Basel Assaf

● Develop and implement strategic plans for nonclinical pathology and toxicology support across stages of drug development. ● Manage and provide scientific leadership to histology laboratory, pathologists, and toxicologists. ● Acting as PI, Study Director, and\or Management Representative on protocols and reports to support study design and execution. ● Oversea Pathology and Toxicology budget and ensure efficient resource allocation. ● Ensure regulatory and operational excellence and compliance according SOPs and regulatory guidelines. ● Act as a subject matter expert in pathology and toxicology providing key strategy and analysis cross-functionally. ● Manage client relationships and studies from concept through interpretation to delivery of study results. ● Support Cell and Gene therapy end–to–end service offerings including partnering with potential clients and consulting services.

Oversee Preclinical Safety support for the Genomic Medicine Unit (GMU). Serve as Preclinical Safety Representative on the GMU governance committee for the review and management of the gene therapy portfolio. Develop the nonclinical safety strategy and program for GMU. Serve as project team representative on multi-disciplinary Discovery and Development teams. Coordinate other Preclinical Safety scientists serving on these project teams. Participate in issue-resolution teams and contribute to hypotheses generation to drive the science for toxicology issue resolution in drug discovery and development. Support the diverse activities of Discovery and Toxicologic Pathologist.

Continuing to support Pfizer's Drug Safety Research and Development Department pathology needs of the Inflammation and Immunology, Internal Medicine, Gene Therapy, RNA modulation, and Rare Disease research units as well as the Centers for Therapeutic Innovation, and to contribute to Pfizer’s global pathology needs. Subject-matter expert in safety assessment of AAV-based gene therapy with thorough knowledge of international regulatory landscape and experience from early discovery and the design and interpretation of efficacy studies to the execution of non-GLP exploratory and IND-enabling GLP toxicology studies. As a primary or peer review pathologist, responsibilities include designing and interpreting safety studies of small and large molecules in rodent and non-rodent species, non-GLP short term signal generations studies and subsequent GLP studies, providing support for characterization of animal models and their relevance to human disease, characterizing the expression of therapeutic targets in animal and human tissue.

Early career stage Veterinary Pathologist in Drug Safety Research and Development Department to support the pathology needs of the Immunoscience and Rare Disease research units as well as the Centers for Therapeutic Innovation, and to contribute to Pfizer’s global pathology needs. As a primary or peer review pathologist, responsibilities include designing and interpreting safety studies of small and large molecules in rodent and non-rodent species, non-GLP short term signal generations studies, providing support for characterization of animal models and their relevance to human disease, characterizing the expression of therapeutic targets in animal and human tissue.

Oregon National Primate Research Center, Vaccine and Gene Therapy Institute, OHSU This position serves multiple pathologist, research, clinical, and managerial capacities within the Infectious Disease Resource (IDR) as a resource for nonhuman primate (NHP) biology and the pathobiology of infectious diseases in NHPs. The main focus is the characterization of spontaneous and research-derived infectious diseases, contributing to biological and image databases, and publication and participation in teaching and presentations. In this position I assist in the plan and coordination of NHP infectious disease studies with the various centers and principle investigators collaborating with ONPRC, formulate budgets for NHP studies and participate in writing portion of grants germane to performing NHP studies; prepare and maintain IACUC and Institutional Biosafety protocol for NHP studies; prepare ONPRC Division of Comparative Medicine (DCM) Animal Planning and Animal Assignment forms; coordinate grant support for NHP research protocols hosted by IDR; supervise technical staff; provide training for IDR and DCM technical staff; and provide technical expertise for clinical procedures and necropsies.

This fellowship is composed of a joint appointment at the Center for Biologics Evaluation and Research (CBER) and the Center for Veterinary Medicine (CVM). Through this fellowship, I will be conducting a regulatory project focusing on advancing the design and evaluation of biodistribution study for viral vector-based gene therapy products.Additionally, I will practice the regulatory review process of biologics Investigational New Drug (IND) and other regulatory submissions for cell and gene therapy products in the Office of Cellular, Tissue, and Gene Therapies (OCTGT) at CBER and in the Office of New Animal Drug Evaluation (ONADE) at CVM. I'm additionally consulting and advising in analysis of histopathology reports of various preclinical studies.At the same time, I'm maintaining my veterinary anatomic pathology experience through participation in the Joint Pathology Center (JPC) activities (Professional Development Activity).

This position is composed of two major elements. First element is developing advanced skills in morbid gross pathology and histopathology culminating in eligibility requirements of the American College of Veterinary Pathology board certification. The second element is carrying out hypothesis-driven research project in the field of experimental pathology. My current project involves characterizing the natural history of rhesus cytomegalovirus infection in the natural host, in addition to characterizing other spontaneous diseases of non-human primates.

Characterizing pathological correlates of differential cellular tropism of cytomegalovirus infection in the rhesus macaque non-human primate model. Dissertation title: "The Role of Cell-Specific Tropism in the Pathogenesis of Rhesus Cytomegalovirus Infection."

Working on multiple projects in the virology and immunology of non-human primate models of Measles and HIV/AIDS. Getting in touch with recent research findings and acquiring various techniques in virology and cellular immunology, including but not limited to: blood processing, cell culture, TCID50, IFA, MLR, cell depletion and PBMC fractionation, chromium-release assay, T-cell proliferation assay, flow cytometric analysis, pulsed-DC vaccination, and basic molecular techniques of PCR, DNA purification, cell transfection, and plasmid construction.

Studying the molecular pathobiology and mechanism of Amyotrophic Lateral Sclerosis and Multiple Sclerosis diseases. Performing both In vivo and In vitro studies on different transgenic mouse models and cell cultures of primary cortical neuronal and spleen lymphocytes. Technical experience includes (but not limited to) DNA extraction and genotyping, PCR and RT-PCR, Proliferation assays, Western Blotting, LDH and Bradford assays, Clinical scoring of animals, Drug dosing and injections. Data collection and analysis, Cell Culturing, Histopathology tissue preparation (paraffin embeddings) and Immunohistochemistry. General lab maintenance, supplies ordering and organizing.

Performed general technical procedures: physical examination (pulse rate, heart rate, respiratory rate, and temperature), draw blood, drug and vaccine administration, catheter placement, and animal restraint. During this time I was also exposed to loads of small animal cases and observed many surgical procedures, including neutering, spaying, declawing, crutiate ligament fixation, and tumor excision.

New England Primate Research Center