COMMERCIAL NEW PRODUCT DEVELOPMENT

NEW PRODUCT DEVELOPMENT
Biotechnology innovation and new product development underpin some of the most impactful public health interventions in recent generations. I have been fortunate to contribute to some of them with my work on the technologies that shifted testing of the nations blood supply to molecular testing, as well as, first-in-class genetic engineering programs for food, health and environment.

EXPERTISE
  • Genetic, genome, and molecular engineering technologies for food and protein production
  • Medical diagnostics, food safety testing, and environmental threat detection
  • Genetic, genome, and molecular engineering of human and animal therapeutics, medicines, and vaccines
  • Molecular epidemiology, epidemic intelligence, environmental and public health interventions

Currently advancing and raising to further execute on R&D projects: (redirect to www.planetary-genetics.com)
  • Engineering SARS-CoV-2 sewer surveillance systems and environmental testing platforms
  • Protein production of animal-free growth factors for cultivated meats with algal expression systems
  • Quantitative serological SARS-CoV-2 (COVID) assay for protective neutralizing antibodies

Executed on multiple first-in-class advanced detection programs yielding FDA cleared CBER regulated blood screening and CDRH regulated medical diagnostics, including:

Participated in technology diligence to support acquisition or internal development and deployment of novel biotechnology platforms and first-in-class products reviewed by FDA, USDA, EPA and US FWS regulators:
  • AquaBounty genetically engineered fish, first GE food animal approved for human consumption (salmon)
  • Oxitec genetically engineered insects to fight infectious disease and agricultural pests ($160M acquisition)
  • ViaGen cloning for food and companion animals, as well as endangered species
  • Trans Ova Genetics bovine reproductive technologies ($110M acquisition)
  • Okanagan Specialty Fruits genetically engineered non-browning apples and other fruits ($41M acquisition)
  • EnviroFlight alternative protein feed nutrition using insect larvae
  • GenVec human and animal molecular vaccine platform
  • Engineered cell therapy platforms
  • ActoGeniX (ActoBiotics™) engineered microbial human and food animal medicinal platform ($60M acquisition)
  • Genomatix proprietary software for promoter design for genetic and genomic engineering
  • ILH, formerly Codexis, protein production facility in Hungary
  • Intrexon’s UltraVector® platform for protein engineering and gene switches for control of protein production [microbes, plants, animals, humans]
  • Intrexon’s pioneering of gene-edited environmental clean-up systems for emerging contaminants of concern [e.g., 1,4-dioxane]
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GLOBAL HEALTH

GLOBAL HEALTH
Mitigation of infectious diseases and malnutrition serves to enable more resilient and stable international communities culminating in reduction of global health burden and foreign conflict. I gained first-hand experience developing blood screening technologies domestically and subsequently translated those learnings to programs and interventions in Sub-Saharan Africa. My time in Malawi has forever left a mark on my heart and mind as it helped shape my world view.

Areas of Expertise
  • Global health and international development field efforts (Sub-Saharan Africa)
  • Molecular epidemiology, epidemic intelligence, environmental health, as well as, infectious disease and vector control
  • Epidemic responses: COVID-19 pandemic, Zika, dengue, malaria, tuberculosis, HIV, influenza, Chlamydia, and Gonorrhea

For over two decades, I have been advancing biotechnologies and gaining expertise on the frontlines of numerous medical, environmental, and public health interventions including:
  • Molecular testing for safety of the U.S. blood supply: HIV, HCV, West Nile virus (Gen-Probe > Grifols)
  • Launch of first combined Chlamydia and Gonorrhea APTIMA molecular tests, eliminating need for male genital swabbing using male/female urine specimens (Gen-Probe > Hologic)
  • Pioneering HIV CD4 mobile testing interventions in Sub-Saharan Africa to ensure efficacy of HIV anti-retroviral therapies (ART) in rural low resource settings (St. Gabriel's Hospital - Malawi)
  • Countermeasures for zoonotic and vector-borne infectious disease control domestically and internationally (Gen-Probe, St. Gabriel's Hospital - Malawi, Intrexon, Oxitec)

NATIONAL SECURITY

NATIONAL SECURITY & BIOSECURITY
Throughout my professional career there has been a national security component to the technology portfolios. My commitment to national biodefense and global biosecurity has fostered numerous relationships across government and the private sector in order to advance new technologies to support US and world health interests.

Current R&D Initiatives

Biodefense & Biosecurity Experience
  • Biodefense and biothreat mobile detection systems for intelligence community (Nanogen / Vectrant)
  • Translation of FDA cleared APTIMA CT/GC nucleic acid test to APTIMA ASR Rapid Response Molecular Detection Platform for biothreats (Gen-Probe > Hologic)
  • Infectious disease testing and vector control interventions for mosquito-borne diseases (Gen-Probe, St. Gabriel’s Hospital - Malawi, Intrexon, Oxitec)
  • Invasive species population control approaches (Intrexon, Oxitec)

Areas of ongoing effort to support global biosecurity and the national defense:
  • Biological and chemical threat detection systems
  • Medical countermeasures and next generation molecular vaccines
  • Biothreat measurement and signature intelligence
  • Engineered food animals and alternative protein sources for enhanced food security
  • Fermentation-based fuels and food production

ONE HEALTH, PLANETARY HEALTH = PUBLIC HEALTH

PUBLIC HEALTH | ENVIRONMENT & PLANETARY HEALTH
I believe a universal view of health is required to reverse the negative impacts currently facing our species and planet. ONE HEALTH and PLANETARY HEALTH perspectives enhance intervention efforts by integrating public health, global health and environmental health disciplines.

Current R&D Initiatives

I've worked across academia, industry, and the international development community to promote improved domestic and global public health by advancing technology-based interventions and applications for:
  • Numerous FDA cleared products including current molecular tests ensuring safety of U.S. blood supply (HIV, HCV, HBV, West Nile Virus) (Gen-Probe > Grifols)
  • Molecular detection systems for environmental testing and biosecurity (Gen-Probe, Nanogen / Vectrant, Intrexon)
  • Medical countermeasures: diagnostics, therapeutics, and vaccines (Gen-Probe, Nanogen / Vectrant, Exonhit, Intrexon)
  • Development of pioneering gene-edited environmental clean-up systems for emerging contaminants of concern (COCs) {e.g., 1,4-dioxane] (Intrexon)
  • Infectious disease testing and vector control interventions for mosquito-borne diseases (Gen-Probe, St. Gabriel’s Hospital - Malawi, Intrexon, Oxitec)
  • Invasive species population control (Intrexon, Oxitec)
  • Endangered species population expansion with cloning of archival veterinary specimens to enhance population genetics (Intrexon, ViaGen) [press] black footed ferret - NYTimes.com | Przewalski's horse - CNN.com
  • Ocean conservation and marine natural products chemistries discovery (redirect to www.rossibixby.com)
  • Gene-editing and GMOs in our food systems (Intrexon)
  • Future of food: plant-based and alternative protein (redirect to www.rossibixby.com)

PATIENT ADVOCACY

PATIENT ADVOCACY & COMMUNITY HEALTH
Medicine focuses on individual health. Public health focuses on populations. Patient advocacy is a critical part of bridging the two disciplines across the health system. My work over the years has been focused at the intersection of technology and public health interventions to benefit patients individually and collectively.

My experiences of the topics below have focused me on the value of patient-centered interventions in terms of approach to both technology development and measuring patient outcomes.
  • Molecular epidemiology
  • HIV and HBV/HCV screening for the U.S. blood supply
  • Infectious disease diagnostics
  • Global health and international development in Sub-Saharan Africa
  • American Lung Association Healthy Air Campaign
  • US domestic and global AIDS policy
  • Genomic and health data management infrastructure
  • Precision medicine
  • COVID-19 pandemic

BASIC RESEARCH

ACADEMIC & BASIC RESEARCH
I have been focused in my work at the intersection of biotechnology and public health. My path in basic research began in immunology and virology in the Neil Cooper Lab at The Scripps Research Institute, Department of Immunology, during undergraduate study in biology at the University California, San Diego. I returned to independent research at the Marine Biology Research Division of the Scripps Institution of Oceanography, UCSD after my time at Gen-Probe working on HIV blood screening. Some years later after my experiences in Malawi, I decided to move to Washington DC to focus on biosecurity and begin my graduate education in public health epidemiology in the Department of Global and Community Health at George Mason University. All of these experiences across my academic, laboratory, and field work were a critical foundation for all of my contributions to new technology development and public health initiatives spanning health, food, energy and environment sectors.

It is with a great fondness that I continue my research in the following fields of study:
  • Molecular epidemiology, infectious disease, medical microbiology, virology, neglected tropical diseases
  • Immunology, complement system, cancer, Alzheimer's, and inflammatory diseases
  • Environmental microbiology, oceanography, marine microbiology, and natural products chemistries