We are establishing the capability to conduct high quality clinical drug trials in Guatemala. To date, we have
• Established a modern research clinic in Guatemala City and developed the capability to establish satellite clinical sites in a host of dispersed communities throughout the country.
• Assembled on-the-ground teams with proven capabilities in research operations.
• Established relationships with highly qualified and experienced physician investigators and study coordinators.
• Built professional relationships with Guatemalan health and government authorities whose support is critical to overcoming inevitable obstacles and, most importantly, we have built trusting relationships with clinical trial patients.
We have established a business entity in Guatemala to support these efforts and are placing business development operations in the US, closer to the majority of pharmaceutical companies. We have made connections with a number of pharmaceutical firms and the partners and have a number of active business proposals under consideration.
We have established a legal entity (LLC, Ohio) and are establishing the equivalent in Guatemala. We have assembled an investigator network in Guatemala consisting of 6 physicians who are licensed, experienced in clinical research, have the necessary training in the regulations and importantly, are motivated by our philanthropic mission. We also have 2 study coordinators who wish to work with us. We have invested in developing standard operating procedures that govern research activities and have completed initial clinical site readiness reviews. We have developed a web site for marketing purposes. We have competed for and won the support of Xavier University’s Williams College of Business through their XLAB program; this partnership brings critical business expertise to us. Lastly, we have developed and tested initial marketing concepts to demonstrate the viability of the business venture.
What will it take for your project to be successful over the next three years? Please address each year separately, if possible.
We must secure a contract for a study. To date, we have prepared three technical proposals for consideration by various drug companies; one was declined on technical grounds and two are still actively undergoing review. We are pursuing other contacts within the industry for business development opportunities. Furthermore, we must then prove ourselves to our client (quality work, on time and on budget) as repeat business is a key driver of success.
Over the next 3 years, we envision participation in 10-14 trials per year in Guatemala and we should be engaged in 6-14 additional studies in other countries. Gross revenue should be sufficient to allow $150-275K annually supporting local philanthropic work.
To secure studies, we are networking into the pharmaceutical business; we recently attended an industry conference in Lima, Peru. We must overcome a number of perceptions about Guatemala (safety, stability, remoteness) as well as low awareness of the potential for research (we are writing a scientific publication to demonstrate the latter). There are several basic business elements we must finish developing, such as an effective finance/accounting infrastructure for international business to ensure efficient business operation and compliance with local laws, cash flow – due to slow reimbursement rates from pharmaceutical companies, study budgeting tools and processes, infrastructure investment (basic medical equipment, computerized data system), legal assistance (e.g., contracts for ongoing business operations, links to banking systems, following laws, IP protection).
What would prevent your project from being a success?
Two things can undermine this project. We must secure a first study. Business development has been one of several focal points to date, yet with limited resources, it has not received the full attention it needs. We have captured the attention and cooperation of several people, both in the US and Guatemala who wish to see this venture successful, but within the next few months, we must ‘seal a deal’ or risk losing momentum. Once we have a study, we must deliver high quality research and adherence to complex regulations. Trials are heavily inspected by several entities; failure to pass any inspection can shut down operations, particularly early in the history of an organization.