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K Karel Lambert, cont.  

Cell: 206 949-1168;  E-Mail: KLambert@4iPT.com.  Link to Video Page.

Professional Experience in depth:

2002-      As Patent Agent, Reg No. 51,912 in private practice.  Sole proprietor of an independent agency dba Lambert & Associates, and as a Consultant on IP, innovation, business development, and technical matters.  Clients include Micronics, Inc, Enertechnix, Inc, Genelex, Inc and Stratos Product Development LLC.

1996-01   As Research Scientist III, employed by Sonus Pharmaceuticals, Bothell WA. Discovered and scaled up a lipid vitamin-based delivery vehicle for paclitaxel (see publication, Feb’ 2000, Pharm Res).  Invented trademarked Tocosol drug delivery technology.  Project leader on chemical synthesis and drug discovery "skunkworks".  Designed and validated videomicroscopic image capture and analysis software for FDA submission.  Discovered candidate NCEs (by rational drug design), novel surfactants, and demonstrated pharmacological activity and safety in pre-clinical models.  Managed CRO special projects.  Wrote patent applications, researched and presented new business proposals to the Board, and assisted outside patent counsel.  Outstanding performance reviews — promoted to Res Scientist III, 76K; 45,000 options.  Resigned to join patent bar.

1991-96   As Associate Scientist, employed by Molecular Biosystems, Inc., San Diego, CA, manufacturer of encapsulated cardiac ultrasound agent Albunex.  As part of engineering team, discovered key new product marketed as Optison, and invented a novel colloid mill process for its manufacture. Conducted engineering studies and build-out on sterile manufacturing process.  Designed CAM-based Peltier temperature unit for modelling manufacturing process on benchtop.   Extensively involved in characterization of Albunex and Optison, both their physical and biological behavior by microscopy with image analysis.  Wrote research proposals, invention disclosures and patent applications as appropriate.  Managed independent project and capital process equipment design and acquisition.  Supervised as many as 3 employees.  Promoted from Research Associate II to RA III to Associate Scientist in 5 years. 45K + options.

1988-91   As Research Associate II, employed by University of California, San Diego, Department of Applied Mechanical Engineering Sciences (AMES).  Assisted in the discovery of 2 new human genes from the red cell cytoskeleton.  Cloned cDNA of interest from lGT11 libraries by antibody screening techniques (western blot).  Assembled full-length clone by PCR and ligation and sequenced them (dideoxy method). Purified mRNA from PNH patient.   Made publication-quality northern blots and restriction maps from the clones. Designed PCR primers.  Also had responsibility for setup and administration of laboratory, and for teaching of graduate students.  Resigned to accept industrial position. 

1986-88   As Research Associate II, employed by University of California, San Diego, School of Medicine. Studied pharmacology, physiology and biotransformation of novel bile acids and choleretic drugs in man and animals. 

1984-86    As Technical Writer, employed by IVAC Corporation, San Diego, CA. Assisted engineers and technicians in describing circuit board function and troubleshooting.  Drafted electrical schematics, circuit block diagrams, wrote service manuals, and prepared illustrations as required.  Familiar with basic microprocessor function, data and address buses, clock dividers, logic gates, EPROM programming, diodes, power supplies, rectifiers, AC invertors, electronics analytical tools, AD/DA convertors, thermistors, LEDs, Hall effect sensors, Peltier unit design for temperature control, etc.

1981-84    Self-employed.   Income from fine Art printmaking and silkscreened teeshirt sales.

1980-81    As Data Analyst, did laboratory and field marine research for Naval Ocean Systems Center (NOSC), San Diego, CA.  As part of team making environmental impact study of Naval activities in San Diego Bay, worked with divers to measure rates of copper and organotin leaching from anti-fouling paints in situ. Primary analytical techniques involved atomic absorption spectroscopy (AAA) and ion-specific electrodes (ISE).

1977-80    As Teaching Assistant, Lecturer, and Faculty for San Diego State University, taught Microbiology, Parasitology, Zoology, and Medical Technology.  Received excellent reviews for a self-designed curriculum introducing the microbial world to general education students.  Included experiments with Agrobacterium tumefaciens transformation of carrot cells, field studies of sewage treatment, methods for canning pickled vegetables, growth of cyanobacteria, Windograski columns, and a series of lectures on Industrial Microbiology as a career. As an employee of the Zoology Department, performed extensive studies of Trematode lifecycles, with application for environmental control of Schistosomiasis. Presented these results to the Secretariat for Schistosomiasis at the World Health Organization in Geneva, Switzerland (WHO).  Obtained Master’s Degree in 1981.

-1979        As Microbiologist for Golden Arrow Dairy, San Diego CA, assisted with milk quality control monitoring.  Responsible for cottage cheese production (2,000 gal/batch) from log-phase starter cultures.

                As Medical Technologist. Part of clinical pathology team responsible for patient diagnosis and monitoring in emergency, acute, convalescent and out-patient settings. Qualified in hematology, serology, immunology, clinical chemistry, blood component therapy, parasitology and microbiology. Routinely developed and validated diagnostic assays. Maintained and repaired analytical equipment. Wrote procedure manuals for hematology and microbiology. Extensive patient contact and case review experience. Supervised as many as 10 technologists and support staff.  ASCP licensed.

 


Appendix I:  Laboratory Skills Sheet

Pharmacology:

Formulation for drug delivery and cardiovascular diagnostics. Successful product launches. Parenteral drug delivery vehicle formulation and GMP scale-up processing. Transmucosal formulation research with penetration enhancers. Isolated, perfused rat Liver (IPRL). Perfused ileal loop. Caco2 enterocyte in vitro membrane permeability model. Hepatic clearance. Radioisotopic tracers and metabolic products in rats and man. Clinical batches, batch record documentation and regulatory submission support. Sterilization validation. Process design and equipment procurement. Colloid mills, homogenizers heat exchangers, and ultrasonic processing. Coordinated in-house and CRO pre-clinical testing of novel parenteral formulations. Physical chemical measurements of solubility, surface tension, interfacial tension, contact angle, viscosity, zeta potential and particle size by Coulter, Nicomp and Malvern. Several patents and publications. Serum, urine and blood diagnostics, etc.

Engineering and Manufacturing:

Digital acquisition and recording of process parameters. Heat and mass transfer. Heat exchanger calculations. Mechanical prototyping. Peltier heat transfer system design. Custom colloid mill (double mechanical and gas seals), in-line mixer, and homogenizer specification and procurement. Stainless steel pharmaceutical design and procurement. PID process control. Fermentation systems equipment and procurement. Cleanroom procedures and GMP. Four patents on pharmaceutical processes for polymeric emulsion manufacture (gas/liquid and liquid/liquid), including terephthaloyl chloride crosslinking and disulfide exchange reagents. Patent application on novel process for synthetic substitution of amine for phenolic hydroxy on benzoquinone ring.  Worked in Engineering Department of Molecular Biosystems (pharmaceuticals process R&D) for 3 years.

Fermentation vessel maintenance, construction and design. Agitation, aeration, inoculation and starter cultures. Photosynthetic bioreactors. Consulted on large hectare installations for astaxanthin harvest and secondary sewage treatment. Lipid extraction methods. Design of media for enrichment and metabolic end-product production. Mutagenesis. Sharples steam and electrical centrifuges. Autoclave validation. Field work and microbial prospecting.

Structural failure testing. Reinforcement of ferrocement structures. Improved cement mixtures. Hydraulic systems and controls. Reef structures. Marine biofilm formation studies on undersea surfaces of US Naval vessels and submarines. Work lead to development of improved sonar-deadening coatings resistant to biofouling.

Design and validation of microprocessor-controlled electrohydraulic devices with failsafe circuitry and sensor arrays. Post-production product documentation. Work was part of transformation in IV drug delivery worldwide. Design and validation of microscope-based digital image acquisition and analysis system with flow through chamber, flow, mixing, temperature and pressure control. Designed, built and validated of a computer controlled, stainless steel miniature reactor with 18 cm2 Peltier heat transfer system, gas and fluid hydraulics, and ultrasound processor at 1:25 scale for process modeling and feedstock evaluation.

Molecular Genetics:

Cloning, electrophoresis, restriction mapping, dideoxy sequencing, expression vector library screening, Northern, Southern and Western blots. Large-scale purification of human mRNA.  PCR, design of primers.  Molecular and chromosomal characterization of human erythrocyte cytoskeletal proteins and key finding on erythrocyte transglutaminases published in PNAS. Leukocyte culture, chromosome staining and light microscopy.

Immunology:

Vaccine design and production, immunization of mice and rabbits, ELISA assay development, latex and hemagglutination diagnostic assay development, complement degradation products assays, radioimmunoassays, lipid adjuvants, RIBI adjuvants, tissue culture, immuno-electrophoresis, SDS PAGE, native gel electrophoresis, immunoblots, histology, toxicology, leukocyte characterization by special staining, and animal work.  Viral culture in vitro (tissue culture) and in ovo.

Hematology and Serology:

Cytological staining, Coulter counts, differentials, bone marrows, cell abnormalities and morphology, photomicroscopy, videomicroscopy. Special staining, including immuno- and enzyme staining. Plasma coagulation factor assay. Wrote programs for image analysis. Phase, fluorescent and Nomarski optics. Blood banking.  Immunoelectrophoresis. Hospital experience, including oncology. Patient contact skills.

Microbiology:

Fermentation scale-up and dairy quality control. Clinical diagnosis of infectious disease, including parasitological and virological work-up. Growth and isolation of cyanobacteria. Also genetics, cloning, sequencing, N/W/S blotting, mRNA isolation, etc.  Thesis on microbial phospholipid physiology.  Field work and characterization of new photosynthetic isolates.  Microbial prospecting. Expert microscopist.

Parasitology:

Post-graduate field work and in vitro growth and differentiation of trematodes. Dispersible environmental cercariacide for schistosomiasis control. Taught college-level parasitology laboratory.

Analytical Chemistry:

Licensed clinical laboratory technologist (MT ASCP). Familiar with manual and automated assays for seawater, blood, urine, CSF, gastric, etc. Set up and managed quality assurance program for busy hospital laboratory. Instrumentation includes atomic absorption spectroscopy, IR, flame photometry, GC, enzyme kinetic and endpoint assays, nephelometry, titrations, ion-specific electrodes, polarimetry, LC, Karl Fischer, nitrogen-fixation, radioimmunoassays, fluorescence, microbubble pressure response and quantitative ultrasonic echogenicity, etc. Training in statistical analysis of error and precision, and in assay validation.

Webpage Design:

HTML good, some JAVA scripting. Background in creative design. Familiar with PC and Mac office tools.

References on request.