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Sanofi

Panel: Reflecting on the Past and Shaping the Future: Enhancing Our Influence on Medicine
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Panel: Reflecting on the Past and Shaping the Future: Enhancing Our Influence on Medicine

Evaluating which production platforms will be most effective for emerging modalities, such as rAAV gene therapies
Considering the next steps for established platforms like mAbs, ADCs, and mRNA: How can we efficiently address significant markets, such as treatments for Alzheimer’s
Examining the changes within the CMC ecosystem and assessing whether we are once again overextending our capacity
Addressing the risks of fragmentation: How can we improve communication, collaboration, and the consolidation of our best ideas to ensure collective success?
Discussing the motivations for launching new companies today and envisioning the future growth and evolution of our business ecosystem

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Are We There Yet? – A Maturity Model for Enabling Process Monitoring and Learning in Biologics Manufacturing

Dr. Jack Prior leads MSAT Process Monitoring & Data Science/AI Strategy at Sanofi, where he spearheads global initiatives in process monitoring and AI-driven yield improvement for biologics manufacturing. Previously as Head of MSAT Digital, he led teams working to develop global process data analytics systems and to digitize laboratory operations for Industrial Affairs Specialty Care drug substance and drug product manufacturing.

His leadership spans nearly three decades at Sanofi-Genzyme, where he has led manufacturing science organizations supporting process characterization, modeling, technology transfer, and manufacturing operations for critical therapies treating rare genetic disorders. Throughout his career, he has focused on integrating process modeling and advanced analytics with manufacturing science to enhance biologics production across US and European operations. He has led manufacturing science teams supporting multiple tech transfers across the Sanofi network, including the team supporting transfer to a new continuous single-use digital facility, while advancing approaches to process modeling and scale-up.

Dr. Prior holds a Doctor of Science in Chemical Engineering from MIT, where his research in data reconciliation for bioprocess development laid the foundation for his work in process monitoring and control. His current work continues to advance manufacturing science through the integration of digital technologies, process modeling, and AI in biologics manufacturing.

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Sanofi Manufacturing Modernization – The Best in Class Ambition
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Sanofi Manufacturing Modernization – The Best in Class Ambition

Koustuv Chatterjee is the Senior Vice President of External Manufacturing & Supply, in the Manufacturing & Supply division of Sanofi. Prior to joining Sanofi in 2023, Koustuv has held several leadership positions in Merck & Co, Teva Biopharmaceuticals USA, and Amgen Inc. Koustuv’s career started in process development and has spanned across manufacturing operations, network strategy, product and device development, Manufacturing Science & Technology, internal and external manufacturing operations. Koustuv obtained his Bachelor’s degree in Pharmaceutical Technology from Jadavpur University, Kolkata, India, Masters. in Industrial Pharmacy from University of Toledo Ohio, and Ph.D. in Pharmaceutics from University of Minnesota.

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Sanofi Manufacturing Transformation: Turning Science into Reality for Patients
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Sanofi Manufacturing Transformation: Turning Science into Reality for Patients

As the Senior Vice President for Specialty Care Manufacturing & Supply at Sanofi in Paris, Daniela Ottini oversees the global Manufacturing Network for Specialty Care products. With extensive experience spanning over a decade at AbbVie, she has held leadership positions such as Vice President of External and Contract Manufacturing in Rome, Italy, and Vice President of Biologics Manufacturing in Dublin, Ireland. Her career highlights include managing diverse portfolios and leading strategic initiatives like the integration of AbbVie-Allergan for Operations. Previously, at Abbott, Daniela held various roles over 16 years, including Manufacturing Director in Italy and Regional Purchasing Manager in the UK. She holds a degree in Chemical Engineering from Sapienza Università di Roma and a Master’s in Business Engineering from the University of Rome Tor Vergata.

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Daniela Ottini of Sanofi — How AI is Helping the Pharmaceutical Industry Reinvent Itself and Build Smart Factories
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Daniela Ottini of Sanofi — How AI is Helping the Pharmaceutical Industry Reinvent Itself and Build Smart Factories

At the 2024 edition of the Pharma Manufacturing World Summit we spoke with Daniela Ottini, Sanofi’s SVP, Manufacturing and Supply Head of Specialty Care, as a follow-up to a keynote presentation she gave the day before showcasing Sanofi’s ongoing transformation that is turning science into reality for patients. We explore how one of the giants of pharmaceutical manufacturing is embracing Artificial Intelligence with real-world examples, what kind of mindset is required from senior leadership to guide an organization through such a transformation, and what the new general of smart factories coming online promise for patients and the future of medicine. It is an exciting and inspiring conversation about the aspirational becoming reality. Give it a listen!

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The Quality Equation
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The Quality Equation

Do you want to ensure that you never have a surprise regulatory inspection outcome? The equation incorporates all you need to assess the status of your site and is even better for companies with networks of sites Data integrity, quality culture, process capability, management commitment and Quality Management Systems are all assessed to produce actionable data whether you are overseeing a CMO or operate your own network of sites — Brandon Varnau Head, Industrial Affairs Specialty Care Global Business Unit Quality Operations Sanofi Brandon Varnau is Head of Industrial Affairs Specialty Care Global Business Unit Quality Operations for Sanofi. He…

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Sanofi Manufacturing Transformation: Turning Science into Reality for Patients
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Sanofi Manufacturing Transformation: Turning Science into Reality for Patients

Our new purpose: we chase the miracles of science to improve people’s lives Our race to make available breakthrough treatments & vaccines for patients supported by diverse modalities: accelerate product launches and optimize our asset performance Our ambition to develop a network of Factories of the Future Our response to COVID: Operating with a global Supply Chain in a changing environment impacted by COVID and leveraging our assets to fight against the pandemic — Brendan O’Callaghan EVP, Global Industrial Affairs Sanofi Brendan O’Callaghan leads an international network of manufacturing and distribution sites. His ambition is to enable successful commercialization of…

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