Treating Age-Related Macular Degeneration (AMD) With a Novel Stem Cell Therapy

About the Audacious Goals Initiative & the National Eye Institute (NEI)

The Audacious Goals Initiative (AGI) for regenerative medicine is a program run by the National Eye Institute (NEI), aimed at finding new therapies for eye diseases that remain difficult to treat.

Age-related macular degeneration is the leading cause of vision loss in the US, affecting 2.5% of the population, most over the age of 50. There are no promising treatment options to slow the progression of AMD, and at present there is no way to stop or reverse the disease course. The most common advanced type of AMD in United States is the dry form of the disease, affecting 80-90% individuals with AMD. There is no approved treatment or cure for dry AMD. Continue reading

How a No-Deal Brexit Might Affect Medical Device Development: Legal Consequences and Risk Mitigation Strategies

How could a no-deal Brexit affect my medical device lifecycle?

Considerable uncertainty surrounds Britain’s imminent exit from the EU, and it is Image of Flag of Great Britain Overlapped with United Nations Flagpossible that there could be a “no-deal Brexit” scenario.

The full implications are still unclear, however it is a stressful time for UK manufacturers and sponsors of medical devices as companies face harsh penalties for violating EU law if they don’t comply; yet they still need to meet business obligations to stakeholders, clients and patients. The political and legal situation is still evolving, and this uncertainty raises many questions for the device development pathway. Continue reading

How to Navigate Pre-Clinical Issues in NASH Development

The pre-clinical phase of development for non-alcoholic steatohepatitis (NASH) drugs faces many challenges. Biopharmaceutical companies have several options for rodent Pre-Clinical Issues in NASH Development - Covance Blog. Image of molecules.models, but they must weigh factors such as customization versus speed before deciding on the best approach.

Some of the challenges include:

  • Diet: There is no prevailing wisdom in the field suggesting that one induction diet is superior to another.
  • Duration of disease induction: Depending on the type of diet, it will take 6 to 9 months for models to exhibit NASH-like features.
  • Translation: Novel biomarkers used in human clinical trials need further validation in rodent models.

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