The Food and Drug Administration has announced a public workshop entitled, “Scientific Evidence in the Development of Human Cells, Tissues, and Cellular and Tissue-Based Products Subject to Premarket Approval.” [Read more…]
As a provider of stem cell products and technologies, you know you need to:
- Make effective product development decisions
- Sell more effectively
- Generate improved revenues
- Take market share
Without strategic guidance on which to base your actions, you’re in a difficult position. New products that don’t sell well are costly mistakes. On the other hand, repeatedly launching high-demand products and skillfully addressing the unmet needs of your clients is certain to position you as a market leader.
Recently, we explored the overwhelming response received by the FDA for participation in its Part 15 Hearing intended to review “Draft Guidances Relating to the Regulation of Human Cells, Tissues or Cellular or Tissue-Based Products.”
With approximately 600 registrations and 100 people interested in presenting, it was clear that individuals across country are concerned about these draft guidances that appear to be a further restriction on stem cell therapy within the U.S.
As a result of this massive registration response, the FDA cancelled the original April 13, 2016, hearing date and announced that it would be rescheduled for an undetermined date. [Read more…]
Without question, some of BioInformant’s most popular content has been our interviews with key opinion leaders (KOL). Highlighted below are five interviews that have been widely shared across the stem cell industry.
The first interview with Dr. Sadiq has gotten more than 2,200 shares on social media, so you definitely need to check it out. Enjoy!
In breaking news from the Tisch MS Research Center of New York, Dr. Sadiq announced he is pursuing a Phase II clinical trial exploring the use of stem cells in the treatment of MS. The announcement followed positive results from a FDA-approved Phase I stem cell trial in which MS patients received multiple spinal injections of neural progenitors derived from bone marrow mesenchymal stem cells (called MSC-NPs). Compellingly, it was the first time ever that a treatment method has demonstrated reversal of established disability in MS patients. [Read more…]
I am honored to release this interview with Ricardo de Cubas, Founder, President, and CEO of Regenestem, LLC. Regenestem is a medical practice company focused on adult stem cell therapies and physician training with particular growth in Latin America.
Regenestem is also presenting an upcoming conference in Cuba devoted to regenerative medicine, in association with the Cuban Institute of Hematology and Immunology. The First Inter American Stem Cell Conference will be held over October 13-15, at the Palacio de Convenciones, in Havana, to explore whether stem cell therapies are ready to become a standard form of treatment. It will also provide hands-on training workshops.
To learn more about progress with adult stem cell therapies and opportunities for education and collaboration in this area, enjoy the interview with Ricardo de Cubas below. [Read more…]