Divya Mekala (M.Sc, Ph.D) Email & Phone Number

Lansdale, PA, US

Suzhou, China, And Rockville, Maryland, United States, CN

Biomarker Program ManagementClinical ScienceTranslational MedicineClinical Biomarker

Princeton, New Jersey, US

Raritan, New Jersey, US

Immunotherapy, Preclinical & Early Clinical Drug Development Translational Biomarker, Safety markers Immunotoxicity & Investigative Toxicology FIH dosing Regulatory contributions Oncology & Inflammation Indications - Large Therapeutic (Biologics) MoleculesManaged direct reports & cross functional scientists

Raritan, New Jersey, US

• Led novel (FcRn, Fc-multimers, sIVIG, Heparin Sulphate) & Follow on-biologics discovery & development programs
• Oncology & inflammatory indications.
• Translational biomarkers of disease and treatment & Pharmacology
• MOA, RO, PK/PD, ADA, Biodistribution, immunogenicity and safety (ICH S6 & S8 based), FIH dose studies
• Successful collaboration across the functional teams, multiple CROs and academic research organizations.
• Immunobiology leader, Managed & trained multiple direct & indirect reports

Cambridge, MA, US

• Lead Biologist in CD200-Fc Program & supported anti-Tweak program
• Successfully led development of robust and sensitive bioassays for drug candidate and defined the biomarker for disease and efficacy.
• Proposed and led in vivo and ex-vivo efficacy and anti-inflammatory analysis of novel antibody-based therapy in arthritis and multiple sclerosis models
• Managed development of critical assays to establish MOA of drug to generate POC for the drug candidate
• Directed estimation and analysis of PK/PD and immunogenicity of novel drug candidate.
• Managed direct report and supervised /trained intern & junior staff members.

Boston, MA, US

• Coordinated and successfully performed grant research focused on in vivo and in vitro modeling of molecular pathways of thromboheamorrhagic vasculitis and immune complex/complement mediated reactions.
• Defined the role of Mac-1, complement and signaling molecules in vasculitis models.
• Designed and established studies leading to new definition of the role of signaling molecules src, syk Rac-1, Dap12 and Vav during Mac-1, immune complex and complement-mediated reaction in neutrophils and macrophages.
• Led development of transgenic mice for mutant mouse CD11b and human CD18.
• Guided and trained junior research scholars and colleagues.
• Presented data and attended international meetings.

Memphis, TN, US

• Led development and mechanistic investigation of antigen-specific CAR T cell therapy for multiple sclerosis (MS) and NonHodgkin’s lymphoma (NHL).
• Breakthrough assessment of in vitro and in vivo models to define CAR-T cell therapeutic mechanism & investigated the PD biomarkers.
• Substantial contribution to emerging knowledge of the mechanism and signal transduction pathways biomarkers involved in inflammatory T cells, anergic or suppressive T-reg cells' nature.
• Trained and guided junior post-docs, students, and laboratory technicians in correct assay procedures and disease models.
• Served as lead author on numerous articles published in peer-reviewed journals and presented research findings internally and at international conferences.

Bangalore, Karnataka, IN

• Defined mechanisms of tumor development and spontaneous regression in in vivo tumor models mediated through ADCC.
• Designed and applied targeted molecular and cellular assays to evaluate apoptosis, cell death, and role of nitric oxide synthases in effector function of macrophages and natural killer cells during tumor regression.
• Led development of bioassays to define the role of different molecules associated with effector functions of macrophages and NK cells.
• Discovered therapeutic application of Curcumin longa in treatment of tumors.
• Observed and described role of cell adhesion molecules (LFA-1 and ICAM-1), CD40-CD40L, Fas-FasL pathways during tumor regression.
• Characterized & defined the role of CD28-B7, ROS and RNS in the spontaneous regression of tumors.

• Developed secretory protein vaccine from M. habana and evaluated the protective response of the vaccine against tuberculosis in mice. Gamma irradiated M. habana was in clinical trial to use as an alternative for BCG.
• Played key role in successfully developing and purifying polyclonal and monoclonal antibodies in support of novel serodiagnosis of tuberculosis patients.
• Designed & directed development of novel ELISA, immunoblot and cell based assays for diagnosis of tuberculosis patients.
• Established, developed and validated development of precise assays to determine macrophage and T cell function after the vaccination.
• Managed & trained lab technicians and undergraduate assistants in correct mycobacterial techniques.

Bachelor’S Degree, Regulatory Affairs & Fda Compliance- Biologics

Medical Research Management

B.S, Biology, Chemistry

Ph.D, Microbial Immunology

M.S, Applied Microbiology