THE LEADING EVENT TO ENSURE CMC, REGULATORY SUCCESS AND EXPEDITED PRODUCT APPROVAL

“With the rapid development of technologies that have application to both the design of novel biological products and alternative bioassays for product characterization, new technical and regulatory issues will continue to emerge. This conference offers an excellent opportunity for participants to learn from the experiences of regulators, industry leaders and experienced scientists, including statisticians, who have played a part in the successful development of a wide array of well-characterized biologics and biological assays, and to engage in open discussions about the current challenges faced by numerous stakeholders.”

“All will share and discuss relevant data and lessons learned so common challenges can be addressed with bioassay colleagues providing practical advice supplemented with case studies.”

“I am looking forward to discussions of common challenges, strategies, and solutions for biological characterization and bioassay development. Especially looking for industry peers and HA/ regulatory feedback on approached to bioassay lifecycle management.”

“More and more novel gene therapy drugs are coming to the market. The discussion on potency assessment of these drugs between different companies and regulators is necessary.”

“With the rapid development of technologies that have application to both the design of novel biological products and alternative bioassays for product characterization, new technical and regulatory issues will continue to emerge. This conference offers an excellent opportunity for participants to learn from the experiences of regulators, industry leaders and experienced scientists, including statisticians, who have played a part in the successful development of a wide array of well-characterized biologics and biological assays, and to engage in open discussions about the current challenges faced by numerous stakeholders.”

“All will share and discuss relevant data and lessons learned so common challenges can be addressed with bioassay colleagues providing practical advice supplemented with case studies.”