Dr. Kiran Avadhani M Pharm, Ph D
Head - Formulation R&D for Biologics Assistant General Manager @ Shilpa Biologicals Private Limited
About
Creative, dynamic professional with diverse expertise in product development including particulate drug delivery systems for various drug molecules, proteins/peptides and mAbs. Proven Lead scientist of various drug delivery research project teams on oral, periodontal, parenteral, cardiovascular, and transdermal delivery systems. Authored in 17 publications and 4 patents for topical drug delivery systems. Oversee the formulation process from preformulation to late stage process development activities, working with biologics including high concentration biosimilar mAb formulations for PFS, liquid injection and Lyophilized presentation with complete process development, CMC support and manufacturing support. Guide teams to perform right direction to move the molecules from development stage to clinic. Late stage formulation activities like Filter validation studies and conducting Extractable & Leachable studies for SUS and container closure system with CROs and CMOs. Addressing challenges associated with same by coordinating with CROs and CMOs. Identifying the gaps during technology transfer activities. Review of documents test results, specifications, and final formula procedures in a standard format for inclusion in the Master File Participates in the technology transfer from pilot scale to commercial manufacturing runs Identify right container closure and device studies include auto injectors and on body injector device. Ensure compliance with regulations for product development and combination of drug products with device as well. Effective interaction with cross functional teams include protein purification development, analytical service, quality assurance, CMC, engineering, bio- manufacturing, operations and regulatory to ensure smooth going process.
India
Bengaluru
Biotechnology
Pharmaceuticals, Regulatory Affairs, Validation, cGMP, Phamacology & Toxicology, Pharmacovigilance actvities, Drug Development, FDA, Drug Delivery, Biotechnology, Drug Safety, Formulation, CMC Regulatory Affairs, CMC development, Common Technical Document (CTD)
Experience
Head - Formulation R&D for Biologics Assistant General Manager
Shilpa Biologicals Private Limited
Dharwad
Head - Formulation R&D for Biologics Assistant General Manager
Ipca Laboratories Limited
India
Senior Manager - Formulation R & D Biologics
Kashiv BioSciences LLC
Ahmedabad, Gujarat, India
Associate Scientific Manager/Senior Research Scientist
Biocon/Biofusion therapeutics
Bengaluru Area, India
Product Development of Biosimilar and Novels mAbs
Research Scientist
Reliance Life Sciences Pvt. Ltd.
Navi Mumbai
Conceptualization of conventional and novel drug delivery systems Novelty search, intellectual property, patentability, and patent drafting experience Knowledge of commercial drug product development and overall pharmaceutical development by using specialized polymer systems. Peptide drug delivery through depot formulations Synthesis and processing of biodegradable polymers.
Executive - Pharmacovigilance
Ipca Laboratories Limited
Charkop, Kandivli(W), Mumbai
Collect the information of the case, reports are both spontaneous and clinical. Narrative writing on case to case studies. Identify duplicate/invalid cases or reports, enter basic data into the drug safety database or tracking, create manufactures control number and acknowledge receipt of case. Evaluate and finish processing of expeditable AEs, SAEs, non-expeditable AEs, SAEs reports, including review for completeness and accuracy of data Doing Single Case Assessment by assessing appropriate labeling documents for company and comparator products, reviewing medical sense of report along with checking labeling of events Use medical dictionaries (MedDRA) and business guidance's to code medical history, drugs, serious adverse event and adverse event terms coding into the global AE database i.e. ADVENT DATABASE Manage case-related information including interpretation of medical conditions, lab results, and procedures. Prepare narratives summarizing the essential details of the case. Preparing PSUR for countries like USA (USFDA), India (DCGI), Russia, Khazakistan, Belarus etc. licencing for product marketing. Handling Product quality complaints and investigation. Presenting respective SOP to related members in organization. Followed 23 SOPs according to US FDA.
Lecturer
Rani Chennamma college of Pharmacy
Belagavi
Teaching subjects with well exposed practical knowledge & other academic activities.
Education
Manipal Academy of Higher Education
Pharmaceutical Sciences
Controlled drug delivery, Peptide drug delivery and Topical drug delivery systems
Rajiv Gandhi University of Health Sciences
Pharmaceutical Sciences
Dr. Kiran Avadhani M Pharm, Ph D's Contact Information
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