ARM fosters investment, research & development, commercialization, and access to safe, effective, and transformational treatments and cures.
ARM fosters investment, research & development, commercialization, and access to safe, effective, and transformational treatments and cures.
The Alliance for Regenerative Medicine (ARM) and the National Institute for Innovation in Manufacturing Biopharmaceuticals (NIIMBL) have released Project A-Cell, a multistakeholder collaboration to incorporate Quality by Design (QbD) principles into cell-based therapy CMC programs.
The Alliance for Regenerative Medicine, the leading international advocacy organization dedicated to realizing the promise of regenerative medicines and advanced therapies, today released its 2021 Annual Report, showcasing a year of significant advances and forecasting continued growth ahead. The 2021 Report presents important milestones for the sector over the past year, including the approval of six new gene, cell, and tissue-based therapies, record sector investment, and promising early-stage clinical readouts.
2021 was an auspicious year for the cell and gene therapy sector. ARM shared highlights from the investment, clinical, and scientific landscape, as well as a look at what’s ahead for 2022 and beyond, at the Cell & Gene Therapy State of the Industry Briefing. Following the presentation, two expert led panels discussed gene therapy for rare disease and next-generation therapies for cancer.
The Alliance for Regenerative Medicine (ARM) and the National Institute for Innovation in Manufacturing Biopharmaceuticals (NIIMBL) today released Project A-Gene, a multistakeholder collaboration to incorporate Quality by Design (QbD) principles into a manufacturing case study of a viral vector commonly used in gene therapies.
Janet Lambert, CEO, ARM
This presentation provides an overview of the investment, clinical, and scientific environment for cell and gene therapy, including major milestones from 2021 and a look ahead at what 2022 has in store.
Janet Lambert, CEO, ARM
This event included ARM’s annual yearly update on the sector’s progress followed by two panel sessions featuring top executives highlighting future inflection points for cell and gene therapies.
Janet Lambert, CEO, ARM
This presentation provided a mid-year update on the cell and gene therapy industry with a focus on manufacturing considerations.
Stephen Majors, Director, Public Affairs
This webinar provided an introduction to cell and gene therapies, as well as a look at the investment and clinical landscape.
Janet Lambert, CEO, ARM
This presentation provides an overview of the investment, clinical, and scientific environment for cell and gene therapies.
Stephen Majors, Director, Public Affairs
This presentation provides an overview of ARM’s mission and the benefits of ARM membership.
Stephen Major, Director, Public Affairs
This presentation provides an overview of the cell & gene therapy landscape with a focus on multiple myeloma.
Janet Lambert, CEO, ARM
This presentation looks at the investment and clinical landscape for gene therapy for rare disorders.
Janet Lambert, CEO, ARM
This presentation identifies major milestones in the gene therapy and cell therapy field over the past year and provides an overview of the financial, clinical, and policy environment.
Janet Lambert, CEO, ARM
On overview of investment considerations for the cell & gene therapy sector.
Janet Lambert, CEO, ARM
The presentation, which provides an overview on value demonstration for cell and gene therapies, cites information from ARM’s library of original policy analyses.
Janet Lambert, CEO, ARM
The presentation, which provides an overview of public policy considerations for the cell and gene therapy sector, cites information from ARM’s library of original policy analyses.
Annie Hubert, Sr. Director, European Policy, ARM
This presentation draws on conclusions from ARM’s 2020 position paper on providing cross-border access to ATMPs in Europe, available here.
Michael Lehmicke, Director, Science & Industry Affairs, ARM
Additional information on ARM’s manufacturing initiatives is available here.
Robert Falb, Director, US Policy & Advocacy, ARM
The presentation provides an overview of the cell and gene therapy sector, with an emphasis on CAR-T therapies and related policy provisions.
Annie Hubert, Sr. Director, European Policy, ARM
This presentation provides an overview of the European ATMP sector, including financings, clinical development, and ARM’s European policy priorities.
Janet Lambert, CEO, ARM
This presentation, which includes data from ARM’s 2019 Global Sector Report, provides an overview of the regenerative medicine and advanced therapy sector for conference attendees.
Janet Lambert, CEO, ARM
ARM’s annual State of the Industry briefing provides an update on global financings, clinical development, public policy considerations, and other regenerative medicine sector trends. A recording of the presentation is available here.
Janet Lambert, CEO, ARM
This roundtable event brought together sector stakeholders to discuss improved patient access to ATMPs in Europe. The presentation included an overview of ARM’s Getting Ready report.
Janet Lambert, CEO, ARM & Michael Werner, Sr. Policy Counsel, ARM
ARM provided an overview of regulatory considerations in the US, Europe, and abroad for the International Coalition of Medicines Regulatory Authorities.
Annie Hubert, Sr. Director, European Policy, ARM
The presentation included an overview of the financial and clinical landscape for the development of gene therapies for rare disorders and policy priorities to promote development and patient access.
Janet Lambert, CEO, ARM
ARM provided an overview of the gene therapy sector for the New York Academy of Sciences, including the clinical landscape for innovative gene-editing technologies.
Janet Lambert, CEO, ARM
This presentation provides an overview of ARM to attendees at the annual Meeting on the Mesa. For more information on the Meeting on the Mesa, click here. A recording of the remarks is available here.
Janet Lambert, CEO, ARM
ARM CEO Janet Lambert annual Meeting on the Mesa. For more information on the Meeting on the Mesa, click here. A recording of the presentation is available here.
This webinar provides guidance to sponsors and developers on the best practices and recommendations in managing manufacturing changes during early development.
This webinar discusses the vector manufacturing process and how it culminates with the formulation and vialing of the purified vector product.
This webinar discusses how a comprehensive control strategy for pharmaceutical products – including gene therapies – is the key to achieving process consistency, product quality, safety, and efficacy.
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