David Blackmon

Hardworking and competent Director with over 15 years of experience in cell & gene therapy, mRNA, and bi-specific antibodies. I with extensive knowledge in Translational, non-clinical, and clinical operations. Seasoned with assessing DMPK studies, biodistribution studies, and safety (ADA and ELISpot).

Strong analytical skills and communication skills to effectively manage projects, teams, and company initiatives.

Platforms: Flow cytometry, MSD, ddPCR, RNA-seq, ELISpot, cell-based assay, HPLC, MS.

Over 15 years of experience in the biotech industry with an emphasis in cell & gene therapy. Major focus on rare diseases, infectious disease, oncology, and neurological disorders. Indications: Hemophilia factor A and B, SMA, Rett syndrome, leukemia, solid tumors MPS-I &II, beta-thalassemia, sickle cell and HIV. Technology: CAR-T, gene therapy, miRNA, gene editing ZFN, Viral vectors (AAV & Lenti), LNP, oligonucleotides, bi-specific antibodies. Platforms; qPCR, digital PCR, nanostring, RNA-Seq, NGS, whole genome sequencing, ELISA, MSD, LC/MS, Western Blots, ELISpot, flow cytometry, and High Content Screening (HCS). Assay type: Potency, Vector copy number (VCN), Cell-based assay, multi-color FAC , ligand binding assay (PK, Nab, ADA); molecular-based assays (qPCR, digital PCR, nanostring, RNA-Seq). Managed PK/PD, biomarkers, and biodistributions assays development/qualification/validation to support toxicology, safety, and efficacy. Strong knowledge and understanding of FDA, EMA, and ICH regulatory guidance. Submitted over 10+ IND to move programs to the clinic. Submit regulatory filings and data analysis for pre-IND, IND, NDA, and BLA submissions. Managed in vivo experimental designs and test conditions based on knowledge gained through prior hands-on experience and/or review of relevant technical literature. Development and execution of experiments for inclusion in regulatory submissions, including safety pharmacology and toxicology (including genotoxicity) and bridging efficacy studies. Managed bioanalysis testing of non-GLP and GLP preclinical and clinical studies. Review clinical study protocols, reports, and bioanalysis data analysis/results. Ensure quality and rigor across nonclinical development programs both internally and at third parties. Provide oversight of sponsored research activities at academic partner laboratories. Excellent interpersonal communication and written skills for presentations, report writing, and day-to-day project team communications. Managed CROs/CDMO and external partners for bioanalytical method development/qualification/validation to support non-clinical studies and clinical studies. Knowledgeable in data analytics such as: JMP, GraphPad Prism, Snapgene, Python, R, Jupyter, and spotfire. Understands GLP and GMP practices to support non-clinical, clinical, and CMC. Excellent interpersonal communication and written skills for presentations, report writing, and day-to-day project team communications. Leadership experience in both project and people management. Strong knowledge in GxP regulations and regulatory guidance documents that apply to bioanalysis.