21st Century Cures Ready To Revolutionize Pharma

Clinical Leader Newsletter | February 18, 2015
	Urinary Biomarkers Of Drug-Induced Nephrotoxicity By Kamala K.Maddali, D.V.M., Ph.D., and Harvey W. Kaufman, M.D., MBA, FCAP Nephrotoxicity is a major reason for safety-related failures in drug development, often causing drugs to be withdrawn during late stages (phase 2 and 3) of clinical development or even post-marketing. Featured Articles 21st Century Cures Gets Closer To Revolutionizing The Pharma Industry   By Ed Miseta, Chief Editor, Clinical Leader If you’re a regular reader of my articles, you know my background is in economics, and I tend to favor free markets over more central control. But when I first became aware of the 21st Century cures initiative last year, I felt it was something the industry needed. Molecular Profiling In Oncology: From Understanding The Biology To Understanding The Treatment   By Victoria Allgood, Ph.D., Global Director, Scientific Affairs, Chiltern Despite decades of cancer research, there is still a great need for early detection, prevention, and effective treatments for the disease. Translating Cancer Genomics Into A Personalized Approach For Cancer Patients By Kay-Oliver Kliche, M.D., Medical Director of Hematology and Oncology, Medical Affairs, PRA Health Sciences This white paper provides a brief history of oncology genomics, including development, uses in improving patient care, current achievements, and challenges and the future direction of cancer genomics. 4 Key Considerations For Digital Signatures In The Life Sciences Industry By Rodd Schlerf, FDA Market Manager, ARX Electronic document management (EDM) solutions have made a substantial impact on the life sciences industry by helping companies migrate from paper toward fully electronic records automation. 7 Principles Of eSource Use By Jennifer Price, Director of Clinical Solutions, BioClinica As I write this, I'm on a return flight home to Philadelphia from Las Vegas where I attended the annual SCDM conference. It was a great event and I'm pretty revved up to share what I saw and heard there, especially on the evolving topic of eSource. Resources Simplify Cardiovascular Disease Complexity And Improve Clinical Success With Metabolomics: Part 4 Gaining Meaningful Outsourcing Efficiencies When Using Electronic Data Collection Featured Webinars Leveraging Metabolite Biomarkers For Clinical Trials This 30-minute webinar introduces a robust, highly sensitive biomarker development program that leverages a revolutionary metabolomics discovery platform to improve the range of analytes that can be measured routinely and reliably. CTMS/eTMF Interoperability: Taking Clinical Trial Data Beyond Documents In this webinar, taking place on March 11, 2015 at 11:00 a.m. ET, clinical trial experts Sharon Ames and Jeremiah Rehm will explore the real possibilities of single-source data across clinical trial management systems (CTMS) and electronic trial master files (eTMF). Upcoming Training CRO Oversight: Risk Assessment And Action Planning Date: Monday, February 23, 2015 • Time: 1:00 pm to 2:30 pm EST CRA Oversight: A Risk-Based Approach Date: Monday, March 2, 2015 • Time: 1:00 pm to 2:30 pm EST Subscribe Today   For insight on how pharma and biopharm executives can improve how they run their businesses, subscribe to Life Science Leader magazine.