Kiran Pathade

Background

About Kiran Pathade

A competent professional and pharmacist with 10+ years of experience in the Pharmaceutical Industry and Healthcare, Global Program and Project Management, R&D Drug Development- Drug Discovery, Formulation and Process Development, Competitive Intelligence, Business Development, Market Research, and Consulting. Proven track record of developing a pharmaceutical product from non-clinical, clinical to commercialization, including successful contribution to preparing the regulatory dossier, CMC section for IND, NDA, and ANDA. Experience in the development of complex and branded solid orals (Tablet-IR & MR, Softgel and Hard Gelatin capsule) and topical (ophthalmic) formulation, providing technical, strategic, and regulatory inputs. Managing multiple projects from pre-clinical, clinical, NCEs, branded, and generic products. Providing strategic input in product selection, Developing project plans, and tracking of product development. Program management and coordination with multiple CRO/CDMOs across the globe to drive product development. Good technical and regulatory knowledge of key issues and current developments in the Pharmaceuticals at Regulated (US/EU/ROW market) and Healthcare Industry in India Well-acquainted with R&D portfolio and Project Management, Competitive Intelligence, Pipeline Assessment, Market Assessment and Forecasting, IMS Data Analysis, Syndicated Research, and Business Intelligence. Experience in Designing formulation (Defining QTPP, CQA) and Process Development as per QbD concept using DOE for oral solid products. Handling statistical data related to, pharmacokinetics (BA/BE studies), QbD analysis, and coordinating with manufacturing units in relation to statistical data collected during process scale-up batches. Specialties: Formulation Scientist, Project Management, Program Manager, PM, PMO, Program & Portfolio Management, R&D Drug Development, Business Development, Business Analytics