PharmaVOICE - 
March 2010
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In Every Issue
Last Word
Pfizer’s Mark Swindell discusses the ­integration of Wyeth’s vaccine business [...]
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Talent Pool
Pharmaceutical POOL John DUCKER, APP Pharmaceuticals Dr. Julie GERBERDING, Merck [...]
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E-media
New Electronic and Web-based Applications, Sites, and Technologies Featured Briefs: [...]
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What’s New
New Healthcare-related Products, Services, and Companies Featured Briefs: GxP Consulting [...]
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PharmaTrax
Sales, Marketing, and R&D Trends from Industry Analysts Featured Briefs: [...]
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Upfront
According to industry experts, the impact of the updated REMS [...]
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On The Cover

Molecule to Market: A Drug-Development Timeline
According to the most recent report from the Tufts Center for the Study of Drug Development, it takes about 10 years on average for an experimental drug to travel from the lab to U.S. patients. Only five in 5,000 compounds that enter preclinical testing make it to human testing, and of these five, only one [...]
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Taren Grom, Editor

Features

Experts
John C. Andrews, Ph.D. Director of Regulatory Affairs, Americas, Chiltern, a global CRO. For more information, visit chiltern.com. Jerome Bailey. VP, Early Phase Business Center, Omnicare Clinical Research, a full-service CRO with diverse therapeutic expertise and comprehensive clinical service offerings. For more information, visit omnicarecr.com. Hal Barron. Global Head, Product Development and Chief Medical Officer, [...]
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Phase IV: Technology Solutions
According to John Hall, global medical affairs, epidemiology and outcomes research, at Quintiles, electronic health record providers are at the leading edge of new solutions, and are providing more effective ways to collect data while protecting physician relationships. The industry faces several critical challenges when dealing with Phase IV and registry studies, which technology can [...]
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Robin Robinson

PostLaunch: A REMS Focus
According to industry experts, the impact of the updated REMS policy in 2007 has had limited impact on the industry thus far. The FDA was granted expanded authority to require REMS (risk evaluation and mitigation strategies) for new drug applications or for existing drugs where the FDA has determined that REMS are necessary to ensure [...]
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Robin Robinson

Launch: Safety Counts
Approval is no longer the final step,” says Anne Tomalin, president of i3 CanReg. “Companies need to consider the possibility that their product may have to be removed from the market one to two years down the road because a safety signal develops.” In addition to collecting data and managing a difficult registration process, companies [...]
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Robin Robinson

Registration and Launch: The Next Steps of a Long Journey
The registration and launch phase is evolving like the rest of drug development, and the industry must evolve its practices along with it. One big aha moment for the industry is to understand that data, study reports, and other regulatory documents are not the end, but rather integral parts of the journey. New regulations, new [...]
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Robin Robinson

Phase III: Market Preparation
How the brand begins to be positioned across the spectrum of medical communications — specifically how the science behind the brand and trial results begin to be discussed at global and local congresses, from interactive and traditional exhibit stands to symposia, from posters to special social events — starts in earnest during Phase III trials, [...]
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Robin Robinson

Phase III Trials: Patient Recruitment and Data Collection
Two of the biggest bottlenecks in the drug development process, particularly at the Phase III juncture, are patient recruitment and data management. Experts say technology, partnering, and strategic planning can improve Phase III clinical trial efficiency. Phase III: Recruitment ­Technologies According to industry sources, almost 70% of U.S. trials do not enroll patients on time, [...]
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Robin Robinson

Phase II: Testing Efficacy, Planning for Marketing
Pharmaceutical companies and their partners are working to address productivity and create efficiency in Phase II development. New types of trial designs, such as adaptive trials, are being considered as solutions to these perennial issues. “There are innovative ways in which biopharmaceutical companies are currently addressing the efficiency issue, which include population pharmacokinetic/pharmaco­dynamic modeling; conducting [...]
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Denise Myshko

Phase I: Patient Recruitment
According to Peter Smith, Ph.D., senior VP, nonclinical development sciences at Millennium Pharmaceuticals: The Takeda Oncology Company, shortages in funding, manpower, and patient availability have created the proverbial perfect storm in the current clinical trial system. “The fact that traditional clinical trial endpoints in assessing novel agents are being reconsidered only puts more pressure on [...]
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Denise Myshko

Phase I: From Animals to First-in-Human Studies
The simple study designs of the past have been replaced with more complex designs with the addition of more screening and study procedures, biomarkers, and pharmacokinetic samples requirements, as well as longer study exposure periods. The trend today is conducting more rigorous, early-phase clinical research that will help biopharmaceutical companies identify and select the most [...]
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Denise Myshko

CROs and Preclinical Development
To create efficiency and offload the need to maintain staff, instruments, and consumables for irregularly scheduled projects and projects that extend beyond their scope, more labs are engaging CROs as outsourcing partners, according to a recent report by BioInformatics LLC. Thomas Jones, Ph.D., senior director, toxicology and pathology, Eli Lilly and Company, believes it is [...]
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Denise Myshko

Preclinical Development: Linking the Lab to Human Trials
The challenge of pharmaceutical discovery and development as a whole is that a large number of conditions need to be met in order for a single molecular entity to successfully reach the market, says Thomas Jones, Ph.D., senior director, toxicology and pathology, Eli Lilly and Company. “The molecule needs to have the appropriate specificity and [...]
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Denise Myshko

Biomarkers Across Drug Development
Biomarkers have a multitude of applications, such as detecting disease early on, identifying potential drug targets, predicting patient response to medication, and accelerating clinical trials. The promise of biomarkers to shorten drug development time and decrease costs in the long term is likely to act in tandem to spur growth in the biomarker analysis market, [...]
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Denise Myshko

Drug Discovery: From Compound to Product Candidate
The first step in finding a drug to bring to the clinic is screening chemical compound databases against a protein target. There are several phases that comprise early development, including target identification and validation, hit finding, and lead optimization. Activities during these steps, which aim to understand the underlying mechanism or cause of disease and [...]
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Denise Myshko

A Long and Winding Road
In today’s biopharma economy, declining R&D productivity combined with increased development costs have made investment portfolio managers skittish, says Chip Gillooly, VP, capital, at Quintiles. “The risks associated with investments are high, and the lack of output is making everyone nervous,” he says. “To manage this new high-risk environment, and continue to deliver valuable and [...]
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Taren Grom, Editor

Letter from the Editor
As PharmaVOICE enters its 10th year, the basic premise on which we founded the publication, and the company, remains as true today as it did on that February afternoon back in 2001: there is a fundamental need to understand the life-sciences industry from a holistic perspective that cuts across industry silos and provides a horizontal [...]
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