As new products come to market, Biotech will increasingly face commercialization and production issues. According to the analysis of the CRL issued by the FDA in 2009, some scholars have concluded that about 40% of the drugs were withdrawn due to CMC rectification, which is more common during the first and second phases of drug clinical trials, such as currently hot treatments. The new ADC drug Sacituzumab Govitecan for triple-negative breast cancer was issued a CRL by the FDA because of CMC, which ultimately affected its launch progress. There are always people who want to take shortcuts, but there are no shortcuts for CMC. We can only keep our feet on the ground and keep studying.

• Thoughts on the full life cycle management of innovative drug CMC
• Innovative drug CMC development experience and case sharing 1
• Innovative drug CMC development experience and case sharing 2
• Innovative drug CMC development experience and case sharing 3
• Early analysis of the druggability of innovative drugs from the perspective of CMC
• Early-stage CMC development strategy for innovative small molecule drugs
• Luncheon party
• 1.CMC-different molecular types
• Analysis of common CMC issues in CDE/FDA/EU return/reissue
• CMC challenges for poorly soluble compounds
• CMC challenges for new Protac drugs
• ADC’s CMC Challenge
• Challenges of CMC, a new small nucleic acid drug
• CMC challenges for peptide drugs
• PDC’s CMC Challenge
• "2.CMC-API"
• What are the common problems in CMC declaration?
• Rapid advancement plan for early stage clinical APIs
• Key crystal form issues in new drug development
• Issues and Thoughts on Process Development of APIs
• Quality Control Standards for Different R&D Stages of Innovative APIs
• The balance between quality, efficiency and cost in the early development stage of new drug APIs
• How to achieve synergy between early registration strategy for innovative drugs and pharmaceutical research and development strategy
• CMC research and deliverables during the IND phase of innovative drugs
• Study on Impurities after Process Change of API
• How to do full-cycle CMC change management
• Evaluation and strategies for formulation changes during clinical trials of innovative drugs
• Developability assessment of innovative small molecule drugs under limited time