Research & Development: Page 68
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Metrics for Faster Clinical Trials
Almost half of clinical trials run late, year after year. Why does this happen? The biggest delaying factor is finding enough patients, and the delay starts with the clinical trial protocol. The protocol includes the inclusion and exclusion criteria that define the patients who are eligible for t...
By Bill Gwinn • May 25, 2011 -
Bringing Process Efficiency to Clinical Trial Randomization
Modern business has fully embraced the benefits of process efficiency. From the widespread adoption of process improvement as driven by Michael Hammer, author of “Reengineering the Corporation," its evolution to the Six Sigma movement, to the more recent “lean sigma" approach, process efficiency ...
By PharmaVoice Team • May 25, 2011 -
Explore the Trendline➔
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TrendlineOncology R&D
Cancer research remains a prime focus for the industry and often leads to pharma’s most impactful breakthroughs.
By PharmaVoice staff -
Partnering with CROs: Achieving Operational Excellence
Our industry is facing a challenge. In 2010, the FDA approved only 21 new drugs, down from 26 in 2009 and 24 in 2008. To counteract this decrease, biopharmaceutical companies are increasingly anxious to launch their products as quickly as possible to benefit from related revenue sooner. One way t...
By PharmaVoice Team • May 25, 2011 -
Effective Use of Health Technology Assessment to Maximize Market Access: Start Early and Update Often
We all know that the face of drug discovery and the market for new pharmaceutical products (and medical devices/diagnostic technologies) is changing. The era of the blockbuster appears to be over, the cost of bringing a new product to market has skyrocketed and when a new product is eventually li...
By Andrew Briggs • May 25, 2011 -
Understanding the Finer Points of the Electronic Source Documentation Draft Guidance
For those involved with collecting data generated by clinical trials, the recent draft guidance on electronic source documentation released by the FDA deserves your scrutiny. The impact of this guidance for sites is significant and the implications for CRAs, data managers, and technology vendors ...
By Jonathan Andrus VP • May 25, 2011 -
Merhaba, Turkey: Opportunity Knocks
As the largest pharmaceutical market in the Middle East and the fastest growing in the Mediterranean region, Turkey presents some exciting opportunities for the pharmaceutical market. Consumption of pharmaceuticals in Turkey totals around $8 billion, with 50% of these drugs being manufactured dom...
By Kim Ribbink • May 24, 2011 -
Changing Oncology Regulations
Developing oncology therapies can be complex. These products often have a tough time making it to the market. In fact, a study released in February by the Biotechnology Industry Organization and BioMedTracker shows that oncology products had the lowest Phase III success rate among seven therapeut...
By Denise Myshko • May 24, 2011 -
Educating the Scientists of the Future
High-quality science education is critical for the success of pharmaceutical and biotechnology companies, not only to meet the need for scientists in the future but also to foster scientific literacy. Education reform is a hot-button issue for the nation in general and the pharmaceutical industr...
By Denise Myshko • May 24, 2011 -
DIA Preview
New Tools, Services, and Products Designed to Improve Drug Development This special Drug Information Association section highlights the new and innovative products being offered by companies exhibiting at the upcoming 2011 DIA — 47th Annual Meeting in Chicago. (Note: briefs are listed alphabetic...
By PharmaVoice Team • May 24, 2011 -
R&D's Technology Evolution
Technology tools are the cornerstones for achieving a drug development process that is faster, cheaper, and easier. Over the last 10 years, there has been increasing use of EDC, ePRO, CTMS, dashboards, and other tools to streamline the drug development process. Now a changing R&D paradigm is ...
By Denise Myshko • May 24, 2011 -
Pharma 3.0: A Call for Collaboration and Experimentation
Success or failure in Pharma 3.0 — an ecosystem comprised of established industry members, nontraditional companies, and an increasingly informed data-empowered consumer — will be based on life-sciences companies’ ability to develop innovative, outcomes-focused offerings through structured, syste...
By Robin Robinson • May 24, 2011 -
Last Word
Combating Drug Resistance Roger Pomerantz, M.D., Senior VP and Head of Infectious Disease Research at Merck, talks about why antimicrobial resistance is a major global concern. PV: How big of a problem is antimicrobial resistance? Pomerantz: For the first time since the antibiotic era started in...
By PharmaVoice Team • May 24, 2011 -
Talent Pool
Pharmaceutical POOL Dr. Janet HAMMOND Roche Strengthens Translational Medicine Leadership Roche has appointed Janet Hammond, M.D., Ph.D., VP, translational medicine – virology in pharmaceutical research and early development (pRED). Dr. Hammond joins Roche from Valeant Pharmaceuticals Internation...
By PharmaVoice Team • May 24, 2011 -
PharmaTrax
Sales, Marketing, and R&D Trends from Industry Analysts Featured Briefs: Specialists More Likely to Open and Click Through Email Sidebar: Email Campaigns to Physicians by Type, July-December 2010 Branded Pharma Sites Help Drive Prospect, Patient Conversions Personalized Medicine Strategy Coul...
By PharmaVoice Team • May 24, 2011 -
UpFront
Awards… GSK Medical Officer Honored Merck Scientists Recognized by PhRMA Kendle Recieves Achievement Award INDUSTRY at Large Going BIOSimiliar Parents Need Education about Nutrition Quote of the Month… Terry Hisey / Deloitte Podcasts Clinical Supply Optimization: Challenges & Solutions Thou...
By PharmaVoice Team • May 24, 2011 -
Letter from the Editor
Ready or Not Here Comes Pharma 3.0 Pharma 2.o was so last decade. Thanks to the good folks at Ernst & Young, who have coined the term Pharma 3.0 to describe a new ecosystem of healthcare, we are indeed entering new territory. As noted back in February, nontraditional pharma companies, such as...
By Taren Grom • May 24, 2011 -
Navigating the New Communications Landscape
The ways patients seek and share information—both in and out of the doctor’s office—are undergoing radical change. From the rise of the Internet to the explosion of social media to the growing patient demand for active participation in treatment decisions, a multitude of forces are converging to ...
By Chris DeAngelis • April 25, 2011 -
Creating a Personalized Medicine Strategy
Considered broadly, healthcare is personal. The goal of medical practitioners has always been to get the right drug to the right person at the right time at the right dose. But now industry experts say personalized medicine is at a tipping point as a multitude of factors converge, including advan...
By Denise Myshko • April 25, 2011 -
Last Word
John Gargiulo, Daiichi Sankyo’s new President and CEO, discusses the future opportunities for the company and the industry. Keeping the Patient Front and Center Last Word PV: What are your goals for Daiichi Sanyko? Gargiulo: The healthcare industry is currently experiencing unprecedented challeng...
By PharmaVoice Team • April 25, 2011 -
Talent Pool
Pharmaceutical POOL Dr. Anirvan GHOSH Roche Selects Head of CNS Discovery Global healthcare company Roche has named Anirvan Ghosh, Ph.D., head of discovery for central nervous system (CNS). Dr. Ghosh is based at Roche’s pharma research and early development organization in Basel, Switzerland, an...
By PharmaVoice Team • April 25, 2011 -
PharmaTrax
Sales, Marketing, and R&D Trends from Industry Analysts Featured Briefs: R&D Productivity Measures Consistently Undervalued Generics Firms Turning to M&A for Market Foothold Sidebar: Top 10 New Product Approvals in 2010 Specialty, Hospital Sales Forces Anticipate Double-Digit Growth P...
By PharmaVoice Team • April 25, 2011 -
Letter from the Editor
The mHealth Revolution The Statistics are staggering. According to a report by research2guidance, by 2015 one in five people around the world will have a smartphone. Another report states that mobile app revenue is expected to reach $35 billion by 2014. Finally, company investment in mobile phone...
By Taren Grom • April 25, 2011 -
Showcase Feature — IRBs Watching the Protectors
Ever-changing clinical-trial regulations and continued growth in multicenter and international studies have resulted in an exponential increase in the volume of data generated for IRB review, including large numbers of individual adverse event (AE) reports, which often lack the context and detail...
By Carolyn Gretton • March 28, 2011 -
Privyet! Russia: Growth and Opportunity
With its promise of expansion, its population of around 140 million potential customers, and a pool of highly qualified staff, Russia has long been recognized as an important market for pharmaceutical companies. The pharma market in Russia has shown stable annual growth of 13% to 20% for several ...
By Kim Ribbink • March 28, 2011 -
Talent Pool
Pharmaceutical POOL Steve FRY Dr. Sue MAHONY Lilly Announces Leadership Shifts Lilly has promoted Steve Fry to senior VP of human resources and diversity. Mr. Fry was previously VP of human resources for two of Lilly’s business areas, biomedicines and emerging markets. Mr. Fry succeeds Sue Mahony...
By PharmaVoice Team • March 28, 2011