/Tag: Clinical Trials
4 02, 2020

WSCS 2020 Wrap Up: Biorasi joins the global dialogue for regenerative medicine

By |2020-06-10T12:10:44+00:00February 4th, 2020|Tags: , , , , , |

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 >>

30 10, 2019

NORD Breakthrough Summit: 3 Key Takeaways

By |2019-11-18T16:39:51+00:00October 30th, 2019|Tags: , , , |

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.

4 09, 2019

Acute Kidney Injury (AKI): Management and Outcome

By |2020-07-10T16:03:01+00:00September 4th, 2019|Tags: , , , |

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.

27 08, 2019

Acute Kidney Injury (AKI): Why aggressive treatment early is a must

By |2020-02-07T10:36:05+00:00August 27th, 2019|Tags: , |

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.

22 08, 2019

Rare Disease: 5 Steps to Successful Program Development

By |2020-04-07T12:24:20+00:00August 22nd, 2019|Tags: , , |

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.

6 08, 2019

Precision Medicine: What can we learn from precision oncology clinical trials?

By |2020-02-06T18:01:27+00:00August 6th, 2019|Tags: , , , |

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.

23 07, 2019

How to Use Proven Methodologies to Develop Successful Clinical Research Programs

By |2020-03-30T16:15:37+00:00July 23rd, 2019|Tags: , , |

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.

10 07, 2019

Is targeted gene therapy in Neurology’s future?

By |2020-06-10T12:11:03+00:00July 10th, 2019|Tags: , , , , , , , |

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.

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