June 2011

Managing Outsourced Development: Designing a Performing Process

May 25, 2011

Ronald S. Waife, MPH, President With the rise of mega-CROs, and the widespread willingness of large pharma to outsource clinical development to them, is there anything left for a sponsor’s clinical development group to do? Indeed yes. More than ever, there are hyper-critical functions that sponsors must execute effectively to produce success in clinical development. […]

Industry Experts Challenge the Status Quo on Content Management

May 25, 2011

For more than two decades, life sciences organizations have purchased, customized, configured, deployed, and maintained a series of ever-expanding and complex content management tools to help them efficiently manage content. The creation of industry-specific applications added to these technologies’ ability to support more specific life sciences needs, such as regulatory submissions and document management. And […]

Clinical Data Gap Analysis ­Uncovering Hidden Opportunities

May 25, 2011

David Fishman, MBA President Snowfish LLC The practice of medicine relies on clinical evidence. From a product’s conception through approval, launch, and post-launch activities, clinical evidence is the rationale for a product’s overall existence. Clinical data is critical for differentiation and ultimately, market acceptance. A solid grasp of the clinical data for a product and […]

Metrics for Faster Clinical Trials

May 25, 2011

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 the study. Criteria are growing in complexity, and […]

Bringing Process Efficiency to ­Clinical Trial Randomization

May 25, 2011

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 has become a business goal for most organizations. The benefits of efficient […]

Partnering with CROs: Achieving Operational Excellence

May 25, 2011

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 they’re looking to speed their development […]

Effective Use of Health Technology ­Assessment to Maximize Market Access: Start Early and Update Often

May 25, 2011

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 licensed, sceptical payers are increasingly demanding […]

Understanding the Finer Points of the Electronic Source Documentation Draft Guidance

May 25, 2011

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 could be potential show stoppers. Since the draft guidance may not […]

SHOWCASE FEATURE: A Changing Rhythm

May 24, 2011

According to Barbara Wirostko, M.D., chief medical officer for Altheos, the question of whether a product candidate will be reimbursed by government and third-party payers is now surfacing in the earliest stages of discovery. “Because there are now issues around who is going to reimburse and who is going to pay for novel, expensive new […]

Merhaba, Turkey: Opportunity Knocks

May 24, 2011

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 domestically and about 70% of this manufacturing is done by foreign companies, according […]

Changing Oncology Regulations

May 24, 2011

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 therapeutic areas, with only 34% of candidates succeeding at this […]

Educating the Scientists of the Future

May 24, 2011

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 industry in particular. Studies show American students are falling behind other […]

DIA Preview

May 24, 2011

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 alphabetically by company and include the booth number for the 2011 DIA exhibitor.) […]

R&D’s Technology Evolution

May 24, 2011

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 leading to systems integration and a convergence of […]

CSR Gets a Makeover

May 24, 2011

Corporate social responsibility (CSR) policies have been in place for decades at most companies, but the increased social awareness of today’s consumers has stepped up the visibility of such programs. The state of the world’s economy, the ever-evolving business environment, and an overall growth in social awareness of corporate sustainability is shining a spotlight on […]

Pharma 3.0: A Call for Collaboration and Experimentation

May 24, 2011

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, systematic, and scalable approaches to business model innovation. The two most prevalent elements that will separate the winners […]

Last Word

May 24, 2011

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 the 1930s, there are organisms in America, Europe, and […]

Talent Pool

May 24, 2011

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 International, where she served as chief medical officer and senior VP of global medical affairs. She received an M.D. […]

OUTLET

May 24, 2011

This year’s report on the pharmaceutical sector by Ernst & Young reminded me of that classic tale of technological transition — the fate of the wagon wheel maker. With the introduction of the automobile, one wheel maker was asked what business he was in. “I make wagon wheels,” he replied. But another wheel maker asked […]

Social Media

May 24, 2011

Patient Communities Improve Adherence TrendWatch: Two recent studies show that online patient communities not only provide ­support for patients that lead to better health outcomes, but they are also great resources for ­tracking and collecting health data and can be used for public health research, surveillance, and other health-related activities. PatientsLikeMe Site Increases Epilepsy Treatment […]

Tools of the Trade

May 24, 2011

New Electronic and Web-based Applications, Sites, and Technologies Featured Briefs: Virtual Pharma Rep Seeks to Reinvent Sales Model The Accelrys Modeling and Simulation Suite E-UPGRADES AND ENHANCEMENTS Trend: New dynamics within the pharmaceutical industry are prompting a paradigm shift to ­virtual sales support and service models that reduce costs while enhancing the pharma-physician relationship. Virtual […]

What’s New

May 24, 2011

New Healthcare-related Products, Services, and Companies Trend: Healthcare agencies are shifting their service models to better address the market’s ­evolving approach to health and well-being. Featured Briefs: GSW Expands Health and Wellness Capabilities Newport Module ­Provides Biologics Intelligence In other news… ON THE SHELVES THE WELL @GSW, the health and wellness capability of GSW Worldwide, […]

PharmaTrax

May 24, 2011

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 Could Benefit Phase III Therapies Industry Collaboration Critical for Specialized Medicines Aggregate Spend Compliance Can Yield […]

UpFront

May 24, 2011

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 Thought Leader: Steven Yoder, Fisher Clinical Services Networked Drug Development — Bringing ­Assets, Capital and Services […]

Letter from the Editor

May 24, 2011

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 Nintendo, are becoming […]

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