Profile Details

Create Project

★★★★★

☆☆☆☆☆

USD 50 /hr

★★★★★

☆☆☆☆☆

Hire Dr. Nidhikumari R.

United Kingdom

USD 50 /hr

Postdoctoral fellow Pharmaceutics expert in gene delivery, formulation development and characterization, Regulatory Aff

Profile Summary

Exceptional research expertise (5+ years) in a novel drug and non-viral gene delivery system including analytical experience in design, physical, biological (micro-biological/biomolecular) and pre-clinical investigations Development and assessment of the nucleic acid (plasmid DNA, miRNA, mRNA) loaded lipidic nanoparticles as a vaccine delivery system: a proof-of-concept study - Troubleshooting in lipid nanoparticle formulation loaded with plasmid DNA, library generation of different compositions of lipid nanoparticle Leading, managing and executing a project related to an innovative, non-sweetened and stable nano-sized lipid-based delivery system (Lipolife®) for immunomodulatory drug-using non-GMO phospholipids based on considering MHRA quality regulatory guidelines, Working in close collaboration with the Anglia Ruskin University, Chelmsford, UK Successfully created, validated and freeze-dried peptide targeted protein-based siRNA-miRNA delivery therapeutics which capable of delivering sensitive cargo in a well-controlled manner to target tissues of diabetic kidneys. Validated via utilizing analytical techniques, cell-based, molecular biology techniques, and pre-clinical testing resulting in an Indian patent (App No: xxxxxxxxxxxxxxxxx research publications. - Established a well-characterized novel polymeric temperature/photo-triggered drug release formulations to deliver chemotherapeutic molecules for the treatment of cancer (breast cancer, triple-negative breast cancer, glioblastoma), diabetic complications (diabetic nephropathy, retinopathy), rheumatoid arthritis (atherosclerosis) etc. and collaborated with the researcher resulting in 7 research publications in an internationally recognized peer-reviewed journal based on a new simple methodology for formulation development - Design and synthesize innovative polymer and lipid-based micro/nanoparticles for advanced therapeutics including nucleic acid delivery. Also having in-depth knowledge of biomaterials for applications in disease therapy - Sound in-depth understandings of drug delivery, pharmacokinetics, biopharmaceutics, a clinical phase of medicine development, human toxicology, animal handling as well as clinical research - Developed insights for regulatory guidelines of EU, MHRA, USFDA, and ICH for drug substance (IND, NDA) and drug product (generics, OTC), marketing authorization (MA), life cycle management, cGMP, eCTD, clinical trials documents, GLP to prepare and contribute to regulatory documentation

Subject Matter Expertise

• ★ Gene Delivery
• ★ Regulatory Affairs
• ★ Manuscript & Journal Article Writing
• ☆ Dispersion Chemistry
• ☆ Surface Science
• ☆ Biopolymers
• ☆ Polymer Chemistry
• ☆ Peptide Synthesis
• ☆ Biochemical Assays
• ☆ Enzyme Activity Assays
• ☆ Plasmid DNA
• ☆ Microscopy
• ☆ Electron Microscopy
• ☆ Cell Culture
• ☆ Biomolecular Engineering
• ☆ Blotting
• ☆ Art Education
• ☆ Pharmacy
• ☆ Pharmacy Education
• ☆ Drug Development
• ☆ Drug Formulation
• ☆ Small Molecule Drug Development
• ☆ Drug Stability Testing
• ☆ Drug-Drug Interactions
• ☆ Preclinical Research
• ☆ In vitro Preclinical Toxciology
• ☆ In vivo Preclinical Toxicology
• ☆ Investigational New Drug (IND) Application Consulting
• ☆ Pharmaceutical Regulatory Affairs
• ☆ Bioavailability
• ☆ Clinical Trials
• ☆ Immunotherapy
• ☆ Technical & Scientific Writing

Services

• Writing
• Research
• Consulting
• Data & AI
• Product Development

Writing Clinical Trial Documentation, Technical Writing, Copywriting

Research Market Research, User Research, Fact Checking, Scientific and Technical Research, Systematic Literature Review

Consulting Scientific and Technical Consulting, Regulatory Consulting, Manufacturing Consulting

Data & AI Statistical Analysis

Product Development Formulation, Stability/Shelf Life Testing, Product Evaluation, Material Sourcing, Product Validation, Quality Assurance & Control (QA/QC), Product Compliance , Concept Development

Work Experience

PostdoctoralResearcher

The University of British Columbia Vancouver

January 2022 - Present

Regulatory Affairs Officer

IQVIA

May 2021 - December 2021

trainee

Alembic Limited

June 2016 - July 2016

Education

PhD (Pharmaceutics)

National Institute of Pharmaceutical Education and Research Ahmedabad

August 2016 - October 2020

M.S.(Pharma) (pharmaceutics)

National Institute of Pharmaceutical Education and Research Ahmedabad

July 2014 - May 2016

Certifications

• Post Graduate Diploma in Global Regulatory Affairs (PGDGRA)

  Raaj Global Pharma Regulatory affairs consultants

  October 2021 - Present

Publications

JOURNAL ARTICLE

(2019). Nanogold-core multifunctional dendrimer for pulsatile chemo-, photothermal- and photodynamic- therapy of rheumatoid arthritis . Journal of Colloid and Interface Science.

(2019). Employment of enhanced permeability and retention effect (EPR): Nanoparticle-based precision tools for targeting of therapeutic and diagnostic agent in cancer . Materials Science and Engineering: C.

(2019). ‘Dendrimer-Cationized-Albumin’ encrusted polymeric nanoparticle improves BBB penetration and anticancer activity of doxorubicin . International Journal of Pharmaceutics.

(2018). Carbon nanotubes in the delivery of anticancer herbal drugs . Nanomedicine.

Nidhi Raval, Dignesh Khunt, Manju Misra(2018). Microemulsion-based delivery of triamcinolone acetonide to posterior segment of eye using chitosan and butter oil as permeation enhancer: an in vitro and in vivo investigation . Journal of Microencapsulation. 35. (1). p. 62--77. Informa {UK} Limited

(2018). Carbon nanotubes (CNTs) based advanced dermal therapeutics: current trends and future potential . Nanoscale.

(2017). Surface Engineered Dendrimers in siRNA Delivery and Gene Silencing . Current Pharmaceutical Design.

BOOK CHAPTER

(2019). Fabrication of Mucoadhesive-Dendrimers as Solid Dosage Forms . Pharmaceutical Nanotechnology.

(2019). Importance of Physicochemical Characterization of Nanoparticles in Pharmaceutical Product Development . Basic Fundamentals of Drug Delivery.

(2019). Surface Modifications of Biomaterials and Their Implication on Biocompatibility . Biomaterials and Bionanotechnology.

(2019). Surface Modification of Biomedically Essential Nanoparticles Employing Polymer Coating . Pharmaceutical Nanotechnology.

(2019). Transportation and Biointeraction Properties in Nanomaterials Across Biological Systems . Basic Fundamentals of Drug Delivery.

(2019). Copolymers and Block Copolymers in Drug Delivery and Therapy . Basic Fundamentals of Drug Delivery.

(2018). Scale-Up Studies in Pharmaceutical Products Development . Dosage Form Design Considerations.

(2018). Basic Concept and Application of Sampling Procedures . Dosage Form Design Parameters.