Gary Douglas Ph.D. - Senior Consultant, In-Vitro Diagnostics (IVD)

Dr. Douglas brings more than 25 years of In Vitro Diagnostics (IVD) experience to Emergo and applies his knowledge of this industry to address the needs of Emergo's IVD and medical device clients worldwide. His vast expertise managing development projects in both the US and European markets gives Gary an understanding of the technical and regulatory compliance issues facing manufacturers.

Gary is actively involved in preparing Technical Files, US FDA 510(k) applications and Investigational Device Exemption (IDE) submissions. His knowledge of the OSHA and CLIA regulations in clinical environments and corresponding US, European and other international quality assurance and regulatory requirements also makes him an invaluable asset to IVD clients.

EXPERIENCE:

Vice-President of Assay Commercialization, LabNow, Inc. (2004-2006)

• Conducted technology assessment prior to licensing a potentially disruptive diagnostic technology from a major university with a subsequent $14 million private placement.
• Responsible for the development of the technology to a commercially viable in vitro diagnostic platform developed under FDA Quality Systems and manufactured under GMP.
  
• Managed outside contractors to accomplish assay development goals in a virtual company environment with emphasis on reagent screening, formulation, stabilization, and manufacture.
  
• Planned performance studies and clinical trials required for product launch.

Director of Licensing-Life Sciences, Science and Technology Corp. at University of New Mexico (2003-2004)

• Managed life sciences portfolio of intellectual property resulting from over $125 million spent annually on research in life sciences at the UNM and The UNM Health Sciences Center.
  
• Increased licensing revenues by 48% over the previous year. Cut the IP portfolio by 25% and consolidated law firms used from nine to three streamlining the IP management process resulting in substantial savings in both time and money.
  
• Established an intellectual property package for client contacts and utilized IPC codes to pair University technologies with potential licensees.
  
• Initiated the restructure of the University IP policy with regard to royalty distributions. Doubled number of disclosures over the same period the previous year.
  
• Served on the Health Science Center Research Council and the Dean's Science Advisory Committee in the School of Medicine.

Vice-President for Strategic Development, OmniSite BioDiagnostics, Inc. (2002-2003)

• Responsible for business development strategies and product selection in a start-up environment. Company focus was on government funded research and development of biosensor technology and diagnostics for detection and identification of infectious diseases.
  
• Major government customers included NASA, EPA, USAMRIID, OSD, DARPA, ARL, and ONR.
  
• Prepared proposals, budgets and presentations. Served as technical lead in contract negotiations.

Principal, Douglas Consulting Services (1999-2002)

• Founded a private consulting practice serving the biotechnology industry with a focus on immunochemical reagent systems and in vitro diagnostics.
  
• Advised clients in the areas of product development, technology assessment, regulatory affairs, and market analysis.
  
• Provided competitive intelligence services with regard to product and competitor benchmarking.

Founder and President, QualiChem, LLC (1990-1999)

• Responsible for the overall operation of an immunology based reagent development company serving the biotechnology and diagnostic industries.
  
• Developed and manufactured FDA cleared products as well as validation materials for manufacturers of immunodiagnostic test devices.
  
• Obtained FDA approval as a licensed, cGMP manufacturing facility for in vitro diagnostics. Launched a product line based on bioluminescence for quality control use in the food industry.
  
• Secured a multi-year contract to produce bulk antisera for use in four different immunodiagnostic test kits.
• Wrote and developed successful SBIR submission.
  
• Conducted technology assessments of companies in Russia, Georgia, Uzbekistan, Hungary, and the UK.

Director of Immunochemical Development, Calbiochem Corp. (1988-1990)

• Responsible for the development and operation of an immunology-based business unit within an international biochemical supply company.
  
• Duties included market analysis, strategic planning, budget preparation, oversight, and product selection for two departments. Managed staff of 18 including Ph.D. level scientists.
  
• Responsible for regulatory (FDA) and scientific affairs of those departments as well as the construction and operation of a USDA licensed research animal facility.

Director of Biologics, Biotech Resources, Inc. (1987-1988)

• Responsible for planning, implementation and oversight of diagnostic research projects in a start-up environment.
  
• Projects included monoclonal antibodies, specialty biochemicals, and diagnostic support reagents. Also served as liaison with other companies and academic institutions regarding reagent contracts and methodologies in the area of HIV, Hepatitis B and Hepatitis C immunodiagnostics.
  
• Responsible for a multi-million dollar research contract with a major diagnostics company to develop an assay for Hepatitis C.

Vice-President for Scientific Affairs, Cone Biotech, Inc. (1984-1987)

• Responsible for research and development, product improvement, technical manufacturing, and professional interaction with other companies.
  
• Projects included contract purification of Hepatitis B viral antigens and affinity purification of polyclonal antibodies to Hepatitis B.
  
• Managed a USDA licensed animal facility.
  
• Advised management on scientific matters related to protein purification, antiserum production, and process scale-ups.

Principal, DNW Biologics, Inc. (1982-1984)

• Founded a small biologics supply company providing specialty materials to diagnostic and catalog companies.

Microbiologist V, Texas Department of Health (1979-1982)

• Managed the State of Texas Tuberculosis screening laboratory (College of American Pathologists licensed) and supervised a staff of 8 technicians.

AREAS OF EXPERTISE:

• Project Design, Management and Marketing Analysis.
• Process Development and Manufacturing Scale-Up.
• Regulatory Affairs/ Quality Systems (21 CFR Part 820)
• In Vitro Diagnostics (IVD) Development.
• Infectious Disease, Cardiovascular, Therapeutic Drug and Abused Drug Immunodiagnostics.
• Proficiency Testing Panel Manufacturing (CAP).
• Numerous other devices used in hematology, immunology, blood bank and special chemistry environments.
• Molecular Diagnostics/PCR.

CERTIFICATIONS:

• SAS JMP Software: Statistical Data Exploration
• SAS JMP Software: ANOVA and Regression
• SAS JMP Software: Design and Analysis of Experiments

EDUCATION:

• B.A. from the University of Arizona.
• Ph.D. from University of Texas at Austin.

HOME BASE:

• Texas USA