FRANCO LOMBARDO

Founder/Principal

CmaxDMPK, LLC.

May 2021 to present

DMPK consulting and training

• DMPK consulting and training, modeling, short courses on the ADME, physicochemical properties and PK/dose prediction. Gap and data analysis. Assistance with CRO selection and data interpretation.

Senior Director/Head of DMPK

Alkermes, Inc.

January 2017 to March 2021

DMPK and Bioanalysis

• Built and currently leading the DMPK group, responsible for studies in preclinical species in vitro and in vivo, mass balance (CRO) and ADME (in house) studies. GLP (CRO) and non-GLP (in house) ADME studies. Preparation/review of IND and NDA sections. Physicochemical properties determination (CRO) and interpretation and application. Human PK scaling and modeling, with extensive in silico and in vitro PK model building expertise. Data retrieval, automation and storage infrastructural work. Strategic role, consulting, mentoring, advisory and supervisory roles toward Ph.D. and non-Ph.D. scientists involved in Discovery and Development activities. Senior Leadership Team member within Discovery contributing to the review of project progression, resources allocation and go/no-go decisions. Project team representative for biologics as well as small molecules.

Principal Research Investigator

Biogen

October 2014 to August 2016

Chemical & Molecular Therapeutics

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• Physicochemical properties determination and application to ADME (Absorption, Distribution, Metabolism and Excretion). Strategic vision, consulting, mentoring, advisory and supervisory role toward both junior and senior members of various line functions, including chemistry, pharmacology, DMPK, and pharmaceutics. Support and ideas toward the development of web tools and approaches in the ADME PK arena are also part of the responsibilities. Creation of new or modification of existing workflows and infrastructure in the ADME, physicochemical properties and DMPK arena. Computational approaches toward ADME and physicochemical properties prediction.

Director

Novartis Institutes for Biomedical Research (NIBR)

April 2010 to October 2014

Metabolism and Pharmacokinetics, Cambridge Laboratories

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• Cambridge member of the Oncology Decision Board, Disease Area Representative role in Oncology. Ophthalmology (February 2011-February 2012) and Exploratory Chemistry Leadership teams (September 2010-March 2012). Lead scientist in animal-to-human scaling efforts and prediction. Physicochemical modeling of in-vivo distribution and clearance behavior of drugs. Hands-on expertise and work in PK simulations and PK/PD data analysis using Phoenix and GastroPlus. Leadership role in global in silico-in vitro-in vivo correlation efforts and training and implementation of pKa prediction software, MoKa. Leadership in global pro-drugs and soft-drugs exploratory and educational efforts. Data interpretation and PK/PD and physicochemical properties guidance to project teams. Partnered with Pharmacology, Biology, Project Management, and Medicinal Chemistry leaders. Led a global MAP project team member forum (March 2012-October 2014) bringing Oncology questions and issues to focus and alignment. Maintained most of the supervisory and scientific responsibilities as described in the Senior Research Investigator II section.

Senior Research Investigator II

Novartis Institutes for Biomedical Research (NIBR)

April 2008 to March 2010

Metabolism and Pharmacokinetics, Cambridge Laboratories

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• Supervision of three to seven laboratory heads and laboratory associates, with responsibilities in the areas of Infectious Diseases and Oncology (Oncology only as of January 2009). Project Team Member. Computational chemistry approaches applied to physicochemical, PK properties, and site of metabolism prediction. MetaSite Consortium participation as the lead scientific contact for NIBR. Advisory and strategic role on drug-like properties, with emphasis on oral drug delivery. Physicochemical modeling of in-vivo distribution and clearance behavior of drugs. PK data analysis using WinNonLin. Human PK parameters prediction via in vivo scaling. Leadership role in a global in silico-in vitro-in vivo correlation efforts. Infectious Diseases Area Decision Board MAP/DMPK representative. Supervision of a visiting scientist (in silico ADME) from September 2008 to August 2009.

Senior Research Investigator I

Novartis Institutes for Biomedical Research (NIBR)

February 2006 to March 2008

Metabolism and Pharmacokinetics, Cambridge Laboratories

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• Supervision of three to six laboratory heads and associates, with responsibilities in the areas of Infectious Diseases and Oncology. Computational chemistry approaches applied to physicochemical and PK properties prediction. Advisory role on drug-like properties with emphasis on oral drug delivery. Physicochemical modeling of in-vivo distribution phenomena. PK data analysis using WinNonLin. PK parameters calculations. Project support.

Associate Research Fellow

Pfizer Global Research and Development

January 2001 to February 2006

Groton Laboratories, Molecular Properties Group

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• Supervision of three to five laboratory assistants. Development and implementation of physicochemical properties high throughput screening methods (logP/logD). Automation of equilibrium solubility determinations. Computational chemistry approaches applied to physicochemical properties prediction. Development of medium-to-high throughput screening methods for oxidative stability assessment. Advisory role on drug-like properties with emphasis on oral drug delivery. Physicochemical modeling of in-vivo distribution phenomena. PK data analysis using WinNonLin. Preparation and presentation of seminars on the above topics, aimed at DM and medicinal chemistry scientists.

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Senior Research Investigator

Central Research Division, Pfizer, Inc.

June 1998 to January 2001

Discovery, Molecular Properties Group

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• Supervision of three to four laboratory assistants. Development and implementation of physicochemical properties high throughput screening methods (logP/logD). Automation of equilibrium solubility determinations. Computational chemistry approaches applied to physicochemical properties prediction. Development of medium-to-high throughput screening methods for oxidative stability assessment. Advisory role on drug-like properties with emphasis on oral drug delivery. Preparation and presentation of seminars on the above topics, aimed at the DM and medicinal chemistry scientists.

Senior Research Investigator

Central Research Division, Pfizer, Inc.

February 1997 to May 1998

Pharmaceutical R&D

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• Oral Drug Delivery: Early Candidates Group. Supervision of two laboratory assistants. Computational chemistry: solvation energy calculations and mechanistic studies on degradation pathways. Discovery support and formulation development, as described below.

Senior Research Scientist

Central Research Division, Pfizer, Inc.

October 1993 to January 1997

Pharmaceutical R&D

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• Oral Drug Delivery: Early Candidates Group. Supervision of two laboratory assistants. Discovery support: physicochemical properties characterization (solubility, pKa, intestinal absorption rate constants), degradation studies, isolation and characterization of degradants. Computational chemistry: solvation energy calculations and mechanistic studies. Oral Dosage Forms Development: drug safety evaluation studies, clinical studies for Phase I and early Phase II. Solutions and solid dosage forms development and stability studies.

Senior Research Chemist

Merck, Sharp & Dohme Research Laboratories

November 1990 to September 1993

West Point, Pennsylvania

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• Pharmaceutical Chemistry Group. Pre-formulation Research: drug stability studies, drug excipient(s) compatibility studies. Formulations stability screening. HPLC methods development. Isolation and identification of degradants. NMR spectroscopy. Synthesis of degradants.

Research Assistant

University of Minnesota. Department of Chemistry

June 1985 to November 1990

Synthetic and physical organic electrochemistry

Research advisor: Professor Essie Kariv-Miller (ret.)

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• Electro-reductive cyclization of carbonyl compounds: synthetic and mechanistic aspects.

• Synthesis of precursors for mono and tandem cyclization. Methods included pericyclic reactions, various oxidations and reductions, alkylations.

• Purification and structure determination of the electro-reductive cyclization products. Synthetic applications exploiting the stereo and regioselectivity of the cyclization reaction.

• NMR spectroscopy.

Research Assistant

University of Rome, Department of Pharmaceutical

June 1983 to November 1984

Chemistry and Technology

Advisor: Professor Vincenzo Carelli

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• Mechanistic study of the reductive behavior of pyridinium salts. Preparation and characterization of precursors and products.

PUBLICATIONS

• In Silico Models of Human PK Parameters. Prediction of Volume of Distribution Using an Extensive Dataset and a Reduced Number of Parameters. Franco Lombardo, Jörg Bentzien, Giuliano Berellini and Ingo Muegge. J. Pharm. Sci. 2020, 110, 500-509.

• Discovery of a Brain Penetrant ATP-competitive Inhibitor of the Mechanistic Target of Rapamycin (mTOR) for CNS disorders. Simone Bonazzi, Carleton P. Goold, Audrey Gray, Noel M. Thomsen, Jill Nunez, Rajeshri G. Karki, Aakruti Gorde, Jonathan D. Biag, Hasnain A. Malik, Yingchuan Sun, Guiqing Liang, Danuta Lubicka, Sarah Salas, Nancy Labbe-Giguere, Erin P. Keaney, Stephanie McTighe, Shanming Liu, Lin Deng, Grazia Piizzi, Franco Lombardo, Doug Burdette, Jean-Cosme Dodart, Christopher J. Wilson, Stefan Peukert, Daniel Curtis, Lawrence G. Hamann, Leon O. Murphy. J. Med. Chem. 2020 63, 1068-1083.

• An Accurate In Vitro Prediction of Human VDss Based on the Oie-Tozer equation and Primary Physicochemical Descriptors. 3. Analysis and Assessment of Predictivity on a Large dataset. Giuliano Berellini, Franco Lombardo. Drug Metab. Dispos. 2019, 47, 1380-1387.

• Discovery of Asciminib (ABL001), an Allosteric Inhibitor of the Tyrosine Kinase Activity of BCR-ABL1. Joseph Schoepfer, Wolfgang Jahnke, Giuliano Berellini, Silvia Buonamici, Simona Cotesta, Sandra W. Cowan-Jacob, Stephanie Dodd, Peter Drueckes, Doriano Fabbro, Tobias Gabriel, Jean-Marc Groell, Robert M. Grotzfeld, A. Quamrul Hassan, Chrystèle Henry, Varsha Iyer, Darryl Jones, Franco Lombardo, Alice Loo, Paul W. Manley, Xavier Pellé, Gabriele Rummel, Bahaa Salem, Markus Warmuth, Andrew A. Wylie, Thomas Zoller, Andreas L. Marzinzik, and Pascal Furet. J. Med. Chem. 2018, 61, 8120-8135.

• Trend Analysis of a Database of Intravenous Pharmacokinetics Parameters in Humans for 1352 Drug Compounds. Franco Lombardo, Giuliano Berellini, R. Scott Obach. Drug Metab. Dispos. 2018, 46, 1466-1477.

• Discovery of LSZ102, a Potent, Orally Bioavailable Selective Estrogen Receptor Degrader (SERD) for the Treatment of Estrogen Receptor Positive Breast Cancer. George Tria, Tinya Abrams, Jason Baird, Heather Burks, Brant Firestone, Lawrence A. Gaither, Lawrence Hamann, Guo He, Christina Kirby, Sunkyu Kim, Franco Lombardo, Kaitlin Macchi, Donald McDonnell, Yuji Mishina, John Norris, Jill Nunez, Clayton Springer, Yingchuan Sun, Noel Thomsen, Chunrong Wang, Jianling Wang, Bing Yu, Choi-Lai Tiong-Yip, Stefan, Peukert.  J. Med. Chem.  2018, 61, 2837-2864.

• In silico ADME-PK utility and best practices – An Industry Perspective from the IQ Consortium. Franco Lombardo, Prashant V. Desai, Rieko Arimoto, Kelly E. Desino, Holger Fischer, Christopher E. Keefer, Carl Petersson, Susanne Winiwarter and Fabio Broccatelli. J. Med. Chem. 2017, 60, 9097–9113.

• Discovery of an Acrylic Acid-Based Tetrahydroisoquinoline as an Orally Bioavailable Selective Estrogen Receptor Degrader for ERα+ Breast Cancer.  Heather E. Burks, Tinya Abrams, Christina A. Kirby, Jason Baird, Alexander Fekete, Lawrence G. Hamann, Sunkyu Kim, Franco Lombardo, Alice Loo, Danuta Lubicka, Kaitlin Macchi, Donald P. McDonnell, Yuji Mishina, John D. Norris, Jill Nunez, Chitra Saran, Yingchuan Sun, Noel M. Thomsen, Chunrong Wang, Jianling Wang, Stefan Peukert. J. Med. Chem. 2017, 60, 2790–2818.

• ABL001, a Novel Allosteric ABL Inhibitor, Prevents Relapse in CML by Enabling a Dual Targeting Approach of BCR-ABL. Andrew A. Wylie, Joseph Schoepfer, Wolfgang Jahnke, Sandra W. Cowan-Jacob, Alice Loo, Pascal Furet, Andreas Marzinzik, Xavier Pelle, Jerry Donovan, Suzanne Zhu, Silvia Buonamici, Quamrul Hassan, Franco Lombardo, Varsha Iyer, Michael Palmer, Giuliano Berellini, Stephanie Dodd, Lilli Petruzzelli, K. Gary Vanasse, Markus Warmuth, Francesco Hofmann, Nicholas Keen, William R. Sellers. Nature, 2017, 543, 733-737.

• In Silico Prediction of Volume of Distribution in Human. Extensive Data Set and the Exploration of Linear and Non-linear Methods Coupled with Molecular Interaction Fields Descriptors. Franco Lombardo and Yankang Jing. J. Chem. Inf. Model., 2016, 56, 2042-2052.

• Antibacterial and Solubility Optimization of Thiomuracin A. Matthew J. LaMarche, Jennifer A. Leeds, Jason Brewer, Karl Dean, Jian Ding, Joanne Dzink-Fox, Gabe Gamber, Akash Jain, Ryan Kerrigan, Philipp Krastel, Kwangho Lee, Franco Lombardo, David McKenney, Georg Neckermann, Colin Osborne, Deborah Palestrant, Michael A. Patane, Elin M. Rann, Zachary Robinson, Esther Schmitt, Travis Stams, Stacey Tiamfook, Donghui Yu, and Lewis Whitehead. J. Med. Chem. 2016, 59, 6920-6928.

• Allosteric Inhibition of SHP2: Identification of a Potent, Selective, and Orally Efficacious Phosphatase Inhibitor. Jorge Garcia Fortanet, Christine Hiu-Tung Chen, Ying-Nan P. Chen, Zhouliang Chen, Zhan Deng, Brant Firestone, Peter Fekkes, Michelle Fodor, Pascal D. Fortin, Cary Fridrich, Denise Grunenfelder, Samuel Ho, Zhao B. Kang, Rajesh Karki, Mitsunori Kato, Nick Keen, Laura R. LaBonte, Jay Larrow, Francois Lenoir, Gang Liu, Shumei Liu, Franco Lombardo, Dyuti Majumdar, Matthew J. Meyer, Mark Palermo, Lawrence Perez, Minying Pu, Timothy Ramsey, William R. Sellers, Michael D. Shultz, Travis Stams, Christopher Towler, Ping Wang, Sarah L. Williams, Ji-Hu Zhang, and Matthew J. LaMarche. J. Med. Chem. 2016, 59, 7773–7782.

• Toward the Systematic Application of Wajima’s Profiling in the Estimation of Human PK. Part 1: IV Profiles. Franco Lombardo, Giuliano Berellini, Laura R. LaBonte, Guiqing Liang and Sean Kim. J. Pharm. Sci. 2016, 105, 1277-1287.

• The benefits of retraining pKa models studied using internally measured data. Peter Gedeck, Yipin Lu, Suzanne Skolnik, Stephane Rodde, Gavin Dollinger, Weiping Jia, Giuliano Berellini, Riccardo Vianello, Bernard Faller, and Franco Lombardo. J. Chem. Inf. Model., 2015, 55, 1449-1459.

• Clearance Mechanism Assignment and Total Clearance Prediction in Human based upon In Silico Models. Franco Lombardo, R. Scott Obach, Manthena Varma, Rowan Stringer, and Giuliano Berellini. J. Med. Chem. 2014, 57, 4397-4405.

• Comprehensive Assessment of Human Pharmacokinetic Prediction Based on In Vivo Animal Pharmacokinetic Data. Part 2: Clearance. Franco Lombardo, Nigel J. Waters, Upendra A. Argikar, Michelle K. Dennehy, Jenny Zhan, Mithat Gunduz, Shawn P. Harriman, Giuliano Berellini, Ivana Liric Rajlic, and R. Scott Obach. J. Clin. Pharmacol. 2013, 52, 178-191.

• Comprehensive Assessment of Human Pharmacokinetic Prediction Based on In Vivo Animal Pharmacokinetic Data. Part 1: Volume of Distribution at Steady State. Franco Lombardo, Nigel J. Waters, Upendra A. Argikar, Michelle K. Dennehy, Jenny Zhan, Mithat Gunduz, Shawn P. Harriman, Giuliano Berellini, Ivana Liric Rajlic, and R. Scott Obach. J. Clin. Pharmacol. 2013, 52, 167-177.

• In Silico Prediction of Total Human Plasma Clearance. Giuliano Berellini, Nigel J. Waters and Franco Lombardo. J. Chem. Inf. Model. 2012, 52, 2069-2078.

• Optimization of the in Vitro Cardiac Safety of Hydroxamate-Based Histone Deacetylase Inhibitors. Shultz, M. D.; Cao, X.; Chen, C. H.; Cho, Y. S.; Davis, N. R.; Eckman, J.; Fan, J.; Fekete, A.; Firestone, B.; Flynn, J.; Green, J.; Growney, J. D.; Holmqvist, M.; Hsu, M.; Jansson, D.; Jiang, L.; Kwon, P.; Liu, G.; Lombardo, F.; Lu, Q.; Majumdar, D.; Meta, C.; Perez, L.; Pu, M.; Ramsey, T.; Remiszewski, S.; Skolnik, S.; Traebert, M.; Urban, L.; Uttamsingh, V.; Wang, P.; Whitebread, S.; Whitehead, L.; Yan-Neale, Y.; Yao, Y.; Zhou, L.; Atadja, P. J. Med. Chem. 2011, 54, 4752-4772.

• Drug Design from the ADME/PK Perspective: Does Chemical Intuition Suffice in Multifaceted Drug Discovery? Lombardo F.; Waters, N. J. Editorial. Curr. Top. Med. Chem. 2011, 11, 331-333. Lombardo F.; Waters, N.J. Issue Guest Editors.

• Use of the Øie-Tozer Model in Understanding Mechanisms and Determinants of Drug Distribution. Waters N. J.; Lombardo F. Drug Metab. Dispos. 2010, 38, 1159-1165.

• Plasma Protein Binding and Volume of Distribution: Determination, Prediction and Use in Early Drug Discovery. Lombardo F.; Obach R.S.; Waters, N.J. Invited chapter in “Hit and Lead Profiling. Identification and Optimization of Drug-like Molecules.” Editors: Bernard Faller and Laszlo Urban. (Methods and Principles in Medicinal Chemistry series). Wiley- VCH, Weinheim, Germany, 2009. Ch. 9.

• In Silico Prediction of Volume of Distribution in Human Using Linear and Non-Linear Models on a 669 Compounds Data Set. Berellini G.; Waters N. J.; Springer, C.; Lombardo F. J. Med. Chem. 2009, 52, 4488-4495.

• Trend Analysis of a Database of Intravenous Pharmacokinetic Parameters in Human for 670 Drug Compounds. Obach, R. S.; Lombardo, F.; Waters N. J. Drug Metab. Dispos. 2008, 36, 1385-1405.

• Measurement of dissociation constants (pKa values) of organic compounds by multiplexed capillary electrophoresis using aqueous and co-solvent buffers. Shalaeva, M.; Kenseth, J.; Lombardo F.; Bastin, A. J. Pharm. Sci. 2008, 97, 2581-2606.

• The Good, the Bad and the Ugly of Distribution Coefficients: Current Status, Views and Outlook. Lombardo, F.; Faller, B.; Shalaeva, M.; Tetko, I.; Tilton, S. Invited chapter in “Drug Properties: Measurement and Computation”. Editor: Raimund Mannhold. (Methods and Principles in Medicinal Chemistry series). Wiley-VCH, Weinheim, Germany, 2007. Ch.16.

• In Silico Prediction of Ionization Constants of Drugs. Lee, P.H.; Ayyampalayam, S. N.; carreira, L. A.; Shalaeva, M.; Bhattachar, S.; Coselmon, R.; Poole, S.; Gifford, E.; Lombardo, F. Mol. Pharm. 2007, 4, 498-512.

• A Hybrid Mixture Discriminant Analysis-Random Forest Computational Model for the Prediction of Human Volume of Distribution of Drugs in Human. Lombardo, F.; Obach, R. S.; DiCapua, F. M; Bakken, G.; Lu, J.J.; Potter, D. M.; Gao, F.; Miller, M. D.; Zhang, Y. J. Med. Chem. 2006, 49, 2262-2267.

• Structure-activity relationships of triazolopyridine oxazole p38 inhibitors: Identification of candidates for clinical development. McClure, Kim F.; Letavic, Michael A.; Kalgutkar, Amit S.; Gabel, Christopher A.; Audoly, Laurent; Barberia, John T.; Braganza, John F.; Carter, Demetrius; Carty, Thomas J.; Cortina, Santo R.; Dombroski, Mark A.; Donahue, Kathleen M.; Elliott, Nancy C.; Gibbons, Colleen P.; Jordan, Crystal K.; Kuperman, Alexander V.; Labasi, Jeff M.; LaLiberte, Ronald E.; McCoy, Jennifer M.; Naiman, Brian M.; Nelson, Kendra L.; Nguyen, Hang T.; Peese, Kevin M.; Sweeney, Francis J.; Taylor, Timothy J.; Trebino, Catherine E.; Abramov, Yuriy A.; Laird, Ellen R.; Volberg, Walter A.; Zhou, Jun; Bach, Justin; Lombardo, Franco. Bioorg. Med. Chem. Lett. 2006, 16, 4339-4344.

• A Recursive Partitioning Model for Blood-Brain Barrier Permeation. Mente, S. R., Lombardo, F. J. Comp.-Aid. Mol. Des. 2005, 19, 465-481.

• Bioactivation of the Nontricyclic Antidepressant Nefazodone to a Reactive Quinone-Imine Species in Human Liver Microsomes and Recombinant Cytochrome P450 3A4. Amit S. Kalgutkar, Alfin D. N. Vaz, Mary E Lame, Kirk R Henne, John Soglia, Sabrina X Zhao, Yuri A Abramov, Franco Lombardo, Claire Collin, Zachary S Hendsch, Cornelis E. C. A. Hop. Drug Metab. Dispos. 2005, 33, 243-253.

• Prediction of Clinical Volume of Distribution for Neutral and Basic Drugs.2. Extended Data Set and Leave-Class-Out Statistics. Lombardo, F., Obach, R.S., Shalaeva, M. Y., Gao, F. J. Med. Chem., 2004, 47, 1242-1250.

• In Silico ADME Prediction: Data, Models, Facts and Myths Lombardo, F., Gifford, E., Shalaeva, M. Invited review article. Mini-Reviews in Medicinal Chemistry, G. Caron, Ed., 2003, 3, 861-875.

• Prediction of Volume of Distribution Values in Humans for Neutral and Basic Drugs Using Physicochemical Measurements and Plasma Protein Binding Data. Lombardo, F., Obach, R.S., Shalaeva, M. Y., Gao, F. J. Med. Chem., 2002, 45, 2867-2876.

• Hydrolysis in Pharmaceutical Formulations. Waterman, K. C., Adami, R. C., Alsante, K. M., Antipas, A. S., Arenson, D. R., Carrier, R.; Hong, J., Landis, M. S., Lombardo, F., Shah, C. S., Shalaev, E., Smith, S. W., Wang, H. Pharm. Dev. Technol., 2002, 7, 113-146.

• Prediction of Volume of Distribution Values in Humans for Neutral and Basic Drugs Using Physicochemical Measurements and Plasma Protein Binding Data. Lombardo, F., Obach, R.S., Shalaeva, M. Y., Gao, F. J. Med. Chem., 2002, 45, 2867-2876.

• Hydrolysis in Pharmaceutical Formulations Waterman, K. C., Adami, R. C., Alsante, K. M., Antipas, A. S., Arenson, D. R., Carrier, R.; Hong, J., Landis, M. S., Lombardo, F., Shah, C. S., Shalaev, E., Smith, S. W., Wang, H. Pharm. Dev. Technol., 2002, 7, 113-146.

• Stabilization of Pharmaceuticals to Oxidative Degradation Waterman, K. C., Adami, R. C., Alsante, K. M., Hong, J., Landis, M. S., Lombardo, F., Roberts, C. J. Pharm. Dev. Technol., 2002, 7, 1-32.

• ElogDoct: A Tool for Lipophilicity Determination in Drug Discovery. 2. Basic and Neutral Compounds” Lombardo, F., Shalaeva, M. Y., Tupper, K. A., Gao, F. J. Med. Chem., 2001, 44, 2490-2497.

• ElogPoct: A Tool for Lipophilicity Determination in Drug Discovery, Lombardo, F., Shalaeva, M. Y., Tupper, K. A., Gao, F., Abraham, M. H. J. Med. Chem., 2000, 43, 2922-2928.

• Preparation of Fluoroadamantane Acids and Amines: Impact of Bridgehead Fluorine Substitution on the Solution and Solid-State Properties of Functionalized Adamantanes, Jasys, V. J., Lombardo, F., Appleton, T. A., Bordner, J., Ziliox, M., Volkmann, R.A. J. Am. Chem. Soc., 2000, 122, 466-473.

• Identification of Photodegradants of Droloxifene by a combined LC-MS, NMR Spectroscopy and Computational Chemistry Approach. Campeta, A. M., Lombardo, F., Sharp, T. R., Horan, G.J., and Rescek, D. M. J. Phys. Org. Chem., 1999, 12, 881-889.

• The Anxieties of Drug Discovery and Development: CCK-B Receptor Antagonists. Lombardo, F., Winter, S. M., Tremaine, L., Lowe, J.A. III. Integration of Pharmaceutical Discovery and Development: Case Studies. R.T. Borchardt et al, Eds., Plenum Press, NY, 1998. Chapter 20, 465-479.

• Experimental and Computational Approaches to estimate solubility and Permeability in Drug Discovery and Development Settings.” Lipinski C.A., Lombardo F., Dominy B. W., Feeney, P.J. Adv. Drug Del. Rev., 1997, 23, 3-25.

• Computation of Brain-Blood Partitioning of Organic Solutes via Free Energy Calculations. Lombardo F., Blake J. F., Curatolo W. J., J. Med. Chem. 1996, 39, 4750-4755.

• A Water Soluble Benzazepine Cholecystokinin-B Receptor Antagonist. Lowe J. A., III, Drodza S. E, McLean S., Bryce D. K., Crawford R. T., Zorn S., Morrone J., Appleton T.A. and Lombardo F., Bioorganic and Medicinal Chemistry Letters, 1995, 5, 1933-1936.

• The 5,6 vs. the 6,5 Electro-reductive Tandem Cyclization of Ketones. Kariv-Miller, E., Lombardo, F., Maeda, H. in Electro-Organic Synthesis. Festschrift for Manuel Baizer, Little, R.D., Weinberg, N.L., Eds. Marcel Dekker, New York, 1991, 75-81

• Cathodic Reduction of (Z, E)-4,8-Cyclododecadien-1-one. Studies on the Regiochemistry and Mechanism of Ketyl Radical Anion Intramolecular Cyclization. Lombardo F., Newmark R. A., and Kariv-Miller E. J. Org. Chem. 1991, 56, 2422-2427.

• Reductive Tandem Cyclization of Allyl Pentenyl Ketones. Kariv-Miller E., Maeda H., and Lombardo F., J. Org. Chem. 1989, 54, 4022-4024.

PATENTS

• Determination of LogP Coefficients via a RP-HPLC Column. Lombardo, F.; Shalaeva, M.Y.; Tupper, K. A. United States Patent 6,548,307 B2, 10 pp. April 15, 2003.

• Self-Emulsifying Formulations of Cholesteryl Ester Transfer Protein Inhibitors. Gumkowski, M. J., Murdande, S.B., Perlman, M. E., Lombardo, F. Jan 3, 2003 WO2003000295 A3.

• Self-Emulsifying Formulations of Cholesteryl Ester Transfer Protein Inhibitors. Gumkowski, M. J.; Murdande, S. B.; Perlman, M. E.; Lombardo F. United States Patent 6962931, 2005.

• ElogDoct: A Tool for Lipophilicity Determination in Drug Discovery. Basic and Neutral Compounds. Lombardo, F.; Shalaeva, M. Y.; Tupper, K. A. EP 1126277 A2Eur. Pat. Appl. 2002, 14 pp. EP1239280 A2 20020911.

• Determination of LogP Coefficients via a RP-HPLC Column. Lombardo, F.; Shalaeva, M.Y.; Tupper, K. A Eur. Pat. Appl. 2001, 13 pp. EP1126277 A2 20010822.