Authors


Rebecca Burton

Latest:

Patent Law: Extracting Maximum Value from Your Patent Portfolio

by Craig R. Kaufman, Orrick, Herrington & Sutcliffe LLP, Rebecca Burton, and Anne-Marie Dinius Your patent portfolio does not make money sitting in a file cabinet. Extracting its value requires both market surveillance and an effective litigation or licensing strategy.


Jeffrey B. Birch

Latest:

A Statistical Method to Account for Plate-to-Plate Variability in Multiple-Plate Bioassays

by James D. Williams, Virginia Polytechnic Institute and State University, Jeffrey B. Birch, and Steven Walfish Statistics don't lie, but if you don't include appropriate data, the resulting statistical analyses can be misleading. In biopharmaceutical development, if the variability from several different microplates is not addressed, assays testing the relative potency against a standard can be inaccurate. A statistical method that accounts for plate-to-plate heterogeneity is needed ? and presented here.


Craig R. Kaufman

Latest:

Patent Law: Extracting Maximum Value from Your Patent Portfolio

by Craig R. Kaufman, Orrick, Herrington & Sutcliffe LLP, Rebecca Burton, and Anne-Marie Dinius Your patent portfolio does not make money sitting in a file cabinet. Extracting its value requires both market surveillance and an effective litigation or licensing strategy.


Heather Simmerman

Latest:

Demonstrating the Consistency of Small Data Sets: Application of the Weisberg t-test for Outliers

by Robert J. Seely, Amgen, Inc. Louis Munyakazi, John Haury, Heather Simmerman, W. Heath Rushing, and Thomas F. Curry Determining whether a data point is an "outlier" ? a result that doesn't fit, that is too high or too low, that is extreme or discordant ? is difficult when using small data sets (such as the data from three, four, or five conformance runs). The authors show that the Weisberg t-test is a powerful tool for detecting deviations in small data sets.


W. Heath Rushing

Latest:

Demonstrating the Consistency of Small Data Sets: Application of the Weisberg t-test for Outliers

by Robert J. Seely, Amgen, Inc. Louis Munyakazi, John Haury, Heather Simmerman, W. Heath Rushing, and Thomas F. Curry Determining whether a data point is an "outlier" ? a result that doesn't fit, that is too high or too low, that is extreme or discordant ? is difficult when using small data sets (such as the data from three, four, or five conformance runs). The authors show that the Weisberg t-test is a powerful tool for detecting deviations in small data sets.


Anne-Marie Dinius

Latest:

Patent Law: Extracting Maximum Value from Your Patent Portfolio

by Craig R. Kaufman, Orrick, Herrington & Sutcliffe LLP, Rebecca Burton, and Anne-Marie Dinius Your patent portfolio does not make money sitting in a file cabinet. Extracting its value requires both market surveillance and an effective litigation or licensing strategy.


Thomas F. Curry

Latest:

Demonstrating the Consistency of Small Data Sets: Application of the Weisberg t-test for Outliers

by Robert J. Seely, Amgen, Inc. Louis Munyakazi, John Haury, Heather Simmerman, W. Heath Rushing, and Thomas F. Curry Determining whether a data point is an "outlier" ? a result that doesn't fit, that is too high or too low, that is extreme or discordant ? is difficult when using small data sets (such as the data from three, four, or five conformance runs). The authors show that the Weisberg t-test is a powerful tool for detecting deviations in small data sets.


James D. Williams

Latest:

A Statistical Method to Account for Plate-to-Plate Variability in Multiple-Plate Bioassays

by James D. Williams, Virginia Polytechnic Institute and State University, Jeffrey B. Birch, and Steven Walfish Statistics don't lie, but if you don't include appropriate data, the resulting statistical analyses can be misleading. In biopharmaceutical development, if the variability from several different microplates is not addressed, assays testing the relative potency against a standard can be inaccurate. A statistical method that accounts for plate-to-plate heterogeneity is needed ? and presented here.


Penny Cass

Latest:

SOX in the Boardroom: What the Sarbanes?Oxley Act Means to You

by Penny Cass, BioPharm International Stay current on the changes in corporate governance regulations ? whether your company is public or private, in the United States or elsewhere. As a capital-intensive industry, many of our third-party associations are going to require that biopharmaceutical companies comply with the new regulations to receive financing. The trend to regulate corporate governance activities hasn't ended ? more rules promulgated by more government entities should be anticipated.


Sean Sales

Latest:

Analytical Advances: Collaborative Effort Results in Automated Cell Culture System

by Sean Sales, RTS Life Science International RTS Life Science International works with clients to develop modular system.


William Allbee

Latest:

The Project Management Institute's Pharmaceutical Specific Interest Group 2002 Benchmark Survey Results: Project Managers and Project Management in the Biotech Industry

by Ellis Wilson, AstraZeneca Pharmaceuticals, James McDonough, William Allbee, and Jann Nielsen Compared with their big pharma counterparts, biotech project managers earn more advanced degrees, have fewer years' experience in the industry, and more frequently classify their role as "senior management."


Ellis Wilson

Latest:

The Project Management Institute's Pharmaceutical Specific Interest Group 2002 Benchmark Survey Results: Project Managers and Project Management in the Biotech Industry

by Ellis Wilson, AstraZeneca Pharmaceuticals, James McDonough, William Allbee, and Jann Nielsen Compared with their big pharma counterparts, biotech project managers earn more advanced degrees, have fewer years' experience in the industry, and more frequently classify their role as "senior management."


JanHasker Jonkman

Latest:

Small Biopharms Face Unique Challenges: Outsourcing in Early-Stage Drug Development

by Bruce Babbitt, PAREXEL International, JanHasker Jonkman, and Paul McKim By partnering with external drug development service providers, small biopharmaceutical start-ups can move their products out of the lab and into clinical development more efficiently.



Bruce Babbitt

Latest:

Small Biopharms Face Unique Challenges: Outsourcing in Early-Stage Drug Development

by Bruce Babbitt, PAREXEL International, JanHasker Jonkman, and Paul McKim By partnering with external drug development service providers, small biopharmaceutical start-ups can move their products out of the lab and into clinical development more efficiently.


Peter Loupos

Latest:

Collaborating Across the Extended Pharmaceutical Enterprise: How Sharing Information Leads to Process Enablement

by Peter Loupos, Aventis Drug Innovation and Approval and Andrew Grygiel A collaborative framework can be a driver for cultural change, encouraging knowledge sharing between internal and external personnel and improving innovation and productivity throughout the enterprise.


Andrew Grygiel

Latest:

Collaborating Across the Extended Pharmaceutical Enterprise: How Sharing Information Leads to Process Enablement

by Peter Loupos, Aventis Drug Innovation and Approval and Andrew Grygiel A collaborative framework can be a driver for cultural change, encouraging knowledge sharing between internal and external personnel and improving innovation and productivity throughout the enterprise.



Susan McLaughlin

Latest:

Survival Strategies: The Life Sciences Industry Turns to eLearning

by Susan McLaughlin, Drug Information Association The Drug Information Association unveils the first in a series of professional development programs delivered through eLearning technologies to members worldwide.


James McDonough

Latest:

The Project Management Institute's Pharmaceutical Specific Interest Group 2002 Benchmark Survey Results: Project Managers and Project Management in the Biotech Industry

by Ellis Wilson, AstraZeneca Pharmaceuticals, James McDonough, William Allbee, and Jann Nielsen Compared with their big pharma counterparts, biotech project managers earn more advanced degrees, have fewer years' experience in the industry, and more frequently classify their role as "senior management."


Paul McKim

Latest:

Small Biopharms Face Unique Challenges: Outsourcing in Early-Stage Drug Development

by Bruce Babbitt, PAREXEL International, JanHasker Jonkman, and Paul McKim By partnering with external drug development service providers, small biopharmaceutical start-ups can move their products out of the lab and into clinical development more efficiently.


Jann Nielsen

Latest:

The Project Management Institute's Pharmaceutical Specific Interest Group 2002 Benchmark Survey Results: Project Managers and Project Management in the Biotech Industry

by Ellis Wilson, AstraZeneca Pharmaceuticals, James McDonough, William Allbee, and Jann Nielsen Compared with their big pharma counterparts, biotech project managers earn more advanced degrees, have fewer years' experience in the industry, and more frequently classify their role as "senior management."


Shirley I. Miekka

Latest:

BioPharm International's Virus Inactivation Series: A Preface

by William N. Drohan, Clearant Inc. and Shirley I. Miekka


Desiree de Myer

Latest:

BioTrends: M&A Malaise

by Desiree de Myer, BioPharm International Despite market conditions favorable to merger and acquisition activity, a frenzy of consolidations still hasn't taken place.


William N. Drohan

Latest:

BioPharm International's Virus Inactivation Series: A Preface

by William N. Drohan, Clearant Inc. and Shirley I. Miekka



Philippe Ledent

Latest:

Sponsor-CMO Conflict Management for Clinical-Phase Biologics

The authors present the CMO's perspective on various potential sources of sponsor-CMO conflicts.


Charles Lipeles

Latest:

Modular Cleanroom Facility Trends

Modular construction, preassembled modules, and independent structures offer advantages for cleanroom users.


Patrice Genois

Latest:

Modular Cleanroom Facility Trends

Modular construction, preassembled modules, and independent structures offer advantages for cleanroom users.


Eppendorf

Latest:

Stirred-tank Bioreactors in Vaccine Development Video

In this eBook, Eppendorf experts will give an overview of the most used vaccine platforms and discuss the important role of stirred-tank bioreactors in this life-saving field.

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