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."

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