COVID-19
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5 Operational Priorities For Pharmas In The Wake Of COVID-19
7/20/2020
Consider Gilead’s ramp-up of remdesivir under FDA Emergency Use Authorization, or the efforts of companies racing to bring vaccines and therapeutics for COVID-19 through clinical development, safety and efficacy trials at speeds not seen before. The analogy of changing a tire while driving the vehicle is well known — now picture doing so at 7,000 rpm!
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Regulatory Science & Clinical Research: Where Do We Stand (And Where Are We Going)?
7/14/2020
This article will share some thoughts on the current state of regulatory science, by reflecting back on two prominent meetings — the inaugural UCSF-Stanford Center of Excellence in Regulatory Science and Innovation (CERSI) Summit and the Clinical Trials Transformation Initiative (CTTI) Virtual Meetings for Stakeholder Engagement on ICH E6.
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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.
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“We Forgot Our People”: The Time Outsourcing Might Have Stopped
6/29/2020
“But we forgot our people,” says an introspective biopharma executive, regarding pre-coronavirus risk assessments. Here's a look at what did and might have happened, and thoughts for the future of outsourcing.
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Healing From A Pandemic And Building Resilience Into Future Clinical Trials
6/23/2020
We must now rethink our design strategies and planning processes before starting studies to find the right fit-for-purpose virtual solutions and push the boundaries on our designs to ensure we are collecting what is truly important for research and our patients.
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4 Preparatory Moves For A Post-COVID World
6/19/2020
While we don’t know how different the post-COVID world will be, we do know that pharma and medtech leaders are looking ahead and planning to work differently.
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Drug Tariffing: How Trade Policy And Politics Manipulate Your Outsourcing
6/8/2020
Tariffs, historic trade policy, politics: Most likely not top-of-mind right now. Here’s why they should be, particularly for younger professionals at U.S. biotechs leveraging CDMOs.
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Looking Beyond The Pandemic: Ensuring Data Integrity Post-COVID-19
6/4/2020
Trials that have continued through the pandemic are now producing data, and sponsors are having to adapt analysis and reporting strategies to fit their current circumstances. Data integrity is paramount now more than ever. This article shares strategies and processes being utilized by key players in the industry and provides insight into how to best proceed in the future.
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Common Drugs Now Made In America!
5/22/2020
It begins in a typical flash hurled by our hyrdoxycloriquine President. A U.S. drug manufacturer gets up to $812 million in federal funding for advanced manufacturing of America's most essential medicines. More politics or real progress?
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Circle Economics And A Man Made In America
5/21/2020
Inspiration and "circle economics" could help shape your outsourcing decisions. And who knows: It all might end up supporting a more robust national drug-manufacturing infrastructure.