2 BioPharm International eBook October 2021 www.biopharminternational.com
© 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 http://www.copyright.com online. For uses
beyond those listed above, please direct your written request to BPpress@mmhgroup.com with
"Permissions" in the subject line. Reprints: Contact Michael Tracey, mtracey@mjhlifesciences.com.
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 mmhinfo@mmhgroup.com 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 mmhinfo@mmhgroup.com
ADVERTISING
Publisher Mike Tracey MTracey@mjhlifesciences.com
National Sales Manager Scott Vail SVail@mjhlifesciences.com
European Sales Manager Linda Hewitt LHewitt@mjhlifesciences.com
European Senior Sales Executive
Stephen Cleland SCleland@mjhlifesciences.com
Senior Vice President, Industry Sciences Michael Tessalone
MTessalone@mjhlifesciences.com
C.A.S.T. Data and List Information
Michael Kushner MKushner@mjhlifesciences.com
AUDIENCE DEVELOPMENT
Audience Development Christine Shappell cshappell@mjhlifesciences.com
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
Vice President, Human Resources & Administration Shari Lundenberg
Vice President, Mergers & Acquisitions Chris Hennessy
Executive Creative Director, Creative Services Jeff Brown
EDITORIAL
Editorial Director Chris Spivey CSpivey@mjhlifesciences.com
Senior Editor Meg Rivers MRivers@mjhlifesciences.com
Managing Editor Susan Haigney SHaigney@mjhlifesciences.com
European Editor Felicity Thomas FThomas@mjhlifesciences.com
Science Editor Feliza Mirasol FMirasol@mjhlifesciences.com
Manufacturing Editor Jennifer Markarian JMarkarian@mjhlifesciences.com
Assistant Editor Grant Playter GPlayter@mjhlifesciences.com
Creative Director, Publishing Melissa Feinen
Senior Art Director Gwendolyn Salas
Senior Graphic Designer Maria Reyes
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
Cover: magele-picture - Stock.adobe.com
Contents
Regulatory Sourcebook
October 2021
INNOVATION
Collecting Industry's Thoughts
on FDA FARS Report
Feliza Mirasol 4
DRUG SAFETY
The Real Danger of Substandard and
Counterfeit COVID-19 Vaccines
Meg Rivers 6
Serialization and Aggregation
from a Manufacturing Perspective
Meg Rivers 10
BIOSIMILARS
The Evolving Biosimilar Approach
Felicity Thomas 14
CMC STRATEGIES
Selecting the Right
CMC Strategy for Biologics
Khanh Ngo Courtney 18
DATA INTEGRITY
How Artificial Intelligence Impacts
the Global Regulatory Environment
Rajesh Talpade 22
BIOBUSINESS
NIST Proposes Clarifications to
Bayh-Dole March-in Rights Regulations
Kevin E. Noonan 26
INDUSTRY PERSPECTIVES
Industry Organizations Assist Pharma
During the Pandemic and Beyond
The Editors of BioPharm International 30
AD INDEX 33
C H A I R M A N & F O U N D E R
Mike Hennexssy, Sr.
