE MANUFACTURING INDUSTRIALIZING ARTIFICIAL INTELLIGENCE HOW TO ENGAGE THE EXPERTISE AVAILABLE IN BIOPHARMA MANUFACTURING FOR AT A DEDICATED ANALYTICAL LAB AND STAY PREDICTIVE OPERATIONAL INSIGHTS AND NIMBLE MICHAEL DELLORTO BUSINESS VALUE REALIZATION VP, Business Development DOMINIC MANCINI MNX Global Logistics Senior Manager, Data Systems and JULIEN DEPOLLIER Analytics Director, Strategic Partnerships bluebird bio CELLULAR THERAPY SHIPPING BEST Polyplus-transfection PRACTICES & SUCCESS STORIES AN AI-ASSISTED APPROACH TO DIGITIZE HOW TO IMPROVE VIRAL TITERS BY PAPER BATCH RECORDS AND IMPROVE ERIC FULMER OPTIMIZING YOUR UPSTREAM PROCESS? OPERATIONAL OVERSIGHT VP, Quality and Compliance Bionova Scientic

ESTABLISHING A STATE-OF-THE-ART CELL CULTURE FACILITY: CONSIDERATIONS IN DESIGN, IMPLEMENTATION, VALIDATION/QUALIFICATION, OPERATIONS, COMPLIANCE

Generis • American Biomanufacturing Summit • Page 6

1:55 pm – 2:30 pm EST WORKSHOPS

MANUFACTURING AND TECHNOLOGY QUALITY AND COMPLIANCE SUPPLY CHAIN AND LOGISTICS

CHRIS PROCYSHYN CHRISTOPHER MURPHY SANDRA ANDERSON General Manager VP & GM, Viral Vector Services SVP, Commercialization and Strategy Vanrx, a Cytiva Company Thermo Fisher Scientic Innomar Strategies

YES, WE CAN DO THINGS QUICKLY IN DRUG BUILDING VIRAL VECTOR CAPACITY AND DECISIONS MANUFACTURERS SHOULD PRODUCT. HERE IS HOW YOU CAN MAKE IT CAPABILITIES TO REALIZE THE PROMISE OF CONSIDER WHEN LAUNCHING HAPPEN. GENE THERAPIES INTERNATIONALLY How the past year has proven that innovations in drug Current overview on Capacity Overview of the landscape and process for product technology can be implemented faster Innovation and Technology Updates commercializing pharmaceutical products Why maintaining the status quo now poses increased An in-depth view of our Capabilities Considerations for each stage of launching a specialty strategic and production risks People: our most valuable resource pharmaceutical or biologic: pre-development, How new production and facility technologies have development, pre-launch and launch helped manufacturing leaders bring drug products to Case study: Illustrating how companies can patients faster and with less risk successfully launch new therapies in Canada The importance of generating Real World Evidence, and an update on how Health Canada is engaging on evidence generation from a regulatory perspective Unique Canadian market dynamics, commercialization considerations and lessons learned Discussion of the supply chain and logistic models for consideration at launch Insights and considerations on commercial, regulatory, market access and payer opportunities

2:35 pm – 3:15 pm EST PRE-ARRANGED 1-2-1 BUSINESS MEETINGS AND NETWORKING

3:20 pm – 3:55 pm EST SESSIONS

MANUFACTURING AND TECHNOLOGY QUALITY AND COMPLIANCE SUPPLY CHAIN AND LOGISTICS

DEREK ADAMS, PH.D. CHARLES L. COONEY, PH.D. JEFF DAVIS Chief Technology and Manufacturing Professor, Chemical Engineering; Executive Director, Clinical Supply Center Ocer Director, Center for Technological and Digital Technologies bluebird bio Innovation Genentech, A Member of the Roche Group MIT - Massachusetts Institute of Technology

DEVELOPING MANUFACTURING PRACTICES REIMAGINING GLOBAL MANUFACTURING: AT A RAPID PACE FOR THE CREATION OF THE FUTURE FOR BIOMANUFACTURING: FOR NOW AND FOR THE FUTURE CELL AND GENE THERAPIES INTENSIFICATION, INTEGRATION AND INTERROGATION Creating a manufacturing network for the future of Exploring recent and signicant milestones in the CAR- personalized medicines T space and beyond Understanding how to best address patients needs How manufacturing standards can create resilience in Reviewing developments at bluebird bio to advance Managing quality, speed, cost and exibility global supply chains Fullling the business case these therapies through to commercialization Leveraging Industry 4.0 solutions to deliver innovative Examining the technical, clinical, and manufacturing medicines to patients challenges involved in live modality therapies Building an organizational culture of agility, resiliency, Exploring evolving FDA guidelines on live modality and sustainability therapies What new practices and tools should we retain after How can the industry contribute more to the future of the pandemic subsides? our regulatory environment? Oering real-world examples from Genentech's Finding ways to reduce costs and improve patient newest manufacturing facility access

4:00 pm – 5:00 pm EST EXPO HALL NETWORKING

Generis • American Biomanufacturing Summit • Page 7 PROGRAM · DAY 3 APRIL 29, 2021

9:45 am – 10:00 am EST LOG-IN AND WELCOME

10:00 am – 10:50 am EST EMPOWER HOUR

FANZIA MOHAMMED LISA WYMAN EVA MARTINS VP and Global Head, Quality Systems SVP, Technical Operations and Global Head, Innovation and Digital and Quality Management Quality Commercial Transformation Genentech Acceleron Pharma Inc. Novartis

ANNE MARIE DE JONGE HEIKE ROEDER SILKE MOHL SCHUERMANS, PH.D. VP, Lead Digital Transformation QMS VP and Head, Technical Development SVP, Global Technical Operations, Bayer AG Roche and Executive Committee Member Sobi Orphan Biovitrum AB

WOMEN IN LEADERSHIP ROUNDTABLE

We invite our attendees to network at the Women in Leadership Roundtable with discussion from inspirational leaders in manufacturing, quality and supply chain.

SPONSORED BY:

Danielle Geissler, Ph.D., Senior Principal

BREAKFAST BRIEFS

KENNY NG Regional Director, Americas Singapore Economic Development Board

SUPPLY CHAIN RESILIENCY THROUGH DIVERSIFICATION: LESSONS FROM COVID, AND HOW BIOPHARMACEUTICAL COMPANIES ARE INCREASING SUPPLY CHAIN RESILIENCY THROUGH SUPPLY CHAIN DIVERSIFICATION

10:50 am – 11:00 am EST CHAIR'S OPENING REMARKS

CHRIS MCDONALD SVP and Global Head, Manufacturing Kite Pharma

11:05 am – 11:40 am EST OPENING KEYNOTES

JOYDEEP GANGULY MICHELANGELO CANZONERI, PH.D. SVP, Operations Global Head, Digital and Data, Healthcare Gilead Sciences Merck KGaA, Darmstadt, Germany

POST-COVID CONSIDERATIONS: RE-IMAGINING THE WAY WE WORK BIOMANUFACTURING 4.0 - HOW TO GET THERE? How COVID-19 has aected the changing landscape of biomanufacturing What is the signicance of new technology innovation in Merck Group's operations? Leveraging technology and digital transformation to digitize aspects of your facility: AI Examining the global manufacturing and supply network for areas of opportunity and infused employee experiences, constraint-based automation, etc. current growth How Gilead is taking digital and unique persona-based approaches to reformulate the How to best onboard and train employees to tech-savvy operations way we work Discussing examples of technology that have improved manufacturing and supply Prioritizing digital transformations now to be ready for the next disruption teams

Generis • American Biomanufacturing Summit • Page 8

11:45 am – 12:25 pm EST PRE-ARRANGED 1-2-1 BUSINESS MEETINGS AND NETWORKING

12:30 pm – 1:05 pm EST SESSIONS

MANUFACTURING AND TECHNOLOGY QUALITY AND COMPLIANCE SUPPLY CHAIN AND LOGISTICS

ASHLEY GROVES CHRISTOPH PISTEK, PH.D. LISA WYMAN Principal Process Engineer, Cell Culture Head, Technology Sciences, R&D, SVP, Technical Operations and Quality Technical Transfer and Production Pharmaceutical Sciences Acceleron Pharma Inc. Support Takeda Sano

LEVERAGING RESILIENCE AND REINVENTION ACCELERATING PIPELINE PROGRESSION: LEVERAGING QBD PRINCIPLES WITH TO ADVANCE BIOPHARMACEUTICAL CHALLENGES AND OPPORTUNITIES OF PLATFORM DEFINITIONS FOR A MORE AGILE QUALITY BIOPROCESSING 4.0 IN PROCESS CLINICAL MANUFACTURING DEVELOPMENT What is the future of biopharmaceutical quality and Reduced time and resources to initiate GMP compliance and how do we get there? How can Bioprocessing 4.0 be a greater enabler of manufacturing Generating competitive advantage using the principles faster global access to therapies? Clarify expectations for sending and receiving units of resilience and learning agility Reviewing Industry 4.0 principles, methods and with established platform denitions Evolving current quality practices to be more ecient computational technologies can help to speed up the Increase condence in program success by leveraging and agile without compromising product quality or delivery of a modality-diverse pipeline QbD principles supply continuity Discussing emerging technologies that can be applied Create and maintain templates for increased plant and from early development on development consistency Achieving transformational, end-to-end innovation in Establish a continuous learning and improvement commercial manufacturing environment Onboarding new capabilities while mitigating risk to development pathways

1:10 pm – 1:50 pm EST LUNCH & LEARN ROUNDTABLE DISCUSSIONS

Benet from additional learning by joining a moderated roundtable discussion on pressing issues in the industry. Registration is required and attendance is limited. Choose from:

BRUNO MARQUES SUSANNE ROMMEL, PH.D., MBA GEOFFREY POT Senior Director and Head, Process and Executive Director, Development and Site Head and VP, Operations Product Development Commercial Quality Takeda Century Therapeutics Gilead Sciences

EXPLORING AVENUES TO ADAPT DISCUSSING THE BENEFITS OF SMALL STRATEGIES TO FOSTER AN AUTOLOGOUS SUPPLY CHAINS TO IMPLEMENTING DIGITALIZED INNOVATIVE QMS ACROSS THE PORTFOLIO ALLOGENEIC PRODUCTS BIOMANUFACTURING OPERATIONS

DIANE WILKINSON, PH.D. PAT HANCOCK RUBY CASARENO, PH.D. Senior Director, Regulatory CMC, Global Executive Director, Global Quality SVP, Technical Operations Regulatory Excellence Systems and Operations Allakos, Inc. AstraZeneca Genentech, A Member of the Roche Group

DEVELOPING VACCINES AND WORKING WITH LEVERAGING RESILIENCE AND REINVENTION HOW DO YOU BUILD YOUR QUALITY AGENCIES FOR GLOBAL APPROVAL TO ADVANCE BIOPHARMACEUTICAL CULTURE? QUALITY AMIDST COVID-19 PRESSURES

Generis • American Biomanufacturing Summit • Page 9

1:55 pm – 2:30 pm EST WORKSHOPS

MANUFACTURING AND TECHNOLOGY QUALITY AND COMPLIANCE SUPPLY CHAIN AND LOGISTICS

KEITH DODSON BUILDING GENE THERAPY SUPPLY CHAINS OF LARS SÖDING VP, Global Business Development THE FUTURE Principal, Production IT Software AST Körber Pharma Understanding the unique challenges in launching an FDA approved gene therapy QUALITY FIRST: REINVENTING YOUR ASEPTIC Discussing emerging technologies to support PROCESSING WITH FLEXIBLE ROBOTIC innovative and individualized product supply CLÉMENTINE TASSAUX MANUFACTURING strategies Associate Principal, Production IT What best practices can we borrow from current Körber Pharma Addressing and responding to the ll-nish challenges of your biologic product pharma supply chains? Exploring challenges for managing gene therapy Discussing the advantages of robotics in aseptic ll supply chain risks DRIVING DIGITAL TRANSFORMATION IN BOTH nish for complex biotech manufacturing processes PHARMA AND BIOTECH: ACCELERATE YOUR What options are there to ensure your aseptic DIGITAL JOURNEY processing and equipment manufacturing are placing quality at the forefront? Overviewing how the global pandemic has forced Highlighting the importance of maintaining quality many businesses around the globe to fast track their aseptic conditions throughout the production process digitization transformation initiatives Even though the future seems obscure, one thing is clear: digital advancement is unavoidable How organizations are undertaking activities focused on the key steps needed to ensure business continuity and resilience Why successful digital transformation initiatives bring exceptional values to organizations

2:35 pm – 3:15 pm EST PANEL DISCUSSION

MICHAEL MULLETTE ANISSA BOUMLIC PHILIP DORMITZER VP, North America Commercial Director, Bioprocessing Strategy VP and Chief Scientic Ocer, Viral Operations Operationalization Vaccines, Pzer Vaccines Research Moderna MilliporeSigma and Development Pzer, Inc.

MANOJ MENON TONY D'AMORE, PH.D. BOB DI SCIPIO Senior Director, Global Drug VP, Product Research and CEO Substance Manufacturing Network Development Skyland Analytics AstraZeneca Sano Pasteur

DEVELOPING VACCINES AT PANDEMIC SPEED Examining the need to rapidly develop vaccines What tools and technologies can support a new era in vaccine development? How the vaccine industry have been asked to respond urgently to epidemics Working in tandem with the regulatory agencies to accelerate the process Utilizing novel platforms and next-generation sequencing technologies Meeting the demand for vaccines around the world

3:20 pm – 3:25 pm EST CLOSING REMARKS & PRIZE ANNOUNCEMENTS

3:25 pm – 4:25 pm EST EXPO HALL NETWORKING