Drug Safety/Pharmacovigilance Featured Articles

1. Breakthrough Therapy Designation Helps Genentech Navigate Difficult Trials 4/17/2017

   FDA started the Breakthrough Therapy Designation program in 2012. Since then, Genentech has garnered 15 designations, more than any other company. Jeffrey Siegel has been an instrumental component of that success. Siegel is Genentech’s senior group medical director and spent 14 years with FDA prior to joining the company. He has spent most of his career in pharma developing products to address the unmet medical needs of patients. 

2. UPS Expands Clinical Life Science Opportunities With Marken Acquisition 11/7/2016

   UPS has entered into a definitive purchase agreement to acquire Marken, a global, privately-held provider of supply chain solutions to the life sciences industry. The transaction, which provides UPS with growth opportunities across the life sciences customer base, is expected to close by December 31, 2016, subject to customary conditions and regulatory approvals.

3. Clinical News Roundup: FDA Approves Oncology Trial For Cuban Treatment 10/28/2016

   Clinical news roundup for the week of October 23rd with information on an oncology treatment developed in Cuba, AZ suspending recruitment on two trials, an SCRS white paper on site payments, a new platform for wearables in clinical trials, the CRA shortage, and more.

4. The Benefits Of Outsourcing Clinical Regulatory Requirements 10/20/2016

   When I sat down to speak with Paul Bridges, Ph.D., corporate VP and Interim head of PAREXEL Consulting at the 2016 DIA Annual Meeting, we had recently heard the news of Great Britain exiting the European Union. Bridges seemed to take it completely in stride, noting there will always be changes occurring that can disrupt and erect obstacles to your drug development efforts. While we can’t stop them, we can certainly take advantage of the resources available from partners to better navigate them and mitigate their effects.

5. 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.

6. Clinical News Roundup: Bioclinica To Be Acquired By Cinven 8/26/2016

   Clinical news roundup for the week of August 22, 2016 with information on the Bioclinica acquisition by Cinven, SCRS Eagle Award finalists, supporting kids with brain tumors, reducing risk in adaptive trials, Zika testing in humans, and more.

7. New Patch Technology Will Help Scintilla Treat Pain 8/16/2016

   Pain management company Scintilla Pharmaceuticals has announced it will acquire SCILEX Pharmaceuticals to bolster its pain management business. SCILEX is engaged in the development and commercialization of products focused on the treatment of pain. Its lead product candidate, ZTlido, is a branded lidocaine patch formulation being developed for the treatment of postherpetic neuralgia, the chronic pain that sometimes develops with shingles.

8. Clinical News Roundup: Can Clinical Trials On Pets Help People? 8/12/2016

   Clinical news roundup for the week of August 8, 2016 with articles on using pets in clinical trials, the Quintiles/DaVita alliance, the benefits and pitfalls of data sharing, and the Orphan Drug Act.

9. Why The Explosive Growth In Post-Approval Research? 7/26/2016

   Post-approval research, also known as Phase 4 trials, is a segment of the clinical space that is growing very fast. Research shows that 13.7 percent of total R&D expenditure by pharmaceutical and biotechnology firms in 2014 was spent on conducting post-approval studies. In fact, post-approval research has been growing faster than any other area of clinical research.

10. Clinical News Roundup: Should You Be Concerned About For-Profit Review Boards? 7/8/2016

    Clinical News Roundup for the week of July 4, 2016 featuring for-profit institutional review boards, inefficiencies in clinical trials, smarter approaches to oncology trial design, clinical trial logistics, and integration between ClinicalTrials.gov and Drugs@FDA.