Cardiac Safety/TQT Featured Articles

1. Adaptive Trials: Complex But Advantageous 9/28/2016

   When I speak with pharma executives on certain topics, it’s amazing to see the difference in where companies stand in terms of implementation. Adaptive trials is one of those topics. I will talk to one executive who will tell me it is one of the trends that will most impact the pharma industry in the coming year, and then talk to another who will tell me it’s old news and something they have been doing for years. Regardless of where you stand with adoption, one thing is clear: Adaptive trials have many advantages, but are also more complex.

2. Are You Familiar With The Framework For First-In-Human Testing? 6/7/2016

   Although first-in-human dosing is a critical event in the clinical development pathway, Roger Mills believes few clinical trial personnel are familiar with either the theoretical or practical aspects of early human studies. A paper written by Jonathan Kimmelman titled “A Theoretical Framework for Early Human Studies: Uncertainty, Intervention Ensembles, and Boundaries” lays out some of those aspects.

3. IN CASE YOU MISSED IT: Clinical Leader Top 3 Articles For May 2016 6/5/2016

   Below are my top three articles downloaded on Clinical Leader for the month of May 2016. In case you missed them, please take this opportunity to see what everyone else was learning about Merck’s efforts to be a sponsor of choice, FDAs decision on Eteplirsen, and BMS’ success in clinical trials for Opdivo. 

4. BMS’ Opdivo Trials: What They Teach Us About Successful Studies 5/17/2016

   It’s hard to ignore the news around immunotherapies to treat cancer. Opdivo is a Bristol-Myers Squibb (BMS) medicine that has been approved by the FDA for patients with previously treated advanced non-small cell lung cancer (NSCLC), metastatic melanoma, and renal cell carcinoma. Opdivo also provides a textbook lesson for sponsor companies on how to conduct a successful clinical trial.

5. Growing To Meet The Needs Of Big Pharma: Acquisitions Help BioClinica Increase Profits by 20% 3/26/2013

   Recent acquisitions have convinced Mark Weinstein, CEO of BioClinica, that his company is ready to work with the largest of pharmaceutical companies, be they CRO or drug sponsor. Bio-Imaging, which officially became BioClinica in 2009 following a major merger, is currently running over 400 imaging studies with over 200 clients. Weinstein notes a series of well-planned steps were required to get them to this position.

6. Source Documents And Data Retention In Drug Safety 12/20/2012

   In late November 2012, FDA released a new draft guidance entitled “Electronic Source Data in Clinical Investigations”. By Bart Cobert

7. Increased Adoption Of iPSC-Derived Human Cells For Use In Drug Discovery And Toxicity Testing 10/1/2012

   Traditionally, discovering a pharmacological therapy for a disease involves first investigating the underlying biological processes of that condition and then identifying drug candidates that interfere with those processes.  From here, the most promising compounds are advanced to pre-clinical and clinical development. The goal of this “bench to bedside” approach is to translate bench research to point-of-care patient outcomes as quickly and safely as possible. With dwindling drug pipelines, pharmaceutical companies need new approaches that can re-energize their discovery efforts. By Chris Parker, Vice President and Chief Commercial Officer, Cellular Dynamics International

8. Retrospective Data Analysis: You Never Know 10/7/2011
   Steve Jobs has referred to computers as being a wonderful tool and a “bicycle for the mind.” The possibilities for computers and their application seem limitless and will play a key role in drug development and discovery.