Janet Lynch Lambert, CEO, Alliance for Regenerative Medicine, Washington, D.C., discusses remaining hurdles that need to be overcome in cell and gene therapies. Dosing as well as delivery strategies need to be optimized, and issues remain within the regulatory and Chemistry, Manufacturing and Controls (CMC) framework. Health Technology Assessments (HTA), GMO regulations, and fundraising methods have additionally restricted the development of gene therapies in Europe. Ms Lambert additionally highlights the need for innovative reimbursement models to ensure affordable treatment for patients. This interview took place at Advanced Therapies Week 2022.
Janet Lynch Lambert is the CEO of Alliance for Regenerative Medicine.