The Biopharmaceutics Classification System (BCS), developed by the U.S. Food and Drug Administration to simplify and accelerate the drug development process, helps companies when they file for bioequivalence of dosage forms based on in vitro dissolution testing. The objective of the BCS system is to predict in vivo performance of drugs from in vitro measurements of solubility and permeability. The system has evolved to classify low-soluble drugs according to their permeability (BCS Class II or IV). A compound’s classification (I through IV) is indicative of its potential bioavailability.
To better understand the issues that biopharmaceutical companies face when planning for clinical and commercial biologic drug substance manufacturing and supply needs, ORC International conducted interviews with biopharmaceutical executives in North America and Europe who consistently utilize forecasts for drug substance and commercial manufacturing planning for biologics. This research explored the causes, consequences, and potential solutions to forecasting challenges specifically related to biologic drug substance manufacturing.
Pharmaceutical company marketing executives have become more accurate in positioning their new product in the marketplace, profiling prescribers, and understanding and responding to the reimbursement landscape. What is still a quagmire for pharma companies is predicting the actual demand for products and the timing of that demand.
Demand forecasts are often wrong because they are developed to inform manufacturing commitments as many as four to five years before product launch. As contractual relationships with CMOs are driven by forecasts inaccurate forecasts can “result in unfavorable pricing, financial penalties, and inappropriate capacity,” according to Jim Miller, President of PharmSource, a pharmaceutical industry contract manufacturing intelligence firm.
The path from molecule to market isn’t getting any easier. The costs of drug development over the last five years have continued to rise while sales during the same timeframe have tumbled. This calls for streamlining of today’s current drug development process. Read how today’s experts think this can be accomplished.
Teva Pharmaceutical Industries Ltd. announced recently that the U.S. Food and Drug Administration (FDA) has accepted for review the company’s new drug applications (NDAs) for two products for adolescent and adult patients with asthma