Michael W. Email & Phone Number

Vancouver, Bc, Ca

Vancouver, British Columbia, Canada

Provide leadership to the translation of strategy into operational plans and success for InMed's products and preclinical and clinical pharmaceutical programs. Utilize operational and managerial procedures, team leadership, reporting structures and operational controls to create growth and build a world class, industry leading organization. Effectively communicate and foster growth among the executive team and all employees to retain and develop a creative, highly productive and profitable company.

Vancouver, British Columbia, Canada

Responsible for for strategy, operational excellence and execution of all CMC activities related to InMed’s APIs and drug products (sterile and non-sterile) including formulation, process and analytical development, scale up, CRO / CDMO selection and management, tech transfer, regulatory filing writing, review and response and all associated CMC planning and budgeting in support of InMed's preclinical and clinical programs.

1503 Cliveden Avenue, Delta, Bc, Canada, V3M6P7

Responsibilities and experience include; - Operational and financial responsibility for Phyton Biotech LLC, Canada, a manufacturer of Active Pharmaceuticals Ingredients (API) from plant cell fermentation (PCF®) including contract development and manufacturing services to global pharmaceutical customers and partners.- Developed and managed operational and capital budgets.- Led a diverse and highly skilled team including Engineering, Quality Assurance, Regulatory, Quality Control and Operations teams. - Developed and implemented manufacturing, quality, regulatory and business activities with sister site producing the API starting material near Hamburg, Germany.- 19+ years of CMC expertise with regards to the development, scale up, validation and commercialization of sterile drug products and API’s with extensive tech transfer and successful CMO management expertise.- Implemented strategic plans for existing API manufacture and other compounds derived from Phyton’s PCF® technology to reduce costs, improve process efficiency and capacity and minimizing regulatory impacts.- Evaluated and promoted business opportunities with regards to expansion, partnerning or other related opportunities.- Experience with organizing teams and directly interacting with FDA, Health Canada, EMEA, Korean and other regulatory auditors.- Maintained and developed an engaging and challenging work environment to attract, develop, manage and retain staff at all levels in the company.

Delta, Bc, Canada

Responsibilities include;- Led the manufacturing operations for the production of starting materials, intermediates and Phyton's commercial GMP API's.- Led the Development Services group consisting of a team of highly skilled PhD, Master's and BSc. chemists focused on the development of Phyton's internal products and, provision of custom solutions for external customers. Projects included synthetic route development, provision of standards, optimization of current API processes to improve yield, reduce impurities and ensure future regulatory needs will be met. - Budget responsibility and strategic planning for operations and development services areas within Phyton including input on the overall supply and distribution network to global customers. - Representative for manufacturing operations during regulatory inspections (e.g. FDA, KFDA, Health Canada, TGA, EDQM)- Provided engineering expertise to Engineering and Facilities groups for new capital or modifications to existing facility and manufacturing support systems and processes.- Coordinated, reviewed and approved GMP documentation for validation, qualification , standard operating procedures and regulatory submission documentation for Phtyon's products.

Burnaby, Bc, Canada

Tekmira Pharmaceuticals Corporation, now Arbutus Biopharma (ABUS) a biopharmaceutical company developing and commercializing proprietary drugs and drug delivery systems to improve the treatment of cancer and other diseases.Key responsibilities included;- Facility management of Tekmira's pharmaceutical research, development and manufacturing and vivarium facilities.- Management of the Facility team. - Coordination and management of the technology transfer of Tekmira's clinical stage products to contract manufacturing sites.- Generation and management responsibility for the facilities and related manufacturing budgets.- Project management, design, installation and commissioning of Tekmira's internal manufacturing suite for Phase I and II clinical trial material.- Management of the maintenance, calibration and equipment qualification programs for Tekmira's equipment, process and laboratory systems. - Technical writing support and approval of GMP documentation to support Tekmira's facility and manufacturing operations.

Vancouver

Cardiome Pharma Corp.(CRME) is a biopharmaceutical company based in Vancouver, B.C., Canada, with offices in USA and Switzerland. Cardiome has commercialized products for various cardiovascular and skin conditions with a pulmonary arterial hypertension product in clinical development.Key responsibilities included;- Identification, selection and leading the technology transfer of Cardiome's late stage development / commercial drug products (e.g. Brinavess) to global contract drug product manufacturing sites.- Provision of CMC and technical support for the manufacture of GMP and GLP drug products for Cardiome's pre-clinical and clinical drug products.- Technical writing, review and auditing of CMC drug product and API CTD sections for Cardiome's regulatory filings. - Auditor and/or team member for external technical or QA audits at contract facilities.- Development and generation of manufacturing budget to support Cardiome's external drug product manufacturing.- Authored technical reports, SOP's and GMP manufacturing documentation to support Cardiome's development and commercial drug products.

Burnaby, Bc

- Led a group of Scientists and Technologists focused on the successful transfer, qualification and process validation of Tekmira's liposomal vincristine drug product, Marquibo.- Managed the interface between Inex and its CMO's for clinical supplies and, ensured compliance at all steps of the process including process and cleaning validation of sterile injectables.- Coordinated, reviewed and provided technical support with regards to CMC sections of the NDA filing.- Participated in face to face meetings with Regualtory agencies for technical meetings or on site audits. - Responsible for the generation and management of the technology transfer and manufacturing budget to support internal development and external contract costs. - Part of the development team responsible for the scale up and commerical development of the drug product process to produce Inex's liposomal drug product formulation for Marquibo.

London, Ontario, Canada

- Provided technical manufacturing and process engineering support for the encapsulated products within the London Capsules (3M Medical Specialties Division) & Adhesives Plants.- Designed, coordinated and managed process equipment and facility upgrades for new and existing products. - Worked with the 3M Research group to provide manufacturing & engineering technical advice and support to scale lab products from bench to production scale.- Technical lead for hazardous operation assessments (HAZOPs) for new and existing equipment and systems used in flammable environments. - Provided feasibility and cost estimates for new processes at early and late stage development. - Technical lead for on site quality or customer audits