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Merck

Navigating the Modalities Landscape: Adapting Manufacturing Strategies for Future Therapeutic Advances
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Navigating the Modalities Landscape: Adapting Manufacturing Strategies for Future Therapeutic Advances

Sanat Chattopadhyay is responsible for the company’s (approx. $64 billion revenue) worldwide manufacturing and supply operations across a global network of sites for pharmaceuticals, vaccines, biologics and animal health products. Merck is known as MSD outside of the U.S. and Canada.

Sanat joined Merck in 2009 as Senior Vice President of Global Vaccines & Sterile Manufacturing Operations, spearheading the transformation of manufacturing and supply chain to grow and globalize its Vaccine business. Under Sanat’s leadership, Merck is currently executing a significant expansion of its biologics and vaccines manufacturing capacity with planned capital investments of more than $20 billion from 2020 through the end of 2024, to reach more patients around the globe.

Before joining Merck, he served as Senior Vice President, Technical Operations & Product Supply, for Wyeth Pharmaceuticals. Previously, he worked at Aventis and its predecessor companies as Senior Vice President, Industrial Operations, having served in many positions with increasing responsibilities for global supply chain, technology and manufacturing sites across North America, Europe and Asia Pacific. Sanat started his career with Hoechst Pharmaceuticals in 1983 and worked in many senior leadership assignments.

Sanat is a graduate in Chemical Engineering and holds a post-graduate degree in Industrial Engineering from India.

Outside of Merck, Sanat is a member of the Board of Directors of Ashland Inc.

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Integrating Customer Centricity and Innovative Technology into a Forward-Looking Manufacturing & Compliance Strategy
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Integrating Customer Centricity and Innovative Technology into a Forward-Looking Manufacturing & Compliance Strategy

Anil Sawant is Senior Vice President, Global Quality Compliance at Merck. He is a healthcare Executive with over 35 years of operations experience in Quality Operations, Ethics & Compliance, Research Integrity and Auditing functions. A strategic thinker experienced in development and deployment of management controls, governance processes, and quality and compliance systems in diverse business environments and cultures. Anil leads groups managing branded and generic products, small molecules, vaccines, bio-pharmaceutical, medical devices and consumer products. He was part of the teams that commercialized the first antibody-drug conjugate product and first photoactive drug. Expertise in interpretation of GMPs, GLPs, and GCPs. Good understanding of SOX, Anti-Kickback, Anti-Trust, Privacy and FCPA. Skilled crisis manager and pragmatic thinker with excellent understanding of regulatory requirements, global pharmaceutical supply chain and R&D operations. Extensive experience in resolving compliance matters with US FDA and international regulatory agencies. Subject matter expert in pharmaceutical microbiology and aseptic processing.

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A Look into the Future: How Pharmaceutical Manufacturing Is Transforming to Bring Hope to Patients
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A Look into the Future: How Pharmaceutical Manufacturing Is Transforming to Bring Hope to Patients

Jennifer Baxter has over 20 years of experience in pharmaceutical development and manufacturing activities. During her tenure at Merck, Jennifer has worked in research & development, technical support, and strategic planning of small molecules in roles across the human health, animal health, research and manufacturing divisions. Jennifer is currently the Vice President of Small Molecule Science and Technology, leading a group of approx. 800 scientists and engineers located worldwide. The group is responsible for the late-stage development of Merck’s small molecule pipeline across drug substance, drug product and packaging for both worldwide and regional products as well as all technical support for in-line small molecule products and lifecycle management activities. The group also manages manufacture and supply of late-stage clinical materials, technology development of new and innovative manufacturing technologies and provides site based technical support to all of Merck’s small molecule sites. Jennifer holds BS, MS and PhD degrees in Chemical Engineering from Rutgers University.

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Fireside Chat: Integrating Customer Centricity and Innovative Technology into a Forward-Looking Manufacturing Strategy
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Fireside Chat: Integrating Customer Centricity and Innovative Technology into a Forward-Looking Manufacturing Strategy

How are biology and patient needs influencing risk-based investment and networking structure in the manufacturing space? Discussing route and location of administration, including MDCP considerations, components and suppliers, design standards including image selection, and packaging network design Exploring flexible facilities, integrated clinical launches, and capital risk avoidance in the quest to get fast to clinical and fast to respond Understanding the need for early investment in platform changes. How is the emergence of ADCs, modality blurring, and market considerations changing the way we traditionally work? Talking about access issues including regionalization and localization, IP considerations, and how higher order BSL…

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Big Future for Small Molecules: How Merck is Reshaping the Manufacture of Small Molecules Within a Broader Manufacturing Transformation

Outline how small molecule manufacturing is being reshaped within the broader transformation of a world-leading biopharmaceutical and vaccine manufacturer Discuss how today’s pipeline and technologies are reshaping this future and how to remain agile for future changes Review case studies and strategies for rapid manufacturing commercialization Focus on the criticality of investing in people and how culture has to evolve as an enabler of transformation — Ger Carmody SVP, Global Pharmaceutical Operations Merck Ger Carmody is responsible for global pharmaceutical and packaging operations comprising approximately 4000 colleagues and internal 9 manufacturing sites.  His organization supplies drug substance and drug product…

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The World of Tomorrow: Serving Patients Through Transformational Change
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The World of Tomorrow: Serving Patients Through Transformational Change

How learnings from the global pandemic combined with the introduction of new technology will enable the patient-centric manufacturing of the future Highlighting what the industry should do differently to achieve an ambitious future where all patients can receive lifesaving medicines safely, swiftly, reliably and affordably Exploring how and where products will be made, and how those products will be delivered by adopting system-driven planning and automation capabilities, leveraging the power of data and advanced analytics Describing a patient-centric pipeline the industry needs in order to deliver transformative therapies for all humanity A glimpse of how the world will evolve as…

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Chair’s Welcome Address and PMWS21 Opening Keynote – A Look into the Future: How Pharmaceutical Manufacturing Is Transforming to Bring Hope to Patients
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Chair’s Welcome Address and PMWS21 Opening Keynote – A Look into the Future: How Pharmaceutical Manufacturing Is Transforming to Bring Hope to Patients

Highlighting what should the industry do differently to achieve an ambitious future where all patients can receive lifesaving medicines safely, swiftly, reliably and affordably Exploring how and where products will be made, and how those products will be delivered by adopting system-driven planning and automation capabilities, leveraging the power of data and advanced analytics Describing a patient-centric pipeline the industry needs in order to deliver transformative therapies for all humanity A glimpse of how the world will evolve as molecular complexity increases in the future for small molecules, blurring the boundaries between small and large molecules — Sanat Chattopadhyay EVP…

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Panel: The Past, Present and Future of the Global Bio-Pharma Supply Chain
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Panel: The Past, Present and Future of the Global Bio-Pharma Supply Chain

How our “new normal” is affecting our critical materials procurement and how do we adapt for the future? Examining how the proposed nationalization of our supply chains will affect risk management and operations planning What does post-COVID19 Supply Chain robustness look like? How do novel modalities (mRNA, Cell & Gene Therapy) with already existing supply chain challenges cope with these new global constraints? How will high volume ultra cold chain products affect existing specialized ultra cold chain logistics? Seismic shifts and emerging fault lines create lasting affects, what are they and how do they shape our industry in the years…

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The Centenarian and the Start Up: How Merck is Realizing its Biomanufacturing Revolution
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The Centenarian and the Start Up: How Merck is Realizing its Biomanufacturing Revolution

Discuss how today’s pipeline and technologies are reshaping our biomanufacturing Review case studies and strategies for rapid manufacturing scale up for leading products Focus on the criticality of investing in people and robust strategies to support the workforce and culture Show opportunities that allow for successful navigation in the future of manufacturing, including leveraging legacy and culture as drivers of change — Karin Shanahan SVP, Global Biologics & Sterile Operations Merck Karin is SVP, Global Biologics and Sterile Operations at Merck Pharmaceutical where she holds operational responsibility for manufacturing Keytruda and Gardasil in addition to other in-line and pipeline products….

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Leading and Leadership in Lean Bio-Manufacturing Operations
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Leading and Leadership in Lean Bio-Manufacturing Operations

Lean applications in Bio-Manufacturing is both complex and simple Sustaining lean performances in Bio-Manufacturing is both science and art Good versus Great Lean leadership… It matters Successful OE polynomial equation for Lean Bio-Manufacturing = … ? — Jacks Lee is an industry executive with global experiences in biopharmaceutical, small molecule drugs and vaccines. His 25+ years of experiences spans across technical, operational and strategic leadership roles in Science-Technology, Engineering, Quality, Supply Chain and Manufacturing. He currently serves as the Senior Vice President of Merck Manufacturing Division-Global Vaccines Operations. Jacks joined Merck in 2007 as head of Global Technology & Engineering….

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