Contact Information

Biography

Dr. Shyamala Ganesan is an accomplished immunologist and vaccine development leader with over 15 years of experience spanning academic research, biotechnology, and pharmaceutical industries. She holds a Ph.D. in Bio-Sciences from Birla Institute of Technology & Science, Pilani, and has built a career at the intersection of translational immunology and strategic R&D leadership. Dr. Ganesan has led end-to-end development of immunological assays and managed vaccine pipelines targeting infectious diseases such as RSV, HSV-2, COVID-19, and universal influenza. Her expertise includes functional, cellular, and molecular immunoassays, regulatory submissions, cGMP oversight, and cross-functional collaboration with CROs, CDMOs, and government agencies such as NIH/NIAID.

Over her career, Dr. Ganesan has held senior roles including Senior Director of Vaccine R&D at BlueWillow Biologics and Onconetix, where she led immunological initiatives from preclinical development to regulatory readiness. She has managed multi-site laboratory teams, developed novel immune monitoring strategies, and mentored diverse scientific teams. A published author of over 30 peer-reviewed articles, she is recognized for her deep scientific rigor and strategic acumen in vaccine innovation and immunology-driven R&D.

Education

  • Ph.D. in Bio-Sciences, Birla Institute of Technology & Science

Research Interests

Vaccine Development and Formulation

  • Design and development of vaccines against infectious diseases (e.g., HSV-2, RSV, COVID-19, Universal Flu, TB).
  • Formulation of recombinant proteins and adjuvants, including intranasal nanoemulsion

Immunological Assay Development

  • Development, optimization, and validation of immune assays including ELISA, ELISPOT, Luminex, and single-cell-based assays.
  • Functional immune profiling of vaccine candidates in both preclinical and clinical

Molecular and Cellular Immunology

  • Analysis of cytokine signaling, TLR pathways, and epithelial immune
  • Use of primary cell cultures, gene arrays, qPCR, and protein expression

Preclinical In Vivo Models

  • Development and use of animal models (e.g., COPD, HSV-2) to study vaccine efficacy and disease pathogenesis.
  • Integration of in vivo immune response data for vaccine mode-of-action

Regulatory and Translational Biotechnology

  • Preparation and review of pre-IND documentation, CMC sections, and regulatory submissions (IND/CTD).
  • Implementation of GLP, GMP, and ICH-compliant processes for assay development and manufacturing.

Collaborative Biotechnology Platforms

  • Cross-functional collaboration with CROs, CDMOs, and government agencies (e.g., NIH/NIAID) for pipeline advancement.

School

Publications

Dr. Shyamala Ganesan’s body of work reflects a dynamic and impactful career at the intersection of immunology, respiratory disease research, and vaccine innovation. Her more recent publications focus on the development and immunogenic profiling of intranasal vaccines, particularly nanoemulsion-adjuvanted S-2P formulations targeting SARS-CoV-2. These studies demonstrate robust systemic, mucosal, and cell-mediated immune responses in animal models, with promising protection outcomes in both mice and hamsters. Notably, her collaborative work has contributed to pioneering strategies combining intramuscular and intranasal vaccine administration for enhanced protection against COVID-19.

Earlier in her career, Dr. Ganesan conducted in-depth investigations into airway epithelial immune responses, exploring the roles of Toll-like receptor (TLR) signaling, IL-33 pathways, and EGFR-FoxO3A signaling in conditions such as rhinovirus infection and chronic obstructive pulmonary disease (COPD). Her research elucidated mechanisms of cytokine regulation, epithelial barrier dysfunction, and immune remodeling in the context of environmental exposures like cigarette smoke and bacterial infections.

Complementing her respiratory immunology focus, Dr. Ganesan also contributed to foundational virology work, developing molecular diagnostic tools such as nested RT-PCR for rubella virus detection and comparing PCR with ELISA techniques in congenital cataract cases, thereby strengthening clinical virology capabilities in earlier stages of her career.

Collectively, her publications showcase a trajectory of translational immunology expertise, from fundamental mechanisms of airway inflammation to the development of next-generation mucosal vaccines.

  1. Ganesan S, Acosta H, Brigolin et al. Intranasal nanoemulsion adjuvanted S-2P Vaccine demonstrates protection in hamsters and induces systemic, cell-mediated and mucosal immunity in mice. PLoS One. 2022 Nov 2; 17 (11):e0272594.
  2. Lin YJ, Lin MY, Chuang YS, Liu LT, Kuo TY, Chen C, Ganesan S, Fattom A, Bitko V, Lien Protection of hamsters challenged with SARS-CoV-2 after two doses of MVC- COV1901 vaccine followed by a single intranasal booster with nanoemulsion adjuvanted S-2P vaccine. Sci Rep. 2022 Jul 5;12(1):11369.
  3. Ganesan S, Pham D, Jing Y, Farazuddin M, Hudy MH, Unger B, Comstock AT, Proud D, Lauring AS, Sajjan US. TLR2 activation Limits Rhinovirus -Stimulated CXCL-10 by Attenuating IRAK-1 Dependent IL-33 Signaling in Human Bronchial Epithelial Cells. J Immunol. 2016 Sept 15; 197(6): 2409-20.
  4. Ganesan S, Comstock AT, Kinker B, Mancuso P, Beck JM, Sajjan US. Combined exposure to cigarette smoke and nontypeable Haemophilus influenzae drives development of a COPD phenotype in Respir Res. 2014 Feb 4;15(1):11.
  5. Ganesan S, Sajjan US. Repair and Remodeling of airway epithelium after injury in Chronic Obstructive Pulmonary Disease. Curr Respir Care Rep. 2013 Sep 1;2(3):10.
  6. Ganesan S, Comstock AT, Sajjan US. Barrier function of airway tract epithelium. Tissue Barriers. 2013 Oct 1;1(4):e24997
  7. Ganesan S, Unger BL, Comstock AT, Angel KA, Mancuso P, Martinez FJ, Sajjan US. Aberrantly activated EGFR contributes to enhanced IL-8 expression in COPD airways epithelial cells via regulation of nuclear FoxO3A. Thorax. 2013 Feb;68(2):131-41.
  8. Ganesan S, Faris AN, Comstock AT, Wang Q, Nanua S, Hershenson MB, Sajjan US. Quercetin inhibits rhinovirus replication in vitro and in vivo. Antiviral Res. 2012 Jun;94(3):258-71. doi: 10.1016/j.antiviral.2012.03.005. Epub 2012 Mar 23.
  9. Shyamala G, Sowmya P, Madhavan HN, Malathi Relative efficiency of polymerase chain reaction and enzyme-linked immunosorbant assay in determination of viral etiology in congenital cataract in infants. J Postgrad Med. 2008 Jan-Mar;54(1):17- 20.
  10. Shyamala G, Malathi J, Moses YS, Therese KL, Madhavan HN. Nested reverse transcription polymerase chain reaction for the detection of rubella virus in clinical specimens. Indian J Med Res. 2007 Jan;125(1):73-8.