https://www.geneostx.com/

Vice President of Research & Development, based at the Inovio San Diego Research Center. Provides the technical and strategic leadership for the R&D group including: preclinical development of cancer immunotherapy (Immuno-Oncology) and vaccine candidates, immunology and immune monitoring approaches, method development, product characterization, and analytical development.

Led a multidisciplinary group for the pre-clinical development of synthetic biologics, in partnership with collaborating companies, from discovery to IND submission in the following therapeutic areas:• Cancer immunotherapies, leveraging in situ expression of immuno-stimulators, immuno-modulators, antibody fragments and protein decoys for the treatment of melanoma, breast cancer and glioblastoma using various delivery modalities: cell-based via genetically modified DCs or MSCs; intra-muscular or intra-tumoral via injections of Adenoviral vectors and DNA plasmid constructs.• Fibroblast-based ex-vivo gene therapy for Recessive Dystrophic Epidermolysis Bullosa (Collagen 7 deficiency), and• AAV-based gene therapies for ocular diseases (AMD, uveitis, glaucoma).Duties encompassed the daily management of 3 teams with scientific, product development activities; define CMC strategies; manage CROs; generate progress and study reports to corporate partners and President of the division, and generate scientific abstracts and publications.Implemented compliance activities through a quality program, and generated related SOPs. Acquired several equipment to streamline processes while boosting data output and quality

Provided scientific leadership to discovery, preclinical, process and analytic assay development, and early clinical programs.Responsible for establishing company’s strategic R&D roadmap and to provide scientific input into company’s research and development programs in order to support the overall corporate strategy set by the Board of Directors.Maintained the highest quality of scientific foundations of the company’s development processes.Provided other members of senior management with continuous scientific input in the areas of clinical development, business development, financial planning and execution, regulatory matters, extramural funding processes and initiatives.Responsible for providing strategic inputs for the company’s mid- and long-term goals, from the scientific standpoint.Specific responsibilities in directing the discovery, preclinical and translational science programs were:• To provide overall scientific and operational leadership in identifying, evaluating and developing novel therapeutic development opportunities and candidates, progressing them into IND-enabling studies and then into proof of concept clinical trials in Humans.• To advance the company’s scientific and translational science leadership in lentiviral vector developments, including vaccines, and RNA trans-splicing based therapies.• To manage partnerships with academic institutions, monitor CROs and CMOs activities and keep open communication channel with regulatory authorities.• To co-manage the company’s patent estate.

Participated in corporate decisions for scientific pipeline and company strategic developments.Supported corporate efforts in fund raisings, presentations to strategic partners, including on-site due diligence meetings.Performed due diligence for the acquisition of Intronn, a RNA technology company, and managed the successful integration of Intronn’s personnel, assets and technology.Supervised phase 2 trial product development Operation including Quality Control and lentiviral vector manufacturing, patient T cell processing and post-infusion immuno-monitoring.Led business development efforts to secure key technologies for Lexgenleucel-T phase 2 and 3 clinical trials (IP licensing and supplier agreements).Contributed to secure the support of the AIDS Clinical Trial Group (NIH/NIAID) for Lexgenleucel-T phase 2b clinical trial.Initiated several collaborations to support the identification of Lexgenleucel-T mechanism of action with academic and corporate partners in the US and abroad.Established collaborative efforts (sponsored agreements, CRADA) with academic institutions related to lentiviral vector and RNA trans-splicing technology platform developments.Supervised developments for a diversified pipeline including HIV vaccine, Dyslipidemia (Apo A-I deficiency), Hemophilia A (Factor VIII deficiency) and induced pluripotent stem (iPS) cells generation:• Led HIV vaccine and Apo A-I gene therapy large non-human primate model preclinical studies, pre-IND meeting, and CMC strategy, including design of related identity, safety and potency assays.• Secured a Maryland Stem Cell Research Fund exploratory grant for the development of safe iPS generation methods with RNA trans-splicing and lentiviral vectors.

Led R&D, Process and Analytical Assay Development efforts including lentiviral vector design and vector production, large scale CD4+ T cell-based process developments for phase 2 trials and patient immuno-monitoring for phase I trial.First author on landmark PNAS paper (PMID 17090675) reporting first lentiviral vector modified adaptive T cell-based immunotherapy tested in HIV infected subjects, and PI of a NIAID SBIR phase 2 grant.Led a successful search for European CMOs related to Lexgenleucel-T phase 2 developments outside the US.Expanded company pipeline and implemented the transition from ex-vivo cell based gene therapy to in vivo direct injectable lentiviral vector based therapies, such as vaccines.

Led Lexgenleucel-T preclinical efforts for NIH RAC, FDA BRMAC and IND submissions.Developed large scale T cell transduction methods with lentiviral vectors and monitored technology transfer process to the University of Pennsylvania for Lexgenleucel-T phase 1 clinical trial.Designed and implemented Lexgenleucel-T phase 2 large scale cGMP cell processes: selected equipment for single use with regard to patient T cell purification, transduction, expansion, formulation, cryo-preservation and thawing.Developed key Quality Control analytical assays for lentiviral vector product and T cell product releases (potency, identity and safety). Authored related CMC sections.Generated key IP for large scale transduction and T cell ex-vivo manipulations.Led efforts establishing immuno-monitoring assays (ELISPOT, ICS) for patients treated with Lexgenleucel-T.Actively participated in the design of VIRxSYS’s cGMP cell processing facility.

Hired at the company inception. Created innovative methods for transduction of T cells, dendritic cells and hematopoietic stem cells with lentiviral vectors.Introduced several new technologies and humanized animal models to support early stage product developments.Performed the key IND-enabling animal model studies for Lexgenleucel-T with regard to characterization and anti-HIV replication potency.Worked on the preclinical development of P140K MGMT modified autologous hematopoietic stem cells for the treatment of glioblastoma.

Research focused on the characterization and tissue distribution of FIC1 (Familial Intrahepatic Cholestasis 1) protein.

Research focused on human fetal hematopoietic stem cell characterization for in utero transplantation.