SR. DIRECTOR > EXECUTIVE DIRECTOR ANALYTICAL DEVELOPMENT
Accomplished leader in gene and cell therapy with demonstrated success translating innovative concepts into robust clinical programs. Expert in ex vivo cell manipulation, gene system design, viral and non-viral gene modification, process optimization, analytical development and CMC supporting the product development lifecycle from concept to clinic.
Leader in cell and gene therapy development for 8 years
Expertise in clinically relevant gene delivery technologies and cell types (T-cells, MSCs, Fibroblasts)
Led development of CAR-T programs from research to preclinical development and IND
Experienced with CAR-T program scale-up, CMC and analytical development
Track record of success translating programs to the clinic
Broad range of experience from early stage discovery to phase 1-2 clinical trials
Technical expertise including gene system design, GM-cell process optimization and analytical development
Experienced manager and mentor helping to build the next generation of biotech leaders
Strategic thinker, able to see the bigger picture and drive strategy to accomplish the mission
Led development of CAR-T programs against hematological malignancies from early research and POC to late stage preclinical assessment and IND in collaboration with a large research institution.
Managed pipeline of several early research CAR-T programs focused on identification and development of novel target antigens, stalks, co-stimulatory domains and surface tags.
Developed CMC programs for CAR-T products and managed technology transfer to CROs and CMOs.
Authored sections of modules 2, 3 and 4 of the CTD to support IND filings.
Led research program to develop and enhance tregs to prevent and treat GVHD following HSCT.
Advanced several gene and cell therapy programs from early discovery to phase
1-2 clinical trials: Adenovirus-based immuno-therapy
to treat melanoma, glioblastoma and breast
carcinoma; Lentivirus-based fibroblast product targeting
Epidermolysis Bullosa; AAV-based gene therapy product targeting wet AMD.
Introduced novel gene delivery systems and provided subject matter expertise leading to incorporation of the technology into several therapeutic programs.
Sr. Director > Executive Director Analytical DevelopmentMar 2013 to Aug 2016 Intrexon Corporation － Germantown, MD
Led development of CAR-T programs with specific focus on CMC and analytical development. Worked directly with CMC director to oversee the selection and day to day progress of technology transfer, process development and analytical at CROs and CMOs.
Conceptualized and oversaw strategy related to CMC, non-clinical and analytical, authored portions of module 2, 3 and 4 of the CTD to support IND filings.
Cross-functional management of all aspects of product development: Concept development, market analysis, program management, resource allocation, gene design and construction, cell biology and gene delivery, assay development, in vitro/in vivo POC, manufacturing process development, CMC, regulatory strategy, authoring regulatory filings.
Led several non-CAR-T gene and cell therapy programs using genetically modified cells (Fbrobalsts, MSCs) or viral vectors (Ad5, AAV) to deliver therapeutic benefit.
Managed several support laboratories providing cloning, LCMS, biochemical assay, process development and laboratory automation support to the internal teams.
Manager > Director > Senior Director, Analytical Development and Screening OpsAug 2009 to Mar 2013 Intrexon Corporation － Germantown, MD
diverse team of scientists supporting the analytical development and screening
phases of several
cell and gene therapy programs targeting
Melanoma, A1AT deficiency, Duchenne Muscular
Dystrophy, Fabry Disease,
Krabbe Disease, Friedreich's Ataxia and Hemophilia.
Oversaw project proposals,
technical feasibility assessment, project plan development, project
execution and generation of high quality
reports for partners, management and business
multiple diverse projects under stringent timelines and tight budgets.
Interfaced with partners and internal
leadership to ensure optimal project performance and foster
laboratory automation approaches focusing on assay miniaturization,
Hamilton and Biomek robotics and
establishment of bioinformatics and data analysis pipelines.
implemented system for mining of experimental data to better understand the
role of natural and synthetic regulatory
elements in driving gene expression from engineered
Scientist > Manager, Cell and Bioassay OperationsApr 2008 to Aug 2009 Intrexon Corporation － Blacksburg, VA
high-throughput plasmid DNA screening platform to support assessment of
occurring and synthetic gene regulatory elements.
processes including cell culture, plasmid DNA transfection, biomaterial
collection and analytical assessment.
Managed the miniaturization
of the processes enabling incorporation of laboratory automation such as
Biomek and Hamilton robotics.
team to develop required LIMS. applications to track sample movement
throughout the analytical process and
associate analytical data with sample lineage.
Established data reduction
and analysis strategies and incorporated data visualization tool Tibco
Spotfire to enhance analytical output and
Worked with the bioinformatics
team to enrich the database structures to optimize the association of
genetic context to analytical outcome, which
led to exponential improvements in machine learning
Associate Scientist > Manager, Histopathology and Tissue Shared ResourceMar 2006 to Apr 2008 Lombardi Comprehensive Cancer Center-Georgetown University － Washington DC
Developed and implemented
laboratory operations and processes that streamlined sample processing,
setup, data analytics, reporting and billing.
Managed the day-to-day activities of the
histology operation including project portfolio management,
control, scheduling, maintenance, billing and managing stakeholder
Supervised a total of 8 scientists and
provided operational, technical and scientific direction to teams
with molecular diagnostics assays (Affymetrix gene-chip, qPCR, ELISA, Western,
microscopy systems for shared use within LCCC: Compound-fluorescent, inverted-
laser-capture, gross-dissection, HistoRx.
Image Pro Plus and ImageJ software for scripted image analysis and data capture.
Managerial: Personnel Motivation and
Coaching, Team Building, Communication, Domain Knowledge,
Management: Project Management Applications (MS Project, MS
Resource allocation, Budgeting, Scheduling, Risk Mitigation, Change Management,
Transfer and Oversight, Contract Negotiation
Process Optimization, Assay Design and Validation, Experimental Design and
High-throughput Screening (Development, Validation and Implementation),
(Biomek FX, Hamilton Star), Biochemical Assays, Plasmid-DNA Transfection, Viral
– AAV, LV, Adenovirus, Stable Cell Line Development - CHO & HEK, Small-scale Protein
and Purification (E. coli, mammalian cells), Biological Process Development and
Optimization, Technical Troubleshooting and Root Cause Analysis, Data Analytics
Spotfire, Microsoft Excel)
Personal Accountability, Self-motivation, Critical Thinking, Positivity,
Process-mindedness, Ability to Drive to Results, Flexibility, Resiliency,
Attentiveness to Detail,
to Foster Positive Interactions
Master of Arts, Biopsychology/Neuroscience-Thesis2007George Mason University － Fairfax, VAAdvisor: Robert Smith PhD
Bachelor of Science, Biopsychology2004George Mason University － Fairfax, VABiopsychology
"Gestational cocaine exposure causes enduring changes in offspring
dendritic morphology and lasting
behavioral changes in
rat." Utilized cutting-edge imaging, molecular and behavioral analyses to
impact of stimulant exposure
on the developing reward centers of the brain.
Suy S, Danner M, Dailey V, Zhang Y, Li H, Hyduke DR, Collins BT, Gagnon G,
Kallakury B, Kumar
D, Brown ML, Fornace A,
Dritschilo A, Collins SP. AMP-activated protein kinase promotes human prostate
cancer cell growth and survival. Mol Cancer
Ther. 2009 Apr;8(4):733-41. PubMed PMID: 19372545; PubMed
Wu K, Li A, Rao M, Liu M,
Dailey V, Yang Y, Di Vizio D, Wang C, Lisanti MP,Sauter G, Russell RG, Cvekl A,
Pestell RG. DACH1 is a cell
fate determination factor that inhibits cyclin D1 and breast tumor growth. Mol
Cell Biol. 2006
Oct;26(19):7116-29. PubMed PMID: 16980615; PubMed Central PMCID:
McDonald CG, Dailey VK,
Bergstrom HC, Wheeler TL, Eppolito AK, Smith LN, Smith RF. Periadolescent
produces enduring changes in dendritic morphology of medium spiny neurons from
nucleus accumbens. Neurosci
Lett. 2005 Sep 9;385(2):163-7. PubMed PMID: 15955627.
Dailey, VK., McDonald, CG., Bergstrom, HC.,
Brown, K & Smith, RF. Gestational cocaine exposure causes
enduring changes in offspring
dendritic morphology and lasting behavioral changes in rat. (2005) Society for
Neuroscience. Washington, DC.
McDonald, CG., Dailey, VK.
Periadolescent nicotine exposure causes lasting changes in dendritic morphology
in rat ventral striatum. (2004) Society for
Neuroscience. San Diego, CA.
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Companies Worked For:
Lombardi Comprehensive Cancer Center-Georgetown University
George Mason University
Job Titles Held:
Sr. Director > Executive Director Analytical Development
Manager > Director > Senior Director, Analytical Development and Screening Ops
Scientist > Manager, Cell and Bioassay Operations
Associate Scientist > Manager, Histopathology and Tissue Shared Resource
Master of Arts , Biopsychology/Neuroscience-Thesis 2007 Bachelor of Science , Biopsychology 2004
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