Nikhil Rautela

• Currently lead commercial activities of USP Biologics in the EU, driving strategic growth and partnerships. • Previously led strategic technical and commercial activities of USP in UK, Ireland, Nordic countries and Sub-Saharan Africa to enhance best practices and utilization of standards.

• Engaged with industry, academia, and regulators to promote Reference and Documentary standards in Biopharmaceutical manufacturing. • Led science-driven strategies for mAbs, Advanced Therapies, Vaccines, and Peptides in the EMEA region.

• Managed the S. Korean subsidiary to partner with Pharma and IVD companies for product development and research. • Collaborated with Pharma and Biotech companies in iPSC cell lines and MSCs for drug and toxicology testing.

Through my own company- Copula Bioscience • Established partnerships with leading Biotech and Diagnostics companies for innovative projects in Immunotherapy and novel AE derived product development. • Acted as the bridge between academic research/start-up companies and the market in the biotechnology, medical device technology, and therapeutics field.

Responsible for white paper to Western Cape Govt. South Africa on business models for contract Research and Manufacturing Unit of Biologics & Biosimilars in South Africa

Designed research methodology and data analytics for responsible trade facilitation (rtf), independent project to make taverns in Western Cape more responsible.

- Developing capacity of in house R&D products (antigens and antibody) for the diagnostics industry by integrating target requirements with market. - Responsible for expanding product outreach through support of research and production activities of the diagnostics companies worldwide. - Part of the strategic partnering team to explore opportunities for collaboration with research institutes and companies for new biomarker discovery.

• Established the Flow cytometer system for enumerating P.berghei ANKA_gfp strain. • Contributed to developing an orthogonal 3H-Hypoxanthine incorporation assay for assessing drug specificity. • Developed various Biological assay methods in diff. Plasmodium strains and cell lines

• Developed assays to test compounds against Plasmodium falciparum in high throughput platforms. • Established and managed the malaria animal lab facility for testing selected compounds. • Studied post-drug effects on parasite recrudescence and compound pharmacodynamic properties.

• Studied the protein biology of Mycobacterium smegmatis and Mycobacterium tuberculosis during oxidative stress conditions. • Investigated the interaction of hypothetical conservative protein Rv0019 on GTPase activity and phosphorylation of cell division protein FtsZ. • Designed truncated constructs of PBP1 and PBP1* to study their role in peptidoglycan synthesis.