Tag

biopharma

Manufacturing Strategies for Sustainable Global Growth: Building a Global Sustainable Supply Operation for the Future Leveraging Digital and Innovation
LIFE SCIENCES, LIFE SCIENCES, VIDEO

Manufacturing Strategies for Sustainable Global Growth: Building a Global Sustainable Supply Operation for the Future Leveraging Digital and Innovation

— Per AlfredssonSVP, Global Biologics Operations AstraZeneca and President AstraZeneca ABAstraZeneca As Senior Vice President, Global Biologics Operations, Per leads the global biologics operations network, which includes five internal manufacturing sites across four countries, as well as the external biologics supply network. Since April 2020, Per has also served as co-lead for the COVID-19 vaccine program, AZD1222, during which he has led the rapid establishment and start-up of a complex manufacturing network of more than 20 partners across more than 15 countries. Throughout his 24 years within AstraZeneca, Per has significant global experience across all aspects of manufacturing and supply…

Continue reading
Industrialization Challenges for ATMPs: Achilles’ Heel AND Opportunity
LIFE SCIENCES, LIFE SCIENCES, VIDEO

Industrialization Challenges for ATMPs: Achilles’ Heel AND Opportunity

— Ralf AltenburgerGlobal Head, Cell and Gene Therapy, Genentech/RocheRoche Ralf Altenburger joined the Technical Operations Leadership Team at Roche/Genentech in July 2015 as Head of Pharma Technical Regulatory. Additionally, in Oct. 2021 he assumed the role of Global Head Cell and Gene Therapy. Ralf has more than 20 years of experience in the pharmaceutical industry and joined Roche in 2009 leading global functions in Technical Development. Prior to joining Roche, Ralf held roles of increasing responsibility in technical R&D at Merck KGaA and Novartis. He has a PhD in pharmaceutical technology from the Philipp University Marburg, Germany.

Continue reading
Accelerating the Pace of Progress for Innovative Biologic Products
LIFE SCIENCES, LIFE SCIENCES, VIDEO

Accelerating the Pace of Progress for Innovative Biologic Products

— Peter MarksDirector – Center for Biologics Evaluation and Research (CBER)FDA Peter Marks received his graduate degree in cell and molecular biology and his medical degree at New York University and completed Internal Medicine residency and Hematology/Medical Oncology training at Brigham and Women’s Hospital in Boston. He has worked in academic settings teaching and caring for patients and in industry on drug development. He joined the FDA in 2012 as Deputy Center Director for CBER and became Center Director in January 2016.

Continue reading
Our Journey in Next Generation Manufacturing: What We Can Achieve Together
LIFE SCIENCES, LIFE SCIENCES, VIDEO

Our Journey in Next Generation Manufacturing: What We Can Achieve Together

— Roberto SilveiraGlobal Technology & EngineeringPfizer As Senior Vice President of Global Technology & Engineering group in Pfizer Global Supply, Roberto leads a group of highly capable Subject Matter Experts and is responsible for capital projects, implementation Integrated Facility Management and Global Reliability programs, technical support for major investigations, Phase III clinical supply sites, technology transfers, implementation of process development and disruptive technology supporting over 35 Pfizer sites and 200 Contract Manufactures globally. Roberto Silveira joined Pfizer in 1989 in Brazil and from 1989 to 1994 he held production positions of increasing responsibilities. In 1995, he was transfer to Pfizer…

Continue reading
Welcome Day Panel: Planning for Biomanufacturing of the Future: What are the Five Big Things We Need to Talk About?
LIFE SCIENCES, LIFE SCIENCES, VIDEO

Welcome Day Panel: Planning for Biomanufacturing of the Future: What are the Five Big Things We Need to Talk About?

— Moderator: Alison MooreCMC Executive Dr. Alison Moore is a CMC Executive who most recently served as the Chief Technical Officer at Allogene Therapeutics. Prior to this role, Moore served as Senior Vice President, Process Development, in Amgen Operations. Moore was previously vice president, Process and Product Engineering (P&PE), where she was responsible for Process Development, Clinical Operations and Global Operations Planning. Moore served as vice president, Corporate Manufacturing, overseeing Supply Chain, Contract Manufacturing, Global Distribution, Manufacturing Technologies, and Operations Risk Management. Before taking on this position, she was vice president, Site Operations at Amgen’s Fremont, California, manufacturing facility (AFR)….

Continue reading
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

— Robert ZamboldiSite Head – US Cell & Gene Therapy, Morris PlainsNovartis 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. Under Rob’s leadership, he oversaw the turnaround from a single product site into a multi-product manufacturing facility, delivering Novartis’ commercial and clinical products as well as securing multiple third-party contracts as a CMO provider. Rob’s…

Continue reading
Towards Industrialization of Cell Therapy
LIFE SCIENCES, LIFE SCIENCES, VIDEO

Towards Industrialization of Cell Therapy

This discussion will focus on the scientific, technical and cultural transformations required to drive towards true industrialization of cell therapies, including: — Jens VogelSVP & Global Head of BiotechBayer Pharmaceuticals 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. Before rejoining Bayer in March 2020, he was President and CEO of Boehringer Ingelheim Fremont and member of BI’s Biopharma Executive…

Continue reading
A Vision for the Future of mRNA Technology: Moderna’s Plans for the Future of mRNA Manufacturing & Expansion
LIFE SCIENCES, LIFE SCIENCES, VIDEO

A Vision for the Future of mRNA Technology: Moderna’s Plans for the Future of mRNA Manufacturing & Expansion

— Luis Mustafa PerezVP Innovation & Operational ExcellenceModerna As the CMC Vice President of Innovation & Operational Excellence at Moderna, Luis leads the CMC Transformation Office, integrating scalable business processes and advance technologies across functional areas to ensure successful launches and secure vaccine supply through sustainable improvements. Luis has a remarkable track record across Biotechnology, Pharmaceutical, Medical Device, and Consumer industries with over 22 years of experience. He has consistently demonstrated his ability to drive innovation, transformation, and deliver substantial business results. Significantly, Luis had the honor of leading the 2022 U.S. launches of Moderna’s first COVID-19 booster and pediatric…

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 A Feldstein, JDVP, Global Head of Supply Chain QualityJohnson & Johnson Innovative Medicines 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. Additionally, Federico has a passion for the people in his organization…

Continue reading
Quality Reborn – Redefining Education of Quality Business Leaders
LIFE SCIENCES, LIFE SCIENCES, VIDEO

Quality Reborn – Redefining Education of Quality Business Leaders

It is time for Quality leaders to transition from a traditional compliance driven role to that of a Quality Business Leader making quality a competitive advantage for companies rather than seen as a cost. To become a successful Quality Business Leader requires mastering the following skills — Anders VintherSVP Pharmaceutical Development & ManufacturingKronos Bio Anders Vinther serves as VP Quality at Kronos Bio. He joined Intarcia Therapeutics in 2018 as VP Global Quality and Engagement, previous to this Anders was the Chief Quality Officer at Sanofi Pasteur accountable for cGMP compliance, quality leadership, and the quality of the company’s vaccines…

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

— Dr. Pascal BécotteManaging DirectorRussell Reynolds Associates 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. Pascal received his Bachelor of Engineering Physics degree from the Royal Military College of Canada and trained as an aerospace engineer with the Royal Canadian Air Force. He…

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

Empowering Innovation: Enhancing CDMO Capabilities for Collaborative Success

— Kevin SharpSVP, Head of Samsung Biologics America SalesSamsung Biologics 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…

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

mRNA manufacturing offers great benefits and potential for infectious diseases and personalized medicines due to the advantages in flexibility, cost, and speed of development, but there are still challenges to overcome to fully realize the potential, especially when addressing small batch manufacturing. Considering manufacturability and scale-up from the beginning will help to deliver process efficiency and scalability along the spectrum of mRNA products. In this presentation, we’ll discuss how digital technology can help accelerate therapeutic development and strategies to adopt a paper free approach at all stages of development. — Katarina StenkloEnterprise End-to End Solutions LeaderCytiva Katarina works for Cytiva…

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

Enabling Acceleration & Risk Mitigation in ATMP Development & Beyond

— Sarah Stevens, Ph.D.President of Azzur Labs & Azzur Cleanrooms on Demand™Azzur Group 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 CurranSVP Manufacturing Excellence SuccessMasterControl, Inc. 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. Curran joined MasterControl in 2002 to direct and expand MasterControl’s product lines. In 2017 he switched to focus on bringing Mx to market, which happened mid-2019 and now has…

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 TomtishenVP OperationsCellares 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…

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 StewartSVP, Operational and Process Technology, Large Scale Business UnitFUJIFILM Diosynth Biotechnologies 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)…

Continue reading