Profile Details

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Hire Dr. Harriet K.

United States

USD 495 /hr

Regulatory Toxicologist

Profile Summary

Regulatory writing and submissions • Regulatory Intelligence and Strategy Development • Toxicology Study Monitoring • Due Diligence and Gap Analysis • Research Support Services

Subject Matter Expertise

• ☆ Drug Development
• ☆ Small Molecule Drug Development
• ☆ Biologic & Biosimilar Development
• ☆ Drug Substance Characterization
• ☆ Preclinical ADME/PK/PD
• ☆ In vitro Preclinical Toxciology
• ☆ In vivo Preclinical Toxicology
• ☆ Investigational New Drug (IND) Application Consulting
• ☆ Medical Devices
• ☆ Medical Device Regulatory Consulting
• ☆ European Medical Device Regulation (MDR)
• ☆ ISO 13485
• ☆ ISO 14971
• ☆ EU In vitro Diagnostic Regulation (IVDR) Compliance
• ☆ In vitro Diagnostics
• ☆ Point-of-Care Devices
• ☆ Lab-on-a-Chip Devices
• ☆ Peer Review
• ☆ Literature Search
• ☆ Gap Analysis
• ☆ Gray Literature Search
• ☆ Regulatory Writing
• ☆ CMC Documentation
• ☆ NDA/BLA Applications
• ☆ Nonclinical Study Documentation
• ☆ Clinical Trial Documentation
• ☆ Clinical Trial Protocol Writing
• ☆ Clinical Study Reports
• ☆ Investigational New Drug (IND) Application Writing
• ☆ Technical & Scientific Writing
• ☆ SOP & Protocol Writing
• ☆ White Papers
• ☆ Textbook Content Writing
• ☆ Literature Review
• ☆ Traditional/Narrative Literature Review
• ☆ Systematic Literature Review

Services

• Writing
• Research
• Consulting
• Product Development

Writing Clinical Trial Documentation, Medical Writing, Non-Medical Regulatory Writing, Technical Writing, Business & Legal Writing, Copywriting, Creative Writing, Newswriting, Audio Transcription

Research Meta-Research, Feasibility Study, Gap Analysis, Gray Literature Search, Scientific and Technical Research, Systematic Literature Review, Secondary Data Collection

Consulting Go-to-Market Strategy Consulting, Scientific and Technical Consulting, Regulatory Consulting

Product Development Quality Assurance & Control (QA/QC), Product Compliance

Work Experience

CEO

Kandih Group LC

January 2014 - Present

Director

NAMSA (France)

June 2020 - July 2022

Manager

Emergent BioSolutions (United States)

January 2016 - July 2017

Senior Scientist

AstraZeneca (United States)

December 2008 - December 2013

Postdoctoral Researcher

George Washington University

March 2005 - November 2008

Education

PhD (Pharmacology)

Howard University

September 1999 - December 2004

BS (Biology)

Coppin State University

September 1998 - May 1999

BEd (Physics/Chemistry)

Egerton University

March 1992 - September 1996

Certifications

• Diplomate of the American Board of Toxicology

  American Board of Toxicology

  January 2011 - Present

Publications

BOOK CHAPTER

Kamendi, H.(2020). Kenya . Information Resources in Toxicology Volume 2 the Global Arena. 5. p. 315-317.

JOURNAL ARTICLE

Kamendi, H., Barthlow, H., Lengel, D., Beaudoin, M.-E., Snow, D., Mettetal, J.T., Bialecki, R.A.(2016). Quantitative pharmacokinetic–pharmacodynamic modelling of baclofen-mediated cardiovascular effects using BP and heart rate in rats . British Journal of Pharmacology. p. 2845-2858.

Kamendi, H., Zhou, Y., Crosby, M., Keirstead, N., Snow, D., Bentley, P., Patel, N., Barthlow, H., Luo, W., Dragan, Y., et al.(2015). Doxorubicin: Comparison between 3-h continuous and bolus intravenous administration paradigms on cardio-renal axis, mitochondrial sphingolipids and pathology . Toxicology and Applied Pharmacology. 289. (3). p. 560-572.

Chen, Y., Brott, D., Luo, W., Gangl, E., Kamendi, H., Barthlow, H., Lengel, D., Fikes, J., Kinter, L., Valentin, J.-P., et al.(2013). Assessment of cisplatin-induced kidney injury using an integrated rodent platform . Toxicology and Applied Pharmacology. 268. (3). p. 352-361.

Lamore, S.D., Kamendi, H.W., Scott, C.W., Dragan, Y.P., Peters, M.F.(2013). Cellular impedance assays for predictive preclinical drug screening of kinase inhibitor cardiovascular toxicity . Toxicological Sciences. 135. (2). p. 402-413.

Dergacheva, O., Kamendi, H.W., Wang, X., Mendelowitz, D.(2011). 5HT1A receptors inhibit glutamate inputs to cardiac vagal neurons post-hypoxia/hypercapnia . Respiratory Physiology and Neurobiology. 179. (2-3). p. 254-258.

Litwin, D.C., Lengel, D.J., Kamendi, H.W., Bialecki, R.A.(2011). An integrative pharmacological approach to radio telemetry and blood sampling in pharmaceutical drug discovery and safety assessment . Biomedical Engineering Online. 10.

Kamendi, H.W., Brott, D.A., Chen, Y., Litwin, D.C., Lengel, D.J., Fonck, C., Bui, K.H., Gorko, M.A., Bialecki, R.A.(2010). Combining radio telemetry and automated blood sampling: A novel approach for integrative pharmacology and toxicology studies . Journal of Pharmacological and Toxicological Methods. 62. (1). p. 30-39.

Dergacheva, O., Kamendi, H., Wang, X., Pinol, R.A., Frank, J., Gorini, C., Jameson, H., Lovett-Barr, M.R., Mendelowitz, D.(2009). 5-HT2 receptors modulate excitatory neurotransmission to cardiac vagal neurons within the nucleus ambiguus evoked during and after hypoxia . Neuroscience. 164. (3). p. 1191-1198.

Kamendi, H.W., Cheng, Q., Dergacheva, O., Gorini, C., Jameson, H.S., Wang, X., McIntosh, J.M., Mendelowitz, D.(2009). Abolishment of serotonergic neurotransmission to cardiac vagal neurons during and after hypoxia and hypercapnia with prenatal nicotine exposure . Journal of Neurophysiology. 101. (3). p. 1141-1150.

Dergacheva, O., Kamendi, H., Wang, X., Pinol, R.M., Frank, J., Jameson, H., Gorini, C., Mendelowitz, D.(2009). The role of 5-ht3 and other excitatory receptors in central cardiorespiratory responses to hypoxia: Implications for sudden infant death syndrome . Pediatric Research. 65. (6). p. 625-630.

Dergacheva, O., Wang, X., Kamendi, H., Cheng, Q., Pinol, R.M., Jameson, H., Gorini, C., Mendelowitz, D.(2008). 5HT2 receptor activation facilitates P2X receptor mediated excitatory neurotransmission to cardiac vagal neurons in the nucleus ambiguus . Neuropharmacology. 54. (7). p. 1095-1102.

Jameson, H.S., Pinol, R.A., Kamendi, H., Mendelowitz, D.(2008). ATP facilitates glutamatergic neurotransmission to cardiac vagal neurons in the nucleus ambiguus . Brain Research. 1201. p. 88-92.

Kamendi, H.W., Cheng, Q., Dergacheva, O., Frank, J.G., Gorini, C., Jameson, H.S., Pinol, R.A., Wang, X., Mendelowitz, D.(2008). Recruitment of excitatory serotonergic neurotransmission to cardiac vagal neurons in the nucleus ambiguus post hypoxia and hypercapnia . Journal of Neurophysiology. 99. (3). p. 1163-1168.

Dergacheva, O., Griffioen, K.J.S., Wang, X., Kamendi, H., Gorini, C., Mendelowitz, D.(2007). 5-HT2 receptor subtypes mediate different long-term changes in GABAergic activity to parasympathetic cardiac vagal neurons in the nucleus ambiguus . Neuroscience. 149. (3). p. 696-705.

Wang, X., Dergacheva, O., Kamendi, H., Gorini, C., Mendelowitz, D.(2007). 5-Hydroxytryptamine 1A/7 and 4α receptors differentially prevent opioid-induced inhibition of brain stem cardiorespiratory function . Hypertension. 50. (2). p. 368-376.

Huang, Z.G., Griffioen, K.J.S., Wang, X., Dergacheva, O., Kamendi, H., Gorini, C., Mendelowitz, D.(2007). Nicotinic receptor activation occludes purinergic control of central cardiorespiratory network responses to hypoxia/hypercapnia . Journal of Neurophysiology. 98. (4). p. 2429-2438.

Griffioen, K.J.S., Kamendi, H.W., Gorini, C.J., Bouairi, E., Mendelowitz, D.(2007). Reactive oxygen species mediate central cardiorespiratory network responses to acute intermittent hypoxia . Journal of Neurophysiology. 97. (3). p. 2059-2066.

Huang, Z.-G., Griffioen, K.J.S., Wang, X., Dergacheva, O., Kamendi, H., Gorini, C., Bouairi, E., Mendelowitz, D.(2006). Differential control of central cardiorespiratory interactions by hypercapnia and the effect of prenatal nicotine . Journal of Neuroscience. 26. (1). p. 21-29.

Bouairi, E., Kamendi, H., Wang, X., Gorini, C., Mendelowitz, D.(2006). Multiple types of GABAA receptors mediate inhibition in brain stem parasympathetic cardiac neurons in the nucleus ambiguus . Journal of Neurophysiology. 96. (6). p. 3266-3272.

Kamendi, H., Dergacheva, O., Wang, X., Huang, Z.-G., Bouairi, E., Gorini, C., Mendelowitz, D.(2006). NO differentially regulates neurotransmission to premotor cardiac vagal neurons in the nucleus ambiguus . Hypertension. 48. (6). p. 1137-1142.

Kamendi, H., Stephens, C., Dergacheva, O., Wang, X., Huang, Z.-G., Bouairi, E., Gorini, C., McIntosh, J.M., Mendelowitz, D.(2006). Prenatal nicotine exposure alters the nicotinic receptor subtypes that modulate excitation of parasympathetic cardiac neurons in the nucleus ambiguus from primarily α3β2 and/or α6βX to α3β4 . Neuropharmacology. 51. (1). p. 60-66.