Reimagining Medicine

Cover: Novartis CEO Joseph Jimenez sits down with Pharmaceutical Engineering to discuss the rapidly changing health care landscape, the role of R&D, and how the industry can develop long-term sustainable models.

The Real Cost of Poor Data Integrity

Feature: James Davidson of Lachman Consultants talks about the impact of GMP data integrity breaches and the costs of regulatory actions such as Warning Letters and import alerts.

JHL Biotech: From Start-Up to cGMP Manufacturer in Less Than Three Years

Feature: JHL Biotech has grown from a start-up to a certified cGMP pharmaceuticals manufacturer in three short years. Nick Kotlarski, VP Validation and Engineering, gives us the backstory.

Supply Chain Manufacturing

Special Report: Jim Curry, CEO of OpStat Group, explores the intersection of globalization, data integrity, and ISPE’s Operations Management Good Practice Guide.

• The Operations Management Guide team leaders Jim Curry; Giuseppe Ravizzini, Group Engineering and Maintenance Manager, Recordati Group; and Marzio Mercuri, Technical Operations Director, Polpharma Group; talk about their new GPG and soon-to-be released survey of industry best practices.
• David Churchward, Expert GDMP Inspector at MHRA, explains how regulators encourage a culture of data integrity.

A Risk-Based Approach to Clinical Research: Solving Problems Before They Occur

Technical: Patricia Santos-Serrao

CPPM for Effective Multivariate Risk Modeling for Life Cycle Management

Technical: Matej Janovjak, John Cunningham, Adam Fermier, Steve Mehrman, and Roger Holenstein