A novel approach to collaborative product development in the medical-equipment industry

In this study, we summarise the requirements for collaborative product development based on our investigation of the differences in the resources and tools that are needed for the various stages of collaborative product development and the needs of system users during these various stages. We proposed a user-oriented approach of collaborative product development for medical equipment and designed a collaborative product development system with the required functionalities to satisfy different areas according to their roles and workflow. The system we developed can drastically simplify the original complex and dispersed process of product development for intelligent medical equipment, thereby allowing the project team to develop new medical-equipment products and promote interactions among the research and development staff, clinical specialists, and the test participants successfully, thereby resulting in a user-oriented collaborative product development process

Flexible Manufacturing Facility for Biopharmaceuticals

Monoclonal antibodies (mAbs) have the potential to treat a wide range of diseases. They possess the ability to bind target molecules in a highly specific and effective manner. Recently, great technological advances have been made to enhance the therapeutic effects of these drugs, making treatment cheaper, easier, and more effective while allowing companies to profit significantly. As a Contract Manufacturing Organization (CMO) for these products, we offer the newest technology and many flexible options for producing these proteins. Our facility is designed to produce protein products in Chinese Hamster Ovary (CHO) cells, followed by modification and purification steps. We present the option to cleave smaller antigen binding fragments (Fab) from the mAb product, removing the crystallizable fragment (Fc) which can interfere with the binding specificity of the drug. We also offer the option for polyethylene glycosylation (PEGylation), which has been shown to improve the effectiveness of these drugs. The attachment of a polyethylene glycol (PEG) molecule to the protein enhances its circulation time in the human body so that less frequent doses are needed. To demonstrate the capabilities of this flexible facility, we have modeled the production of an innovative PEGylated anti-TNF-α mAb. Celltech and Pfizer currently have similar products in Phase III clinical trials; and UCB Incorporated’s Cimzia® recently received FDA approval for the first humanized PEGylated anti-TNF-α Fab’ therapeutic protein. Many non- PEGylated TNF-α inhibitor mAbs are currently on the market to treat pathologies including rheumatoid arthritis and Crohn’s disease. PEGylated products have a clear advantage over these drugs. Our facility can produce up to 55 batches of protein product a year for a maximum yield of 993 kg. For economic analysis of this product, sales from the first year of Cimzia® were considered since this product is almost identical to the one being modeled. Producing at 75% of the total design capacity, this facility has a NPV of $1,319,592,100, an IRR of 33.51% and an ROI of 53.0%. This level of production would leave a significant amount of time remaining for other products to be manufactured as well. The additional products that the facility will produce will be mAbs of all forms (i.e. cleaved, uncleaved, PEGylated, non-PEGylated) that are protected under IP for small biotech firms that do not have the capital to build such facilities. Currently, small biotech firms are producing 81 mAbs and are looking to license production for their Phase III molecules. Clearly, this will become a very profitable CMO as we would be able to capture much of this demand. A major threat looming over the mAb market, however, is the production of small molecular inhibitors, which are currently in Phase I and Phase II clinical trials. Such molecules may be able to capture the full market since they would not only have significant delivery advantages over TNF-α inhibitors, which require injection, but also might have an enhanced side effect profile compared with biologics

Monomorphic Ventricular Arrhythmias in Athletes.

Ventricular arrhythmias are challenging to manage in athletes with concern for an elevated risk of sudden cardiac death (SCD) during sports competition. Monomorphic ventricular arrhythmias (MMVA), while often benign in athletes with a structurally normal heart, are also associated with a unique subset of idiopathic and malignant substrates that must be clearly defined. A comprehensive evaluation for structural and/or electrical heart disease is required in order to exclude cardiac conditions that increase risk of SCD with exercise, such as hypertrophic cardiomyopathy and arrhythmogenic right ventricular cardiomyopathy. Unique issues for physicians who manage this population include navigating athletes through the decision of whether they can safely continue their chosen sport. In the absence of structural heart disease, therapies such as radiofrequency catheter ablation are very effective for certain arrhythmias and may allow for return to competitive sports participation. In this comprehensive review, we summarise the recommendations for evaluating and managing athletes with MMVA