- Strategic advisory and embedded preclinical/clinical/regulatory support for medtech and biopharmaceutical startups- Negotiate with FDA, Health Canada, CE Mark Notified Bodies and other global regulators to enable the most cost and time efficient path to market- Creative ideation of potential "Minimal Viable Regulatory Approvals" and securing accelerated pathways (e.g. FDA Breakthrough Designations)- Regulatory Correspondent for Submissions: FDA IDE, 510(k), PMA, Health Canada MDLs… Show more - Strategic advisory and embedded preclinical/clinical/regulatory support for medtech and biopharmaceutical startups- Negotiate with FDA, Health Canada, CE Mark Notified Bodies and other global regulators to enable the most cost and time efficient path to market- Creative ideation of potential "Minimal Viable Regulatory Approvals" and securing accelerated pathways (e.g. FDA Breakthrough Designations)- Regulatory Correspondent for Submissions: FDA IDE, 510(k), PMA, Health Canada MDLs Class II-IV, CE Mark Class IIa/b, III (including combination drug-device products) - Pro bono work for non-profits seeking cures for pediatric rare diseases Show less

Acquired by Avania- Consult on regulatory, product development and clinical trial design for medical devices across a wide range of therapeutic areas, such as: surgical/interventional implants, surgical navigation & robotic systems, machine learning-based diagnostics, medical imaging (MR, CT, US, PET, NIR), combination products, in vitro diagnostics- Drafting and meeting with FDA and Health Canada on pre-submissions and marketing applications; particular focus on arguments to… Show more Acquired by Avania- Consult on regulatory, product development and clinical trial design for medical devices across a wide range of therapeutic areas, such as: surgical/interventional implants, surgical navigation & robotic systems, machine learning-based diagnostics, medical imaging (MR, CT, US, PET, NIR), combination products, in vitro diagnostics- Drafting and meeting with FDA and Health Canada on pre-submissions and marketing applications; particular focus on arguments to support existing or proposed clinical trial and biocompatibility testing- Compiling CE Mark Technical Files (and Technical Documentation/Medicinal Dossiers under MDR) for Class II & III medical devices, including authoring Clinical Evaluation Reports and drafting Risk Analysis documentation Show less

- Support product development and scientific due diligence for clients in the biopharmaceutical and medical technology industries- Project responsibilities have included conducting market research, helping with trial design, analyzing clinical data, preparing regulatory submissions and generating reports/proposals for multiple, overlapping projects. - My contract work has contributed to product regulatory approvals, investment decision-making, and non-dilutive funding of R&D projects

- Seed financing from VCs and angels- Building the business model from the ground up with a keen focus on product/market fit- Identifying key behaviours of target customers which can be leveraged to accelerate product adoption and how to encourage behaviours which will help the customer adapt to the product- Establishing relationships with key business partners, both local and multinational- Delving into market research and conducting primary research to understand the potential… Show more - Seed financing from VCs and angels- Building the business model from the ground up with a keen focus on product/market fit- Identifying key behaviours of target customers which can be leveraged to accelerate product adoption and how to encourage behaviours which will help the customer adapt to the product- Establishing relationships with key business partners, both local and multinational- Delving into market research and conducting primary research to understand the potential responses from business partners and competitors and determine how the product will change the status quo of the current market- Broad thinking about potential vertical expansion yet concurrently ensuring product development remains focused on the current market opportunity Show less

The main goal of the Translational Addiction Research Lab (TARL) is to improve the treatment and understanding of addictive disorders. We have a particular interest at studying how addiction works in the brain in order to develop novel therapeutic strategies using pre-clinical models, human neuroimaging, genetic studies and clinical studies.