EDITOR'S DESK

• Patient Reported Outcomes: A Key To Compliance Success Factors

  Subject compliance is a hot topic in the industry right now. Some of the discussions out there can be a little misleading since ‘compliance’ means different things to different people / companies.

• Enabling Technology Can be Critical To Timely CMO Delivery
• Tapping Into Metabolites To Overcome R&D Challenges And Develop Novel Biomarkers: Part 1
• Acquisition Expands Phase I Capabilities
• FDA Presents Regulatory Challenges For Finished Dosage Manufacturers

CLINICAL PERSPECTIVES

• 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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  FDA Warnings Going Social

  We all know that social media is a vital part of any company’s marketing today. Now that Facebook has over 1 billion active users and Twitter has 200 million, we can all understand why so many marketers use these tools to communicate important information about their products. This is true in the pharmaceutical and supplement industry as well (see How Pharma Should Be Using Social Media).
  
  However, we all should be aware that FDA has in recent months issued a number of Warning Letters that make it obvious that FDA is also keeping an eye on social media, and the growing number of consumers that pharma and supplement companies connect with by Tweet and Facebook posts.

• 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

• International Clinical Trials In Serbia: Why Not Enroll The Right Patients Fast?

  It would be fair to say that applying the principles of evidence-based medicine and more stringent requirements of regulatory authorities (among which the FDA is first and foremost) to prove the efficacy and safety of newly developed drugs leads to the stable and steady growth of the number of clinical trials. It would be good to mention here that in the last 5 years clinical trials involved approximately 50,000 sites across the globe annually enrolling 1.5 million patients each year. At the same time, it is obvious that such a number of patients may not be enrolled by the United States alone, this country currently enrolling only about half this number, and that drug developers and Clinical Research Organizations (CROs) are constantly in need of finding new clinical sites outside the US borders where studies may be conducted in adherence to the proper safety requirements, where treatment standards are high and sufficient public control of the clinical trials may be ensured.

• Growing Freight Tonnage Equals Growing Cargo Security Concerns
• Preparing For The Physician's Payment Sunshine Act Of 2009

WHITE PAPERS AND CASE STUDIES

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  Examining Tau Phosphorylation As A Potential Alzheimer’s Disease Biomarker

  Covance scientists are always on the lookout to apply the latest research to their work and contribute additional findings to the scientific community. They will present a poster studying the regulation of Tau phosphorylation at the upcoming 2013 Society for Neuroscience conference in San Diego. By Jordan Jensen and Robert Martone, Covance

• DATATRAK ONE™ Delivers Over $1.3M In Cost Savings For Phase III Clinical Trial Supply Management & Shipping Procedures
• Despite The Presence Of Typhoon Vincente, Good Teamwork And Communication Made A Valuable Pharmaceuticals Shipment From Toronto To Sydney Possible
• FDA Inspections Of Clinical Investigators: Are You Ready?
• Outsourcing Regulatory Lifecycle Management: An Efficient New Model Meets Increasing Global Demands

NEWS HEADLINES

• Johnson & Johnson Subsidiary Submits FDA Application For New Drug To Treat Castleman Disease, A Rare Blood Disorder

  Clinical trials conducted by Janssen Research & Development, LLC points to evidence that its experimental drug, siltuximab improved symptoms and shrank growths in patients with Castleman disease, a rare blood disorder that causes enlarged lymph nodes. This condition can lead to a multitude of symptoms and weaken the immune system, making it hard to fight infection.  Infections in people with Castleman can be very serious and even fatal. No other approved therapies currently exist for the disease.

• NovoNordisk Drug Demonstrates Superior Blood Sugar Control
• Sansum Clinic Cardiologists Initiate Clinical Trial To Test Bioresorbable Vascular Scaffold For Treatment Of Heart Disease
• Sarah Cannon Research Institute Announces Acquisition Of Clinical Development Group
• Genocea Biosciences Initiates Phase 1 Study Of Vaccine Candidate GEN-004 To Prevent Infections Caused By Pneumococcus

FEATURED SERVICES AND PRODUCTS

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  Contract & Regulatory Services

  With tight timelines and complicated regulatory documentation requirements, getting a clinical trial up and running quickly is easier said than done. Key milestones—including drug shipment, IRB approval, and patient randomization—can be achieved only after the successful negotiation of clinical trial agreements and completion of essential regulatory documents.

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  Cold Chain Product Integrity: Platform-as-a-Service (PaaS)

  Dyzle is a global innovator in measuring, analyzing, distributing and displaying business process data in real-time, providing complete visibility in the cold chain. Our innovative and world-leading platform-as-a-service (PaaS) solution provides our customers with complete and accurate intelligence and automated compliance reports related to the quality of temperature sensitive products.

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  Customer Complaint Software

  The MasterControl Customer Complaints software is an integrated customer complaint management system that is a configurable and easy-to-use solution that helps ensure regulatory compliance.

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  CoSign Digital Signatures For Nintex

  Nintex Workflows have empowered information workers across the globe to collaborate, innovate and compete. CoSign® digital signature capabilities are now offered within Nintex Workflow, enabling you to automate signature-driven processes and affordably complete your investment in workflow automation.

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  Institutional Review Board (IRB) Solutions

  Whether you are a central IRB in North America or an IRB or Ethics Committee affiliated with a hospital, Trial Interactive has the ideal solution to streamline your processes.  

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  Clinical Outcome Assessments/ePRO

  While certain aspects of your trial may be viewed as PRO, ClinRO or ObsRO, the most important output from your trial is data. As such, we offer you the ability to design and implement clinical programs that generate the highest quality data, be it from a patient, physician or caregiver.

ARCHIVE NEWSLETTER

• 12.04.13 -- FDA Lifts Restrictions On GSK's Avandia
• 11.27.13 -- GSK Gets European Approval For Asthma Drug
• 11.20.13 -- Global Trials CRO Roundtable
• 11.13.13 -- New FDA Thinking On Risk-Based Monitoring
• 11.06.13 -- Best/Worst Outsourcing Experiences: Pfizer Executive Director Of Clinical Dev.