PDF Available > Focusing on patients and improved outcomes in a rapidly evolving environment requires maintaining appropriate controls to ensure quality and compliance from early in the lifecycle. A well-designed and stage-appropriate Quality Management System (QMS) is essential to facilitate the development and commercialization of these advanced treatments. Converge Consulting understands the complexities and [...]
PDF Available > Planning for, establishing, and managing the Clinical Supply Chain has its own set of challenges – regulatory requirements, clinical uncertainties, nuances of sourcing drug substance and API material, and logistical constraints including access to new points of patient care. Clinical supply leaders need to manage all of these while ensuring quality [...]
PDF Available > DSCSA serialization regulations in the U.S. and EUFMD directives in Europe are now being enforced for manufacturers. Other standards around the globe are also advancing. The focus of Life Sciences manufacturers is shifting from serialization planning and preparation to execution, management, and business value. With manufacturer requirements in place, serialization is [...]
After spending years researching, developing, and testing innovative drug candidates, emerging biopharmaceutical companies successfully progressing in clinical development begin preparing for their first commercial launch. As this organizational transformation nears, the focus of the IT organization shifts from infrastructure and help desk support to business enablement as new functions like Sales, Medical Affairs, [...]
As life science companies advance beyond the first launch of commercial products, strategic focus shifts. Attention moves to expanding the business, regulatory and geographic reach of their treatments. Market expansion, label expansion, and further pipeline development create more opportunities. Companies pursue these efforts in parallel as quickly as possible. The initial supply and [...]
PDF Available > Cellular and regenerative medicine introduces a shift in healthcare - the promise of using the body’s own abilities to heal. Innovation in this area is driving dramatic change in the prevention, treatment and cure of diseases and disorders. The nature of cell and gene therapies (CGT) requires rethinking traditional business models [...]
PDF Available > Development of advanced therapies requires innovative manufacturing and process engineering. CMC (Chemistry, Manufacturing, and Controls) activities expand, evolve, and refocus over time. Companies move from toxicology studies through IND-enabling activities, and from preclinical and clinical testing through commercialization. Tasks and objectives change, but the need for speed, precision, flexible thinking, and [...]
PDF Available > Managing enterprise information technology in emerging and growing Life Science companies is challenging beyond the typical IT dilemma. This info sheet explains how Converge develops Enterprise IT strategies in life science. Emerging biopharma companies work with limited resources, scientific and regulatory uncertainties, and strict compliance requirements. New business and information needs [...]
PDF Available > Biopharmaceutical firms face huge challenges as they commercialize their drug discoveries. This info sheet explains Converge Consulting's Operational Excellence services that help mature companies optimize their processes at both the large and small scale. The level of internal risk is high given daunting technical challenges and complex regulatory requirements. You are [...]
PDF Available > Biopharmaceutical firms face an array of challenges in commercializing innovative therapies. This info sheet explains how Converge helps firms navigate the business challenges involved in Commercial Launch transformation. Business risk is high. There are daunting technical hurdles, evolving regulatory requirements, and you need to invest significant capital before success is assured. [...]