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CMO

‘First in Human’ Continuous Manufacturing in Biopharmaceuticals — A Conversation with Magnus Schroeder of Just – Evotec Biologics
LIFE SCIENCES, VIDEO, LIFE SCIENCES, PODCAST

‘First in Human’ Continuous Manufacturing in Biopharmaceuticals — A Conversation with Magnus Schroeder of Just – Evotec Biologics

At the 2024 edition of the Biomanufacturing World Summit series we sat down with Magnus Schroeder, the VP, Process & Product Design for Just – Evotec Biologics, to talk about some of the advantages of continuous manufacturing in biopharmaceutical manufacturing, especially for companies whose products are approaching the First in Human (FIH) stage. It is never too early to think about process optimization, scalability, and controlling costs, but there is an understandable position where companies focused on the medicine and the science believe that can be sorted out later. Just – Evotec Biologics is a passionate advocate for taking lessons from other industries that build their businesses’ success into the R&D stage of their products’ development. So what does that look like in the Life Sciences? What role do CDMOs need to play to help the industry succeed at this, especially at the crucial FIH stage? For all this and more, give this episode a listen!

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Contract Manufacturing as an Enterprise Capability Multiplier When Strategically Managed
FOOD MANUFACTURING, VIDEO, MANUFACTURING

Contract Manufacturing as an Enterprise Capability Multiplier When Strategically Managed

Tanya Peterson is an accomplished executive with a proven track record in driving operational excellence and fostering strategic partnerships in the consumer goods industry. As the Vice President of External Manufacturing at Mondelez International, she plays a pivotal role in overseeing the company’s external manufacturing operations in North America. With over two decades of experience in supply chain management, Tanya has honed her expertise in optimizing manufacturing processes, ensuring product quality, and maximizing efficiency across diverse production networks. Her commitment to innovation and continuous improvement has led to significant cost savings and enhanced productivity within Mondelez’s external manufacturing ecosystem. Tanya is recognized for her strong leadership skills and ability to build collaborative relationships with external partners, suppliers, and internal stakeholders. Under her guidance, Mondelez has strengthened its global manufacturing capabilities, enabling the company to meet evolving consumer demands while maintaining the highest standards of quality and safety. Prior to joining Mondelez, Tanya held various leadership positions in supply chain management at Danone & Georgia Pacific, where she spearheaded initiatives to streamline operations and drive business growth. She holds a Bachelor’s degree in Mechanical Engineering & a Master’s Degree in Chemical Engineering from Canadian universities, along with an MBA from Portland State University. She continues to stay abreast of emerging trends and best practices in manufacturing and supply chain management. As Vice President of External Manufacturing at Mondelez, Tanya Peterson continues to leverage her expertise and vision to drive sustainable growth and innovation, further solidifying Mondelez’s position as a global leader in the consumer goods sector.

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Accelerate Your Bench to Production Timeline by Collocating Research with Process Development and Pilot Scale Production
LIFE SCIENCES, VIDEO, LIFE SCIENCES

Accelerate Your Bench to Production Timeline by Collocating Research with Process Development and Pilot Scale Production

Peter is a biopharmaceutical manufacturing expert with more than 20 years of experience in the industry. He comes to SmartLabs from Catalent Biologics where he managed business development efforts in the northeast region. Prior to that, he held various roles in Product Development and Product Management for GE Healthcare’s Biomanufacturing Solutions business incorporating both automated unit operations and single-use connectivity.

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The CDMO of the Future
LIFE SCIENCES, VIDEO, LIFE SCIENCES

The CDMO of the Future

JR Humbert is currently the VP, Quality at INCOG BioPharma Services, and created and implemented the quality system at INCOG, which in three years went from company creation through successful FDA inspection in 3 years.

JR has over 20 years of pharmaceutical and biotechnology industry experience in validation, quality, technology transfer, process engineering, and program management. Some of JR’s previous companies include Piramal Pharma Solutions, Roche/Genentech, Hospira, and Cook Pharmica.

JR has participated in multiple global health authority inspections and developed inspection responses. JR has an MBA from Indiana University, and a BA in Chemistry and Biochemistry from the University of Colorado-Boulder.

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The Future of Medicine Will Cost Less and Move Faster Than We Ever Imagined
LIFE SCIENCES, VIDEO, LIFE SCIENCES

The Future of Medicine Will Cost Less and Move Faster Than We Ever Imagined

Brian Taylor is the Head of Biopharma Solutions at SmartLabs. SmartLabs provides teams of all sizes enterprise-grade labs customized within weeks for any stage of research or modality and can be reconfigured within days as your research evolves. Outsource your infrastructure and avoid the extensive costs of traditional lab builds while your own teams accelerate your research in a private lab.

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Build vs Buy vs Blend: Comparing Challenges and Opportunities for Early-Phase Biopharmaceutical Manufacturing Options
LIFE SCIENCES, VIDEO, LIFE SCIENCES

Build vs Buy vs Blend: Comparing Challenges and Opportunities for Early-Phase Biopharmaceutical Manufacturing Options

Ravi Samavedam is a Biochemical Engineer with more than 20 years of experience in the pharmaceutical and biotechnology industries. Before he was appointed Chief Innovation Officer at Azzur Group, he was President and Chief Operating Officer of Azzur Cleanrooms on Demand™. In 2019, Ravi was the General Manager of Azzur Boston and has been with the company since 2012. Prior to Azzur, Ravi has been part of the technical operations and quality/validation departments at Baxter, Amgen, and Shire. Ravi is an expert in phase-appropriate cGMP implementation, process validation, supplier management, and technology transfer.

Chris Mansur serves as Azzur Group’s Executive Vice President of Corporate Development and specializes in providing innovative quality and compliant solutions to the life sciences industry. Throughout his career, Chris has specialized in the startup of new and renovated facilities, project management, commissioning and qualification, computer validation, quality management systems, and application of QRM principles. He is passionate about the use of phase appropriate GMPs to help companies solve problems that accelerate their product’s lifecycle or project timeline. Chris holds a Bachelor of Science degree in Mechanical Engineering from Worcester Polytechnic Institute.

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LIFE SCIENCES, VIDEO, LIFE SCIENCES

Technical Operations Strategies in an Uncertain Market

 State of the current market and impact on manufacturing cell and gene therapies Key factors to consider when scaling up a facility for advanced medicines Make vs. Buy and the advantages and challenges of both solutions given the current market Moderator: Adam Pfeiffer VP of Strategy Project Farma Adam Pfeiffer is the Vice President of Strategy at Project Farma. In his role, Adam drives overall business strategy, aligning with operations, marketing, and business development groups in growing the firm’s global life sciences partnerships.With 16+ years of life sciences consulting experience, Adam has supported countless drug manufacturers in bringing life-saving therapies…

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Realizing Gilead’s 2030 Ambition: Advancing a Diverse Portfolio with a Complex Manufacturing Network
LIFE SCIENCES, VIDEO, LIFE SCIENCES

Realizing Gilead’s 2030 Ambition: Advancing a Diverse Portfolio with a Complex Manufacturing Network

Gilead’s ambition is moving from a predominantly virology focused portfolio to a more diverse one with an emphasis on adding oncology and inflammation asset To accomplish this a wide net needed to be deployed to rapidly build a portfolio through external sourcing and internal innovation This has resulted in a diverse set of acquisitions, partnerships, opt-ins, and collaborations across program phases and modalities, resulting in a complex manufacturing network This talk will cover the strategies being deployed across the pillars of Process Development, Supply Chain, Quality, Regulatory, and External Manufacturing to realize Gilead’s 2030 ambition — Art Hewig VP of…

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Acceleration of Clinical Timelines Using Azzur Cleanrooms on Demand™, a Novel Approach to Biopharmaceutical Manufacturing
LIFE SCIENCES, VIDEO, LIFE SCIENCES

Acceleration of Clinical Timelines Using Azzur Cleanrooms on Demand™, a Novel Approach to Biopharmaceutical Manufacturing

Current industry challenges and opportunities related to biopharma manufacturing Internal manufacturing capability establishment challenges for biopharma Challenges related to outsourcing of technology and process throughout product lifecycle The Azzur Cleanrooms on Demand™ model Case Studies — Ravi Samavedam Chief Innovation Officer Azzur Group Ravi Samavedam is a Biochemical Engineer with more than 20 years of experience in the pharmaceutical and biotechnology industries. Ravi joined Azzur in 2012, and prior to his appointment as CINO of Azzur Group, Ravi was the President and COO of Azzur Cleanrooms on Demand™ and previously served as  General Manager of the Boston-area consulting practice.  Prior…

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