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About Oro Valley Innovation Labs (OVIL)

Oro Valley Innovation Labs (OVIL), formerly known as BioSA Innovation, was incorporated in May 2015 in Arizona as a non-profit in the Bioindustry of Southern Arizona and was granted 501(c)(3) tax exempt status by the IRS in 2017. OVIL was created as a community effort to foster the success of new bioscience products resulting from biomedical research performed in Southern Arizona.  A primary focus is the development and operation of a business incubator/accelerator in Oro Valley, Arizona planned for occupancy in 2019.  The incubator/accelerator will occupy approximately 6,000 SF with room for expansion as shown in the design below.

 

How do we intend to improve the public health?

OVIL will create a facility in which it will provide space and conduct educational and training programs for translational scientists in Southern Arizona, i.e. those who work to convert research findings into new and useful technologies. 

Donate now to support innovation in science in Southern Arizona.

What we do

New scientific advances in biomedical research often fail to reach patients because of the long and complex development process that often takes more than a decade and financial investments that can total in the billions of dollars.  For scientific advances from university research to reach the public, the scientists guiding the testing and development of these complex technologies require special training that is not often readily available to increase their likelihood of success. The long process of moving a scientific idea from the academic or industrial lab to commercial success (shown below), has many steps and requires a broad set of skills, expertise and risk.  Analysis of the current environment for product development has identified the need for a business incubator/accelerator as a critical gap (Sun Corridor Report: Securing the Lead - A comprehensive focus on diagnostic business growth in Southern Arizona, May 23, 2013).  

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OVIL will bring value to the community and Southern Arizona, focused on the generation and success of life science technology companies by integrating the efforts of academic and anchor industry partners.

Oro Valley Innovation Labs, Inc., a non-profit 501(c)(3) organization, will operate and manage the accelerator planned for occupancy in 2019, offering startup and early stage companies access to training programs in biomedical product development and significantly lower occupancy costs to help nurture their success.

OVIL's mission is to conduct and support educational and translational research efforts and programs to promote bioscience either alone or in collaboration with public and private educational and other institutions and to operate facilities for such purposes. 

Non-profit agencies and academic programs will be co-located to increase interactions that promote the creation of successful applications for funding/investment, development of business plans, including counsel for preclinical and clinical trials, device approval and reimbursement, and manufacturing.The above diagram shows the movement of "ideas" for use-inspired technology from academic research through three stages of proof of concept (POC) to enter the market. Those "ideas" that have been successfully incubated (found to have scientific Proof of Concept) will be invited to enter OVIL's innovation labs in which the technology will be accelerated through the development of clinical proof of concept (POC).  Clinical POC will require data that meets both the standards of the Food and Drug Administration (FDA) and payers such as the Center for Medicaid and Medicare Services (CMS).  OVIL will enable the companies  to submit essential data required for a market prototype and attract funding for final development and marketing of their products.  It is expected that the successful companies emerging from OVIL will remain in the southern Arizona region where they will be able to demonstrate commercial POC.

Conceptual Diagram of Facility

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Oro Valley Innovation Labs Core Facilities planned for 2019:

  • Offices and Labs for startups
  • Fully equipped GLP compliant and CLIA-compliant laboratories
  • Informational Technology - HIPAA Compliant and Highest Level Security
  • CFR 21 Part 11 Compliant records facility for FDA-directed R&D
  • GCP-compliant biorepository
  • Regulatory consultations and advisors
  • GXP (GCP or GLP) compliant recording keeping
  • Conference Facility
  • Networking environment

Development and production stage companies focused on the following areas are anticipated to be located in the Accelerator:

  • Diagnostics
  • Biotechnology (bio-printing, nanotechnology)
  • Healthcare IT (bioinformatics, sequence analysis),
  • Therapeutics
  • Medical Devices
  • Research Diagnostic Platform Technology (Molecular pathology, sequencing, micro-fluidics). 
  • Information Technology and App Development

By providing a modern training environment for university scientists and biotechnology startup scientists to gain and share scientific, regulatory and biotech business development knowledge, advanced methods and skills in the development process for biomedical innovations, BioSA Innovation will thereby improve the likelihood of success for biotechnology products and the public health.

Training Programs

The training will include programs that address the following educational needs of translational scientists:

  • How to conduct research and development for specific products in accordance with FDA-required Good Laboratory Practices standards.
  • How to conduct research and development for specific products in accordance with HIPAA regulations
  • How to conduct research and development for specific products in compliance with CLIA (Medicare/Medicaid) laboratory standards.
  • How to collect data according to CDISC standards for common data elements that are now required by FDA for research and development for specific products.
  • How to gain access to and utilize free, open-source software for research that meets the above standards, e.g. RedCap, i2B2, SMART, FHIR, etc.
  • How to obtain laboratory evidence of proof of concept for the medical or clinical value of a scientific observation.
  • How to define product development plans for specific products that meet FDA or CMS standards.

The OVIL educational programs and the facilities will enable hands-on experience in product development during the critical early phase of product development and include direct interaction with experts who have experience in the successful development of biomedical products.

How is the activity funded?  Charitable contributions and grants. Grant applications will be submitted to government entities, foundations and other grant making organizations.  Training fees will be charged for educational programs conducted in the facility to cover the costs of maintaining the facility and delivering the programs.

 

Board of Directors:

Officers:

Chairman –Paul August, PhD (ICAGEN)

Vice-Chair – Raymond Woosley, MD, PhD (AzCERT)

Treasurer - Neil Simon (Venture West)

Garry Brav (BFL Construction)

Matthew Lingard, PhD (Bayer)

Robert Robbins, MD (President, University of Arizona)

Fletcher McCusker (UA Ventures)

Dave Perry (Oro Valley Chamber)

Mary Jacobs (Town of Oro Valley)

Kissy Black (BioConvergence Media Lab | Lotos Nile)

Thomas Koch, PhD (Roche)

Joe Tasto, PhD (Roche)

Ken Wertman, PhD (BIOSA)

Nina Ossanna, PhD (BIOSA)

Pete Bantock (Accelerate Diagnostics)

Base Horner (Desert Angels)

Joseph Snell (Sun Corridor)

Sharon Hesterlee, PhD (Lion Therapeutics)

Lawrence M. Hecker, JD (Hecker PLLC)

Chuck Huckelberry (Pima County)

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