Communication – VJRegenMed

Establishing Chain of Identity & Chain of Custody standards in CGT manufacturing

Simon Ng — Thu, 03 Feb 2022 10:27:37 +0000

Kwok Pang, COO, Autolomous, London, UK, comments on Autolomous’ recent strategic partnership with Vineti, which aims to deliver supply chain management solutions in the cell and gene therapy (CGT) space by creating a seamless end-to-end CGT delivery process. Mr Pang explains that integrating the chain of identity (CoI) and chain of custody (CoC) will allow any issues to be identified and resolved during the manufacturing process, which will result in an increased transparency and improve the exchange of information to and from stakeholders. 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.

Enhancing communication in the advanced therapies sector

admin_vjr_user — Mon, 08 Nov 2021 11:54:35 +0000

Neil Hunter, Image Box Ltd., Surrey, UK, shares an overview of Image Box’s ongoing work in driving the communication of data, conclusions and expert opinion from scientific conferences in the advanced therapies to key stakeholders in the wider field, including regulators, investors, analysts and industry leaders. By enhancing the dissemination of information and consensus across the sector, Neil hopes that this will help to accelerate advanced therapy development and their delivery to patients. This interview took place at the Advanced Therapies Congress & Expo 2021.

The evolving landscape of scientific communication in advanced therapies

admin_vjr_user — Mon, 08 Nov 2021 11:54:33 +0000

Neil Hunter, Image Box Ltd., Surrey, UK, comments on the evolution of scientific communication platforms and formats and how this is being leveraged in the life science sector. He explains that the move toward increasingly digital formats has enhanced the accessibility of scientific information for a wider international audience and enables experts and key opinion leaders to communicate their research and perspectives to stakeholders in a more personal manner. He also discusses the increasing use of social media platforms to communicate advances and connect the life sciences and specifically, regenerative medicine sector and anticipates that the formats and modes of communication will continue to evolve in the future to reach an even wider audience. This interview took place at the Advanced Therapies Congress & Expo 2021.

Rekindling communication in the sector following the pandemic

admin_vjr_user — Mon, 08 Nov 2021 11:54:30 +0000

Neil Hunter, Image Box Ltd., Surrey, UK, considers the impact of the COVID-19 pandemic on scientific communication within the life science sector, which has received an increased level of investment in this time. He discusses the challenges surrounding communication, networking and collaboration through online events during the pandemic and looks forward to the wider return of in-person events, which he anticipates will be highly attended in the coming years in order to re-establish streams of communication across the sector. This interview took place at the Advanced Therapies Congress & Expo 2021.

Collaboration in the cell & gene therapy industry

admin_vjr_user — Mon, 08 Nov 2021 11:54:28 +0000

Neil Hunter, Image Box Ltd., Surrey, UK, describes the growing importance of building collaborations and partnerships across the cell and gene therapy industry to accelerate the development, manufacture and delivery of advanced therapies. He describes different collaborative approaches seen across the sector and looks forward to seeing how the results of these approaches and how they impact the field in the coming years. This interview took place at the Advanced Therapies Congress & Expo 2021.

Integrating electronic software solutions into healthcare systems

Simon Ng — Thu, 21 Oct 2021 17:14:27 +0000

Kwok Pang, COO, Autolomous, London, UK, explains the challenges involved with integrating electronic software solutions for the management of critical manufacturing data for cell and gene therapies into healthcare systems. He describes an initiative that aims to develop and implement a UK NHS-owned digital system that integrates with manufacturer software in order to enhance the management of patient data, clinical samples and the ordering of advanced therapies by the NHS. He highlights the need for uniformity across the sector in the technologies, standards and methods used for information exchange. This interview took place at the Advanced Therapies Congress & Expo 2021.

Looking forward to the Advanced Therapies Congress & Expo 2021

admin_vjr_user — Wed, 20 Oct 2021 17:41:43 +0000

Sven Kili, MD, Antion Biosciences SA, Geneva, Switzerland, shares his excitement toward the return to in-person congresses while attending the Advanced Therapies Congress & Expo 2021. He discusses the value of having the opportunity to network with other colleagues working in the field of advanced therapies and to learn about the latest scientific advances and breakthroughs made during the COVID-19 pandemic. This interview took place at the Advanced Therapies Congress & Expo 2021.

Learnings from the COVID-19 pandemic for the advanced therapies sector

admin_vjr_user — Wed, 13 Oct 2021 17:11:14 +0000

Miguel Forte, MD, PhD, Bone Therapeutics SA, Gosselies, Belgium, outlines some of the key lessons that can be learnt from the COVID-19 pandemic in order to drive the advanced therapies industry. During the pandemic, we saw the streamlining of regulatory processes and clinical trial protocols during COVID-19 vaccine development and testing, and the field learned how to work together and conduct clinical trials remotely. He also highlights the advances in supply chain management following COVID-19 vaccine delivery and how these should be applied to the delivery of cell and gene therapy products in the future. This interview took place at the Advanced Therapies Congress & Expo 2021.

Tackling unproven cell-based therapies and the impact of COVID-19

admin_vjr_user — Thu, 19 Aug 2021 10:30:48 +0000

Aaron Levine, PhD, MPhil, BS, Georgia Institute of Technology, Atlanta, GA, provides an overview of the current landscape of direct-to-consumer marketing of unproven cell-based therapies in the United States. As the FDA’s enforcement discretionary period comes to an end, Dr Levine hopes to see an increased level of enforcement activity toward stem cell clinics operating outside of FDA guidelines and formal regulatory processes. He also highlights the impact of the COVID-19 pandemic, which saw an increase in the spread of health misinformation and the marketing of unproven cell-based interventions for COVID-19, resulting in enforcement action from the FDA. Finally, Dr Levine expresses his concerns surrounding the unregulated and premature growth of speculative commercial cell banking services. This interview took place during the International Society for Cell & Gene Therapy (ISCT) Annual Meeting 2021.