Contributed by Tiffany N. Ellison, Joseph R. Fortunak, Frederick E. Nytko III, Howard University, Department of Chemistry

 

Some time ago (December, 2012) we published a story about the work being done by Professor Joseph Fortunak and his research group at Howard University (HU) in Washington, DC. This communication is an update on that story.  Last year (2014) Dr. Fortunak estimates he was in nineteen countries including Equatorial Guinea, Nigeria, Tanzania, South Africa, Nicaragua, Brazil, Switzerland, and China. Before joining HU in 2004, Dr. Fortunak spent over twenty years in the pharmaceutical industry, contributing to the launch of over a dozen new drugs and a similar number of new generic products during that time. Howard University is an HBCU (Historically Black College/University) founded in 1867 to provide higher education for freed slaves. Howard has had a PhD program in Chemistry since 1954 and has trained over 20% of the African-American PhD Chemists in the United States.

 

Picture2.pngThese details are pertinent to this “update report” because the mission of Howard University meshes with Professor Fortunak’s work. Dr. Fortunak and his group members concentrate their efforts on developing new chemistry and technologies for the more efficient, less expensive production of essential medicines of assured quality. The results of this work are shared with pharmaceutical manufacturers in India and China who produce essential medicines for the treatment of HIV/AIDS, malaria, TB, and opportunistic infections. Dr. Fortunak’s work was awarded the ACS Astellas Foundation Award in 2009 for “Chemistry Impact on Human Health.” This research continues in collaboration with the World Health Organization, UNITAID, the William J. Clinton Health Access Initiative, and the Medicines Patent Pool.  An article in the Wall Street Journal (May 13, 2011) by Mark Schoofs described how Mr. Adrian Williams, an MSc student in the group, made a lasting impact on the availability of medicines for HIV/AIDS for low- and middle-income countries by improving the process chemistry for making the drug tenofovir disoproxil fumarate.  This chemistry was published in the Organic Process Research and Development Journal (2010).

 

Mount Kilimanjaro.jpgOne particular interest is the collaboration between HU and the St. Luke Foundation/Kilimanjaro School of Pharmacy (SLF/KSP) in Moshi, Tanzania.  Moshi is the nearest city to Mount Kilimanjaro, African’s tallest mountain. The area is a favorite with adventurous tourists because Kilimanjaro can be climbed in a several day trek without special equipment, while other famous sites including Olduvai Gorge, the Serengeti Desert, and Ngorongoro Crater are in close proximity.

 

Sister Zita Ekeocha is the founder and Director of the IPAT (Industrial Pharmacy Advanced Training) at the KSP, while Mr. Wilson Mlaki is the Principal of the School.  The IPAT is taught by faculty from the United States, including Dr. Fortunak and other individuals whose varied experiences in pharmaceutical R&D and manufacturing complement each other well.  The German organization GiZ (Deutsche Gesellschaft für Internationale Zusammenarbeiten) has provided support to build a pilot plant for pharmaceutical production at the SLF/KSP.  With support from the United Nations Industrial Development Organization (UNIDO) the IPAT has provided advanced training in pharmaceutical manufacturing and Current Good Manufacturing Practice (cGMP) to National Drug Regulators, University faculty, and pharmaceutical professionals since 2008.  With occasional courses being offered in a sequence either two or three times per year, approximately 120 participants have completed the core curriculum of four, two-week, full-time courses in drug discovery, development, GMP, and drug regulation.

 

Dr. Fortunak’s students (notably, Tiffany N. Ellison and Drs. Joseph Williams Jr. and Christopher L. King) have developed new instructional materials and taught at various IPAT courses in Moshi.  Dr. King was awarded an ACS GREET Fellowship (Graduate Research Experiences, Education, and Training) to support part of his work for the KSP. The research work done by these students has so far contributed to five publications and six invited presentations at various research symposia, including at the Gordon Research Conferences “Green Chemistry Conference” in Hong Kong (August, 2014).  Several African participants have also been able to visit Howard University as a result of these collaborations. One recent outcome from these collaborations has been the submission of a book chapter on “The Business Case for Green Chemistry in Drug Discovery” co-authored by Professors Fortunak and Simon Xiang of Howard University, and the African scientists Drs. Harriet Kamendi (Ghana) and Martins Emeje (Nigeria).

 

Tablet press 2.jpgThe IPAT program has recently divided its efforts in two directions. Purdue University (PU) is offering a Master’s degree to individuals who take additional, online courses and continue through a Purdue sequence. The original IPAT program continues, and the SLF/KSP efforts include transfer of the original program to other African Universities including the University of Ibadan in Nigeria.  These efforts are overseen by Dr. Fortunak.  Ibadan is also developing their own Master’s degree curriculum as part of this continuing collaboration with HU, and Howard is also helping the KSP to develop a Bachelor’s degree program in Industrial Pharmacy.

 

Synthesis-of-ACTs-at-KSP.jpgOther, exciting aspects of this collaboration have come into being since our last report.  In 2013 the United Nations ANDI (African Innovation for New Drugs and Diagnostics) Program designated the SLF/KSP as a Center of Excellence for drug training and manufacturing.  In 2013 the US FDA also taught a one-week Course in advanced topics for Abbreviated New Drug Applications (ANDAs, generic drug marketing) at the KSP. Participants from 19 African countries attended this training, overseen by (the late) Dr. Beverly Corey who until recently headed the US FDA/Africa. The SLF/KSP was distinguished with a US FDA Honor Award in 2013 for Excellence and Innovation in Regulatory Sciences for this Course In 2014 the SLF/KSP was also designated a Regulatory Center of Excellence (RCORE) in drug regulation by the African Medicines Harmonization program, an effort funded by the Bill and Melinda Gates Foundation. In 2013 Dr. Fortunak was also part of a Team award from the African Union (AU) for Social Responsibility. The AU represents the entire membership of fifty-four independent African nations.

 

Joe2.jpgAnd so, efforts continue on this fruitful collaboration. As Dr. Fortunak notes,“there is never enough funding” for work such as this.  The importance of this type of an approach to new science and technology is sometimes difficult to qualify for traditional research grant awards. Any readers who are interested in their organization possibly supporting these efforts are urged to contact Dr. Fortunak directly.This work carries both short-term and long-term rewards. Four African companies have used their IPAT training to good effect, and have manufacturing facilities that have been certified as cGMP-compliant by the US FDA and/or the World Health Organization “Pre-Qualification of Medicines Program.” Over the long term, the training of people contributes to economic development, job creation, and national independence and self-determination for creating access to medicines. The most rewarding part of these efforts is the personal interactions that result from international experience in training and in research.

 

Pictures:

1) KSP Pilot Plant, 2) Mount Kilimanjaro, 3) Tablet press at KSP Pilot Plant, 4) Synthesis of ACTs at KSP Pilot Plant, 5) Dr. Joeseph Fortunak with Sister Zita Ekeocha (Director, KSP IPAT Program) and Mr. Wilson Mlaki (Principal of KSP).

 

 

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