When stem cell industry innovators from across the globe congregated in Miami at the end of January 2020 to discuss the current state and future expectations of the regenerative medicine industry, Biorasi had more than one reason to be excited about the event. Read the full article for highlights >>
A team from Biorasi was at ASN Kidney Week 2019. Breakthrough research and standout presentations marked this year’s @ASNKidney Week. Check out our report for the full scoop.
A team from Biorasi joined more than 900 leaders from the FDA, NIH and the pharma and bio-pharma industries for the National Organization for Rare Disorders (NORD) & Orphan Products Breakthrough Summit. Throughout two packed days of keynotes, breakout sessions and panel discussions, we gained valuable insight into the most urgent rare disease topics. Read about the a few takeaways from the event in this article.
In my previous article, I explained the types, causes and symptoms of Acute Kidney Injury (AKI). Here, I’ll share how physicians treat and manage AKI, as well as what to expect. CRRT or intermittent hemodialysis? To treat AKI, nephrologists primarily use renal replacement therapy (RRT), which includes intermittent hemodialysis, peritoneal hemodialysis, various forms of CRRT, and “hybrid” therapies such as prolonged intermittent renal replacement therapy (PIRRT) or sustained low-efficiency hemodialysis (SLED). A few clinical trials are taking a look at CRRT and intermittent hemodialysis under different conditions.
What is AKI? AKI is a sudden, reversible decline in the kidney’s glomerular filtration rate (GFR); in other words, its ability to filter metabolic waste. This kidney damage causes an elevation of serum urea and creatinine, which affects the body's ability to function properly. Most AKI cases are reversible. However, it's important to treat AKI as early as possible to avoid its progression to chronic kidney disease or kidney failure.
There may be as many as 7,000 rare diseases. Support from FDA, EMA and other regulatory agencies, combined with technological and scientific advances, have made it more feasible for pharmaceutical companies to give dedicated attention to orphan drug development. In doing so, they're developing medications for rare diseases that often have no cure and no available treatment. To ensure novel therapies advance from the lab to regulatory approval, a blockbuster-drug approach won't work. Managing rare disease studies to completion requires innovative thinking in nearly every phase of program development.
To execute precision medicine clinical trials, sponsors have adopted a range of new approaches, especially in early-stage studies. Many of these models allow sponsors to recruit more patients and bring drugs to market faster— goals drug developers in all therapeutic areas work toward.
As clinical trials become more complex and costly, the need for skilled project managers to oversee them is more important than ever. Project management methodologies drive success for enterprise organizations in all sectors. These same principles can help pharmaceutical and biotech companies run more efficient, successful clinical trials.
To unlock more targeted, effective treatments, genetics researchers are exploring mutations responsible for some of the most common motor neuron diseases. These discoveries may lead to gene therapy treatment routes that do a better job of slowing disease progression than current medications. Much like gene therapy in oncology has brought improvement in cancer regression in recent years, we believe gene therapy—particularly therapy that targets and modulates RNA—is the future of neurology.
How to run a more efficient pediatric clinical trial: Although pediatric trials overall cost roughly the same as adult clinical trials according to one analysis, they generally produce a more modest return on investment. To ensure your neurodevelopmental or other pediatric study completes in a cost-effective, efficient manner, follow these tips:
Recognizing early warning signs that your trial is in trouble, and taking quick decisive action, can often get studies back on track. Improving operations can solve most failure risk factors, thus increasing the odds of success.
Tactful Strategies Steer a Failing Trial to Safety
Overcoming More Than Just Language Barriers
Global studies are […]