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 > After delays in the U.S., federal DSCSA serialization regulations are in effect for manufacturers. EUFMD directives in Europe and other standards around the globe are advancing. The focus of Life Sciences manufacturers is shifting from serialization planning and preparation to serialization execution and management. Serialization is now a standard part of [...]
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. [...]
PDF Available > This info sheet explains our Supply Chain services in more depth. After all, each stage of a company’s lifecycle has its own set of Supply Chain challenges – regulatory requirements, clinical and commercial uncertainties, logistical constraints and reaching new points of patient care. These all need to be managed while ensuring [...]
PDF Available > Converge Consulting helps Life Sciences companies focus on patient outcomes and succeed in today’s marketplace. This company profile explains how we bridge the gap between sound strategy and reliable execution. Clients benefit from the experience and capabilities of our practitioners, direct interaction with our senior team, and our commitment to delivering [...]