circular RNA biotherapeutics. Deep tech AI generates noncoding RNA candidates for currently undruggable disease targets.

Strategic consulting for the biotechnology and biopharmaceutical industry with a focus on company startups, virtual operations, and product development.

Provide strategic marketing and technical support for contract development and manufacturing services and synthetic biology/metabolic engineering support for protein expression process and products.

Designed 100 kiloton/yr GMP botanical processing facility compliant with CFR 117 and 111 for food and dietary supplements, built quality management system, ran regulatory under FDA CFR 21, compiled GRAS dossier data, worked on Non-GMO, Kosher, Halal certifications.

Supported Prof. Daniel Wang on mass transfer and clone selection projects

• R&D on eukaryotic synthetic biology relating to yeast industrial biotechnology, adoptive cell therapeutic engineering, transgenic animal engineering• Assisted founders in forming corporation• Acted as startup CEO• Supported pre-financing work with grants and corporate partnerships• Negotiated technology licenses

DARPA grant: Developed strategy for gene indels to make platelets produced in transgenic swine compatible for human platelet transfusions

DARPA grant: A Systems Biology Approach to Identify Strategies to Enhance Ground Troop Readiness at High Altitude. Worked on repurposing approved drugs to prevent and treat acute mountain sickness.

• Head of US site and operations• Virtual company structure in US and EU• Intellectual property• Clinical development• Regulatory affairs• Contract Manufacturing• Merger and acquisition• Investor and partnering due diligence

• Founder and Member of the Board of Directors• Recruited all key scientific and technical personnel• Led molecular biology, protein chemistry, fermentation and downstream processing R&D staffed with 40 scientists and technicians focused on precision fermentation of globins• Invented intellectual property critical to key programs• Identified and in-licensed lead IND-stage product from a Japanese company• Transitioned company technology from recombinant R&D base to early stage clinical development and GMP manufacturing• Designed studies in non-clinical models of cancer and inflammation (acute and chronic).• Planned and implemented clinical development program from start of Phase 1 into Phase 3 clinical trials• Authored, edited, and approved clinical trial documents including investigator brochures, protocols, and final study reports• Negotiated all decisive clinical development plans with FDA and EU Competent Authorities/Ethics Committees• Selected, contracted, and managed clinical and regulatory CROs and CMOs• Authored and presented due-diligence documents to investors and corporate partners• Reviewed and conducted due diligence on M&A opportunities• Established relationships with experts and opinion leaders in various fields related to strategic areas of research and therapeutic focus• Planned, negotiated, and managed research with academic and industry partners