This document provides a summary of Charlene M. Jett's career experience and qualifications. She has over 30 years of experience in clinical research, regulatory affairs, and management for the pharmaceutical, biotech and medical device industries. Her background includes managing clinical trials, auditing clinical data, assisting with FDA submissions, and developing new drugs and medical devices. She has worked in various therapeutic areas and has experience across all phases of clinical trials.
Gongronema Latifolium A Plant with Cardioprotective Potentialsijtsrd
Gongronema latifolium GL has gained research interest in the field of Medicine. The present study investigated the cardioprotective potentials of the ethanolic and ethyl acetate fraction of the leaves extract of G.L. 18 Male Wistar rats were divided equally into three groups. Group 1 was the control group, and was administered 0.9 normal saline. Group 2 was administered 200mg kg ethanolic leaves extract of GL. Group 3 received 200mg kg ethyl acetate fraction of the leaves extract of GL. Administration was via oral gavage and lasted for 14 days. The rats were sacrificed under chloroform anaesthesia. Blood was collected via cardiac puncture, allowed to clot, and later centrifuged to get serum. Laboratory assays were done for serum concentrations of total cholesterol Tc , total triglycerides Tg , high density lipoprotein HDL-c , low density lipoprotein LDL , malondialedyde MDA , total antioxidant capacity TAC , and total plasma peroxide TPP . The heart, aorta, and kidneys were also harvested for organ weight and histological studies. Administration of GL extracts resulted in an increase p 0.001 serum concentrations of HDL-c and TAC, with a consequent reduction in the serum concentrations of Tg, LDL-c, VLDL, MDA, and TPP. There was no significant p 0.01 change in organ weights of the heart, aorta, and kidneys across the groups. Histology of the blood vessels showed intact layers across the groups. There was no derangement of cellular architecture in the heart and kidney. This study therefore concludes that Gongronema latifolium leaves extract is cardioprotective, and thus provides a basis for the use of this plant as an alternative for the prevention, management or control of cardiovascular diseases. Justin Atiang Beshel | Favour Nyoh Beshel | Clement Oshie Nku | Daniel Udofia Owu "Gongronema Latifolium: A Plant with Cardioprotective Potentials" Published in International Journal of Trend in Scientific Research and Development (ijtsrd), ISSN: 2456-6470, Volume-3 | Issue-2 , February 2019, URL: https://www.ijtsrd.com/papers/ijtsrd21431.pdf
Paper URL: https://www.ijtsrd.com/medicine/physiology/21431/gongronema-latifolium-a-plant-with-cardioprotective-potentials/justin-atiang-beshel
Gongronema Latifolium A Plant with Cardioprotective Potentialsijtsrd
Gongronema latifolium GL has gained research interest in the field of Medicine. The present study investigated the cardioprotective potentials of the ethanolic and ethyl acetate fraction of the leaves extract of G.L. 18 Male Wistar rats were divided equally into three groups. Group 1 was the control group, and was administered 0.9 normal saline. Group 2 was administered 200mg kg ethanolic leaves extract of GL. Group 3 received 200mg kg ethyl acetate fraction of the leaves extract of GL. Administration was via oral gavage and lasted for 14 days. The rats were sacrificed under chloroform anaesthesia. Blood was collected via cardiac puncture, allowed to clot, and later centrifuged to get serum. Laboratory assays were done for serum concentrations of total cholesterol Tc , total triglycerides Tg , high density lipoprotein HDL-c , low density lipoprotein LDL , malondialedyde MDA , total antioxidant capacity TAC , and total plasma peroxide TPP . The heart, aorta, and kidneys were also harvested for organ weight and histological studies. Administration of GL extracts resulted in an increase p 0.001 serum concentrations of HDL-c and TAC, with a consequent reduction in the serum concentrations of Tg, LDL-c, VLDL, MDA, and TPP. There was no significant p 0.01 change in organ weights of the heart, aorta, and kidneys across the groups. Histology of the blood vessels showed intact layers across the groups. There was no derangement of cellular architecture in the heart and kidney. This study therefore concludes that Gongronema latifolium leaves extract is cardioprotective, and thus provides a basis for the use of this plant as an alternative for the prevention, management or control of cardiovascular diseases. Justin Atiang Beshel | Favour Nyoh Beshel | Clement Oshie Nku | Daniel Udofia Owu "Gongronema Latifolium: A Plant with Cardioprotective Potentials" Published in International Journal of Trend in Scientific Research and Development (ijtsrd), ISSN: 2456-6470, Volume-3 | Issue-2 , February 2019, URL: https://www.ijtsrd.com/papers/ijtsrd21431.pdf
Paper URL: https://www.ijtsrd.com/medicine/physiology/21431/gongronema-latifolium-a-plant-with-cardioprotective-potentials/justin-atiang-beshel
A Java professional with 8 years of experience in designing web applications. Made use of j2ee, mvc design pattern with spring and struts 2 frameworks. Ajax and JQuery experience in single page web applicatrions. Angular JS for bringing in lightweight on applications
Personalized medicine involves the prescription of specific therapeutics best suited for an individual based on their genetic or proteomic profile. This talk discusses current approaches in drug discovery/development, the role of genetics in drug metabolism, and lawful/ethical issues surrounding the deployment of new health technology.
The "Cady White Paper" Review & Rationale for Antioxidant and Nutrient supple...Louis Cady, MD
In this presentation, delivered at the 2nd Health Care Professional Summit in Los Angeles, CA - 9 24 2011 - Dr. Cady reviews the critical points in the Cady White Paper on the Biophotonic Scanner, as well as a cogent explanation from the literature about the need to monitor antioxidant status and supplement appropriately.
2014 Report: Medicines in Development for Older AmericansPhRMA
As life expectancy continues to climb—up to more than 81 years for women and 76 years for men—the growing number of Americans age 65 and older will face new challenges from chronic conditions such as arthritis, Alzheimer’s disease, cardiovascular disease and diabetes, which impact their health, productivity and independence. Those diseases not only impact the individuals living with them, but burden their families and cost the health care system billions of dollars.
Biopharmaceutical research companies are developing 435 medicines targeting 15 leading chronic conditions affecting seniors—Alzheimer’s and dementia, anemia, arthritis, benign prostatic hyperplasia, cataracts and glaucoma, chronic
kidney disease, chronic obstructive pulmonary disease (COPD), depression, diabetes, heart failure, hyperlipidemia,
hypertension, hypothyroidism and ischemic heart disease.
A Java professional with 8 years of experience in designing web applications. Made use of j2ee, mvc design pattern with spring and struts 2 frameworks. Ajax and JQuery experience in single page web applicatrions. Angular JS for bringing in lightweight on applications
Personalized medicine involves the prescription of specific therapeutics best suited for an individual based on their genetic or proteomic profile. This talk discusses current approaches in drug discovery/development, the role of genetics in drug metabolism, and lawful/ethical issues surrounding the deployment of new health technology.
The "Cady White Paper" Review & Rationale for Antioxidant and Nutrient supple...Louis Cady, MD
In this presentation, delivered at the 2nd Health Care Professional Summit in Los Angeles, CA - 9 24 2011 - Dr. Cady reviews the critical points in the Cady White Paper on the Biophotonic Scanner, as well as a cogent explanation from the literature about the need to monitor antioxidant status and supplement appropriately.
2014 Report: Medicines in Development for Older AmericansPhRMA
As life expectancy continues to climb—up to more than 81 years for women and 76 years for men—the growing number of Americans age 65 and older will face new challenges from chronic conditions such as arthritis, Alzheimer’s disease, cardiovascular disease and diabetes, which impact their health, productivity and independence. Those diseases not only impact the individuals living with them, but burden their families and cost the health care system billions of dollars.
Biopharmaceutical research companies are developing 435 medicines targeting 15 leading chronic conditions affecting seniors—Alzheimer’s and dementia, anemia, arthritis, benign prostatic hyperplasia, cataracts and glaucoma, chronic
kidney disease, chronic obstructive pulmonary disease (COPD), depression, diabetes, heart failure, hyperlipidemia,
hypertension, hypothyroidism and ischemic heart disease.
Chemical contaminants form a vast chemical soup in the Great Lakes, and from available data, we know exposure may be cause for concern. This workshop will discuss the threat of “emerging contaminants” in the Lakes, as well as give an overview of research, policy implications and recommendations for moving forward.
Review of the New ACC/AHA Cholesterol GuidelinesTerry Shaneyfelt
The ACC/AHA recently released updated cholesterol treatment guidelines. I review them along with what I feel are their limitations. Watch my YouTube video describing these slides: http://youtu.be/2BlUhW6Zu2E
Mel Reichman on Pool Shark’s Cues for More Efficient Drug DiscoveryJean-Claude Bradley
Mel Reichman, senior investigator and director of the LIMR Chemical Genomics Center at the Lankenau Institute for Medical Research presents at the chemistry department at Drexel University on November 12, 2009.
Modern drug discovery by high-throughput screening (HTS) begins with testing hundreds of thousands of compounds in biological assays. The confirmed hit rate for typical HTS is less than 0.5%; therefore, 99.5% of the costs of HTS are for generating null data. Orthogonal convolution of compound libraries (OCL) is 500% more efficient than present HTS practice. The OCL method combines 10 compounds per well. An advantage of this method is that each compound is represented twice in two separately arrayed pools. The potential for the approach to better enable academic centers of excellence to validate medicinally relevant biological targets is discussed.
Early phase drug development and the fda roadmap final version 2axE. Dennis Bashaw
This is the slide deck used in my webinar that was presented on 2/1/2018 on the FDA Predictive Toxicology Roadmap. It was presented at a webinar hosted by BioIVT in my private capacity and is not an official statement of FDA policy
1. Charlene M. Jett
329 S 4th Street
Vandalia, Illinois 62471
618-283-4073
charlenemjett@yahoo.com
SUMMARY
Powerful dual track career in clinical aspects of pharmaceuticals, chemicals, medical devices and
diagnostics. She is an ideal senior scientist, Sr. CRA or project manager. In-depth experience managing
clinical research and clinical/regulatory scientific requirements, including assisting in the preparation and
evaluation of submissions to FDA. Current on regulations pertaining to informed consents and clinical
research on patients for medical devices and pharmaceuticals. Demonstrated ability to achieve timely
results while conducting clinical and discovery research, managing and monitoring clinical trials and
critical aspects of regulatory reviews. Very experienced clinical trial monitor, Sr. CRA, writer and
executive. Originator of "Record of Conception of Invention" for pharmaceuticals, chemicals, medical
devices and diagnostics. Strong communicator and negotiator, able to design, build and manage
effective teams to accomplish product goals. Responsible for managing contracts and millions of dollars.
Past DOD clearances (3) and patient homecare responsibilities. Prior management consultant for U S
Army, American Red Cross and others.
EDUCATION
MS Management-- Lake Forest Graduate School of Management
Lake Forest, Illinois (International-Oxford, UK).
MS Biology-- minor Biochemistry—Northeastern Illinois University
Chicago, Illinois.
BS Physiology—minor Biochemistry— University of Illinois Urbana, Illinois.
PROFESSIONAL CAREER EXPERIENCE
Independent Consulting (3R’s Management Consulting etc.)
Founder, President and Principal 1988- present
Clients: St. Jude, Medpace, Monitor for Hire, Home Care (mother), Biovail, Premier, Pentech, Med
Institute/Cook, Lysonics, Baxter-Edwards CVS, Schering Plough, Abbott, G. D. Searle/Monsanto,
In Vivo, US Army/Amdex, American Red Cross, Boston Scientific, Biomerieux, Mallinckrodt,
Allergan, Chiltern, US Army/Cambridge Consulting.
Complete responsibility for business providing advanced consulting services and short term employment
on project by project basis to major pharmaceutical, chemical, medical device and diagnostic corporations
nationwide in areas of science, clinical research, regulatory reviews, and pharmaceutical project/program
management.
Experienced in and knowledgeable on clinical/regulatory SOP's, GCPs, GLPs and regulatory reviews for
FDA and ICH guidelines.
Audited clinical trials of pharmaceuticals, medical devices, chemicals and combination products.
Assisted in filings, including INDs, NDAs, 510ks, IDEs, PMAs and In vitro Diagnostics.
Audited patient and product data prior to FDA submission.
Wrote scientific reports, protocols, scientific/medical and clinical research monitoring reports.
Assisted in re-engineering two organizations.
Conducted clinical trials on new clinical products in various therapeutic/device areas.
Conducted clinical trials in hypertension, angina, congestive heart failure, Alzheimer's,
schizophrenia, memory problems, heart-valves (mechanical and tissue), surgical sutures, stents,
dental video equipment, anesthesia, in-line glucose and blood pressure sensors, sexual
2. dysfunction, Parkinson’s, arthritis, re-stenosis, glaucoma, anti-infective therapies, diabetes and
chemicals (MRI contrast agent and aquaculture).
o Inventor (Baxter’s Tisseal)
o PC, Laptop and Microsoft Office experience. Experienced with internet, webinars and
security issues.
Abbott Laboratories, North Chicago, Illinois
Project Manager
1987-1988
Sr. Clinical Research Associate
1985-1987
Clinical Research Associate
1980-1985
Fortune 500 developer, manufacturer, and seller of wide range of pharmaceutical products worldwide.
Served as lead scientist and worked in areas including angina, hypertension, congestive heart failure,
medical devices, anesthesia, and veterinary medicine. In addition, worked in regulatory reviews, staffing
and training, interfaced with physicians, scientists, statisticians, nurses etc. Experienced in monitoring,
budgets, data collection, corrections and safety reviews. Phase I-IV and Class I-III experience.
Assisted in preparation and advised on FDA filings including INDs, NDAs, 510ks and IDEs.
Researched, designed and wrote medical protocols and summaries.
Managed clinical research, audits and regulatory compliance of clinical trials, audited clinical trials
of pharmaceuticals. Wrote literature review and in-licensing review for cardiac drugs.
Audited patient and product data prior to FDA submission.
Conducted clinical trials (Hytrin and Cartrol) and on medical devices (Transpac II, Etomidate,
Pulse-oxcimeter, surgical canister).
Managed project, hired staff, and designed field trials for new chemical product
(fluoroquinolone antibiotic for aquaculture).
Inventor (new diagnostic product - Matrix).
Designed and placed studies which resulted in FDA approval, monitored and closed sites
for two drug approvals (Hytrin and Cartrol).
Critiqued In-License Drug Candidate (Cholesterol Reduction).
Recommended scientific and medical consultants.
G.D. Searle, Skokie, Illinois
Senior Research Biochemist
1975-1980
Research Biochemist
1972-1975
Major developer, manufacturer and seller of pharmaceutical products serving markets worldwide.
Laboratory and animal experimentation,trained technicians and wrote numerous scientific reports.
Lead scientist working in areas of endocrinology and cholesterol metabolism.
Co-inventor of new chemicals tested for structure activity relationships in cholesterol reduction.
This contributed to M. Brown and J. Goldstein’s Nobel Prize.
Researched and wrote scientific reports and summaries.
Developed animal models and biochemical RIA assays (kinetically validated) for endocrinology
and cholesterol-metabolism(3-beta,5-alpha-hydroxy-steroid-dehydogenase,HMG-CoA
Reductase, 7alpha hydroxylase, Acetyl Coenzyme A Transferase- ACAT).
Modified marketed HDL diagnostics kit for use in animals.
Prepared and delivered scientific presentations and publications.
Interfaced with chemists and other scientists on programs.
3. University of Illinois, Physiology and Agronomy Depts.
Research Technician
1970-1971
Research Assistant
1971-1972
Enzyme (catalase) assay development and atomic absorption of heavy metals from plant
extracts.
PUBLICATION and PRESENTATIONS
1. Hypolipidemic Activity of 5-Aryl-3 Methylvaleric Acid Derivatives. Dygos, JH; Jett, CM; Chinn LJ; Miller,
JE. J. Med. Chem. Dec, 1977, 20 (12) p1705-8.
2. Inhibition of HMG CoA Reductase by Derivatives of Glycyrrhetic Acid. Jett, CM and Miller, JE.
Abstracts of 175th Meeting of the American Chemical Society, Chicago, IL. V174 Aug. 1977. (Conf.
Paper).
3. Control of HMG-CoA Reductase During Reduction of Serum Cholesterol in the Rat. Jett, CM; Taite,
B., and Miller, JE. American Heart Association, Council on Arteriosclerosis. 31st Annual Meeting, Miami
Beach, Fl. Nov. 1977 (Conf. Paper).
4. Regulation of HMG, CoA Reductase Activity by 3 Hydroxy-3 methyl glutaric Acid and Derivatives
During Reduction of serum Cholesterol Levels in Rats. Jett, C, Langford D, Baran J. and Miller J.-
Abstracts of Council on Arteriosclerosis, American Hart Assn. Nov 1977.
5. Attempts to Inhibit De Novo Cholesterol Synthesis by Derivatives of 3-Hydroxy-3-Methylglutaric Acid.
Jett, CM; Langford, D; Baran J. and Miller, J. International Symposium on Prevention and Reversal of
Atherosclerois, Miami Beach, FL Jan. 1978. (Conf. Paper).
6. Effects of Mevalono-Lactone as a Modulator of 3-Hydroxy-3-Methyl Glutaryl Coenzyme A-Reductase,
Toronto, Ont. Canada, July 7, 1979. J. Lipid Research, 20(8) 1979. (Conf. Paper).
7. The Role of Guinea Pigs in the Study of Atherosclerosis Abstracts of Illinois State Academy of
Science, April. 1979.
8. Jett C. and Miller J.E. Shift is Guinea Pig Lipoprotein Profiles Induced by Modulation of HMG-CoA
Reductase Activity. Abstracts of 5th International Symposium an Atherosclerosis, Houston 1979.
9. Inhibition of HMG CoA Reductase by Substitute B Hydroxy B Alkyl Glutaric Acids. 17th National
Medical Chemistry Symposium. Rensselaer, NY June 1980. Baran, JS., Liang CD, Langford D. Laos I
and CM. Jett.
10. Hyperlipemic Serum Induced Cholesterol Esterification Of Smooth Muscle Cells Is Inhibited By 22-
Hydroxy-Cholesterol And Its Analog. Bates, SR; Jett, CM; Miller, JE. 65th Annual Meeting of the
Federation of American Society for Experimental Biology, Atlanta, GA April 12-17, 1981. (Conf. Paper)
Fed Proc 1981(40) p349.
11. Prevention Of The Hyperlipidemic Serum Of LDL-Induced Cellular Cholesterol Ester Accumulation By
22-Hydroxycholesterol And Its Analogue. Bates, SR; Jett, CM;Miller, JE; Biochem. Biophys. Acta. 1983,
753 (3) p281-93.
4. 12. Correlation Of In Vitro Inhibition of Liver HMG-CoA Reductase With Reduction Of Rat Serum Total
Cholesterol By 3-Hdroxy-3 Methylglutaric Acid Derivatives. Stewart, L; Miller, JE; Baran, J; Rohrbacher,
E; Jett, CM; Taite, B; J. Lipid Research 1983 (10) p1414
13. Presentation at Abbott Laboratories to Divisional, President- HPD. ”Solutions to Problems in Clinical
Research”. 1985.
14. 22-Hydroxycholesterol Derivatives as HMG CoA Reductase Suppressors and Serum Cholesterol
Lowering Agents. Chorvat, RJ; Desai, BN; Radak, SE; McLaughlin, KT; Miller, JE; Jett, CM;
Rohrbacher, E. J. Med. Chem. 1985, 28 (2)p194-200.
15 3-Alky-l,3-Hydroxyglutaric Acid A New Class of Hypocholesterolemic 3-Hydroxy-3-Methylglutaric-Acid
Coenzyme A Reductase Inhibitors, Baran , JS; Laos, I; Langford, DD; Miller, JE; Jett, CM; Taite, B;
Rohrbacher, E. J. Med. Chem. 1985, 28 (5) p597-601.
16. Created and delivered “3R’s-Talent for Hire” 1991-North Shore Chamber of Commerce, Wilmette,
Illinois.
17. Created a presentation for In Vivo-3/1992 “Aging”, Princeton, NJ.
18. Created and delivered-Poster presentation at Baxter-Edwards CVS 3/1993 “Denaflex CABG (
Coronary Artery Bypass Graft) Graft”. Palm Springs, California.
19. Created and delivered-Internal Presentation at Baxter on 3/1993 “Status of Denaflex Graft Clinical
Trials”. Irvine, California.
20. Created and delivered “3R’S- Talent for Hire” 1993 Irvine, CA. and 1995 Carpinteria Chamber of
Commerce, Carpinteria, CA.
21. American Business Women’s Association-Summer, 1994-Created and Delivered-Presentation on
“Stress Management.” Carpinteria, California.
22. Redhill Lutheran (Tustin) and Methodist Churchs, joint Choir Special (~ 1994)
23. Created a presentation for Lysonix, Inc., 7/1997 “Clinical Trials in Liposuction”. Carpinteria, CA.
24. Created a presentation for Solvay 3/1998 “Clinical Research on Women’s Health Problems ”A
Review of Hypertension, Angina and Cholesterol Reduction.”
25. Good Clinical Practices in Monitoring Antihypertensive Clinical Trials (Hytrin and Carteolol). Am.
Journal of Hypertension, 1999, New York, New York.
26. Good Clinical Practices Review- Battelle, Columbus, Ohio ~2000.
27. Quality and Compliance- Clinical Research Issues in the Post 9/11 World. Oct 13,2004.
Regulatory Affairs Professionals Annual Conference, Oct 13, 2004. Washington DC.
28. A Hypothesis for the Heart (Nuclear Magnetic Resonance). 41st Midwest Regional Meeting of
American Chemical Society. Oct 25-27, 2006. Quincy, Illinois.
29. Created a “Review of Basic Clinical Statistics”, Regulatory Affairs Professionals (RAPS) 2007.
Unpublished.
30. First United Methodist Church, Chancel Choir and Christmas Cantata- 2008, 2011 – 2015, Vandalia,
Illinois.
5. 31. QA/QC and Validation in Clinical Trials of Pharmaceuticals or An Ounce of Prevention is Worth a
Pound of Cure. OMICs, Philadelphia Dec 3, 2012
32. Created a presentation for ComplianceOnline.com "Basic Clinical Research" to be delivered in
Oakland Ca in Jan 2014 (canceled).
Professional Affiliations : Sigma Xi, American Chemical Society, past member of Regulatory Affairs
Professionals, Linkedin Professional Network.
Additional Professional classes since 1990 - Global Clinical Research, Advanced Project
Management, and Planning and Managing a Drug Research Portfolio: Improved Decision Making.
Also studied University classes in electron microscopy, advertising, marketing, strategic planning,
statistics, lasers, law and computers.
Volunteer Activities:
Church: Sing in choir regularly, teach Sunday school monthly, write in devotional booklet, member of
Church women's group, member of Evergreen Outreach and write weekly.
Community Activities: Singing and lead devotions for Fayette County Nursing Home occasionally in the
summer and holidays.