Program and Portfolio Management (Sandoz partnered and non-partnered biosimilars)

End-to-end program management (ideation to launch) of biosimilar portfolio, covering oncology, autoimmune and multiple other therapeutic areas. Act as central connect with various functions, such as R&D, Manufacturing, Quality, Marketing & BD, Commercial, Corporate Communications, SCM etc.Key achievements - Trastuzumab & Pegfilgrastim biosimilar approvals in the US & EU; development, submission and approval of Bevacizumab in India • Program Management - good understanding of biosimilar development – CMC, clinical, IP strategy, regulatory strategy (developed and emerging markets), launch strategy, manufacturing capacity planning etc.o Responsible to timeline, budget and scope management of Biocon’s entire biosimilar portfolio –  liaise with key stakeholders in R&D, Clinical, Regulatory, Mfg., Quality etc. to drive delivery of programs Preside over the monthly review meetingso Present portfolio updates to CMD, CEO, CFO, BU heads during quarterly reviews and other key meetings. Provide key inputs for board meetings•Portfolio expansion – played pivotal role in biosimilar portfolio expansion - identification & selection of molecules, providing key inputs for business case analysis etc. •Business development – led efforts related to in-licensing opportunities for biosimilar assets, especially development stage assets. •Commercial - training of sales force ahead of product launches; represent Biocon in various conferences and commercial platforms•Key vendor management – led efforts toward setting up Master Service Agreements, Consultancy Agreements etc. Acted as focal point for key vendor relation management•Corporate communications – provide key inputs for press releases; provide inputs for annual reports; quarterly input for CMD’s town-hall meeting•Event management - lead the presentation and proceedings in Business Unit (BU) town-hall meetings and other events organised by the BU

Prescient Healthcare Group (Prescient) is a speciality biopharmaceutical consultancy whose mission is to help clients develop products that deliver optimal outcomes for launch and beyond. Prescient's solutions are founded on clinical/medical, market access and disease area expertise underpinned by ‘best-in-class’ stakeholder and competitor insights. Partnering with Prescient enables clients to develop and communicate a product related value proposition that better resonates with the current and future needs of their customers. My role at Prescient entailed successful delivery of strategic business consulting services to the global top 20 pharmaceutical and biotech companies. Expertise and diverse experiences in pharmaceutical/biotech consulting and project management in areas such as biosimilars, oncology, CVMD, orphan diseases, autoimmune diseases etc. spanning across functions such as R&D, commercial and regulatory

Strategic consultant for the life sciences industry; providing services in wide range of functional and therapeutic areas such as biosimilars (including complex molecules such as mAbs and Cepts), oncology, CVMD, orphan diseases, autoimmune diseases etc spanning across functions such as R&D, commercial and regulatory- Market analysis- Disease area modeling and reviews - Product development and positioning - Life cycle management- Synthesizing research and data analytics in to strategic recommendations

Development of mAbs for research use: high throughput antibody development involving immunogen designing (full-length protein and peptide), LC and HC cloning, primary and secondary screening of potential candidates. Setting up molecular cloning lab, primary and secondary screening labsSetting up robotics lab for high throughput molecular cloning, cell biology and screening of potential antibody candidate

I worked on two projects focusing on building research tools based on microRNA Designing, development and validation of microRNA inhibitors Designing, development and validation of microRNA mimetics

Study of transcriptome in human colorectal cancer cells (HCT116) lacking DNA methylatransferase genes Effects of changes in DNA methylation on transcriptome of colorectal cancer cells. Effect of DNA methylation changes on expression of L1 retrotransposons and other transposable elements Effects of changes in DNA methylation on expression of Cancer-Testis (CT) genes, Tumor suppressor genes (TSG), imprinted genes and several other genomic elements and compartments Generated Serial Analysis of Gene Expression libraries, Microarray etc.

1) Receptor binding studies to screen Neuroblastoma cells (SK-N-MC) for various dopamine receptors2) Evaluation of effects of Oxidative stress on various cell lines3) Evaluation of SK-N-MC cells as model for screening neurotoxic agents

Business Development & Regulatory Affairs