MAY - 2023LIFE SCIENCES REVIEW6Life sciences companies have a deep-rooted process for clinical development, but the outbreak of the pandemic has disrupted the traditional ways of testing new drugs. As the post-pandemic era continues to unravel the limiting scopes of clinical studies, life sciences companies keep expanding their search for other possibilities and devise new ways of working with accelerated digital adoption and innovation, particularly to refine their approach to regulatory requirements. Real-world data (RWD) is becoming increasingly important in the regulatory demands of life sciences companies. In the past, the FDA has primarily focused on considering clinical data from controlled clinical studies when reviewing and approving drugs. However, the FDA is now recognizing the value of RWD in monitoring post-market safety, adverse events, and making judicious regulatory decisions.Equally interesting is the use of Pragmatic clinical trials (PCTs) in improving regulatory needs by providing a more efficient and effective way to generate timely evidence to guide drug approvals, especially during pandemics like COVID-19. These patient-centred, outcome-based trials compare the benefits and risks of therapeutic interventions to inform clinical and policy decision-making. These trends are driving the life sciences market to grow at a CAGR of 8.7 percent.To put the spotlight on the key developments, Life Sciences Review APAC illustrates how companies are leveraging the latest developments in the regulatory services space to give value-based solutions to their customers. This edition also features leadership articles from Philippe Pinton, VP, Global Head Translational Medicine and Clinical Pharmacology, Ferring Pharmaceuticals; Jon Kallay, Senior Technology and Market Development Manager at Charles River Laboratories; Joel Finkle, Associate Director, Regulatory Information Management, BeiGene USA; Narayana Rao, Vice President of Biopharma, Asia Pacific Middle-East Africa, Avantor. They shed light on how the rapid emergence of cell and gene therapy (CGT) has offered hope for the treatment of both rare and common genetic disorders as well as previously incurable life-threatening diseases.In this edition of Life Sciences Review APAC, we also bring the stories of the most successful companies in the regulatory services domain. In the list, Critical Compliance particularly stands out for offering quality and regulatory consulting services to organizations of all sizes in manufacturing and distribution and assisting them in achieving compliance goals. Through the following pages, we aim to highlight the innovative trends and latest developments in the regulatory services space. We would like to know your thoughts.EDITORIALEnsuring Regulatory Compliance with RWD and Pragmatic Clinical Trials Copyright © 2023 ValleyMedia, Inc. All rights reserved. Reproduction in whole or part of any text, photography or illustrations without written permission from the publisher is prohibited. The publisher assumes no responsibility for unsolicited manuscripts, photographs or illustrations. Views and opinions expressed in this publication are not necessarily those of the magazine and accordingly, no liability is assumed by the publisher thereof.Email:sales@lifesciencesreview.comeditor@lifesciencesreview.commarketing@lifesciencesreview.com MAY - 01 - 2023, Vol 03, Issue - 35 (ISSN 2831-8331) Published by ValleyMedia, Inc.To subscribe to Life Sciences ReviewVisit www.lifesciencesreview.com Editorial StaffAaron PierceCarolynn WaltersShirley FaithRussell ThomasVisualizersDisclaimer: *Some of the Insights are based on our interviews with CIOs and CXOsJeremy WilliamsManaging Editoreditor@lifesciencesreview.comManaging EditorJeremy WilliamsWill FortClara Matthew
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