Center of Innovation for Nanobiotechnology

Newsletter Issue No. 1: January 17 2011 Subscribe to Our Newsletter

In This Issue

• Membership and Sponsorship Update
• Featured Article: Navigating the Regulatory Path
• Featured Article: The Nanomaterials Registry
• Recent News
• Upcoming Events
• Expert Spotlight
• NanoBioConnect Reports
• Stay in Touch

Membership & Sponsorship Update

MEMBERSHIP: COIN staff are working hard to create a nurturing infrastructure and supportive ecosystem for nanomedicine companies in North Carolina and beyond. Becoming a member is one of the best ways to support COIN’s mission and activities. COIN will offer an affordable annual membership in 2011 for companies within the ecosystem and hopes that if the organization supports you through its work, you will support COIN to be around for many years to come. 

MEMBER SERVICES: COIN has begun to offer tailored innovation management services  to clients and members and has partnerships that offer further resources specifically for incubation and translation. COIN can assist with:

• Business development, new company formation,  incubation, licensing, SBIR funding
• Grant writing  to increase funding for investigators & companies with strong IP
• POC/preclinical characterization and toxicology work

Affiliations with service providers offer further help with applied research & development, manufacturing, and quality assurance.

SPONSORSHIP: There are numerous opportunities to sponsor COIN’s events and activities and raise the profile of your organization in the nanobio community. Indeed, COIN is proud to announce annual NanoBio Executive Roundtable Series sponsors, RTI International, McDonnell Boehnen Hulbert & Berghoff LLP (MBHB), Grant Thornton, and MEMSCAP. COIN is also grateful for the support from the NC Biotech Center, NC A&T University, and Kymanox.

As mentioned above, COIN is also working on upcoming new events such as the NCNCC add-on Nanomedicine Commercialization Workshop in Charlotte on March 29th and an international nano/nanobiotechnology conference coming to NC in September 2011. Several companies have signed up to sponsor the March workshop including CMG Partners, Poyner Spruill LLP, and Foley & Lardner LLP as well as Ken Russell. 

Please contact Jim Roberts, Director of Membership and Fund Raising for details on membership and sponsorship.

 

Navigating the Regulatory Path

Lessons from Liquidia's Commercialization Strategy

Guest Author: Tom Templeman, SVP Integrated Supply Chain, Liquidia Technologies

Today more than ever, innovation is an important differentiator among companies striving to be successful. In the life sciences industry, not only is innovation critical for developing drugs that will address important unmet needs, it also plays a critical role in a company’s ability to successfully navigate the market-based economic pressures and the regulatory hurdles posed by the FDA.

One need look no further than the significant changes that large pharmaceutical companies are making as they retool their approach to Research & Development (R&D) in order to reverse the slump in FDA product approval and earning trends. It is clear that a renewed focus on innovation is a key driver behind their development plans. And, in contrast to prior R&D realignments, large pharmaceutical companies are now allocating a smaller portion of this R&D spend for internal projects. Instead, they are more frequently turning their sights externally to find their innovation through small technology companies that can provide them with the differentiated products they ultimately strive to commercialize. 

North Carolina is home to many of these small technology companies. In fact, according to the most recent edition of Forbes magazine’s list of Best States for Business and Careers, North Carolina is now considered the third best state in the nation for business, up from a fifth place ranking just a year ago. Among the many factors that have contributed to the state’s attractiveness, the low cost of doing business and the highly educated and skilled work force rank high on the list. Despite these advantages, small companies in this region are still faced with tough challenges and decisions that impact their ability to successfully grow and access capital, especially on the heels of a recent recession. 

Today, many companies are realizing they may have to invest more money over longer horizons in order to build successful companies. Therefore, not unlike the large pharmaceutical companies, local companies and investors are looking to innovation to drive blockbuster products and long-term growth. Liquidia Technologies is one such North Carolina company advancing a technology that brings innovation to investors and large pharmaceutical companies working to differentiate their products from their competitors. Liquidia develops precise particle-based vaccines and therapeutics for the prevention and treatment of human disease. And despite the struggling US economy – the company continues to grow by advancing innovative products.

For Liquidia, its innovation engine is the PRINT platform.  The PRINT platform is the industry’s only particle based platform that enables the design and fabrication of a uniform population of particles that can be precisely controlled in size, shape and chemistry (Figure 1).  Over the last three years Liquidia has increased manufacturing scale over 1000-fold and developed processes and analytics critical to ensuring cGMP compliance. Tom Templeman, Liquidia’s Senior Vice President Supply Chain, has commented that “the precise process control that the PRINT technology enables over particle construction has facilitated the company’s rapid institution of cGMP systems. Furthermore, Liquidia's unique ability to engineer and generate monodispersed particles gives our products an increased potential to influence a wide range of desired clinical effects, while at the same time addressing many of the heterogeneity concerns brought forward by the FDA in response to other nanoparticle preparations.”   

Innovation is a critical component of a successful product company, but it isn’t the only element needed to become a strong competitor in today’s marketplace. One of the key challenges that Liquidia and many other companies like it face is the transition from innovative research to product development. There are many companies that never make this transition successfully. Product development is expensive and usually involves a significant level of risk.  For Liquidia, making this transition is much more than just selecting a product to develop, it is selecting the right product and ensuring their technology demonstrates a unique ability to overcome the vast array of barriers that have stood in the way of product development for decades. Thus the innovation of the PRINT platform forms the foundation, but the strength of the management, the investors and the employees is necessary to parlaying the innovation into compelling products that drive success for the company. Today, with its lead vaccine in a clinical trial and a portfolio of vaccines and other therapeutics moving in the pipeline behind it, Liquidia is rapidly making the transition to product development and building a successful company.

Like Liquidia, many other North Carolina companies are also focused on advancing innovative  technology and building great teams who can convert that innovation hub into viable products that address important unmet needs. The groups that focus on both of these critical elements and execute well, will ultimately build great companies, even in this uncertain economic and regulatory environment.

 

The Nanomaterials Registry

RTI Leverages NIH Contract to Create Nano Resource

Guest Author: Michele Ostraat, Director of Center for Aerosol Technology, RTI International

The Nanomaterials Registry, an ambitious and much needed resource for the nanotechnology community, is currently being developed by RTI International, a large not-for-profit research institute headquartered in RTP, NC.  This project is in partnership with the National Institute of Biomedical Imaging and Bioengineering (NIBIB), the National Institute of Environmental Health Sciences (NIEHS), and the National Cancer Institute (NCI). 

In this multi-year project, RTI is working  to establish a web-based registry that will provide a centralized resource of curated information on the biological and environmental interactions of well-characterized nanomaterials.  The project’s primary goal is to establish an authoritative nanomaterial registry that will provide consistent and authoritative information on the biological and environmental interactions of well-characterized nanomaterials.  In addition, the registry will provide additional information, including links to associated publications, modeling tools, computational results, and manufacturing guidance.  Through this project, the team will also work to:

• Create and effectively facilitate an Advisory Board of domain experts that span stakeholder groups and technology expertise

• Develop a consensus-generated set of Minimum Information About Nanomaterials (MIAN) and a logical nanomaterial ontology that spans broad biological and environmental implications

• Design and implement a curation process to organize and evaluate information into a web-accessible database that is user-friendly and engaging to nanomaterial users and the public alike

• Maximize opportunities for public and professional participation and comment and to educate interested professionals and individuals on nanomaterial data relevant to biological and environmental implications through outreach and other communication activities.

As a public resource, the registry is being designed to facilitate data validation and data quality improvement of nanomaterials; enhance the development of new models, assays, standards, and manufacturing methods; and accelerate the translation of new nanomaterials for biomedical and environmental applications. This activity will also specifically address such diverse activities as regulation, product development, and environmental remediation and will allow for the integration of diverse data sources in this field.

Furthermore, through Advisory Board and outreach activities, the project team will engage scientists in the nanomaterials community to promote common nanomaterials standards and to identify reliable information that can be used in regulatory decision making as RTI continues to work with industry groups, standards organizations, and government agencies to develop and validate the registry.

The project team recognizes that the successful creation, maintenance, and launch of this authoritative registry requires the active participation and contributions from many professional resources, including those with specialization in nanotechnology and bioinformatics and in database creation and organization. Many of the experts engaged in this program will be able to contribute towards

• Describing the set of MIAN that impacts and alters biological and environmental interactions with nanomaterials, including desirable and undesirable interactions
• Identifying instrumentation issues associated with properly characterizing nanomaterial properties and with general instrumentation availability
• Identifying issues associated with assays, methods, and protocols and with interpretation of biological and environmental implications
• Developing a registry that is most useful to broad end-users, including one that (1) functions as a powerful tool that can be used to facilitate predictive modeling of biological and environmental interactions given a set of nanomaterial characteristics and (2) guides the production of inherently safer nano-enabled products for biological and environmental health.

Over the next several months and years, continue to look for updates from the RTI project team on this exciting program!

 

Recent News

Raleigh-based Xanofi launches game-changing nanotech fiber product

Xanofi, using technology derived from seven years of research at North Carolina State University, is offering several nanotech products, including XanoShear, which creates polymeric fibers with shear force in liquids, an inherently simple and efficient design that also accepts a wide range of additives to create functionalized fibers (fibers that have coatings, additives or other enhancements). (read more)

Micell Technologies enrolls first patient in DESSOLVE I first-In-human study of MiStent DES

Micell Technologies enrolled the first patient in the  a first-in-human clinical trial, DESSOLVE I (DES with Sirolimus & a bioabsorbable polymer) at Mercy Hospital in Auckland, New Zealand. The MiStent™ Drug Eluting Coronary Stent System (MiStent DES) is being evaluated for  treatment of patients with de novo lesions in the native coronary arteries. (read more)

RTI wins $6.6M contract to study nanoparticle safety

Scientists at RTI International have received a $6.58 million, 5-year contract with  the National Institute of Environmental Health Sciences to research the effect of carbon nanoparticles in expectant mothers and children. RTI will collaborate with East Carolina University and The Hamner Institutes for Health Sciences on the project. (read more)

NanoCor Therapeutics, Inc is awarded a grant under the Qualifying Therapeutic Discovery Projects Grant Program

Tech company with Duke roots raises $1.2M

150 N.C. companies get biotech grants

Liquidia testing seasonal influenza vaccine

Asklepios Biopharmaceutical enters into a patent license agreement with Pfizer

Nanotechnology group to hold national conference in Greensboro