Robert Settineri, President
Robert (Bob) Settineri, MS
Sierra Productions Research
Mission Viejo, CA – 1987 to Present
Provides strategic biomedical communications, research coordination and medical research consulting services for medium to large multi-national pharmaceutical, nutraceutical diagnostic, medical, and health care professional companies. Over 30 years experience in biomedical research. Currently consults on formulations, pre-clinical/clinical research and product development. Also writes, produces and directs medical educational videos & films which garnered 37 international awards. Produced internationally acclaimed therapeutic DVD, “Immuno-Imagery” – visualization and guided imagery for immune enhancement utilized in numerous clinics and by health care professionals.
Partial list of clients:
APPLIED-BIORESEARCH, INC. – Research Division Irvine, CA
Research Director 2010 – Present
Oversees all product development
Pre-clinical and clinical research management
Manages of outside GLP and GMP labs
Manages of all scientific and medical consultants
Lead supervisor of FDA consulting groups
Assists in writing and approves all final pre-clinical and clinical protocols
Patent preparation, and writing and interfacing with patent attorneys
WORLD HEALTH PRODUCTS, LLC. Draper, UT
Consulting Manager of Clinical Research 2003 – 2010
Designed and wrote protocols for clinical and preclinical studies
Coordinated and managed major clinical prostate trials
Designed and coordinated preclinical pharmacokinetic studies
Developed and managed an “On-Line” internet-based, IRB approved BPH stud
Instrumental in the preparation of five publications for the company
Wrote numerous technical and medical articles on chelation therapy and heavy metal toxicity
Developed product profile materials for health care professionals and pharmacies
Produced international award-winning DVD – “Living in a Toxic World”
Coordinated international medical conferences and seminars for reporting research findings
Published four medical journal articles on original research
Published chapter on detoxification in medical text book – “Anti-Aging Therapeutic Medicine”
Co-author of a detoxification book for the public
NUTRITIONAL THERAPEUTICS, INC. Commack, NY
Consulting Director of Clinical Research 1996 – Present
Designed protocols for clinical studies
Coordinated major clinical research
Developed and managed an “On-Line” internet-based, IRB approved Asthma Clinical Trial
Instrumental in the preparation of three publications for the company
Product profile development and marketing materials for health care professionals & pharmacies
Published five peer-reviewed medical journal articles
Produced educational/promotional product videos
Coordinated 13-part product radio infomercial on KRLA radio “Healthy Advice with Dr. Gene”
Created technical power point presentations for medical professionals
Research and development and writing of new patents
CLRS TECHNOLOGY, INC. Irvine, CA
Consulting Research Director 2008 – Present
Designed and conducted microbiological research assay for acne device
Coordinated and managed FDA 510K device research to test and validate acne device
Conducted expanded devise survey research for FDA 510K approval
Research studies resulted in full FDA 510K approval for acne device
Instrumental in the preparation of five publications for the company
AMERICAN NEUTRACEUTICAL ASSOCIATION Birmingham, AL
Senior Consulting Vice President, Member of Board of Directors 1996 – Present
Coordination and organization pre-clinical and clinical research with major research institutions
Responsible for the development and production of bio-medical multi-media educational programs
Direct liaison for new and existing clients in the nutraceutical industry
New business development & project supervision with physicians, nurses, naturopaths, pharmacists
Interface with nutraceutical manufacturers, scientific and technical advisors, formulators, distributors consultants and pharmacies for new and existing business development
Assisted in Nutraceutical in Medicine Conferences
LANE LABORATORIES Allendale, NJ
Consultant 2003 – 2005
Designed protocol and carried out in-vitro research for anti-infective agents
Published research findings in JANA 2003
Presented at American Academy for Anti-Aging Medicine conference in 2004
Targeted research to supported launch of product
INSTITUTE FOR MOLECULAR MEDICINE Huntington Beach, CA
Consultant 1999 – Present
Elected member of Investigational Review Board (IRB)
Review and approval determination for clinical research submissions
Brought in three clinical trial for the Institute
Organized, wrote protocols, coordinated and managed three clinical trials – two published
Consultant to Principal Investigator of IMM
M. PRODUCT GROUP Scottsdale, AZ
Consultant 2002 – 2006
Wrote protocol, IRB submission and Informed Consent for AIDS clinical trial
Successful approval at Raritan Bay Medical Center for study
Coordinated physicians, nurses and staff
Responsible liaison between client and research institution
DAVSTAR, INC. Costa Mesa, CA
Consultant 1994 – 2000
Concept and development of clinical diagnostic product for urinalysis “Censlide”
Wrote protocols, coordinated, managed clinical laboratory research
Published key study in conjunction with UCLA
Successfully brought product to market internationally
NEWPORT PHARMACEUTICALS – Pharmaceutical Co. Newport Beach, CA
Director Biological Research 1975 – 1986
Responsible for biomedical research and development of immunological products
Designed tissue culture and animal research laboratory facilities
Coordinated compilation of New Drug Application (NDA) for FDA submission
Research led to approvals drug approvals in 80 countries
Published 21 scientific articles in viral immunology and related fields in medical journals
Assisted in protocol design, monitoring, and final publication of multi-center clinical trials
Developed time-lapse cinemicrophotographic films – cancer target cell destruction by human cells
Master of Science, Emphasis, Microbiology & Immunology, Cum Laude 1976 California State University
HONORS AND AWARDS
Alpha Chi National Honorary Society • Biology Book Award for Outstanding Achievement in Biology • American Medical Writer’s Association, Finalist Award • John Muir Medical Film Festival, Gold Leaf Award • International Scientific and Technical Film Award • Chicago International Film Award, 2nd Place • U.S. Industrial Film Festival, Creative Excellence Award • American Association for the Advancement of Science, Silver Film Award • Houston International Film Festival, Gold & Silver Award • National Educational Festival, Silver Award • IFPA, Gold Cindy Award• Outstanding Ski Industry Representative, Bill Mackey Award
NATURAL MEMBRANE PHOSPHOLIPID SUPPLEMENTS FOR CELLULAR REPAIR, THE TREATMENT OF ACUTE AND CHRONIC ILLNESSES, FATIGUING ILLNESSES AND MITOCHONDRIAL DISORDERS
Inventors: Robert Settineri and James F. Palmer, Patent # EP 2603090 A1
CHEWABLE WAFERS CONTAINING LIPID SUPPLEMENTS FOR MAINTAINING HEALTH AND THE TREATMENT OF ACUTE AND CHRONIC DISORDERS
Inventor: Robert Settineri, Patent #
AN EDTA COMPOSITION AND METHOD OF ADMINISTERING EDTA COMPLEXES
Inventor: Robert Settineri, Provisional application
PRO-DRUG FOR ADMINISTRATION OF EDTA
Inventor: Robert Settineri, Provisional application
INTERESTS AND HOBBIES
Skiing, sailing, cycling, tennis
Nicolson, G.L., Settineri, R. and Ellithorpe, R. Neurodegenerative and fatiguing Illnesses, infections and mitochondrial dysfunction: use of natural supplements to improve mitochondrial function. Funct. Foods Health Dis. 4(1): 23-65 (2014).
Ellithorpe, R., Calpp, L, Jimenez, T., Jacques, B., Settineri, R., Dyck, H. and Nicolson, G.L. Antimicrobial plus CaNa2EDTA chelation suppository therapy for chronic prostatitis/chronic pelvic pain syndrome: preliminary study. Revised (2013).
Nicolson, G.L., Settineri, R. and Ellithorpe, E. Lipid Replacement Therapy with a Glycophospholipid Formulation, NADH and CoQ10 Significantly Reduces Fatigue and Improves Mood and Cognition in Intractable Fatiguing Illnesses and Chronic Lyme Disease. Townsend Lett. 347(6): 58-61 (2012)
Nicolson, G.L., Settineri, R. and Ellithorpe, E. Glycophospholipid formulation with NADH and CoQ10 significantly reduces intractable fatigue in chronic Lyme disease patients: preliminary report. Funct. Food Health Dis. 2(3): 35-47 (2012)
Ellithorpe, R.R, Settineri R., Ellithorpe, T. and Nicolson, G.L. Blood homocysteine and fasting insulin levels are reduced and erythrocyte sedimentation rates are increased with a glycophospholipid-vitamin formulation: a retrospective study in older subjects. Funct. Food Health Dis. In press (2013).
Ash, M., Settineri R. and Nicolson, G.L. Fatigue, Immunity and Inflammation: their resolution using natural medicine. Townsend Lett. 352(10): 48-51 (2012).
Nicolson, G.L., Settineri, R. and Ellithorpe, E. Lipid Replacement Therapy with a glycophospholipid formulation with NADH and CoQ10 significantly reduces fatigue in intractable chronic fatiguing illnesses and chronic Lyme disease. Int. J. Clin. Med. 3(3): 164-170 (2012)
Ellithorpe, R.A., Settineri, R., Jacques, B. and Nicolson, G.L. Lipid Replacement Therapy functional food with NT Factor for reducing weight, girth, body mass, appetite, cravings for foods and fatigue while improving blood lipid profiles. Funct. Food Health Dis. 2(1): 11-24 (2012)
Ellithorpe, R.A., Settineri, R., Mitchell, C.A., Jacques, B., Ellithorpe, E. and Nicolson, G.L. Lipid replacement therapy drink containing a glycophospholipid formulation rapidly and significantly reduces fatigue while improving energy and mental clarity. Funct. Food Health Dis. 1(8): 245-254 (2011).
Nicolson, G.L. and Settineri, R. Lipid Replacement Therapy: a functional food approach with new formulations for reducing cellular oxidative damage, cancer-associated fatigue and the adverse effects of cancer therapy. J. Funct. Food Health Dis., 1(4):135-160 (2011).
Garth L. Nicolson, PhD, Rita R. Ellithorpe, MD, Cyndee Ayson-Mitchell, MD, Brett Jacques, ND and Robert Settineri, MS. Lipid Replacement Therapy with a Glycophospholid-Antioxidant-Vitamin Formulation Significantly Reduces Fatigue Within One Week, JANA – 13(1): 10-14 (2010).
Ellithorpe, R., Jimenez, T., Jacques, B., Settineri, R., Clapp, L. and Nicolson, G.L. Calcium disodium EDTA chelation suppositories: a novel approach for removing heavy metal toxins in clinical practice. In: Anti-Aging Therapeutics, (R. Klatz and R. Goldman, eds.), vol. 11, American Academy of Anti-Aging Medicine, 107-118 (2009).
Rita Ellithorpe, M.D., Robert Settineri, M.S., “Detox Outside the Box”, published by Sierra Productions, 2009.
Nicolson, G.L., Ellithorpe, R., and Settineri, R. Dietary supplement Healthy Curb for reducing weight, girth, body mass, appetite and fatigue while improving blood lipid values with NTFactor Lipid Replacement Therapy. J. Invest Myalgic Encephalomyelitis 3(1): 39-48 (2009).
Ellithorpe, R., Clapp, L., Jimenez, T., Jacques, B., Settineri R., Nicolson, G. The Effects of an Anti-Microbial plus CaNa2 EDTA Chelation Suppository Therapy on Prostate Conditions/Prostatism. J. Complementary and Alternative Medicine, 2008, In Press
Reynolds, J., Hamill, R., Ellithorpe, R., Settineri, R. Retarding Cognitive Decline with Science-based Nutraceuticals. JANA, 2008; 11(1):19-27
Ellithorpe, R., Mazur, P., Glenwood, G., Button, G., Le, J., Pfadenhauer, E., Settineri, R., Nicolson, G. Comparison of the Absorption, Brain and Prostate Distribution, and Elimination of CaNa2 EDTA of Rectal Chelation Suppositories to Intravenous Administration. JANA, 2007; 10(2):38-44
Ellithorpe, R., Settineri, R., Nicolson, G., Reduction of Fatigue by Use of a Dietary Supplement Containing Glycophospholipids. JANA; 2003 6(1): 23-28
Agadjanyan, M., Vasilevko, V., Ghochikyan, A., Berns, P., Kesslak, P., Settineri, R., Nicolson, G., Nutritional supplement (NT Factor) restores mitochondrial function and reduces moderately severe fatigue in aged subjects. J. Chronic Fatigue Syndr., 11(3): 23-36 0ct. 2003
Settineri, R., Krassner, S., Antimicrobial Effects of Plant-Derived Essential Oil Formulations on Pathogenic Bacteria, JANA, 2003; 7(2)
Colodny, L., Settineri, R., Rosenblatt. Immune Function and the Role of Keratin. JANA, 2000, 3(3)
Lenani, C., Settineri, R., Garrison, R., Fu, P., Urinary Sediment: Evaluation of Cen-Slide 1500 and KOVA Methods. Harbor UCLA. American Association of Clinical Chemists. Abstract, 1995.
Tipper, P., Yang, G., Nichols, L., Settineri, R., Comparison of Cen-Slide and Standard Methodology for Microscopic Urinalysis. Diagnostic and Clinical Testing, 1993.
Settineri, R., for Newport Pharmaceuticals International Inc. and American Social Health Resource Center. Herpes: The Evasive Invader (Film Brochure). Newport Pharmaceuticals International Inc., 1985.
Settineri, R., for Newport Pharmaceuticals International Inc. Inosiplex: The Immunostimulant (Film Brochure). Newport Pharmaceuticals International Inc., 1984.
Settineri, R., for Newport Pharmaceuticals International Inc. The Immune Response (Film Brochure). Newport Pharmaceuticals International Inc., 1982.
Hadden J., Hadden, E., Spira, T., Settineri, R., Effects of NPT 15392 In Vitro on Human Leukocyte Function. Int. J. Immunopharmac. 1982; 4: 235-242.
Simon, L., Maxwell, K., Ginsberg. T., Settineri, R., Immunomodulation by Synthetic Purine Derivatives. American Chemical Society Book of Abstracts, 1981.
Simon, L., Settineri, R., Pfadenhauer, E., etc. al., NPT 15329: A Pharmacologic and Toxicologic Profile. Intl. J. Immunopharmac. (1st Intl. Conf. on Immunopharma.) 1980; 2.
Simon, L., Settineri, R., Coats, H., Glasky, A., Isoprinosine: Studies on Mechanism of Anti-Influenza activity. Annual Meeting of the American Society for Microbiology, 1978.
Simon, L., Settineri, R., Coats, H., Glasky, A., Isoprinosine: Integration of the Antiviral and Immunoproliferative Effects. Current Chemotherapy (10th Intl. Congress of Chemotherapy), 1977; 1: 366-368.
Settineri, R., Simon, L., Coats, H., Glasky, A., Immunopotentiation of Mitogen-Induced Murine Lymphocyte Proliferation by Isoprinosine. 77th Annual Meeting of the American Society for Microbiology, 1977.
Glasky, A., Settineri, R., Coats, H., Simon, L., Immunopotentiation of Mitogen Induced Murine Lymphocyte Proliferation by Isoprinosine. Intl. Congress on Immunology, 1977.
Settineri, R., Rothman, A., Ginsberg, T., Glasky, A., Application of Several Tissue Culture Methods to the Evaluation of Antiviral Action of a New Drug: Inosiplex. 18th Symposium of California Branch of the Tissue Culture Association, 1976.
Ginsberg, T., Settineri, R., Glasky, A., In Vitro and In Vivo Effects of Inosiplex in Experimental Influenza. Sixteenth Interscience Conference Antimicrobial Agents and Chemotherapy, 1976.
Glasky, A., Friebertshauser, G., Holker, J., Settineri, R., Ginsberg, T., The Role of Cell Mediated Immunity in the Therapeutic Action of Viral Disease Processes. 9th International Cong of Chemotherapy, 1975; 6: 235-238.
Settineri, R., Development of Methods to Study Antiviral Drug Activity and the Testing of a New Drug: Isoprinosine. Thesis-Cal State Fullerton, 1975.
Glasky, A., Pfadenhauer, F., Settineri, R., Ginsberg, T., Isoprinosine, a Purine Derivative; Metabolic, Immunological and Antiviral Effects. Combined Immunodeficiency Disease and Adenosine Deaminase Deficiency, A Molecular Defect. Academic Press, 1975:157-172.
Settineri, R., Friebertshauser, G., Pfadenhauer, E., Ginsberg, T., Analysis of Antiviral Effects of Isoprinosine in Tissue Culture Animals and Man. Publications of the 1974 Pacific Slope Biochemical Conference, 1974.
Friebertshauser, G., Settineri, R., Ginsberg, T., Glasky, A., Relationships Between Molecular Biochemical Effects of Isoprinosine and Immunological Phenomena. Publication of the 1974 Pacific Slope Biochemical Conference 1974.
Ginsberg, T., Settineri, R., Pfadenhauer, E., Glasky, A., Isoprinosine: Suppression of Cytopathic Effects (CPE) of Influenza A2 and Rhinovirus in Tissue Culture. 73rd Annual Meeting, American Society for Microbiology, 1973.
Glasky, A., Settineri, R., Lynes, T., Isoprinosine: Therapeutic Antiviral Activity Action Against Influenza A2 in the Mouse. 7th International Congress on Chemotherapy, 1972:1:19.
Glasky, A., Settineri, R., Lynes, T., Isoprinosine: Therapeutic Antiviral Action against Influenza A2 in the Mouse. Advances in Antimicrobial and Antineoplastic Chemotherapy, 1972: 319-320.
Lynes, T., Anderson, M., Settineri, R., The Interaction of Isoprinosine and Some Immunosuppressive Agents and Chemotherapy, 1972.