Mark Tracy Email & Phone Number

Tracy BioConsulting, LLC provides clients in the biotechnology and pharmaceutical industries with consulting services focused on effectively and pragmatically transforming research into new biopharmaceutical products. The company supports clients in bridging the knowledge, experience and capability gaps that very often exist as organizations strive to rapidly take biomedical research programs into and through the clinic. Tracy BioConsulting, LLC provides•Documented success in the development of nucleic acid, protein, peptide, and small molecule based medicines•Expertise in developing products incorporating novel drug delivery systems, nanotechnology, and targeting•Proven product development know-how and best practices, as well as successful advancement through the regulatory review and approval processes•Management and integration of alliance and collaboration partners•An extensive network of CROs and CMOs•Identification of new business opportunities and creation of value from technology platforms and capabilitiesPlease see www.tracybioconsulting.com for more information.

Cambridge, Massachusetts, Us

Built and led a multi-national RNAi delivery research and development alliance of industry and academic partners that enabled human clinical proof of concept for RNAi and a growing pipeline of clinical products. Matrixed-managed an international multi-department, mutli-organizational team of over 50 FTE. Directed technology assessment and due diligence activities. Headed delivery project and alliance management and business and financial planning.

Past President of the Controlled Release Society (CRS). President (2010-11). Board member (2008-12). As member of the Board of Directors and President of the CRS, a 1500 member international professional society for delivery science and technology, strengthened the organization by leading approval of new bylaws, a staff reorganization to enhance cost-effectiveness and value, launching a new website, and updating the strategic plan. Launched a new journal, "Drug Delivery and Translational Research," a new book series, established CRS College of Fellows, opened a new chapter in China, and chaired 2011 CRS Annual Meeting of ~1400 delegates.

Dublin, Ie

Played key role in establishing and building company's parenteral product development capabilities. Supervised a department responsible for formulation development and supporting regulatory filings and CMC aspects of product development for products enabled by novel parenteral and inhalable formulations including four commercialized products: Nutropin® Depot, Risperdal® Consta, Vivitrol®, and Bydureon®. Key member of the team that developed and scaled-up the first sustained delivery system for proteins approved by the FDA. Led project teams and collaborations with major international pharmaceutical and biotech companies through key product and clinical development decisions. Directed technology assessment and diligence activities.

Ph.D., Chemistry

Ms, Chemical Engineering

Bs, Chemical Engineering

Greater Boston Executive Program, Business Administration And Management