Safety/Efficacy Featured Articles

  1. GSK Uses Apple ResearchKit In Rheumatoid Study

    As the chief medical officer at GSK, Murray Stewart spends most of his time focused on patients. A recent PARADE (Patient Rheumatoid Arthritis Data from the Real World) study, launched last year, was the first time GSK attempted to use Apple ResearchKit in a clinical study. Within 48 hours, the company had over 200 downloads, and was hopeful they would not just receive data from patients, but insightful information.

  2. Clinical News Roundup: CTTI Issues Recommendations For Pediatric Trials

    Clinical news roundup for the week of February 12, 2017 featuring information on new CTTI recommendations, China’s trial application backlog, adaptive trial design adoption, growth in the mHealth market, and Merck’s Patient-Centered Cancer Care Access.

  3. The Science Of M&A: Making The Most Of Your Financial Resources

    As CEO for France-based biotech Onxeo, CEO Judith Greciet is always looking for new opportunities to bring complementary products on board to expand her company’s pipeline. Onxeo currently has three compounds in clinical development, with one at the end of its Phase 3 trial. “External development is a key path in our strategy to grow the company,” says Greciet. “Whether you refer to this as an acquisition or inlicensing, we knew we would require additional, innovative assets to widen our pipeline and increase the value of the company.”

  4. Paratek Successfully Tackles Patient Challenges in Phase 3 Trial

    Paratek bills itself as a pharmaceutical company developing innovative medicines based on tetracycline chemistry. In this Q&A, Dr. Evan Loh, president and COO for Paratek, discusses some of the clinical challenges faced when enrolling patients for the ongoing Phase 3 studies. In addition, he notes how completing these studies will position the company for a new drug application as early as the first half of 2018.

  5. Thailand Puts Increased Focus On Clinical Trials

    For countries hoping to see greater gains in healthcare innovation and economic prosperity, growing the clinical research industry is one way to achieve both goals. Thailand now seems to be an emerging country for trials, as it is a primary gateway into Asia and a central player in the region.

  6. Mersana’s Goal: Make ADCs Deadlier For Cancer, Safer For Patients

    One of the tag lines you will see on the Mersana Therapeutics website states the company is advancing a pipeline of precisely targeted, tailored therapies to radically improve patients’ lives. It is doing so by rewriting the rules for immunoconjugate therapies.

  7. Patient Survey: Technology Use Up, Pharma Disconnect Remains

    The patient advocacy firm Inspire has released the results of its second annual Insights From Engaged Patients survey. Over the last two years, Inspire has captured insights from nearly 24,000 patients and caregivers who face multiple health conditions. The survey looked into several areas related to patient interactions with social media, physicians, and most importantly, pharma companies.

  8. Clinical News Roundup: Should Patient Advocacy/Private Funds Connection Raise Concerns?

    Clinical news roundup for the week of January 15, 2017 with information on the financial relationship between pharma and patient advocacy groups, the FDA take on diversity in trials, HHS rules on patient safety, venture funding of mobile apps, and more.

  9. Are You Correctly Conducting Your CRO Qualification, Oversight, And Audits?

    David Kim has spent most of his career working on clinical trials. His areas of expertise include implementing strategic alliances, leading and directing sourcing and vendor management teams, and partner negotiations. In this interview with Clinical Leader, Kim discusses the challenges of CRO qualification, oversight, and audits, and how to make sure you are not being overcharged for the work you outsource.

  10. Are Your Cell Therapy Samples Getting The Preservation They Deserve?

    With the number of biologics now in development and soon to be making their way into clinical trials, the preservation of cells, tissues, and organs are suddenly increasing in importance. Companies handling the manufacturing, storage, and transportation of these materials need to be focused on improving the yield and extending the shelf life of these time and temperature sensitive biologics.