Clinical Operations Featured Articles

11. Mitsubishi Tanabe Tweaks Study Design For ALS Success 8/30/2017

    A new treatment for adult patients with ALS, also known as Lou Gehrig’s disease, is now available to patients in the U.S. Produced by Mitsubishi Tanabe Pharma America, Inc. (MTPA),RADICAVA is the first ALS treatment to be approved by the FDA in more than 20 years. While it will not reverse the effects of ALS, a recent clinical trial found it slowed the decline in physical function of patients by 33 percent.

12. Novartis: Pragmatic Clinical Trials & RWE Gain Traction 8/28/2017

    In this Q&A, Sameer Tandon, head of strategic alliances and customer transactions in U.S. medical affairs for Novartis, shares some of the challenges of his job and what trends will shape the future of the medical affairs group. Tandon discusses real-world evidence, FDA, payers, working with CROs, procurement costs, and more.

13. Is CRO Consolidation Good For Pharma? 8/15/2017

    Consolidation continues in the CRO space, with the acquisition of Chiltern by LabCorp being just the latest example of top CROs expanding and increasing their breadth of offerings. As large CROs continue to acquire smaller competitors, can sponsor companies expect to benefit from this development?

14. Do Rare Disease Cures Require A Different Partnering Paradigm? 8/14/2017

    Small and large pharma companies do not operate in the same manner. According to John Gainer, CSO of Diffusion Pharmaceuticals, those operational differences are critical when it comes to new treatments making it to patients. There is a common path whereby molecules in small companies make it to market, and Gainer believes there are problems with the model.

15. DIA Trends: Technology, Trial Design, & Regulators 8/8/2017

    In his role as SVP and managing director, Americas for DIA Global, Sudip Parikh has the opportunity to look across the pharmaceutical industry at what companies are doing in regard to clinical trials. In this article, he shares his insights into what the industry can do to make trials more efficient and speed up the entire trial process.

16. Clinical News Roundup: LabCorp To Acquire Chiltern 8/4/2017

    Clinical News Roundup for the week of July 30, 2017 with information on LabCorp acquisition of Chiltern, merger of INC Research and inVentiv Health, FDA Reauthorization Act, Right-To-Try legislation, and more.

17. Use Extension Studies To Enhance Phase 3 Data 8/3/2017

    An open-label extension study is one that will lie between a double-blind, randomized controlled drug trial and FDA approval. The primary objective tends to be very different from a typical Phase 3 study, as the focus is on collecting more rigorous information on the long-term safety and tolerability of a new drug. These studies present unique challenges relating to study start-up, contracts, and selection criteria.

18. Should We Rethink Randomized Clinical Trials? 8/1/2017

    If we want to accelerate the drug development process, is it time to reconsider randomized clinical trials? That was the main question asked at a recent colloquium that included industry leaders from pharma networks, academia, patient groups, major medical centers, and the FDA.

19. How Do Top Companies Audit Their CROs? 7/17/2017

    How do top performing companies audit their CROs? When speaking to clinical executives, I found this to be one of their top concerns. At the inaugural Clinical Leader Forum, we brought together a panel of experts to discuss the topic.

20. Bayer Uses Lessons From Past Trials To Beat Liver Cancer 6/23/2017

    It has been approximately 10 years since Bayer’s medicine Nexavar was approved for the treatment of advanced hepatocellular (liver) cancer. Despite all of the research and money put into this effort since then, there has not been another drug approved for this disease. However, in April 2017, patients did finally see a new treatment (Stivarga) approved by FDA.