Lakshmanan Thiruneelakantapillai

As Head of PK, Bioanalysis, and Preclinical Safety at Alltrna, leading the nonclinical development of the company's engineered tRNA therapeutics formulated in lipid nanoparticles for the treatment of premature stop codon diseases. Defined the strategic direction for DMPK, bioanalysis, preclinical safety, and translational development, and drove AP003 — Alltrna's lead candidate — from preclinical studies through IND filing and into first-in-human trials. Oversaw all ADME, PK, and GLP toxicology studies, managed CRO partnerships, and collaborated cross-functionally with Discovery, CMC, Regulatory, and Clinical Development teams to advance the program.

As Vice President at Orna Therapeutics, led the preclinical and clinical bioanalytical strategy for Orna's circular RNA portfolio, including panCAR® drugs in LNP formulation — advancing from early discovery through GLP toxicology to first-in-human readiness. Built and led a cross-functional team of 18 scientists spanning bioanalysis, translational science, and toxicology, serving as the strategic bridge between Research, Preclinical, and Clinical Development. Managed an annual budget exceeding $5M and oversaw CRO partnerships for LC-MS/MS, flow cytometry, qPCR, and ligand-binding assays across IND-enabling programs.

At Xilio Therapeutics, led research, process analytics, and bioanalytical strategy for a portfolio of masked tumor-activated cytokine therapeutics. Successfully transitioned three cytokine-based programs from early discovery through preclinical development to first-in-human trials for solid tumors, delivering all milestones on schedule. Managed a five-member analytical sciences team, oversaw CRO partnerships for GLP toxicology studies, and authored nonclinical and bioanalytical sections for global regulatory submissions.

Ra Pharma acquired by UCB At Ra Pharma, defined the end-to-end bioanalytical strategy for the company's macrocyclic peptide pipeline and served as global nonclinical lead for Zilucoplan® — which received FDA approval for generalized myasthenia gravis (gMG) in 2023. Designed and oversaw preclinical and clinical bioanalytical development across all programs, authored nonclinical and bioanalytical sections for worldwide regulatory submissions, and guided health authority interactions as the subject matter expert for bioanalytical sciences. Collaborated closely with chemists, biologists, toxicologists, and clinical teams to align strategy and accelerate timelines.

Head of Bioanalytical Development responsible for developing and implementing the overall bioanalytical strategy to support the entire Ra pipeline of macrocyclic peptides and NCEs•

Over seven years at Momenta Pharmaceuticals, progressed from Principal Scientist to Director, building and leading the preclinical bioanalysis and biomarker development function for seven biosimilar programs spanning monoclonal antibodies and fusion proteins. Directed in vitro and in vivo pharmacology teams delivering molecular, cell-based, and serum biomarker assays supporting functional comparability assessments. Contributed to the biosimilar development of an adalimumab program and authored regulatory sections for INDs, CTAs, BLAs, and MAAs. Represented research in FDA interactions and served as research lead on joint project teams with Baxter, Shire, and Mylan. Hired, developed, and managed a team of ten scientists.

At Virdante, directed a joint research program with the scientific founder's laboratory to elucidate the IgG Fc sialylation mechanism, advancing the sialic-switch model and strengthening the scientific rationale for next-generation anti-inflammatory biologics. Generated process development insights for fusion proteins and monoclonal antibodies, and contributed to intellectual property through invention disclosures and patent applications in glycoengineering.

In my early career at Momenta, designed and executed studies examining how upstream process conditions influence glycoprotein quality attributes in mammalian cell systems, generating data that informed CMC process development strategies for biologics programs.

Conducted postdoctoral research in protein engineering and chemical biology, including expressed protein ligation of cMyc with post-translational modifications, synthesis and characterization of glycopeptides and phosphopeptides, and expression, purification, and kinetic studies of O-GlcNAc transferase (OGT).