JULY 2023LIFE SCIENCES REVIEW8IN MY OPINIONBy Safwan Kezbor, M.D., Medical Director, Clinical Development, Shionogi Inc. great deal of discussion has evolved in the last few years to come up with out-of-the-box creative notions to accelerate the drug development process and shorten the time to deliver innovative, life-saving therapies to patients. There is no doubt that the COVID-19 pandemic has fueled this dialogue in the light of the unprecedented development timelines observed in COVID-19 therapies which challenged both the pharmaceutical industry and the regulatory agencies to apply these accelerated timelines to other therapeutic areas programs. Many great proposals and lessons-learned topics were emphasized, with many already implemented. For most of the fellows engaged in these discussions, the topics were mainly focused on the later ACCELERATING EARLY-STAGE DRUG DEVELOPMENT stages in drug development which include global multi-centre studies by nature with intensive discussion on boosting enrollment, enhancing study participants' experience and engagement, and delivering numerous effective and convenient options through decentralized clinical trials and other strategies. Understating the fact that late-stage drug development contributes only to a limited part of the entire clinical program strategy will underscore the need for equivalent thoughtful discussion around accelerating the decision-making process in earlier phases of drug development.The decision to move the clinical program to global phase 3 clinical study is often not an easy one given the noteworthy investment and commitment required at that stage and often requires good deliberation inside the organization by careful review of the data and the evidence ASafwan KezborPlanning for diversity in clinical trials is essential. This planning should typically start in the early phases of clinical development
< Page 7 | Page 9 >