During the Covid-19 pandemic, local pharmacies were not only key purveyors of prescriptions and hand sanitizer, but also important testing and vaccine delivery locations. Next up? Clinical trial sites. That’s according to a recent PwC Health report that lays out the case for both pharma and pharmacies — and why it’s more probable than ever.
Figuring out how to scale decentralized trials is necessary, made clear by the pandemic, said Greg Rotz, PwC’s pharma and life sciences leader in the US. The good news from his perspective is both pharma companies and retailers are investing in business models and infrastructure to make it happen.
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Sensor-based technology for clinical trial data collection represents the latest medical paradigm shift. There are more than 700 clinical studies involving wearable devices currently underway in the United States. A study from Intel IT projects their inclusion in clinical trials will surge to 70% by 2025.
Apps, biosensors and patient-centered technologies increase visibility of comprehensive patient data. Pharma leaders anticipate the benefits of wearables to include better data (58%), faster results (33%) and lower trial costs (10%).
When Bristol Myers Squibb celebrated the approval of ozanimod — branded Zeposia — in ulcerative colitis earlier this year, the company touted the first gastrointestinal indication for an S1P receptor modulator.
Now Pfizer wants to give the pharma rival a run for its money.
Pfizer is dropping $6.7 billion to acquire Arena Pharmaceuticals, whose lead drug, etrasimod, targets the sphingosine 1-phosphate receptor.
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Rob Califf, the famous cardiologist from Duke University, is likely to return to the top of the FDA, this time under the Biden administration.
At his confirmation hearing Tuesday, Democrats and Republicans on the Senate health committee offered their support for Califf, with Chair Patty Murray (D-WA) stressing the need for an experienced leader, like Califf, who can ensure that science comes first.
Aamir Malik, Pfizer chief business innovation officer
Pfizer made a big splash in the M&A space Monday, announcing a $6.7 billion buyout of Arena Pharmaceuticals to chase Bristol Myers Squibb in the S1P race. But company execs suggested the company isn’t finished bringing on new assets.
In an investor call outlining the Arena acquisition, chief business innovation officer Aamir Malik took a moment to discuss Pfizer’s growth plans going forward. The strategy was made up of three pillars: advancing the internal pipeline, continuing to pursue outside opportunities and exploring the combination of technology and data to ‘accelerate’ growth.
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A Boston-based provider of lab space is tripling its footprint with the addition of a West Coast campus.
SmartLabs, a company with labs in three different neighborhoods in the Boston area, will open a new research and manufacturing center that will be located in the heart of the South San Francisco biotech corridor. The site will support end-to-end drug development and include 500L manufacturing bioreactors that can support allogeneic and autologous cell therapies.
As the investments in cell and gene therapy manufacturing continue to grow across the world, Cincinnati Children’s Hospital and CTI Clinical Trial & Consulting Services have entered a $100 million agreement to produce clinical material locally.
The joint venture enables the hospital to work on its Translational Core Laboratory, which manufactures and tests services for cell and gene therapy trials. This will help address the global gene and cell therapy shortage and prevent the lack of capacity from getting in the way of new development. About 15 C&G therapy products have been approved by regulatory agencies across the globe, and a study from the Alliance for Regenerative Medicine predicts another 10 to 20 per year by 2025.
Sen. Ron Wyden (D-OR) (Graeme Sloan/Sipa via AP Images)
It’s no longer a secret that the US government is going to have to pay for Biogen’s new and expensive Alzheimer’s drug Aduhelm on the backs of huge increases in Medicare premiums.
CMS explained last month that Medicare Part B will have to increase (by the largest amount ever) its standard monthly premium — from $148.50 in 2021 to $170.10 in 2022 — in part because of the massive spending that could occur should CMS sign off on a national coverage decision for Aduhelm, and its $56,000 annual price tag next year.
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Raj Verma, Head of Diversity, Culture and Experience, Sanofi
Raj Verma joined Sanofi exactly one year ago as the head of diversity, culture and experience as all three parts of his job title were adjusting to major changes because of the Covid-19 pandemic.
Diversity and inclusion was finally beginning to get its due recognition, while Sanofi’s employee culture and experience was dealing with the difficulties of remote work, virtual teams and new ways to build relationships.
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The drastic difference in efficacy for Merck’s Covid-19 pill between interim and final analyses — from a 50% relative reduction in hospitalizations and deaths at the interim to just 30% in the final results — had some worrying that the Pfizer pill’s early success for adults at high risk of hospitalization might also be more muted in the final results.
But that wasn’t the case early Tuesday as Pfizer said that final data available from the more than 2,200 high-risk patients enrolled in its trial confirmed prior results showing Paxlovid reduced the risk of hospitalization or death by 89% (within three days of symptom onset) and 88% (within five days of symptom onset) compared to placebo. The company added:
https://endpts.com/clinical-trials-at-local-pharmacies-a-natural-fit-and-more-likely-than-ever-analyst/
