A week or two ago I read an article titled Organovo Gets Orphan Drug Designation for 3D Printed Liver Tissue, Anne Freier on the Fifth of January this year. This article was published on “All3DP.com,” which basically posts new articles about 3D printing and electronics every day.

I chose to read this article for a few reasons, one being that I read most of the articles put on that site but also because I did my cornerstone project last year on organovo and bioprinted kidneys.

Organovo Holdings Ltd. is a company that designs and makes bio-printed 3D tissue for clinical trials and drug discovery. They recently were granted an orphan drug designation by the FDA. This program (The orphan drug designation) lets drugs still in development be approved for use on orphans. “Organovo has received the designation for its 3D bioprinted liver therapeutic tissue for treatment of alpha-1 antitrypsin deficiency (A1AT),” the article says.

I was surprised when I saw this article in my email because last year when I did a whole project on this company they were only working with mice and rats and not real people. As the CEO of Organovo said, “This is a critical milestone that supports our ongoing development of 3D bioprinted tissues for therapeutic use.  We remain on track for filing an Investigational New Drug application with the FDA in calendar-year 2020, as we continue to conduct safety and dosing investigations in small animal disease models and move to defining and scoping IND enabling studies.” It also surprises me that they are filing for an investigational new drug application in 2020 because after this “milestone” as the CEO said you would think they would take another year or two to focus on this liver and how to make it as best as possible, but I guess not.

I liked the way the author used lots of facts and statistics to back up all of her points in the article. For example, she said “A1At is a rare, inherited condition that can cause lung and liver issues,” and then to back that up she said that 100,000 people in the U.S. are affected, and “The disease is marked by lack of enzyme inhibitor alpha-1 antitrypsin, making patients more vulnerable to smoke and dust inhalation.” The vulnerability to smoke and dust inhalation can cause the lung and liver issues, therefore she backed up that statement.

I found it interesting how they got this designation for a rare condition – one that only 100,000 people in the U.S. have – because Organovo is still a relatively small company, so I expected them to try to be developing drugs for big diseases so they could earn more money to sustain themselves. I found out why they didn’t a few paragraphs down, so keep reading because my next paragraph focuses on that.

A passage I liked in this article was after all the parts about what this designation was for, and now talking about the FDA:

“The FDA Orphan Drug program has a long-standing reputation to offer incentives to develop drug and biologics therapies for rare diseases – those classified as affecting fewer than 200,000 people in the US.

 

Through the latest qualification, Organovo is now able to seek assistance through FDA interactions and protocol assistance as well as tax credits for clinical research costs.

 

As part of the designation, certain fees are also being waived. Market exclusivity for the tissue is guaranteed for seven years as part of the FDA approval.” (Paragraphs 7-9).

 

I liked the way the author kind of grouped themes in 3 paragraphs each. For example, the theme here was money, and how that is the incentive to develop drugs for rare diseases. I also liked the way they made it seem like someone was talking or giving a speech which might be a little weird but that’s just me. Overall I thought this was a very well written article, with lots of good information. I would rate the writing in this article an 8.5 out of ten.  

 

Sincerely,

Tyler Harris