The chemokine system belongs to a large family of inflammatory cytokines and receptors. Approximately 50 chemokines and 20 receptors have been identified and shown to play a critical role in tumor growth, inflammatory response, infection, autoimmune disorders, neoplasm, vascular diseases, and transplant rejection (Locati et al. 2005, Slettenaar and Wilson 2006).
The single most important factor influencing pharmaceutical and biopharmaceutical decisions is demand forecasting. Forecasts impact decisions regarding capital cost, outsourcing for product commercialization, and many other critical aspects of production. It’s no secret that drug forecasts are notoriously incorrect, and often by large margins. John LaMattina, former president of Pfizer Global R&D, foresees no improvement in forecasting accuracy. How then, do companies minimize risk?
While forecasts can never be 100% accurate, the goal for biopharmaceutical forecasters should be to minimize the degree of inaccuracies as much as possible. To reduce the impact of inaccurate forecasting over the life cycle of a product, companies need to focus on those variables that they have the most control over.
From discussions with pharmaceutical and biotechnology industry leaders, it is clear that demand forecasting is a significant challenge when planning biologic drug substance production.
Novel therapeutics such as gene and cell therapies, nanoparticles, and combination products requiring targeted delivery, novel treatments for wound healing, cardiovascular disease, and bone regeneration, and new medical device technologies call for innovative surgical procedures in preclinical trials to determine safety and efficacy.
Genentech, a member of the Roche Group , recently announced that the U.S. Food and Drug Administration (FDA) approved Xolair (omalizumab) to treat moderate to severe persistent asthma in children six to 11 years of age, who have had a positive skin test or in vitro reactivity to an airborne allergen and have symptoms that are inadequately controlled with inhaled corticosteroids4