Research & Development: Page
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PharmaVoice Team/PharmaVoice
Strategic Phase II Planning -- More Important Than Ever for the Biotech Industry
Strategic Phase II Planning — More Important Than Ever for the Biotech Industry Lukas Makris, Ph.D. CEO Phase II programs should not only be judged on how well the objectives were met, but on how well they might predict the Phase III outcome. The biotechnology industr...
By PharmaVoice Team • Jan. 2, 2008 -
PharmaVoice Team/PharmaVoice
Recruitment: To Centralize or Decentralize? This is the Question.
Recruitment: To Centralize or Decentralize? This is the Question. Liz Moench President and CEO Patient and Investigator Recruitment In many people’s minds, centralized recruitment often symbolizes big money and big studies. But in actuality, nothing could...
By PharmaVoice Team • Jan. 2, 2008 -
Explore the Trendline➔
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TrendlineTech for Clinical Trials
Companies that utilize these emerging technologies wisely are likely to find an edge in the increasingly competitive drug development arena.
By PharmaVoice staff -
PharmaVoice Team/PharmaVoice
Creating a Guidance System for Life-Science Brands
Creating a Guidance System for Life-Science Brands While meaningful biomedical research depends on proteomics, genetics, and genomics tools, their ultimate application also will depend on successful commercialization and marketing tools. Mark Stinson President ...
By PharmaVoice Team • Jan. 2, 2008 -
PharmaVoice Team/PharmaVoice
Drug Development
Drug Development Strong Clinical-Trial Management Systems Market Offers Opportunities for suppliers, Clinical Sponsors, and CROs Alike The U.S. clinical-trial management systems (CTMS) market is poised for steady growth through 2008, achieving a five-year compound annual growth rate (CAGR) of abo...
By PharmaVoice Team • 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
Cover
On the Cover The Business of R&D Metrics Unlock Innovation with Marh Ahn Venture Capital Environment March 2005 www.pharmavoice.com Volume 5 Number 3 The Forum for the Industry Executive PharmaVOICE Download PDF
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
Dr. Leo H. Sternbach -- The Inventor's Inventor
Eminent scientist Leo H. Sternbach, Ph.D., is being inducted into the National Inventors Hall of Fame nearly 42 years after his landmark invention Valium was approved by the FDA. PharmaVOICE is taking this opportunity to honor Dr. Sternbach, 97, for his extraordinary achievements. We would like t...
By Kim Ribbink • Jan. 2, 2008 -
PharmaVoice Team/PharmaVoice
Diabetes: Novel Pipeline Compounds Offer New Hope
Tremendous progress has been made in the treatment of diabetes over the last decade. Still, many people with diabetes have poor glycemic control, and there is a need for more convenient therapies. As the prevalence of diabetes, especially type 2 diabetes, continues to increase, products in develo...
By Lisa Dress • 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
Innovation
Innovation Drakeman. The engine that drives growth in the pharmaceutical industry is the discovery of new medicines for unmet medical needs. Much of the innovation in development now resides in the biotech sector. The challenge is to find the most efficient and productive ways to combine biotech’...
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
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
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
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
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
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
CDISC Study Data Tabulation Model
CDISC Study Data Tabulation Model B. Thompson. We are carefully reviewing the new Study Data Tabulation Model (SDTM) to ensure that our company is doing everything possible to streamline submissions of data to the agency. It should be a goal of companies and the agency to find and implement great...
By PharmaVoice Team • Jan. 2, 2008 -
PharmaVoice Team/PharmaVoice
Importation/Price Controls
Importation/Price Controls Nash-Wong. Pharmaceutical price differential in the international markets will be top of mind. So extreme it’s been called a trade deficit; the U.S. market is currently carrying the cost of R&D for the world. This price differential is just adding fuel to the pharma...
By PharmaVoice Team • Jan. 2, 2008 -
PharmaVoice Team/PharmaVoice
Patient Safety
Patient Safety Barrett. Patient safety is a cornerstone of clinical trials. But with the increasing pace of trials, it’s no longer efficient to be reactive; proactive, real-time monitoring can increase the safety of those participating in trials, spotting potential interactions, and flagging comm...
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
Financing
Kolodny-Hirsch. As a long-time participant in this industry, it is certainly encouraging to finally see that more biotech companies are on the verge of profitability. Nonetheless, there are still hundreds of private and publicly traded biotech firms that are in the red and struggling to survive. ...
By PharmaVoice Team • Jan. 2, 2008 -
PharmaVoice Team/PharmaVoice
PharmaTrax
Sales, Marketing, and R&D Trends from Industry Analysts Pharmaceutical Companies Rethink Consumer Marketing Strategies in 2005 Facing increased scrutiny from the federal government and the public, pharmaceutical companies are looking beyond direct-to-consumer (DTC) marketing to more effective...
By PharmaVoice Team • Jan. 2, 2008
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