Hire Lakshmi Bhagat, a pharma consultant specializing in Clinical Studies and Drug Development. See services offered, experience summary, and connect via apicule.
Based in: U.S.A.
Willing to work in: Global
Consultant Type: Independent Consultant
Expertise summary: Lakshmi Bhagat, Ph.D., is an experienced scientific leader with more than 20 years of hands-on research and development experience across antisense oligonucleotides, siRNA, mRNA therapeutics, innate immune modulators, and other innovative drug modalities. Her expertise spans target identification, candidate screening, GLP toxicology, DMPK, safety pharmacology, translational biomarkers, PK/PD strategy, regulatory documentation, and clinical development through Phase 3. She has led cross-functional development programs, managed global CROs, designed nonclinical and translational studies, and contributed to IND, CTA, IMPD, and Investigator's Brochure submissions. Her experience also includes RNA delivery platforms such as GalNAc and LNP systems, mRNA formulation, biomarker and bioanalytical strategy, and regulatory interactions, enabling her to support biotechnology and pharmaceutical organizations across complex drug-development programs. - Show More
Lakshmi supports clinical development programs through extensive experience advancing therapeutic candidates from discovery and preclinical development into clinical studies. Her work has included translational strategy, biomarker development, PK/PD assessment, nonclinical-to-clinical transition planning, and support for programs progressing through Phase 1, Phase 2, and Phase 3 development. She can help organizations integrate scientific, translational, regulatory, and clinical considerations to support informed development decisions.
Lakshmi brings extensive experience in advanced therapeutic formulation and delivery technologies, particularly for RNA-based medicines. Her work includes mRNA and DNA co-formulation, lipid nanoparticle systems, GalNAc conjugates, hydrogels, nucleic-acid delivery platforms, and optimization of RNA therapeutic constructs. She can support organizations developing innovative formulations and delivery strategies for oligonucleotide and mRNA therapeutics, including evaluation of formulation performance, stability, delivery efficiency, and translational suitability.
Lakshmi provides study and protocol design support based on extensive experience developing preclinical, toxicology, safety pharmacology, DMPK, and translational study strategies. She has designed GLP toxicology protocols, contributed to an approved master protocol for individualized antisense oligonucleotide therapies, and supported study approaches for rare-disease and precision-medicine programs. Her experience enables her to assist organizations in developing scientifically robust protocols aligned with program objectives and regulatory requirements.
Lakshmi has substantial experience supporting regulatory submissions for innovative therapeutics. She has authored and reviewed nonclinical sections of INDs, CTAs, IMPDs, Investigator\'s Brochures, and related regulatory documents and has participated in interactions with regulatory authorities. Her experience in toxicology, pharmacology, DMPK, translational science, and RNA therapeutics enables her to support the preparation and scientific review of regulatory submission packages throughout drug development.
