Early clinical development (phase 1 and 2) of novel anti-cancer immunotherapies, including large molecules and gene therapies

Early clinical development (phase 1 and 2) of novel anti-cancer immunotherapies, including large molecules and gene therapies

Clinical Scientist supporting early stage (Phase 1 and 2) clinical development in oncology.

Clinical Scientist supporting late stage (Phase 2 and 3) clinical development:- 2018-2019: Phase 3 neurodegeneration studies (e.g., Alzheimer's Disease)- 2017-2018: Phase 2 and 3 lymphoid hematological malignancy (e.g., CLL and NHL) studies, including FDA and EMA filing experience.

- Early stage clinical development of CB-5083 for solid tumor and heme oncology indications- Worked closely with CMO and medical monitor to design and implement the CDP- Collaborated with DM and clin ops for EDC design and revisions and data review/cleaning - Lead author and major contributor to clinical protocols, IND, IB, CRF, ICF and other regulatory submissions - Involved in site selection, vendor selection and KOL/site interface; including organizing and presenting at SIVs - Responsible for managing the development and implementation of clinical pharmacodynamics and patient enrichment biomarkers and strategies (and eventual CDx development).

Discovery and development of novel small molecule therapeutics targeting protein homeostasis pathways for oncology indications.- Oversee high-content cell-based compound screening, drug mechanism of action and combination studies.- Collaborate with the translational biology group for clinical biomarker discovery and development and patient enrichment studies.- Manage external academic collaborations.- Involved in new target discovery/validation, assay development, high throughput screening and regulatory filings.- Involved in lead optimization and preclinical development of CB-5083, which was tested in phase 1 clinical trials for oncology indications.Selected Publication:Anderson DJ, LeMoigne R, Djakovic S, Kumar B, Rice J, Wong S, Wang J, Yao B, Valle E, KissvonSoly S, Madriaga A, Soriano F, Menon M, Wu ZY, Kampmann M, Chen Y, Weissman J, Aftab B, Yakes FM, Shawver L, Zho H, Wustrow D, Rolfe M. Targeting the AAA ATPase, p97, as a novel approach to treat cancer through disruption of protein homeostasis. Cancer Cell. 2015.

SRA (contract) reporting to Avi Ashkenazi in the Department of Molecular Oncology involved in discovery of cancer therapeutics. - Collaborated with antibody engineering to generate novel dual specificity antibodies targeting two RTK oncogenes.- Developed a cell based screen to identify hits.- Successfully characterized antibodies and assessed in vitro efficacy.- Selected lead antibodies that were tested for efficacy in xenograft models.Selected Publication:Yin Y, Djakovic SN, Marsters S, Tien J, Peng J, Tremayne J, Lee G, Neve R, Wu Y, Merchant M, Ashkenazi A, Carter PJ. Redesigning a monospecific anti-FGFR3 antibody to add selectivity for FGFR2 and expand anti-tumor activity. Molecular Cancer Therapeutics. 2015.

• Project: To investigate the role of autophagy and mitophagy in neurodegenerative disease• Collaborated with multiple academic and biotech labs in translational research projects• Became skilled in mouse genetics, molecular biology and biochemistry • Trained and supervised 2 undergraduates and 1 graduate student • Postdoctoral Fellowship - NIH Neuroplasticity of Aging Training GrantSelected Publication:Dubinsky A, Dastidar S, Hsu C, Zahra R, Djakovic SN, Duarte S, Esau C, Spencer B, Ashe T, Fischer K, MacKenna D, Sopher B, Masliah E, Gaasterland T, Chau N, Almeida L, Morrison B, La Spada A. Let-7 coordinately suppresses components of the amino acid sensing pathway to repress mTORC1 and induce autophagy. Cell Metabolism, 2014.

- PhD in Biology, with a focus on neuroscience from the laboratory of Dr. Gentry Patrick. - Developed novel live imaging based reporter assays to investigate the role of the ubiquitin proteasome system in synaptic function and neurodegenerative disease. - Author on 5 publications.- Helped setup the lab (ordering, hiring, protocol establishment, administration).- Managed and supervised undergraduate and high school interns/employees.- Funded by the Neuroplasticity of Aging training grant.- Established viral based gene delivery system for the lab. Also assisted/collaborated with other labs on viral projects leading to 1 authorship and 4 acknowledgements.Selected Publication:Djakovic S, Marquez-Lona E, Jakawich S, Wright R, Chu C, Sutton M, Patrick G. Phosphorylation of Rpt6 Regulates Synaptic Strength in Hippocampal Neurons. Journal of Neuroscience. 2012 April 11.

Worked as a research associate in the laboratory of Laurie G. Smith. Investigated the role of the actin cytoskeleton in plant cell morphogenesis using molecular and genetic techniques and Arabidopsis Thaliana as a model system.Selected Publication:Djakovic S, Dyachok J, Burke M, Frank MJ, Smith LG. BRICK1/HSPC300 functions with SCAR and the ARP2/3 complex to regulate epidermal cell shape in Arabidopsis.Development. 2006 Mar;133(6):1091-100