Sancilio and Company
Pharmaceuticals professional with 18 years’ experience in the industry in various leadership and management positions. Experience of working with small molecule and large molecules. Responsible for establishing and managing a broad range of complex global alliances with external BioPharma companies and own the entire alliance management process (from identifying potential partners, understanding their needs, to defining joint projects) and will work closely with our team of Product Managers to ensure a smooth project delivery.
Experience working in oncology, neurology (Als, Alzheimer’s, dementia and TBI), rare diseases, nephrology, respiratory tract infections (PMDI and Nasal Sprays), infectious diseases, GI, pain management therapeutic areas. Extensive laboratory experience, successfully manage business development, projects and delivers organizational and project leadership for drug discovery and Generic commercialization and lifecycle projects which include commercial product development activities, clinical trials, preclinical trails, manufacturing, analytical development, commercial process development, process characterization and validation, new formulations, new manufacturing processes, process and technology transfers and new or platform drug delivery devices.
Regulatory submission experience (NDAs, MAAs, BLA, INDs) includes authoring (Modules 2 and 3) as well as building IND/NDA/MAA submission plans from ground up. Extensive laboratory experience, successfully manages a group of Senior Scientist/Scientists, seamlessly plans and manages the daily activities of the analytical department including the testing, calibration, method development & validation and technology transfers.Pharmaceuticals professional with 18 years’ experience in the industry in various leadership and management positions. Experience of working with small molecule and large molecules. Responsible for establishing and managing a broad range of complex global alliances with external BioPharma companies and own the entire alliance management process (from identifying potential partners, understanding their needs, to defining joint projects) and will work closely with our team of Product Managers to ensure a smooth project delivery. Experience working in oncology, neurology (Als, Alzheimer’s, dementia and TBI), rare diseases, nephrology, respiratory tract infections (PMDI and Nasal Sprays), infectious diseases, GI, pain management therapeutic areas. Extensive laboratory experience, successfully manage business development, projects and delivers organizational and project leadership for drug discovery and Generic commercialization and lifecycle projects which include commercial product development activities, clinical trials, preclinical trails, manufacturing, analytical development, commercial process development, process characterization and validation, new formulations, new manufacturing processes, process and technology transfers and new or platform drug delivery devices. Regulatory submission experience (NDAs, MAAs, BLA, INDs) includes authoring (Modules 2 and 3) as well as building IND/NDA/MAA submission plans from ground up. Extensive laboratory experience, successfully manages a group of Senior Scientist/Scientists, seamlessly plans and manages the daily activities of the analytical department including the testing, calibration, method development & validation and technology transfers.
This person is not in any teams
This person is not in any offices
Sancilio and Company
1 followers
Incorporated in 2019, Sancilio and Company is wholly owned by Dr. and Mrs. Sancilio. Offices of the firm are in Stuart, Florida. Sancilio and Company has three lines of businesses: Clearway Global operates as a pharmaceutical research & development service through a network of associates that span the entire development process from discovery through clinical trials; Omega Blu, a company which sells high quality nutritional products; and Altemia, a medical food company, with products developed for the dietary management of sickle cell disease. At present, Sancilio is involved in the management of several NDA programs at various stages of development. We are actively engaged in sourcing API from global manufacturers, designing regulatory strategies for new and existing drugs, project managing the creation of CMC packages for NDA submissions and developing clinical research programs for eventual submission to the US FDA. More recently, we've began working with global CROs to design pathways to approval external to the United States. Hence, we are meeting with regulators in Japan and elsewhere to design parallel international regulatory strategies. We have been operating our contract development business as "Clearway Global" for the past 2 years and recently incorporated Sancilio and Company, Inc. to manage the internal research programs and product offerings. The former company using a similar name (Sancilio Pharmaceutical Company, Inc.) was founded by the Sancilio family in 2005. Following a change of control in 2017, the Sancilio family departed and operations and management was reorganized. Eventually assets of the former company were sold to several acquirers and remaining operations were terminated. The new Sancilio and Company, is sponsoring its own development work in fatty acid research, improved bio-availability of lipids and applications of essential fatty acids to treat disease.