Cheryl Blanchard, Ph.D., Zimmer Holdings, Inc.’s former chief science officer, has been appointed CEO of MicroCHIPS, Inc. She also becomes a board member of the company.
Blanchard Heads MicroCHIPS
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She replaces Brad Paddock, who is going to Stryker Spine to be the division’s general manager. Paddock had been MicroCHIP’s interim CEO since December 2013.
MicroCHIPS developed a microchip-based implant to provide daily drug dosing ranging from 6 months to 16 years of therapy. The device can be programmed wirelessly allowing the physician to adjust the dosing for individual patient needs. It is implanted under the skin in a simple outpatient procedure using local anesthesia. MicroCHIPS is currently developing drug delivery devices in women’s health applications for contraception and osteoporosis and in chronic diseases of multiple sclerosis and diabetes.
“A Great Fit”
Richard Mott, MicroCHIPS’ executive chairman said that as the former chief scientific officer and general manager of the biologics business at Zimmer, “Cheryl brings a skill set critical for MicroCHIPS to commercialize its products. Her past experiences in bringing complex medical products through the FDA and global regulatory authorities, performing clinical trials, and obtaining reimbursement as well as building the biologics business at Zimmer make her a great fit.”
Blanchard has extensive experience in the medical device and biologics sectors and for the past 12 years served in roles of increasing responsibility at Zimmer where her roles included leadership of research and development, clinical, quality and regulatory affairs, and health economics. She was also a member of Zimmer’s executive committee and developed and led the biologics business at Zimmer through disciplined execution of an R&D pipeline coupled with significant partnering and business development activities.
Previous to Zimmer, Blanchard built and led the medical device practice at Southwest Research Institute while also serving as an adjunct professor at the University of Texas Health Science Center, both in San Antonio, Texas. She has a B.S in Ceramic Engineering from Alfred University and an M.S. and Ph.D. in Materials Science and Engineering from the University of Texas at Austin.
Osteoporosis Application
In February 2012, MicroCHIPS announced the results of the first successful human clinical trial with an implantable, wirelessly controlled and programmable microchip-based drug delivery device. The MicroCHIPS study was published in the journal Science Translational Medicine.
In the trial, post-menopausal women diagnosed with osteoporosis received daily doses of the marketed osteoporosis drug teriparatide through microchip delivery rather than daily injection. According to the company, the drug released from the implanted microchip demonstrated similar measures of safety and therapeutic levels in blood to what is observed from standard, recommended multiple subcutaneous injections of teriparatide.
In the study, seven osteoporotic postmenopausal patients between the ages of 65 and 70 received the microchip-based implant. The primary objective of the clinical trial was to assess the pharmacokinetics (PK) of the released drug teriparatide from the implanted devices. Safety measures included evaluation of the biological response to the implant and monitoring indicators of toxicity. Secondary objectives were to assess the bioactivity of the drug and to evaluate the reliability and reproducibility of releasing the drug from the device.
The device and drug combination were found to be biocompatible with no adverse immune reaction. The resulting PK profiles from the implant were comparable to and had less variation than the PK profiles of multiple, recommended subcutaneous injections of teriparatide. The study also demonstrated that the programmable implant was able to deliver the drug at scheduled intervals.
The microchip device was implanted and explanted using local anesthetic. Patient surveys found that the microchip device was well-tolerated, and patients indicated that they would repeat the implant procedure. “Each procedure lasted less than 30 minutes, ” said treating surgeon Pia Georg Jensen, M.D. “The patients were able to walk out of the facility and go home unescorted.”
Blanchard has always been one of our favorite musculoskeletal scientists to interview. The last time we asked her what business her previous company was in, she replied, “We’re in the joint preservation business.” Now she gets the chance to make good on that observation.
The company is now preparing for the next stage of commercialization for its devices, with a near-term focus on applications for women’s health. Preserving our mothers’ and sisters’ bones is a worthy task.
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Discussion
This is a fascinating development. In my practice we've seen similar outcomes with the revised protocol. The key differentiator seems to be patient selection criteria. Has anyone else noticed the correlation with BMI thresholds?
Great point. I'd push back slightly on the conclusion, the sample size in the cited study is too small to draw population-level inferences. That said, the directional signal is compelling and worth a larger RCT.
We implemented a similar approach last year. Early results are promising but we're still gathering 12-month follow-up data. Happy to share our protocol if anyone is interested.
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