CMC Archives - Executive Platforms: Thought Leader Series

Innovative CMC Contributions: Advancing the Future of Patient Care, Society & Roche

December 2, 2024

Tongtong joined Genentech in 2018 as the head of Pharmaceutical Technical Development for US Biologics, and was named global head of Pharma Technical Development in April 2021. Prior to her role at Genentech, Tongtong held several scientific, managerial and strategic roles at Eli Lilly, with increasing responsibilities in the Bioproduct Research and Development organisation. Tongtong also worked at Corixa Corporation, a biotech company, where she gained valuable experiences both as a discovery scientist and as a CMC leader in support of therapeutic antibody and cancer vaccine platforms.

Tongtong received her B. Sc. in Molecular Biology from University of Science and Technology of China, a doctorate in Biology from Syracuse University, and completed her postdoctoral training in cell biology and yeast genetics at Cornell University.

LIFE SCIENCES, VIDEO, LIFE SCIENCES

Panel Discussion: Reflecting on the Past, Envisioning the Future: Shaping the New Landscape of Biomanufacturing

December 2, 2024

Assessing Changes in the CMC Ecosystem: Are We Overbuilding Capacity Again?
Uniting for Success: Strategies to Prevent Fragmentation and Foster Collaboration in Biomanufacturing
Pioneering New Ventures: Reasons to Establish a New Company Today and Anticipating Future Growth in the Business Ecosystem
Evaluating Production Platforms for Emerging Modalities: Which Platforms Will Best Serve the Future of Medicine?
Navigating the Future of Existing Platforms: Efficiently Addressing Market Needs for Established Therapies such as mAbs, ADCs, and mRNA-based Treatments

LIFE SCIENCES, VIDEO, LIFE SCIENCES

Advancing Cell Therapy Industrialization: Key Focus Areas

December 2, 2024

Thomas has been serving as the Senior Vice President of Cell Therapy Development and Operations at BMS since August 2023. Before joining BMS, he held multiple roles with Merck & Co, where he gained experience in basic research, early and late-stage process development, capital project management, site-based technical operations, commercialization, manufacturing science and technology, and supply chain. Before that, Thomas worked for startup, GlycoFi, founded at Dartmouth College, where he conducted post-doctoral research after receiving his PhD in Bioprocess Engineering from the University of Cape Town in South Africa.

LIFE SCIENCES, VIDEO, LIFE SCIENCES

Enhancing the Timely Introduction of Novel Therapies

December 2, 2024

John Pinion has over 30 years of global biotech leadership experience across multiple modalities, including gene therapy, and spanning multiple functions across CMC and translational sciences.

John joined Ultragenyx in July 2015 and provides leadership for Quality, Compliance and Translational Sciences to include Pharmacology, Toxicology, Research and Bioanalytical Development. As an executive leader, he contributes to corporate strategy and portfolio management.

Prior to joining Ultragenyx, Mr. Pinion held senior leadership roles at Roche and Genentech departing the organization as Senior Vice President, Global Head of Quality and Compliance. Prior to Genentech, Mr. Pinion spent 17 years in operational and global senior leadership roles at Baxter International.

In addition to his position at Ultragenyx, John is currently COO of Amlogenyx, a subsidiary of Ultragenyx and is a member of the Board of Directors of Aroa Biosurgery Ltd.

He holds a B.S. in Mechanical Engineering from West Virginia University.

LIFE SCIENCES, VIDEO, LIFE SCIENCES

Towards Industrialization of Cell Therapy

November 22, 2023

Dr. Jens Vogel is SVP & Global Head of Biotech, Bayer Pharmaceuticals Product Supply, leading biologics operations, development and strategy across five sites, including cell & gene therapy industrialization. Jens has more than 20 years of professional and leadership experience in biologics development, operations, program management and regulatory affairs.

LIFE SCIENCES, VIDEO, LIFE SCIENCES

Fireside Chat: Building the Future from a Distinguished Tenure in CMC

November 23, 2022

Introducing Prime Medicine and its vision for the future of medicine How are we thinking about the inclusion of novel types of automation into molecular medicine workflows? Examining how we view Talent in the emergent technology space, and how do we best deploy remote and hybrid work? Historically, pharmaceutical manufacturing leaders were predominantly men; however, many important CMC leadership positions are now held by women. Why is this the case, and how do we sustain this pattern? What are the most significant learnings from having achieved success in licensing autologous cell therapies? — Ann Lee Chief Technical Officer Prime Medicine…

LIFE SCIENCES, VIDEO, LIFE SCIENCES

Moderna: The Rise of mRNA Vaccines – CMC Operations During a Once-in-a-Lifetime Pandemic

November 23, 2022

Our journey from a “platform” to a “multi-product” company How we achieved the seemingly impossible What we learned along the way Where we are today and where the journey takes us next — Tara Jones SVP, North America Operations Moderna Tara is responsible for end-to-end operations for DNA, Drug Substance, and Drug Product for global clinical trial materials and commercial product for the North America region. Prior to joining Moderna she was at Amgen where she led drug substance operations at Amgen Puerto Rico and was responsible for both the mammalian and bacterial drug substance manufacturing operations for multiple commercial…

LIFE SCIENCES, VIDEO, LIFE SCIENCES

Towards Industrialization of Cell Therapy

November 23, 2022

Cell therapy, such as regenerative therapies based on iPSCs and adoptive cell therapies targeting cancer with CAR-T cells, CAR-NKs or TCRs hold enormous potential for the future of medicine, enabling for the first time curative approaches. However, the field is still in its infancy and CMC remains a critical bottleneck in bringing these therapies to patients on a global scale. This discussion will focus on the scientific, technical and cultural transformations required to drive towards true industrialization of cell therapies, including: The critical challenges in CMC for cell therapies today How more in-depth understanding of cells, their critical quality attributes…

LIFE SCIENCES, VIDEO, LIFE SCIENCES

“Applying Lessons Learned from Covid 19 for Future Pandemic Preparedness!”

February 28, 2023

Given the experiences of Covid 19 Pandemic Response, we are even more aware of the need to be ready for what lies ahead with emerging and existing infectious diseases. Covid 19 continues to be a problem with evolving variants, Flu season ahead is anticipated to be worst in years, and we’re learning about new or resurfacing infectious disease outbreaks around the world on a daily basis. Therefore, Pandemic Preparedness is more important now than ever. This presentation will share the key CMC lessons learned from the past two years that can be applied to Pandemic Preparedness – with focus on…

CMC

Innovative CMC Contributions: Advancing the Future of Patient Care, Society & Roche

Panel Discussion: Reflecting on the Past, Envisioning the Future: Shaping the New Landscape of Biomanufacturing

Advancing Cell Therapy Industrialization: Key Focus Areas

Enhancing the Timely Introduction of Novel Therapies

Towards Industrialization of Cell Therapy

Fireside Chat: Building the Future from a Distinguished Tenure in CMC

Moderna: The Rise of mRNA Vaccines – CMC Operations During a Once-in-a-Lifetime Pandemic

Towards Industrialization of Cell Therapy

“Applying Lessons Learned from Covid 19 for Future Pandemic Preparedness!”

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