Cell & Gene Therapy Thriving Market: The Promising Future of Precision Medicine
The need for precision medicine drives growth of gene and cell therapy market, with the sector raising $2.9 billion in venture capital in 2018, twice the 2017 amount, according to the Alliance for Regenerative Medicine.
Though the CAR-T is driving the market growth, there are other segments which deserve attention, including stem cells. The US Food and Drug Administration expects to see a wave of cell and gene therapy New Drug applications; currently the agency has more than 800 such applications on file.
Kite Pharma’s Yescarta® or Novartis’ Kymriah® autologous cell therapies, demonstrated that adding Cell & Gene therapies to biopharma’s R&D pipeline could be an attractive business model. Approval of the CAR T-cell treatments Kymriah and Yescarta and US’ first bona fide gene therapy, Luxturna, which uses an adeno-associated virus (AAV) to deliver a healthy copy of DNA to treat a rare form of inherited blindness, taken this field from experimental to truly commercial.
There are critical components of clinical development that need to be addressed when it comes to cell and gene therapies.
These include thinking through manufacturing, long term safety and robust clinical trial design. These are necessary to ensure return on investments for these programs, which are associated with high upfront costs and could become economically inviable to the developers. Several products of the gene therapy market have seen themselves withdrawn due to their non-financial viability.
De-risking such programs requires a well-thought study design consolidated with a commercially minded and pragmatic approach to advanced therapy development.
Join @IAG’s webinar on cell & gene therapy development with our experts discussing the landscape and strategies for study design, regulatory pathways, use of novel technologies and value creation.
Dr. Olga Kubassova, CEO of IAG, Image Analysis Group. Our goal is to accelerate novel drug development by using the right analytical tools and modern trial infrastructure.We take a broader view on the assets’ development and bring expertise in study design, execution and commercialization. As needed to deploy AI, Machine Learning and smart image analysis methods to ensure the speed and cost-effectiveness.
We work with investors and executive teams on deploying the right strategies for early efficacy assessments, objective response prediction and critical analysis of advanced treatment manifestations. Thus, lowering the investment risks into advanced therapies while helping to accelerate study outcomes.
We are here to create successful partnerships and see more patients cured with the drugs, that we can help you to develop www.ia-grp.com
Our goal is to accelerate novel drug development by using the right analytical tools and modern trial infrastructure. We take a broader view on the assets’ development and bring expertise in study design, execution, and commercialization. As needed, we deploy AI, Machine Learning, and smart image analysis methods to ensure the speed and cost-effectiveness of clinical programs. IAG’s team supports investors and biotech executive teams with deploying the right strategies for early efficacy assessments, objective response prediction and critical analysis of advanced treatment manifestations. Thus, lowering the investment risks into advanced therapies while helping to accelerate study outcomes. www.ia-grp.com
Engage with our team
Dr. Olga Kubassova, CEO: www.linkedin.com/in/olgakubassova/
David Chia, CCO: https://www.linkedin.com/in/jahyungdavidchia/
Dr. Diana Dupont-Roettger, Chief Scientific Alliance Officer: https://www.linkedin.com/in/dianaroettger/