NAGENDRA NINGARAJ

Morgan Hill, CA***** 859-***-**** ad3knz@r.postjobfree.com Scopus Author ID 660-***-****

https://orcid.org/0000-0003-2076-9661 www.linkedin.com/in/nagendra-ningaraj-b5bab06/

Ningaraj, Nagendra S. - Author details - Scopus Preview

SUMMARY AND SKILLS

Clinical Pharmacology Research Director / Scientific / Medical Research Writer

A solutions-focused and knowledgeable Clinical Research Scientist and Clinical Project Director who has held progressive leadership roles in pre-clinical and clinical oncology research and development projects at major academic, Pharma and CRO settings focused on pharmacology and toxicology, medicinal chemistry aspects of anti-cancer drug development.

A bicultural leader, with achievements in publications, presentations, and leadership roles on boards, plus patents in the US, EU, and Japan. A recognized researcher who leads by example to foster a culture of accountability, motivation, and service to deliver a cohesive and productive environment focused on consistently meeting – and often exceeding – goals.

Selected Achievements

R&D Projects – Leadership roles in clinical pharmacology, toxicology, and extensive firsthand drug metabolism and bioanalytic chemistry expertise in leading project teams at Cedars-Sinai, Vanderbilt University, Memorial Health University, Mercer University Medical Centers, Dr. Reddy’s Laboratories, and Scintilla Bio-MARC Pvt. Ltd.

Study design and Analysis- Demonstrated expertise in clinical pharmacology study design. Extensive knowledge in performing pre-clinical assays using liver microsomes, hepatocytes, CACO2, CHO models, and assessment of experimental data.

Communications: Clinical study reports, SOPs, investigator brochures, new drug applications, technical documents pertaining to non-clinical drug metabolism, bioanalytic, and clinical pharmacology data. Authored clinical protocols, executed protocols, lab manuals to support bioanalytic laboratories, clinical Pharmacology and DMPK teams at stages of the drug development efforts. Reviewed FDA, EMA/CPMP, PMDA pre submissions and answered queries from referees for resubmissions.

Clinical/Medical Project Director - Recognized leader in full-cycle project management with keen ability to consistently improve project efficiency, apply quality metrics, SOPs and integrated study management for drug development and clinical execution with successful project outcomes including on-time and within budget delivery.

Anti-Cancer Drug – Led collaborations in academic and CRO settings for development of pre-clinical brain and breast cancer models to evaluate the toxicity and mechanism of MK801 targeting glutamate receptors, radio-labeled and non-radiolabeled Temozolomide of Schering-Plough Research Institute targeting and sunitinib malate of SUGEN targeting PDGFR in brain tumors.

Diseases – Conducted IVD of infectious diseases including HPV, HCV, HBV, and HIV, and non-infectious diseases. Validated molecular and RUO MDx in Oncology at Scintilla Bio-MARC in collaboration with Neuberg Supratech, a CAP-approved lab on PCR-7500 Dx, FACS, and ELISA platforms.

Scientific/ Medical Writing - Succeeded in securing over $5M in research grant funding in collaboration with organizations on the leading edge of research, disease control, and funding to expand brain tumor treatments. Successful Patent applications, SOPs, presentations to client sin peers as part of Business Development and securing funding and collaborations.

Leadership – Directed the Human Tissue banking and biorepository and New Animal Facility. Published over 75 peer-reviewed research articles and presented at several national and international meetings. Raised start-up capital for Scintilla Academy and Scintilla Bio-MARC Pvt. Ltd.

PROFESSIONAL EXPERIENCE

Aragen Lifesciences, Morgan Hill, CA

Senior Director, Scientific Affairs & Alliances 2022-2024

Liaison between global pharma clients and Laboratory operations, lead expert reviewer of in vivo pharmacology for IND-enabling preclinical studies in various diseases, including Infectious Disease, Fibrosis, Oncology, Immunooncology and CDMO services. Created content for capabilities presentations, Website, White Papers, Scientific articles, press releases and LinkedIn posts. Managed alliances with entities that Aragen outsources projects such as Biologics bioproduction, GMP work, Histopathology, GLP tox and preclinical efficacy studies.

PPD (now Thermo Fisher Scientific) – Highland Heights, KY

Logistics Coordinator/ Investigator Services 2019-2022

Led quality control of clinical tests and preparation of clinical trial test kits for global clients.

Increased Services – Key contributor to a 3000% increase in creation of clinical trial test kits for United States and global pharma companies while ensuring quality control.

SCINTILLA BIO-MARC PVT. LTD. (CRO)

Business Owner / Managing Director 2011 - 2019

Entrepreneurial business owner of start-up for Molecular Diagnostics (MDx), clinical pharmacology, and toxicology services. Raised capital, set up, and built a diagnostic laboratory to meet needs of essential cancer MDx market.

Partnerships – Collaborated with medical centers and oncologists to identify and validate immune-oncology markers offering affordable lab-developed and validated cancer biomarkers.

DR. REDDY’S LAB – Hyderabad, India

Director 2008 - 2009

Drug Development – Managed clinical drug development projects of biosimilars, plus clinical trial protocols for GCSF, Peg-GCSF in cancer patients, and clinical pharmacology.

Protocols – Created clinical protocols and accountable for analytics of biosimilars in Oncology trials.

Dialysis – Led collaboration with KOLs for Darbepoetin trials in pre-dialysis and dialysis patients.

Liaison – Contact between pre-clinical and clinical pharmacology in dose optimization and pharmacometrics.

MEMORIAL HEALTH UNIVERSITY MEDICAL CENTER, ANDERSON CANCER INSTITUTE (ACI)

Associate Member, Departments of Oncology and Molecular Pharmacology, Savannah, GA

Associate Professor – Pediatrics & Internal Medicine, Mercer University School of Medicine

Director, ACI Vivarium Core Facility, Human Tumor Biorepository 2006 – 2008; 2009 – 2010

Teacher – Taught Pharmacogenomics for medical students.

Projects – Led planning of translational clinical Neuro-oncology research with medical school faculty.

GCC-Funded Project – Lead of project focused on role of RNA splice variants in brain and breast tumor progression and growth.

Team Leadership – Supervised animal research technicians and post-doctoral fellows evaluating anti-cancer drugs in appropriate human cancer xenograft models.

Protocols – IRB Member trained in JACHO for evaluation of clinical trial protocols. Developed IACUC protocols and SOPs and served on the IACUC Committee.

VANDERBILT UNIVERSITY – Nashville, TN

Research Associate Professor / Director 2004 - 2006

Collaborations – Fostered key collaborations with lead researchers to study therapeutic monoclonal antibodies (MAb), chemotherapeutics, EGFR/tyrosine receptor kinase (RTK) inhibitors.

Clinical Study – Utilized population-based PK/PD models for clinical study design for interaction of cancer with its microenvironment in collaboration with biostatisticians.

Grant – PI in ACS-funded research grant for mechanism of BKCa channels in anti-cancer drug with small and large molecules delivery to brain tumors.

TARGEN INC. – San Diego, CA

Investigator / Consultant 2003 - 2006

Consulting Services – Provided consulting services for design and execution of pre-clinical non-steroid anti-inflammatory drug development project.

Project – Created a core research team for pre-clinical studies on small molecule kinase inhibitors for the treatment of cancer.

CEDARS-SINAI MEDICAL CENTER – Los Angeles, CA

Research Scientist and Group Leader 1998 - 2004

Projects – Led design and management of multiple NIH-funded projects valued over $5M.

Pre-Clinical Studies – Conducted pre-clinical pharmacology and toxicology studies on MAbs and potassium channel agonists in human cancer models.

Clinical Trials – Collaborated with CROs to develop IND package on sponsor/investigator-initiated clinical trials.

Discovery – Discovered a novel drug delivery strategy where potassium channel agonists transiently open blood-brain tumor barrier.

Clinical Studies – Participant in multiple dose escalation and mechanism-based safety Phase I and II clinical studies.

Licensing – Licensed drug delivery technology.

UNIVERSITY OF KANSAS – Lawrence, KS

Fellow – Pharmacology & Toxicology / Medicinal Chemistry 1993 - 1998

Studies – Conducted pre-clinical drug development studies with rodent models including ADME, PK-PD and toxicology. Cultured primary neurons isolated from neonatal mice brains to study neuro-degenerative mechanisms.

Research Project – Technical Lead of US Navy research-funded project for oxygen-induced neurotoxicity in deep-sea divers.

Mentor – Provided mentoring to undergraduate and graduate students and junior post-doctoral fellows.

Doctoral Research in Neurochemistry

Dissertation: In vitro and in vivo metabolism and pharmacokinetics of Disulfiram and S-S-Methyl N, N-diethylthiolcarbamate Sulfoxide. Studied neuropharmacology and toxicity of Antabuse drugs.

EDUCATION AND OTHER

MBA in Business Administration, GPA 4.0 – Stetson Business School, Mercer University, Macon, GA, 2008

Post Doc Fellow, Pharmacology & Toxicology – University of Kansas, Lawrence, KS, 1998

Ph.D. in Neurochemistry – National Institute of Mental Health & Neurosciences, Bangalore, India, 1994

CCRP – Certified by SOCRA

Professional Affiliations

Past Professional Member – ACRP AACR ASCO Society of Toxicology Society for Neuroscience AHA Council

The Society for Clinical Research Associates (SoCRA) Association of Clinical Research

Professional Committees

Mercer University Medical School – IACUC

Associate Member – Children Oncology Group

Member – MHUMC Diversity Council

Member – MHUMC Institutional Review Board – Oncology

Member – MHUMC Institutional Human Tissue Biorepository - Oncology

Issued Patents – U.S., EU, and Japan (12 Submitted)

Method for using potassium channel agonists for delivering a medicant to an abnormal brain region and/or a malignant tumor-Patent No. US7, 018,979B1 (Application No. US09/491,500) 2006

Potassium channel mediated delivery of agents through the blood-brain barrier 2003 (WO/2005/025511)

Induction of apoptosis of malignant cells by activation of calcium-activated potassium channels-USPTO Application

# 200******** (2006)

Selected Publications

Ningaraj N, Khaitan D. Inflection point in glioma growth and angiogenesis driven by potassium channels. Glioma [serial online] 2019; 2:105-15.

Divya Khaitan & Nagendra Ningaraj, Evidence of BK Ca channelopathy- driven Breast cancer Metastasis to Brian, InTechopen, 2019; 1-12.

Divya Khaitan & Nagendra Ningaraj, Primary and Metastatic Brain Tumors Dissipate-Understanding and Intervention, Journal of Neurosurgery Imaging and Techniques, 2019; 4(2):205-212.

Divya Khaitan & Nagendra Ningaraj, Evidence of KCNMA1 as a key promoter of Glioma growth and Tumorigenicity, Glioma 2019;2:46-54.

Divya Khaitan, Polluru L. Reddy and Nagendra Ningaraj, Targeting Brain Tumors with Nanomedicines: Overcoming Blood Brain Barrier Challenges, Current Clinical Pharmacology (2018) 13: 110. https://doi.org/10.2174/

Khaitan Divya & Ningaraj Nagendra & B. Joshua, Lincy. (2018). Role of an Alternatively Spliced KCNMA1 Variant in Glioma Growth. 10.5772/intechopen.74509.

Honors & Recognition

2017 – As CSO of Scintilla Bio-MARC Pvt. Ltd – Recognized as one of the most innovative biotechnologist grant awards by government of Karnataka, India

2008 – Member – The National Scholars Honor Society (USA)

2003 – Cover Page Article – The June issue of the Drug News & Perspectives

2002 – Summer Mentor Fellowship – The American Brain Tumor Association

2003 – CSMC – Institute’s Employee of the Quarter

2002 – Cover Page Article – June issue of the JPET

Invited Reviewer / Referee

UK Medical Research Council Fellowships

Brain Research

Microvascular Research

Journal of Neurochemistry

Expert Opinion on Drug Delivery

Cancer Control

Neurological Research

Molecular Cancer Research

Journal of Neuroscience

Invited Subject Expert & Editor

Bentham Science

Elsevier Inc.

InTech Open

Journal of Experimental & Clinical Cancer

J. Cancer Research & Clinical Practice

Asian Oncology Research Journal

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