TAHER SATHALIYA

Focus: Foudned a startup Scientific Cosulting company to provide expert scientific services for pre-clinical and clinical immunotherapy and immunology focused drug development focused on discovery and translational science and medicine areas. Manage complex projects from inception to completion, meeting milestones and delivering results within budget constraints utilizing inernal and external resources

Infixion Bioscience: 01/2023 - Now
Focus: Development of Neurofibromatosis Therapetuics

• Work with internal scientists and external clinical advisors to guide drug screening assay development and biomarker strategy to support drug development program targeting NF1 protein
• Review of science data to advice on discovery strategies
• Contributed to planning and writing of NIH biomarker discovery and development grant to define PD marker to measure activity of NF1 protein

SiRNAgen Therapeutics: 08/2023 - 03/2024

Focus: Proprietary RNAi technology based drug development

• Completed in depth research and analysis of Pulmonary Fibrosis pre-clinical and clinical drug development landscpe to guide the company in target prioritization
• Conducted a through literature review and designed a pre-clinical and proof of concenpt biomarker study plan
• Presented a poster at a major confernece and established KOL relationships in Pulmonary Fibrosis field
• Conducted comprehensive literature reviews, providing valuable insights for indication prioritiztion targeting NF-kb and Inflammasome pathways for selected autoimmune diseases

Eurofins-Viracor Biopharma CRO: 02/2023 - 07/2023

Focus: Flowcytometry based bioanalytical assay development to support immunotherapy and immunology drug development

• Project and technical lead to design, execute and implement Flowcytometry based validated live cell assays and train junior scientists
• Designed and developed validated multiparameter T cell immune-phenotyping assay for conventional and spectral flow cytometer platforms
• Workd with regulatroy teams to define the regulatory parameters and developed a protocol
• Worked closely with business development unit as scientific liaison to define client SOW and costing parameters.

Focus: Biomarker/Bioanalytical Lead on projects to develop large molecule for the treatment of chronic kidney diseases

• Biomarker Lead for Phase 1, Phase 2a and Phase 3 clinical trial studies to develop anti-APRIL antibody therapy for the treatment of IgA nephropathy
• Strategic planning and execution of biomarker project to develop PK/PD data utilizing bioanalytical methods resulting in optimal dose prediction for anti-APRIL antibody based on the role of APRIL in B cell biology and impact on various immunoglobulin productions
• Identified, vetted, and set up new GLP CRO and managed existing once to generate biomarker data using ELISA, MSD, Simple Plex, RNAseq and Flow Cytometry platforms
• Established cross functional collaboration with internal research and discovery, bioinformatics and data analysis teams to support translational science efforts
• Executed and managed contracts and budgets of biomarker projects.

Focus: Translational Science/Biomarker lead for ImmunoDermatology projects

• Developed actionable science, translational science, and biomarker strategies to define target occupancy, MOA and drug and disease related PD biomarkers to correlate efficacy with clinical outcome as biomarker lead as part of cross functional clinical development team for Phase 2a clinical trial to develop anti-NKG2D antibody therapy for treatment of Alopecia Areata, Phase 2b study to develop ani-IL1a antibody therapy for treatment of Hidradenitis Suppurativa, Phase 3 study to develop anti-FcRn antibody therapy for antibody mediated skin blistering disease
• Authored actionable science and biomarker sections on company and regulatory drug development documents, and presented them to different governance meetings
• Developed flowcytometry and ELISA based receptor/target occupancy assay to measure free and bound drugs for anti-NKG2D, anti-IL1a and anti-FcRn therapeutics
• Worked with internal scientists and central lab to measure cytokine and cellular changes to define PD biomarkers and prepared reports to submit for the regulatory documents
• Collaborated with computational and bioinformatics team to analyze and interpret big data generated from RNAseq, flow cytometry, and multiplex cytokine experiments using human samples from clinical trials
• Served as a translational science expert on due diligence teams to acquire assets for the treatment of immunodermatological diseases
• Executed and managed contracts and budgets of biomarker projects.

Focus: an early stage startup company to develop off the shelf cell therapy

• Designed and executed lab experiments to develop genetic engineering tools to generate immune-compatible mesenchymal stem cell line for the development of NK-CAR cellular therapies
• Authored SBRI grant proposal on off the shelf NK-CAR cellular immunotherapy approach for multiple myeloma
• Trained and managed one lab scientist and technical to execute molecular cloning, cell line transformation, selection, development and maintenance experiments
• Successfully developed research grade NK-CAR targeting CD33 from modified mesenchymal stem cell line

Focus: Translational Medicine/Biomarker Lead for the development of CAR-T cell therapy for hematological malignancy

• Lead a team of two Research Scientists for assay development and biomarker discovery to support lymphoma and multiple myeloma clinical trial programs
• Authored translational science section on clinical trial protocol and worked closely with medical director and cross-functional clinical development team to develop lab manual and sample collection plans
• Defined Multiplex IHC and Next-generation sequencing strategies and initiated method development contracts with external vendors and academic partners to define biomarkers of PD and response vs non-response
• Successfully developed Quantitative PCR and Flowcytometry based assays to detect CAR-T cells in patient samples and transferred the assay to external vendor for utilization in phase 2b clinical trial
• Developed functional mouse anti-CD19 CAR anti-id antibodies which is patented by Juno
• Worked along side clinical team to study neurotoxicity in CAR-T cells treated patients; devised a plan to perform proteomic analysis on CSF and serum samples
• Executed and managed contracts and budgets for biomarker projects.

Focus: Experimental study lead to design and execute human blood and tumor-based assay development to select lead antibody drug candidates and understand the mechanism of action

• Characterized TIL from anti-PD1 (Pembrolizumab) antibody treated patients renal cell carcinoma clinical trial samples and applied in vitro functional assays to define MOA
• Developed primary cell-based functional assays (MLR, anti-CD3 and CD8+ T cell assay) for characterization of humanized antibody drug candidates for immunotherapy application, anti-TIGIT, anti-TIM3 and anti-GITR
• Established expression of targets (PD1, PDL1, TIGIT, TIM3) in the blood of healthy donors and cancer patients using multi-color flow cytometry to support PK/PD modeling and dosing.

Focus: Development of humanized anti-VISTA antibody for cancer immunotherapy to target the VISTA negative checkpoint regulator pathway for immunotherapy and VISTA-Fc fusion protein for autoimmune diseases

• Developed cell based in vitro assays (human Mixed Lymphocyte Reaction, antigen specific and anti-CD3 T cell proliferation) to screen anti-VISTA antibodies, resulting in the identification of lead drug candidates which went into clinical trial
• Designed and executed T-cell line based functional assay to develop 'drug release assay'
• Performed multi-color flow cytometry analysis to characterize the expression of VISTA in immune cells of both healthy volunteers and cancer patients to help predict First-In Human dose
• Worked with cancer biology team to investigate anti-VISTA antibody immunotherapeutic Mechanism of Action in mouse models (B16 melanoma, CT26 colon, and MB49 bladder tumor lines)
• Carried out in vivo efficacy of VISTA-Fc in pre-clinical mouse autoimmune disease models of EAE, Lupus and RA to develop immunosuppressive therapy.

Focus: Lead human immunology project to establish healthy baseline immunity against which immune deregulation can be measured

• Developed a fifteen-color flow cytometry assay to characterize human NK, T, B, and Dendritic cells
• Used anti-CD3 and intracellular cytokine assay for functional studies
• Initiated collaborative projects to study microbiome and mucosal immune cells in human colon samples
• The project resulted in identification of tissue-resident human memory T cell marker and delineated immune system compartmentalization
• This resulted in key pulications in major scientific journals and academic collaborations

Focus: Study of Dendritic cell development and function using DC-specific gene knock-out mouse model

• Conceptualized a project to define a signaling pathway downstream of the FLT3 receptor which resulted in the elucidation of the Pi3 kinase/Akt/mTOR/S6 pathway activation
• Developed PTEN/CD11c-cre, PTEN/ER-cre and GFP knockout and transgenic mice for the study
• DC functions were studied using in vitro cell culture, in vitro and in vivo T cell activation and proliferation and mouse Listeria infection model
• This resulted in an immunity publication defining role of PTEN in CD8+ DC development via Flt3 pathway.

Focus: Development of in-vitro phage display system to construct multi-component vaccines

• Designed recombinant Phage-HIV proteins to display on the phage capsid surface to construct a novel multicomponent HIV vaccine to elicit stronger antibody and cell-mediated immune responses
• Gained expertise in recombinant DNA technology, protein expression, and purification systems
• Used molecular and structural biology techniques in collaboration with other academic groups to define the minimum capsid binding domain and design stable vaccine epitopes