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Highly motivated and results-focused translational scientist with a passion to drive preclinical and clinical studies forward. Led biomarker strategy, clinical assay validation, CRO management, and patient sample testing for 3 first-in-human in vivo and ex vivo CRISPR/Cas gene therapies from Phase 1 to 3. Developed bioanalytical PK/PD assay strategy and development for immune-oncology, hematology, hepatic, and HSC-targeting preclinical gene and cell therapy programs. Diverse fit-for-purpose assay development experience including qPCR, ddPCR, NGS, ELISA, and flow cytometry for assessment of drug product potency, biodistribution, PD, safety, and efficacy.Keywords: Assay development, bioanalytical strategy, biochemistry, biomarker discovery, cell therapy, clinical development, CLIA, CRISPR/Cas, CRO management, gene therapy, GxP environment, molecular biology, operations, pharmacodynamics, pharmacokinetics, phase I/II/III clinical trial, precision medicine, project management, regulatory-compliant assay qualification/validation, SOP writing, translational scienceDisease areas: Cardiovascular, hematology, immuno-oncology, ocular, oncology, rare diseases
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Scientist IiEditas MedicineCambridge, Ma, Us
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Senior Scientist I - Translational SciencesEditas Medicine Jul 2023 - PresentCambridge, Massachusetts, Us• Led bioanalytical PK/PD assay strategy for preclinical LNP/mRNA in vivo gene therapy programs, facilitating the selection of drug product intermediates for DC declaration• Designed and implemented a patient-focused safety and efficacy strategy to support the short- and long-term clinical study of in vivo and ex vivo gene-edited cell medicines• Managed transfer and CLIA-level validation of assays for patient stratification and subgroup safety and efficacy analysis• Served as the Translational Sciences lead for authoring critical FDA communications, clinical trial amendments, long-term follow-up, briefing books, Development Safety Update Reports (DSURs), scientific posters, publications, and other essential documents to support regulatory submissions.• Developed data visualizations and led cross-functional analyses of biomarker data to inform clinical development strategies and drive drug product differentiation strategy• Collaborated with clinical dev/ops and data management/biostats teams to establish DTAs and streamline workflows to deliver timely key safety and efficacy data updates to support BLA filing
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Scientist Ii - Translational SciencesEditas Medicine Jul 2022 - Jul 2023Cambridge, Massachusetts, Us• Coordinated clinical assay validation, sample testing, and data transfer across 10+ CROs to compile key efficacy and safety data packages to support interim analyses and patient cohort expansion of multiple FiH ex vivo CRISPR/12a gene therapy clinical studies.• Led preclinical PD strategy of challenging analytes in LNP/mRNA in vivo studies using mouse and NHP models and generated critical datasets to position the organization as a leader in in vivo gene editing.• Developed assays for PK/PD characterization of a gene-edited, iPSC-derived cell therapy and minimal residual disease.• Authored essential clinical trial documents, including amendments, informed consent forms, data transfer agreements (DTAs), lab service agreements, lab manuals, SOWs, and other supporting materials to ensure regulatory compliance and operational efficiency.• Designed and optimized strategies for clinical sample life cycle and data management of numerous matrices and assays.
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Scientist I - Translational SciencesEditas Medicine Nov 2020 - Jul 2022Cambridge, Massachusetts, Us• Developed and validated numerous bioanalytical PK/PD assays both in-house and at regulatory-compliant CROs (CLIA, GxP), generating critical safety and efficacy data from multiple in vivo and ex vivo gene therapy clinical trials.• Led qualification and internal transfer of drug product characterization assays, which were instrumental lifting the FDA’s partial clinical hold on a first-in-human (FiH) ex vivo CRISPR/Cas12a gene therapy clinical study.• Managed clinical sample testing and data management across multiple clinical CROs, ensuring timely delivery of key clinical efficacy and safety data for presentation to independent data monitoring committees and regulatory agencies, including the FDA.
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Postdoctoral AssociateState University Of New York Upstate Medical University May 2020 - Nov 2020Ny, Us• Independently led research project to provide foundational data for an awarded 4-year, $2+ million NIH RO1 Research Grant for the laboratory.• Optimized scale up of a novel expression and purification system for large, challenging protein complexes in Saccharomyces cerevisiae for their kinetic and structural (EM/Cryo-EM) characterization. • Developed and optimized biochemical assays to identify and measure key protein-protein interactions through qualitative (fluorescence microscopy, protein pulldowns & yeast two-hybrid) and quantitative, high-throughput (BLI) kinetic techniques.• Demonstrated strong technical expertise on all aspects of multiple protein-protein interaction projects ranging from protein and organism engineering, molecular cloning, expression, purification, and scale up resulting in generation of 100+ yeast and bacterial strains and protein constructs. -
Phd StudentState University Of New York Upstate Medical University Aug 2014 - May 2020Ny, UsOur lab focuses on the structure, function, and regulation the V-ATPase, a proton pump essential for organelle acidification. My focus was to characterize the function of an assembly factor, known as the RAVE complex, and to elucidate its mechanistic role in V-ATPase regulation. I utilized gene editing, microscopy, protein biochemistry, and high-throughput screening to identify and thoroughly characterize essential protein-protein interactions between the V-ATPase and RAVE complex. While the V-ATPase has been an unsuccessful therapeutic target in the past, the protein-protein interactions that I have identified and characterized could serve as more efficacious therapeutic targets for diseases such as cancer, metabolic acidosis, neurodegeneration, and osteoporosis.Advisor: Dr. Patricia Kane, PhDDepartment: Biochemistry and Molecular Biology
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Summer Undergraduate Research Fellowship (Surf) Journal Club AdviserState University Of New York Upstate Medical University Jun 2016 - Aug 2019Ny, Us• Mentored multi-disciplinary groups of 10+ undergraduates on scientific analysis and presentation skills.
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Tutor For Foundations In Biochemistry And Molecular BiologyState University Of New York Upstate Medical University Jan 2016 - Dec 2017Ny, Us• Developed active learning strategies to breakdown complex topics into digestible practice questions which improved the average grade by >25%.
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Biochemistry & Molecular Biology Research AssistantPenn State University Jan 2012 - Jun 2014University Park, Pa, UsProjects: o Identification of Plants Using the Fingerprinting Genes matK and rbcL• Spearheaded research project to identify plant species using DNA sequencing and bioinformatics, which led to 3 awarded research fellowships, 1 award at a nationally recognized conference, and 1 publication o Determining the presence of 2-amino-5-phenylpentanoic in unroasted Kentucky coffee tree seeds using HPLC• Optimized assays to identify the presence and synthesis location of a novel amino acid (2-amino-5-phenylpetanoic acid) from Kentucky coffee tree seeds which led to 1 awarded research fellowship. -
Laboratory TechnicianPenn State University Jan 2012 - May 2014University Park, Pa, UsPrepared media and stock solutions for an entire biology department (~150 people)
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Teaching Assistant For Mammalian AnatomyPenn State University Aug 2013 - Dec 2013University Park, Pa, Uso Maintained office hours for student questioningo Held study sessions to provide students with extra time for preparation o Supervised students undergoing laboratory procedures, including microscopy and mammalian dissections
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Teaching Assistant For Function And Development Of OrganismsPenn State University Jan 2013 - May 2013University Park, Pa, Uso Supervised students undergoing laboratory procedureso Helped students understand concepts of laboratory experiments
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Note Taker For PsychologyPenn State University Jan 2013 - May 2013University Park, Pa, Us
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Microbiology Research AssistantPenn State University Sep 2012 - Jan 2013University Park, Pa, UsProject: o Population Analysis of Agrobacterium vitis Diversity to Uncover the Geographical Origins•Utilized aseptic techniques to maintain 40+ bacteria strains and isolated single-cell cultures for DNA sequencing
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Psychology Research AssistantPenn State University Jan 2012 - May 2012University Park, Pa, UsProject: Attachment, Social Support, and Pain• Instructed participants to perform various tasks while collecting heart rate and galvanic skin response data. Participants were stressed during tasks and asked to self-report their stress level. Self-reported data was compared with heart rate and galvanic skin response.
Michael Jaskolka, Phd Skills
Michael Jaskolka, Phd Education Details
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Upstate Medical UniversityBiochemistry And Molecular Biology -
Penn State Erie, The Behrend CollegeBiochemistry And Molecular Biology
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Penn State Erie, The Behrend CollegePsychology
Frequently Asked Questions about Michael Jaskolka, Phd
What company does Michael Jaskolka, Phd work for?
Michael Jaskolka, Phd works for Editas Medicine
What is Michael Jaskolka, Phd's role at the current company?
Michael Jaskolka, Phd's current role is Scientist II.
What is Michael Jaskolka, Phd's email address?
Michael Jaskolka, Phd's email address is mi****@****ate.edu
What schools did Michael Jaskolka, Phd attend?
Michael Jaskolka, Phd attended Upstate Medical University, Penn State Erie, The Behrend College, Penn State Erie, The Behrend College.
What are some of Michael Jaskolka, Phd's interests?
Michael Jaskolka, Phd has interest in Writing, Kayaking, Technology, Weight Training, Science, Education, Environment, Reading, Arts And Culture, Fitness.
What skills is Michael Jaskolka, Phd known for?
Michael Jaskolka, Phd has skills like Research, Microsoft Office, Microsoft Word, Powerpoint, Data Analysis, Technical Writing, Biochemistry, Molecular Biology, Technology, Laboratory, Statistics, Molecular Cloning.
Who are Michael Jaskolka, Phd's colleagues?
Michael Jaskolka, Phd's colleagues are Peter Faust, Marissa Culbertson, Kevin Ruttenberg, Becki Pildner, Claire Lee, Eric Lorion, Sajith Buddhika.
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