Objectives

Although the Center is new, nanotechnology is not.  New high-profile, FDA-approved, nanotechnology-based products for oral delivery of compounds, topical delivery, and injectable therapeutics and diagnostics have captured the attention of lay people and scientists alike. At no other time has Paul Ehrlich’s magic-bullet theory from the year 1900 been more tangible. Over the past ten years two fields have reached a critical intersection of opportunity and necessity.  One field, drug discovery, has exploited the knowledge of molecular and cell biology to discover new potent therapeutics that absolutely require membrane transport or intracellular accumulation for their mechanism of action.  The other field, drug delivery, has drawn from key aspects of nanotechnology, biomaterials and engineering to assemble nanoparticles and/or nanoconjugates to deliver such therapeutics across membranes or into cells. Coming together, these two fields are poised to make significant advances in the biomedical field relating to the detection, treatment, and prevention of human diseases.  The advanced drug delivery market (currently about $70 billion) is growing at a rate of 20-25% each year. The NIH Roadmap and North Carolina’s Roadmap for Nanotechnology (April 2006) highlight the potential that nanotechnology may have on human health and in creating sustainable economies, respectively.

Currently, about 50 to 60 percent of all drugs fail in preclinical evaluation due to poor ADME (absorption, distribution, metabolism, and excretion) and toxicology (Business Insights, 2006). Clearly, successful formulation and drug-delivery solutions must advantageously address and solve poor ADME properties and/or decrease toxicity. The CNDD in the UNC Eshelman School of Pharmacy will develop a vital partnership with scientists in drug discovery to decrease the attrition rate of otherwise potent new molecular entities (NMEs) and to increase the probability of clinical success in drug development at UNC.  Importantly, the National Cancer Institute's “The Nation's Investment in Cancer Research 2008” highlights the use of novel formulations and delivery systems including nanotechnology to achieve a seamless transition for taking new molecular entities (small molecules and biologicals) from preclinical development through commercialization. Often drug-discovery programs are successful in identifying promising NME leads, but poor drug physical-chemical properties (such as poor solubility, lack of chemical stability, and poor permeability) make further progress toward preclinical efficacy studies and defining toxicology very difficult. Moreover, seemingly simple approaches to address these problems with the NMEs may result in a therapeutic approach that cannot be scaled up easily or in a cost-effective way to ensure a safe and efficacious dosage form for administration to patients.

In order to capitalize on drug discovery efforts at UNC and to increase the probability of clinical success, the CNDD will bring together and synergize five critical areas / disciplines at UNC to achieve a critical mass of expertise needed for successful nanotechnology.

The science objective of the CNDD is to be “first in human”, demonstrating proof of product safety and utility. This science objective meshes very well with the NIH Roadmap’s emphasis in translational sciences and nanotechnology, as well as the NCI’s call to bring nanotechnology discoveries more efficiently into human clinical trials (Nov. 2006). In fact, the NCI’s Rapid Access to Intervention Development (RAID) Program and Nanotechnology Characterization Laboratory (NCL) initiatives were specifically designed to facilitate such goals. The CNDD will be part of a larger nanomedicine program at UNC and will partner with already-existing and successful centers and schools such as NCCNM (Area 1), the UNC Eshelman School of Pharmacy (Area 2), and CCCNE (Area 3), as well as the EPA and NIEHS in RTP (Area 4) and the anticipated UNC Clinical and Translational Science Award (Area 5).  Faculty in the CNDD will come from many academic units, including the College of Arts and Sciences and the Schools of Medicine, Pharmacy, and Public Health. A common thread of CNDD members will be the focus in translational nanotechnology.

The academic objective of CNDD is to become the world’s leader in nano-drug delivery research, training and intellectual property creation. As a direct consequence, business plans and faculty start-up companies will be created using the expertise of UNC’s Office of Technology Development (OTD) and Kenan-Flagler Business School. These companies will in turn seek private equity to further develop these products and companies.

The business objective of the CNDD is to create a sustainable business model that will provide for a meaningful return-on-investment for all Stakeholders. For at least a period of five years, it is proposed that UNC and the state of North Carolina invest in the core and infrastructure of CNDD. The CNDD's executive board will provide guidance and oversight. In addition to grants and contracts from public and industrial sources, the CNDD will seek private funds to support the development of early concepts and technologies. Funding from NCI’s RAID and NCL programs will provide additional support for these efforts.

Importantly, all CNDD stakeholders benefit from this sustainable public/private business model. For example, the NIH-NCI will realize its goal of translational nanomedicine. The state of North Carolina will share in the wealth of company and job creation in the state. UNC students will be trained in an emerging, high-technology discipline and will be highly sought by high-tech companies in the state. The private sector will benefit from its investment since positive clinical data has the highest early impact on technology/company valuation in the market place. Thus, the sustainable business model of the CNDD ideally provides benefit to all stakeholders helping to achieve a set of common goals.