Denise L. Mayfield

Cannabis
Denise worked as a research scientist in the department of Pharmacology at the University of Texas Health Science Center in San Antonio, and her work was widely published in Science and other respected peer reviewed scientific journal articles specifically examining pharmaceutically active preparations containing  purified components of marijuana (THC, CBD, CBN).  Her group was also consulted by several governmental agencies concerning their early findings with these and other recreational substances in evaluating public health policies. Denise held a Schedule 1 license for these and other regulated substances, and her group was awarded federal research grants to examine the physiological and behavioral effects of cannabinoids and other substances in animals. She works with companies and academic research centers to patent formulations of these cannabinoids and other pharmaceutically active substances. Growing methodologies and methods of extracting and processing raw marijuana materials for improved preparations and commercially valuable products containing components of various cannabinoids, are topics typically protected in patents in the United States and abroad. Commercial licensing arrangements and branding programs for these and other products are also components of the services Denise provides to clients in this particular cannabinoid product space. Denise also counsels companies on state and federal regulatory requirements, and production and distribution requirements, for marijuana component containing products.

Medical Device, Bone Repair/Regeneration, 3-D Bioengineering
Extensive experience assisting clients in the protection and management of intellectual property assets associated with diverse medical device portfolios, including:

• Implantable devices for repair of shoulder, spine and knee
• Suture anchors (soft anchors, knotless and knotted; hard body anchors)
• Soft tissue repair systems
• Hard-body anchors
• Bone drill sets
• Shoulder, rotator cuff replacement devices
• Orthopedic screws and pins (hip)
• Surgical adhesive materials,
• Sterilized human tissue allografts
• PTFE grafts
• Biologically engineered surgical materials (bone putty/bone slurry’s (demineralized), collagen matrix materials, skin tissue gels, tissue adhesives)
• Wound repair materials (tissue skin graft materials (sheets), wound repair and healing preparations, drug-releasing wound repair materials)
• Hemostatic and blood collection materials and devices (specialty blood collection devices, blood loss calibrating devices, blood anti-coagulant coated devices, anti- coagulant formulations, treated blood collection bags)
• Artificial tissue fabrication methods and processed harvested donor tissue fabrication
• Human tissue sterilization techniques and devices for performing human tissue sterilization suitable for human implantation in compliance with FDA requirements
• Human amniotic membrane preparations
• Placenta tissue derived tissue patch
• Medical device coatings (polymer, anti-bacterial, drug release)
• Stem cell and implantable device systems for rapid bone and tissue healing/regeneration, bone replacement and bone regenerating materials and methods
• In vivo cranial bone regeneration materials and methods
• FDA compliant testing of laboratory procedures for sterilizing tissue grafts from human donor materials (infectious agent testing and compliance study compliance)

FDA-Related Experience:

• Identified and analyzed patents included in Paragraph IV Certification statements in Abbreviated New Drug Applications (ANDA)
• Assisted clients in developing Phase I, Phase II and Phase III protocols/materials and in meetings with Food and Drug Administration (FDA) officials
• Obtained FDA 510(k) clearance for adult stem cell therapeutic methods, stem cell products and processes for producing stem cell related products
• Reviewed clients' website materials to remove/edit representations concerning potentially FDA-regulated activity
• Advised on physician/clinic client’s exemption for “off label” use and “practice of medicine” exemption of products
• Advised numerous clients during FDA on-site inspection visits
• Assisted with therapeutic biological products clearance within FDA’s Drug Evaluation and Research (CDER) office
• Advised multiple clients on FDA labeling/branding requirements and misbranding of products, drug or devise under the FDCA, “Rx only” labeling

Additional Experience:

• Developed proprietary and non-proprietary product and business services commodity pipelines for biologics divisions/spin-offs of large domestic and foreign companies, including Samsung Biologics
• Prepared and coordinated the creation of strategic international and domestic patent portfolios in client/corporate target markets
• Developed international patent and proprietary information licensing strategies to facilitate new product launches
• Developed and secured compliant and coordinated branding (trademark) strategies for domestic and/or international product launches
• Negotiated client services agreements and created client materials for providers/manufacturers (quality/specification of materials received, return/refund provisions, suitability for specific commercial uses)
• Reviewed and developed effective compliant product inserts (FDA, branding) and product packaging
• Developed suitable product delivery protocols for perishable and/or limited shelf-life product delivery to consumers/purchasers
• Developed appropriate delivery protocols of perishable materials (biological tissues, sensitive biological reagents, etc.)
• Handled import/export of numerous perishable and/or border-regulated materials

Human Genetics Patents:

• 10,087,489 Biomarkers and uses thereof in prognosis and treatment strategies for right-side colon cancer disease and left-side colon cancer disease
• 10,087,463 Methods and compositions for transposition using minimal segments of the eukaryotic transformation vector piggyBac
• 9,956,263 Composition for improving skin conditions comprising a fragment of human heat shock protein 90A as an active ingredient
• 9,580,756 Stratification of left-side and right-side colon cancer
• 9,721,067 Accelerated progression relapse test
• 9,598,460 Antibody purification via affinity chromatography
• 9,464,328 Biomarkers and uses thereof in prognosis and treatment strategies for right-side colon cancer disease and left-side colon cancer disease
• 9,357,755 Production of human glycosylated proteins in silk worm
• 9,283,266 Metastasis inhibition preparations and methods
• 9,220,770 Extracellular matrix materials as vaccine adjuvants for diseases associated with infectious pathogens or toxins
• 9,157,909 Male reproductive health panel and uses thereof
• 9,125,858 Compositions and methods relating to resveratrol
• 9,006,393 Molecular constructs and uses thereof in ribosomal translational events
• 8,992,214 Orthodontic self-ligating brackets
• 8,846,059 Extracellular matrix adjuvant and methods for prevention and/or inhibition of ovarian tumors and ovarian cancer
• 8,802,113 Extracellular matrix cancer vaccine adjuvant
• 8,778,362 Anti-tumor/cancer heterologous acellular collagenous preparations and uses thereof
• 8,778,360 Extracellular matrix cancer vaccine adjuvant
• 8,637,265 Cathepsin E as a marker of colon cancer
• 8,597,885 Accelerated progression relapse test
• 8,512,754 Stabilized products, processes and devices for preparing the same
• 8,491,947 Paeoniflorin preparations and uses thereof for fat reduction
• 8,293,088 Direct determination of carbohydrates, amino acids and antibiotics by microchip electrophoresis with pulsed amperometric detection
• 8,257,715 Tissue vaccines and uses thereof
• 8,062,646 Tissue vaccines and uses thereof
• 8,013,022 Stabilized products, process and devices for preparing same
• 7,943,187 Paeoniflorin preparations and uses thereof for fat reduction
• 7,932,088 High efficiency transformation of Plasmodium falciparum by the lepidopteran transposon, piggyBac
• 7,892,750 Cathepsin E as a marker of colon cancer
• 7,790,677 Insulin production methods and pro-insulin constructs
• 7,968,324 Helicobacter system and uses thereof
• 7,632,678 Cancer stem cells and uses thereof
• 7,534,857 Methods and compositions for the treatment and prevention of staphylococcal infections
• 7,494,767 Assay for TSG101 as inhibitors of HIV production
• 7,105,343 Methods and compositions for transposition using minimal segments of the eukaryotic transformation vector Piggybac
• 6,962,810 Methods and compositions for transposition using minimal segments of the eukaryotic transformation vector piggyBac
• 6,492,104 EIA test using non-denatured HIV Antigen for Early Detection of HIV Infection
• 6,136,530 Compositions and methods for assessing risk factors in Alzheimer's disease
• 5,994,108 Mutant TAR virus and transdominant tat mutants as pharmacological agents
• 5,919,621 Methods for diagnosing human male infertility
• 5,856,103 Method for selectively ranking sequences for antisense targeting
• 5,831,061 Nucleic acid encoding ecdvsis-triggering hormone
• 5,763,400 Ecdvsis-triggering hormone compositions
• 5,466,676 Satellite cell proliferation in adult skeletal muscle
• 10,174,382 Breast cancer prognostication and screening kits and methods of using same
• 2018/0160713 Methods Of Screening
• 2017/0241971 Phosphorothioate Dnazyme Complexes And Use Thereof
• 2016/0333413 Breast Cancer Prognostication And Screening Kits And Methods Of Using Same
• 2016/0039907 Protein Folding And Methods Of Using Same
• 2017/0333524 Molecular Constructs And Uses Thereof
• 2017/0247766 Late ER+ Breast Cancer Onset Assessment And Treatment Selection
• 2010/0186099 Production Of Human Glycosylated Proteins In Silk Worm
• 2017/0035860 Compositions and methods for treatment of neurogenerative diseases
• PCT/US2016/29874 Scalable Production Of Standardized Extracellular Vesicles, Extracellular Vesicle Preparations And Uses Thereof
• PCT/US2007/005072 Piggybac Constructs In Vertebrates
• PCT/US2015/041625 Molecular Constructs And Uses Thereof
• PCT/US2016/032913 Triple Negative Breast Cancer Screen And Methods Of Using Same In Patient Treatment Selection And Risk Management
• PCT/US2015/047052 Late ER+Breast Cancer Onset Assessment And Treatment Selection
• PCT/US2016/58519 A Picometer-Diameter Pore In An Inorganic Membrane For Sequencing Protein
• PCT/US2017/031624 Prognosis Biomarkers And Anti-Tumor Compositions Of Targeted Therapeutic Treatments For Triple Negative Breast Cancer
• 20080146492 Insulin production methods and pro-insulin constructs
• 20160289291 Lis-Pro Proinsulin Compositions And Methods Of Producing Lis-Pro Insulin Analogs Therefrom
• 20160030520 Aspart Proinsulin Compositions And Methods Of Producing Aspart Insulin Analogs
• 20160024168 Aspart Proinsulin Compositions And Methods Of Producing Aspart Insulin Analogs Therefrom
• 20120214963 Liquid Insulin Compositions And Methods Of Making The Same
• 20120214965 Lis-Pro Proinsulin Compositions And Methods Of Producing Lis-Pro Insulin Analogs Therefrom
• 20120214199 Insulin Production Methods And Pro-Insulin Constructs
• WO 2017070692 A Picometer-Diameter Pore In An Inorganic Membrane For Sequencing Protein
• WO 2019/209831 A1 Clinician/Patent Data Input and Monitoring Systems and Methods