Poonam Sonawane

·         Cross-Functional Management: Coordinate matrixed program management for advanced gene therapy assets, driving seamless alignment from preclinical IND-enabling stages through global clinical execution. ·         Strategic Collaboration: Partner with Clinical, Translational Science, Medical Affairs, Regulatory, CMC, and Quality to support and execute comprehensive asset development strategies. ·         Alliance & Sponsor Management: Support external operations and execution for sponsor programs and strategic alliances, helping manage day-to-day relationships with CROs, CDMOs, and external partners. ·         Program Coordination & Risk: Assist with portfolio tracking, manage program budgets, and track active risk-mitigation strategies to preserve critical paths. ·         Milestone Delivery: Drive team accountability to hit clinical data readouts and regulatory milestones, helping accelerate transformative therapies for rare disease populations.

• Lead and manage clinical development and translational (PK/PD) studies for HER2-targeted CAR myeloid cell-based Phase 1 clinical trials (CT-0508, CT-0525). Oversee the design and execution of immune profiling assays to evaluate safety correlates (serum cytokine monitoring), assess persistence and tissue trafficking through biopsies (ddPCR, RNAScope), and monitor immune cell recruitment and activation (TCR ImmunoSeq, Multiplex IHC). Conduct transcriptomic profiling at both the single-cell and tissue levels (RNAseq, 10X Genomics), alongside comprehensive genomic profiling (WES). • Develop biomarker panels to monitor patient responses throughout clinical trials, facilitating real-time assessments of therapeutic effectiveness. • Oversee and manage CROs conducting immuno-oncology correlative studies, ensuring efficient workflow, high-quality analysis of Phase 1 patient samples, and strict adherence to regulatory standards. Prepare contracts, monitor data quality, and ensure timely project completion. • Lead preparation of IND submission documents and regulatory filings for preclinical data, ensuring full regulatory compliance and seamless approval for clinical trial progression.

• Lead and manage projects for the pediatric brain tumor preclinical model development, targetable biomarkers identification and drug testing team. • Leading the projects in identifying co-occurring mutations/biomarkers by next generation sequencing along with the loss of NF1 (neurofibromatosis I) in pediatric low grade glioma tumors. • Developing pre-clinical models from pediatric tumor samples, characterization of tumor derived primary cell lines and design drug screening platforms using the Crispr Cas9 arrays for pediatric brain tumors. • Investigating the molecular mechanisms of gene fusions and identifying novel targets for treatment. • Understanding role of ACVR1 gene and identifying novel targets in patients with Diffuse Intrinsic Pontine Glioma. • Writing and managing scientific grants and manuscripts. • Developing molecular tool platform for gene editing and immortalization of primary tumor derived cell lines using Crispr/Cas9, lentivirus and retrovirus systems. • Training and providing scientific guidance to graduate students and technicians.

• Developed novel multi-compartment targeted antitumor immunotherapy using bispecific antibody drug conjugate (ADC) proteins against glioblastoma multiforme. • Developed unique immunotherapy approach using single bispecific antibody drug conjugates targeting four receptors ephrin Receptors A2, A3, B2 and Interleukin-13 Receptor Alpha 2 in glioblastoma multiforme. • Validated various antibody drug conjugate constructs for ephrin and interleukin 13 (IL13) receptors. • Protein expression using mammalian CHO cell line and insect SF9 line. • Developed methods for protein purification of toxin/drug conjugated and unconjugated antibodies using FPLC and verified the cytotoxicity of ADC constructs. • Managed manuscript writing and resubmission of NIH funded grants. • Trained graduate students.

• Performed SNP genotyping assays on neuroblastoma patient DNA samples examining various different alleles and SNP’s in samples and correlated them with 13-cis retinoic acid drug treatment outcome. • Developed and performed validation of HPLC methods for analyzing various anticancer drugs and compounds in GLP/cGLP compliant laboratory. • Worked with ~40 human tumor cell lines, performed and optimized in vitro cell based assays, western blotting, real time RT-PCR, qPCR and drug cytotoxicity assays. • Identified phase I and II metabolites of 13-cis retinoic acid (13-cRA) using inhibitors of drug metabolizing enzymes (e.g. CYP and UGT) and Mass Spectroscopy (LC/MS) and HPLC.

• Supervised manufacturing process of oral cough syrup and tablets according to FDA and GMP requirements. • Managed Batch Manufacturing Records (BMR). • Ensured proper weighing, mixing, portioning, and packaging of ingredients into containers.

• Applied Quality Assurance and Quality Control (QA/QC) techniques to production of oral liquids and tablets.