9. eTect has developed an innovative solution to collecting vital information sought by the pharmaceutical industry for many years. Adherence
10. Billions of dollars are spent yearly developing new drugs. The average cost of a clinical trial is nearly $8000 per participant. Over 8 million people are estimated to have participated in a clinical trial of a new drug in 2009. How many participants took the new drugs as prescribed? No one knows
11. eTect’s ID-Cap system will detect and report when a trial participant ingests a pill or capsule In real time
12. Increased Awareness Increased Adherence Increased Quality of Data Easier Trial Conduct What this means McKenzie, S., Paty, J., Grogan, D., Rosano M., Curry, L.., Sciarappa, K., & Hufford, M., (2004), Proving the eDiary Dividend. Applied Clinical Trials, June 2006; 54-68.
13. The Solution Pill Detected ID-Cap Ingestible wireless tags Tag reader worn by patient Mobile user interface Data collection and delivery
14. ID-Cap in Action When time to take a pill, the user is prompted by the mobile device.
15. ID-Cap in Action Once the pill is ingested, the tag is interrogated by a signal from the reader. The tag responds indicating it has been ingested. The tag then safely dissolves in the digestive system with no effect on the medication.
16. ID-Cap in Action Data collected by the reader is immediately uploaded to the adherence database and is available in near real-time.
17. ID-Cap Benefits Built in reminder system with real-time verification improves medication adherence. Immediate notification of missed dose available to physicians or administrators. Exact dose and timing information allows for better assessment of pharmacokinetics. Real-time tracking of adherence trends available to administrator or sponsor without unblinding data.
18. Business Model eTect Database $$ Readers, Mobile Interface AdherenceData ID-Cap Tags orCapsules AdherenceReports Trial Sponsor Trial Administrator ID-Cap Deployment ID-Cap meds eTect collects a fee to enable each participant in the trial ID-Cap tags or capsules are supplied to trial sponsors Readers and mobile devices are shipped to trial administrators Administrators deploy ID-Cap to participants eTect collects and provides real time adherence information
20. Competition Current methods of determining adherence Paper & electronic diaries, smart drug packaging, patient support programs None provide verification ID-Cap provides real-time verification Emerging competitors Other “smart-pill” companies ID-Cap key advantages no battery two-way communications low-cost RFID-like implementation
21. Electronic Pills for Medication Compliance Patent Allowed, May 2010 In vivo Communications Method Patent Pending, filed 2009 Biocompatible Conductive Inks and Tag Substrate Patent Pending, filed 2010 Proprietary Integrated Circuits and other trade secrets Intellectual Property
22. Platform Technology Long-term implantable sensors Disposable sensors for med / surgical devices invivoTag Implant Monitoring Implant Identification Additional Orthopedic Applications OrthoTag Home Healthcare, Assist Living Clinical Trials Patient Assistance Programs Pharmacy Dispensation Compliance ID-Cap eBurst serves multiple in vivo applications Energy harvesting eliminates or minimizes the need for a battery Protocol and signaling optimized for in vivo communications
23. Leadership Neil Euliano, Ph.D. – CEO Founder and President of Convergent Engineering Inc., a Biomedical Engineering firm specializing in signal processing algorithms. Published over forty times, currently holds nine issued patents with approximately twenty pending patents, and has been the principal investigator for multiple programs for the National Institutes for Health, National Science Foundation, and industry sponsors. Ph.D. EE, University of Florida Eric Buffkin – President Founder of Pelagic Group, Identity Stronghold, Indian River Silicon. Former executive with Intellon Corp. and consulting executive to Entropic Communications. Over 20 years experience in integrated circuits market. BSEE, University of Florida; MBA, Rollins College RizwanBashirullah, Ph.D. – Chief Science Officer Assistant Professor, Electrical and Computer Engineering, University of Florida. Holds four issued patents. Fields of research include biomedical circuits, in vivo wireless interfaces and low power analog/digital VLSI. Ph.D. EE, North Carolina State University Brent Myers, Ph.D. – Technical Lead Wireless communications integrated circuits pioneer. Leader of development teams responsible for shipment of over 400 million integrated circuits while at Harris Semiconductor, Intersil, and Conexant.Ph.D. EE, Florida Institute of Technology Dan Robinson, Pharm.D., Chief Pharma Officer Developer of multiple applications for improved pharmacy health care outcomes, pharmacoeconomics, pharmaceutical care reimbursement, adverse drug reactions, drug usage evaluation, disease state management, adherence improvement, and clinical monitoring. BS in Pharmacy from the University of Georgia and a Ph.D. in Pharmacy from the University of Cincinnati.
24. Current Status Over $1 million invested to date Core technologies developed Biocompatible conductive ink and tag substrate – g.inkIn vivo communication system and proof-of-concept IC – eBurstInitial safety and dissolution testing completed Experienced technical team assembled Product development in process
25. TV20 News. Read about eTect in the Gainesville Sun. Antenna Pill video — University of Florida News CNET News Business Week Daily News India CBC Canada Tom’s Guide UberGizmo DVICE Popular Science Meridian Institute Italian AGI Salute Austrian pressetext Discovery Channel Daily Planet Time eTect-referenced Blogs Live links at www.etectbio.com/news Press Coverage Confidential and Proprietary
26. Contact Info Additional information is available at our private website – www.etectbio.com. Login credentials may be obtained upon request. Eric Buffkin President eTect, LLC 4817 SW 34th St, Suite 4 Gainesville FL 32608 352-367-8328 x102 phone 352-262-8947 cell eric@etectbio.com
Hinweis der Redaktion
eTect has developed proprietary technology enabling true in body communications and diagnostics, WITHOUT BATTERIESNumerous applications, both medical and social, are possibleFrom capsule endoscopy pills to smart pacemakers to embedded sensors and diagnostics, in vivo communications is a large and RAPIDLY growing fieldWe believe our technology will enable even more and larger opportunities.
Through my original company, Convergent Engineering, we’ve been working on this concept for 4 years with UF EEWe have a truly exception technical team, 12 months ago Eric and I put together a wish list for our development team and we got EVERY ONE OF THEM!Brent Myers – developed the first commercial wifi chipsets and has designed chipsets that shipped over 400M unitsRizwanBashirullah – Professor at UF with 10 years of R&D on in vivo communication systemsPhDs in physics, RF Communications and imaging, and materials science. If anyone has ever met a guy with a PhD in physics, you know they know EVERYTHING.I’ve worked in biomedical devices and signal processing for 20 yearsTHIS IS NOT A VIRTUAL TEAM – WE ARE WORKING NOW MAKING REAL PROGRESS in all of the areas required to bring the system to reality – multiple types of wireless communications, sensors, materials science, IC and electronic hardware design, mobile devices, web based software
Average cost to develop a new drug - $802 millionAll new drug candidates must pass multiple phases of clinical trialsClinicalTrials.gov currently lists over 30,000 open trialsClinical trials can represent up to 50% of the development cost of a new drugThe ultimate goal of a clinical trial is to produce definitive information on the efficacy and safety of the drug under trial† Approximate mean adherence rates in long-term medicine-taking trials is estimated at 60%‡ Conventional industry target rate for adherence in clinical trials is 80%Robiner, W. N. (2004). Enhancing Adherence in Clinical Research. Contemporary Clinical Trials, November, 2005; 59-77.Average cost per patient of $7,931 in Phase III Clinical Trials Centerwatch
Represents Drug Trials only – typically 60-80% of all trials are drug trials.Historical growth ratesUS Trials – 6%Project Pipeline – 10%Average enrolleesPhase IV: up to several thousandPhase III: 1000 - 3000Phase II: 100-300Phase I: 20-80