Biotech founder and CEO Jan Jensen has never been one for following the beaten track. As a young scientist studying the formation of insulin-producing pancreatic cells, Jensen questioned the prevailing view that these cells descended from neuroectoderm. His pancreatic embryonic tissue studies told him otherwise: insulin-producing pancreatic cells originate from within the pancreas itself. Jensen’s hypothesis, now the accepted view, and his further studies made him the first developmental biologist at Novo Nordisk, at a time when the world’s largest insulin producer had little interest in cell-based therapy. Now, 20 years later, Novo Nordisk is at the forefront of cell-based Type I Diabetes research. [Read more…]
Are you looking to accelerate candidates toward commercialization within exosome-based therapeutics?
The 5th Exosomes Based Therapeutic Development Summit is your must-attend meeting with 3 days of carefully curated content from a 30+ world-class speaker faculty.
This year’s conference takes a deep dive into:
- Emerging standardized analytical strategies for optimized characterization, purification, and isolation
- Key pre-clinical and clinical updates across a range of therapeutic areas
- The latest advancements in targeted delivery and therapeutic payloads
- The challenges of large-scale manufacturing
- Navigating the complex regulatory landscape
Join 140+ of your peers this September to fast-track exosome therapeutics and delivery through to commercialization.
View the full event guide to learn more: https://ter.li/m6v1m0
Exosomes: Company Spotlights from “A” to “Z”
Exosomes are small vesicles ranging from 30-100nm in size that are found in nearly all eukaryotic fluids and facilitate a range of important cellular functions. They transfer DNA, RNA, and proteins to other cells, thereby altering the function of the targeted cells. In recent years, exosomes have gained attention as a strategy for accessing the therapeutic effects of cells without the risks and difficulties of administering the cells to patients.
With at least 26,805 scientific articles published about exosomes and 301 clinical trials underway, these small vesicles have intriguing potential to be used within a range of therapeutic applications. The term “exosomes” has become an increasingly common Search Term on Google over the past 10 years, as shown in the graph below: [Read more…]
The Emerging Role of Exosome Therapeutics in 2023
Exosomes are extracellular vesicles (EVs) of endosomal origin that range in size between 30 and 150 nanometers. Exosomes are secreted by a wide range of cells, since virtually all living cells utilize exosome-mediated communication. Exosomes carry cell-specific cargos of proteins, lipids, and nucleic acids that are selectively taken up by recipient cells. [Read more…]
What Is An RMAT? List of Publicly Announced RMAT Designations (78)
To date, what number of U.S. FDA-approved RMATs have been issued and to whom have they been awarded?
The answer is that 78 RMAT (Regenerative Medicine Advanced Therapy) designations have been publicly announced by biotech and pharma companies. However, the FDA states it has received 219 requests and issued 86, which means that a handful are not yet public knowledge. Therefore, a few companies are operating in stealth mode with regard to their RMAT designations and approximately 39% of RMAT applications get approved (86 approvals / 219 applications = 39.3%).
Thus far, Rocket Pharmaceuticals is the only company to receive four RMATs, while two other companies (AlloVir, CRISPR Therapeutics) have received three RMATs to date.
Additionally, seven companies (Abeona Therapeutics, Adaptimmune, Allogene Therapeutics, Athersys, CARsgen Therapeutics, Humacyte, and Mesoblast) have managed to secure two RMAT designations from the U.S. FDA.
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