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CDMO

How Medical Device Companies and CDMOs are Partnering Together to Drive Innovation and Serve Patients Better
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How Medical Device Companies and CDMOs are Partnering Together to Drive Innovation and Serve Patients Better

January 23, 2025

In the run-up to the 2025 edition of the Medical Device Manufacturing Excellence Summit series we spoke with Shawn McCarthy, Jessica Swanson, and Peggy Hansen of Regenity Biosciences about exciting developments in the Medical Device space, with a particular emphasis on both the power of collaboration and the importance of a regulatory strategy. Regenity is an industry-leading CDMO working with 120 different industry partners and offering special expertise in regenerative devices. In this wide-ranging conversation we talk about industry trends, how medical device manufacturers are evolving to continue to meet the needs of patients, and also about some of the big ideas Regenity wants to share with the executives attending MDMES25. For all this and more, give this episode a listen!

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KojoX™ – Transforming the CDMO Industry with a Patient-Centric Approach Fueled by Innovation
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KojoX™ – Transforming the CDMO Industry with a Patient-Centric Approach Fueled by Innovation

December 2, 2024

John Stewart, Vice President KojoX Strategy, serves as part of the Global Strategic Business Services group at FUJIFILM Diosynth Biotechnologies. His responsibilities include the execution of the Company’s novel KojoXTM Strategy. John is an executive with 30 years tenure in the pharmaceuticals industry with a background in international multi-site leadership of both small molecule and biologics manufacture and supply networks and with responsibility for internal and external manufacturing of clinical and commercial stage biologics.

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

December 10, 2024

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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How CDMOs are Contributing to the Ongoing Future of Medicine — A Conversation with Nick Maragos of Northway Biotech
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How CDMOs are Contributing to the Ongoing Future of Medicine — A Conversation with Nick Maragos of Northway Biotech

December 11, 2024

At the 2024 edition of the Biomanufacturing World Summit series we sat down with Nick Maragos of Northway Biotech to talk about how biopharmaceutical manufacturers are increasingly partnering with CDMOs to advance the future of medicine, how that working relationship is evolving over time, and what CDMOs need to do to continue to grow and meet the needs of the industry. With special reference to Northway Biotech’s own example, Nick talks about how companies can ensure they are compatible, what the working relationship needs to be, and what factors need to be included in any informed decision-making before and during a partnership. Give this episode a listen!

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

May 21, 2024

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
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The CDMO of the Future

May 21, 2024

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 Role CDMOs Play in the Future of Medicine — A Conversation with JR Humbert of INCOG BioPharma Services
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The Role CDMOs Play in the Future of Medicine — A Conversation with JR Humbert of INCOG BioPharma Services

May 30, 2024

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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Empowering Innovation: Enhancing CDMO Capabilities for Collaborative Success
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Empowering Innovation: Enhancing CDMO Capabilities for Collaborative Success

November 22, 2023

Kevin Sharp is the Senior Vice President and Head of Samsung Biologics America Sales. He joined the company in 2017 and has served as the Head of Global Sales and Head of Alliance Management at Samsung Biologics. Kevin has held various commercial and business development positions in pharmaceutical companies in the U.S. throughout his career. Kevin was the Director of Business Development at Contract Pharmacal Corp and served over 9 years at GSK in multiple business development and procurement roles supporting their vaccines, pharmaceutical and consumer healthcare businesses. Kevin has completed the Executive Development Program at the Northwestern University Kellogg School of Management to enhance his business and leadership capabilities.

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

November 27, 2023

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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Fireside Chat: The Emerging Role of the CDMO in Commercialization of Advanced Therapeutics
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Fireside Chat: The Emerging Role of the CDMO in Commercialization of Advanced Therapeutics

May 26, 2023

Spencer has more than 30 years of experience in Manufacturing and CMC product development. While at Rubius, Spencer built the technical functions to design and deliver the RED™M manufacturing platform, including clearance of 4 IND’s over 4 years.

He also led the acquisition and re-fit of their Red Cell Therapeutics manufacturing site in Smithfield Rhode Island, where the team transferred and delivered clinical supplies for their 3 oncology programs. Prior to joining Rubius, Spencer served as VP & Global Head of Cell & Gene Technical Development and Manufacturing at Novartis where he led the CMC development and manufacturing organization to deliver the CAR-T portfolio. Under his leadership, the team successfully registered and launched the first CAR-T cellular therapy product, Kymriah, which has demonstrated transformative efficacy in patients with acute lymphoblastic leukemia. While at Novartis, Spencer also led technical development teams across the Novartis Biologics portfolio in support of the commercialization of Cosentyx® and the registration and approval of Erelzi™M? and Rixathon®.

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Technical Operations Strategies in an Uncertain Market

November 30, 2022

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

March 15, 2023

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

January 19, 2023

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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