DECEMBER - JANUARYLIFE 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 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 ACCELERATING EARLY-STAGE DRUG DEVELOPMENT 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 generated at the early stages of the clinical trials. Applying the concepts of quality of design and systematic critical thinking during the early stages of clinical development and First-In-Human (FIH) studies can deliver the accurate and adequate data-driven information needed to accelerate this decision and gain momentum in the global clinical program as a result. The thinking around FIH study design has moved away from the traditional design targeting winning a fast proof of the drug safety and tolerability as primary objective to more dynamic thinking of the secondary objectives desired to gain additional information beyond the safety and the pharmacokinetics (PK) data to enable better and faster-informed decision in the further steps. Several sub-studies Safwan KezborA
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