KeraNetics LLC
Richard Dean Research Building, Suite 168
391 Technology Way
Winston-Salem,North Carolina 27101
Company Website: www.keranetics.com
Number of employees: 13
Non-confidential description of company and nature of business:
KeraNetics is a biomaterials company focused on creating inexpensive keratin-based products for use in areas of regenerative medicine, trauma care, tools for research scientists and hair and skin care products. The Company was formed in May 2008 and is headquartered in Winston-Salem, North Carolina. KeraNetics has raised $8 million in initial investment from a select group of high net worth individuals mostly located in North Carolina.
This level of investment is possible due to the fact that keratin biomaterials research has been an ongoing activity at the Wake Forest University Health Sciences (WFUHS) since 2004 and progress towards commercialization has exceeded initial expectations.
To finish the preclinical development of the company’s core technologies, KeraNetics has completed 18 months of a Sponsored Research Agreement (SRA) that delivers $3.6 million in funding to WFUHS over three years. These investigations are ongoing using keratin biomaterials for applications in bone regeneration, nerve regeneration, wound healing, hemostasis, resuscitation fluid, coatings for tissue culture as well as the continued study of the basic material properties of the biomaterials. These projects as well as those to be conducted solely by KeraNetics will provide additional data and understanding related to materials processing, characterization, biocompatibility, efficacy, mechanisms, manufacturing, packaging, delivery, shelf life, sterilization and validation of the keratin family of biomaterials.
To move these technologies from the pre-clinical stage to product approval, KeraNetics has validated a Quality Systems Regulation (QSR) manufacturing facility in one of the Piedmont Triad Research Park’s Wet Lab Launchpads™. This facility is producing keratin materials for the FDA regulated products within its clinical pipeline and research materials for its subsidiary KeraFAST available for sale at www.kerafast.com . Ongoing research such as the project proposed here, is being conducted in leased wet-laboratory space that is part of the Babcock Demon Incubator in the Piedmont-Triad Research Park. KeraNetics is in the process of spinning out a health care and beauty products company that will produce keratin products for hair straitening and skin care that require research and product development. This spin-out company launch should occur by Q2 of 2011.
Non-confidential description of company's core technolog(ies):
KeraNetics holds a portfolio of 26 patent filings related to keratin-based biomaterials that have been developed over the past six years at WFUHS. KeraNetics holds a license agreement with WFUHS that assigns exclusive rights to these pending patents on a worldwide basis for the life of the patents.
The keratin family of products in the company’s pipeline consists of wound healing applications, bone regeneration, nerve regeneration, hemostatic gels, resuscitation fluids and coatings for tissue culture ware. These technologies are based on a proprietary protein extraction process that produces a variety of keratin biomaterials that can be tailored to specific tissues or biological processes. The company has conclusive pre-clinical data for each of these applications and is in the process of testing each in large animal in vivo and in situ models.
The mission of the company over the next 24 months is to commercialize these technologies in the patent portfolio by completing all the pre-clinical development studies. The company will be submitting Investigational Device Exemptions (IDE) to the FDA in April-May 2010 in order to conduct Phase I clinical trials for three of its technologies in the pipeline. Additionally KeraNetics has formed a research tools company that sells various products including keratin coatings for cell culture applications and is in the process of forming a beauty-aids company that will produce products for skin and hair care.
Proposed Scope of Work for Fellow:
One of the key aims of this fellowship is to give the prospective scientist the opportunity to develop an understanding of the use of novel biomaterials in the context of the business environment of a start-up biotechnology company. This experience is unique for scientists wanting to enter industry in that KeraNetics has a strong collaboration with Wake Forest University Health Sciences that will uniquely prepare him/her to enter the North Carolina biotechnology community as a Primary or Senior Scientist in a company who collaborates with academia or other industry partners. The incumbent scientist would employ a strong working knowledge of biomaterials and cell biology to implement and interpret key experiments aimed at optimizing the characteristics of keratin biomaterials for over-the-counter skin and hair care products. These experiments are a critical step in optimizing materials that will be used in the company’s pipeline of products and consist of a series of in vitro studies that will assess biochemistry, efficacy and long term storage of several keratin biomaterials. The ultimate goal of this work will be to optimize a specific formulation of keratin biomaterials that will be used in future products of a spin-out company. The candidate will be under the supervision of Luke Burnett PhD, the company’s Director of Product Development and Research but will also receive mentoring from Mark Van Dyke PhD, Assistant Professor Wake Forest University Health Sciences and the company’s Chief Scientific Officer who has a demonstrated track record of transitioning academic technologies to businesses. Additional mentoring will be provided by Kim Westmoreland, the managing director of the company and Professor of Entrepreneurship at the Wake Forest University School of Business. Mr.
Westmoreland will provide the prospective scientist with mentorship in the area of business plan development.
Proposed Activities :
1. Familiarization in the extraction and purification process of keratin proteins within a QSR environment.
2. Execution of the aims of a product development study funded by KeraNetics to optimize formulations of keratin biomaterials for over-the-counter skin and hair care products.
3. Development and execution of experiments to evaluate the long term storage and shelf life of a direct to market keratin material for these applications.
4. Participate in business plan development for direct to market keratin over-the-counter products.
5. Work with mentor to develop a defined budget for project
6. Responsible for conducting and completing experiments and milestones within defined budget
7. Participate in comparative analyses of multiple strategies based on technical outcome, cost and intellectual property
8. Contribute actively to the generation and protection of company intellectual property
Desired Qualifications of Fellow:
1. PhD in Biomedical Engineering, Cell Biology or related biological field
2. At least (2) peer-reviewed research publications in related field
3. Outstanding oral and written communications skills
4. Adept in team-oriented environment
5. Interest in business plan development, undergraduate business experience a plus
6. Hands-on experience with biomaterials processing and production techniques. Experience with cell isolation and culture, molecular methods and in vitro assessment of cell function a plus.
Benefits Description: Benefits for this position include health (Blue Cross and Blue Shield of North Carolina) and dental (Companion Life), 14 days paid vacation, office space, parking and visiting scientist privileges at Wake Forest University Health Sciences. Benefits package roughly totals $13,500