Policy – VJRegenMed

Building collaborative relationships to overcome challenges in the CGT industry

Simon Ng — Thu, 03 Feb 2022 12:25:11 +0000

Sharon Brownlow, PhD, Cell and Gene Therapy Catapult, London, UK, talks on the importance of collaborating between different stakeholders across academia, healthcare and industry in order to overcome barriers in the cell and gene therapy (CGT) space. Dr Brownlow comments on a consortium created by Cell and Gene Therapy Catapult to help maintain confidentiality, and supporting companies in their manufacturing process. Dr Brownlow additionally highlights the benefits of harnessing the power of pre-competitive collaboration. This interview took place at Advanced Therapies Week 2022.

Achieving operational excellence in CGT through automation

Simon Ng — Mon, 31 Jan 2022 17:59:03 +0000

Sharon Brownlow, PhD, Cell and Gene Therapy Catapult, London, UK, discusses the challenges in achieving operational excellence in the cell and gene therapy (CGT) field and strategies to overcome these challenges. Achieving operational excellence is necessary as the timeframe to release a product is very limited, but is challenging due to the highly complex process of manufacturing CGTs. Whilst automation will have a dramatic impact in improving operational excellence, many of the systems currently used in CGT are not tailored to early product development. Dr Brownlow additionally highlights how many companies are integrating processes together and developing more configurable systems, as well as ‘factory-in-a-box’ technologies which can manufacture multiple CGTs simultaneously in a fully automated fashion. 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.

Increasing recruitment in the cell and gene therapy sector

Simon Ng — Fri, 28 Jan 2022 15:31:40 +0000

Sharon Brownlow, PhD, Cell and Gene Therapy Catapult, London, UK, comments on the growing skills gap in the cell and gene therapy (CGT) industry and strategies to alleviate the issue. The industry, particularly in the manufacturing sector, is currently going through a labor shortage and apprenticeships and tax incentives have encouraged school leavers and graduates to join the industry. National training centers have also been established to equip workers with the necessary skills. Dr Brownlow additionally highlights the use of technologies such as virtual and augmented reality, which have already been used in the development of the COVID-19 vaccine, as well as outreach programs in schools and academia. 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.

The ISCT’s ongoing battle against unproven cell & gene therapies

admin_vjr_user — Mon, 08 Nov 2021 18:22:07 +0000

Miguel Forte, MD, PhD, Bone Therapeutics SA, Gosselies, Belgium, discusses the efforts being made by the International Society for Cell & Gene Therapy (ISCT) to tackle the use of unproven cell- and gene-based therapies. He discusses the ISCT’s alignment with regulators such as the US Food and Drug Administration (FDA) and their actions against developers treating patients with unvalidated products that are marketed with unsubstantiated claims. He also highlights the importance of the growing role the cell and gene therapy industry in the translation of products to patients. This interview took place at the Advanced Therapies Congress & Expo 2021.

The challenges of CMC in cell and gene therapies

admin_vjr_user — Sat, 10 Apr 2021 10:58:00 +0000

Mike Lehmicke, Director of Science & Industry Affairs, Alliance for Regenerative Medicine (ARM), Washington, D.C., discusses the challenges faced by the advanced therapy medicinal products (ATMP) field as a result of chemistry, manufacturing and control (CMC) regulations. ARM works with regulatory bodies and stakeholders to overcome CMC issues and aims to improve the clarity with which requirements are communicated to prevent them delaying commercialization. This interview took place during the Cell & Gene Meeting on the Mediterranean 2021 virtual conference.

Supporting the future of ATMPs in the EU

admin_vjr_user — Sat, 10 Apr 2021 10:57:59 +0000

Paige Bischoff, Senior VP of Global Public Affairs, Alliance for Regenerative Medicine (ARM), Washington, D.C., discusses the future of the policy and regulatory landscape for advanced therapy medicinal products (ATMPs) in the European Union (EU) and how ARM aims to support the sector’s growth in the coming years. She describes the importance of implementing innovative payment models for ATMPs in Europe and how the use of real-world evidence should be incorporated into health technology assessment (HTA) frameworks going forward. This interview took place during the Cell & Gene Meeting on the Mediterranean 2021 virtual conference.

A-Gene: a best practice guide for gene therapy development

admin_vjr_user — Sat, 10 Apr 2021 10:57:57 +0000

Mike Lehmicke, Director of Science & Industry Affairs, Alliance for Regenerative Medicine (ARM), Washington, D.C., introduces A-Gene, a best practice guide for developing and manufacturing gene therapy products. This open-source educational resource, currently being developed by ARM, is intended to be used as a reference guide for companies in gene therapy sector and aims to establishing consensus on best practice within the industry and help drive advancement. This interview took place during the Cell & Gene Meeting on the Mediterranean 2021 virtual conference.