A company serving Unmet Needs and Underserved PopulationsUNandUP is building tomorrow’s life-science technologies. Traditional dilutive pathways to early-stage capital are punitive. Securing IP rights and raising follow-on capital cannibalize the time and money needed to build a technology’s value proposition. As a result, risk to investors is increased, founder ownership is diluted, productivity is reduced, and control is lost. UN&UP’s model is different and builds upon proven start-up entrepreneurship, a deep understanding of intellectual property, and a long history of success with non-dilutive federal grant funding. Federal dollars are optimally leveraged among multiple efforts to result in the fast formation of healthy companies at Series A; with strong IP, greater founder ownership, and lower risk to investors.

In this role, I serve as a technology and commercialization reviewer for the NIH, where I evaluate novel technologies and make funding recommendations. To date I have assessed nearly $1B in NIH grant proposals. My areas of primary focuses related to medical and drug-delivery devices, which includes a range of surgical tools, robotic systems, diagnostic equipment, and delivery platforms. I serve as lead reviewer for several innovative technologies, including real-time surgical systems, telehealth monitoring solutions, microinfusion technologies, motion monitoring and gating, image-guided robots and devices, tomography and breast cancer detection systems, localization technologies (catheters, mico-devices, scopes, and probes), bloodless surgical systems, and spirometry.

I am a commercialization reviewer for new technologies in the treatment of cancer. I primarily contribute to magnetic-particle-based solutions and their detection systems. My knowledge pertaining to MR and hyperthermia is leveraged for those technologies involving magnetically tagging cancerous cells and their eradication.

I was asked to join the the Washington University BioDesign program to help define and strengthen the structure, goals, and endpoints of the effort. My responsibilities include overseeing the participant-led projects, offering guidance when needed, and judging the progress of the students' work.

I serve as a technology reviewer for both groups, where the focus is primarily on novel biosensing systems, biorecognition strategies, multifunctional nanomaterials and interfaces, bio-macromolecules confinement, and molecular sensors. My expertise includes targeted drug delivery, magnetic nanoparticle functionalization, particle manipulation and control, and hyperthermia delivery.

Sbmission reviewer.

Submission reviewer.

I have assisted in the diligence on a number of technologies and their respective market, IP, and clinical strategies. I have been successful in leveraging my work experience and my involvement with the NIH, NSF, & NCI to evaluate a number of innovative technologies, including the following: * Assays using magnetic particles * Telemedical solutions (EP & stroke) * Robotic systems (surgical and minimally-invasive) * Tomography * Real-time localization systems (e.g., GMR) * SpirometryIn this role, I have performed analysis reports on life-science growth in emerging markets (e.g., China & India) and macro analysis of medical device performance and the respective clinical endpoints. In addition, I assemble relevant literature to help analyze new medical technologies.

In early 2009, I founded Pulse Therapeutics based upon a breakthrough discovery in nanoparticle drug delivery. The technology overcame all major limitations of magnetically-directed drug therapy. By using a low-cost magnetic workstation and proprietary intravascularly-administered iron oxide nanoparticles, the technology resulted in a 100X improvement in drug diffusion. While the technology represented a platform, improved thrombolysis for acute ischemic stroke was selected as the first commercial embodiment. Most significantly, the company successfully argued to multiple regulatory bodies that the technology should be clinically evaluated as a medical device, making the Pulse Therapeutics technology the first drug delivery nanoparticle platform to be assessed as a medical device (versus a drug or biologic). I have served in several roles, including CEO, before focusing on new innovations as the Chief Innovation Officer. I achieved the following in by roles:* Invented the core technology* Authored documents for regulatory bodies, including mechanism of action justifications and reports of prior investigations* Successfully argued clinical evaluation of the technology as a device (FDA, MHRA, and TGA)* Successfully engaged the FDA’s Early Feasibility Study program* Managed the worldwide IP plan, resulting in multiple accelerated US approvals* Awarded multiple NIH SBIR awards, with more than $2M awarded in a single year* Maintained relationships with leading worldwide neurology and cardiology experts* Developed relationships with the NIH, FDA, MHRA, and notified bodies* Managed a pilot clinical study in Australia* Successfully raised early funds (state, federal, university, incubation, PE, angel networks, VC)* Awarded slot in the NIH Commercialization Accelerator Program* Familiar with ISO10998, IEC60601, GMP, and GLP practices* Oversaw preclinical studies* Author of the 1st-place business plan for the St. Louis Business Plan Competition

Manuscript reviewer

I served as the principal inventor and architect of the company’s core technology and methods, including the Niobe robotic system. During my employment, I was awarded 30 US patents. I worked closely with the CEO and Board of Directors to develop new robotic technologies, techniques, and devices for EP and IC/INR/IR. I was responsible for researching new applications, performing the initial market analysis, and building clinical relationships. My responsibilities included directing R&D efforts, working alongside integration partners, and identifying methods to dramatically reduced cost of goods.* Principal investigator for emerging technologies and new market opportunities, including AVM, aneurysm, pulmonary navigation/ablation, stroke therapies, stem and gene delivery.* Invented systems, devices, and methods for robotic navigation which resulted in 2X size and 10X cost reductions.* Leader in integration efforts with major device companies, including Siemens, Philips J&J, Terumo, and GE.* Established strong relationships with leading global manufacturers to enable the development and rapid release of next-generation custom magnetic materials. * Patent authoring and IP strategy.