Mike O'Neill Email & Phone Number

Boston, Massachusetts, United States

Project & Alliance Management, Life Sciences:o Member of Data Governance and Project Manager for AI-ML drug discoveryo Alliance Manager for an international, billion-dollar drug development project for neurological disorder.o Project Manager for multiple neurological and pain management drug developments using small molecules, and gene therapy. Discovery, Pre-Clinical, IND, Clinical trials (Ph1-3) and regulatory submissions. Cross functional, international teams.o Preparation and review of briefing books, IND submissions, NDA/BLA filingso Project Manager for multiple combination devices for small and large molecules, gene therapy, biosimilars, and “smart” products for clinical and at home use.o Project Manager for corporate wide QMS endeavour to ensure appropriate execution of R&D QMS functions at the affiliate level.o Participated with cross functional team to define the future of data use; by whom, for which purpose, including data cleaning and rules for use.

Greater Boston Area

Research & Product Development:o Designed combination products for wound healing, and drug delivery. Efforts also included preparation and submission of IND.o Partnered on the development and pre-clinical trials for plasma based, tissue sealant and adhesion barrier devices “patch” for human useo Cross functional development, of an anticoagulation PoC device, based on microfluidics and optical array, for a platelet activity determination. Brought this device to the clinic for FIH testing.o Directed the development and regulatory pathway, including IND submission, delivering, the first implantable, passive RFID tag, for tumour marking in breast cancer.o Designing a single lead, EKG, wearable for home monitoring and integration into EHR systemo Developing an advanced healthcare device to address the social-economic divide: “30 million Word Gap”, by translating natural linguistics of family voice(s) using NLPo Collaborated with non-profit group to bring convalescence plasma to randomized clinical trials as well as at risk patients during the initial stages of COVID-19 pandemico Engaged with leading University to design a fully integrated interoperative imaging and guidance system for oncology surgery. Design involves complex datasets and active learningOperations:o Developed end to end supply chain, and manufacturing operations, for multiple start-ups delivering IoT, sensor-based products.

Boston

• Successfully managed overall operations and finances for medical, biomedical, and healthcare products, ensuring optimal performance and profitability.• Spearheaded the design and execution of pre-clinical and clinical trials for multiple oncology medical devices, resulting in the development of wireless and robotic probes for detecting Sentinel Lymph Node during surgery and generating $30M USD in annual sales.• Led cross-functional teams in the development of biomedical products, including wound sealing, extended platelet storage, and hypothermia design for TBI, resulting in successful product launches.• Delivered a real-time data and imaging system for early triage at the Fukushima Daiichi Nuclear sites, demonstrating exceptional technical expertise and project management skills

Greater Boston Area

Start-up focused on women’s health care, specifically mammography

Woburn, Ma

Start-up that delivered the world's first X-ray tube-based portable XRF analyzer. The company expanded into bench top, standalone, and large metal and contamination systems based on XRF technology.

Greater Boston Area

Start-up that developed the industry’s first RDMA-enabled Ethernet sever adapter. Markets included life science, biomedical, informatics, and HPC companies.

Greater Boston Area

Start-up that delivered VoIP switch for integration into soft PBXPurchased by Alcatel for $2B

Waltham, Ma

Greater Boston Area

Wilmington, Ma

Mba, Operations And Finance

Bsee, Electronics

Education record