DAVID P. ROTELLA, Ph.D.
`
`Work:
`Margaret and Herman Sokol Professor of Chemistry
`Department of Chemistry and Biochemistry
`Montclair State University
`Montclair NJ 07043
`973-655-7204
`rotellad@mail. montclair. edu
`
`Home:
`13 60 Fountain Road
`Newtown PA 18940
`mobile: 215-801-0191
`drotella@comcast.net
`
`Summary of Accomplishments:
`• Wyeth Research-led chemistry teams in CNS drug discovery projects and key leader for
`collaboration with Solvay Pharmaceuticals. Delivered a clinical candidate, managed chemists in
`group that delivered another. Oversaw activities and mentor group leaders responsible for two
`programs in lead discovery. Key member of department leadership team that managed project
`prioritization and strategy.
`• Lexicon Pharmaceuticals- Beginning from a screening hit, in less than one year, led project
`team that identified potent, selective, orally bioavailable inhibitors of PDE7 A Key member of
`leadership team that managed departmental growth and development. Managed interactions with
`chemistry CROs to provide intermediates and explore scale up synthesis processes.
`• Bristol-Myers Squibb-First to publish the discovery of novel phosphodiesterase type 5 inhibitors
`with better in vitro potency and selectivity compared to sildenafil. Contributed to discovery of 2
`clinical candidates (PDE5 inhibitor, DPP4 inhibitor).
`• Cephalon-Responsible for initial conception and development of several programs. Key leader in
`collaborations with Kyowa Hakko and Schering Plough. Discovered CEP 1347, which advanced
`to phase III trials for Parkinson's Disease.
`
`•
`
`Experience:
`• Department of Chemistry and Biochemistry, Montclair State University, July 5, 2011-
`present
`Margaret and Herman Sokol Professor of Chemistry-engaged in drug discovery research,
`undergraduate and graduate teaching
`Independent Consultant, February 2010-present
`Established consulting agreements with pharmaceutical companies and law firms to advance drug
`discovery programs and provide expert information on selected topics in drug development
`• Wyeth Research/Pfizer, 2005-February 2010
`Principal Research Scientist III, chemistry team leader. 4 direct reports (3 Ph.D., 1 MS; 9
`scientists in group). Directed up to 20 chemists. Member of Princeton Chemical Science
`leadership team.
`• Lexicon Pharmaceuticals, 2003-2005
`Senior Group Leader, responsible for multiple drug discovery programs. Directed up to 18 FTEs
`with 4 direct reports. Member of department leadership team.
`• Bristol-Myers Squibb PRI, 1997-2003
`Principal Scientist, 2 direct reports. Focus on cardiovascular and metabolic disease drug
`discovery
`• Cephalon, Incorporated, 1991-1997
`Group Leader (up to 4-Ph.D. and MS/BS chemists). Focus on CNS and cancer drug discovery.
`
`Ranbaxy Ex. 1024
`IPR Petition - USP 8, 772,306
`
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`

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`• Department of Pharmacognosy, School of Pharmacy, University of Mississippi, August 1987
`-August 1991
`Assistant Professor
`• Department of Medicinal Chemistry, School of Pharmacy, University of Mississippi, 2009-
`present
`Adjunct Professor-engaged in collaborative drug discovery research
`• Center for Drug Discovery, Northeastern University, 2010-present
`Adjunct Professor-engaged in collaborative drug discovery research
`
`Education:
`
`• Postdoctoral Scholar, Department of Chemistry, The Pennsylvania State University,
`1985-1987, under the direction ofProf. K. S. Feldman.
`• Ph.D. Medicinal Chemistry, The Ohio State University, 1985, under the direction ofProf.
`D. T. Witiak.
`• B.S. Pharm., Magna cum laude, School ofPharmacy, University ofPittsburgh, April
`1981.
`
`Professional Service:
`American Chemical Society, Organic and Medicinal Chemistry Divisions
`Fellow, Royal Society of Chemistry
`Division ofMedicinal Chemistry, American Chemical Society:
`Five year term as Vice Chair/Long Range Planning Committee chair, Program Chair, Chair and
`past Chair. These roles required leadership and collaborative interactions nationally and
`internationally.
`Program co-chair, National Medicinal Chemistry Symposium (2010), several sessions at
`American Chemical Society National Meetings (1999-2007)
`Organizer and conference co-chair for "Frontiers in CNS and Oncology Medicinal Chemistry",
`Siena, Italy, October 7-9, 2007, jointly organized with European Federation for Medicinal
`Chemistry.
`Is it Necessary?", Vienna, Austria, 20th European
`Session organizer for "Kinase Selectivity:
`Federation for Medicinal Chemistry Meeting, August 31-September 4, 2008.
`Session organizer for Gordon Research Conference on Medicinal Chemistry (2003)
`Co-editor, ih edition, Burger's Medicinal Chemistry 2007-present. Extensively revised and
`updated contents to reflect progress in the field since 6th edition (2003).
`Senior Editor, Royal Society of Chemistry series on Drug Discovery, 2008-present. Responsible
`for identification of topic selections and individual book editors in topics covered by series (e.g.
`case studies in drug discovery, research technologies)
`Co-editor, Drug Development Research 2009, 70(2), special issue on Alzheimer's Disease Drug
`Discovery with Albert J. Robichaud.
`
`Page2
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`

`Publications:
`
`1. "Stereocontrolled Syntheses for the Six Diasteromeric 1,2-Dihydroxy-4,5-
`Diaminocyclohexanes: Pt(ll) Complexes and P388 Antitumor Properties", Donald T. Witiak,
`David P. Rotella, Joyce A Filppi, and Judith Galucci, J Med Chem. 30, 1327 (1987).
`
`"Synthesis and P-388 Antitumor Properties of the Four Diastereomeric Dichloro 1-Hydroxy-3,4-
`2.
`diaminocyclohexane Pt(II) Complexes", Donald T. Witiak, David P. Rotella, Yong Wei, Joyce A Filppi
`and Judith C. Gallucci J Med Chem. 32, 214 (1989).
`
`3. "Mechanistic and Preparative Studies of the Intramolecular Photocyclization of Methylated 2-( 4-
`Pentenyl)tropones", Ken S. Feldman, Jon H. Come, Benedict J. Kosmider, Pamela M. Smith, David P.
`Rotella and Ming-Jung Wu, J Org. Chem. 54, 592 (1989).
`
`"Homoallylically Controlled Epoxidation of L14-cis-1,2-Disubstituted Cyclohexenes", David P.
`4.
`Rotella, Tetrahedron Letters, 1913 (1989).
`
`5. "Application of an Intramolecular Tropane-Alkene Photocyclization to the Total Synthesis of(±)
`Dactylol", KenS. Feldman, Ming-Jung Wu and David P. Rotella, JAm. Chem. Soc. 111, 6457 (1989).
`
`6. "Chloroperoxidase Mediated Halogenation of Phenols", Cheryl F. Wannstedt, David P. Rotella and
`Jerome F. Siuda, Bull. Contamin. Environ. Toxicol. 44, 282 (1990).
`
`7. "Stereocontrolled Iodolactonization of Erythro and Threo Tertiary Amides", David P. Rotella and
`Xun Li, Heterocycles 31, 1205 (1990).
`
`"The Total Synthesis of(±) Dactylol and Related Studies", Ken S. Feldman, Ming-Jung Wu and
`8.
`David P. Rotella, JAm. Chem. Soc. 112, 8490 (1990).
`
`"Synthesis and Structural Analysis of Stereospecific 3,4,5-Trisubstituted y-Butyrolactone
`9.
`Phospholipids", Xun Li and David P. Rotella, Lipids 29, 211-224 (1994).
`
`"The Effect of Pyrrolo[3,4-c]Carbazole Derivatives on Spinal Cord ChAT Activity" David P.
`10.
`Rotella, Marcie A Glicksman, J. Eric Prantner, Nicola Neff and Robert L Hudkins, Bioorganic and
`Medicinal Chemistry Letters. 5,1167-1170 (1995).
`
`11. "Microbial Metabolites of Ophiobolin A and Antimicrobial Evaluation of Ophiobolins",
`Li, Alice M. Clark, David P. Rotella and Charles D. Hufford, J Nat. Products 58, 74-81, (1995).
`
`Erguang
`
`12. "Stereoselective Synthesis of Erythro a-Amino Epoxides" David P. Rotella, Tetrahedron Letters
`35, 5453-5456 (1995).
`
`13. "Genesis and Degradation of A~ Protein by Cultured Human Neuroblastoma Cells", Robert Siman,
`John T. Durkin, E. Jean Husten, Mary J. Savage, Seetha Murthy, Suzanne Mistretta, David P. Rotella,
`Sankar Chatterjee, Bruce Dembofsky, Roger Poorman and Barry D. Greenberg, Recent Advances in
`Alzheimer's Disease and Related Disorders, John Wiley and Sons (1995).
`
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`

`

`14. "Facile Lewis Acid-Mediated Ring Opening of 4-Hydroxypyrrolidin-2-ones by Amino Acid Esters",
`David P. Rotella, Synlett, 479-480 (1996).
`
`15. "Solid Phase Synthesis of Olefin and Hydroxyethylene Peptidomimetics", David P. Rotella, J Am.
`Chem. Soc. 118, 12246-12247 (1996).
`
`"Neurotrophic 3,9-Bis[(alkylthio)methyl]- and -Bis(alkoxymethyl)-K-252a Derivatives", Masami
`16.
`Kaneko, Yutaka Saito, Hiromitsu Saito, Tadashi Matsumoto, Yuzuru Matsuda, Jeffry L. Vaught, Craig
`A Dionne, Thelma S. Angeles, Marcie A Glicksman, Nicola T. Neff, David P. Rotella, James C. Kauer,
`John P. Mallamo, Robert L. Hudkins, Chikara Murakata, J Med Chem. 40, 1863-1869 (1997).
`
`17. "An Update on COX-2 and Farnesyltransferase Inhibitor Development", David P. Rotella, Curr.
`Opin. In Drug Discovery and Development, 1, 165-174 (1998).
`
`18. "Rank-Order ofPotencies for Inhibition of the Secretion of A~40 and A~42 Suggests that Both are
`Generated by a Single y-Secretase", John T. Durkin, Seetha Murthy, E. Jean Husten, Stephen P. Trusko,
`Mary J. Savage, David P. Rotella, Barry D. Greenberg and Robert Siman, J Bioi. Chem. 274, 20499-
`20504 (1999).
`
`19. "N-3 Substituted Imidazaquinazolinones: Potent and Selective PDE5 Inhibitors as Potential Agents
`for Treatment of Erectile Dysfunction" David P. Rotella, Yeheng Zhu, Zhong Sun, John Krupinski,
`Ronald Pongrac, Laurie Seliger, Diane Normandin, John E. Macor, J Med Chem. 43, 1257-1263
`(2000).
`
`20. "Optimization of Substituted N-3-Benzyl Imidazoquinazolinone Sulfonamides as Potent and
`Selective PDE5 Inhibitors" David P. Rotella, Yeheng Zhu, Zhong Sun, John Krupinski, Ronald Pongrac,
`Laurie Seliger, Diane Normandin, John E. Macor, J Med Chem. 43, 5037-5043 (2000).
`
`21. "Phosphodiesterase 5 Inhibitors: Discovery and Therapeutic Utility", David P. Rotella, Drugs of the
`Future 26, 153-162 (2001).
`
`"Osteoporosis: Challenges and New Opportunities for Therapy", Curr. Opin. In Drug Discovery
`22.
`and Development 5, 477-486 (2002).
`
`"Phosphodiesterase Type 5 Inhibitors: Current Status and Potential Applications", Nature Reviews
`23.
`Drug Discovery 1, 674-683 (2002).
`
`24.
`
`25.
`
`"Tadalafil (Lilly/ICOS)", Curr. Opin. Invest. Drugs 4, 60-65 (2003).
`
`"SB-480848. GlaxoSmithKline", Curr. Opin. Invest. Drugs 5, 348-351 (2004).
`
`"Novel Second Generation Approaches for the Control of Type 2 Diabetes", J Med Chem. 47,
`26.
`4111-4112 (2004).
`
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`

`

`of 2-Benzylpyrrolidine-Substituted
`Structure Activity Relationships
`and
`"Discovery
`27
`Aryloxypropanols as Calcium-Sensing Receptor Antagonists", Wu Yang, Yufeng Wang, Jacques
`Roberge, Zhengping Pa, Yalei Yu, David P. Rotella, Ramakrishna Seethala, R. Michael Lawrence, Jean
`H. M. Feyen, John K. Dickson, Bioorg. Med Chem. Lett. 15,1225-1228 (2005).
`
`28. "Phosphodiesterase Inhibitors: Potential CNS Applications", Nicholas J. Brandon, David P. Rotella,
`Annual Reports in Medicinal Chemistry, 42, 3-12 (2007)
`
`"Potent Non-nitrile Dipeptidic Dipeptidyl Peptidase IV Inhibitors", Ligaya M. Simpkins, Scott
`29.
`Bolton, Zulan Pi, James C. Sutton, Chet Kwon, Guohua Zhao, David R. Magnin, David J. Augeri, Timur
`Gungor, David P. Rotella, Zhong Sun, Yajun Liu, WilliamS. Slusarchyk, Jovita Marcinkeviciene, James
`G. Robertson, Aiying Wang, Jeffrey A Robl, Karnail S. Atwal, Robert Zahler, Rex A Parker, Mark S.
`Kirby, Lawrence G. Hamann, Bioorg. Med Chem. Lett. 17, 6476-6480 (2007).
`
`"Alzheimer's Disease: A Light at the End of the Tunnel?", Albert J. Robichaud, David P. Rotella,
`30.
`Drug. Development Res. 2009, 70, 57-59.
`
`"Tetrahydrocarbazole-based Serotonin Reuptake Inhibitors/Dopamine D2 Partial Agonists for the
`31.
`Potential Treatment of Schizophrenia", David P. Rotella, Geraldine R. McFarlane, Alexander Greenfield,
`Cristina Grosanu, Albert J. Robichaud, Rajiah Aldrin Denny, Rolf W. Feenstra, Sara Nunez-Garcia, Jan(cid:173)
`Hendrik Reinders, Martina van der Neut, Andrew McCreary, Chris G. Kruse, Kelly Sullivan, Farhana
`Pruthi, Margaret Lai, Jean Zhang, Dianne M. Kowal, Tikva Carrick, Steven M. Grauer, Rachel L.
`Navarra, Radka Graf, Julie Brennan, Karen L. Marquis, Mark H. Pausch, Bioorg. Med Chem. Lett. 2009,
`19, 5552-5555.
`
`"WS-50030 [7-{ 4-[3-(1H-inden-3-yl)propyl]piperazin-1-yl }-1,3-benzoxazol-2(3H)-one]: A Novel
`32.
`Dopamine Receptor Partial Agonist/Serotonin Reuptake Inhibitor with Preclinical Antipsychotic-Like
`and Antidepressant-Like Activity", Julie A Brennan, Karen L. Marquis, Mark H. Pausch, Chad E. Beyer,
`Zoe Hughes, Radka Graf, Steven Grauer, Qian Lin, Sharon Rosenzweig-Lipson, Farhana Pruthi,
`Claudine Pulicicchio, David P. Rotella, Albert J. Robichaud, Deborah L. Smith, Rolf Feenstra, Chris G.
`Kruse, Andrew McCreary, Pierre Broqua, Wouter Grotier, Martina van der Neut, J Pharmacal. Exp.
`Ther. 2010, 332, 190-201.
`
`"Potent Dihydroisoquinolone-Based Dopamine D 2 Partial Agonist/Serotonin Reuptake Inhibitors
`33.
`for Treatment of Schizophrenia", Yinfa Y an, Ping Zhou, David P. Rotella, Rolf Feenstra, Chris G. Kruse,
`Martina van der Neut, Jan-Hendrik Reinders, Farhana Pruthi, Dianne Kowal, Tikva Carrick, Margaret
`Lai, Karen L. Marquis, Mark H. Pausch, Albert J. Robichaud, Bioorg. Med Chem. Lett. 2010, 20, 2983-
`2986.
`
`Page 5
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`

`Patents:
`
`1. "Diastereomeric Mono- and Di-Substituted Diaminocyclohexane Compounds and Methods of
`Preparation Thereof'' Donald T. Witiak and David P. Rotella, US 5,206,400.
`
`2. "K252a Functional Derivatives Potentiate Neurotrophin-3 Activity for the Treatment ofNeurological
`Disorders" Marcie A Glicksman, Robert L. Hudkins, David P. Rotella, Nicola Neff and Chikara
`Murakata, US 5,468,872.
`
`3. "K252 Derivatives Which Enhance Neurotrophin-Induced Activity" Marcie A
`Robert L. Hudkins, David P. Rotella, Nicola Neff and Chikara Murakata, US 5,516,772.
`
`Glicksman,
`
`4. "Quinazolinone Inhibitors of cGMP Phosphodiesterase", David P. Rotella, John E. Macor, David
`Cushman, Joseph Yevich, US 6,087,368
`
`5. "Quinoline Inhibitors of cGMP Phosphodiesterase", Yingzhi Bi, David P. Rotella, Guixue Yu, John
`E. Macor, US 7,378,430.
`
`6. "2-Substituted cyclic amines as calcium sensing receptor modulators", Ashvinikumar Gavai, Roy J.
`Vaz, John K. Dickson, Jacques Y. Roberge, Wu Wang, Timur Gungor, James R. Corte, David P.
`Rotella, Yufeng Wang, Wu Yang, US 7,105,537.
`
`7. "Preparation of substituted pi peri dines and pyrrolidines as calcium sensing receptor modulators",
`John K. Dickson, Michael R. Lawrence, Jacques Y. Roberge, David P. Rotella, Wu Yang, US
`7,265, 145.
`
`Books & Book Chapters:
`
`"SSRis" David P. Rotella and Wayne E. Childers, 2010, "Analog-Based Drug Discovery, volume
`2, Wiley-VCH, Janos Fischer and Robin Ganellin, editors.
`
`"Medicinal Chemistry Challenges in the Discovery ofNovel Antidepressants", 2010, "Progress in
`the Discovery of Novel Antidepressant Agents", Cambridge University Press, Chad E. Beyer,
`editor.
`
`"Drug Discovery for Non-Life Threatening Disorders", 2010, "Burger's Medicinal Chemistry",
`volume 5, ih edition, John Wiley and Sons, Donald J. Abraham and David P. Rotella, co-editors.
`
`"CNS Applications for Phosphodiesterase Inhibitors", in press, 2011, "Cyclic-Nucleotide
`Phosphodiesterases in the Central Nervous System: From Biology to Drug Discovery", John
`Wiley and Sons, Anthony West, Nicholas J. Brandon, editors.
`
`Inhibitors and Therapeutic Applications" 2006, 919-957
`"Phosphodiesterase Enzymes,
`"Comprehensive Medicinal Chemistry II" Elsevier Science Publishers, Walter H. Moos editor.
`
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`

`

`Abstracts and Presentations:
`
`More than 30 invited lectures at US universities since 1991 on drug discovery topics.
`
`"Antipsychotic-like profile of WS-50030, a combined partial D2 receptor agonist and selective
`serotonin reuptake inhibitor", Julie Brennan, Karen Marquis, Claudine Pulichiccio, Mark Pausch,
`Steven Grauer, David P. Rotella, Rolf Feenstra, Andrew McCreary, poster presentation, Society
`for Neuroscience meeting 2008, Washington DC, November 2008.
`
`"PDE5 Inhibitors: Comparison of Current Agents and Future Prospects", David P. Rotella, 2nd
`Annual Phosphodiesterases in Drug Discovery and Development, November 8-9, 2004.
`
`"Phosphodiesterase Type 5 Inhibitors: Is There Room for More?'' David P. Rotella, American
`Society of Andrology 291h National Meeting, April 18, 2004.
`
`"Effects of the M3 antagonist, darafenicin, on food intake and body weight in two models
`of obesity." M.J. Cullen, M.A. Pelleymounter, D. Rotella, K Carlson and K. Behnia,
`Keystone Symposium: Obesity: New Insights into Pathogenesis and Treatment,
`Keystone, CO, January 21-26, 2003.
`
`"Discovery and Optimization of PDE5 Inhibitors" David P. Rotella, Zhong Sun, Yeheng Zhu,
`Laurie Seliger, Ronald Pongrac, Diane Normandin, John Krupinski, John E. Macor, 2201h
`National American Chemical Society Meeting, Washington DC, August 21-24, 2000, MEDI 322.
`
`"Neurotrophic Derivatives of K252A. Profile of CEP 1347/KT7515 and SAR of Survival
`Promoting Analogs", Chikara Murakata, Masami Kanedo, Yuzuru Matsuda, Hiromitsu Saito,
`Yutaka Saito, Eriko Tanaka, Tatsuya Tamaoki, Tadashi Matsumoto, James C. Kauer, Robert L.
`Hudkins, David P. Rotella, Marcie A Glicksman, Michael Saporito, Susan Carswell, Forrest
`Haun, Ernest Knight, Jr., Craig Dionne, Nicola T. Neff, Jeffry L. Vaught and John P. Mallamo,
`212th National American Chemical Society Meeting, August 25-29, 1996, Orlando, FL, MEDI
`211.
`
`"Potent and Selective Neurotrophic Derivatives of K252a", John P. Mallamo, James C. Kauer,
`Robert L. Hudkins, David P. Rotella, Marcie A Glicksman, Michael Saporito, Susan Carswell,
`Forrest Haun, Ernest Knight, Jr., Nicola T. Neff, Jeffry L. Vaught, Chikara Murakata and Masami
`Kaneko, Second Symposium on Medicinal Chemistry Approaches to Alzheimer's Disease,
`August 28-30 1995, Strasbourg, France.
`
`"Neurotrophic Structure Activity Relationships for Potent and Selective Derivatives of K252a",
`Robert L. Hudkins, Chikara Murakata, Masami Kaneko, Yuzuru Matsuda, David P. Rotella,
`Craig A Dionne, Ernest Knight, Jr., Marcie A Glicksman, Nicola T. Neff and John P. Mallamo,
`Second Symposium on Medicinal Chemistry Approaches to Alzheimer's Disease, August 28-30
`1995, Strasbourg, France.
`
`"Carbazole and Carboline Derivatives of K252C as Potential Small Molecule Neurotrophic
`Agents", David P. Rotella, Marcie A Glicksman, J. Eric Prantner and Robert L. Hudkins, First
`
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`

`Annual Medicinal and Bioorganic Chemistry Conference, Steamboat Springs Colorado, January
`29-February 2, 1995.
`
`"The Effect of Hydroxyl Protection on Stereochemistry and Stereocontrol During Amide
`Iodolactonization" David P. Rotella, 202nd National Meeting ofthe American Chemical Society,
`August 25-30, 1991, New York, NY, ORGN 258.
`
`"Conformationally Restricted Substrate Analogues as Potential Phospholipase A2 Inhibitors"
`David P. Rotella, Xun Li and John K. Baker, Fifth Annual National Meeting of the American
`Association ofPharmaceutical Scientists, November 4-6, 1990, Las Vegas, NV.
`
`"Synthesis and Preliminary 31 P NMR Evaluation of Lactones as Substrates for Phospholipase
`A2" David P. Rotella, Xun Li and John K. Baker, invited poster presentation to the National
`Meeting of the American Association of Colleges of Pharmacy, Salt Lake City, UT, July 8-11,
`1990.
`
`"Structure-Activity and Cytotoxicty Studies of Irreversible Calmodulin Antagonists Based on a
`Natural Product Model" David P. Rotella, Qingwu He, John M. Pezzuto and Carl L. Tipton,
`poster presentation at the National Medicinal Chemistry Symposium, Austin, TX, July 29-August
`2, 1990.
`
`"Homoallylically Controlled Epoxidation of L14-cis-1,2-Disubstituted Cyclohexenes", David P.
`Rotella, 197th National Meeting of the American Chemical Society, Dallas, TX , April 9-14,
`1989, ORGN 34.
`
`"Synthesis and Biological Evaluation ofNovel Hydroxycyclohexanediamine Pt(II) Complexes as
`Potential Antitumor Agents", David P. Rotella and Donald T. Witiak, 191st National Meeting of
`the American Chemical Society, New York, NY, April16-21, 1986, MEDI 54.
`
`"Synthesis and Antitumor Activity of Novel Pt(II) Hydroxycyclohexanediamine Complexes",
`D.P. Rotella, D.T. Witiak, and J.A. Filppi, First International Biotechnology Conference,
`Columbus, OH, November 13-15, 1985.
`
`"Synthesis and Antimetastatic Properties of Stereoisomeric Bisdioxopiperazines", D. T. Witiak,
`B.S. Zwilling, B.K. Trivedi, R.V. Nair, and D.P. Rotella, 183rd National Meeting of the
`American Chemical Society, Kansas City, MO, August 25-30, 1982.
`
`Page 8
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