Enhancing access to medical care in Guatemala

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Enhancing access to medical care in Guatemala

Guatemala
Organization type: 
for profit
Budget: 
$10,000 - $50,000
Project Summary
Elevator Pitch

Concise Summary: Help us pitch this solution! Provide an explanation within 3-4 short sentences.

Americas Clinical brings clinical drug trials to Guatemala by pulling together drug companies, patients, physician investigators and conducting FDA-approved studies, thus giving people access to high quality medical care attendant with clinical research. By operating philanthropically, we significantly give back to support local efforts enriching education and community health care.

About Project

Problem: What problem is this project trying to address?

Guatemala experiences both infectious diseases typically associated with a poor, tropical country and a growing prevalence of chronic disease due to urbanization and associated lifestyles. There are numerous water and vector borne diseases such as malnutrition, malaria,dengue fever and chronic diarrhea due to parasitic infection as well as growing numbers of people with untreated diabetes and hypertension. It has one of the highest infant mortality rates and one of the lowest life expectancies at birth of countries in Latin America. Only 11 percent of the population has effective access to health services, based on the World Health Organization’s definition of travel time to a health facility. There is only approximately 1 physician per 1000 people. Higher quality medical care is available for the wealthy but generally lacking for the majority. Thus, medical care resources are sorely needed.

Solution: What is the proposed solution? Please be specific!

The disease burden in Guatemala is highly problematic for individuals and the national health care system. Medically, Guatemala is two countries in one. In more rural areas, there is a prevalence of infectious, water-borne and vector-borne diseases. At the same time, the incidence of diseases often associated with urban lifestyles and diets is increasing. But in the midst of these problems lies a solution; these very factors make it an ideal environment for many types of clinical drug trials. The large numbers of potential patients who are treatment naïve and otherwise in need of medical care are very important to the pharmaceutical industry as currently, the rate limiting factor in clinical research is access to patients. Thus, drug companies are attracted to countries like Guatemala due to faster research. Drug trials themselves are a source of free, high quality medical care and can make a difference if brought to the country in sufficient numbers. Today, only 5% of all drug studies take place in Latin America and only 2% of those involve Guatemala; we can substantially change this situation. Because the medical benefit directly attributable to clinical trials is limited to the patients who participate, we are operating as a philanthropic business to give back earnings to further aid people and their communities. The approach is sustainable; the drug industry is firmly expected to continue seeking clinical research sites outside the US and Europe and the international regulations in place that govern these activities have been standardized.
Impact: How does it Work

Example: Walk us through a specific example(s) of how this solution makes a difference; include its primary activities.

We are deeply involved in start-up activities of establishing the necessary business infrastructure and operating model that will attract investment from pharmaceutical companies who are the sponsors of drug studies.
About You
Organization:
Americas Clinical
Section 1: You
First Name

Stephen

Last Name

McClanahan

Organization

Americas Clinical

Country
Section 2: Your Organization
Organization Name

Americas Clinical

Organization Phone

1-513-260-6949

Organization Address

6399 Ironwood Drive, Loveland, OH 45140 USA

Organization Country

, OH, Clermont County

Your idea
Country and state your work focuses on

, GU

Innovation
Do you have a patent for this idea?

Impact
Actions

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.

Results

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.

How many people will your project serve annually?

101‐1000

What is the average monthly household income in your target community, in US Dollars?

$100 ‐ 1000

Does your project seek to have an impact on public policy?

Yes

Sustainability
What stage is your project in?

Operating for less than a year

In what country?

, GU

Is your initiative connected to an established organization?

If yes, provide organization name.
How long has this organization been operating?

Less than a year

Does your organization have a Board of Directors or an Advisory Board?

Does your organization have any non-monetary partnerships with NGOs?

No

Does your organization have any non-monetary partnerships with businesses?

No

Does your organization have any non-monetary partnerships with government?

No

Please tell us more about how these partnerships are critical to the success of your innovation.

We do not have partnerships with government,business or NGO organizations. However, we have recently been selected for one of (Cincinnati’s) Xavier University’s prestigious XLAB awards; this award provides us critical business consulting and training by faculty and MBA students from Xavier’s Williams College of Business in order to successfully launch our endeavor. Details of this award are available at http://www.xavier.edu/campusuite/modules/news.cfm?news_id=7828&grp_id=2677
Individuals involved are experienced in the technical side of research. The partnership with Xavier brings us the needed business, marketing and finance expertise we need to be successful. It provides two senior business advisors (a faculty member and a local business executive) and access to an extensive series of workshops devoted to specific business topics that are critical to success. Through these learning/working sessions, a business plan is developed. Networking events will connect us with potential additional advisors, partnering organizations and investors in order to capitalize our venture and take it to the next level of performance.

What are the three most important actions needed to grow your initiative or organization?

Primary market research. The objective is to better determine the value-added benefits we must offer pharmaceutical clients/customers that drive competitive advantage to us. We know Guatemala presents barriers to clients and we must fully understand the nature of these barriers, develop effective strategies to eliminate or minimize them and to determine what we must offer from a business service perspective in order to successfully attract clinical trials to the country.
We need to develop an overall marketing strategy of the company. We must determine the most effective means to raise awareness of our venture and the advantages we offer. We must determine, within each large pharmaceutical company, who are the real decision makers with respect to placing clinical studies. We must know the parameters that enter into those decisions and how we can better win the ‘moment of truth’. Without a successful marketing strategy, we cannot attract the studies we need in order to improve access to medical care. On the flip side, once we determine an effective marketing approach and win studies, we should be able to fully realize our vision since repeat business is the norm (provided quality is maintained).
We must seek and secure funding sources who believe in our vision and who wish to help us bring this vision to life. To date, we have personally funded all efforts (approximately $30,000). We estimate we need to raise an additional $30,000 to carry us through to launch. All four partners involved today are working without compensation. Most of Xavier’s support is without cost to us. Yet we have expenses to deal with, including funding the primary research mentioned above, travel to the region, the building of a database of patients in Guatemala (expected by pharmaceutical companies of a research site) and some legal expenses.

The Story
What was the defining moment that led you to this innovation?

Upon retiring from a corporate career in research & development from a Fortune 50 company, I wanted to use my training and experience in clinical research to make a difference. I was aware of the plight of the Guatemalan people through other travels there and I had (have) a good friend and colleague, Dr. Luis Archila, who lives there. During personal prayer in February of 2010, I was led to the idea of helping people through research. I was very aware of the high quality of medical attention given to patients in drug trials. I did some research to better understand the true nature of the health issues that people of Guatemala face. I also did the research to see what kind of drug trials were being conducted as it is important to attract studies focused on disease states impacting Guatemala. These pieces came into focus and through much additional prayer and conversation with trusted friends, the idea was born and I committed to it.

Throughout all this, there was an image that stayed in my mind; I met Michaela on a vacation with my wife to Lake Atitlan in Guatemala. Michaela is a middle aged woman living in the small Mayan village of San Juan Atitlan. Her home is tiny, her material possessions meager. Yet she is just like you and I, concerned about her sons and husband, busy with her work. And gracious, eagerly sharing what little she owns. Her face was before me as I weighted the merits and difficulties of this venture.

Tell us about the social innovator behind this idea.

Stephen McClanahan is a visionary, energetic, passionate and creative leader who believes in the power of teams of individuals with differing skills and points of view to accomplish great feats. He believes in the power of strategic vision, of enrolling others to that vision, of building capability and morale through collaboration and of constantly challenging himself and other to grow. He has tackled difficult issues with integrity and honesty.

After earning a doctorate in chemistry from the University of Kentucky and a post-doctoral appointment in chemistry at the University of North Carolina at Chapel Hill, Dr. McClanahan joined Procter & Gamble in 1986. His career was invested in clinical research endeavors in support of health care initiatives. He managed clinical science, operations, clinical imaging, data management, biostatistics, pilot plant operations and sensory science. He has managed groups of up to 50 scientists across multiple geographies and has built successful clinical organizations in Beijing China. He has numerous peer reviewed manuscripts and research presentations and patents and has given multiple invited lectures.

Stephen is a devoted follower and disciple of Jesus Christ and has a driving desire to give back, to help other people. He believes that businesses need higher motivations that just profits and wants to see a business thrive that puts others first. He is convinced this is possible because of higher, deeper motivation by all involved. Stephen and his wife, Judy have been married 32 years and have three children.

How did you first hear about Changemakers?

Web Search (e.g., Google or Yahoo)

If through another, please provide the name of the organization or company

50 words or fewer

randomness