Steven Daly Email & Phone Number

Seattle, Wa, Us

Seattle, Wa, Us

Seattle, Wa, Us

Seattle, Wa, Us

Inmedix is an angel financed startup biotechnology company working in a new field of medicine called Immuno-autonomics. The lead product uses heart rate variable as an indicator of autonomic function and balance. Clinical studies have shown imbalance within the autonomic nervous system drives patient outcomes with autoimmune disorders such as Rheumatoid Arthritis. Steven is the Chief Operating Officer with wide ranging responsibilities including corporate strategy, licensing, financial and business plan development, medical device development, and ISO 13485 infrastructure development.Accomplishments:- Successfully in-licensed and established a collaboration partnership with the core technology provider.- Successfully converted an existing LLC and setup the C-Corp structure for future equity requirements.- Created and built business models, financial models, and integrated operating plans leading to a successful capital raise of $1.5MM of convertible notes. - Created the first medical device prototype that integrated the partners technology and clinical requirements established within Inmedix clinical studies.- Managing the medical device development through a contract design and manufacturing partner. - Setup ISO-13485 medical device development QMS system enabling commercial registration and sale of the product worldwide.

General responsibilities included; executive management of licensing and partnering Light Sciences technology, management and evaluation of new strategic business opportunities, and provide financial and market analysis supporting broad corporate development decision making. Accomplishments:- Successfully out-licensed the company’s assets through a structured option and asset purchase agreement to a privately owned specialty pharmaceutical company.- Managed all aspects of technology transfer activities to licensor.- During the option period, Managed all aspects of the medical device technology development, manufacturing, and scientific knowledge base while the partnership completed a phase 2b clinical study in Urology.- Managed all aspects of technology transfer and re-integration of technology advances when the licensor declined to exercise their asset purchase option.- Managed and establish relationships with potential pharmaceutical and medical device partners for out-licensing and/or M&A transactions.- Upon completion of four clinical studies (two phase 3 studies in Oncology, one phase 1 study and one phase 2a study in BPH) all aspects of corporate strategy were re-tooled and focused for new investment. Incorporated all aspects of clinical development and commercial development into financial models, corporate presentations, and pitched plans to various venture capital and private equity investors.- Built various quantitative financial models to evaluate multiple exit scenarios leading to updated common stock pricing.- Completed a comprehensive commercialization plan that integrates sales, marketing, distribution, reimbursement, and medical affairs under an assumption LSO will commercialize the technology without a partner.- Built and integrated all financial aspects (Revenues and Expenses) for the company into a 5 year financial plan to be used for a variety of activities including; valuation, term sheet analysis, revenue scenario analysis, etc …

Responsibilities:- Serve as the contractual Alliance Manager between LSO and corporate partners.- Report to the CEO and represent the commercial aspects of LSO as a member of the executive staff.- Help shape and drive the corporate strategy within the partnership agreement by serving on the joint steering committee.- Provide business development activities including sourcing contacts, initiating discussions, and being the point of contact for all due diligence efforts.- Manage outside council shaping the reimbursement strategy.- Provide market / opportunity qualitative and quantitative modeling.Accomplishments:- Created and validated (via our Investment Bank) the Benign Prostatic Hypertrophy (BPH) Program Revenue and Valuation Model for external partnering discussions.- Built a worldwide Oncology market potential model (12 indications, 13 countries) using Secondary Market Research. - Built a forecasting model based on Bass Diffusion Modeling Theory using prior product launches. - Completed a corporate wide integration plan in conjunction with partnership negotiations to be initiated upon execution of the partnership.- Developed the cross-functional Oncology Program Development Plan integrating Clinical, Non-Clinical, Regulatory, CMC, and Device Manufacturing Strategies.- Formalized the Commercial Reimbursement Strategy.- Conceived, built, and organized our internal electronic dataroom for early due diligence activities.

Responsibilities:- Manage development programs, contract personnel, budgets and performance standards. - Develop, direct, manage, and participate in engineering / scientific pre-clinical in-vivo testing.- Collaborate with the Chief Medical Officer and CEO in translating clinical needs into customer requirements and engineering specifications.- Actively pursue intellectual property and examine where new concepts can be converted into patent applications.Accomplishments:- Assembled, organized and led a team of 15 engineers across five different companies to re-design our medical device for commercial launch. Managed the program from the concept stage though design transfer into manufacturing. The program reduced product cost by 800% and increased throughput 1,000%. - Managed a series of in-vivo studies to understand human liver movement and the impact of that movement on the potential migration of our medical device during treatment.- Managed multiple in-vivo studies to ensure bio-equivalence across multiple generations of devices and developed the FDA standard test platform.- Led a team to develop a patent disclosure for up to 3 patent applications.

Responsibilities:- Act as the project manager for two contract manufacturers - the key optoelectronic component manufacturer and the final medical device manufacturer.- Manage material supply, resources and budgets.- Design and develop optoelectronic technology to be integrated into the design and testing of the medical device.Accomplishments:- Provided approximately 500 sterile medical devices used in Phase 2 and Phase 3 clinical trials within budget and time constraints.

Responsibilities:- Act as the project manager for two contract manufacturers - the key optoelectronic component manufacturer and the final medical device manufacturer.- Manage material supply, resources and budgets. - Design and develop optoelectronic technology to be integrated into the design and testing of the medical device.Accomplishments:- Provided approximately 500 sterile medical devices used in Phase 2 and Phase 3 clinical trials within budget and time constraints.

Responsibilities:- Conceive, Design, Prototype, and Test LED-based lighting solutions to be integrated into medical devices.- Manage the building and testing of prototype devices.- Specify, support and qualify optical testing equipment.Accomplishments:- Re-designed a first generation prototype and reduced the diameter by half. - Managed the design and manufacturing transition from the first generation device to the second generation device.

Responsibilities:- Manufacturing engineering responsibility for all custom military products and three medical products representing approximately 50% of annual sales ($30 million).- Process engineering support for all products within specific process areas.Accomplishments:- Developed and introduced into production seven new products or re-designs.- Identified as a subject matter expert, providing support to approximately 80% of all process areas.

Mba

Ms, Medical Engineering

Bs, Ceramic Engineering