Alex Harwig, Phd Email & Phone Number

Dublin, Ca, Us

San Francisco, Us

Sevenoaks, Gb

Redwood City, California, Us

Earli uses gene therapy to turn cancers against themselvesSome of the highlights of my work at Earli as the Director of Therapeutics include:➤ Developed and implemented Earli's therapeutic strategy, providing leadership and direction to the therapeutics team to ensure alignment with company goals and objectives.➤ Collaborated with senior management to set strategic priorities and guide research and development efforts within tight timelines.➤ Spearheaded the research and development of several innovative anti-cancer radiotherapy programs utilizing small molecules and antibody-drug conjugates (ADCs).➤ Developed an immune therapy using protein-engineered cytokine variants.➤ Established, expanded, and supervised teams and infrastructure to support both radiotherapy and immune oncology pipelines internally and externally, including protein engineering and production, radioisotope supply, linker chemistry, computational modeling, efficacy testing in vitro and in vivo, etc.➤ Directed the development of appropriate in vitro and in vivo models (including mice, rats, and oncopigs) to characterize and test functionality and safety parameters of therapeutic applications, including efficacy, biodistribution, PK/PD, and toxicology.➤ Led assay development for immunotoxicity, antibody and cytokine pharmacokinetics (PK) and pharmacodynamics (PD), surface receptor exposure, and tumor exposure analyses.➤ Coordinated with regulatory affairs, manufacturing, and quality assurance departments to ensure seamless development and production of therapeutics.➤ Fostered partnerships with academic institutions, research organizations, consultants, and industry collaborators to facilitate efficient testing of therapeutic molecules.➤ Prepared and reviewed abstracts, presentations, grants, data reports, and regulatory documents to ensure compliance and accuracy.➤ Anticipated and addressed issues to ensure alignment between internal teams and external stakeholders.

Redwood City, California, Us

Some of the highlights of my work at Earli as the Director of Molecular Biology include:➤ Developed and implemented Earli's in vivo PET imaging strategy, providing leadership and direction to ensure alignment with company goals and objectives.➤ Collaborated with senior management to set strategic priorities and guide research and development efforts within tight timelines.➤ Spearheaded the development of several innovative radiotracer–PET reporter gene combinations, including 18F-FDG, 18F-FHBG, 68Ga-DOTATATE (NetSpot), and 89Zr-labeled antibodies.➤ Established a multi-site canine imaging trial enrolling 24 patients, overseeing patient enrollment and reimbursement, radiotracer supply, veterinary support, PET/CT imaging, and image and sample analysis.➤ Led assay development around tumor and off-target tissue exposure, biodistribution, ADC stability, PK/PD, toxicology, etc.➤ Fostered multi-year partnerships with academic institutions, research organizations, consultants, and industry collaborators, facilitating efficient testing of imaging techniques. Conducted over 50 imaging studies in small animals.➤ Collaborated with academic partners to create the first multi-site oncopig PET/MRI imaging experiment using both transgenic and subcutaneously implanted tumors.➤ Established, expanded, and supervised teams and infrastructure to support the imaging of PET reporter genes utilizing gene therapy.➤ Prepared and reviewed abstracts, presentations, grants, data reports, and regulatory documents to ensure compliance and accuracy.➤ Anticipated and addressed issues to ensure alignment between internal teams and external stakeholders.

Redwood City, California, Us

Some of the highlights of my work at Earli as the Team Lead Molecular Biology include:➤ Developed and implemented Earli's in vivo cancer detection strategy, providing leadership and direction to ensure alignment with company goals and objectives.➤ Collaborated with senior management to set strategic priorities and guide research and development efforts within tight timelines.➤ Spearheaded the development of several innovative secreted synthetic biomarkers detectable in blood, urine, and breath.➤ Designed and executed toxicity studies (acute, subacute, chronic exposure), analyzed results, and reported to senior management.➤ Designed and executed several IND-enabling studies, including toxicology, range finding, integration, biodistribution, and serum PK/PD, contributing to IND writing and FDA responses.➤ Assisted in running a clinical phase I trial and interpreting data from biomarker, imaging, and safety parameters.➤ Led the development of assays capable of measuring synthetic biomarker presence in complex matrices such as serum, plasma, urine, and breath down to the femtogram/ml level.➤ Established, expanded, and supervised teams and infrastructure to support assay development, cell biology, and molecular biology.➤ Prepared and reviewed abstracts, presentations, grants, data reports, and regulatory documents to ensure compliance and accuracy.➤ Anticipated and addressed issues to ensure alignment between internal teams and external stakeholders.

Redwood City, California, Us

Earli is developing a radically new technique that uses gene therapy to turn cancers against themselves. Instead of searching for natural biomarkers that may, or often may not, exist, Earli biologically forces cancer cells to produce synthetic biomarkers that do not belong in the human body. That makes them directly localizable in a PET scan. The same technique may also apply to destroy the cancer, by forcing it to make itself vulnerable, or kill itself.Some of the highlights of my work at Earli as Molecular Bio-Engineer include:➤ Introduced novel expression vector that minimizes bacterial contamination and sequences, while optimizing and simplifying production.➤ Locked synthetic biomarker for initial clinical trial.

Madison, Wi, Us

WiSolve consultancy provides research-based business recommendations to address challenging problems in the Madison business community. ➤ Ensure the progress and competency of the consultancy group, preparing them to take on complicated life-science related cases from the local business community➤ Identifying, organizing, and executing workshops and networking events in various aspects of business➤ Lead a team of four consultants to develop a profitable business model including market assessment for cell therapy.➤ Escort local medical imaging software start-up with their ‘Small Business Innovation Research’ (SBIR) phase 2 (worth $1M) grant application, including primary and secondary market research, investor-facing pitch deck, and commercialization plan.➤ Set up regulatory timeline with cGMP validations for three different dosimetry software solutions covering four different radionuclides. This includes applications for IDE and Premarket Notification 501(k)➤ 3rd place Tufts New England Case Competition (TUNECC 2018) for life science consultancy➤ Short- and long-term strategic planning for WiSolve planning as one of the board members

Madison, Wi, Us

Project title: Regulatory interplay between nascent RNA folding and transcription. Advisor: Robert LandickAchievements:➤ Created a deep sequencing technique that combines 3' end sequencing of nascent RNA (NET-seq) and RNA structure probing (SHAPE-MaP). ➤ Set up targeted NET-seq approach, increasing specificity of sequencing to targets of interest.➤ Investigated the regulatory effects of sense and antisense transcription, showing a novel gene expression pathway in the E. coli bgl operon.➤ Supervised undergraduate student project using CRISPR/Cas-directed pull-down to investigate protein-content of DNA regions under variable environments.➤ Supervised undergraduate student project using RNA structure probing of co-transcriptional folding of riboswitches.➤ Cloned several bacterial expression constructs for different purposes, altered the bacterial genome using various methods.➤ Organized monthly journal club.➤ Organized lab retreat.

Amsterdam, Nl

Project title: Transcription regulation, miRNAs and antiviral RNAsAdvisors: Ben Berkhout & Atze T. DasTechniques: ➤ Northern blot ➤ SOLiD deep sequencing ➤ BSLIII tissue culture➤ Western blot ➤ PCR ➤ luciferase assays➤ etc.

Amsterdam, Nl

Project title: HIV in the RNA world: Transcription regulation, miRNAs and antiviral RNAsAdvisors: Professor B. Berkhout & A.T. DasPh.D. obtained on April 30th, 2015Thesis contains 12 publications within 4 yearsTechniques: ➤ Tissue culture➤ SOLiD deep sequencing➤ northern blot➤ Gene expression assays➤ molecular cloning➤ qPCR➤ etc.

Amsterdam, Nl

Project title: life attenuated HIV and SIV virusesAs a research technician B, under associate Professor A.T. Das and Professor B. Berkhout, I performed and designed experimentation to optimize a doxycycline-induced, life attenuated HIV vaccine. These optimizations centered around the strict control of gene regulation, i.e. perfecting the on/off-switch.This research led to several important discoveries that learned us more about how HIV-1 replicates and expresses its genes, but it also led to a more optimized generation of the tet-ON system. This specific tet-ON system is currently distributed by Clontech as the world's most used eukaryotic gene expression system: Tet-ON-3GTechniques: ➤ molecular cloning ➤ BSLIII tissue culture➤ 454 deep sequence ➤ real time PCR➤ etc.

Amsterdam, Nl

After I've completed my internship at the department of Ecology and Toxicology of Plants, I continued my research for four months on assessing genetic variability in S. hermonthica and S. aspera by RAPD and SCAR markers.

Doctor Of Philosophy (Ph.D.), Molecular Virology

Bachelor’S Degree, Biologie En Medisch Laboratoriumonderzoek

Certificaat Algemene Ondernemingsvaardigheden (Aov)

Module Interventiestrategien In Organisaties