Facilitating Clinical ProtocolsWed, 09/09/2015 - 11:55
Q: What were the most important opportunities you identified in the CRO industry segment?
A: Inspire Pharma was established in 2013 with the idea of developing a different kind of clinical research center. We wanted to bridge a gap between two sides of the sector. On one side, the pharmaceutical industry is in dire need of professionals trained in clinical research and on the other, the private medical community has a high patient flow rate but does not perform clinical research due to a lack of knowledge and experience in the field. Therefore, Inspire Pharma can help the pharmaceutical industry to identify researchers and physicians who meet all the necessary requirements for conducting clinical research. Simultaneously, we can train and advise these physicians on the correct procedures for carrying out the entire research process surrounding clinical research. Therefore, we facilitate the process of conducting clinical protocols in Mexico due to our quality research services.
Q: What do physicians need to understand better about the clinical trials industry?
A: Doctors are not familiar with many aspects of the pharmaceutical industry, such as functionality, purpose and the avenues for professional development it can offer them. To counter this, we propose the integration of education related to clinical research into university curricula, and in the meantime, forums should be created to train doctors on target areas and to help future researchers better understand the pharmaceutical industry. We believe that, by educating physicians about key issues facing the clinical research industry, future medical specialists will be trained with a clear idea of how their medical practice correlates with clinical research. As a result, there will be more opportunities for conducting clinical trials in Mexico.
Q: What are the priority areas for your clinical trial studies?
A: We are working on projects related to ophthalmology, metabolism, and medical weight loss devices. We determined these areas as our priorities since the incidence of diseases related to these specific fields is high in Mexico, yet treatment options remain limited, providing the ideal environment for us to support the country’s medical infrastructure. We are also unique in terms of research centers as, instead of adopting the traditional structure of setting up and managing research from our facilities, we embed ourselves in the habitat of the patient and investigator. This reduces project risk by ensuring that investigation procedures are carried out in a familiar environment for patients and physicians alike.
Q: What proportion of your clients is represented by CROs and how have their criteria for research sites evolved?
A: Around 70% of our customers are represented by CROs. When selecting a research center, they mainly look for extensive experience in conducting clinical trials and a high population of potential patients. Our working model involves providing the necessary experience and knowledge to obtain quality results while our partners provide clinical expertise and high patient volume. Our partners agree that the best way to develop quality clinical research is to develop projects in the same environment the patients are accustomed to, so they have a deep understanding of our infrastructure model and provide invaluable support. Developing Phase I projects is not currently in our immediate plans. Furthermore, patients experience real benefits through Inspire Pharma. The main advantage for the patients involved in such research is the access they are given to a new generation of drugs and medical devices with the potential to help cure their diseases, as well as being able to access private healthcare services, which will closely monitor the development of their condition.
Q: What do you look for in potential clinical research sites?
A: All our procedures are based on operating manuals and SOPs that meet the requirements of any quality system, but do not have a certification by an official entity such as ISO. So far, none of our clients have requested that specific certification but we believe that it would beneficial for COFEPRIS to create specific accreditations for research centers. This would be a long term project and we do not anticipate the implementation of these measures in the near future. We have also participated in FDA audits and we know that we are subject to further audits at any given time. Our operations rely on manual procedures because we realize there is a direct correlation between the number of successful audits received by Mexican companies and the attraction the country poses as a beneficiary of foreign investment.