Dhanalakshmi Kasi

About Dhanalakshmi Kasi

Research Areas: Medicinal Chemistry, Process Chemistry, Development of new PET Imaging…

Experience

1. Cmc Reviewer

   FDA

   Mar 2014 — Present · Washington, DC, US

   Office of Pharmaceutical Quality Assessment, OPQ, CDER, FDA, Silver Spring, MD. • Application Technical Lead for several clinical divisions: Division of Diabetes, Lipid Disorders, and Obesity, Non-Malignant Hematology, Division of General Endocrinology and Office of Specialty Medicine - Division of Imaging and Radiation Medicine, OTC, Ophthalmology, Oncology. In the ATL role I synthesize a cohesive approach to NDA review by directing a multidisciplinary team. This includes guiding the scientific content of review done in Team Based Review setting by working with reviewers from different disciplines, OPQ (drug substance, drug product, process, micro, facility and biopharmaceutics) and OND (clinical, pharmacology/toxicology and labeling).• Served as a primary and secondary CMC reviewer for IND, NDA, Supplements and ANDA\'s. • Conducted primary and secondary reviews of manufacturing process development, risk assessment of manufacturing process, batch formula, in process controls, critical process parameters and scale up.• Trained in facility evaluations, pre-approval inspections, data integrity, continuous manufacturing process, lyophilization technology, blow fill seal technology, etc.• Pre-Approval Inspections: Participated in foreign and local pre-approval inspections as a SME.• Government Liaison for United States Pharmacopeia• Completed FDA Emerging Leader Program “Aspiring”: Served as a chair of ONDP Education Committee, ONDP Site Visit Committee Chair• Participated in policy development• Won CDER awards• Independently authored and presented at conferences: Society of Nuclear Medicine and Molecular Imaging, World Molecular Imaging representing FDA.

Education

• Madras University

  Master of Science (M.Sc.)

• Madras University

  Bachelor of Science (BSc)

• Indian Institute of Technology

  Doctor of Philosophy (Ph.D.)

Skills

• Gpc
• Chemistry
• Drug Discovery
• Organic Synthesis
• Method Validation
• Natural Products Synthesis
• Uv
• Asymmetric Synthesis
• Laboratory
• Nmr
• Medicinal Chemistry
• Heterocyclic Chemistry
• Formulation
• Biochemistry
• Click Chemistry
• Oncology
• Analytical Chemistry
• Metal Catalysed Organic Reactions
• Gc-Ms
• V&V
• Combinatorial Chemistry
• Peptides Synthesis
• Lcms, Gcms
• Spectroscopy
• Structure Elucidation
• Hplc
• Process Chemistry
• Ir
• Protein Chemistry
• Cmc