Continuous Improvements in ATMPs and Cell & Gene Therapies
ATMPs, Cell and Genetic therapies - or whatever other jurisdictions use – have come a long way. I am unsure how many of us have forgotten the early failures and setbacks. There was a time, in the early years, when serious side effects, such as deaths, endangered the field. It prompted the regulators to halt research, introducing various constraints and safeguards. In Europe, it felt like every day brought a new rule to set you back to the drawing board, when an approval of a mere clinical trial application was a never-ending process, with people sometimes looking at you and secretly thinking, “Why bother? It will never happen.” Although frustrating, it perfectly fitted in the “regulatory pendulum.” The principle of “first do no harm” is very prominent in the mind of regulators; they respond to science but aren’t immune to the swinging moods of public opinion, and sometimes death, even if ultimately unrelated to the therapy, is impossible to put aside. On the plus side, this also prompted researchers to step back and reconsider their approaches. By persevering, they found more therapeutic targets and ways to make them safer.