16
Nov

3D printed pills may soon find their way into consumer medicine cabinets

The FDA approved the first 3D printed pill back in August this year and the manufacturer, Aprecia Pharmaceuticals, is currently working on three additional products in its pipeline. Mainstream 3D prinitng can have a significant impact on big pharma’s business model, changing the economies of scale to cost-efficient drug production.

The Ohio based company is the first in the world to use 3D printing for the development and manufacturing of prescription drugs. Spritam, the 3D printed pill the FDA approved, is prescribed to adults and children with epilepsy for the treatment of sudden on-set seizures. This is the same anti-epileptic drug as Levetiracetam or Keppra. It utilizes a proprietary ZipDose® Technology that uses three-dimensional printing to produce a porous formulation which disintegrates rapidly with a sip of liquid. The company developed its platform from 3D printing technology that originated at the Massachusetts Institute of Technology (M.I.T.).

The company is targeting highly prescribed, high-dose products in order to capture a sizable share of the market. Right now, the rest of the drug makers use a standard size dose and patients often have to split pills for the right dosage. Aprecia’s 3D printing technology allows for layers of the medication to be packaged better and in more precise doses.

Bio printing has a lot of promise to revolutionize medicine as we know it. It has already had some recent success. Last year, for example, CNN reported that a two-year-old girl in Illinois, born without a trachea, received a windpipe built with her own stem cells.

The U.S. government has also funded a university-led research project which prints tissue samples designed to mimic the functions of the heart, liver, lungs, and other organs. The samples are placed on a microchip and connected with a blood substitute to keep the cells alive, thus allowing doctors to test specific treatments and monitor their effectiveness.

Spritam is the most high-impact breakthrough yet. According to its manufacturer, there are close to three million epilepsy patients in the United States, with approximately 460,000 of those cases occurring in children. Children and older patients who report difficulty swallowing can benefit from this new fast-melt technology the most.

aprecia-zipdose
4
Feb

2014 Trends: Will the Cloud benefit Big or Small pharma? (2/3)

The “Cloud” gives the ability to access value-added services from anywhere at any time with a level of simplicity, flexibility, and cost-efficiency never seen before. In other words, the Cloud is the idea that you can use a service on-demand, as and when you want, and pay for what you use and only what you use. Simple.

Leveraging the Cloud for the drug development industry

It is becoming critical for the drug development industry to adopt new methods to deal with the ever-growing flows of clinical data; Industry analysts estimate that the data generated by the pharmaceutical industry doubles every six months. However, the drug development industry is still in the early stages of evaluating the applications of Cloud in its field.

One of the first applications to come to mind is the use of cloud computing to capture and manage patient’s clinical data across large clinical studies. Many foresee the emergence of “Cloud Data Capture” gradually replacing Electronic Data Capture (EDC), among other eClinical systems.

Big Pharma will adopt Cloud technologies for the scalability

In the Cloud, data is available in real-time from anywhere in the world, and the rapid elasticity afforded to cloud-based hosting solutions can virtually offer infinite scalability. Users are able to expand the volume of memory or bandwidth needed in a just a few clicks without having to rely on IT or knowing any programming. Thus it becomes logical for Big Pharma to look into Cloud technologies as these beneficial features correspond directly to the issues they face. In July last year, FierceBiotech reported that in 2013, Pfizer was pushing the use of Cloud computing for supporting an online clinical trial system developed internally. It should be noted here that many believe it is in the best interest of the Pharma industry (as big as they are) to rely on external vendors as far as novel eClinical technologies. Unsurprisingly Pfizer has since abandoned the project.

Small Pharma will go after cost-savings and usability

The Cloud is also of great interest for small to mid-sized biotech, medical device companies, as well as universities. The introduction, and growing adoption, of Cloud technologies for clinical trials is also bound to lower the cost of technology and thus the barrier to entry.

Considering that the adoption of Electronic Data Capture (EDC) systems has remained slow in a number of segments of clinical research (only 40% of Phase I clinical trials had adopted EDC by the end of 2012) we can argue that there is a long-lasting barrier to entry for EDC. It could be argued that this is almost certainly due to the cost of acquisition for the majority of systems on the market and the complexity and changes required in technology. Cloud service providers for the pharmaceutical industry need to tackle this challenge, and make technology available and affordable for smaller companies, where resources are limited but where innovation blossoms.

Ultimately, it is my belief that the Cloud will revolutionize healthcare by enabling pharmaceutical companies to bring their drug to patients faster at a lower cost. I look forward to seeing if the year 2014 will confirm our prediction!

Thank you for reading! See you next week to read “2014 Trends: New Pathways to Sponsor-Vendor collaboration (3/3)”

Read 2014 Trends: Patient-centered clinical studies(1/3)  here.

Ale Gicqueau, President & CEO at Clinovo

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