Michael Lehmicke – VJRegenMed

The role of ARM in the cell and gene therapy industry

Simon Ng — Thu, 03 Feb 2022 10:27:39 +0000

Michael Lehmicke, Senior Director of Science & Industry Affairs, Alliance for Regenerative Medicine, Washington, D.C., describes the influence of ARM in the cell and gene therapy (GCT) industry and future plans for ARM within the sector. The A-Gene and A-Cell projects have been providing guidance to companies and academic institutions. Collaboration with the FDA and EMA, as well with the network of manufacturers and industry experts have additionally proven useful to address Chemistry, Manufacturing and Controls (CMC) issues. This interview took place at Advanced Therapies Week 2022.

The impact of COVID-19 on the advanced therapy sector

Simon Ng — Tue, 01 Feb 2022 18:03:40 +0000

Michael Lehmicke, Senior Director of Science & Industry Affairs, Alliance for Regenerative Medicine, Washington, D.C., provides an overview of how the cell and gene therapy (GCT) industry has adapted to the COVID-19 pandemic. Overall, the industry has shown resilience to the pandemic, with clinical trials successfully adapting to the change in circumstances. The advent of remote working has additionally increased the pool of available workers, and remote inspections by regulatory authorities may positively impact the regulatory process. This interview took place at Advanced Therapies Week 2022.

Addressing labor and educational gaps in the CGT industry

Simon Ng — Mon, 31 Jan 2022 17:59:01 +0000

Michael Lehmicke, Senior Director of Science & Industry Affairs, Alliance for Regenerative Medicine, Washington, D.C., comments on the skills shortage in the cell and gene therapy (GCT) industry. Whilst people working in different companies during their career can enhance the exchange of technology and expertise, it highlights the need for additional workers across different disciplines including manufacturing, engineering and regulatory affairs. This interview took place at Advanced Therapies Week 2022.

Upscaling cell and gene therapy manufacturing

Simon Ng — Fri, 28 Jan 2022 15:31:41 +0000

Michael Lehmicke, Senior Director of Science & Industry Affairs, Alliance for Regenerative Medicine, Washington, D.C., talks on the growing interest in developing technologies to improve cell and gene therapy manufacturing, notably in implementing automated processes. Mr Lehmicke emphasizes the importance of standardizing these processes. This interview took place at Advanced Therapies Week 2022.

The need for standardization in cell and gene therapy manufacturing

Simon Ng — Fri, 28 Jan 2022 09:54:52 +0000

Michael Lehmicke, Senior Director of Science & Industry Affairs, Alliance for Regenerative Medicine, Washington, D.C., discusses the importance of generating and adhering to best practices and standards in cell and gene therapy (CGT) manufacturing. Mr Lehmicke explains that a major issue in the CGT industry is disagreement on best manufacturing practices. He outlines some of the efforts being made by ARM to tackle this problem, highlighting the A-Gene and A-Cell projects which aim to describe the application of quality by design to the development of CGT products. This interview took place at Advanced Therapies Week 2022.

CMC challenges in cell and gene therapy manufacturing

Simon Ng — Thu, 27 Jan 2022 18:16:21 +0000

Michael Lehmicke, Senior Director of Science & Industry Affairs, Alliance for Regenerative Medicine, Washington, D.C., comments on some of the key chemistry, manufacturing and controls (CMC) obstacles in cell and gene therapy (CGT) manufacturing. The development process of CGT products from early-phase clinical trials to commercialization is complex and can lead to major regulatory delay, if it is not addressed early on. Although there have been improvements in the regulation of cell and gene therapies, guidance is still lacking in the late-stage development of CGT products.. This interview took place at Advanced Therapies Week 2022.