Mark Orr Email & Phone Number

Seattle, Wa, Us

Seattle, Washington, United States

Seattle, Washington, United States

Played a crucial role as a core member for six early development project teams for immune cell engager platforms responsible for translational biology and collaborating with leaders from early development project leadership, early clinical development, project management, regulatory, competitive intelligence, commercial and other functions to deliver program progress through clinical proof of concept. Key responsibilities included representing programs at development decision making by the Research and Early Development Operating Committee to advance programs from development candidate nomination to early clinical development and full clinical development.- Provided NK cell and translational research subject matter expertise for external collaboration with Century Therapeutics for the development of iPSC derived CAR NK and T cell therapies for hematologic malignancies identifying key benchmarks of activity and minimal and optimal target product profiles- Directed senior scientists to demonstrate the relationship between receptor occupancy of an innate checkpoint inhibitor and enhanced tumor clearance which justified the choice of a recommended phase 2 dose for clinical safety and efficacy testing- Strategized the development of BMS next-generation T cell engager strategy as a core team member resulting in a prioritized set of new discovery programs to expand the T cell engager platform- Contributed to several Search and Evaluation groups including the Cell Therapy Search and Evaluation Triage Team and Solid Tumor Engager Working Group providing immuno-oncology subject matter expertise for opportunity analysis and preparing triage recommendations- Sponsored academic research at the Fred Hutchinson Cancer Research Center that identified key factors of activity and efficacy of a clinical stage NK cell engager in AML which were presented at the 2024 meeting of the American Society of Hematology and a manuscript in submission

Seattle, Washington, United States

Managed a translational research team of six scientists and senior scientists to develop new combination therapies, identification of novel mechanisms of action, and selection of new indications for early development hematology and oncology biologics including bi- and tri-specific antibodies, including NK cell engagers, T cell engagers, innate immune checkpoint inhibitors, and antibody drug conjugates.- Led research team to identify potentially efficacious doses and therapeutic index that was used to justify the starting dose for clinical dose escalation studies for NK cell engagers to the FDA and European Health Authorities- Identified promising drug combinations to enhance activity of early clinical stage assets supporting clinical development plans of an NK cell engager platform and an innate immune checkpoint inhibitor- Authored non-clinical pharmacology pre-IND questions to FDA, IND sections 2.6.1, 2.6.2, and 2.6.3, clinical protocol asset background and mechanism of action, and Investigator’s Brochure non-clinical pharmacology content resulting in three IND approvals- Led biology review of program opt-in decisions of partnership with Dragonfly Therapeutics making recommendation for three NK engager tri-specific program opt-in decisions including both Accept and Reject recommendations to senior decision-makers- Identified a novel mechanism of action of an innate immune checkpoint inhibitor which supported entering into a new disease indication and identified a standard of care treatment that further augmented the activity of the checkpoint inhibitor for early combination studies- Recognized as BMS Seattle Culture Champion using a data-driven, leader-led approach to improve site-wide culture, collaboration, and morale

Seattle

- Authored non-clinical pharmacology pre-IND questions to FDA, IND sections 2.6.1, 2.6.2, and 2.6.3, clinical protocol asset background and mechanism of action, and Investigator’s Brochure non-clinical pharmacology content- Directed contract research organization work to demonstrate activity of lead development candidates in patient bone marrow aspirates which supported a successful IND filing- Led research team to clearly demonstrate mechanistic differences in an internal TIM-3 asset and sabatolimab that informed a no-go decision to move into a new indication, saving the company at least $10 million in development costs- Trained co-workers in the BMS PRIDE Alliance Safe Zone program, leading 10+ trainings developing a more inclusive and welcoming work environment

Seattle, Wa

Taught course on vaccine adjuvants. Conducted lectures on infectious diseases affecting global health.- Served as a member of the Student Affairs Committee- Mentored students as a member of the Graduate Student Thesis Committee

Greater Seattle Area

Biomarker lead for first-in-class NK cell engager in AML responsible for identifying key biomarkers and assessments to inform clinical development including measurements of activity and modes of action.- Developed Biomarker Implementation Plan- Oversaw developed four novel biomarker assays at contract research organizations- Developed non-clinical pharmacology strategy to execute IND-enabling studies resulting in a successful IND - Celgene acquired by BMS 2019

Greater Seattle Area

Principal Investigator for adjuvanted influenza vaccine development. Small business innovative research grant from the US Centers for Disease Control

Greater Seattle Area

- Co-led vaccine development for enterotoxigenic E. coli with external partners from Sanofi-Pasteur, the Bill & Melinda Gates Foundation, the Naval Medical Research Center, and PATH Vaccine Solutions managing multi-million dollar budget- Awarded R01 grant from NIAID for the development of a nanoparticle alum adjuvant- Awarded research grant from the Centers for Disease Control to develop an adjuvanted influenza vaccine- Led a team of postdocs and research associates in discovery and non-clinical pharmacology characterization of a novel adjuvanted vaccine for tuberculosis through Phase 2 clinical development-Principal Investigator and Key Investigator on >10 grants and contracts from BMGF, BARDA, and NIAID as well as collaborative research programs with multiple pharmaceutical companies- Contributed to multiple successful IND filings for new adjuvanted vaccines- Collaborated on the designs of multiple Phase 1 and Phase 2 vaccine clinical trials- Developed new vaccine adjuvant candidates with defined immune profiles- Identified mechanisms of action of clinical stage vaccine adjuvants - Patents issued for novel vaccine adjuvants

Seattle

- Led a team of researchers performing pre-clinical vaccine development focused on adjuvanted subunit vaccines for tuberculosis- T cell characterization: Flow cytometry, intracellular cytokine staining, in vivo and in vitro cytotoxicity, ELISA, ELISpot- B cell characterization: ASCs, antibody affinity ELISA, flow cytometry- Mechanisms of action of vaccines and adjuvants- Biostatistics- Software: FlowJo, Prism, MS Project

Developed pre-clinical vaccine candidates for tuberculosis

- Cancer Research Institute Fellow studying natural killer and T cell responses to infection with Lewis Lanier.- Awarded American Cancer Society Postdoctoral Fellowship.- Identified a novel signaling pathway for NK cell activation upon viral infection- Elucidated the role of NK cell licensing in response to viral infection

Phd, Immunology

Activities and Societies: Howard Hughes Predoctoral FellowshipThesis Advisor: Christopher B Wilson Elucidating the host-pathogen.

B.S., Acs Chemistry

Activities and Societies: Honors Program Phi Kappa Phi Omicron Delta Kappa