Manufacturing: Page 12


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    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
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    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
  • digital pill Explore the Trendline
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    Trendline

    Artificial intelligence & machine learning

    After years of excited buzz around the potential of artificial intelligence and machine learning, pharma has begun to realize the true implications and potential value of these technologies.

    By PharmaVoice staff
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    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
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    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
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    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
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    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
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    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
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    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
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    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
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    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
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    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
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    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
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    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
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    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
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    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
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    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
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    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
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    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
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    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
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    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
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    Making Metrics Matter -- The Changing Paradigm of R&D Metrics

    Making Metrics Matter The Changing Paradigm of R&D Metrics As the pharmaceutical industry comes under greater scrutiny across the board, everything from discovery processes to R&D productivity to profit margins is subject to review. In response, top industry executives are reexamining the...

    By PharmaVoice Team • Jan. 2, 2008
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    The Asthma Market Breathes Easier

    The Asthma Market Breathes Easier The approach to treating asthma continues to evolve. Rescue bronchodilator therapies are giving way, both in medical practice and in the market, to prophylactic strategies, which include inhaled corticosteroids, long-acting beta2 agonists, and leukotriene antagon...

    By PharmaVoice Team • Jan. 2, 2008
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    Talent Pool

    Pharma POOL Dr. Mahdi B. Fawzi Dr. Frank S. Walsh Wyeth Promotes Two Research Scientists to Executive VPs Wyeth Pharmaceuticals, Madison, N.J., a division of Wyeth, has promoted Mahdi B. Fawzi, Ph.D., to executive VP, head of preclinical development, and Frank S. Walsh, Ph.D., to executive VP, he...

    By PharmaVoice Team • Jan. 2, 2008
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    Medicare Part D: A Whole New Market

    Medicare Part D: A Whole New Market By Kim Ribbink Marketers, manufacturers, health plans, and other stakeholders who will play a central role in the Medicare Modernization Act (MMA) are gearing up for implementation. And while there is widespread support for a change that will improve coverage t...

    By PharmaVoice Team • Jan. 2, 2008
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    Talent Pool

    Pharma POOL Dr. Alan Colowick Threshold Pharmaceuticals Appoints Chief Medical Officer Threshold Pharmaceuticals has named Alan Colowick, M.D., chief medical officer. Threshold Pharmaceuticals, Redwood City, Calif., is focused on the discovery, development, and commercialization of small-molecule...

    By PharmaVoice Team • Jan. 2, 2008