Corden Pharma Experts taking care. APIs DRUG PRODUCTS FACILITIES PLATFORMS ABOUT US CONTACT US In the News Home About Us News and Press Article >> Pharmaceutical Technology, June 2015 > Dr. Roberto Margarita Thought Leader Profile Article >> Pharmaceutical Technology, June 2015 > Dr. Roberto Margarita Thought Leader Profile Jul 06, 2015 Dr. Roberto Margarita, Director, Global Antibiotics & Oncology Platforms, CPI - Pharmaceutical Technology Thought Leader Profile - Resistance to Antibiotics is Driving A New Product Wave With Innovative Challenges. "Antibiotics have saved millions of lives since their discovery almost a century ago. Despite new infectious diseases that have been discovered nearly every year for the past 30 years, very few new drug treatments have been discovered and developed in the last 40 years, with some exceptions in the beginning of the new millennium. This technological gap has left space in the disease evolution that, combined with inefficient compliance with therapeutic regimes, has provided the space for bacterial species to become resistant to existing treatments. These increasing threats of drug-resistant “superbugs” have drawn the attention of regulator and pharmaceutical players to expedite the race for new solutions, whether they be natural products, naturally-derived products, synthetic or protein peptides. Clinical development scientists have been active in combining products to increase the efficacy of the treatments. By continuing to respond to the sensitization of certain classes of antibiotics, regulators have also increased the requirements for dedicated manufacturing facilities in different sub-classes of pharmaceutical products like beta-lactam antibiotics and their combination with protease inhibitors. The FDA has been a leading agency in this field with a formal guideline issued in 2013. Having also recognized the need for an accelerated regulatory path for drugs meeting the required lifesaving criteria, regulators have installed a fast track to breakthrough program and other sponsorship programs to optimize the development costs for new treatments. This competitive race to new compounds shortens the dedicated time needed to understand the process required to meet the fast development cycle, leading to new challenges for process and formulator manufacturers. In light of this, identifying the critical process parameters has become even more crucial to ensuring development and launch with acceptable robustness. CordenPharma approaches this challenge by supporting biotechnology and pharmaceutical companies with segregated and non-segregated facilities to meet their requirements for driving antibiotic development and global supply chain. The expertise CordenPharma offers in the battle against “superbugs” is a fully dedicated business platform that provides technical solutions to the formulation of oral dosage and sterile products, all within a facility network capable of global market supply to the US, Europe, Japan and other BRIC countries." Read the full article here. About Us Leadership Our History Compliance News and Press Events ICIG Careers Corden Pharma ©2012 CordenPharma International Media Contact Impressum Terms and Conditions Privacy Policy Website by Boston Interactive Facebook LinkedIn Corden Pharma International GmbH, Otto-Hahn-Strasse, 68723 Plankstadt, Germany. APIs API Development API Contract Manufacturing Generic API Manufacturing Highly Potent APIs Sterile APIs Peptides Building Blocks Conjugate Products Carbohydrates Derivatized Phospholipids Support Services Drug Products Drug Product Development Drug Product Contract Manufacturing Sterile Formulation Highly Potent Formulation Oncology Cephalosporin Manufacturing Penicillin Manufacturing Parenterals Large Pre-Filled Syringes Sterile Oncology Oral Oncology Two-layer tablets Clinical Supply Services Packaging Pharma-Logistics Support Services Facilities Bergamo, IT Boulder, US Brussels, BE Caponago, IT Chenôve, FR Latina, IT Plankstadt, DE Liestal, CH Platforms Antibiotics Highly Potent & Oncology Small Molecules Peptides, Lipids & Carbohydrates Injectables About Us Leadership Our History Compliance News and Press Events ICIG Careers Contact Us Find Your Expert Schedule an Appt