EDITOR'S DESK

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  Give Credit To The U.S. Pharma Industry For Leading Reincorporation

  You’ve got to give credit to companies in our industry. If punitive U.S. taxation policy is going to drive them to do deals overseas, they are going to go big-time and in style. If they are not allowed to repatriate global dollars in a sensible manner, they will invest them with fanfare abroad.

• Pennsylvania Continues Aggressive Push For Life Sciences
• Covance Brings Together Pharma And Biotech To Speed Drug Development
• How To Prepare A Facility For The Biopharmaceutical Revolution
• Will Technology Adoption Change Your Partnering Strategy?

CLINICAL PERSPECTIVES

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  BRIC Nations: Divergent Patterns in the Clinical Trials Landscape

  The clinical trial landscape in BRIC countries is changing. Long heralded as a low-cost alternative to Western markets, Brazil, Russia, India and China are experiencing a shift in trial initiation by global sponsors.

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  FDA Safety Labeling Requirements

  Prior to 2007, the U.S. Food and Drug Administration’s labeling authority was limited; the agency could only request changes to the labeling of approved drug products. That changed, however, with the enactment of the Food and Drug Administration Amendments Act of 2007, in particular, section 505(o)(4). In that section, the FDA was given new authority to require safety labeling changes for approved drugs.

  This means the FDA can now order labeling changes if it becomes aware of new safety information that it believes should be included in the labeling of a drug. This article summarizes the FDA’s thinking in this regard, as indicated by its guidance released in recent weeks.

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  Gaining Greater Predictability, Control And Quality In Bioprocessing With Metabolic Biomarkers

  Biologics are an integral part of the landscape of current therapies as pipelines continue to fill with them. Due to their importance and this ever expanding pipeline, the demands continue to escalate due to cost pressure, competition, regulatory requirements, disposable systems, and biosimilars. To date, these demands arguably have primarily been met with empirical understanding. However, there is a critical need for new approaches, tools, and technologies to deliver deeper understanding beyond the empirical realm. By Dr. Kirk Beebe, Director of Application Science, Metabolon, Inc.

FROM THE INDUSTRY EXPERTS

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  Maximizing Your Data Quality: Our Relentless Journey

  It’s simple: You need to get the most from your clinical trial. So it’s no wonder that at Covance, we’re constantly asking: “How can we deliver higher quality data to you, faster?”

• eTMFs: Moving From Electronic Filing Cabinet To Strategic Asset
• GCC Price Harmonization Process: Implications And Outcomes
• An Update On The Buzz Around Oncology

WHITE PAPERS AND CASE STUDIES

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  10 Questions: FDA Compliance Using Electronic Signatures — Part 1

  Digital signatures are a subset of electronic signatures. Digital signatures is the term that we use to describe standard electronic signatures. In the United States, the digital signature standards are published and maintained at the federal government level by the National Institute of Standards and Technology (NIST).

• Contemporary Science Insights Next Generation Therapies I. Stem Cells
• Seeing Around Corners: Risk Assessment Is The Foundation Of Risk-Based Monitoring
• Managing Clinical Trial Risk: It's A Tough Job, But One Person Has To Do It
• Preferred Relationships Between CRO’s And Investigators: A Proactive Approach To Speeding Patient Enrollment

INDUSTRY NEWS

• Outsourced Pharma West Conference To Feature Andy Skibo of MedImmune/AstraZeneca

  Andy Skibo, EVP Operations for MedImmune, as well as RVP Supply Biologics for AstraZeneca, will be a featured panelist at the Outsourced Pharma West Conference and Exhibition, November 10-11 in San Francisco.

• Ruthigen Doses First Patient In RUT58-60 Anti-Infective Trial
• Basilea and Quintiles Unite To Launch Zevtera/Mabelio Antibiotic In Europe
• What You Missed From Regulatory Agencies Last Week—July 14-18, 2014
• Ganymed Completes Recruitment For Phase 2 IMAB362 Cancer Trial

FEATURED SERVICES AND PRODUCTS

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  Neurosciences

  Our neuroscience team is driven to help our clients manage the complex world of nervous system disorders to deliver therapies quickly and within budget. While the neuroscience environment is moving at a rapid pace with shortening development times, PPD’s clinical team and medical professionals are prepared to step in and effectively navigate our clients’ trials in disorders of central nervous system (CNS), peripheral nervous system, sleep medicine and pain management.

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  Bio-STAR Technology: Clinical Trial Logistics Management

  World Courier pioneered the development of an advanced technology to streamline the management of clinical trial logistics. Unparalleled within the industry, World Courier’s cutting edge technological innovations provide you with logistical tools to effectively manage your study – from the pre-trial phase right through to your last shipment.

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  In-Vitro Diagnostic Device Clinical Trials

  LabCorp Clinical Trials provides full-service central laboratory services in support of 510(k) and PMA clinical trials for in vitro diagnostics (IVD). We have extensive experience working with diagnostic companies to bring new tests to market by combining our broad-based laboratory capabilities with expert project management, data management and regulatory insight developed from working over 20 years on thousands of clinical trials across all major therapeutic areas.

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  uPRO™ - Facilitate And Collect Patient-Driven Data

  Collects Patient-Driven Data over the internet. When deployed in conjunction with DATATRAK’s uEDC™ product, study team members access a single location to view and manage all study data.

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  Xcellerate™ Clinical Trial Optimization™ Research shows that clinical trial enrollment comes up short a good 50% of the time, which costs you valuable time and money. But now there’s a unique new way to better predict which clinical sites are likely to deliver the right patients. So you can engage them from the start and avoid sites that are more likely to underperform.
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  CoSign Cloud

  From large enterprises to small businesses, CoSign is the proper digital signature solution for anyone looking to finally make the move to more efficient paper-free processes.

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  Biometrics Services

  Chiltern provides fully comprehensive Data Management, EDC Study Build, EDC Training / Consultancy, Statistical and Medical Writing services.

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  eClinical OS Trial Connect Mobile App

  Access your trials virtually anywhere, at any time. Critical study data – now at your fingertips.

CLINICAL LEADER WEBINARS

• Digital Signatures: Enabling Compliant Collaboration and Streamlined Corporate Governance

  In this webinar, we’ll focus on the middle office where life sciences organizations can achieve tangible operational improvements and cost savings.

• Adaptive Trials In Oncology Research Webinar

  Adaptive trial design is critical in all phases of oncology drug development and helps overcome many hurdles of traditional study design. In a recent webinar, PPD’s Dirk Reitsma, M.D., vice president, global product development, and Niklas Morton, vice president, global biostatistics, programming and medical writing, analyzed the incorporation of adaptive trial design in oncology trials. They were joined by Scott Berry, Ph.D., president and senior statistical scientist with Berry Consultants, to assess the early decision making benefits that are critical to the decreasing drug development time and providing increased benefit to patients.

• Will BRIC be the Savior for the Life Sciences and Medical Devices Sector?

  Will BRIC be the Savior for the Life Sciences and Medical Devices Sector?  Discover key lessons from the field and best practices vital to reap rewards from these countries during Frost & Sullivan’s complimentary webinar. The briefing will benefit any senior manager in the corporate strategy or global marketing areas that focuses on emerging markets, as well as any healthcare company looking to explore BRIC countries.

• New Indications For Existing Medical Entities

  This webinar will take a critical view at the diverse technologies that have been proposed for repositioning. 

ARCHIVE NEWSLETTER

• 07.23.14 -- FDA Updates 16-Year Old Policy On Informed Consent In Clinical Trials
• 07.16.14 -- FDA Releases Blueprint For Pediatric Rare Disease Drug Discovery
• 07.09.14 -- Inspection Focus In Clinical Trials Using A Risk-Based Monitoring Approach
• 07.02.14 -- Pfizer's Five-Year Plan Moves From Integration To Optimization
• 06.25.14 -- Big Pharma In Neck And Neck Race Toward Meningitis Vaccine Approval