Monica Shah – VJRegenMed

Challenges in developing cardiovascular advanced therapies

Simon Ng — Wed, 03 Nov 2021 15:14:01 +0000

Monica Shah, MD, IQVIA, Washington, D.C., considers some issues in developing cell and gene therapies for cardiovascular diseases that need to be addressed, including administrating advanced therapies directly to the heart and large-scale manufacturing cell and gene therapies. Trial design is an additional barrier to overcome, as defining the right target population and specific endpoints are necessary. Dr Shah also highlights how future cell and gene therapies need to show value and superior efficacy compared to existing treatments for them to be commercially viable. This interview took place at Meeting on the Mesa 2021.

Developing advanced therapies in different disease areas

Simon Ng — Wed, 03 Nov 2021 15:14:00 +0000

Monica Shah, MD, IQVIA, Washington, D.C., talks on the differences between developing advanced therapies for cardiovascular diseases and other therapeutic areas. Treating rare diseases and cancers can involve identifying and correcting a certain mutation on a gene, whereas many cardiovascular diseases such as heart failure are multifactorial, which complicates the development of advanced therapies in that sector. Consequently, developing alternatives to a precision medicine approach will be necessary for these conditions. This interview took place at Meeting on the Mesa 2021.

Addressing key issues in manufacturing advanced therapies

Simon Ng — Wed, 03 Nov 2021 15:13:59 +0000

Monica Shah, MD, IQVIA, Washington, D.C., discusses ongoing hurdles that need to be overcome in manufacturing cell and gene therapies. Companies must be able to mass-produce products to ensure clinical trials can be conducted and for commercial use. Dr Shah additionally emphasizes the need for careful planning to ensure a robust supply is maintained, especially when treating prevalent diseases as a large patient population can put pressure on current manufacturing capabilities. This interview took place at Meeting on the Mesa 2021.

Advancements in cardiovascular advanced therapies

Simon Ng — Wed, 03 Nov 2021 15:13:58 +0000

Monica Shah, MD, IQVIA, Washington, D.C., provides a brief overview of innovations within the cardiovascular cell and gene therapy sectors. Dr Shah highlights cell therapies treating acute myocardial infarctions, and heart failure, as well as gene therapies treating hypertrophic cardiomyopathy. She additionally discusses novel approaches in conducting clinical trials including decentralized clinical trials and alternative recruitment strategies. Biomarkers and artificial intelligence will also impact future trials by effectively determining patients who will benefit from these treatments the most. This interview took place at Meeting on the Mesa 2021.