Justin David Email & Phone Number

Princeton, Nj, Us

Mainz, Rhineland-Palatinate, De

Lawrence Township, Nj, Us

• Biomarker lead for Ph2/Ph3 oncology trials supporting development of immune checkpoint inhibitors in lung (RELATIVITY-104, -1093), bladder (CheckMate-274, -901, -078), and prostate (CheckMate-650, -7DX, -9KD) cancers.• Design, develop, align, and execute biomarker strategies to drive understanding of target engagement, asset MoA/R, patient selection/CDx strategies, and other clinically-relevant biomarker endpoints to advance overall R&D portfolio goals. • Enable cross functional collaboration on the translational strategy, leading the design, execution, analysis, communication, and publication of clinical biomarker studies. Efforts resulted in 4 abstracts and 2 manuscript submissions.• Author and review translational medicine-related sections in clinical study/regulatory documents (IBs, trial protocols/ops manuals, ICFs, HA briefing books, CSRs, etc). Efforts supported submission of CheckMate 901 trial results resulting in HA approval.• Manage external academic collaborations that advance the overall translational objectives for the program. Efforts resulted in 2 scientific abstracts.• Communicate key biomarker program information, risks, and milestones to project teams, review forums, decision committees, and governance bodies.• Represent translational medicine at advisory boards and health authority interactions to advance translational research and clinical biomarker objectives for the program.

Lawrence Township, Nj, Us

• Biomarker lead for Ph2/Ph3 oncology trials supporting development of immune checkpoint inhibitors in bladder (CheckMate-274, -901, -078), and prostate (CheckMate-650, -7DX, -9KD) cancers. Efforts focus on driving improved understanding of disease biology, asset MoA/R, patient selection/CDx strategies, and other clinically-relevant biomarker endpoints to advance overall R&D portfolio goals.

Lawrence Township, Nj, Us

• Designed, coordinated, and implemented experimental strategies testing clinically relevant hypotheses to enable decision-making for a late-stage IO program. Efforts focused on generating MoA insights, identifying exploratory biomarkers, and informing on patient selection and combination strategies.• Directed and delivered the analysis of a mass cytometry profiling data package of peripheral and human solid tumor-infiltrating immune cells. Efforts identified unique immune cell subsets with potential mechanistic and biomarker utility and resulted in an abstract presentation at SITC 2020.• Championed the development and implementation of novel ex vivo primary cell IO functional assays for translational research. Efforts yielded 2 model systems to probe aspects of human T cell functional suppression.• Led the acquisition and implementation of a novel immune functional assay technology platform.• Interfaced extensively with key internal stakeholders to drive research program advancement in alignment with major development objectives.• Interfaced with TM colleagues to provide translational insights for an internal review of putative targets to determine their relevance for a specific tumor indication. Efforts enabled delivery of target priority recommendations to senior discovery leadership.• Interfaced externally with academic thought leaders in clinical advisory boards and evaluated proposed research partnerships from academic investigators for alignment with major program objectives.• Managed and mentored one high-achieving scientist direct report and one PhD-level contractor. Efforts contributed to a promotion for the direct report.

Lawrence Township, Nj, Us

• Designed, coordinated, and implemented experimental strategies testing clinically relevant hypotheses to enable decision-making for a late-stage IO program. Efforts focused on generating MoA insights, identifying exploratory biomarkers, and informing on patient selection and combination strategies.

Lawrence Township, Nj, Us

• Biology lead for an early-stage discovery program. Directed and managed target validation, MOA, and lead development strategies to progress from hit identification to lead identification/optimization. Led cross-functional and core team meetings.• Led delivery of in vitro and in vivo MOA studies to inform target validation and clinical translational strategy for the program. Efforts validated MOA in mouse/human and identified novel synergy with IO agents. • Interfaced extensively with chemistry and screening colleagues to revise and implement new triage screening assays to improve the lead series identification strategy for the program.• Interfaced with internal and external colleagues to propose and prioritize novel targets for evaluation. Efforts resulted in 2 targets progressing to in vivo mechanistic testing, and 1 target progressing to formal internal target review.• Interfaced with commercial and translational colleagues to provide discovery insights internal strategy initiatives. Efforts helped enable strategy presentations delivered to the head of discovery and the CSO.• Managed and mentored one high achieving senior scientist direct report.

Germantown, Maryland, Us

• Launched and co-led a novel technology platform development project.• Designed/conducted human immune ex vivo MOA experiments for 2 novel multifunctional therapeutic agents. Efforts confirmed proposed MOA and identified previously unrecognized activity in enhancing NK function.• Designed/conducted human immune ex vivo antigenicity experiments to guide the lead selection strategy for 5 vaccine candidates. Efforts enabled progression of 2 candidates to lead evaluation.• Operated independently and collaboratively within highly matrixed multidisciplinary R&D teams.

• Designed/conducted target characterization, MOA, and hypothesis-driven studies for the NEO-201 mAb. Efforts resulted in progression to clinical testing (NCT03476681) and the generation of new IP (named inventor, W019160970A1).• Developed/conducted binding and functional assays for the clinical development of NEO-201.• Developed IND-enabling assays, prepared SOPs, and contributed to the generation of regulatory documents.• Collaborated with external partners to drive R&D projects, communicated research to the scientific community.• Managed daily laboratory operations and functionality.

Bethesda, Md, Us

Laboratory of Tumor Immunology and Biology, Center for Cancer Research, National Cancer Institute, National Institutes of Health• Led a collaborative project with EMD Serono to demonstrate the utility of the αPDL1-TGFβRII trap (M7824) in reverting epithelial-mesenchymal transition in human NSCLC.• Discovered and validated the utility of targeting MUC1-C to overcome resistance of mesenchymalized tumor cells to killing by immune effector cells.• Contributed to the development of adenoviral vaccines targeting TAAs and novel targets to overcome therapy resistance in lung (IL-8, ER) and breast cancer (IL-8).• Collaborated with external academic (JHU) and biopharma partners (EMD-Serono, Etubics).• Presented research abstracts at 4 international conferences.• Published 8 research articles and 4 reviews articles in quality peer-reviewed journals.• Supervised/mentored 1 technician and 1 summer intern.• Led a team of 5 postdoctoral scientists in developing and implementing industry career sessions for the 2015 NIH Career Symposium.• Completed internal training courses in 1) management; 2) project management; 3) translational research in clinical oncology; 4) workplace psychology and dynamics; and 5) science pedagogy.

Springfield, Mo, Us

• Taught ~2 ballroom/Latin dance group classes weekly for 10-40 customers per class.• Taught private dance lessons and coached competitive dancesport athletes weekly.• Generated thousands of dollars in sales of dance lessons.• Maintained excellent ongoing clientele relations to ensure the highest level of customer satisfaction.• Managed social dance events.

Jacksonville, Florida, Us

• Conceived and conducted the development of gramicidin A as a novel therapeutic agent for kidney cancer. Efforts led to the identification of anticancer and anti-angiogenesis properties for this agent.• Led the revision and completion of a study detailing the role WT1 in inducing a hybrid dual epithelial-mesenchymal differentiation state in kidney cancer cells.• Published 4 research articles and 2 review articles in quality peer-reviewed journals.• Secured travel funding from 3 sources to travel and present an abstract at 1 international conference.• Presented research at numerous project meetings, departmental seminars, and symposia.• Provided technical training and project management support for 3 junior graduate students and 1 technician.• Instructed/supervised undergraduate students in 4 laboratory sections for 2 introductory biology courses.• Assisted with the composition and revision of numerous exploratory and development grants.• Collaborated with external academic colleagues on basic science projects (St. Joseph's Hospital and Medical Center).

Arlington, Virginia, Us

287th Army Band, Delaware Army National Guard, Wilmington, DE• Served honorably as an army soldier and professional military musician.• Functioned as an effective team-member in completing a diverse range of large and small ensemble musical missions for both military and civilian audiences.• Trained in squad-level leadership of soldiers.• Consistently met or exceeded training standards in all periodic soldier skill assessments and specialty school evaluations.

Cambridge, Cambridgeshire, Gb

• Conducted all genotyping for the schizophrenia transgenic model mouse colony (50-100+ mice per week).

Ph.D., Molecular Biology And Genetics

B.S., Biological Sciences