Michael Brubaker Email & Phone Number

Texas, United States

Fort Worth, Texas, Us

Basel, Baselstadt, Ch

* * Accountable for the integration of the acquired global dry eye treatment asset into Novartis.* * Accountable for the leadership (acting as a CEO) of a matrixed global program team, setting & communicating global strategy, development planning and budgeting for market expansion and life-cycle management.* * Accountable for the development of novel drug/drug-device product that addresses patient unmet medical needs.* * Accountable for global maintenance of the marketed product.* * Member of the Novartis Ophthalmology Development Unit leadership team.

Basel, Baselstadt, Ch

* * Responsible for defining the ophthalmology data & digital research & development strategy that spans the entire patient journey with a focus on enhancing the value of branded ophthalmic drug assets under development.* * Accountable for the leadership (acting as a CEO) of a matrixed global program team, setting & communicating global strategy, development planning and budgeting for ophthalmic medical devices.* * Accountable for the development of innovative software as a medical device products, connected drug delivery devices, artificial intelligence SaMD products, remote at home or in-clinic ocular imaging devices and digital clinical and real world evidence clinical endpoint data collection medical device products designed to be used at home in the patient hands that addresses patient, healthcare provider & drug clinical development unmet needs.* * Serve as an Ophthalmology subject matter expert for the due diligence, licensing and acquisition of medical devices

Basel, Baselstadt, Ch

* * Responsible for ensuring the wellbeing & safety of all Novartis associates at the site.* * Responsible for the planning and execution of site-wide communications and events.* * Responsible for site communication and driving cultural and business change for the site* * Chair of site wide committees (HSE, events, cultural, leadership)

Basel, Baselstadt, Ch

* * Member of the Novartis Ophthalmology Development Unit leadership team.* * Accountable for setting the glaucoma and ENT disease area development strategies based on unmet medical needs.* * Accountable for the development of pharmacological assets designed to meet the significant unmet medical needs in the glaucoma and ENT disease areas.* * Accountable for the leadership of the glaucoma and ENT global project teams, developing drug/drug-device products that address the patients unmet medical needs.* * Accountable for global maintenance of the Novartis ophthalmology marketed product portfolio.

Geneva, Switzerland, Ch

* * Member of the Alcon R&D leadership team.* * Accountable for the project management of 200+ projects across distinct pharmaceutical, medical device and consumer product (device) portfolios. * * Responsible for the leadership of a global 25 associate project management organization.* * Accountable for the portfolio management of 3 distinct portfolios ranging from OTC, Pharmaceutical, medical device and consumer device product projects at the franchise and corporate level.* * Responsible for defining and executing project and portfolio management methodologies and processes, inclusive of the project and portfolio management IT solution as the single source of truth.* * A member of the Alcon R&D Governance Committees, responsible for the management of the committees.

Geneva, Switzerland, Ch

* * Responsible for identifying and defining global unmet medical needs, creating and obtaining executive governance approval of the global ophthalmic biological asset, RTH258 for the treatment of wAMD, DME and RVO. Responsible and accountable for defining and executing proof of concept and Phase III project/product development strategies and plans with R&D spend in the hundreds of millions (USD).* * Accountable for the leadership and management of project leader(s) of multiple projects for development of pharmaceutical drugs and drug/device products for the treatment of ophthalmic retina diseases.

Geneva, Switzerland, Ch

* * Responsible for identifying and defining global unmet medical needs, creating and obtaining executive governance approval of the global Ophthalmic External Disease (inflammatory diseases of the cornea, conjunctiva and anterior segment of eye, allergic conjunctivitis, dry eye, surgical inflammation and pain, uveitis (anterior & posterior), OTC dry eye and nutritional supplements) pipeline strategy and project/product development strategies for pharmaceutical drugs and drug/device products. * * Responsible for identifying and defining global unmet medical needs, creating and obtaining executive governance approval of global Otic infectious diseases, (acute otitis externa, acute otitis media w/ tubes, acute otitis media) pipeline strategy and project/product development strategies for pharmaceutical drugs, drug/device products. * * Responsible for the development of Ophthalmic Surgical Solution drug/device products.* * Responsible for the development and management of medical expert advisory boards for defining unmet medical needs, strategy validations and expert input and opinion on clinical study designs and outcomes. * * Responsible for all aspects (scientific and technical focus) of global clinical trials from Phase I to III (including POC studies), medical communications and publications.* * Directly manage a group of Project Heads who are responsible for providing global leadership to multi-disciplinary project teams for the execution of therapeutic area strategies.* * Responsible for the Health Economics & Outcomes Research strategies, development plans and product value dossiers for all pharmaceutical ophthalmic, otic and nasal products and ophthalmic surgical products. Directly manage a group of HE&OR experts.* * Responsible for providing and ensuring the strategic direction for all regulatory filings and submissions. Achieved 10+ major region product approvals.

Geneva, Switzerland, Ch

* * Responsible for identifying and defining global unmet medical needs, creating and obtaining executive governance approval of the global Ophthalmic Glaucoma Disease (IOP lowering) pipeline strategy and project/product development strategies for pharmaceutical drugs and drug/device products. * * Responsible for all aspects (scientific and technical focus) of global clinical trials from Phase I to III (including POC studies), medical communications and publications.* * Directly manage a group of Project Heads who are responsible for providing global leadership to multi-disciplinary project teams for the execution of therapeutic area strategies.* * Responsible for the technical evaluation, assessment and due-diligence of all glaucoma pharmaceutical product candidates from external sources. Also, served as primary clinical reviewer.* * Responsible for providing and ensuring the strategic direction for all regulatory filings and submissions. Achieved 4 major region product approvals.

Geneva, Switzerland, Ch

* * Responsible for the full development of ophthalmic Rx drug products indicated for the treatment of the signs and symptoms of dry eye.* * Instrumental in the setting and execution of the dry eye drug product development strategic plan.* * Participate as the dry eye clinical expert in the review and assessment of external technology opportunities.* * Responsible for the clinical development of global ophthalmic Rx dry eye drug products, including clinical trial design, management, analysis, reporting and submission of clinical trial data to regulatory authorities.* * Manage and provide technical direction and support to multiple ophthalmic Rx drug product (anti-infective/anti-inflammatory combination, dry eye and glaucoma) development teams * * Directly responsible for the management of a group of multi-degreed clinical research scientists and professionals.* * Achieved 2 major region product approvals.

Geneva, Switzerland, Ch

* * Responsible for the clinical development of Nasal dosage form drug products, including clinical trial design, execution of clinical trials, reporting and submission of clinical trial data to regulatory authorities.* * Managed and provided technical direction and support for the CMC related development activities of a Nasal dosage form product. * * Responsible for the project management of the development, regulatory submission and gaining regulatory approval of proprietary Nasal dosage form products.

Bridgewater, Nj, Us

* * Responsible for the development, FDA submission and gaining FDA approval of generic (ANDA) and proprietary (NDA) Ophthalmic (sterile), Nasal (non-sterile) and Inhalation (sterile) solution, suspension, semisolid, solid and sustained release dosage form products.* * Managed a 1.5x expansion of a multi-degreed Ophthalmic, Inhalation and Nasal pharmaceutical product development group of scientists whose skills range from packaging engineering, formulations, process development, analytical method development / validation, stability and data acquisition and network management. Total group size of 72 technical professionals.* * Achieved FDA approval for the first generic Nasal product, Desmopressin Acetate Nasal Solution 0.01% followed by Cromolyn Sodium Nasal Solution USP 5.2 mg/spray, Flunisolide Nasal Solution USP 0.025 mg/spray, Ipratropium Bromide Nasal Solution 0.021 mg/spray and Ipratropium Bromide Nasal Solution 0.042 mg/spray. * * Achieved FDA approvals for Carteolol Ophthalmic Solution (1%), Albuterol Sulfate Inhalation Solution (0.083%), Tobramycin (0.3%) and Dexamethasone (0.1%) Ophthalmic Suspension, Betaxolol Hydrochloride Ophthalmic Solution, (0.5%), Cromolyn Sodium Inhalation Solution (1%) and Ipratropium Bromide Inhalation Solution (0.02%). * * Managed and provided technical support for drug product commercialization, PAI’s, NDA/ANDA post approval amendments and annual updates.* * Produced clinical trial material for ophthalmic proprietary products.* * Managed multi-million dollar expense and capital budgets.* * Developing a core competency for the development of Over the Counter drug products.* * Instrumental in the R&D strategic resource and product planning process.* * Participated in the review and assessment of external pharmaceutical technology and biotechnology opportunities for Bausch & Lomb.

Bridgewater, Nj, Us

* * Responsible for the development, FDA submission and gaining FDA approval of generic (ANDA) and proprietary (NDA) Ophthalmic (sterile), Nasal (non-sterile) and Inhalation (sterile) solution, suspension and semi-solid dosage form products.* * Managed a 2x expansion of a multi-degreed Ophthalmic and Nasal pharmaceutical product development group of scientists whose skills ranged from packaging engineering, formulations, process development, analytical method development / validation, stability and data network management.* * Produced clinical trial material for an ophthalmic proprietary product.* * Achieved FDA approval for Bausch & Lomb Pharmaceuticals flagship proprietary products, Lotemax® and Alrex® (NDA’s).* * Achieved FDA approval for Albuterol Sulfate Solution for Inhalation, 0.5% (ANDA).

Bridgewater, Nj, Us

* * Project managed 2 proprietary ophthalmic steroid suspension products through post- FDA submission leading up to approval.* * Project managed 1 proprietary ophthalmic steroid suspension product through development leading up to an European submission.* * Project managed 1 proprietary ophthalmic combination suspension product through development into clinical studies.* * Instrumental in developing and implementing a formal project management system.* * Lead a multinational technical team for the development and optimization of the commercial chemical synthesis of a steroid Active Pharmaceutical Ingredient.

Abbott Park, Illinois, Us

* * IMx Free T3 Project Manager with the direct responsibilityof the feasibility, research and development, process and test method validations, clinical evaluation and market entry of an automated thyroid hormone immunoassay diagnostic device.* * Development of two automated microparticle enzyme immunoassays (MEIA) for the picogram/ml detection of a free thyroid hormone (Free T3) in blood serum or plasma.

Post-Doctoral Fellowship, Cell/Cellular And Molecular Biology

Doctor Of Philosophy (Ph.D.), Bioorganic Chemistry

Master’S Degree, Chemistry

Bachelor’S Degree, Chemistry Biochemistry