Table Of Content

Project Management for Drug Developers Project managers in drug development are the driving force behind the coordina- tion of efforts. This book provides a practical reference for project managers in the pharmaceutical and biotech drug development industry, with the goal of assisting in creating an efficient and effective team structure and environment. The text details the role of project managers at each stage of drug development, the key interfaces that the project manager will need to work closely with, and essential tools of the trade, including frequently used techniques and methodologies. This book is use- ful for both entry-level and advanced-level project managers, as well as non-project managers from other functions. Features • Includes authors’ recent experience with improved tactics and technologies/ software at various stages of drug development. • Provides the most up-to-date and best practices, techniques, and methodologies in project management. • Details the role of the project manager at each stage of drug development, including working with the key interfaces throughout the process. • Diverse audience, including non-project managers in clinical development, clinical operations, regulatory affairs, medical affairs, clinical pharmacology, and biostatistics. • Provides templates and timelines for critical paths from development to commercialization and has potential as a textbook on relevant courses. Drugs and the Pharmaceutical Sciences A Series of Textbooks and Monographs Series Editor Anthony J. Hickey RTI International, Research Triangle Park, USA The Drugs and Pharmaceutical Sciences series is designed to enable the pharmaceutical scientist to stay abreast of the changing trends, advances, and innovations associated with therapeutic drugs and that area of expertise and interest that has come to be known as the pharmaceutical sciences. The body of knowledge that those working in the pharmaceutical environment have to work with, and master, has been, and continues, to expand at a rapid pace as new scientific approaches, technologies, instrumentations, clinical advances, economic factors, and social needs arise and influence the discovery, development, manufacture, commercialization, and clinical use of new agents and devices. High Throughput Screening in Drug Discovery Amancio Carnero Generic Drug Product Development: International Regulatory Requirements for Bioequivalence, Second Edition Isadore Kanfer and Leon Shargel Aqueous Polymeric Coatings for Pharmaceutical Dosage Forms, Fourth Edition Linda A. Felton Good Design Practices for GMP Pharmaceutical Facilities, Second Edition Terry Jacobs and Andrew A. Signore Handbook of Bioequivalence Testing, Second Edition Sarfaraz K. Niazi FDA Good Laboratory Practice Requirements, First Edition Graham Bunn Continuous Pharmaceutical Processing and Process Analytical Technology Ajit Narang and Atul Dubey Project Management for Drug Developers Joseph P. Stalder For more information about this series, please visit: www.crcpress.com/Drugs-and- the-Pharmaceutical-Sciences/book-series/IHCDRUPHASCI Project Management for Drug Developers Edited by Joseph P. Stalder Founder, Groundswell Pharma Consulting San Diego, USA First edition published 2023 by CRC Press 6000 Broken Sound Parkway NW, Suite 300, Boca Raton, FL 33487-2742 and by CRC Press 4 Park Square, Milton Park, Abingdon, Oxon, OX14 4RN © 2023 selection and editorial matter, Joseph P. Stalder; individual chapters, the contributors CRC Press is an imprint of Taylor & Francis Group, LLC Reasonable efforts have been made to publish reliable data and information, but the author and pub- lisher cannot assume responsibility for the validity of all materials or the consequences of their use. The authors and publishers have attempted to trace the copyright holders of all material reproduced in this publication and apologize to copyright holders if permission to publish in this form has not been obtained. If any copyright material has not been acknowledged please write and let us know so we may rectify in any future reprint. Except as permitted under U.S. Copyright Law, no part of this book may be reprinted, reproduced, transmitted, or utilized in any form by any electronic, mechanical, or other means, now known or hereafter invented, including photocopying, microfilming, and recording, or in any information storage or retrieval system, without written permission from the publishers. For permission to photocopy or use material electronically from this work, access www.copyright. com or contact the Copyright Clearance Center, Inc. (CCC), 222 Rosewood Drive, Danvers, MA 01923, 978-750-8400. For works that are not available on CCC please contact mpkbookspermissions@ tandf.co.uk Trademark notice: Product or corporate names may be trademarks or registered trademarks and are used only for identification and explanation without intent to infringe. ISBN: 978-1-032-12668-5 (hbk) ISBN: 978-1-032-12920-4 (pbk) ISBN: 978-1-003-22685-7 (ebk) DOI: 10.1201/9781003226857 Typeset in Times by codeMantra Contents Foreword ...................................................................................................................ix Preface.......................................................................................................................xi Glossary of Terms and Abbreviations....................................................................xiii Editor ......................................................................................................................xxi Contributors .........................................................................................................xxiii PART 1 The Role of PM in Drug Development Chapter 1 Overview of Drug Development ..........................................................3 Hourik Miller Chapter 2 Project Management’s Place in Drug Development and the Various Project Management Roles in Biopharma ............................17 Joseph P. Stalder Chapter 3 Project Teams .....................................................................................33 Joseph P. Stalder Chapter 4 The Project Management Office ........................................................55 Norbert Leinfellner Chapter 5 Project Portfolio Management............................................................71 Mark Christopulos PART 2 Contemporary Topics in Drug Development Chapter 6 Agile Project Management and Its Application to Drug Development .......................................................................................91 Kamil Mroz Chapter 7 Managing International Projects ......................................................109 Henri Criseo v vi Contents Chapter 8 Managing Combination Drug–Device Projects ...............................123 Rhonda Peck Chapter 9 How Technology Can Assist Project Managers Now and in the Future .........................................................................................133 Dave Penndorf Chapter 10 Assessing, Selecting, and Implementing a Project Management Information System ..........................................................................153 Dave Penndorf Chapter 11 Creating an Asset Development Plan ...............................................177 Joseph P. Stalder Chapter 12 Creating a Clinical Development Plan .............................................185 Joseph P. Stalder Chapter 13 Creating a Market Application Submission .....................................203 Joseph P. Stalder PART 3 G RIDALL: A Comprehensive Framework for Managing Projects Chapter 14 Introduction to GRIDALL ...............................................................215 Joseph P. Stalder Chapter 15 Goals ................................................................................................221 Joseph P. Stalder Chapter 16 Risks .................................................................................................233 Joseph P. Stalder Chapter 17 Issues ................................................................................................243 Joseph P. Stalder Contents vii Chapter 18 Decisions ..........................................................................................249 Joseph P. Stalder Chapter 19 Actions ..............................................................................................259 Joseph P. Stalder Chapter 20 Lessons Learned...............................................................................265 Joseph P. Stalder Appendix I: Team Performance Survey ............................................................271 Appendix II: List of Common Agile Practices ..................................................273 Appendix III: New PM Onboarding Checklist .................................................275 Appendix IV: Transition Plan ............................................................................279 Appendix V: Resource Management Definitions ..............................................281 Appendix VI: Generic Job Description for a Director-Level Development Project Manager ...........................................................................283 Index ......................................................................................................................287 Foreword Development of pharmaceutical products is one of the most complex and expensive challenges for teams to undertake. It requires the identification of a novel approach to treat a sickness or disease, executing a plan for confirming compound utility, manu- facturing of trial drug lots (and subsequent scale-up), non-clinical testing to support safety studies, determining the effectivity of the drug in animal models, and prepar- ing information for submission to regulatory agencies to allow the work to continue. Years of evaluation are needed before a company can even request the initiation of a small clinical trial. Challenging regulatory requirements must be met, and consider- ations of those for each target geographic region need to be addressed. Competitive pressures for speed to market drive taking the most efficient pathway possible. It is a daunting task for even the most experienced companies. Project management methodologies are being used in all functional areas of the development process to meet these challenges. Project managers are assigned to drug asset development, CMC activities, clinical trials, and regulatory submission prepa- rations. Project management for the entire product development program requires alignment of the activities of all the functional teams to keep the program on track. This herculean task requires using the best approaches and continually making improvements. There are some challenges that make pharma product development more difficult than other industries. The large number of cross-functional teams needed at every stage of development can lead to communication challenges and unnecessary delays. Since healthcare solutions are global, product development is also global with teams spread across time zones, supply chains, and cultural working norms. Making management even more difficult, many functional activities are outsourced to specialty firms, which can lead to issues and delays. The testing of the target molecule(s) for effectivity and safety while development is ongoing can require pivoting when unex- pected results occur. Finally, regulatory requirements differ in each country and are continually being upgraded, leading to new challenges throughout the development cycle to ensure a smooth pathway to regulatory approvals. Each of these complexities requires particular attention and are the bedrock challenges that project management addresses. This book discusses the challenges that project managers face, and approaches and solutions to improve project management results. It provides a framework for the overall processes that must be managed and details on how workstreams inter- act. Beginning with descriptions of how project management overlays on the drug development process, specific topics include different roles for project managers, managing teams, using a project management office approach to improve project management and dealing with project portfolios. Then, information on several best practice approaches for handling major challenges is detailed. The authors tackle topics including management of international projects, information systems, creation of key plans, and successful regulatory submissions. ix