R & D Summary

 

RESEARCH SUMMARY

Over twenty five years of exploratory research and translational development studies in both conventional and integrative healthcare.  My current focus is developing innovative nutraceutical technologies and products with enhanced bioavailability based on my diverse expertise in both conventional and complementary medicine.

EDUCATION

Virginia Polytechnic Institute and State University

B.S.

1986

Biochemistry & Nutrition, Minor Chemistry

University of Wisconsin – Madison
McArdle Laboratory for Cancer Research

Ph.D.

1991

Experimental Oncology & Environmental Toxicology

 

FELLOWSHIPS

Predoctoral Traineeship

National Institute of Environmental Health and Safety

1986 - 1991

Honorary Fellow

Interdisciplinary Programs in Health
Harvard School of Public Health

1991 - 1993

Post- Doctoral Fellow

Dana Farber Cancer Institute, Harvard Medical School

1991 – 1993

RESEARCH GRANTS

Co-Principal Investigator, Prospective Outcomes and Efficacy Monitoring System, funded by the Department of Defense and the Samueli Institute of Information Biology, 2003
Investigator, Prospective Outcomes and Efficacy Monitoring System, DOD renewal, 2004
Integrative Health Research Grant, Fondacion Lucie & Andre Chagnon, Montreal, 2003

EMPLOYMENT

2010 - 2013            Wellah™ Corporation
2007 - 2009            Chief Scientific Officer, NanoSynergy™ Worldwide
2006 - 2013            Clinical Advisory Board Member of Human Health Project
2005 - 2006            International Integrative Healthcare Business Consultant
2002 - 2004            President, National Foundation for Alternative Medicine
2001 - 2002            Vice President of Medical Research, National Foundation for Alternative Medicine
1993 - 2001            Senior Research Scientist, RAIID and Cancer Departments, Pfizer Pharmaceuticals
1991 - 1993            Post-Doctoral Fellow, Dana-Farber Cancer Institute, Harvard Medical School
1991 - 1993            Honorary Fellow, Harvard School of Public Health                                   
1986 - 1991            Doctoral Student, McArdle Laboratory for Cancer Research           
1984 - 1986            Environmental Toxicology Laboratory Technician, Virginia Polytechnic Institute            
1982 - 1985            Cancer Synthetic Organic Chemistry Technician, Virginia Polytechnic Institute           
1984 - 1988            Nationally Registered Emergency Medical Technician

CAREER HIGHLIGHTS AND KEY ACHIEVEMENTS

  • Using a variety of animal and in vitro studies demonstrated that a common mechanism of tumor promoters is the reversible inhibition of gap junctional intercellular communication.  Worked with collaborators to identify a family of connexin genes that are differentially modulated by tumor promoters.  Collaborated with the EPA and FDA to develop toxicology regulatory guidelines based on my research findings.
  • Utilized gene expression profiling to identify a class II tumor suppressor gene our lab named Maspin.  The molecule is a potent angiogenesis inhibitor in clinical development and hundreds of publications have documented the importance of Maspin for the diagnosis and treatment of a large variety of solid tumors.
  • First publication of the EGFR kinase inhibitor called Tarceva (CP-358,774) that has been tested in hundreds of clinical trials leading to FDA approval as a drug for both NSCLC and pancreatic cancer.  This was the first drug to extend lifespan in NSCLC that is responsible for more deaths than prostate, breast, and colon cancers combined.
  • Patented Pfizer’s first human antibody drug candidate in clinical development for cancer immune enhancement (CP-675,206, Tremelimumab) and published studies on the mechanisms of CTLA4 signaling.  Participated on developing proof of concept endpoints, scaleup, toxicology, and phase I/II clinical trial design. 
  • Identified the gene for a novel anti-microbial peptide involved in cancer cachexia, tumor growth, angiogenesis, inflammation, and neuronal survival.  Published the first paper disclosing the unique biological activity of DSEP, also known as cathhelicidin/PIF/DCD-1.
  • Obtained grants and private donations at the National Foundation for Alternative Medicine to improve the clinical evaluation of complementary and integrative therapies for pain, HIV, cancer, Parkinson’s, and cardiovascular diseases.
  • Developed novel methods to formulate dietary supplements in liquid forms for rapid and effective absorption using nanotechnology.  Combine expertise in molecular genetics and nanoformulation technology to create novel condition specific dietary supplements ranging from capsule to carbonated beverage products.  
  • Collaborated on the first study that documented the effectiveness of a low cost water purification system that reduces the number one cause of infant mortality in developing nations (i.e. dysentery).  The filters are currently being developed by MIT and being used in 15 countries.

SUMMARY OF PROFESSIONAL EXPERIENCE

Wellah™ Corporation (2007 - Current)
Created Wellah™ to assist promising early stage nutraceutical companies with cutting edge research services to drive consumer demand for innovative health and wellness products.  Wellah™ provide strategic scientific direction to cost-effectively develop and validate innovative products that are legally defensible, ethically appropriate, and clinically responsible.  Wellah™ helps companies develop ingredients and products that work, are safe, can’t be duplicated and generate consumer buzz.  By applying cutting edge scientific principles to the development, validation and marketing of natural products, Wellah™ can protect the credibility—and ultimately the survival—of innovative companies.  For example, as a consultant I served as Chief Scientific Officer responsible for setting up R&D for formulating novel nutraceuticals oral sprays and related liquid products using nanotechnology.  Designed and setup state of the art particle sizing laboratory complete with Dynamic Light Scattering, Laser Diffraction, and Cytoviva microscopy to characterize and validate new products and competitors.  Creating new formulation technologies to create nano liquid capsules and functional beverages.  Formulated products are manufactured in cGMP facilities and licensed to marketing companies.

 

Integrative Health Projects (2005 – 2007)
Conducted market feasibility research and business planning for a variety of international clients in the integrative health, anti-aging, and MedSpa industries.  My diverse scientific background was leveraged to ensure that product and service delivery systems were clinically responsible, ethically appropriate, and legally defensible.   The integrative health programs include innovative diagnostic testing (direct to consumer, and point of care) in order to develop personalized products based on a clients’ genetic and biochemical imbalances.  In addition, I have contributed integrative health research articles for Life Extension Magazine and serve on the board of the Ultimate Health Group. 

 

National Foundation for Alternative Medicine (2001 - 2004)
In order to evaluate a promising alternative cancer treatment at a clinic in Guatemala I self-funded a nine month onsite clinical investigation.  My growing interests in integrative medicine led to a position as President of the National Foundation of Alternative Medicine that was founded by former Congressman Berkley Bedell.  For three years I focused on creating low cost and efficient strategies for the international identification and early stage clinical evaluation of the most promising complementary and alternative therapies for degenerative diseases.  I have traveled to over twenty countries to catalog the diverse health and wellness therapies used internationally.  As President, I solicited over one million dollars of financial support that was used to support research studies for HIV, Parkinson’s, cancer, and cardiovascular diseases.  Our approach was to study “best case” patient records to identify promising therapies, to train investigators how design and implement early stage clinical trials, and to statistically analyze outcomes.  In addition, I was co-principle investigator for a Department of Defense grant to create a prospective outcomes and efficacy management system for identifying and clinically evaluating non-traditional therapies for pain and wound healing.  Under my leadership, NFAM provided grants and research support for numerous investigators including a therapy developed by Dr. Sun that is the first natural product that has advanced to a Phase III clinical study for NSCLC. 

 

Pfizer Pharmaceuticals Global R&D (1993 - 2001)
Eight years experience in managing pharmaceutical research laboratories in the RAIID (respiratory, allergy, immunology, and infectious disease) and Cancer Departments.  The primary lab focus was to utilize molecular and cell biology research to initiate new drug discovery programs for cancer (EGFR, RXR, aVb3 integrin, ErbB2, IGF-1R, c-Met, Bcl2/Bax, cachectic factor/DSEP), immune suppression (JAK3, ZAP-70, Lck, p38, JNK1/2, PKC theta, CD44, MEKK, MKK4), immune enhancement (CTLA-4, CD40, TGF beta-R, Lyn), and hematopoiesis (REDK).  Generated purified proteins for compound screening, selectivity assays, and NMR/X-ray crystallography efforts.  Developed numerous assays to detect in vitro and cellular activity of compounds.  Initiated a CTLA4 therapeutic antibody research program in collaboration with Abgenix, Lonza Biologics, and Genzyme Transgenics.  The efforts produced the first protein clinical candidate developed at Pfizer.  Used homologue replacement mutagenesis to map antibody epitopes.  Participated on development team for antibody scale up (NSO, transgenic goats) and proof of concept clinical endpoints in order to develop CANTOX and CMC regulatory documents.  Initiated and managed research collaborations with Harvard, Stanford, Columbia, U Chicago and several other Universities.  In collaboration with academic laboratories elucidated novel pathways for lymphocyte cell signaling and identified novel drug targets based on genomic (i.e. Affymetrix, Incyte, Celera) and proteomic (MS/MS, BIAcore, MALDI, FACS, immunostaining) technologies. For example, bioinformatics were used to identify a novel Incyte cDNA clone encoding a cancer cachectic factor and neuronal survival factor (DSEP).  Developed external collaborations with antisense oligonucleotide companies (Sequitor, OEI) and demonstrated effectiveness of the technology for target validation experiments.  Produced novel non-viral (mammalian and bacterial) and viral vectors (retrovirus, Sindbis virus, feline immunodeficiency virus, baculovirus) for transient and stable protein expression.  Developed biomarkers and clinical strategies for proof of concept studies for both small molecules and protein therapeutics.  Managed internal collaborations with toxicology and GMP scaleup to prepare IND for Pfizer’s first protein drug.  The research resulted in several novel anti-cancer and immunotherapy drugs that are currently in clinical trials including Tarceva (EGFR kinase inhibitor) that has been approved for pancreatic cancer and non-small cell lung cancer.  One of the immune enhancement protein therapies (Tremelimumab, human antibody to CTLA-4) developed and patented by my laboratory is currently on Forbes Top 10 list of new cancer drugs. 

 

Harvard Post-Doctoral Research (1991 – 1993)  
Experiments in the Department of Cancer Genetics at the Dana Farber Cancer Institute further characterized the cascade of phenotypic molecular changes that occur during the development of human mammary cancer.  The primary goals of this work were to determine the expression/function of candidate class II tumor suppressor genes identified using gene expression profiling (i.e. differential PCR display).  Dr Ruth Sager was Chief of Cancer Genetics and her laboratory was not equipped for cellular biology research.  I introduced to the lab immunohistopathology, mRNA in situ hybridization, and several cell biology assays.  In addition, the research objectives also required that I develop expertise in protein purification, anti-peptide polyclonal antibody production/purification, immunoblotting, functional protein assays, FACS using antibodies and various fluorescent tracers, as well as various cell culture projects.  For example, I developed an in vitro differentiation system using matrigel to study mammary duct morphogenesis.  The research was very successful in identifying a large series of phenotypic alterations in breast cancer.  One gene we identified, Maspin, was later shown to be an anti-angiogenic factor more potent than endostatin.  In addition, I worked with the Harvard School of Public Health on improving the government guidelines for cancer risk assessment.  In collaboration with Potters for Peace, I designed an epidemiology study to determine the efficacy of colloidal silver artesian filters and education on the number one cause of infant morbidity in developing nations (i.e. dysentery).

 

McArdle Laboratory Graduate Research (1986 – 1991) 
In Henry Pitot's lab I investigated the mechanisms that non-genotoxic chemicals utilize to promote hepatocarcinogenesis.  Dr Pitot was the Director of McArdle Cancer Laboratory and the Founding Director of President Nixon’s National Cancer Advisory Board.  My research examined the expression of oncogenes during the initiation and promotion stages of cancer development.  My thesis focused on alterations in the regulation of gap junction genes (i.e. connexins) during normal and neoplastic liver proliferation.  During these studies I gained expertise in molecular biology (Southern blotting, Northern blotting, mRNA in situ hybridization, PCR, plasmid construction, transfection, DNA sequencing, cDNA cloning), protein chemistry/analysis, cell culture, and a variety of animal models (i.e. transgenics, spontaneous, and chemically induced carcinogenesis).  The research was very productive and resulting in several research publications and invitations to conferences (e.g. Banbury Conference at Cold Spring Harbor) and government EPA/FDA regulatory meetings.

 

Undergraduate Chemistry Research (1982 – 1986)
In Thomas Hudlicky's lab I researched the synthesis of the anti-tumorigenic tricyclic quinane terpenes, Coriolin and Pentalenic Acid.  The experiments involved synthetic organic chemistry utilizing NMR, IR, UV and GC Mass Spectroscopy to verify the products.  In addition, I worked with Roderick Young at the State of Virginia Laboratory for Environmental Testing stationed in the Biochemistry Department at Virginia Tech.  My responsibilities involved the design and execution of experiments to quantitatively measure toxic chemicals in the environmental samples and nutritional components in a variety of nutritional products (i.e. from Arby’s to Quaker Oats).  During this time I gained experience using HPLC, GC (electrochemical), and AA.