Category

LIFE SCIENCES

Building Flexible, Scalable and Sustainable Cell Therapy Manufacturing Network to Serve Patients
LIFE SCIENCES, LIFE SCIENCES, VIDEO

Building Flexible, Scalable and Sustainable Cell Therapy Manufacturing Network to Serve Patients

Rob Zamboldi is the Site Head and General Manager of Novartis’ flagship cell processing operation in Morris Plains, NJ providing worldwide supply of novel CAR-T therapies. Rob was instrumental in the ramp up of the first to market CAR-T, Kymriah ® of which more than 7,000 treatments have been supplied from his facility.

Continue reading
Strengthening our Industry: Intersection of Innovation, Customer Experience, and Proactive Resilience
LIFE SCIENCES, VIDEO

Strengthening our Industry: Intersection of Innovation, Customer Experience, and Proactive Resilience

Federico Feldstein is Vice President, Head of Janssen Supply Chain Quality at Johnson & Johnson. In this capacity, Federico is responsible for providing strategic direction and oversight for all areas of Quality for both Large and Small Molecule products as well as Advanced Therapies, such as CAR-T. In his role, Federico is focused on product launches and reliability and the overall compliance profile of our internal manufacturing sites, as well as our external partners.

Continue reading
Unlocking the Power of Gene Therapy to Accelerate Healthcare Transformation
LIFE SCIENCES, LIFE SCIENCES, VIDEO

Unlocking the Power of Gene Therapy to Accelerate Healthcare Transformation

As Spark Therapeutics’ Chief Patient Supply Officer, Chris Stevens leads a team of dedicated professionals working together in manufacturing and technical operations, supply chain, quality and compliance to deliver transformational therapies for patients globally. Chris is also responsible for capital investments, engineering, EHS, real estate and facilities management across the enterprise.

Continue reading
Expanding Scalability Potential of T-Cell Therapies with Allogeneic Approaches
LIFE SCIENCES, LIFE SCIENCES, VIDEO

Expanding Scalability Potential of T-Cell Therapies with Allogeneic Approaches

Amy has been at Atara Biotherapeutics for 5 years. She is currently the Vice President of Manufacturing, which includes External Manufacturing, Material Sciences, and Manufacturing Science and Technology functions. Prior to her current role, she led the joint team that transitioned the commercialization of the first approved allogeneic T-cell therapy to Atara’s strategic partner, Pierre Fabre.

Continue reading
Global Talent Trends in Pharma and Biotech Technical Operations
LIFE SCIENCES, LIFE SCIENCES, VIDEO

Global Talent Trends in Pharma and Biotech Technical Operations

Pascal leads operations for Russell Reynolds Associates in New York and Canada. He works closely with top healthcare clients around the globe, advising them on their talent strategy, including leadership assessment, succession planning, and the recruitment of directors, CEOs, and other senior executives. Within the healthcare industry, Pascal specializes in biotech and pharma technical operations, including process development, manufacturing, quality, engineering, and supply chain leadership.

Shannon Knott is a member of Russell Reynold’s Leadership and Succession Practice, and is based in Durham, NC. She specializes in executive transition and development, partnering with clients to build more effective and aligned leadership teams. Shannon leverages more than two decades of experience in executive education program development and strategy to provide market-leading insights. Shannon has a passion for leadership development and individual growth, and supports clients in creating future-focused, comprehensive succession processes.

Continue reading
Empowering Innovation: Enhancing CDMO Capabilities for Collaborative Success
LIFE SCIENCES, LIFE SCIENCES, VIDEO

Empowering Innovation: Enhancing CDMO Capabilities for Collaborative Success

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.

Continue reading
Small But Mighty: How Digital Technology Can Support Small Batch Manufacturing of mRNA Therapeutics
LIFE SCIENCES, LIFE SCIENCES, VIDEO

Small But Mighty: How Digital Technology Can Support Small Batch Manufacturing of mRNA Therapeutics

Katarina works for Cytiva in the Manufacturing capacity solutions business unit. She has worked over 20 years in the industry and has extensive expertise in developing end-to-end manufacturing solutions that includes process workflows, process equipment, automation, consumables, and facilities. Her focus over the last few years has been developing and designing solutions for the manufacture of new product modalities such as viral vectors, plasmids, and mRNA therapies.

Continue reading
Enabling Acceleration & Risk Mitigation in ATMP Development & Beyond
LIFE SCIENCES, LIFE SCIENCES, VIDEO

Enabling Acceleration & Risk Mitigation in ATMP Development & Beyond

In her role as President, Azzur Labs & Azzur Cleanrooms on Demand™ (COD), Sarah Stevens is responsible for operations and strategy across all Azzur Labs and Azzur COD locations throughout the United States. Prior to joining Azzur, Sarah held senior leadership roles within the CDMO and pharmaceutical service provider space. Sarah holds a Doctorate of Pharmaceutics from the University of Manchester (Manchester, UK), as well as a Master of Business Administration and a Master of Pharmacy from the University of Strathclyde (Glasgow, UK).

Continue reading
Deliver Products to Patients Faster with a Purpose-Built, No-Code EBR and MES
LIFE SCIENCES, LIFE SCIENCES, VIDEO

Deliver Products to Patients Faster with a Purpose-Built, No-Code EBR and MES

Brian Curran oversees the success of MasterControl’s Manufacturing Excellence (Mx) solution in the quest to digitize the 80% of life sciences manufacturing, large and small, that still use paper for their batch records or device history records. Curran has the privilege of working externally with Mx customers and internally across MasterControl from R&D to sales, services, and support to ensure Mx success and adoption.

Continue reading
The Integrated Development and Manufacturing Organization: The Future of Cell Therapy Manufacturing
LIFE SCIENCES, LIFE SCIENCES, VIDEO

The Integrated Development and Manufacturing Organization: The Future of Cell Therapy Manufacturing

John Tomtishen is Vice President of Operations at Cellares Corporation. At Cellares, John is responsible for Cellares’ IDMO business, supporting partnership activities, and facilitating accelerated market adoption of Cellares’ Cell Shuttle technology to transform the cell therapy manufacturing paradigm and address industry bottlenecks to accelerate access to life saving cell therapies. John has extensive experience in cell and gene therapies, biologics, and vaccines with diverse roles in Business Operations, CMC/Technical Operations, R&D, Supply Chain, Engineering/Facilities, and Operational Excellence. While at Novartis Pharmaceuticals, John had an integral role in the filing and approval of the first CAR T-cell BLA, Kymriah™ (tisagenlecleucel) for pALL (pediatric acute lymphoblastic leukemia) and DLBCL (diffuse large B-cell lymphoma).

Continue reading
Unleashing the Potential: Leading the Future of Biologics Market Supply
LIFE SCIENCES, LIFE SCIENCES, VIDEO

Unleashing the Potential: Leading the Future of Biologics Market Supply

Dave Stewart, Senior Vice President Operational and Process Technology, Large-Scale Business Unit, is a proven leader in the biologics manufacturing industry, with a focus on building diverse, multi-disciplinary teams that drive customer deliverables. He brings a servant-leadership mindset and more than two decades of biotech leadership experience to cultivate accountability, collaboration and agility – assembling engaged, high-performing teams and partnerships built on trust. Dave is responsible for ensuring a consistent operations and equipment model, performance and incorporating emerging capabilities across the large-scale network at FUJIFILM Diosynth Biotechnologies (FDB) and is a key driver in building the world’s largest and most tightly connected CDMO network.

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

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.

Continue reading