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June 29, 2011

Colombian Doctor Starts Training with Eisai Experts in the US

Dr. Laureno Mestra from Colombia has become Eisai's 2011/12 TDR Clinical Research Fellow, starting the Fellowship program with Eisai Inc. in Woodcliff Lake, New Jersey in June 2011. Involvement in this program is a reflection of Eisai's desire to contribute to the building up of health care capacity in developing countries, an essential part of improving patients' access to medicines across the world. It provides the Fellow with an opportunity to learn the full spectrum of clinical drug development in order to foster and expand state of the art clinical research in developing nations.

TDR - the Special Program for Research and Training in Tropical Diseases - is based at and administered by the World Health Organization (WHO). TDR invites researchers from developing countries to apply for Fellowships in clinical research and development. Fellows are placed with participating pharmaceutical companies, where they are trained in clinical trial science and learn to develop clinical trial managerial skills. These Fellows are then expected to return to their home countries and assume a leading role in the global R&D effort to diagnose and treat tropical infectious diseases.

Eisai's first TDR Fellow was Dr. Glory Ogunfowokan from Nigeria, who began his program with Eisai Inc. in April 2010, returning to his home country in March 2011. Dr. Ogunfowokan was involved in three main drug development projects relating to: a treatment for Chagas disease, adjunctive therapy in the treatment of cerebral malaria, and a drug to treat invasive fungal infections. In Nigeria, Dr. Ogunfowokan will lead a team of researchers to explore new research areas based on the skills and knowledge he gained at Eisai, with a view to develop drugs and vaccines to prevent and treat diseases such as malaria, tuberculosis and HIV.

Dr. Mestra, Eisai's second Fellow, will have the opportunity to be directly involved in the Phase 2 clinical trial that DNDi (Drugs for Neglected Diseases initiative) is conducting on Eisai's new treatment candidate for chronic indeterminate Chagas disease, which is endemic in Colombia. He will also learn about the early development of antimalarial compounds, which will also be directly applicable to his clinical practice and clinical research work in Colombia.

Dr. Mestra received his medical training in Colombia and has a background in internal medicine and epidemiology. He is a Professor of Clinical Research and Research Methodology at CES University in Medellin.

• More about Second TDR Fellow (2011-2012):
  Dr. Mestra - his clinical research interest and aspiration for his training at Eisai
• More about First TDR Fellow (2010-2011):
  Dr. Ogunfowokan - his programme at Eisai and his plan after returning to Nigeria

More about TDR Programme and Eisai

The Special Programme for Research and Training in Tropical Diseases (TDR) is a global programme of scientific collaboration that helps coordinate, support and influence global efforts to combat a portfolio of major diseases of the poor and disadvantaged. Established in 1975, TDR is based at and administered by the World Health Organization (WHO), and is sponsored by the United Nations Children's Fund (UNICEF), the United Nations Development Programme (UNDP), the World Bank and WHO.

In 2009, TDR invited researchers from disease endemic countries to apply for the first round of 12-month Career Development Fellowships on Clinical Research & Development (Clinical R&D). The goal of the program is to develop human resources in these developing countries so as to promote high-quality clinical R&D. Qualified professionals who are accepted as Fellows are enabled to expand and enhance their home country's product development capacity in the fields of diagnostics, drugs and vaccines for the diagnosis and treatment of infectious diseases that disproportionately affect poor and marginalized populations. Upon completing their Fellowships, the individuals are expected to return to their home institutions and assume a leading role in the global R&D effort to diagnose and treat neglected tropical infectious diseases.

The program calls for successful candidates to also be affirmed by leading pharmaceutical companies, where they are trained in clinical trial science and learn to develop clinical trial managerial skills. The IFPMA coordinates the industry's participation, inviting member companies to take Fellows for one-year placements. In 2009, during the first round of calls for companies to join the program, Eisai agreed via the IFPMA to participate by providing a Fellowship. Eisai has agreed to take a second Fellow for 2011-2012.

More about Second TDR Fellow (2011-2012):
Dr. Mestra - his clinical research interest and aspiration for his training at Eisai

Dr. Laureno Mestra, from Medellin, Colombia will be the 2011-2012 TDR Fellow at Eisai. He will be starting the Fellowship program with Eisai Inc., in Woodcliff Lake, New Jersey, USA in June, 2011.

Dr. Mestra received his medical training in Colombia and has a background in internal medicine and epidemiology. He is a Professor of Clinical Research and Research Methodology at CES University in Medellin. His current research interests and efforts include:

• 1.
  American cutaneous leishmaniasis and other manifestations of this disease
• 2.
  Rational selection of drugs for neglected and tropical diseases
• 3.
  New rational diagnostic strategies for tropical diseases
• 4.
  Vaccines and drugs in development for malaria and dengue

Dr. Mestra will receive the same background training as Dr. Ogunfowokan but will have the additional benefit of learning about drug development from the U.S. and Japanese perspective since he will be spending time at both Eisai locations. He expects to learn more about clinical research and further develop his knowledge and skills in planning and conducting clinical studies as he learns about clinical trials from the pharmaceutical industry perspective.

He plans to apply the acquired skills and knowledge after returning to his home country/institution to design, conduct, analyze clinical studies and publish results from:

• 1.
  clinical trials in tropical diseases
• 2.
  cohort, cross-sectional, case control studies in tropical diseases
• 3.
  diagnostic tests evaluations
• 4.
  control programs for tropical and neglected diseases in Colombia and other developing countries

He further plans to develop and conduct local and regional academic meetings to train others in the study of tropical and neglected diseases.

He will have the opportunity to be directly involved in the Phase 2 clinical trial that Eisai and DNDi (Drugs for Neglected Diseases initiatives) are conducting for the treatment of chronic indeterminate Chagas disease, which is endemic in Colombia. This will provide extensive experience in the treatment of a disease which can immediately be put to use when he returns to Colombia. He will also gain experience in learning about the early development of antimalarial compounds which would also be directly applicable to his clinical practice and clinical research work in Colombia.

More about First TDR Fellow (2010-2011):
Dr. Ogunfowokan - his programme at Eisai and his plan after returning to Nigeria

Dr. Glory Ogunfowokan, our first TDR Fellow, was from Nigeria and began his one-year Fellowship program with Eisai Inc., in Woodcliff Lake, New Jersey, USA in August, 2010.

Dr. Ogunfowokan was involved in three main drug development projects that were at various stages of development ranging from preclinical to clinical. The projects were:

• 1)
  A novel drug for the treatment of chronic indeterminate Chagas disease.
• 2)
  A novel drug for adjunctive therapy in the treatment of cerebral malaria.
• 3)
  A novel drug for the treatment of invasive fungal infections.

Dr. Ogunfowokan's training consisted of his learning about the following:

• ⅰ)
  The various stages of drug development from the early drug discovery processes, through pre-clinical studies and then through the four phases of clinical trials.
• ⅱ)
  Project planning and implementation involving various team members
• ⅲ)
  Collaboration between industry, academic institutions, contract research organizations, consultants and funding organizations.
• ⅳ)
  Study designs involved in pre-clinical, phase 1 and phase 2 clinical
• ⅴ)
  Regulatory functions of FDA and other regulatory bodies in drug development.
• ⅵ)
  Importance and contents of the investigator's brochure and the processes for developing it.
• ⅶ)
  How to develop a study protocol compliant with standard operating procedures and ICH guidelines.
• ⅷ)
  Learn GCP and ICH guidelines and the application of these guidelines in practice.
• ⅸ)
  The essence and contents of an IND annual report to FDA.
• ⅹ)
  How to determine first in human doses
• ⅺ)
  Literature search and preparation of a briefing book for a pre-IND meeting with FDA.

How Dr. Ogunfowokan will apply his recently acquired knowledge and experience in Nigeria

Dr. Ogunfowokan plans to use his new skills and knowledge to do the following in Nigeria:

• 1.
  Continue his research on tropical diseases using the knowledge gained during the fellowship training
• 2.
  Lead a team of researchers to explore new research areas based on the skill and knowledge gained, with a view to develop vaccines to prevent tropical diseases such as malaria, tuberculosis and HIV.
• 3.
  Collaborate with other alumni of the TDR fellowship program in Africa on clinical research and development.
• 4.
  Write proposals for grants towards tropical disease research and the development of vaccines to prevent tropical diseases.
• 5.
  Strengthen the IRB in his institution.
• 6.
  Encourage research collaboration between pharmaceutical companies and tropical disease clinical researchers in his country.
• 7.
  Advocate for stronger regulatory roles of the clinical research regulatory authorities in Nigeria.