I work for growing biopharmaceutical leaders in development of innovative new medicines. Most recently, I helped develop and gained approval for one of the Covid-19 vaccines, a cardiovascular medicine for PAH (pulmonary arterial hypertension) and led the organizational process improvements to grow an oncology company from a single compound to a portfolio of compounds in clinical development.

Oncology Program Lead for development company and commercializing partner. Developed and commercialized Inqovi, which received early approval for the US, Canada and Australia during the critical Covid crisis and enabled patients to receive their medicine at home instead of requiring hospitalization. Inqovi is a cedazuridine / decitabine combination, a novel first in class oral nucleaoside metabolic inhibitor and anti-cancer DNA hypomethylating agent providing significant quality of life benefits for intermediate and high-risk myelodysplastic syndromes (MDS) and chronic myelomonocytic leukemia (CMML) patients, and a portfolio of hematology follow-on compounds

Leader of drug product development team (PDT) and global expansion for Respiratory & Immunology and Infectious Disease programs.Partnered with Deloitte and TayganPoint Management Consultant Teams for Cubist Pharmaceuticals acquisition and integration infectious disease portfolio.

Worked with large and small pharmaceutical/biotech leaders and management consulting companies on new product development, strategy, commercialization, regulatory registrations, supply chain, company acquisitions and integrations, due diligence and and business improvements using PMP project management and six sigma methodologies.

Worked with biopharmaceutical companies on product development, strategy and commercialization.

Leader of function to partner with technology centers of excellence to advance new innovations to give the company a competitive advantage.

- R&D New Product Development Leader, who played a key role in delivery of over 100 name brand healthcare medicine new products, innovations and line extensions of diverse delivery systems. Shepherded them through the development process, prepared clinical supplies, prepare for FDA and international filings in the Americas, EU and ROW and gained approval and commercialised. Dosage forms include liquids, solid dose, powders, sterile, tablets, liquigels.- Developed the product, conducted process development experimentation, pilot scale-up, clinical supply production, technology transfer, validation and start-up of new products- Played a key role in licensing opportunity evaluations, due diligence and cGMP audits of potential development partners, manufacturing plants and third party contract manufacturers (CMOs).- Led the company Simply Better Way Business Process Excellence program which transformed the company division to focus on medicines and divest non-core businesses. Part of the Team which established a cGMP pilot plant/manufacturing processes and prepared for FDA registration and inspections.- Led several process improvement programs, utilizing six sigma methodologies to trouble shoot and improve problems related to formulation, product quality, manufacturing operations and regulatory compliance at US and ex-US manufacturing sites, change management following several acquisitions and helping company become a global leader.

Lead for portfolio of complex fine powder imaging toner product development programs for Siemens (Munich) and several Japanese OEM co-development partners.