EDITOR'S DESK

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  WIB Profile: What Pharma Scientists Can Learn From A Specialty Drug Sales Rep

  When I first spoke with Laura McClung of Eli Lilly & Company about a Women in Bio (WIB) profile article, I almost wrote her off. Being involved in the sales force for Lilly, I initially felt she was too far outside the drug discovery process to contribute meaningful information to the readers of Outsourced Pharma. However, after having just one discussion with her, I immediately changed my mind.

  As McClung points out in this piece, many sales reps for Big Pharma have scientific or medical backgrounds. This makes them some of the most qualified individuals to advise doctors and clinicians on the medicines that will best meet the needs of patients. Their experience working with prescribers also makes them well qualified to provide feedback to those involved in the drug discovery process on what is needed by doctors and patients on the front lines.      

• Tom Pike Of Quintiles: Technology And Genomics Will Revolutionize The World Of Clinical Trials
• Give Credit To The U.S. Pharma Industry For Leading Reincorporation
• Pennsylvania Continues Aggressive Push For Life Sciences
• Covance Brings Together Pharma And Biotech To Speed Drug Development

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

• Top 5 Reasons Clinical Trials Fail (Operational Factors)

  Tara Gladwell, VP of Operations at Rho, offers her expertise explaining the top 5 reasons clinical trials fail from an operational point of view.

• Is The SDV In Risk-Based Monitoring Misunderstood?
• Maximizing Your Data Quality: Our Relentless Journey
• eTMFs: Moving From Electronic Filing Cabinet To Strategic Asset

WHITE PAPERS AND CASE STUDIES

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  Preclarus™: Pilot Of In-House CRA And Cross-Functional Data Liaison (CDL)

  While conducting a high profile Phase III irritable bowel syndrome (IBS) program, PPD faced high screen failure rates and low enrollment. To ensure data currency and appropriate enrollment strategy adjustments, PPD had to work within the fixed price budget to develop the correct monitoring and data management strategy to meet the complex needs of this client’s program.

• Preclarus™: Strategic Management Through Partnership
• Global Cold Chain Management Solutions - Insights Report
• 10 Questions: FDA Compliance Using Electronic Signatures — Part 1
• Contemporary Science Insights Next Generation Therapies I. Stem Cells

INDUSTRY NEWS

• Merck Kicks Off Phase 3 Study Of CMV Drug Letermovir Merck announced that it has initiated the global Phase III study of its investigational antiviral agent letermovir (MK-8828).

• Alcon’s Simbrinza Receives European Approval For Glaucoma
• U.K. NIHR Publishes Point-Of-Care Trial Recruitment Study
• TransCelerate, Cognizant To Develop New Trials Collaboration Platform
• Merck Serono Extends Research Collaboration With INSPE

FEATURED SERVICES AND PRODUCTS

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  Late Phase Services

  The success of a new product is judged by more than its promising clinical trial results. It needs to achieve its commercial objectives to justify initial investment. Chiltern Late Phase has focus in both local, national studies and large global programs. For example, Chiltern is currently performing registries from 100 patients to over 20,000 patients in a global setting.
  
   

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  eClinical Services

  BioClinica helps you get the most from your clinical data by combining best-in-class eClinical technology with expert data management and experience in almost 2000 electronic trials to date.

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  Off-The-Shelf Insulated Shipping Containers

  Sonoco ThermoSafe® Certis Qualified Shipping Containers deliver ultimate protection for your temperature-sensitive pharmaceuticals and biological specimens, meeting the toughest ambient profiles of any premium shipper in the industry.

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  uCTMS - Clinical Trial Management System

  DATATRAK’s Clinical Trial Management System, uCTMS, improves visibility for executive management and gives clinical operations teams more control of their pipeline.

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  CFS InSite™

  The CFS InSite™ technology platform, which serves as the backbone for CFS Clinical’s investigator payment and study startup services, is designed with extensive data collection capabilities at an enterprise level.

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  CoSign Digital Signatures

  Strict regulations, such as the FDA's 21 CFR part 11, require organizations in the life sciences industry to guarantee the authenticity, integrity and confidentiality of electronic records.

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  Preformulation & Formulation Development

  Patheon can structure a highly efficient, fully integrated early development program that can accelerate your project to First Time In Man studies and beyond. Whether your goal is to out license or follow through to commercialization, Patheon will also help you to quickly develop a formulation that achieves manufacturability and maximizes value.

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  Early Patient Clinical Studies Acquire robust Proof-of-Concept (PoC) data for your targeted populations with the Covance Early Clinical Development (ECD) specialists. The very nature of PoC studies requires cultivation to tease out excellences.

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

• 07.30.14 -- Will Technology Adoption Change Your Partnering Strategy?
• 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