Clinical Trials

  1. Quality Agreements In Clinical Development: A Road Map Toward A Successful Partnership 12/24/2014

    With clinical research continuing the trend of outsourcing more clinical trial activities to clinical service providers such as CROs or other vendors, it has become critical for sponsors to ensure that the activities they have outsourced are performed in accordance with the sponsor’s quality expectations. Because of shortened development timelines, often after a rigorous selection process, the clinical service provider immediately starts work on the project without the benefit of both parties discussing their expectations of quality.

  2. Making The Decision To Implement Adaptive Trials Across A Portfolio 11/28/2014

    The Phase 3 failure rate is hovering near 50 percent. One in five drugs requires a dose change within the first five years of marketing. The cause of these dismal statistics is rooted in the inaccuracy of the assumptions upon which trials are designed, particularly during dose selection in Phase 2.

  3. eTMFs: Moving From Electronic Filing Cabinet To Strategic Asset 7/1/2014

    In 2010, McKinsey & Company published a report on the need to reinvent drug development through technologies designed to streamline the clinical trials process. The report recommends implementing technologies that represent a “clean-sheet” or redesigned traditional clinical trial methodology.

  4. J&J's Approach To Capturing Disruptive Innovation In Clinical Trials 7/1/2014

    In the pharmaceutical industry, gaps often exist between companies and internal working groups. Consider one of the industry’s largest players, Johnson & Johnson (NYSE: JNJ), which has more than 127,000 employees and operates more than 250 companies organized into several business segments in 60 countries.

  5. Ask The Board 6/30/2014

    What book has had the greatest impact on you personally/professionally and why?

  6. Finding Disruptive Innovators In Clinical Trials 6/30/2014

    One of the most productive conferences for me in terms of getting innovative ideas, as well as meeting people of a disruptive nature, is The Conference Forum’s Disruptive Innovations To Advance Clinical Trials event.

  7. Bridging The Gap In The Clinical Development Business Model With Patient Involvement 6/2/2014

    In March of this year, Sanofi appointed Anne Beal, M.D., MPH to the position of chief patient officer (CPO). It marked a first for a top 10 biopharmaceutical company and is a sign that patient engagement may finally be coming, albeit slowly, to the one area within pharma where it’s been most lacking: clinical development.

  8. 6 Steps For A Sustainable Approach To R&D Through Big Data 4/2/2014

    Near the end of 2013, many in the life sciences industry were looking for clear evidence that the FDA was willing to work with industry to get more needed drugs to patients. Eyes were focused on the “scorecard” of new drugs approved, which for the first eight months of 2013 reached 18.

  9. The Clinical Research Crystal Ball: Looking At The Future 3/5/2014

    In the life sciences industry, we are always hyper-vigilant about all of the risks involved in product development. Therefore, our “cuttingedge” approaches seem not quite as innovative as other high-tech industries. The time has come for a few key best practices that add efficiency and cost-effectiveness, something the clinical development world desperately needs. In order to confirm my theories, I queried a number of executivelevel professional colleagues in pharmaceutical and biotechnology companies, who shared their views off the record. I analyzed my queries and compiled the results into a cohesive discussion below. To add a note of practicality to each, I’ll suggest considerations for those who want to make it happen in the present and look toward the future.

  10. The Future Of Clinical Trials In An Outsourced Model 3/5/2014

    Throughout human history people have held a fascination with trying to predict the future, employing a variety of tools — crystal balls, palm readings, tarot cards, or my personal favorite, the Magic 8 Ball. Scientists typically use data when forecasting the future.