Mitsuo Kitada is a senior project leader of Technical R&D in Novartis Pharma Japan. He has more than 10 years and 8 years industrial experiences in pharmaceutical and regenerative medicines, respectively. He is the CMC team leader for Kymriah and other CAR-T programs in Japan and has many experiences in communication with health authorities for these programs.
Naoyuki Hanada is a regulatory CMC manager of Novartis Pharma Japan. He has more than 10 years industrial experience in biopharmaceutical process development, commercialization, global submission and post-approval change. For the last 2 years, he has been working in regulatory CMC for cell therapy product. He also belongs to EFPIA Japan Biological Product Sub committee.