Manufacturing: Page 12

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Flying High On A Vision

Flying High on a Vision By Kim Ribbink Entrepreneurs are individuals who make innovation possible; they are the people who stake their reputation, finances, and future on running their own businesses and achieving something different. As pharmaceutical and service companies continue to merge, bus...
By PharmaVoice Team • Jan. 2, 2008
PharmaVoice Team/PharmaVoice

The Continuing Evolution of EDC

Paper may still reign supreme, but the EDC industry is coming of age. There is widespread agreement — at least intuitively — that the use of an electronic device or software application that allows direct data entry into electronic format has the potential to reduce time and money within the drug...
By PharmaVoice Team • Jan. 2, 2008
Explore the Trendline➔

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Trendline

Cell and gene therapies

How the industry is overcoming hurdles in cell and gene therapy space and pushing for the next generation of treatments.
By PharmaVoice staff
PharmaVoice Team/PharmaVoice

GMP: A Change in FDA Thinking

GMP: A Change in FDA Thinking Experts on this topic David Barr. VP, regulatory compliance consulting, AAC Consulting Group Inc., Rockville, Md.; AAC Consulting, a subsidiary of Kendle International Inc., provides a full range of support and assistance to industries regulated by the FDA and simila...
By PharmaVoice Team • Jan. 2, 2008
PharmaVoice Team/PharmaVoice

Talent Pool

Pharma POOL Michael J. DuBois Jeffrey A. Winton Schering-Plough Announces VP Appointments Schering-Plough, Kenilworth, N.J., has appointed Michael J. DuBois senior VP of global licensing. In this role, Mr. DuBois, 56, is responsible for the acquisition of new products discovered outside Schering-...
By PharmaVoice Team • Jan. 2, 2008
PharmaVoice Team/PharmaVoice

On the Calendar

May 16-17 Global Clinical Trials Hyatt Regency Jersey City, Jersey City, N.J. For more information, contact Caria Badenhorst, Marcus Evans, at 246-417-5321, e-mail [email protected], or visit marcusevans.com. May 16-17 5th Annual Sample Accountability Hyatt Regency Princeton, Princeton, N....
By PharmaVoice Team • Jan. 2, 2008
PharmaVoice Team/PharmaVoice

Table of Contents

On the Cover Culture of compliance: Cutting through the confusion To be compliant with the many regulations and guidances that apply to the marketing of prescription products, companies need to create a culture of compliance that fosters and promotes an ethical atmosphere and compliant behavior. ...
By PharmaVoice Team • Jan. 2, 2008
PharmaVoice Team/PharmaVoice

Shifting the Compliance Paradigm

VIEW on regulatory compliance Michael Kuehne is President of ACSYS Inc., Hillsborough, N.J., which specializes in developing quality and compliance solutions that combine R&D and manufacturing capabilities to deliver sustained improvement in R&D, Quality, Operations, Clinical, and Regulat...
By PharmaVoice Team • Jan. 2, 2008
PharmaVoice Team/PharmaVoice

From Bar Codes to Chips & Antennas

Pharmaceutical companies are now testing the use of radio frequency identification (RFID) technologies, which hold the potential for protecting the patient, protecting the brand, and strengthening the supply chain. New applications of a not-so-new technology are about to completely change how the...
By Denise Myshko • Jan. 2, 2008
PharmaVoice Team/PharmaVoice

Letter from the Editor

Leadership is not magnetic personality — that can just as well be a glib tongue. It is not ‘making friends and influencing people’ –that is flattery. Leadership is lifting a person’s vision to high sights, the raising of a person’s performance to a higher standard, the building of a personality b...
By Taren Grom • Jan. 2, 2008
PharmaVoice Team/PharmaVoice

On the Calendar

February 15-17 WCBF Six Sigma in Chemicals & Pharmaceuticals Hyatt Regency Dallas, Dallas For more information, contact Louise Gosling, WCBF Six Sigma Solutions, at 44-14-83 76-0883, e-mail [email protected], or visit wcbf.com. February 15-18 18th Annual DIA Electronic Document Manageme...
By PharmaVoice Team • Jan. 2, 2008
PharmaVoice Team/PharmaVoice

Supply Chain

Supply Chain Szwast. Pharmaceutical manufacturers face the challenges of accelerating new product introductions, shifts in global sourcing and distribution, the intensifying need for companies to meet regulatory and customer compliance rules, and enhancing shareholder value. Product introductions...
By PharmaVoice Team • Jan. 2, 2008
PharmaVoice Team/PharmaVoice

Intellectual Property

Intellectual Property Shanahan. The ability to codify and share intellectual property (i.e., scientific understanding) can bring the 20% R&D cost closer to 16% to 18% of revenue. The current inability to codify and share is at the root of the following challenges: bringing new drugs and thera...
By PharmaVoice Team • Jan. 2, 2008
PharmaVoice Team/PharmaVoice

Shareholder Value

Shareholder Value Freedman. The ability to consistently deliver more novel new chemical entities and therapies is a huge challenge but it is the way to increase value for shareholders and patients. Innovative companies, the ones with superior ROIs, seem to be more receptive and willing to adopt t...
By PharmaVoice Team • Jan. 2, 2008
PharmaVoice Team/PharmaVoice

Cover

PharmaVOICE The Forum for the Industry Executive Year In Preview: 2005 More than 100 experts talk about the industry’s future www.pharmavoice.com December 2004 Special Issue Volume 4 Number 12 Download PDF
By PharmaVoice Team • Jan. 2, 2008
PharmaVoice Team/PharmaVoice

Table of Contents

Contents Kristine Nash-Wong, Marketing Manager at HealthMedia, speaks about reputation enhancement. Dr. Thomas Wicks, VP of Regulatory Affairs at Odyssey Pharmaceuticals, talks about continuing treatment innovation while limiting costs. Scott Szwast, Sector Marketing Manager at UPS Supply Chain S...
By PharmaVoice Team • Jan. 2, 2008
PharmaVoice Team/PharmaVoice

Letter from the Editor

2005 Year In Preview Taren Grom In keeping with PharmaVOICE’s mission of providing insightful and provocative commentary on the business practices, strategies, and services that affect the life cycle of products from molecule through market, it is our pleasure to publish the first annual Year in ...
By Taren Grom • Jan. 2, 2008
PharmaVoice Team/PharmaVoice

Introduction

The Pulse of the Industry By Taren Grom This first annual PharmaVOICE Year in PreVIEW is designed to provide an overview of the challenges and trends expected to impact the life-sciences industry in the coming year and beyond. For this special forum, a distinguished list of more than 100 industry...
By Taren Grom • Jan. 2, 2008
PharmaVoice Team/PharmaVoice

Business Models

Turett. The pharmaceutical industry needs to resolve multiple bipolarities: being a business and being a public utility; being doctor-focused and being consumer-focused; and being about medical innovation and being about marketing. The industry has begun a process of self-reinvention that in 2005...
By PharmaVoice Team • Jan. 2, 2008
PharmaVoice Team/PharmaVoice

Medical Education

Medical Education Nash-Wong. Last year’s predictions on regulatory changes had us believing medical education was a thing of the past. Not so, if one considers the fact that physicians continue to attend educational meetings, despite limited food budgets and a ban on spouses. So rather than forec...
By PharmaVoice Team • Jan. 2, 2008
PharmaVoice Team/PharmaVoice

Multifunctional Teams

Multifunctional Teams Wilson. Historically, the pharmaceutical industry has faced two hurdles: achieving product registration and securing reimbursement. Today, demonstrating product value is becoming a much stronger issue. It’s not just a matter of product price, but the impact on total cost of ...
By PharmaVoice Team • Jan. 2, 2008
PharmaVoice Team/PharmaVoice

Technology

Technology Cauwenbergh. Ideally, predictive tools, including assays, computer modeling techniques, and biomarkers could shorten development time, reduce the cost of development, and increase the accuracy of diagnosis, making sure that the right patient gets the right drug because of proper diagno...
By PharmaVoice Team • Jan. 2, 2008
PharmaVoice Team/PharmaVoice

Risk Management

Risk Management Turett. The term risk management implies a defensive, prepare-for-the-worst strategy. While defensive preparation is certainly important, taking a fresh look at conducting business in a “patient-first” manner will reduce the need to implement a defensive approach. In other words, ...
By PharmaVoice Team • Jan. 2, 2008
PharmaVoice Team/PharmaVoice

Talent Pool

Pharma POOL Matthew E. Czajkowski aaiPharma Appoints Executive VP, Chief Financial Officer Matthew E. Czajkowski has been appointed executive VP and chief financial officer of aaiPharma, Wilmington, N.C., a science-based pharmaceutical company focused on pain management. Mr. Czajkowski, 55, previ...
By PharmaVoice Team • Jan. 2, 2008
PharmaVoice Team/PharmaVoice

Fee-For-Service: Getting What You Pay For

VIEW on Wholesale Pricing Models In an exclusive to PharmaVOICE, Adam J. Fein, Ph.D., Founder and President of Pembroke Consulting Inc., a firm that helps senior executives of wholesale distribution, manufacturing, and B2B technology companies build and sustain market leadership, discusses why ph...
By PharmaVoice Team • Jan. 2, 2008
PharmaVoice Team/PharmaVoice

On the Calendar

On the Calendar April 17-19 Medical Manufacturing Summit The Homestead Resort, Hot Springs, Va. For more information, contact Caria Badenhorst, Marcus Evans, at 246-417-5321, e-mail [email protected], or visit medicalmanufacturingsummit.com. April 18-19 Neurodegeneration in Alzheimer’s, Pa...
By PharmaVoice Team • Jan. 2, 2008