Gaurav Kumar Gulati

About Gaurav Kumar Gulati

I am a pharmaceutical scientist with 15+ years of experience advancing nanoformulations, RNA vaccines, and immune-based therapeutics from discovery through IND-enabling development and early clinical translation. My work has supported progression of LION/repRNA vaccine platforms, LNP-based HIV therapeutics (TLC-ART), and PLGA nanoparticle systems into Phase I clinical evaluation, with a focus on immunology, preclinical pharmacology, and translational development. Earlier in my career, I also developed antibody-conjugate–based point-of-care diagnostic systems and preclinical electronic skin patches delivery platforms.My expertise spans preclinical pharmacology, immunology, and formulation/CMC strategy. I have designed and executed biodistribution, pharmacology, and immunological studies integrating PK analysis and immune profiling to guide development decisions. This includes evaluation of adjuvant-loaded LION formulations in murine tumor models such as E0771 (triple-negative breast cancer) and CT-2A (glioblastoma), assessing survival outcomes, antigen-specific CD4⁺/CD8⁺ T-cell responses, and cytokine profiles. I have led formulation optimization, CQA identification, analytical assay development, and process scale-up for LNP and LION platforms, supporting tech transfer to CDMOs and regulatory readiness. I also led an IND-enabling biodistribution program for an RNA vaccine platform at HDT Bio, preparing regulatory reports, and responding to FDA queries. I am motivated by developing translational strategies that connect product quality, immune response, and in vivo performance to advance next-generation immunotherapies, including cancer vaccines and cell-based therapies, toward clinical impact.

Experience

1. Scientist-ii

   Hdt Bio

   Feb 2023 — Present · Seattle, WA, US

   Currently at HDT Bio, I develop RNA vaccine formulations, conduct immunological assays, and perform animal studies.Manufacturing: I create lab-to-clinic scale formulation batches of our LION (o/w emulsion) formulation, transfer technology to CROs and CDMOs, develop CQAs, and prepare for clinical trials. I develop LNP and PLGA-based formulations for efficient delivery of the repRNA vaccine across various routes (ID, IM, IN, IV), encapsulating small molecules and adjuvants in nanoformulations for immunogenicity studies and quantification by HPLC.In vitro: I conduct functional assays to evaluate the potency of the repRNA vaccine in mammalian cell lines and primary cultures. I have proficiency in in vitro immunological assays (flow cytometry, cytokine release, cytotoxicity), reporter assays (SEAP, nLuc, GFP), RNA-seq data analysis, RT-qPCR for RNA quantification, and HPLC-MS/MS for bioanalytical validation of small molecules.In vivo: I administer the repRNA vaccine to mice to assess antigen expression and immunogenicity. I am the first author and corresponding author of a paper on the lyophilized LION/repRNA platform published in JCR 2024, with two additional papers under review. I conducted IND-enabling biodistribution studies of LION/repRNA vaccine to quantify our formulation and RNA construct in mouse organs using RT-qPCR and HPLC. Additionally, I collaborated with the FDA on validation and quantification of repRNA and the LION formulation. I perform animal immunogenicity studies to evaluate T and B cell responses through ELISA and ELISPOT analyses. I conducted animal PK/PD studies and evaluated kinetic parameters using Excel, Phoenix, and Simcyp.Management and Leadership Skills: I lead one direct report and several indirect reports. I collaborate with colleagues to write grants and publish papers and work with regulatory teams on assay validation and quantification.

Education

• Postgraduate Institute of Medical Education and Research (PGIMER), Chandigarh

  Doctor of Philosophy - PhD, Pharmacology and Pharmaceutical Sciences

• Postgraduate Institute of Medical Education and Research (PGIMER), Chandigarh

  Doctor of Philosophy (PhD), Department of Pharmacology; Field: Pharmaceutical Sciences, Title: Development, Pharmacokinetic and Toxicology of anti-tubercular drug-loaded PLGA nanoparticles

  2006

• Sardar Bhagwan Singh (PG) Institute of Biomedical Sciences and Research; Dehradun, India

  Bachelor of Pharmacy (B.Pharm.)

  1997 — 2001

• Postgraduate Institute of Medical Education and Research (PGIMER), Chandigarh

  M S Pharmacology, Department of Pharmacology; Title of Dissertation:, Effects of NSAIDs in Combination with Paracetamol on Gastrotoxicity and Renal Toxicity in Rats.

  2003 — 2006

Skills

• Smartphone App Framework Based on Clinical Stratergies for Smoking Cessation Treatment
• Cell Biology
• Elisa
• Molecular Biology
• Fluorescence Microscopy
• Hplc - Ms/Ms
• Biochemistry
• Electrochemistry
• Enzymatic Assay
• Phamacokinetic Studies
• Langendorff Experiments
• Pcr
• Hplc
• Medical Device Desiging
• Western Blotting
• Drug Delivery
• Life Sciences
• Characterization
• Cell
• Nanotechnology
• Cell Culture
• Nanoformulation
• Toxicological Studies