Economics – VJRegenMed

Accelerating manufacturing with real-time data analysis

Simon Ng — Mon, 14 Feb 2022 17:40:23 +0000

Kwok Pang, COO, Autolomous, London, UK, describes practical efforts in implementing real-time data analysis to optimize the value chain in the cell and gene therapy (CGT) space. Processing the data in real-time enables manufacturing processes to be scaled-up as decisions can be made instantaneously. Manufacturing costs can additionally be lowered as a result, where increased density of the relevant infrastructure in a given area can increase efficiency. This interview took place at Advanced Therapies Week 2022.

Enhancing patient access to advanced therapies

Simon Ng — Mon, 07 Feb 2022 17:06:06 +0000

Whilst the cell and gene therapy (CGT) sector has greatly expanded, patient access to these treatments remain poor. Delara Motlagh, PhD, MS, EMBA, Terumo Blood and Cell Technologies, Lakewood, CO, describes strategies to improve patient access to cell and gene therapies. Dr Motlagh emphasizes the need to improve reimbursement pathways, which will have to take into account the curative nature of these treatments. She additionally highlights current accessibility problems patients face, as these therapies can only be typically administered from a select number of medical centers or academic institutions. This interview took place at Advanced Therapies Week 2022.

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.

Ensuring successful commercialization of advanced therapies

Simon Ng — Fri, 21 Jan 2022 11:14:48 +0000

Kurt Gielen, MedAce, Maastricht, The Netherlands, comments on important factors researchers and academics must consider when attempting to commercialize their product for clinical use. He highlights the need to focus on developing the final product, as opposed to constantly making changes. The financial aspects of developing the product must also be considered, as long term costs such as manufacturing costs will overshadow the viability of the product regardless of scientific innovations. This interview took place at the 6th World Congress of the Tissue Engineering and Regenerative Medicine International Society (TERMIS 2021).

Overcoming challenges in tissue engineering

Simon Ng — Wed, 05 Jan 2022 17:32:26 +0000

Małgorzata Lewandowska-Szumieł, PhD, Medical University of Warsaw, Warsaw, Poland, provides an overview of remaining issues that need to be addressed in the field of tissue engineering. Animal models may not be as reliable due to the fundamental differences in human and animal cells and Prof. Lewandowska-Szumieł highlights need for carefully designed clinical trials as a result, as well the potential cost of tissue engineered products. This interview took place at the 6th World Congress of the Tissue Engineering and Regenerative Medicine International Society (TERMIS 2021).

Remaining barriers in commercializing advanced therapies

Simon Ng — Mon, 29 Nov 2021 11:36:57 +0000

Pascal Touchon, President & CEO, Atara Biotherapeutics, San Francisco, CA, addresses issues relating to the commercialization of cell and gene therapies. Major challenges remain in terms of logistics and delivery. Off-the-shelf allogeneic therapies can be given to patients quicker than autologous therapies, as in the case of tabelecleucel, a novel CAR-T cell therapy which can be delivered to patients in three days. He additionally highlights reimbursement issues for these one-off treatments. This interview took place at Meeting on the Mesa 2021.

Barriers to tissue engineering research in academia

Simon Ng — Mon, 15 Nov 2021 15:14:42 +0000

Małgorzata Lewandowska-Szumieł, PhD, Medical University of Warsaw, Warsaw, Poland, discusses problems academics face in the field of tissue engineering. As tissue engineering products are classed as medicinal products, research laboratories must face increased regulations and adhere to good manufacturing practice (GMP) guidelines, increasing costs. Prof. Lewandowska-Szumieł additionally highlights the need for specialized research grants and describes her experiences in conducting clinical trials investigating adipose-derived stem cells in healing foot ulcers. This interview took place at the 6th World Congress of the Tissue Engineering and Regenerative Medicine International Society (TERMIS 2021).

Addressing remaining barriers to the commercialization of ATMPs

admin_vjr_user — Mon, 08 Nov 2021 18:22:11 +0000

Matthew Durdy, CEO, Cell and Gene Therapy Catapult, London, UK, discusses some of the key remaining barriers to the commercialization of cell and gene therapies. He highlights challenges with patient access to therapies and the way they’re delivered, as well as the importance of enhancing communication with payers in the early stages of product development in order to tackle reimbursement issues. He also notes that increasing manufacturing scale of advanced therapies would lower the cost of goods and facilitate patient access and discusses ongoing work in the UK to better educate academic researchers about the pathway to commercialization. This interview took place at the Advanced Therapies Congress & Expo 2021.

Driving the development of gene therapies for more common conditions

Simon Ng — Wed, 13 Oct 2021 17:11:13 +0000

Paul Gissen, MD, PhD, UCL Great Ormond Street Institute of Child Health, London, UK, discusses translating advances made in gene therapies for rare monogenic disorders to more common chronic conditions, including neurodegenerative and liver diseases. The global COVID-19 vaccine rollout demonstrated that technologies initially designed for the treatment of a small number of patients, including RNA and viral vector-based therapies, were able to be manufactured at a greater scale and administered to a very large number of patients. Prof. Gissen highlights the importance of global investment to enhance the development and manufacturing capacity of such gene therapies in the future. This interview took place at the Advanced Therapies Congress & Expo 2021.