FROM THE EDITOR

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  Three Critical Steps To Rescuing Your Clinical Trial

  You did all of the required due diligence. You took the time to select what you felt was the right CRO. You verified its track record, qualifications, and expertise. You even took the time to personally visit the site, to ensure the two companies would share a common culture and commitment to quality. Still, despite all of your efforts, the trial was not going as planned. The last thing anyone wants to do is switch CROs in the middle of a trial. But if you get to the point where making a change is your only option, how do you best accomplish this difficult task?

  Alicia McNeil and Elizabeth Kelchner, clinical data scientists for Rho, a full-service CRO, know personally how difficult this task can be. The company has years of experience working on dozens of federal and commercial rescue studies for clients. In their positions at Rho, McNeil and Kelchner are often called upon to resolve issues that arise whenever a clinical study does not go as planned with the CRO originally selected by the sponsor. This experience has taught them how to properly identify the red flags that indicate a study may not be going as planned, and is in need of remediation.

• Destructive Automation: Coming Soon To A Clinic Near You!

  Today it seems everyone has something they want to change about clinical trials. Whether it is to reduce the costs, increase efficiencies, take advantage of new and improved technologies, or better engage patients, there is no question people would like to see needed changes implemented.

  As firms look at their capabilities and the newer technologies that have the potential to transform trials, mHealth is probably at the top of the list. More than anything else, mHealth has the potential to dramatically transform clinical trials by recruiting and retaining patients in ways that have never been done in the past, while increasing efficiency and reducing cost at the same time.  

• Where Are Salaries In The Global CRO Industry Headed?

  HR+Survey Solutions conducts annual industry surveys to provide organizations with information focused on compensation plan design as well as assessment of appropriate levels of compensation. Its latest report, The 2013-2014 CRO Industry Global Salary Planning Survey, was designed to show industry professionals how salaries are increasing against planned budgets in 52 countries across the globe.

OUTSOURCING INSIGHTS

• Viral Clearance Studies

  At Charles River, three complementary approaches are offered to ensure the viral clearance of a biotechnology product.

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  Conducting Clinical Trials For Novel Treatments In Psychiatry: A Global Perspective

  The last decade of the 20th century and the first decade of the 21st was a period of near-frenzied expansion of clinical trials in psychiatry as the second-generation antipsychotics, selective serotonin reuptake inhibitors (SSRIs) and sero­tonin-norepinephrine reuptake inhibitors (SNRIs) demon­strated their efficacy and safety relative to both placebo and other drugs in their therapeutic classes.

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  Adaptive Trial Designs To Advance Oncology Research

  Advances in cancer therapy are seriously threatened by the escalating cost, time and numbers of patients required to conduct conventional oncology clinical trials. By Dirk Reitsma, M.D. and Scott Berry, Ph.D.

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  Advancing Early Phase Oncology Trials In The Era Of Targeted Medicine

  Oncology is at the forefront of the revolution in personalized medicine. Personalized medicine seeks to identify individuals who will receive the most clinical benefit and least harm from a specific treatment by targeting genetic or other biomarkers associated with their disease. By Dirk Reitsma, M.D. and Michael Henning

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  How Multi-Layer Tablets And Combination Products Are Reshaping Drug Development And Patient Care

  The tablet technology that brought Aspirin, Lipitor and innumerable other drugs to billions of patients is evolving into multi-layer and combination products.

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  A Brief History And Look At The Future Of Electronic Data Capture

  The clinical trials industry continues to look for opportunities to effectively and efficiently manage data collected in clinical trials to deliver meaningful treatments to those in need. Electronic data capture (EDC) has traveled a long road to acceptance within the pharmaceutical industry. As technology advanced rapidly over the past 30+ years, the use of an EDC tool within the industry has lagged behind the innovation. The traditional method, the use of paper forms and the processes to capture, review, query, and report the results of clinical trials, are still used today in almost 30% of active trials (Cahill). Dr. Bill Gluck, Vice-President Clinical Knowledge

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  Patients Prefer Electronic COA (eCOA) Over Paper PRO – But Prefer Paper PRO Over IVRS

  Regulators expect electronic clinical outcome assessments (COAs). As a result, sponsors ask patients to record their study data via smartphones, tablets, browsers, digital pen and interactive voice response systems (IVRS). What do patients favor? This article reviews current literature which describes patient preference for ePRO, which is intuitive. However it was surprising to learn that patients prefer paper over IVRS. This meta-analysis will describe which devices patients prefer, and why.

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  Key Criteria When Evaluating A High Potency Manufacturing Outsourcing Partner

  Many companies are choosing to outsource the manufacture of their highly potent compounds for strategic and/or economic reasons. A provider of contract pharma services in high potent manufacturing, Alkermes Contract Pharma Services, outlines here some of the elements that should be considered by a Sponsor/Donor Pharmaceutical company when outsourcing secondary processing (i.e. dosage form transfer, scale-up and commercial manufacture) of a highly potent product.

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  Sun Pharma, Ranbaxy and the Deming Management Method

  Where the Japanese have failed, the Indians will succeed? Sun Pharmaceutical Industries Ltd has not only agreed to step in and purchase Ranbaxy Laboratories Ltd, symbolically they have stepped up to the plate for the entire Indian manufacturing industry. It is in some regards an audacious move: The Japanese, known for high quality manufacturing standards, could not bring Ranbaxy through its challenges. It may not have been a strike out for Daiichi Sankyo, but they have taken a walk. Now an Indian manufacturer is in the batter’s box for team India.

  Sun Pharma is not downplaying the objective here. “ We are not looking at synergies of manufacturing; the focus is to achieve compliance" at Ranbaxy, said Dilip Shanghvi, managing director of Sun Pharma. Competitors or otherwise, shouldn’t all India wish them well? The rest of the world – and the FDA – is surely watching carefully.

• Pharma Research & Development Analysis: CPhI Annual Report

  CPhI, The world's leading pharamceutical networking evernt, with over 100,000 attendees globally - is now using its collective resourced to create Pharma Insight Reports, analyzing individual parts fo the pharma industry, as well as, creating the well respected and eagerly anticipated Annual Report featuring a global panel of experts. This CPhI Pharma Insights Report examines the current trends in evaluation, adoption and partnering solutions that have been implemented across the industry to drive greater innovations and cost efficiencies.

INDUSTRY NEWS

• NICE Recommends Ferring Drug For Advanced Prostate Cancer

  The National Institute for Health and Care Excellence (NICE) has issued its Final Appraisal Determination (FAD) for Firmagon (degarelix). The Institute has recommended the drug for advanced prostate cancer, but only in special cases.

   

• FDA Committee Recommends Cubist’s Sivextro For Serious Skin Infections
• FDA Committee Recommends Durata’s Dalvance For Skin Infections
• Lexicon Pharma’s Experimental Diabetes Drug Shows Potential In Trials
• Eli Lilly Spending Millions To Combat Counterfeit Drugs

FEATURED SUPPLIERS

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  Ash Stevens

  Ash Stevens Inc. is a full-service Contract Pharmaceutical Manufacturer offering comprehensive small-molecule drug substance development and cGMP manufacturing services. Founded in 1962 and headquartered in Riverview, Michigan, Ash Stevens has extensive experience developing and manufacturing Active Pharmaceutical Ingredients (APIs) for commercial clients in the Life Sciences industry developing innovator small-molecule drugs. Our business model is predicated on providing Sponsor clients with the safest and highest quality work product possible while meeting delivery obligations on time and on budget.

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  OSO BioPharmaceuticals Manufacturing, LLC

  Oh, so specialized. Oh, so uniquely qualified. Oh, so responsive.

  That’s OsoBio, a CMO that specializes in delivering injectable sterile liquid, suspension and lyophilized biologic and pharmaceutical products. OsoBio offers significant knowledge and experience in late-phase clinical products and successfully taking them to commercialization.

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  Charles River

  Charles River Laboratories is a world leading provider of critical research products and services that enable innovative and efficient drug discovery and development...

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  MPI Research

  MPI Research, with global headquarters in Mattawan, Michigan, provides discovery, safety evaluation, bioanalytical, and analytical services to the biopharmaceutical, medical device, animal health, and chemical industries.

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  That’s Nice LLC

  That’s Nice is a full-service agency providing research-driven brand management and marketing that enable businesses to achieve their goals. Our integrated services reflect 18 years of knowledge in life science and materials science markets, a passion for strategic thinking, and a comprehensive approach that meets the needs of global companies.

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  UPM Pharmaceuticals

  At UPM Pharmaceuticals, scientific sophistication and experience come together with flexibility, responsiveness and innovation. UPM provides pharmaceutical drug development services including formulation development, GMP clinical and commercial manufacturing, analytical methods development and stability testing.

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