Joseph M. Fortunak, PhD — Howard University

Expert Witness services and experience

Have acted as an expert witness in cases involved pharmaceutical drug discovery and development issues.  These include anticipation and obviousness, utility, breach of contract, Net Present Value, drug development, infringement, and validity.  Clients have been both originator and generic companies as well as Universities and Government Agencies. 

NAME Joseph M.D. Fortunak
NATIONALITY United States citizen
ADDRESS 5 Countryside Court
Silver Spring, MD 20905 USA
TELEPHONE & E-MAIL
+1 (301) 928 7568 (Mobile)
jfortunak@comcast.net

EDUCATION & ACADEMIC BSc, Purdue University 
With highest distinction
University of Wisconsin-Madison
PhD, Organic Chemistry, With highest distinction
Cambridge University, United Kingdom
Postdoctoral Fellow and Research Assistant Professor
CAREER SUMMARY
(1983 – 1993) SmithKlineBeecham (GlaxoSmithKline) Pharmaceutical Corp. Associate Senior Research Investigator, Senior Research Investigator, Assistant Director
(1993 – 2000) DuPont Pharmaceutical Company
Associate Director, Director,
Senior Director, Executive Director
(2000 – 2004) Abbott Labs; Pharmaceutical Company
Head of Global Chemical Development
(2004 – Present) Howard University. Professor of Chemistry and Pharmaceutical Sciences

PERSONAL STATEMENT OF PURPOSE
I am a Professor at Howard University, a Research Tier-1, historically-black college/university (HBCU) in Washington, DC, USA.

Prior to my faculty appointment, I worked as a scientist and manager in the Innovator Pharmaceutical Industry (from 1983-2004). During that time I contributed to over 100 New Chemical Entities (NCEs) that moved from Discovery into Development. Twelve of these NCEs were approved for commercial marketing, including important drugs for HIV/AIDS, cardiovascular and cancer therapeutics. In my most recent (2001-2004) industrial position I was the Head of Global Chemical Development for a major healthcare company, administering annual budgets of up to $150MM and managing over 400 scientists and technical staff. I am intimately familiar with the science and technology of Active Pharmaceutical Ingredient (API) and finished pharmaceutical product (FPP) drug production. I also have extensive, hands-on knowledge of drug formulations, patents, quality assurance, drug regulation, salt selection and polymorphs, physicochemical properties, clinical and marketing (IND and NDA) submissions, and Current Good Manufacturing Practice (cGMP). I was a company representative to the Pharmaceutical Research and Manufacturers Association (PhRMA) Technical Group and contributed to industry collaborations with the US FDA in drafting the ICH Q7A Guidance governing GMP for the production of APIs.

My research group of PhD/PharmD and MSc/undergraduate students creates new science to decrease the production cost and increase global access to quality-assured medicines. We have contributed new chemistry and technologies that have improved production and reduced cost of of several drugs for HIV/AIDS, including efavirenz, tenofovir disoproxil fumarate, ritonavir, and atazanavir. We have discovered new, “green” chemistry for the production of the malaria drugs amodiaquine, piperaquine, and lumefantrine. We have also worked on pediatric formulations for the Artemisinin Combination Therapies (ACTs) DHA:piperaquine and artesunate:amodiaquine.

In 2005 I helped found the Drug Access Technical Team (DAT) of the William J. Clinton Health Access Initiative (CHAI). I have had the privilege of contributing to successes in the following areas with CHAI to increase access to medicines for HIV/AIDS, malaria, and TB:

1. The identification of suppliers meeting international standards of quality assurance for generic drug production
2. Negotiating transparent, ceiling prices based on volume demand and cost of production for Low- and Middle-Income Countries (LMICs)
3. Providing technical assistance to generic suppliers to speed their time-to-market for WHO-Prequalified and US FDA-approved products.
4. Assisting suppliers with achieving regulatory approval for new combinations of drugs (eg, ritonavir/atazanavir; efavirenz/tenofovir/lamivudine)
5. Discovering and transferring novel technology to reduce the cost of Active Pharmaceutical Ingredients (APIs) for HIV/AIDS drugs, including: (a) efavirenz; (b) tenofovir; (c) ritonavir; and (d) lopinavir.

I presently work with organizations including the World Health Organization, UNITAID, and the Medicines Patent Pool on the production, cost, novel chemistry for manufacturing, market dynamics, and regulation of quality-assured medicines for LMICs. I assisted UNIDO (United Nations Industrial Development Organization) and the UN ANDI (African Network for Drugs and Diagnostics Innovation) organizations in preparing a Pharmaceutical Manufacturing Plan for Africa that was approved by the Heads of State of the 54 nations of the Organization of African States in June, 2012.

I regularly teach (2-3 times a year) a training curriculum of two-week, full-time courses in drug development, GMP and quality-assurance at the St. Luke Foundation / Kilimanjaro School of Pharmacy (SLF/KSP) in Moshi, Tanzania. Funding from the German GIZ (Gesellschaft fur Internaschenallen Zussamenarbeiten) and UNIDO was used to build and equip a drug development facility, classrooms, and a development laboratory at the SLF/KSP. Participants in this training include National Drug Regulators and African pharmaceutical professionals. Attendees learn how to detect counterfeit and substandard drugs, as well as the science and practice of drug development, GMP, quality-assurance and how to write Regulatory submissions. Our objectives are to assist National Drug Regulatory Agencies to achieve Strict Regulatory Authority status and to enable African companies to achieve WHO Prequalification status for their facilities and products. As of 2014 the Merck Foundation (USA) is providing support for expanding this effort into a Master's Degree program in Industrial Pharmacy.

Our work with CHAI was awarded the American Chemical Society's Astellas Foundation award for “Chemistry Impact on Human Health” in 2009. I was one of four scientists (and two administrators from the American Chemical Society and the National Institutes of Health) representing the United States at the Chemical Sciences and Society Summit in Beijing, in September, 2011. A White Paper from this Conference was provided to agencies of the US Government, including NSF, NIH, and the EPA. Our African partners, the St. Luke Foundation/Kilimanjaro School of Pharmacy and the College of Pharmacy, University of Ibadan (Nigeria) are both UN ANDI Centers of Excellence and Centers of Excellence in Regulatory Sciences (RCORE, 2014). We received a 2013 US FDA “Honor Award” for excellence and innovation in drug training and regulatory sciences.

RECENT AWARDS AND APPOINTMENTS

1. Howard University Faculty Senate Award for contributions to Africa and the African Diaspora (May, 2014).
2. Appointment as an Associate Lecturer, University of Ibadan, (May, 2014).
3. African Medicines Regulatory Harmonization (AMRH) designated RCORE Center of Excellence in Regulatory training, awarded to the St. Luke Foundation / Kilimanjaro School of Pharmacy Industrial Pharmacy Advanced Training (IPAT); Moshi, TZ (April, 2014).
4. Host of the American Chemical Society "Green Chemistry” webinar series (2014-2016; 4 presentations/year).
5. WHUR radio interview with our research group on green chemistry and increasing global access to medicines, broadcast on February 13, 2014 available at: http://wamu.org/programs/metro_connection/13/02/14/this_week_on_metro_connection_chemistry_transcript
6. United Nations Industrial Development Organization (UNIDO) Consultancy on training needs of the South African Pharmaceutical Industry for achieving Strict Regulatory Authority Status (December, 2013).
7. African Union Commission Award for Corporate Social Responsibility.
8. US FDA Honor Award for Excellence and Innovation in regulatory sciences, (September, 2013).
9. “Howard Prof. relies on green chemistry to improve drugs,” Interview with National Public Radio reporter Jonathan Wilson broadcast on February 15, 2013. Available on the Internet at WAMU Radio 88.5 “Metro Connection” at: http://wamu.org/programs/metro_connection/13/02/15/howard_prof_relies_on_green_chemistry_to_improve_drugs
10. Appointed member of the Strategic Advisory Group for funding priorities, UNITAID (2012-2013).
11. Posted on the American Chemical Society's Nexus Blog: “Dr. Joseph Fortunak: Green Chemistry and Equal Access to Medicines,” by Christina Briddell, December, 7, 2012. Accessible at: https://communities.acs.org/community/science/sustainability/green-chemistry-nexus-blog/blog/2012/12/07/dr-joseph-fortunak-green-chemistry-and-equal-access-to-medicines
12. United Nations ANDI (African Initiative for New Drugs and Diagnostics) designated Center of Excellence in drug manufacturing and training awarded to the St. Luke Foundation / Kilimanjaro School of Pharmacy IPAT (2012).
13. Invited Presenter — American Chemical Society Webinar: “Chemistry, Human Rights, and Health,” April 18, 2012. Accessible at: http://www.acs.org/content/acs/en/global/international/science-and-human-rights/webinars.html.html
14. Invited Presenter — American Chemical Society Webinar: “Green Chemistry and Global Access to Medicines,” presented June 14, 2012 http://article.wn.com/view/2014/07/01/Taxing_the_Sick/
15. One of six scientists (including one from the ACS and one from the NAS) selected by the American Chemical Society and the National Academy of Sciences to represent the United States at the “Chemical Sciences, Society, and Sustainability” (CS3) summit in Beijing, China (September, 2011). The 2011 meeting had a focus on the Chemical Sciences contributions to improving human health. The White Paper resulting from this meeting is available at: http://www.acs.org/content/acs/en/global/international/regional/eventsglobal/cs3.html .
16. “Researchers manipulate drug's chemistry in bid to lower treatment cost,” Article authored by Mark Schoofs and published in the Wall Street Journal, May 13, 2011. This article described our new chemistry at Howard University to lower the costs of the HIV/AIDS drug tenofovir disoproxil fumarate, and how this contributes to increased access to HIV medicines in low- and middle-income countries. Available online at: http://online.wsj.com/news/articles/SB10001424052748703730804576319480990825422
17. American Chemical Society “Astellas Foundation” Prize for Chemistry Impact on Human Health; included $40,000 unrestricted R&D cash award (ACS National Meeting, August 16, 2009).
18. Appointed external Co-Director of the St. Luke Foundation / Kilimanjaro School of Pharmacy “Industrial Pharmacy Advanced Training” (IPAT) Program: August, 2008.
19. Editorial Board, Tropical Journal of Pharmaceutical Research (2008-present)
20. Appointed member of Nigerian National Institute of Pharmaceutical R&D (NIPRD); Expert Scientific Advisory Committee (ESAC; July, 2008).
21. Appointed member of World Health Organization's Stop TB Secretariat “Global Drug Facility” Business Advisory Committee (2006-2012).
22. Editorial Board, Current Opinion in Drug Discovery and Development (2004-2009).

23. Member of the Royal Society of Chemistry, Scientific Advisory Board; specialty in Green Chemistry.
Other Awards
• State of Illinois Governor's Pollution Prevention Team Award (2004)
• Corporate Award from Abbott Labs for manufacturing improvements the reduced the rate of volatile organic emissions (VOEs) over the island of Puerto Rico by 60% (2004)
• Howard University Fund for Academic Excellence (2006)
• National Science Foundation (USA), Discovery Corps Senior Fellow (2006-2008)
• Collaboration with the African Union – drafting a Business Plan for the Pharmaceutical Manufacturing Plan for Africa (2011-2012); approved by the Heads of State of the 54 countries comprising the African Union
• Consultant; Medicines sans Frontieres (Doctors Without Borders) Patent Pool; (2012-present)
• Partners for Supply Chain Management / USAID collaborative consulting agreement; waste reduction and expired drug recycling in Africa, Latin America, and the Caribbean (2013) 

SERVICE AND CONSULTING

Bill, Hillary, and Chelsea Clinton Foundation Healthcare Access Initiative (August, 2005 – present)
See above for a description of this work.

St. Luke Foundation / Kilimanjaro School of Pharmacy IPAT (Industrial Pharmacy Training Unit; 2007-Current)
External Director of the IPAT, designated as a Center of Excellence in Africa for drug manufacturing and training by the WHO ANDI (African Initiative for New Drugs and Diagnostics; 2012). The IPAT provides professional training for African Drug Regulators and pharmaceutical professionals to eliminate counterfeit and substandard medicines from the market and to enable African pharmaceutical companies to manufacture essential medicines meeting all international standards of Quality-Assurance.

Medicines sans Frontieres (MSF; Doctors Without Borders; (2006; 2010; 2013-2014)
Consultancy evaluating Brazilian pharmaceutical companies and their potential to produce HIV/AIDS drugs and APIs with quality-assurance and cost-competitive with Indian/Chinese generic products.

Assistance evaluating technology transfer packages for the “Patent Pool” enabling the generic production of critical medicines for the treatment of HIV/AIDS, malaria, and tuberculosis.

Brazilian Ministry of Health (September, 2010, January, 2014)
One-week courses training the Brazilian pharmaceutical industry in the production of the HIV/AIDS drug efavirenz. One week of training in drug development and green chemistry for drug manufacturing. Collaborative work on continuous flow processing to produce intermediates for HIV/AIDS medications.

WHO “Stop TB” Campaign – Global Drug Facility, Business Advisory Council (BAC; 2006 – 2012)
Member of the Business Advisory Council, Global Drug Facility (GDF) of the WHO Stop TB Secretariat. The mission of the GDF is to provide effective medicines for the treatment of tuberculosis with assured quality.

UNITAID Advisory Group on Funding Priorities (2011-2013)
UNITAID is an organization with $400-500 million/year in funding whose strategic objective is to enable the introduction of new commodities into markets for developing nations that will 1) significantly improve global health for low- and middle-income populations; and 2) be sustainable for lasting impact. Examples of UNITAID initiatives include the introduction of generic pediatric medicines for HIV in Sub-Saharan Africa. My work with UNITAID includes co-authorship of the 2014 “Global HIV Medicines Landscape” and assisting UNITAID and the WHO in assuring the supply of quality-assured medications for clinical trials of HIV/AIDS and HCV treatments in children, women, and for patients with HIV-TB co-infection.

National Academy of Sciences and American Chemical Society (NAS, ACS)
• NAS council on “Grand Challenges for Sustainability in the Chemical Industry” (2005)
• NAS “Green Chemistry Education Committee” (2005 – 2007)
• ACS “Strategic Redesigning the Petroleum Research Fund” (2007 — 2008)
• NAS “Committee on Chemical Substitution in Industry” (2008)
• Organizer, ACS Symposium on Process Chemistry in the Pharmaceutical and Agricultural Industries (2008)
• Session Chair, ACS Symposium on Green Chemistry and Chemical Manufacturing; ACS 239th National Meeting, (August, 2009)
• Reviewer on Panel for funding of the ACS Teva Grants Panel (2009)
• Reviewer on Panel for REU Grants (2011, 2013)
• Reviewer on Panel for ACS GREET Awards (2012)
• Member of the ACS “Motivational Speakers Bureau” (2012)
• Host of the American Chemical Society's “Green Chemistry” Webinar Series (2012-2014)
• Presenter (twice) of Chemistry for the improvement of global health and green chemistry for developing nations for the ACS' Webinar series (2012, 2013)
• Organizer and Session Chair, “Industrial Applications of Green Chemistry,” Green Chemistry International meeting, Rockville, MD; June 18-20, 2014.

Adjunct Professor
• University of Alabama, Green Chemistry Manufacturing Institute (2006 – present)
• St. Luke Foundation / Kilimanjaro School of Pharmacy, Industrial Pharmacy Advanced Training (2008 — present)
• University of Ibadan, School of Pharmacy (2014)

Advisory Boards of Commercial Entities or NGOs
• LaGray Foundation for Drug Discovery and Development for Neglected Populations (Nsawam, Ghana)
• Initiative for Medicines Access and Knowledge (New York, NY and India; 2006 — present)
• Arvir Chemical manufacturing company (2007-2010), Republic of South Africa
• UNITAID Advisory Group on Funding Priorities (2011-2012)
• Scientific Advisory Committee, AviMed Pharma. AviMed is a biotechnology startup company involved in drug discovery for Schizophrenia and Alzheimer's disease (2012)
• Scientific Advisory Board for the Public-Private Partnership “PlantSource” with the objective of bringing reliable medicines for malaria to the market at a cost of not more than $0.10 per treatment (2012)

Nigeria, Zimbabwe and Liberia (2005 — 2009)
• Taught the first training course on GMP production of medicines in West Africa; Abuja, Nigeria, July 11 – 16, 2005.
• Collaborating with the National Institute of Pharmceutical R&D in Nigeria (NIPRD), NIH and USAID to construct a facility to prepare generic antimalarial drugs (2006 – 2008; 2011-2012)
• Co-PI; grant from the USAID-UNCF Program to help re-build the University infrastructure for the AME University of Liberia (2007)
• Organized, arranged funding from the National Science Foundation (USA) and co-hosted an International Workshop on Green Chemistry and the Production of Essential Medicines, March 17-20, 2008
• Member, External Scientific Advisory Committee (ESAC) for NIPRD, (2008-2010)
• Member of the Organizing Committee, Conference on Green Chemistry and Conferences on Appropriate Technologies in Africa; Zimbabwe (2006), Rwanda (2008), South Africa (2007), and Ghana (2010)
• Co-PI on a MacArthur Foundation Award to the University of Ibadan, Nigeria for drug discovery, development and quality-assurance (2012-2014)

Non-Governmental Organization “Essential Medicines for Africa” (2008 – present)
• Founding member and co-Director
• Taught principles of Industrial Pharmacy, drug development, cGMP and Quality-Assured medicines production to representatives from 15 companies and 23 National Drug Regulatory Agencies at the St. Luke Foundation / Mount Kilimanjaro School of Industrial Pharmacy
• Funded by the United Nations Industrial Development Organization (UNIDO), the German, Gesellschaft fur Technischen Zusammenarbeiten (GTZ; now the GIZ), and the Merck Foundation (USA).

Editorial Boards, Scientific Journals
• “Current Opinion in Drug Discovery and Development” 2006 – 2011
• “Journal of Tropical Pharmaceutical Research” 2008 – present

RESEARCH ACTIVITIES
• New synthetic chemistry and methodology for the manufacture of essential medicines for the treatment of HIV/AIDS, malaria and tuberculosis
• New technologies for Green Chemistry, safety and waste reduction
• Teaching drug development and industrial pharmacy in Less Developed Countries to enable local production according to international standards of Current Good Manufacturing Practice (cGMP) to enable companies to achieve Pre-Qualification by the World Health Organization (WHO PQ)