Presents at the Cell and Gene Therapy Seminar on 04 Nov. 2020
Gaithersburg, MD (28 Oct. 2020) – BLA Regulatory, LLC, a full-service biopharma regulatory consultancy, announced that it’s CMC expert, Ms. Areman, will be presenting virtually at the Cell and Gene Therapy Industrialization Development and Policy Seminar (CGT) to be held on 04 Nov. 2020.
The CGT Seminar will jointly explore industry opportunities in the cell and gene therapy from the fields of policy and regulation, quality standards, process development, non-clinical evaluation, and clinical trial application. The seminar includes discussion on key issues in the cell and gene therapy industry chain to realize the global innovation and overtaking of China biomedicine.
Ms. Areman, the principal CMC consultant at BLA, will give a presentation virtually about the CMC Focus of Cell and Gene Therapy Products for FDA Registration from 10:20 to 11:10 am Beijing time.
Ms. Areman served as an expert CMC reviewer at FDA (CBER) for Cell and Gene Therapy. As a primary reviewer, she reviewed over 50 cell therapy IND and BLA Applications and DMFs in therapeutic areas such as cardiovascular, autoimmune, hematopoietic stem cell transplantation, cord blood banking, and cancer immunotherapy. Ms. Areman has spent more than 30 years mastering cell and gene therapy product development. Among other roles, she was the Clinical Services Coordinator of the Cell Processing Section at the NIH Clinical Center and the Director of the Cellular Engineering Laboratory at Georgetown University (GU) Medical Center. While at GU she also served as the Laboratory Manager of the Pediatric Cancer and Stem Cell Research Program.
About BLA Regulatory, LLC
BLA Regulatory, LLC, is a full-service drug regulatory consultancy focusing on the US with global reach to other major markets. BLA provides comprehensive regulatory strategy and operation services from pre-IND strategic planning, IND preparation & submission, all the way to submission and approval of BLA/NDA. Our goal is to help move your product through the development cycle efficiently. With credits of 300+ INDs and 50+ NDAs/BLAs to our senior consultants, BLA brings clients a broad range of experiences from Big Pharma, CROs, and the FDA. Our services expand across regulatory, CMC, nonclinical, clinical, biostatistics, scientific writing, project management, eCTD publishing, and submission. We have extensive experience across therapeutic areas such as oncology, respiratory, addiction, autoimmune, inflammatory, metabolic, and cardiovascular diseases.
For further information contact:
T: (240) 425-7668 | F: 240-448-4817
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509 Quince Orchard Road, #366, Gaithersburg, MD 20878