Present at the 2nd Global Biomedicine CDMO Development Forum, 2-3 Nov. 2020, Suzhou, China
Gaithersburg, MD (26 Oct. 2020) – BLA Regulatory LLC, a full-service biopharma regulatory consultancy, announced that it’s Founder, Dr. Li, will be presenting virtually at the 2nd Global Biomedicine CDMO Development Forum 2020 to be held between 2-3 Nov. 2020, Suzhou, China.
This Forum will focus on the complete industrial chain for the development of the Biomedicine industry in China. This forum aims to address the full range of needs of the participants – from pre-clinical, clinical, CMC, and regulatory affairs, to investment and commercial. This Forum will cover therapeutic antibodies, cellular and gene therapies, vaccines, and stem cell medicine.
Dr. Li will share his recent experience on the FDA’s Application of the Coronavirus Treatment Acceleration Program (CTAP) in accelerating clinical review of anti-coronavirus treatment drugs at Human Vaccine Sub-forum on 02-Nov-2020 from 15:30 to 16:00 Beijing time.
Dr. Li has worked in the biopharmaceutical industry for more than 15 years at companies such as AstraZeneca, MedImmune, AZ BioVenture, Ascentage, and SNBL. He contributed significantly as the Regulatory Lead for FASENRA (Benralizumab for asthma) from Ph-2 to major marketing approvals. Before his career in regulatory affairs, Dr. Li has worked extensively on clinical Adoptive Immunotherapies using CTL/TIL and Dendritic cells. Dr. Li obtained his Ph.D. in Molecular Medicine from Kyoto University, Japan, and his medical education/residency training in China.
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:
Jiangang He
Business Development
Jiangang.He@bla-regulatory.com
T: (240) 425-7668 | F: 240-448-4817
E: info@bla-regulatory.com | W: www.bla-regulatory.com
509 Quince Orchard Road, #366, Gaithersburg, MD 20878