September/October 2016

Volume 36, Number 5

 

IN THIS ISSUE

Cover: Creating Supply Chain Excellence, Achieving Superior Performance

Lou Schmukler, President of Global Manufacturing and Supply at Bristol-Myers Squibb, shares his views on fundamental elements of supply chain strategy.

NEW COLUMN

Message from the Chair

New ISPE Board of Directors Chair Mike Arnold outlines his focus for the year ahead.

FEATURES

How to Fight a Bully: Compassionate Use Policy Offers Options When None Exist

Nicole Pierson tells how Pfizer’s compassionate use program provided lifesaving treatment for her son, who was dying from an incurable brain tumor.

Shire plc: Expanded Facility in Italy Responding to Increased Market Demand

To meet increasing demand for plasma fractionation, Shire expanded the capacity of its plant in Rieti, Italy, from 600,000 to 1.7 million liters per year with minimal downtime.

QUARTERLY REPORT: BIOTECHNOLOGY

Our first quarterly report on biotechnology offers a variety of viewpoints on what it takes to succeed in biotech and biopharma.

ONLINE EXCLUSIVE

Defects Produced in Orbital Welding for Pharmaceutical Process Piping: Case Study and Simulation
Jorge Domingo and Margarita Morquillas

TABLE OF CONTENTS

Editor's Voice

Message from the Chair

New Board of Directors

Cover Story

Creating Supply Chain Excellence, Achieving Superior Performance
An interview with Lou Schmukler, President of Global Manufacturing and Supply at Bristol-Myers Squibb

Features

  • How to Fight a Bully: Compassionate Use Policy Offers Options When None Exist
  • The New World of Patient Engagement
  • Consulting: A Young Professional Perspective
  • Shire plc: Expanded Facility in Italy Responding to Increased Market Demand

ISPE News

  • ISPE Training Institute Marks First Anniversary
  • Japan Affiliate Annual Meeting Focused on New Manufacturing Trends
  • IPSE Ireland YPs Host Summer Seminar and BBQ
  • Hot Off the Presses
  • Appointments

Profile

Singapore Affiliate: A Leading Force in Southeast Asia

A YP State of Mind

New Opportunities for a Young Professional

Career Q&A

What Makes a Qualified Candidate?

QUARTERLY REPORT: BIOTECHNOLOGY

Every Patient, Every Time
Andy Skibo talks about biologics supply chain risks

A Brief History of Medical Biotechnology
The scientists, discoveries, and gene therapies that have changed the biomedical landscape

Breaking the Paradigm
The pharmaceutical industry’s shift to biotech technologies, ideas, and methodologies

The State of Biopharmaceutical Manufacturing in Ireland
Ireland is a hot spot of biotechnology and biopharmaceutical R&D and manufacturing

CRISPR: Genome Editing to Aid Drug Discovery
One of CRISPR’s most immediate benefits is the acceleration of the drug-development profile

Using the Power of Biotechnology to Deliver Affordable Health Care: Biocon’s Innovation Mission in India
Kiran Mazumdar-Shaw fosters a sustainable culture of innovation at Biocon through strong investment in R&D

Fostering the Next Generation of Biotech Entrepreneurs: JLABS Incubator Space at Texas Medical Center
Biopharmaceuticals, medical devices, and consumer health care products flourish in a Silicon Valley–like culture of innovation

Environmental Footprints of a Flexible Pharmaceutical Production Facility: A Life Cycle Assessment Analysis
Understanding the environmental impact of a biopharmaceutical facility across its entire life cycle will help focus efforts to be more sustainable

Sustainability’s Relevance to the Pharmaceutical Supply Chain
A robust and transparent supply chain is a critical element of a sustainability strategy that encompasses the entire value chain

TECHNICAL ARTICLES

Characterization of Silicone Tubing:  Effect of Pressure and Irradiation on Tubing Diameter
Pietro Perrone, Csilla Kollar, Andrew Diehl, and Ernie Jenness

Balancing Pre- and Post-Market Control of Health Supplements
Chan Lai Wah, Benjamin Tan Zhi Yang, Vimal Sachdeva, and Sia Chong Hock

Manufacturing and Packaging Line Clearance in an OSD Manufacturing Facility
Michael DeBellis, Jim Cahir, and Robert Matje

ONLINE EXCLUSIVE

Defects Produced in Orbital Welding for Pharmaceutical Process Piping: Case Study and Simulation
Jorge Domingo and Margarita Morquillas


NOTE: Pharmaceutical Engineering articles are not to be posted on any website, blog site or page, or any other internet site without prior permission from ISPE. (Copyright © 2016 ISPE. All rights reserved.)

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