Miguel Forte – VJRegenMed

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.

Developing iPSC-derived MSCs for therapeutic purposes

Simon Ng — Wed, 20 Oct 2021 17:41:42 +0000

Miguel Forte, MD, PhD, Bone Therapeutics SA, Gosselies, Belgium, discusses the recently announced research partnership between Bone Therapeutics and Implant Therapeutics, which aims to drive the development of hypoimmunogenic induced pluripotent stem cell (iPSC)-derived mesenchymal stromal cell (MSC)-based therapies for various indications. Dr Forte explains that the implementation of iPSC technology offers the potential to optimize the effects of current MSC-based therapies such as ALLOB, an allogeneic MSC-based cell therapy platform being investigated for bone regeneration in orthopedic indications. 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.

Addressing the unproven cell-based therapy market

admin_vjr_user — Thu, 24 Jun 2021 17:15:43 +0000

Miguel Forte, MD, PhD, Bone Therapeutics SA, Gosselies, Belgium, suggests how the cell and gene therapy industry can help to address the unproven cell-based therapy market. He highlights that strong evidence-based research is required to determine whether the benefits of a particular cell-based therapy outweigh the risks before they are used in patients. Additionally, the education of patients and stakeholders is required to improve understanding of how products are developed, which products have been proven to be safe and effective and how they should be used. This interview took place during the International Society for Cell & Gene Therapy (ISCT) Annual Meeting 2021.

Improving patient access to cell & gene therapies

admin_vjr_user — Thu, 24 Jun 2021 17:15:43 +0000

Miguel Forte, MD, PhD, Bone Therapeutics SA, Gosselies, Belgium, discusses some of the key recent developments and remaining challenges in the commercialisation of cell and gene therapy (CGT) products. Dr Forte highlights that although CGT products offer transformative long-term benefits to patients via complex mechanisms, patient access remains limited due to difficulties in their characterization, manufacture and distribution. Due to the potential curative nature of these therapies, it will also be necessary to implement new mechanisms of payment and reimbursement. This interview took place during the International Society for Cell & Gene Therapy (ISCT) Annual Meeting 2021.

Off-the-shelf cell therapy for bone indications: ALLOB & JTA-004

admin_vjr_user — Thu, 24 Jun 2021 17:15:41 +0000

Miguel Forte, MD, PhD, Bone Therapeutics SA, Gosselies, Belgium describes ongoing research investigating allogeneic mesenchymal stromal cell (MSC)-derived osteoblastic cells (ALLOB) for the formation of bone in orthopedic conditions. The safety and efficacy of ALLOB has been tested in patients with degenerative disc disease (NCT02205138) and long bone fractures (NCT02020590), and its impact in tibial fractures is being evaluated in the ongoing Phase IIb ALLOB-TF2 trial (NCT04432389). Dr Forte also describes JTA-004, an intra-articular injectable currently being investigated in patients with knee osteoarthritis (NCT04333160), as well as plans to expand their MSC platform into immunomodulatory conditions. This interview took place during the International Society for Cell & Gene Therapy (ISCT) Annual Meeting 2021.