Lisa Risen Email & Phone Number

Contract With Ibis Biosciences, Carlsbad, Ca

In vivo selection strain development team in support of a U.S. Defense Threat Reduction Agency (DTRA) grant research program • Provide support for selection of a genetically engineered bacterial strain capable of screening large libraries of candidate reporter enzymes. This complementation assay will be used to develop an implantable electrode to monitor human biomarkers. • Perform recombineering techniques including P1 phage transductions, competent cell preparations and bacterial electroporation/transformationAssay development team member for a multi-analyte respiratory diagnostic on the MAP (Mobile Analysis Platform)• Performed assay design, optimization and validation on a diagnostic platform incorporating microfluidics and multiplex RT/PCR for detection of viral RNA via oligonucleotide probe hybridization on a microarray. The diagnostic platform was developed for the Defense Advanced Research Projects Agency (DARPA).• Conducted on-site personnel training for IRB reviewed clinical studies at the Naval Health Research Center and John Hopkins University School of Medicine.Supported Verification & Validation project teams for bacterial, fungal and viral assays on the CE Marked IRIDICA in vitro diagnostic platform. • Direct pathogen identification on the IRIDICA platform using human clinical and contrived specimens. Performed sample preparation, nucleic acid amplification, post PCR-purification and analysis by ESI mass spectrometry. • Assisted Quality Assurance department with documentation review for CE Mark compliance. Trained in over 150 courses in Abbott Quality System for product design, development, verification and validation. Certified CAPA Respondent. Responsible for maintaining all USDA and CDC permits for the transport and use of viral, bacterial and fungal pathogens.

Carlsbad, Ca

Reviewer and editor for pharmaceutical risk management reports submitted to the FDA.• Recruited and screened healthcare professionals (HCPs) for participation in pharmaceutical risk management studies.

Carlsbad, Ca

Coordinated a respiratory pathogen research study with Johns Hopkins University Medical Center under the guidance of an Institutional Review Board (IRB). • Managed clinical specimen collection at JHU, specimen database tracking, microbial identification on a prototype high throughput multi-locus base composition analyzer which coupled nucleic acid amplification with ESI mass spectrometry.• Responsible for study materials acquisition and incentive procurement for the participating laboratory and patients. • Completed NIH PHRP certification (Protecting Human Research Participants)

Carlsbad, Ca

Responsible for high throughput screening for the Ibis Chemistry Department • Performed all Gram +/- MIC and bacterial transcription/translation screening for the Antimicrobial Project Team on a consulting basis.

Carlsbad, Ca

Responsible for developing and implementing multiple high throughput screening (HTS) assays for the Ibis drug discovery effort • Performed all MIC screening for the Antimicrobial Project Team.• Developed HTS coupled bacterial transcription/translation assay for antimicrobial drug discovery.• Developed and performed an in vitro biological screening assay for compounds that specifically inhibit HCV IRES mediated translation. • Collaborated with outside university research groups (UCI, Iowa State) for cloning and sequencing of the HCV IRES.• Responsible for HTS transcription/translation and MIC testing for chemical Structure Activity Relationship (SAR) studies. • Developed HTS data analysis and reporting procedures with a computer programming consultant.• Performed tissue culture and clinical sample preparation under Biosafety Level-3 containment requirements and practices.• Managed laboratory supplies and equipment maintenance for over 25 scientists in drug discovery.• Received CONFIDENTIAL Security Clearance in 2003 from the U.S. Defense Security Service

San Diego, Ca

Responsible for development of DNA probe diagnostics for direct detection of respiratory pathogens within the Product Development Group. Also responsible for developing genetic testing products for forensic, paternity and clinical research applications.• Performed product design, protocol development and validation, and management of pre-clinical studies. • Optimized target RNA immobilization, oligonucleotide hybridization kinetics and chemiluminescent detection methods.• Prepared GMP documentation for manufacturing, quality control and technology transfer. • Designed single and multi-locus oligonucleotides for RFLP analysis of human genomic DNA. • Optimized DNA Typing procedures and transferred these synthetic nucleic acid probe (SNAP) methodologies to FBI forensic scientists.• Collaborated with physicians and researchers to develop DNA analysis applications for bone marrow transplantation, hypertension studies, and paternity studies.• Supported FDA 510k submission for SNAP Rotavirus diagnostic product.

La Jolla, Ca

Responsible for preparation and analysis of environmental samples for trace metal composition. • Performed acid digestion and organic extractions of soil, water and tissue samples for analysis by atomic absorption spectrophotometry. • Submitted final data reports to EPA and commercial contracts.