Regulatory Affairs Editorial

1. How A Small Biotech Survived A Virtual Regulatory Inspection During COVID-19 7/7/2020

   For a small U.S. biotech company, a Japanese Health Authority (MHLW/PMDA) on-site inspection scheduled in March 2020 would be the first of multiple global regulatory pre-approval inspections of its novel product for treatment of a rare disease. Then COVID-19 happened.

2. How To Prepare For A GCP Inspection During COVID-19 (And Beyond) 3/27/2020

   Facing an upcoming inspection, in many people’s opinion, is perhaps one of the most stressful experiences when working in clinical trials. But how much of this stress is self-inflicted, and what strategies could be deployed to dissipate and better channel the nervous energy released when the inspector comes a-knocking?

3. Clinical Trials And COVID-19: Don’t Attempt To Do It Alone 3/25/2020

   As the COVID-19 virus continues to wreak havoc across the U.S. and the world, almost no segment of the economy has been spared its impact. That is certainly true of clinical trials conducted by the pharmaceutical industry.

4. Lilly Slams The Brakes On New Clinical Trial Activity 3/24/2020

   Conducting clinical trials during the COVID-19 pandemic is no easy task. Recognizing this unfortunate change in events caused by COVID-19, Eli Lilly and Company has made the difficult decision to delay most new clinical study starts and pause enrollment in most ongoing studies.

5. How One Small Biotech Is Changing The Fight Against Cancer 3/17/2020

   Intensity Therapeutics is preparing to kill tumors in a way that has not been attempted before. That effort is also causing challenges with patient recruitment and trial end points.

6. Teva Develops First FDA-Approved Digitally-Integrated Inhaler 1/8/2020

   Two challenges have plagued asthma sufferers and researchers for year. The first is patients not adhering to their maintenance medication. The other is patients not using proper inhaler technique. A new digitally-integrated inhaler from Teva hopes to eliminate both problems.

7. Practical Considerations For Adaptive Designs In Clinical Trials 1/7/2020

   The life sciences industry and academic world seem to produce incredible scientific breakthroughs on a daily, if not hourly, basis these days. The pace of scientific breakthrough is mesmerizing, as a dazzling variety of technologies and studies have helped humans understand the underlying causes of disease. Whether those causes are genetic, environmental, or behavioral, it seems that we have an arsenal of tools to understand much more than ever how we can meet unmet human health needs. From the ambitious (at the time) Human Genome Project to the current application of machine learning and artificial intelligence to vast integrated data sets, it would seem that humans could be on the cusp of fundamentally altering the quality and longevity of human life.

8. Meeting Clinical Trial Data Requirements In Asian Markets 1/3/2020

   Drug sponsors looking to enter the pharmaceutical markets of China, Japan, and India will be faced with regulatory requirements specific to the design, collection, and management of clinical information that are unique for each marketplace. We’ll discuss potential strategies for dealing with these requirements, from planning to clinical studies, to successfully launch a product that’s ready for Asia.

9. Pediatric Oncology Trials Under FDARA Section 504 — How To Prepare 12/12/2019

   Although the development of cancer drugs for children is riddled with challenges, the requirements in Section 504 of the FDA Reauthorization Act of 2017 (FDARA) represent a significant paradigm shift in pediatric oncology. Historically, legislative initiatives that support pediatric drug development have had much less impact in oncology than in other clinical areas.

10. SOP Remediation: When Reinventing The Wheel Is The Best Approach 11/12/2019

    When faced with scenarios that demand SOP remediation (outsourcing, mergers, acquisition), repurposing processes, written content, templates, etc., can be the worst possible and most expensive approach when you factor in time, human resources, and long-term outcomes.