Safety Science & Drug Development Expertise

CONSULTING SERVICES:

  •   Preclinical Drug Development
  •   Risk Assessment & Gap Analysis
  •   Scientific Program Management
  •   Due Diligence and Licensing
  •   Worldwide Regulatory Filings: 
    • FDA, EU, Canada, Australia
    • eCTD, IND, CTA, IB, DSUR 
  •   GLP Study Design and Monitoring 
    • Toxicology, Safety Pharm
    • Impurity Qualification
  •   White Papers
  •   Environmental Risk Assessment

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Biography - Stephanie Greene, PhD., RDN

As a preclinical safety scientist with over 20 years experience with biopharmaceutical companies, Dr. Greene is the founder of Trovare Preclinical Consulting, LLC. Dr. Greene was the PharmTox lead for Afrezza® inhaled insulin new drug application at MannKind Corp and for the first small molecule eCTD at Amgen for Sensipar™. She has authored the nonclinical sections of 7 NDA’s and over 30 investigative new drugs primarily in the areas of oncology, metabolic disorders and cardiovascular disease. She has interacted with global regulatory agencies including US-FDA, EU, Canada, and Australia and has participated in Advisory Committee meetings. As the previous head of the PharmTox Department at MannKind Corp, she represented nonclinical development on multi-functional teams, led a team of scientists and vivarium staff to support all preclinical programs across three different locations, and audited/monitored GLP toxicology studies. 


Dr. Greene has extensive experience with due diligence and BD licensing/partnership activities in oncology and diabetes.  Dr Greene was also a member of the metabolic disorders and cardiovascular licensing teams at Amgen. She provided preclinical leadership on the team that successfully acquired Biovitrum. In addition, Dr. Greene has been very active in professional safety science groups and has presented at the Society of Toxicology Meetings since 2005. She has published multiple patents and scientific articles. Dr Greene guest lectures at USC, University of California, Santa Barbara, School of Biotechnology & Engineering, California State University, Channel Islands and also, in Honors Bioscience programs at Foothill Technology High School. Dr. Greene received her PhD in 1995 from the University of California at Davis.


PUBLICATIONS: 

Patents

*IRE1 inhibitor in combination with cancer therapeutic agent for cancer treatment. International Patent Number PCT/CN2018/113783.

*Val(8) GLP-1 composition and method for treating functional dyspepsia and/or irritable bowel syndrome. Patent Number: 8,642,548.

*Glucagon-like-peptide 1 (GLP-1) pharmaceutical formulations. Patent Number: 07760728.1-2108 PCT/US2007066728.

*Metallotetropyrolic photosensitizing agents for use in photodynamic therapy. Patent Number US682792B2 / US20050137180A1.


Journal Articles and Book Chapters

*IRE1-XBP1s pathway promotes prostate cancer by activation c-MYC signaling. Nature Communications, December, 2018.

*Inhibition of IRE1α RNase activity modulates the secretome of Triple Negative Breast Cancer cells and enhances the effectiveness of chemotherapy. Nature Communications, June, 2018.

*Long-term pulmonary safety assessment of Technosphere Insulin (Afrezza).in rats and dogs. J Tox Path, submission 2016.

*Sigma receptors [Rs]: Biology in normal and diseased states. Journal of Receptors and Signal Transduction, May, 2015.

*Receptor-mediated inhibition of small bowel migrating complex by GLP-1 analogue ROSE-010 delivered by pulmonary and systemic routes in the conscious rat. Regulatory Peptides, 2012, 179 (1-3): 71-6.

*Evaluation of novel particles as an inhalation system for GLP-1. Diabetes, Obesity and Metabolism, 11, 2009, 1050-1059.

*Serum 2 macroglobulin and 1 inhibitor 3 concentrations are increased in hypoalbuminemia by post translational mechanisms. Kidney International, 1998 Jan, 53(1):67-75.

*Longevity in obese and lean male and female rats of the Zucker strain: Prevention of hyperphagia. American Journal Clinical Nutrition, 1997 66:1-14.

*Administration of arachidonic acid in vivo alters muscle fatty acid composition and insulin secretion in obese rats. International Journal of Obesity, 12:26-32, 1997.

*Insulin secretion in obese-derived islets is normalized with in vivo administration of arachidonic acid. Obesity Res, 29:245-255, 1997.

*The male obese Wistar Diabetic Fatty rat is a new model of extreme insulin resistance. Obesity Res 2: 432-443, 1994.

*Use of glycated hemoglobin to assess strain differences and age changes in Wistar Diabetic Fatty rats and Zucker fatty rats. Obesity Research 2: 535-540, 1994.

*Studies in the Wistar Diabetic Fatty rat (fa/fa): A model of NIDDM. In: Lessons in Animal Diabetes V, 75-82, E. Shafrir (ed.), 1993. 

*Effect of the beta-adrenergic agonist, isoproterenol, on protein deposition and adipose cellularity of chickens. Proceeding of Poultry Science, 1988.

*Effect of dietary or in ovo isoproterenol administration on growth and fattening of broilers. Poultry Science, 1988. 


Abstracts 

*Inhibition of IRE1α RNase activity modulates the secretome of Triple Negative Breast Cancer cells and enhances the effectiveness of chemotherapy. European Cell Death Organization, 2016.

*Preliminary safety assessment of a novel IRE1α–inhibitor in rats. The Toxicologist 2015.

*Preclinical Long Term Safety Assessment of Technosphere Insulin (Afrezza). The Toxicologist; 120 (Suppl 2): 175, 2013.

*Long Term Pulmonary Safety Assessment of Technosphere Insulin (Afrezza) in Rats and Dogs. The Toxicologist; 120 (Suppl 2): 175, 2011.

*Formulation/Device Combination for Systemic Drug Delivery by Inhalation. Inhalation. 2009.

*Mimicking Endogenous Peptide Secretion by Inhalation. AAPS, 2009.

*Immunology poster AACR Tumor Immunology Meeting, Miami, Dec 2009.

*Synergy of Technosphere Insulin Inhalation Powder Used in Combination with Other Diabetes Medications in the Obese Zucker Diabetic Rat. Diabetes, 2008.

*GLP-1 Superior Systemic Pharmacokinetics After Pulmonary Delivery as MKC253 Compared to Intravenous or Subcutaneous Routes in Rats. Diabetes. 2008.

*Oxyntomodulin and Peptide YY Pulmonary Delivery by Technosphere Particles: Decreased Food Intake in Normal and Diabetic Rats. Diabetes Technology, 2008.

*Effects of GLP-1 Technosphere Powder Administered by Pulmonary Insufflations in Male Obese Zucker Diabetic Fat Rats. Diabetes 2007.

*Development of GLP-1 Technosphere Powder: An Inhaled GLP-1 Product. Diabetes, 2007.

*Bone Growth in Juvenile Dogs with Administration of Cinacalcet. American Society of Bone Mineral Research. ASBMR, Oct, 2004.

*Hemolytic potential of vehicles used for rapid in vivo screening of small molecules. Society of Toxicology, 41st Annual Meeting, Nashville Tennessee, 2002.

*A Comparison of the Sensitivity of Detection of the Hepatotoxicity of Allyl Alcohol in the Rat Using 1H NMR of Urine Versus Histopathology and Clinical Pathology.

*Metabonomics: A sensitive technique to assess toxicity. SMDD poster session, May 25, 2002.

*Photodynamic therapy and topical application of the new photosensitizer MV6401. International Photodynamic Association, 8th World Congress of Photodynamic Medicine, 2001.

*MV6401: A new potent photosensitizer for photodynamic therapy. International Photodynamic Association, 8th World Congress of Photodynamic Medicine, 2001.

*Prevention of hyperphagia normalizes median lifespan and delays the onset of renal disease in male and female genetically obese Zucker rats (fa/fa). IV Benjamin Franklin Symposium. La NaPoule, France. 1996.

*Administration of arachidonic acid in vivo alters skeletal muscle phospholipid fatty acid composition and food intake in obese Zucker (fa/fa) and Wistar Diabetic Fatty (fa/fa) rats. Obesity Research, 1996.

*Arachidonic acid administration in vivo alters PGE2 release and decreases insulin secretion in pancreatic islets from obese Zucker rats and obese, diabetic rats. Diabetes, 1995.

*Delayed onset of degenerative renal disease in pair-fed genetically obese female Zucker rats compared to ad-libitum fed genetically obese female rats and pair-fed obese male rats. Gerontological Society of America, 48th Annual Science Meeting, Los Angeles, CA, 1995.

*Modest food restriction influences survival in aging obese male and female Zucker rats. Gerontological Society of America, 48th Annual Science Meeting, Los Angeles, CA, 1995.

*Differences in glucose-stimulated phospholipid metabolism in lean and obese Zucker rats. Obesity Research Supplement 1995.

*Obesity and Longevity: A longitudinal study of obese and lean Zucker rats. American Society Clinical Nutrition 35th Annual Meeting, San Diego, CA, 1995.

*Administration of arachidonic acid in vivo decreases insulin secretion in pancreatic islets isolated from obese (fa/fa) Zucker rats. International Journal of Obesity, 18 (Suppl 3):0447, 1994.

*The role of arachidonic acid in insulin hypersecretion of the obese Zucker rat. American Diabetes Association 29th Research Symposium & ICO Satellite Conference, August, Boston MA, 1994.

*Obesity and hyperinsulinemia: a role for arachidonic acid. American Diabetes Association 29th Research Symposium & ICO Satellite Conference, August, Boston MA, 1994.

*Sexual dimorphism and age changes in glycated hemoglobin of Wistar Diabetic Fatty rats. Diabetes 42 (Suppl 1):48A, 1993.

Morphological investigations of endocrine pancreas from obese Wistar Diabetic Fatty rats: comparison with Zucker rats. Obesity Research 1, (Suppl 2):101S, 1993.

*Glucose homeostasis measured by glycated hemoglobin on obese Wistar Diabetic Fatty (WDF) rats and Zucker obese rats. International Congress Nutrition, Adelaide, Australia, Sept. 1993.

*High sucrose diet alters insulin receptor number and binding affinity and tyrosine kinase activity in the Wistar Diabetic Fatty (WDF) rats. FASEB J, 6:A1647, 1992.

*Muscle insulin receptor tyrosine kinase activity and adipose cellularity is altered in male obese Wistar Diabetic Fatty (WDF) rats. International Journal of Obesity, 16 (Suppl.1):P173, 1992.

*Muscle insulin receptor tyrosine kinase (TK) activity is directly related to plasma glucose and insulin concentration in male Wistar Diabetic Fatty rats. J American Diabetes Association 41:144A, 1992.

*In ovo administration of triiodothyronine enhances broiler responsiveness to a dietary beta-adrenergic agonist. FASEB J, 3:A102, 1989.