BioPharm International - March 2021

BioPharm International - Regulatory Sourcebook - March 2021

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BioPharm I N T E R N AT I O N A L eBook T h e S ci e n ce & B usi n e ss o f B i o p h a r m a ce u t i c a ls 2 BioPharm International eBook March 2021 Cover: wladimir1804 - QUALITY Can FDA Reinvent On-Site Inspections? Agnes Shanley 4 Growing Pipeline of Antisense Oligonucleotides Prompts Guidance Feliza Mirasol 6 Gene Therapies Target Neurodegenerative Diseases Feliza Mirasol 12 OPERATIONS A Real-World Approach to Evaluating Cleanroom Garments Anne Marie Dixon-Heathman 14 QUALITY COLLABORATION Special Section: It Takes a Bio/Pharma Village The editors of Biopharm International 22 Overcoming Challenges to Biopharmaceutical Development and Manufacture with Science and Risk-Based Strategies Saroj Ramdas, Renata Varga, Martin Gastens, Twinkle R. Christian, Bharat Jagannathan, Barbara Rellahan, and Jillian Brady 23 Enabling the Virtual Human Through Physiologically-based Pharmacokinetic Modeling Heidi J. Einolf, Stephen D. Hall, Tracy Williams, Aarti Patel, Christopher Gibson, Nancy G.B. Agrawal, and Jens Sydor 27 Extrapolating Data from Adult Clinical Trials to Advance Pediatric Drug Development Sebastian Haertter, S.Y. Amy Cheung, Angela James, Ashley Strougo, Christina Bucci-Rechtweg, Jing Liu, Meina Tao Tang, Paulien Ravenstijn, Raafat Bishai, Satyendra Suryawanshi, and Solange Corriol-Rohou 31 Collaborative Efforts Address Key Data Integrity Challenges Ganapathy Mohan, Christopher Turner, Dennis O'Connor, Lisa Fink, Thomas Purdue, Jeffrey Beebie, Kerri Robles, and Karen Waetje 36 RESOURCES FDA 2021 Guidance Agenda Sees Focus on Generics 39 Resources, Guidelines, and Guidance Documents 42 Regulatory and Standard Setting Organizations 44 Ad Index 48 Regulatory Sourcebook March 2021 Contents © 2021 MultiMedia Pharma Sciences LLC All rights reserved. No part of this publication may be reproduced or transmitted in any form or by any means, electronic or mechanical including by photocopy, recording, or information storage and retrieval without permission in writing from the publisher. Authorization to photocopy items for internal/educational or personal use, or the internal/educational or personal use of specific clients is granted by MultiMedia Pharma Sciences LLC for libraries and other users registered with the Copyright Clearance Center, 222 Rosewood Dr. Danvers, MA 01923, 978-750-8400 fax 978-646-8700 or visit online. For uses beyond those listed above, please direct your written request to Permission Dept. Alexa Rockenstein, Reprints: Contact Michael Tracey, MultiMedia Pharma Sciences LLC provides certain customer contact data (such as customers' names, addresses, phone numbers, and e-mail addresses) to third parties who wish to promote relevant products, services, and other opportunities that may be of interest to you. If you do not want MultiMedia Pharma Sciences LLC to make your contact information available to third parties for marketing purposes, simply email and a customer service representative will assist you in removing your name from MultiMedia Pharma Sciences LLC lists. BioPharm International does not verify any claims or other information appearing in any of the advertisements contained in the publication, and cannot take responsibility for any losses or other damages incurred by readers in reliance of such content. BioPharm International welcomes unsolicited articles, manuscripts, photographs, illustrations, and other materials but cannot be held responsible for their safekeeping or return. To subscribe, email ADVERTISING Publisher Mike Tracey National Sales Manager Scott Vail European Sales Manager Linda Hewitt European Senior Sales Executive Stephen Cleland Senior Vice President, Industry Sciences Michael Tessalone C.A.S.T. Data and List Information Michael Kushner AUDIENCE DEVELOPMENT Audience Development Christine Shappell MJH LIFE SCIENCES TM Chairman and Founder Mike Hennessy, Sr Vice Chairman Jack Lepping President and CEO Mike Hennessy, Jr Chief Financial Officer Neil Glasser, CPA/CFE Chief Marketing Officer Michael Baer Executive Vice President, Global Medical Affairs and Corporate Development Joe Petroziello Senior Vice President, Content Silas Inman Senior Vice President, Operations Michael Ball Senior Vice President, I.T. & Enterprise Systems John Moricone Vice President, Human Resources & Administration Shari Lundenberg Vice President, Mergers & Acquisitions Chris Hennessy Executive Creative Director, Creative Services Jeff Brown EDITORIAL Editorial Director Rita Peters Senior Editor Agnes M. Shanley Managing Editor Susan Haigney European Editor Felicity Thomas Science Editor Feliza Mirasol Manufacturing Editor Jennifer Markarian Assistant Editor Lauren Lavelle Creative Director, Publishing Melissa Feinen Senior Art Director Marie Maresco Senior Graphic Designer Maria Reyes

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