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Joseph M. Fortunak

Associate Professor of Chemistry

Organic Synthesis

TELEPHONE & E-MAIL

(202) 806 6880 (W) (301) 879 9194 (H) (301) 928 7568 (C)

jfortunak@howard.edu jfortunak@comcast.net

EDUCATION & TRAINING

Purdue University BSc, Chemistry (1976) With highest distinction;

University of Wisconsin-Madison MSc & PhD, Organic Chemistry (1981) With highest distinction;

Cambridge University, United Kingdom NSERC postdoctoral fellow and Research Assistant Professor (1981-83)

CAREER SUMMARY 1983-1993

SmithKlineBeecham (GlaxoSmithKline) 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 Director and Head, Global Process R&D August, 2004 –Present

Howard University Associate Professor of Chemistry and Pharmaceutical Sciences

PRESENT POSITION Associate Professor of Chemistry with a joint appointment in Pharmaceutical Sciences,Howard University, Washington DC, USA

RESEARCH ACTIVITIES My research group is active in the following areas of synthetic and physical organic chemistry research:

- New chemical syntheses of drugs for the treatment of malaria, diabetes and HIV/AIDS

- New synthetic reagents and reactions for Green Chemistry, safety and waste reduction

- The use of ionic liquids to optimize reactions for multi-step organic reactions without workup, isolation of natural products

- Engineering controlled crystallizations to provide APIs with physical properties that are optimized for formulation, bioequivalence

and bioavailability

EXAMPLES OF RELEVANT RESEARCH My research accomplishments include the following examples of significant discoveries of:

- nucleophilic additions to aldehyde, ketone and imine electrophiles with very high enantioselevtivity

- Novel, intramolecular {4 + 2] cycloadditions for the rapid, efficient construction of polycyclic systems and natural product synthesis

- Design and use of new, ÒGreen ChemistryÓ reagents to accomplish difficult organic transformations with high efficiency and atom economy

RELEVANT SERVICE AND CONSULTING

William J. Clinton Foundation HIV/AIDS Initiative I am a consultant for the Clinton FoundationÕs HIV/AIDS Initiative (CHAI) and the World Health

Organization; advising these organizations on pricing and production of antiretroviral drugs (ARVs) as well as advising generic manufacturers

of ARVs on the requirements for Current Good Manufacturing Practice (cGMPs), general strategies for process development and route

discovery for the production of ActivePharmaceutical Ingredients (APIs).

National Academy of Sciences, Board on Chemical Sciences and Technology Member of the committee on ÒGrand Challenges for

Sustainability in the Chemical IndustryÓ

Adjunct Professor University of Alabama, Green Chemistry Manufacturing Institute

Scientific Advisory Board LaGray Foundation for Drug Discovery and Development for Neglected Populations

Nigerian Institute of Pharmaceutical R&D (NIPRD) Developed and taught the first training course delivered in the West African Economic

Community (ECOWAS) on cGMP production of Active Pharmaceutical Ingredients (APIs) and finished dosage forms, July 11 – 16, 2005.

Presently collaborating with NIPRD to develop a budget for construction of a cGMP facility to prepare APIs for antimalarial drugs and on Green

Chemistry for manufacturing purposes

PREVIOUS POSITIONS

Head of Global Process R&D for Abbott Labs. Managed between 225 - 500 people / ~50% PhD scientists.

Prepared all Active Pharmaceutical Ingredients (API, drug substance) for AbbottÕs Development. Responsible for route discovery, Clinical supplies, testing, process development and validation for Abbott and external customers. Manufactured several small-volume, commercial products. Group consisted of four main functions.

Analytical Chemistry – Developed and validated test methods for intermediates, in-process controls and cleaning; responsible for specifications and Process Analytical Technologies.

Chemical Pilot Plants - Operated two pilot plants, a kilolab and a potent drug facility for R&D, commercial, and 3rd party manufacturing following cGMPs.

Process Chemistry - Performed synthetic route discovery and development ranging from Medicinal Chemistry to process validation for Manufacturing

Process Engineering - Provided engineering development and technology transfer with special expertise in solid state, thermo chemistry, kinetics and hazards evaluation.

MAJOR ACCOMPLISHMENTS

Created a Process Engineering Department with expertise in separations sciences, solids engineering and process modeling. Solid State Chemistry.

Hired and integrated world-class scientists with other areas.

Utilized improved science to decrease by 80% the API needed to develop a commercial formulation.

Successfully validated processes for four New Drug Applications including the drug-device combination rapalog, the nucleotide anti-retroviral drug emtricitabine for the treatment of HIV/AIDS and the prostate drug atrasentan currently awaiting approval by the US FDA.

Founded a Green Chemistry program that won the Corporate Environmental Health and Safety Award in 2004. Team winner of the State of Illinois GovernorÕs Pollution Prevention Award, 2003.

MAJOR ACCOMPLISHMENTS WITH DuPONT PHARMA (1993-2000)

Led the API team for Losoxantrone (breast cancer) including Regulatory issues, marketing application and pre-approval inspections. Led the API development team for Efavirenz, an inhibitor of HIV-1 reverse-transcriptase

MAJOR ACCOMPLISHMENTS WITH SMITHKLINE BEECHAM CO. (1983-1993)

Invented commercial processes for the malaria drug Halofantrine and Ropinerole, a selective dopamine D3 antagonist for the treatment of Parkinson's disease.

Invented the commercial process for Topotecan, an inhibitor of Topoisomerase I for the treatment of breast, ovarian and small cell lung carcinomas.

Invented the API process for Eprosartan, an inhibitor of Angiotensin II for the treatment of hypertension and congestive heart failure.

CAREER SUMMARY AND SIGNIFICANT CONTRIBUTIONS Throughout my career I have invented new chemical reactions and have a strong record of publications, patents and presentations. I am experienced in dealing with the FDA and other Regulatory agencies. I have worked on industry initiatives (PQRI, BACPAC I & II) and as a member of the PhRMA API Technical Group. Commercial processes that I have significantly contributed to include:

Drug
Trade Name
Indication
Halofantrine
Halfan
Malaria
Ropinerole
Requip
Parkinson's Disease
Topotecan
Hycamptin
Ovarian, Breast and Small-Cell Lung cancer
Eprosartan
Eprosar
Hypertension and Congestive Heart Failure
Losoxantrone
Breast cancer
Efavirenz
Sustiva
AIDS (NNRTI)
Paclitaxcel

(consultant for NaPro BioTherapeutics)

Breast, Ovarian cancer and Karposi's sarcoma
Emtricitabine
Coviracil
AIDS (NRTI)

RELATED ACCOMPLISHMENTS

Member of Scientific Advisory Board and Consultant - NaPro Biotherapeutics, Boulder, CO, 1993-1999

A process for the commercial semi-synthesis of paclitaxcel from renewable biomass was approved by FDA and numerous foreign Regulatory agencies.

Speaker - US FDA internal sessions to train inspectors on Marketing Applications and Pre-Approval Inspections

Chair - Regulatory and Compliance Section for the Midwest Pharmaceutical Process Chemistry Consortium.

PUBLICATIONS

1. Trost, B.M., Verhoeven, T., and Fortunak, J.M., ÒIsomerization of Allylic Acetates Catalyzed by Palladium. New Method for StereocontrolÓ Tetrahedron Letters, 2301, 1979.

2. Trost, B.M. and Fortunak, J.M. "A New Diene Synthesis via Organopalladium ChemistryÓ J. Am. Chem. Soc., 102, 2841, 1980.

3. Trost, B.M. and Fortunak, J.M., "Palladium-Catalyzed Fragmentation Reaction as an Approach to Vitamin A Ester" Tetrahedron Letters, 22, 3459, 1981.

4. Trost, B.M. and Fortunak, J.M. "Cyclizations Initiated by a Pd2+-Ag+ Mixed-Metal System" Organometallics, 1, 7, 1982.

5. Fleming, I., Murahashi, S.-I., Naota, T., Tanigawa, Y. and Fortunak, J., ÒPalladium-Phosphine Complex Catalyzed Reaction of Organolithium Compounds and Alkenyl Halides: (Z)-b-[2-(N,N-dimethylamino)phenyl]styreneÓ Organic Syntheses, Vol. 62, 1984, p. 39.

6. Fleming, I., Fortunak, J.M., et al., ÒAn Approach to the Synthesis of GelsemineÓ In New Trends in Natural Products Chemistry, Atta-ur-Rahman, LeQuesne, P.E., Eds.; Elsevier: Amsterdam, 1986; p. 83.

7. McMurry, J.E., Musser, J.H., Fleming, I., Fortunak, J. and Nubling, C., ÒPreparation of b-nitro acrylic esterÓ Organic Syntheses, Coll. Vol. 6, 1988, p. 799.

8. Fleming, I., Fortunak, J.M. et al., "An Approach to the Synthesis of Gelsemine" Tetrahedron, 44, 3931, 1988.

9. Fortunak, J.M., Mellinger, M. and Wood, J. "A Convenient Preparation of Mappicine Ketones from Camptothecins: Chemistry of the Camptothecin E-Ring" Tetrahedron Letters, 35, 5763, 1994.

10. Fortunak J.M., Walsgrove, T.C., Giles, R.G., et al. "Some Synthetic Approaches to Ropinerole (SK&F 101468-A): A Potent Dopamine Receptor Antagonist" J. Het. Chem. 32, 875, 1995.

11. Wood, J.L., Fortunak, J.M., Mastrocola, A.R., Mellinger, M., and Burk, P.L. ÒAn Efficient Conversion of Camptothecin to 10-Hydroxycamptothecin.Ó J. Org. Chem., 60, 5739, 1995.

12. Pierce, M.E., Islam, Q. and Fortunak, J.M. "A Practical Photochemical Synthesis of 6-Aza-1,10-Phenanthroic Anhydride" Synth. Commun. 26, 3645, 1996.

13. Fortunak, J.M.D., Mastrocola, A.R., Mellinger, M., Sisti, N.J., Wood, J.L., and Zhuang, Z.-P. "Novel Syntheses of Camptothecin Alkaloids, Part 1. Intramolecular [4+2] Cycloadditions of N-Arylimidates and 4H-3,1-Benzoxazin-4-ones as 2-Aza-1,3-Dienes" Tetrahedron Letters, 37, 5679, 1996.

14. Fortunak, J.M.D., Kitteringham, J., Mastrocola, A.R., Mellinger, M., Sisti, N.J., Wood, J.L. and Zhuang, Z.-P. "Novel Syntheses of Camptothecin Alkaloids, Part 2. Concise Synthesis of (S)-Camptothecins" Tetrahedron Letters, 37, 5683, 1996.

15. Shilcrat, S.C., Mokhallalati, M.K., Fortunak, J.M.D. and Pridgen, L.N. "A New, Regioselective Synthesis of 1,2,5-Trisubstituted 1H-Imidazoles and Its Application to the Development of Eprosartan" J. Org. Chem., 62, 8449, 1997.

16. Wang, Z., La, B., and Fortunak, J.M. "Enantioselective Synthesis of a-Hydroxy Carboxylic Acids: Direct Conversion of a-Oxocarboxylic Acids to Enantiomerically Enriched a-Hydroxy Carboxylic Acids via Neighboring Group Control" Tetrahedron Letters, 39, 5501, 1998.

17. Williams, R.C., Riley, C.M., Sigvardson, K.W., Fortunak, J., Ma, P., Nicolas, E.C., Unger, S.E., Krahn, D.F. and Brenner, S.L. "Pharmaceutical Development and Specification of Stereoisomers" J. Pharm. Biomed. Anal., 17, 917, 1998.

18. Pierce, M.E., Parsons, R.L., Radesca, L.A., Fortunak, J.M.D., et al. "Practical Asymmetric Synthesis of Efavirenz (DMP-266) an HIV-1 Reverse Transcriptase Inhibitor" J. Org. Chem., 63, 8536, 1998.

19. Wang, Z., Zhao, C., Pierce, M.E. and Fortunak, J.M. ÒEnantioselective Synthesis of b-Hydroxy Carboxylic Acids: Direct Conversion of b-Oxocarboxylic Acids to Enantiomerically Enriched b-Hydroxy Carboxylic Acids via Neighboring Group ControlÓ Tetrahedron Asymmetry, 10, 225, 1999.

20. Wang, Z., Yin, J.G., Campagna, S., Pesti, J.A. and Fortunak, J.M. ÒAn Alternative Approach for the Conversion of Aldehydes to Terminal AlkynesÓ J. Org. Chem., 64, 6918, 1999.

21. Kauffman, G.S., Harris, G.D., Dorow, R.L., Stone, B.R.P., Parsons, R.L., Pesti, J.A., Magnus, N.A., Fortunak, J.M., Confalone, P.N. and Nugent, W.A. ÒAn Efficient Chiral Moderator Prepared from Inexpensive (+)-3-Carene: Synthesis of the HIV-1 non-Nucleoside Reverse Transcriptase Inhibitor DPC 963Ó Organic Letters, 2, 3119, 2000.

22. Wang, Z., Campagna, S., Xu, G., Pierce, M.E., Fortunak, J.M. and Confalone, P.N. ÒA New and Practical Synthesis of Vinyl Dichlorides via a non-Wittig-Type ApproachÓ Tetrahedron Letters, 41, 4007, 2000.

23. Wang, Z., Fortunak, J.M. et al. "A Practical Preparation of Terminal Alkynes From Aldehydes" J. Org. Chem., 65, 1889, 2000.

24. Fortunak, J.M., Pesti, J.A., Earl, R.A. et al., ÒEfficient Pyridinylmethyl Functionalization: Synthesis of 10,10-Bis[(2-fluoro-4-pyridinyl)methyl]-9(10H)-anthracenone (DMP 543), an Acetylcholine Release Enhancing AgentÓ J. Org. Chem., 65, 7718, 2000.

25. Parsons, R.L., Fortunak, J.M., Collum, D.B., et al. "NMR Spectroscopic Investigations of Mixed Aggregates Underlying Highly Enantioselective 1,2-Additions of Lithium Cyclopropylacetylide to Quinazolinones" J. Am. Chem. Soc. 123, 9135, 2001.

26. Sigvardson, K.W., Adams, S.P., Barnes, T.B., Blom, K.F., Fortunak, J.M., Haas, M.J., Reilly, K.L., Repta, A.J. and Nemeth, G.A. ÒThe Isolation and Identification of a Toxic Impurity in XP315 Drug SubstanceÓ J. Pharm. Biomed. Anal., 27(1-2), 327, 2002.

27. Fortunak, J.M., Storace, L., Confalone, P.N. et al., ÒAn Efficient Large-Scale Process for the Human Leukocyte Elastase Inhibitor, DMP 777Ó J. Org. Proc. Res. Dev., 6(1), 54, 2002.

28. Choudhury, A., Moore, J.R., Pierce, M.E., Fortunak, J.M., Valvis, I.I. and Confalone, P.N. ÒIn situ Recycling of Chiral Ligand and Surplus Nucleophile for a non-Catalytic Reaction: Amplification of Process Throughput in the Asymmetric Addition Step of Efavirenz (DMP 266)Ó J.Org. Proc. Res. Dev., 7(3), 324, 2003.

29. Pesti, J.A., Yin, J., Fortunak, J., et al., ÒEfficient Preparation of a Key Intermediate in the Synthesis of Roxifiban by Enzymatic Dynamic Kinetic Resolution on a Large ScaleÓ J. Org. Proc. Res. Dev., 8(1), 22, 2004.

30. Briggs, T.F., Collum, D.B., Fortunak, J.M., et al., ÒStructural and Rate Studies of the 1,2-Additions of Lithium Phenylacetylide to Lithiated Quinazolinones: Influence of Mixed Aggregates on the Reaction Mechanism.Ó J, Am, Chem. Soc., 126, 5427, 2004.

PRIMARY PATENTS GRANTED

Inventor on over one hundred patents issued worldwide. In order to accurately represent scientific productivity only filings covering substantially different processes or compositions of matter are listed.

1. Fortunak, J.M., ÒProcess for Preparing Substituted Isoindolinone DerivativesÓ United States Patent 4,997,954 issued March 5, 1991; see also EP 0300614 and Japanese Patent JP 01019065 (1/25/89 & 1/23/89).

2. Fortunak, J.M., Wood, J.L., Mastrocola, A.R., Mellinger, M. and Burk, P.L. ÒWater-soluble Camptothecin Analogs, Processes and MethodsÓ PCT International Patent WO 9205785 A1 issued April 16, 1992 ; see also EP 0547165 A1 & B1 (6/23/93; 11/10/99).

3. Fortunak, J.M., Mellinger, M., Wood, J.L. ÒMethod for Making Certain Pyrano(3Õ,4Õ:6,7)indolizino(1,2-b)quinolinones by Decarboxylation of CamptothecinsÓ PCT International Patent WO 9206095 A1 issued April 16, 1992; see also EP 0550621 A1 & B1, (7/14/93; 11/11/98).

4. Fortunak, J.M., Mellinger, M., Wood, J., ÒMethod for Making Certain Pyrano[3Õ,4Õ:6,7]indolizino[1,2-b]quinolines and Analogues Thereof.Ó United States Patent 5,155,225 issued October 13, 1992.

5. Fortunak, J.M., ÒMethod for Making Certain Pyrano[3Õ,4Õ:6,7]indolizino[1,2-b]quinolinesÓ European Patent EP 91917720.4 issued April 8, 1993.

6. Fortunak, J.M., Giles, R.G. and Walsgrove, T.C. ÒProcess for the Preparation of Substituted Indolinone DerivativesÓ European Patent EP 0300614 B1 issued August 25, 1993.

7. Fortunak, J.M. and Zhuang, Z.-P. ÒProcess for Preparing Certain Pyrrolo[3,4-b]quinolines, Certain 1H-pyrano[3Õ,4Õ:6,7]indolizino[1,2-b]quinolin-3,14(4H,12H)-diones, and Certain 8-Methyl-7-(oxopropyl)-indolizino[1,2-b]quinolin-9(11H)-onesÓ PCT International Patent WO 9405672 A1 issued March 17, 1994; see also European Patent EP 0660835 A1 (7/5/95).

8. Wells, A.S., Lewis, N.J., Walsgrove, T.C., Oxley, P. and Fortunak, J.M. ÒProcess for the Preparation of Substituted Indolone Derivatives (e.g., Ropinirole)Ó PCT International Patent WO 9415918 A1 issued July 21, 1994.

9. Fortunak, J.M., Kitteringham, J., Sisti, N. and Wood, J. ÒProcess for Asymmetric Total Synthesis of CamptothecinÓ PCT International Patent WO 9429310 A1 issued December 22, 1994; see also European Patent EP 0705262 A1 (4/10/96).

10. Fortunak, J., Kitteringham, J., Sisti, N. and Wood, J. "Process for Asymmetric Total Synthesis of Camptothecin Analogues and Intermediates Prepared Thereby" United States Patent 5,405,963 issued April 11, 1995.

11. Fortunak, J.M., Dorow, R.L., Pierce, M.E., and Matos, J.R. ÒA Process for the Synthesis of DMP315 and Unsymmetrical (bis)-NaphthylimidesÓ PCT International Patent WO 9500490 issued June 10, 1995.

12. Fortunak, J., Kitteringham, J., Sisti, N. and Wood, J. ÒProcess for Asymmetric Total Synthesis of Camptothecin AnaloguesÓ United States Patent 5,468,859 issued November 21, 1995.

13. Fortunak, J., ÒIntermediates Prepared in an Asymmetric Total Synthesis of Camptothecin AnalogsÓ United States Patent 5,541,329 issued July 30, 1996.

14. Fortunak, J.M.D., ÒIntermediates Useful in Camptothecin SynthesisÓ United States Patent 5,700,939 issued December 23, 1997.

15. Burk, P.L., Fortunak, J.M., Mastrocola, A.R., Mellinger, M. and Wood, J.L. ÒProcess for the Preparation of Certain 9-Substituted CamptothecinsÓ United States Patent 5,734,056 issued March 31, 1998.

16. Christ, D.D., Markwalder, J.A., Fortunak, J.M., Ko, S.S., Mutlib, A.E., Parsons, R.L. jr., Patel, M. and Seitz, S.P. ÒPreparation of 3,1-Benzoxazin-2-ones as HIV Reverse Transcriptase InhibitorsÓ PCT International Patent WO 9814436 issued April 9, 1998, cf. EP 0929533 A1 & B1 (7/21/99; 9/03/03).

17. Fortunak, J.M., Wang, Z. and Yin, J. ÒA Process for the Preparation of CyclopropylacetyleneÓ International Patent WO9906341 A1 issued February 11, 1999; see also European Patent EP 1000001 A1 (5/17/00).

18. Sheeran, P.J., Li, H.-Y., Fortunak, J.M., Storace, L. and Anzalone, L. ÒProcess for the Preparation of L694458 and IntermediatesÓ International Patent WO 200012474 A1 issued March 9, 2000.

19. Wang, Z. and Fortunak, J.M. ÒNovel Method for the Preparation of Monosubstituted Acetylenes, Especially CyclopropylacetyleneÓ PCT International Patent WO 200018706 A1 issued April 6, 2000.

20. Fortunak, J.M.D., Wang, Z. and Yin, J. "Process for the Preparation of Cyclopropylacetylene" United States Patent 6,049,019 issued April 11, 2000.

21. Fortunak, J.M. and Parsons, R.L. jr. Ò4,4-Disubstituted-1,4-dihydro-2H-3,1-benzoxazin-2-ones Useful as HIV Reverse Transcriptase Inhibitors and Intermediates and Processes for Making the SameÓ United States Patent 6,140,499 issued October 31, 2000.

22. Sheeran, P.J., Anzalone, L., Li, H.-Y., Fortunak, J.M. and Storace, L. ÒEfficient Process for the Preparation of [S-(R,S)]-N-[1,3-benzodioxol-5-yl)butyl]-3,3-diethyl-2[4-[4-methyl-1-piperazinyl)carbonyl]phenoxy]-4-oxo-1-azetidine carboxamide, a Human Leukocyte Elastase InhibitorÓ United States Patent 6,194,569 issued February 27, 2001.

23. Pesti, J.A., Fortunak, J.M., Huhn, G.F., Maurin, M. and Yin, J. ÒCrystalline 10,10-Bis((2-fluoro-4-pyridinyl)methyl)-9(10H)-anthracenone and an improved process for Preparing the SameÓ U.S. Patent 6,214,847 issued April 10, 2001; see also PCT International Patent WO 9909010 A1 I(2/25/99) and European Patent EP1003722 A1 (5/31/00).

24. Stone, B.R., Anzalone, L., Fortunak, J.M., Harris, G.D., Valvis, I.I. and Waltermire, R.E. ÒPreparation of Asymmetric Cyclic Ureas Through a Mono-acylated Diamine IntermediateÓ U.S. Patent 6,218,534 issued April 17, 2001; see also PCT International Patent WO 9918085 A2 (4/15/99) and European Patent EP 1025092 A2 (8/9/00).

25. Wang, Z., Yin, J., Fortunak, J.M. and Campagna, S. ÒProcess for the Preparation of Cyclopropylacetylene and Related Alkynes from Aldehydes and Trichloroacetic or Tribromoacetic AcidÓ United States Patent 6,288,297 issued September 11, 2001.

26. Parsons, R.L., Dorow, R.L., Davulcu, A.H., Fortunak, J.M., Harris, G.D., Kauffman, G.S., Nugent, W.A. and Radesca, L.A. ÒAsymmetric Synthesis of Cyclopropylethynyl-substituted Quinazolin-2-ones, Useful as HIV Reverse Transcriptase Inhibitors, Using Chiral Ligand-Mediated Alkynylation with CyclopropylacetylideÓ PCT International Patent WO200170707, issued September 27, 2001, cf. EP 1268447 A2 (1/2/03).

27. Fortunak, J.M., Wang, Z. and Yin, J. ÒProcess for the Preparation of CyclopropylacetyleneÓ United States Patent 6,297,410 issued October 2, 2001.

28. Fortunak, J.M., Parsons, R.L. jr. and Patel, M. Ò4,4-Disubstituted-1,4-dihydro-2H-3,1-benzoxazin-2-ones Useful as HIV Reverse Transcriptase Inhibitors and Intermediates and Processes for Making the SameÓ United States Patent 6,303,780 B1 issued October 16, 2001.

29. Wang, Z. and Fortunak, J.M. ÒProcess for the Preparation of CyclopropylacetyleneÓ United States Patent 6,359,164 issued March 19, 2002.

30. Stone, B.R., Anzalone, L., Fortunak, J.M., Harris, G.D., Valvis, I., Waltermire, R.E. ÒPreparation of Asymmetric Cyclic Ureas Through a Monoacylated Diamine IntermediateÓ United States Patent 6,452,000 issued September 17, 2002.

31. Fortunak, J.M. and Patel, M. Ò4,4-Disubstituted-1,4-dihydro-2H-3, 1-benzoxazin-2-ones Useful as HIV Reverse Transcriptase Inhibitors and Intermediates and Processes for Making the SameÓ United States Patent 6,492,515 B2 issued December 10, 2002.

32. Parsons, R., Dorow, R., Davulcu, A., Fortunak, J., Harris, G.D., Kauffman, G.S., Nugent, W.A. ÒAsymmetric Synthesis of Quinazolin-2-ones Useful as HIV Reverse Transcriptase InhibitorsÓ International Patent WO2003007965 A1 issued January 30, 2003; see also European Patent EP 1268447 A2 (1/2/03).

33. Parsons, R.L., Dorow, R., Davulcu, A. H., Fortunak, J.M., Harris, G.D., Kauffman, G.S., Nugent, W.A. and Radesca, L.A. ÒAsymmetric Synthesis of Quinazoline-2-ones Useful as HIV Reverse Transcriptase InhibitorsÓ U.S. Patent 6,555,686 issued April 29, 2003; see also PCT International Patent WO 0170707 A2 (3/7/02).

34. Mutlib, A.E., Parsons, R.L., Seitz, S.P., Markwalder, J.A., Christ, D.D. and Fortunak, J.M. Ò4,4-Disubstituted-1,4-dihydro-2H-3,1-benzoxazin-2-ones Useful as HIV Reverse Transcriptase Inhibitors and Processes for Making the SameÓ European Patent EP 1359147 A1, issued November 5, 2003.

REPRESENTATIVE PRESENTATIONS

"Synthesis of Indolones from b-Nitrostyrenes. Regiocontrolled Hydroxylation of Indolones." Co-authors R.E. Dagger and A.R. Mastrocola. Cambridge-Oxford Bi-annual Symposium on Organic Synthesis, Cambridge, United Kingdom, July 23, 1991.

"An Efficient Conversion of Camptothecin to 10-Hydroxycamptothecin." Co-authors J.L. Wood and P.L. Burk. Abstract 439, at the 204th National Meeting of the American Chemical Society, Washington, D.C., August 27, 1992.

"Total Synthesis of Camptothecin and Analogues. Design and Development of Novel Antitumor Agents." Brandeis university, October 26, 1992.

"A New, Regioselective Synthesis of 1,2,5-trisubstituted 1H-Imidazoles." Co-authors S.C. Shilcrat, L.N. Pridgen and M. Mokhallalati. Abstract 36, presented at the 208th National Meeting of the American Chemical Society, Washington, D.C., August 21, 1994.

"Drug Development in the Pharmaceutical Industry." Fisher-Rosemont Symposium on the pharmaceutical industry, Philadelphia, PA, November 3, 1994.

"An Efficient Synthesis of Topotecan, SK&F (S)-104864-A." Co-authors J.L. Wood and M. Mellinger. Abstract 356, at the 210th National Meeting of the American Chemical Society, Chicago, IL, August 18, 1995.

"Selectivity in the Syntheses of Biologically Important Drugs." University of California-Irvine, October 7, 1995.

"Progress and Perspectives in AIDS Chemotherapy." Wesleyan University, April 25, 1997.

"Characterization and Scale-up of Bulk Drug Manufacturing - Issues and Consequences" Lecturer and panel leader, 17th National Drug Information AssÕn. Conference, Philadelphia, PA, September 17, 1997.

In Situ Recycling of Chiral Ligand and Surplus Nucleophile for a Noncatalytic Reaction: Dramatic Amplification of Process Throughput in Asymmetric Addition. Book of Abstracts ORGN-019, 216th ACS National Meeting, Boston, August 23-27, 1998.

Development of a Synthetic Process for DMP 543, a New Acetylcholine Release Enhancing AgentÓ Book of Abstracts ORGN-021, 216th American Chemical Society National Meeting, Boston, August 23-27, 1998.

"Drug Product - Quality Control and Performance in the Pharmaceutical Industry." University of Maryland Department of Biomedical and Pharmaceutical Sciences, April 2, 1999.

"Recent Examples of Process Chemistry and Asymmetric Synthesis." American Chemical Society Northeast Regional Meeting, June 11, 1999.

"Enantioselective Processes for Non-Nucleoside Reverse Transcriptase Inhibitors DMP-961, 963, 082 and 083." IBC/Sepracor Conference on New Synthetic Methods, April 19, 2000.

"Regulatory and Compliance Initiatives for APIs in the Pharmaceutical Industry." 5th Annual API Forum, Lake Geneva, WI, October 3, 2002.

"cGMPs for the 21st Century, a Risk-Based Assessment." Albany Molecular Research Institute symposium on drug development, Albany, NY, May 8, 2003.

ÒGreen Chemistry and Waste Reduction - Invention of a Highly Selective New Reagent.Ó State of Massachusetts, Office of Technology Assessment/University of Massachusetts Symposium on Industrial Innovation, October 20, 2003.

ÒSelectivity in Synthesis – Preparation and Crystallization Control of Early Clinical Candidates.Ó American Chemical Society ProSpectives conference on Process Chemistry and the Pharmaceutical Industry, March 1, 2004.

ÒDesignation and Justification of Starting Materials for Synthetic APIs.Ó American Chemical Society ÒProSpectivesÓ conference on Process Chemistry and the Pharmaceutical Industry, March 2, 2004.

ÒCurrent Challenges and the Future of Drug DevelopmentÓ University of Maryland Departments of Chemistry and Biochemistry, May 11, 2004.

PRESENTATIONS AS A FACULTY MEMBER OF HOWARD UNIVERSITY

1. ÒSelectivity in the Synthesis and Crystallization Control of New Drug CandidatesÓ Invited Lecture at the Balticum Organicum Symposium, Riga, Latvia, June 29, 2004.

2. ÒProduct Stewardship and Green Processing in the Pharmaceutical IndustryÓ invited lecture at the Green Chemistry Gordon Research Conference, Roger Williams University, July 5, 2004.

3. ÒGreen Chemistry and the Future of the Pharmaceutical Industry,Ó American Chemical Society Midwest Regional Meeting, Peoria, IL, October 18, 2004.

4. ÒNew, Concise Synthesis of the Antimalarial Drug Halofantrine,Ó Georgetown University Undergraduate Research Symposium, Washington, DC, April 7, 2005.

5. ÒGreen Chemistry and the Use of Ionic Liquids for New Syntheses of Antimalarial Drugs,Ó American Chemical Society/Green Chemistry Institute International Meeting, Washington, DC, June 27, 2005.

6. ÒNovel Chemistry for the Manufacture of Antimalarial Drugs: Increasing Healthcare Capacity and Sustainable Manufacturing of Medicines in West AfricaÓ, American Chemical Society 230th National Meeting, Washington, DC, August 29, 2005.