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Training
- BA, Biology, University of California at Irvine, CA.
- MS, Cellular and Developmental Biology, University of California at Irvine, CA.
- Special Pre-Doctoral Fellow, Hyland Laboratories
- Ph.D., Microbiology/Immunology, University of Washington, Seattle, WA.
- Post-Doctoral, Carbohydrate Chemistry/Glycolipids, Sen-itroh Hakomori (National Academy Sciences, NAS), Fred Hutchinson Cancer Research Center, Seattle.
- Post-Doctoral, Complement Enzymology/Molecular Immunology/Immunochemistry, H.J. Müller-Eberhard, (NAS), Molecular Immunology, Scripps Research Institute, La Jolla, CA.
- Associate I/II, The Scripps Research Institute, La Jolla, CA: protein purification (complement, coagulation), antibody fragment purification (Fab, Fab', F(ab')2), monoclonal antibody, immunoassay development - ELISA, FIA, RIA, cellular immune assays
- NSF SBIR peer reviewer: medical devices, drug delivery, technology tools, drug development (2008-present)
- Registered US Patent Agent #34,446 (1990)
- Regulatory certificates: GLP, 510(k), ICH
- CfPIE Certification Program, Certified Regulatory Medical Writer Professional.(2009-2010).
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Startup Corporate Development
- Crafted the business plan; technology summaries, product summaries, proformas, corporate website, product development strategy, corporate investor and scientific PowerPoint presentations
- Operations, staff (to 45), programs (3) and budgets ($5M/annum)
- Established and implemented business plan on a path to investigator-initiated clinical trials in Europe with regulatable manufacturing of novel individualized iPS stem cell therapeutics in Switzerland for use in treatments for age related macular degeneration, acute renal disease, diabetes and bone marrow transplantation
- Developed five year budget proforma anticipating capital and stock requirements to achieve full manpower staffing, funding and stock requirement for corporate development with CMO process development and CMC-section, CRO controls for IND-enabling preclinical trials, IND and Phase I clinical trials
- Raised to $3M in private equity financing
- Business liaison to Georgia Academy of Sciences and Eliava Institute, T’blisi, Republic of Georgia
- Board positions, Chairman of the Board, Secretary for the Corporation
- Roles: Senior Scientist, Manager, Director, Vice President, President, CEO
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Scientific, Regulatory and Medical Writing
- 2010, Certified Medical Writer, CfPIE (Center for Professional Innovation & Education) with the following course work:
- Writing Effective Standard Operating Procedures and Other Process Documents (16 hrs; Nov. 2009); Overview of FDA Regulatory Compliance for Medical Devices (16 hrs; July 2009); Preparation of FDA Submissions (INDs, NDAs, BLAs, ANDAs, Post-Approval Supplements) and Communicating with the FDA (16 hrs; Dec. 2009); Technical Writing for the Pharmaceutical, Medical Device and Biotech Industries (16 hrs; Sept. 2009).
- Certificates:
- Familiarity:
- ICH Guidelines; US 21 CFR; EMEA
- GLP, cGMP
- API: small molecule drugs, biologics (protein, peptide), IVD medical devices, blood brain barrier delivery; anti-infective agents (anti-fungal, anti-microbial), oncology products, non-steroidal anti-inflammatory agents, Parkinson's dopaminergic agents, anti-Alzheimer's agents, microvascular insufficiency (amyloidosis, diabetic) agents, paresthesis agents, vaccines (infectious diseases, autoimmune diseases, Alzheimer's)
- Director, designer, author, editor and co-editor:
- CRO analytical assay development, verification, validation; editor study design, interim and final reports; CMO Manufacturing Process Instructions (MPI), SOPs, control documents for equipment installation, verification, validation; manufacturing process documents for process change; analytical comparability testing protocols, interim and final reports; animal bioequivalence and safety studies
- CMC section components:
- biologics protein purification (for DMF) and small molecule synthesis (for IND)
- Development history:
- eCTD format protein purification
- Q6B controls:
- QA/QC test methods protein biologic; nucleic acid, endotoxin, identity, purity, potency
- Post-launch comparability and safety studies:
- Zyderm; author and study designer for immunology safety study for manufacturing process change that reduced theprocessing time from 13 days to 3 days
- Adverse Events Corporate Representative:
- post-launch; dermatomyositis clinical events, sole corporate scientific expert in convened expert medical review panel, co-author company summary findings
- Preclinical toxicology, biodistribution and pharmacology studies:
- rodent and canine; participant for study design; co-author documentation; liaison for GLP; editor for review; co-author for study report
- Phase I/II Clinical Trial:
- topical dermal nitroglycerin treatment for diabetic microvascular insufficiency and paresthesia; participant study design, co-author investigator brochure; co-editor for study summary results; co-author for Phase I/II clinical trials study report
- 2012 Scientific Technical Author:
- scientific grants (2), manuscripts(1), reviews(1), abstracts(5), poster presentations(3), websites(2), corporate Power Point presentations (6),
- Medical Science Liaison: establish liaison with national and international thought leaders in symptomatic pulmonary sarcoidosis (Rheumatologists and Pulmonologists); facilitate information flow and understanding leading to Investigator-Initiated studies and clinical trials for the US West of the Mississippi.
- Medical Information: manage medical information for Acthar (Questcor Pharmaceuticals), draft compliant medical information responses in the general areas of infantile spasms, exacerbations of multiple sclerosis, nephrotic syndrome, sarcoidosis, rheumatoid arthritis, SLE, dermatomyositis, polymyositis and other syndromes.
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- Roles:
- Senior Scientist, VP R&D (Process Development), CSO, COO, Manager of Medical Information, Medical Science Liaison (MSL)
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Patent Agent 
- Patent portfolio development
- technology platform development
- including prophetic
- Corporate business development
- freedom-to-operate, infringement and competition analysis
- Client counseling
- Patent and prior art searching
- patentability analysis
- strategy development
- intellectual property tracking
- Patent preparation
- Patent prosecution
- US and Foreign
- including Interference and Opposition Practice
- Patent strategy
- development and implementation
- Reviewing and assessing third party patents
- Liaison with outside counsel
- business and patent matters
- docket to 130 active US and international cases
- Patent auditing and valuation
- merger and acquisition
- in-licensing
- Litigation support
- Federal Circuit: SIBIA v. Cadus Pharmaceuticals
- CAFC: Cytran Corporation v. Russian Cancer Center
- CA Trade Secret: BioRad v. Triton Biosciences div. Shell Oil (sole expert witness)
- With counsel:
- MTAs, CDAs, term sheets and draft licensing terms, letters of intent, consulting agreements, scientific advisory board agreements, SCRO/ESCRO/IRB documents
- Roles:
- Law firm Associate, Manager, Director and Vice President of Intellectual Property
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Patents (Inventor)
- Hair testing device for drugs of abuse
- Electronic business process for drug testing
- Super-critical fluid extraction of drugs of abuse
- Wound healing
- iPS stem cells
- Anti-Parkinson’s small molecule therapeutics
- Adjuvants
- Vaccine carrier proteins
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Patents Assistance Rendered
- Agricultural
- Light Mechanical and Hydraulics
- Electronic Telecommunications
- Electronic Business Processes
- Gene Transfer: Retroviral Vectors
- Cell Biology Drug Screening
- Drug Delivery
- Small Molecule Pharmaceuticals
- Biologics
- Medical Devices
- Non-steroidal anti-inflammatory agents, Parkinson’s, Alzheimer’s disease, wound healing, autoimmunity, bacteriophage therapeutics, adjuvants, vaccines
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