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EDITORIAL
Editorial Director Chris Spivey CSpivey@mjhlifesciences.com
PharmTech Europe Editor Felicity Thomas FThomas@mjhlifesciences.com
Senior Editor Meg Rivers MRivers@mjhlifesciences.com
Managing Editor Susan Haigney SHaigney@mjhlifesciences.com
Manufacturing Editor Jennifer Markarian JMarkarian@mjhlifesciences.com
Science Editor Feliza Mirasol FMirasol@mjhlifesciences.com
Assistant Editor Grant Playter GPlayter@mjhlifesciences.com
Creative Director, Publishing Melissa Feinen
Senior Art Director Marie Maresco
Senior Graphic Designer Maria Xelo
Susan J. Schniepp sue.schniepp@mac.com; Eric Langer info@bioplanassociates.com;
and Cynthia A. Challener, PhD challener@vtlink.net
485 Route One South, Building F, Second Floor, Iselin, NJ 08830, USA
Tel. 732.596.0276, Fax 732.647.1235, PharmTech.com
Address
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Tel. +44 151 705 7601
SALES
Publisher Michael Tracey MTracey@mjhlifesciences.com
Sales Manager Linda Hewitt Tel. +44 (0) 151 705 7603 LHewitt@mjhlifesciences.com
Senior Sales Executive Stephen Cleland Tel. +44 (0) 151 705 7604 SCleland@mjhlifesciences.com
Sales Operations Executive Sarah Darcy SDarcy@mjhlifesciences.com
Senior Vice President, Industry Sciences Michael Tessalone
C.A.S.T. Data and List Information Michael Kushner MKushner@mjhlifesciences.com
Permissions PTpress@mmhgroup.com with "Permissions" in Subject Line
Audience Development Research Director
Christine Shappell cshappell@mjhlifesciences.com
MJH LIFE SCIENCES®
President & CEO Mike Hennessy Jr
Chief Financial Of ficer Neil Glasser, CPA/CFE
Chief Operating Of ficer Michael Ball
Chief Marketing Of ficer Brett Melillo
Executive Vice President, Global Medical Af fairs & Corporate Development Joe Petroziello
Senior Vice President, Content Silas Inman
Vice President, Human Resources and Administration Shari Lundenberg
Vice President, Mergers & Acquisitions Chris Hennessy
Executive Creative Director Jeff Brown
Bio/Pharma Outsourcing
Innovation 2022
OUTSOURCING SERVICES
4 The Next Frontier in
Pharmaceutical Outsourcing
Stephan Hütter
8 What Outsourcing
Partners Wish You Knew
Meg Rivers
ANALYTICS
12 Establishing Systems Suitability
and Validity Criteria for Analytical
Methods and Bioassays
Thomas A. Little and Daniel S. Harding
DEVELOPMENT
18 Method Development in Demand
Felicity Thomas
20 Gaining Formulation
Expertise through Partnerships
Felicity Thomas
23 Balancing Internal Focus
Against External Capabilities
Chris Spivey
MANUFACTURING
28 Preparing for the Future: Expanding
Capacity and Facilitating Multi-modalities
James Park
30 Spray Drying Finds Growing Use for ASDs
Jennifer Markarian
QUALITY/REGULATIONS
34 Fostering Orphan Drugs
Susan Haigney
36 Ad Index
On the cover: Monstar Studio - Stock.adobe.com
Art Direction: Maria Xelo