APR May/June 2023 - 4

IN THIS ISSUE
10 INSIDER INSIGHT
Data-Driven Science: How AI and Open Data will Revolutionize
Scientific Discovery
Dr. Ryan Brinkman, Vice President and Research Director
Dotmatics
38 DRUG DISCOVERY
Exploring New Chemical Space for the Treatments of Tomorrow
Adityo Prakash, CEO
Verseon International Corporation
38 FACILITY TOUR
Investing in the Future of Biopharmaceuticals
Eurofins BioPharma Product Testing
42 FORMULATION AND DEVELOPMENT
Building a Strong Data Foundation for Decentralized Clinical Trials
with an FSP Model
Robert King, Executive Director, Functional Service Partnership (FSP) Solutions
PPD Clinical Research Business of Thermo Fisher Scientific
Jenna McDonnell, Senior Director, Consulting,Innovation and Strategy,
Digital and Decentralized Solutions
PPD Clinical Research Business of Thermo Fisher Scientific
George Weir, Senior Director, Clinical Data Management
PPD Clinical Research Business of Thermo Fisher Scientific
50 FORMULATION AND DEVELOPMENT
Unlocking the Potential of Medical Imaging as Real-World Data
Elif Sikoglu, Senior Director of Life Sciences Solutions
Flywheel
54 MICROBIOLOGY
Improving the Sterility Assurance Section of an Application to Allow for
More Efficient Assessment of ANDA and NDA Submissions to the FDA
John Arigo, PhD1
and Erika Pfeiler, PhD2
1
Division Director, Division of Microbiology Assessment 1, Office of
Pharmaceutical Manufacturing Assessment, Office of Pharmaceutical Quality,
Center for Drug Evaluation and Research, Food and Drug Administration
2
»
66 BIOPHARMACEUTICALS
Next-Generation Cell Line Development for Biotherapeutics Applications:
Driving Precision and Productivity from the Molecular Level
Anis H. Khimani, PhD, Senior Strategy Leader, Life Sciences Strategy Group
Revvity
Tanaya Surve, enior Scientist, Bioproduction Group
Revvity
QC CORNER
34 Two Strategies to Improve the Productivity and Compliance of
Sterility Testing
Sponsored Content from MilliporeSigma
VENDOR VIEWPOINT
58 Reducing LAL Usage in Compliant Endotoxin Assays
Hayden Skalski
Veolia Water Technologies & Solutions, Sievers Instruments
54 Lipid Nanoparticles for Dermal Drug Delivery
Dr. Alison Halliday
ELGA LabWater
INTERVIEW
60 An Interview with Exyte
Chris Miller, President, Global Business Unit, Biopharma and Life Science
Exyte
72 An Interview with ACG
Rafael Costa, Vice President of Sales
ACG
REGULAR FEATURES
6 Message from the Editor
7
8 CN Perspectives
9
Branch Chief, Division of Microbiology Assessment 2, Office of Pharmaceutical
Manufacturing Assessment, Office of Pharmaceutical Quality, Center for Drug
Evaluation and Research, Food and Drug Administration
62 MICROBIOLOGY
Method Validation/Verification: How Important is it in Your QC
Microbiology Laboratory?
Laurie Boyd, MBA, AT, Manager, Quality Control
A mid-sized biopharmaceutical company
4 |
| May/June 2023
Editorial Advisory Board
Social Media Connections
78 P.I.N. Points
80 Advertiser's Index
SPECIAL FEATURES
48 Equipment Focus
74 Editor's Top Tech
76
INTERPHEX Award Winners 2023
APR May/June 2023

Table of Contents for the Digital Edition of APR May/June 2023
