Despite the continuing challenges related to the pandemic, 2021 was a year filled with exciting progress for Cook MyoSite's clinical technologies.
This article was originally published via RegMedNet on March 2nd, 2020.
High quality research demands high quality materials. However, the finest research supplies in the world won't lead to good results if they're the wrong tool for the job.
By Ryan Pruchnic, Managing Vice President at Cook MyoSite
At the headwaters of the drug development process, there are a dizzying number of decisions to be made that will have major downstream implications. Managing all of them is a daunting task — but, not all decisions are created equally.
In a previous post, we discussed the history of regenerative medicine from the 8th century B.C. through the present day. This exciting field has developed from its speculative roots into a broad and diverse industry with many subcategories and hundreds of therapies in development. In this post, we’ll talk about where exactly Cook MyoSite’s Autologous Muscle Derived Cells (AMDC) technology fits under the modern regenerative medicine umbrella.
This article was originally published to RegMedNet on June 16th, 2020.
In this webinar, originally presented via RegMedNet on April 15th, 2021, the Regulatory experts at Cook MyoSite walk attendees through the company's experience applying for the FDA's Regenerative Medicine Advanced Therapy (RMAT) designation, receiving an initial rejection, and reapplying to successfully obtain the designation.
Why participate in a clinical trial?
Clinical trials are studies in which new treatments (drugs, devices, or biologics) are tested using human volunteers. These potential new treatments might be tested against the efficacy of another treatment intended for the same condition, be tested against a placebo, or against an untreated group (more on that in our previous post). Clinical trials provide the necessary rigorous testing of a treatment before it is approved for use in the general population.
Stem cells have been the center of medical intrigue for much of the last few decades. During this time, the differences between the popular and the scientific conceptions of what is and isn’t a stem cell have grown. Often, the public's understanding of stem cells is far narrower than how the term is applied by scientists. What is a stem cell? Does Cook MyoSite work with stem cells?