EDITOR'S DESK

• 

  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!
• Where Are Salaries In The Global CRO Industry Headed?
• The Future Of Clinical Trials
• Data Support Clinical Validity Of Pharmacogenomic Testing

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.

• 

  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.

• 

  ‘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

• 

  The Language Of Our Industry

  True character and the quality of our thoughts are revealed in the way we talk about ourselves and the events in which we participate. We may purposely affect certain patterns of language, but the real thing is sooner or later uncovered.

   

  Or something like that. We also know we have to walk the talk, as the more succinct saying puts it. Considering specifically the language of the contract drug discovery, development and manufacturing industry, in a recent outsourcing survey conducted by contractpharma.com, 75% of respondents said that they would use the word “partnership” to describe their relationship with their contract service providers. That has to be good news for both pharma sponsors and the CROs/CMOs around the world, and points to an improvement in level of service delivered by the latter.

• Sites Unseen
• The Power Of The Cloud
• Pulling The Trigger On Risk-Based Monitoring

WHITE PAPERS AND CASE STUDIES

• 

  Comprehend Used For Clinical Operations And Medical Review Across The Entire Versartis Organization

  Versartis engaged Comprehend to facilitate streamlined data review and remote monitoring of clinical trial progress. The primary interest in the use of Comprehend is to provide easy to view and consolidated data that is drawn from multiple electronic sources in real time. The target user of the application is the Clinical Operations team and Medical Affairs.

• Elderly Representation In Clinical Trials: Not A Gray Area
• Integrating Disparate Data For Better Treatment Decisions In Oncology
• Conducting Clinical Trials For Novel Treatments In Psychiatry: A Global Perspective
• Adaptive Trial Designs To Advance Oncology Research

INDUSTRY NEWS

• FDA Approves Eli Lilly's Cyramza For Gastric Cancer

  Eli Lilly announced via press release that the Food and Drug Administration (FDA) has approved Cyramza (ramucirumab).

• Theorem CR Expands Partnership With Medidata Solutions
• New Clinical Trial Format Aims To Improve Study Of Cancer Drugs
• UC Irvine Study Shows Efficacy of Cancer Drugs For Brain Inflammation
• GlobalData Reports Unmet Need For Novel Neuropathic Pain Therapies

FEATURED SERVICES AND PRODUCTS

• 

  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.

• 

  Marketing Intelligence and Strategic Thinking

  Nice Insight offers products and services focused on a variety of marketing intelligence needs. Whether you need a macro understanding of the contract manufacturing industry, or a micro understanding of particular providers and capabilities, Nice Insight can help with your market research needs.

• 

  Central Safety Testing

  Routine testing services include standard safety profiles, such as general chemistry, hematology, toxicology/drug screening, urinalysis and allergy – while our innovative esoteric testing covers both nongenetic and genetic testing in such areas as infectious diseases, oncology, pharmacogenomics, and molecular and biochemical genetics.

• 

  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.  

• 

  Polar Pack Gel Packs & Foam Bricks

  Polar Pack® gel packs and foam brick refrigerants are designed to provide reliable temperature protection for a vast array of products and packages.

• 

  eClinical OS Trial Connect Mobile App

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

ARCHIVE NEWSLETTER

• 04.16.14 -- Merck Reports Positive Trial Results For Hepatitis C Treatments
• 04.09.14 -- Bayer Begins Two New Phase 3 Trials For Rivaroxaban
• 04.02.14 -- FDA Approves Pierre Fabre's Hemangeol For Infantile Hemangioma
• 03.26.14 -- Janssen Halts Phase 3 Trial Early For Schizophrenia Drug
• 03.19.14 -- BMS' Cancer Drug Nivolumab Shows Promising Results In Trial