- Company beginning first discussions with the FDA regarding IND development and submission of intra-cerebral gene therapy product
- Intent to gain agreement on completed nonclinical program to support first in human study
- Intent to gain agreement on the use of historical controls to support clinical development in rare disease space
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Biopharma Excellence is a fusion of three scientific powerhouses, PharmaLex, ERA Consulting and Biopharma Excellence – all under the PharmaLex brand. This global team of scientific, regulatory and commercial professionals provide strategic product development and proactive regulatory services to developers of biopharmaceuticals, cell and gene therapies, monoclonal antibodies (MABs), vaccines and biosimilars.