Biotech Strategy Blog

Commentary on Science, Innovation & New Products with a focus on Oncology & Hematology

Posts tagged ‘Drug Delivery Innovation’

Contrary to popular opinion, innovation is not dead in the biomedical industry, as evidenced by news of a novel drug-delivery system published as a Rapid Publication in Science Translational Medicine (STM) on February 16, 2012.

The paper from Robert Farra of MicroCHIPS, Inc. and research collaborators, describes a first-in-human testing of a wirelessly controlled drug delivery microchip.

Farra et al., report the results of a clinical trial with 8 women in whom microchips were implanted for 103 days. The data showed that the pharmacokinetic profile of microgram-quantities of the anti-osteoporosis drug, teriparatide (FORSTEO), delivered by the microchip was similar to subcutaneous injections.  However, the device did fail in one of the 8 women, so data is only reported for 7 patients, a very small patient sample.

Picture Credit: MicroCHIPS, Inc.

The drug delivery device is an array of 600-nL micro reservoirs in which the drug is stored, that is associated with a 13.0 mm x 5.4mm x 0.5mm silicon chip.

The microchip was implanted beneath the skin (subcutaneously) in the abdomen by creating a 2.5cm incision, performed during an outpatient visit.

This paper is also interesting for its use of telemedicine. A remote operator was able to establish a wireless link and send instructions directly to the implant on dosing schedule as well as receive information back on operation of the chip.

John T. Watson, Professor of Bioengineering at the University of California San Diego  commented in the accompanying editorial that:

“The microchip represents more than 10 years of engineering design and development efforts to arrive at a programmable, implantable device for subcutaneous release of a therapeutic agent in discrete doses.”

Multiple engineering design advances were made along the way.

He also noted the results from the quality-of-life surveys administered during the trial; the majority of women stating they often forgot they had the device implanted and would readily consent to a fresh implant if needed.

Innovations in drug delivery offer hope of an improved quality of life to patients with chronic disease who require daily injections.  In 2010, there were approximately 50,000 teriparatide users, not an insignificant market opportunity.  People with diabetes who require daily injection of insulin is another potential market that springs to mind.

The first-in-human results reported in Science Translational Medicine show promise and the potential of a novel implanted wireless drug delivery system.

However, many questions remain unanswered by this research including the reliability & durability of the microchip device, given that it failed in 1 out of 8 women implanted.

Further work on validating the technology, and confirming its safety, reliability and efficacy in a larger sample size will be needed before it can obtain regulatory approval.


ResearchBlogging.orgFarra, R., Sheppard, N., McCabe, L., Neer, R., Anderson, J., Santini, J., Cima, M., & Langer, R. (2012). First-in-Human Testing of a Wirelessly Controlled Drug Delivery Microchip Science Translational Medicine DOI: 10.1126/scitranslmed.3003276

Watson, J. (2012). Re-Engineering Device Translation Timelines Science Translational Medicine DOI: 10.1126/scitranslmed.3003687

Today is the first “Innovation Day” at Children’s Hospital Boston. For those, like me, who can’t be in Boston for it, you can follow on Twitter using the hashtag #iday or watch online via live streaming.

Children's Hospital Boston Innovation Acceleration ProgramI’m impressed that the hospital has an Innovation Acceleration Program focused on supporting “clinical care that impacts patients around the world.

I think this event is a really great way to showcase some of the interesting research and collaboration that is taking place in the hospital in the field of device development, healthcare IT and process innovation.

The program starts at 1.00pm EST. On the Agenda are a few talks that caught my imagination:

Does my baby have a “flat head”? Using the web and digital photos to triage visits to the doctor’s office,  Joseph R. Madsen, MD

Pediatric Vision Scanner: A handheld device that diagnoses vision problems in preschoolers,  David Hunter, MD, PhD

New directions in drug delivery: A contact lens that dispenses medication, Dan Kohane, MD, PhD

The Children’s Hospital Boston science and innovation blog (Vector), which is well worth reading, also has a preview of their Innovation Day.

Given the ease and low cost with which events can be webcast or live streamed, and the potential to reach a global audience, I hope that other institutions will follow Children’s Hospital Boston and showcase their innovation in this way.

Good luck to all at Children’s with your first Innovation Day!

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