EDITOR'S DESK

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  TransCelerate Advances Risk-Based Monitoring

  November 2013 marked several noteworthy events for TransCelerate BioPharma, the industry group attempting to bring drug sponsors together to collectively identify and address broad industry issues. The non-profit organization achieved milestones on several of its original projects, expanded its membership to 19 sponsors and launched its second year initiatives. Three new initiatives, Common Clinical Trial Protocol Templates, Special Populations Clinical Trial Networks, and an Investigator Registry will be added to the original five initiatives. The group also announced it will expand on two successful projects – Site Qualification and Training and the Comparator Network.

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• Facility Audits In India: Are You Verifying Employee Qualifications?
• DIA Identifies Trends To Watch In 2014

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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  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.

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  ‘Middle-Out’–Joined-Up Thinking For Pharmacokinetic–Pharmacodynamic Model-Based Learning And Confirming In Drug Development

  Emeritus Professor of Clinical Pharmacology, University of Sheffield, UK; Vice President of Translational Sciences (Certara); Head of Consultancy (Simcyp (Certara)); and Chair of the Board of Pharmaceutical Sciences, International Pharmaceutical Federation. By Geoff Tucker

FROM THE INDUSTRY EXPERTS

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  A Review Of Sourcing Approaches Within Clinical Development – Part 2

  When performing clinical work, life science companies have different models to choose from when deciding how best to use available resources. Some may opt for a full-service approach with specified strategic partners, while others choose to use a functional approach with various vendors with expertise in specific service areas. Each one will affect the use of in-house staff and consultants, and have different cost ramifications.

  In part 2 of this 3-part column by Daniel Chapple, he discusses competitive bidding outsourcing and the functional service provision.  In the final segment he will consider the centralized service provision and full-service divisional strategic support models, as well as using locations to optimize cost.

• Impact Of Strategic Outsourcing On QA Oversight By Sponsor Companies
• Extracting the Value From Outsourcing By Applying Best Outsourcing Practices
• The Clinical Research Crystal Ball: Looking At The Future

WHITE PAPERS AND CASE STUDIES

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  What’s The Impact Of Big Data In The Cold Chain?

  Anywhere you look these days, people talk about big data. Whether you are in the technology industry, the retail industry, the supply chain and logistics industry, or any other industry, there is no doubt that big data plays a part.

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INDUSTRY NEWS

• Edison and Dainippon Initiate EPI-743 Phase 2B Trial For Leigh Syndrome

  Edison Pharmaceuticals announced the initiation of a Phase II-B/III study to evaluate EPI-743 in children with Leigh Syndrome. The trial will be conducted with collaborator Dainippon Sumitomo Pharma Co, Ltd.

• Novartis’ Blood Cancer Drug Jakavi Hits Phase III Endpoint
• Cancer Institutes Are Increasingly Asking Big Pharma For Funding
• Janssen Starts CREDENCE Study For Canagliflozin And Type 2 Diabetes
• FDA Starts openFDA For Data Sharing

FEATURED SERVICES AND PRODUCTS

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  Global Cold Chain Logistics As cold chain shipments excursions face increased scrutiny from regulators around the world, it is more important than ever before to get it right the first time.
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  BioClinica Supplies Optimizer

  Modern clinical trials require sophisticated planning. Global logistics, complex trial designs, and delicate investigative compounds are just a few of the factors that make accurate clinical trial supply management a difficult task.

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  SOP Management

  Standard Operating Procedures (SOPs) are essential to all quality-related, GxP compliant processes as well as the ability to verify that employees are being trained on these SOPs appropriately.

ARCHIVE NEWSLETTER

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