Pharmacologic Advances Essay -- bioservices, anti-body

Aligning to IBT BioServices’s business model and core competency, the top four critical needs and requirements have been identified from Model 1 assessment. These criteria are compared and contrasted to the company’s model and key strengths to develop a strategic roadmap for further expansion of the market position and share. The key learning from this assessment includes (Figure 4): 1. Need of surrogate assays model that are reliable (in-vitro and in-vivo assays) and predictive of protective immunity against RSV and DEN. This is a demonstrated key strength area for IBT BioServices with their cotton rat model. The company successfully tested RSV vaccine and therapeutic candidates that led to IND and clinical development (IBT BioServices). Their in-vitro assay platform, particularly CPE assay, provides high correlation of inhibitory and efficacy measurements of vaccine candidates to human subject. This is essential preliminary data needed to design pre-clinical and clinical trials direction. 2. Develop new assays platform that is compatible for next generation technology and approach e.g. structural-based design to develop RSV vaccines (vaccine research center- NIAID-NIH). This approach utilized atomic-level details of RSV protein to detect binding mechanisms of fusion glycoprotein needed to neutralize human RSV antibody (Oplinger, 2013). The assays must be able to measure and follow the activity of the protein-antibody complex to develop higher efficacy vaccine. 3. Compliance and data integrity. Early phase R&D programs do not require GLP certification; however, there are benefits in establishing such programs. In this industry the concept of speed to market is essential and critical for market share and profit generation. The th... ...o 2016, Stockpile Analysis, Competitive Benchmarking and Pipeline Analysis. Retrieved from: http://www.researchandmarkets.com/reports/1195531/the_future_of_global_vaccines_market_forecasts (n.d.). Services for respiratory syncytial virus research. Retrieved from IBT BioServices website: www.ibtbioservices.com (n.d.). Services for dengue virus research. Retrieved from IBT BioServices website: www.ibtbioservices.com Thomas, S. (2011). The Necessity and Quandaries of Dengue Vaccine Development. J Infect Dis., 203 (3), 299 303. doi: 10.1093/infdis/jiq060 WHO. (2014). Dengue. Retrieved from: http://www.who.int/immunization/diseases/dengue/en/ Wilson, P. (2010). Giving developing countries the best shot: An overview of vaccine access and R&D. Retrieved from: http://www.oxfam.org/sites/www.oxfam.org/files/giving-developing-countries-best-shot-vaccines-2010-05.pdf