Matt Campagna Bristol Myers Squibb
With over 8 years of experience in regulatory affairs CMC, I am passionate about supporting the development and global commercialization of innovative cell and gene therapies that can transform patients' lives. My core competencies include developing
and implementing successful CMC strategies, preparing and filing global regulatory submissions, and managing and facilitating agency interactions. I am currently an Associate Director, Global Regulatory Affairs CMC Cell Therapy at Bristol Myers Squibb,
where I work with a diverse and collaborative team of experts to advance BMS's pipeline of cell and gene therapies.
In my current role, I leverage my skills in bioassay, cell biology, and protein purification to support the CMC aspects of BMS's cell and gene therapy programs, including CAR-T and gene editing products. I am responsible for preparing and filing CMC submissions (including initial IND/IMPD, BLA, post approval variations), as well as responding to CMC questions from global health authorities. I also coordinate and provide strategic input for agency meetings and interactions, ensuring that BMS's CMC positions are aligned with the regulatory requirements and expectations. Prior to joining BMS, I supported the global commercialization of Daiichi Sankyo's ADC pipeline, primarily focused on datopotamab deruxtecan, a novel antibody-drug conjugate for the treatment of various cancers.
In my current role, I leverage my skills in bioassay, cell biology, and protein purification to support the CMC aspects of BMS's cell and gene therapy programs, including CAR-T and gene editing products. I am responsible for preparing and filing CMC submissions (including initial IND/IMPD, BLA, post approval variations), as well as responding to CMC questions from global health authorities. I also coordinate and provide strategic input for agency meetings and interactions, ensuring that BMS's CMC positions are aligned with the regulatory requirements and expectations. Prior to joining BMS, I supported the global commercialization of Daiichi Sankyo's ADC pipeline, primarily focused on datopotamab deruxtecan, a novel antibody-drug conjugate for the treatment of various cancers.