`95 Berkshire Court, Gurnee, IL 60031- 6226, USA
`Office: + 1-847-599-9496; Mobile: +1-224-430-0383; E-mail: constantinpp@aol.com
`
`EXECUTIVE SUMMARY
`
`Career Objectives: Expand therapeutic utility and market value of small molecule and macromolecule drugs, approved and New
`Molecular Entities (NMEs), from innovative drug formulation and delivery technology, strategic product development and
`commercialization, life-cycle management and business development perspectives.
`
`Education: University Diploma/B.Sc. Chemistry, 1977 (Athens University), Ph.D., Biochemistry, 1983 (Brown University),
`Postdoctoral Training, Pharmacology/Cancer Research, 1983-1985 (Yale University).
`
`Industrial Experience: Big Pharma (8yrs), Specialty Pharma/Drug Delivery/Biotech (9yrs); consultant (13 yrs). Dosage Forms:
`parenteral (intravenous solutions, cyclodextrins, liposomes, micelles, emulsions, micro-/nanoparticles; liquid and lyophilized
`formulations); oral hard and soft gelatin capsules (liquid, suspension, semi-solid fill); immediate and controlled release tablets and
`capsules; nasal sprays and topical formulations (gels, creams, ointments). Drug Molecules: Small molecule and macromolecules
`(peptides, proteins and vaccines); BCS II/IV and BCS III molecules; approved/marketed drugs and New Molecular Entities
`(NMEs). Therapeutic Areas: Cancer, Immune System, Cardiovascular, CNS, GI, Infectious Diseases, Endocrinology/Metabolic,
`Inflammation and Tissue Repair. Regulatory Filings: IND, ANDA, 505 (b) (2), NDA.
`
`Academic Experience: Teaching and Research Assistant, Postdoctoral Fellow, Associate Research Scientist, Adjunct Assistant
`Professor of Biochemistry, Adjunct Associate Professor of Pharmaceutics, Professor in-Charge/Instructor of special short courses,
`Affiliate Associate Professor and Professor of Biopharmaceutical Sciences. Delivered lectures in physical chemistry, biochemistry,
`pharmaceutics and drug delivery, biotechnology, nanotechnology, entrepreneurship and R&D management. Advisor to academic
`inventors and founders of university spin-off companies.
`
`
`
`Management Experience: Scientific leader and seasoned executive and experienced consultant with excellent organization,
`
`interpersonal and communication skills. Results oriented, resourceful and able to interface with the right people/groups both
`
`internally and externally to achieve timely results. Timely and focused planning and execution with problem-solving skills and
`
`assertiveness in decision making. Responsibilities: Founder and Principal, President, Biopharmaceutical & Drug Delivery
`
`Consulting, LLC, Vice President of R&D, Director of Research, Section Head, Team Leader/Project Manager in the areas of
`
`Discovery Research, Technology and Intellectual Property Development and Management, and Product Development (formulation
`
`and method development and validation, scale-up and manufacturing and technology transfer). Developed and managed research
`
`and development collaborations and contracts with major universities, big pharma, biotech/drug delivery companies and contract
`
`research organizations.
`
`
`Publications/Patents : 30 original research papers, 1 Commentary, 13 review articles/book chapters, 2 theme issues editor, 3
`interview publications, 1 professional development article, 20 poster presentations, 101 invited talks, 12 US Patents (6,008,192;
`6,458,373; 6,479,540; 6,660,286; 6,667,048; 8,241,664;8,481,084; 8,492,369;8,536,650; 8,778,916; 8,778,917, 8,828,428), 4
`European Patents (1871384,1460992, 2056835,2167069), 17 WO patents (93/02664, 93/02665, 94/08603, 94/08605, 94/08610,
`94/19000, 94/19001, 94/19003, 95/08986, 98/40051, 03/047494, 03/047493, 03/057128, 03/057193, 06/113505,
`07/117556A2,15/100406), 5 US Patent Applications (US20080317844, US2007/0224293/ 0231412,/0281025, US2011/0086069)
`and 2 other (AU 02/9482601 and US 03/087954). Editorial board member and referee for peer-reviewed journals and frequent
`invited speaker at national and international scientific and business meetings. Serves as Expert Witness in patent litigation cases.
`
`Professional Associations and Honors: American Chemical Society, Controlled Release Society and American Association of
`Pharmaceutical Scientists (AAPS). AAPS Fellow, Past Chair of the Formulation Design and Development (FDD) Section, the
`Lipid-Based Drug Delivery Systems Focus Group and the Nanotechnology Focus Group of AAPS. Member spotlight in the April
`2015 issue of AAPS News Magazine. Organizer/Chair/Moderator/Speaker, national and international biomedical, pharmaceutical
`and nanotechnology conferences, special workshops and short courses. Advisory Board member of university spin-offs and
`contract development and manufacturing organizations. Associate Editor, AAPS Open journal. Recipient of various awards and
`recognitions.
`
`
`
`1
`
`Purdue 2002
`Collegium v. Purdue, PGR2018-00048
`
`
`
`
`Education
`
`1983 - 1985
`
`
`1977 - 1983
`
`
`1973 - 1977
`
`EDUCATION AND WORK EXPERIENCE
`
`Postdoctoral Fellowship, Pharmacology and Cancer Research, Yale University,
`Department of Pharmacology and Cancer Center , School of Medicine, New Haven,
`Connecticut.
`
`Ph.D, Biochemistry (Physical), Brown University, Chemistry Department Providence,
`Rhode Island. Thesis Title: "Physical Properties of Long-Chain Fatty Acyl-CoAs."
`Advisor: Professor Joseph M. Steim.
`
`University Diploma (B.S.), Chemistry, National and Kapodistrian University of
`Greece, Athens, Greece.
`
`
`Research and Development Interests/Areas of Involvement
`
`
`Preformulation: API salt, cocrystal and polymorph screening, solubility studies in
`aqueous solutions as a function of pH and in biorelevant media, API excipient
`compatibility studies.
`
`formulations, solutions,
`lyophilized
`(liquid and
`Parenteral drug development
`cyclodextrins, suspensions, micelles, emulsions, liposomes, and other lipidic and
`polymeric nanoparticles).
`
`Topical formulations (solutions, liposomes, emulsions, creams, gels, foams, ointments
`shampoos and lotions).
`
`Oral formulation development and dosage forms of BCS II, III and IV, small molecules
`and macromolecules (peptides/proteins) using enabling drug delivery technologies to
`improve drug solubility and/or intestinal permeability.
`
`Early formulation development with drug discovery compounds to improve drug
`solubility and/or permeability limitations for preclinical toxicology and PK studies and
`proof-of-concept studies in humans.
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`Life cycle management strategies and product line extensions with marketed drugs.
`
`Particle Engineering in API and Drug Product Design; Combination drug products.
`
`Pharmaceutical applications of nanotechnology.
`
`Sustained and Controlled release technologies and dosage forms.
`
`Generic drug development, particularly with branded generics and 505 (b) (2) filing.
`
`Processing and manufacturing aspects of drug formulations and strategies to address
`physical and chemical stability issues.
`
`Functional excipient development and qualification (DMF Type IV); novel excipients for
`pharmaceutical development and new uses of pharmaceutical excipients.
`
`2
`
`Purdue 2002
`Collegium v. Purdue, PGR2018-00048
`
`
`
`
`
`
`
`
`Lipid- and/or polymer-based micro- and nanoparticulate systems for targeted drug
`delivery and controlled release.
`
`Development of lipidic and polymeric drug complexes and conjugates for oral and
`parenteral administration.
`
`QbD applications in drug formulation and process development and optimization.
`
`
`
`
`
`
`Experience
`
`Industrial Research & Development
`
`2005 - present
`
`Founder and Principal/President, Biopharmaceutical & Drug Delivery Consulting,
`LLC Gurnee, Illinois (website: www.bpddc.com)
`
`
`
`
`
`Areas of Consulting: Drug product and drug delivery technology development.
`Chemistry, Manufacturing and Controls (CMC) aspects for small molecule and
`macromolecule drugs (peptides, proteins and vaccines). Reformulations of marketed
`drugs and product line extensions. Scientific, strategic and business assessment (due
`diligence) of drug product candidates and delivery technologies along with in-/out-
`licensing recommendations. Identifying, structuring and executing milestone-driven
`research and development collaborations with corporate partners. Biomedical
`applications of nanomaterials and nanoparticles. Development and qualification of novel
`excipients and/or new uses of excipients for pharmaceutical development (DMF Type
`IV). Intellectual property development strategies and assistance with patent filings and
`expert witness in patent litigation cases. Development and teaching of short courses for
`industrial and academic parties.
`
`Clients: biotech and pharmaceutical companies, generic/specialty pharma, nutraceutical,
`cosmeceutical, chemical and nanotechnology companies, excipient vendors, contract
`development and manufacturing organizations (CDMOs), academic
`institutions,
`management consulting companies, patent law firms and expert witness service
`organizations.
`
`Therapeutic Areas : Cancer, Cardiovascular, CNS, Endocrinology, Infectious Diseases,
`Inflammation and Tissue Repair, Metabolic Disorders and other.
`
`Dosage forms: parenteral/intravenous, small and large volume parenteral solutions,
`suspensions, emulsions, lipidic and polymeric micro- and nanoparticles; polymeric
`microspheres, oral solid (immediate and controlled release), semi-solid and liquid
`formulations; topical solutions, liposomes, emulsions, gels, creams, foams, ointments,
`shampoos and lotions).
`
`Current and Past Projects (working with internal R&D and/or external CROs/CMOs)
`
`Assists several early stage drug discovery companies with diverse product portfolios and
`targeted disease areas on the execution of their business plan and provides technical input
`and direction on product development particularly as related to formulation and analytical
`development, Chemistry, Manufacturing and Controls (CMC) aspects.
`
`Working with a virtual company, intimately assists with the development of a proprietary
`oral delivery technology from the discovery phase to its progression to advanced clinical
`
`3
`
`Purdue 2002
`Collegium v. Purdue, PGR2018-00048
`
`
`
`development of a drug that is marketed as injectable or topical drug product. Key
`contributor to the intellectual property development and patent prosecution.
`
`Provides technical guidance to a pharmaceutical company on the development of a
`combination parenteral drug product.
`
`Assists specialty pharma companies on the CMC aspects of generic and novel
`formulations of marketed drugs for ANDA and 505(b) (2) filings.
`
`Provides strategic and technical input to a manufacturer of capsule dosage forms using
`lipid-based systems.
`
`Provides strategic, technical and business development consulting to a vendor of
`pharmaceutical excipients.
`
`Serves as a consultant and advisor on chemistry, formulation, manufacturing and controls
`(CMC) aspects of new molecule entities developed by academic institutions and funded
`by NIH SBIR/STTR grants.
`
`Working with patent attorneys, assists client companies as a technical expert and/or
`inventor with the drafting of patent applications, responses to patent office actions and
`other patent prosecution aspects.
`
`Working with patent law firms and expert witness organizations, serves as expert witness
`in patent litigation cases dealing with pharmaceutical formulations and drug delivery
`technologies.
`
`Provides on-site training seminars to interested parties on early and advanced formulation
`development of challenging molecules exhibiting solubility and/or permeability limited
`absorption including nanoformulation strategies.
`
`Provided strategic and scientific direction to an established chemical company on several
`healthcare applications of a GRAS nanomaterial, particularly in the areas of infectious
`diseases and metabolic disorders.
`
`Working with internal and external groups and senior management, timely and
`effectively addressed formulation development, physical/chemical stability and scale up
`and manufacturing issues with proprietary new chemical entities, further advancing their
`clinical development.
`
`Prepared and submitted to senior management of a client company, a technical
`assessment of an outside developed formulation/drug delivery technology as an in-
`licensing opportunity.
`
`Assisted a contract research organization that provides analytical and formulation support
`services with strategic and technical guidance.
`
`Assisted a large diversified company on strategic plans and provided technical direction
`on product development and commercialization aspects of a new drug delivery
`technology.
`
`
`
`
`4
`
`Purdue 2002
`Collegium v. Purdue, PGR2018-00048
`
`
`
`Successfully served as expert witness in several patent litigations cases between
`innovator and/or generic companies on major injectable and oral drug products.
`
`Developed and served as professor in-charge of a new short course for an academic
`institution on the Formulation and Drug Delivery Applications of Nanoparticles.
`
`Developed and served as instructor of a Biotechnology Laboratory Operational
`Management short course offered by an academic institution.
`
`Vice President, Research and Development, Morton Grove Pharmaceuticals,
`Vernon Hills, Illinois. Reported directly to the President & CEO.
`
`Led all internal and external product development activities in the areas of generic oral
`liquids, suspensions, syrups, inhalation solutions, nasal sprays and topical formulations
`(shampoos, lotions). Direct reports included: formulation and analytical method
`development and validation, process and instrument/computer validation.
`
`Major Accomplishment: Instrumental in revamping the company’s R&D efforts and
`building the team.
`
`2003 –2004
`
`
`
`
`
`
`2001- 2003
`
`
`
`Vice President, Research & Development (1/01-7/02) and Consultant (8/02-12/02)
`DOR BioPharma, Inc (formerly ENDOREX Corporation), Lake Forest, Illinois.
`Reported directly to the President & CEO.
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`Major Accomplishments:
`
`Expanded the company’s R&D team including outside consultants.
`
`Streamlined resources and focused R&D activities of the company.
`
`Managed R&D collaborations with two major pharmaceutical companies.
`
`Managed contract manufacturing, stability testing and regulatory filings of OrBec (oral
`beclomethasone dipropionate, IR and CR tablet) a Phase II/III drug product for Graft-vs-
`Host Disease (GVHD) and Grohn’s disease.
`
`Led company’s vaccine program (tetanus and influenza) on microparticle formulation
`and animal immunization studies upon subcutaneous, peroral and nasal administration.
`
`Expanded company’s drug delivery platform and intellectual property portfolio. Created
`3 new technology platforms: LPM (lipid polymer micelles) for enhancing the intestinal
`absorption of water-soluble drugs/peptides and LPE/PLP
`(lipid polymer
`emulsions/polymer lipid particles) for enhancing the solubilization and oral absorption of
`water-insoluble drugs. Preclinical proof-of-concept of enhanced oral bioavailability has
`been demonstrated with leuprolide and paclitaxel, respectively.
`
`Primary inventor of four WO patents and presented company’s technologies and product
`portfolio at six national/international meetings and
`to business and financial
`communities.
`
`5
`
`Purdue 2002
`Collegium v. Purdue, PGR2018-00048
`
`
`
`In July of 2002 after the company adapted the implementation of a major restructuring
`and downsizing plan, served as a consultant of Oradel Systems Inc. a subsidiary of DOR
`BioPharma to further develop and/or out license these technologies to big Pharma or
`other drug delivery companies.
`
`Director of Research, SONUS Pharmaceuticals, Bothell, Washington. Reported
`directly to the President & CEO.
`
`Major Accomplishments:
`
`Established the company’s drug delivery program and expanded its technology base and
`intellectual property portfolio. Created and developed the company’s TOCOSOL drug
`delivery technology.
`
` Leading a team of scientists, developed a novel, stable, filter-sterilizable and efficacious
`injectable nanoemulsion of paclitaxel (TOCOSOL-Paclitaxel) from idea inception to
`scale up, preclinical evaluation and initiation of clinical studies.
`
` Made significant contributions to the company’s efforts to build research and
`development collaborations with big pharmaceutical companies.
`
`Section Head, Formulation Development, Pharmaceutical and Analytical Research
`and Development, Pharmaceutical Products Division, Abbott Laboratories, North
`Chicago, Illinois.
`
`Major Accomplishments:
`
`Led project activities on formulation development, scale-up and manufacturing of oral
`liquid solutions, liquid-filled soft gelatin and semi-solid-filled hard gelatin capsule
`formulations of cyclosporine.
`
`Contributed to the commercialization of a generic cyclosporine formulation from
`preclinical development to clinical manufacturing and bioequivalency testing along with
`all necessary material (CMC section) for the ANDA. Gengraf® approved by the FDA on
`May 15, ’00 as cyclosporine capsules, USP (bioequivalent to Novartis Neoral).
`
`Led prior art search and patent filing strategy on generic cyclosporine formulations that
`resulted in 2 major patent filings. Major inventor on the Gengraf patent (US 6, 008,
`192, December 28, 1999).
`
`Key member of a multi-disciplinary Drug Delivery Technology Evaluation Team within
`the Formulation Center that interfaced with Corporate Licensing and Business
`Development to evaluate outside developed technologies with potential applications to
`Abbott’s compounds.
`
`
`Investigator/Team Leader, Pharmaceutical Product Development,
`Senior
`Pharmaceutical Technologies, SmithKline Beecham Pharmaceuticals, King of
`Prussia, Pennsylvania.
`
` Major Accomplishment:
`
`6
`
`
`1997-2000
`
`
`1995-1997
`
`
`
`
`
`1994-1995
`
`
`
`
`
`
`
`Purdue 2002
`Collegium v. Purdue, PGR2018-00048
`
`
`
`
`
`
`
`1990 -1994
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`Led a project team that developed a Phase I formulation of a water-soluble molecule
`which in preclinical studies in dogs and primates
`showed enhanced oral absorption compared to a solution formulation.
`
`Senior Investigator, Drug Delivery Department, Pharmaceutical Technologies,
`SmithKline Beecham Pharmaceuticals, King of Prussia, Pennsylvania.
`
`
` Major Accomplishments:
`
`Interfaced between Discovery Programs and Development Project Teams within
`SmithKline Beecham, to identify early development candidates and address pre-
`formulation, formulation development and drug delivery issues with various preclinical
`compounds, development compounds and product line extensions.
`
`Established a drug delivery program and a useful lipid microemulsion database using
`model and proprietary water-soluble molecules/peptides from idea inception and
`formulation development to preclinical evaluation for toxicity and oral bioavailability
`assessment.
`
`Creation of a strong intellectual property portfolio in the area of oral delivery of water-
`soluble molecules/peptides using microemulsions. Invented and developed (hands-on)
`lipid microemulsion formulations that significantly improved the oral absorption of
`poorly absorbed drugs/peptides in animal models..
`
`
`Led research activities on the feasibility of liposomal and emulsion formulations to
`improve the efficacy and reduce toxicity of antitumor and antiviral drugs upon parenteral
`administration and comparison to drug solutions or suspensions.
`
`Provided several technical appraisals/reports on outside developed drug delivery
`systems/technologies with recommendations for potential licensing.
`
`
`1988 - 1989
`
`Project Leader/Liposome Technology Development, Lipogen Inc. Knoxville,
`Tennessee.
`
`
`
`
`
`
`
`
`
`
`
`
`1987-1988
`
`
`
`
`
`
`
`Major Accomplishments :
`
`Provided technical and management support of a group of scientists on the development
`of a homogeneous liposome-based immunoassay which allows rapid qualitative (yes/no),
`or quantitative detection of a variety of classes of analyte i.e. therapeutic drugs in
`biological fluids (serum or urine).
`
`Interfaced group's activities to those of the Marketing and Quality Control departments.
`
`Developed a homogeneous liposome-based immunoassay for the detection and
`quantification of therapeutic drugs and other analytes in biological fluids.
`
`Research Scientist and Senior Research Scientist/Formulations, Lipogen Inc.
`Knoxville, Tennessee.
`
`Major Accomplishments:
`
`7
`
`Purdue 2002
`Collegium v. Purdue, PGR2018-00048
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`1976
`
`
`
`Research and Development in the area of drug delivery systems using liposomes and
`other lipid-based carriers. Hands-on experience with drug-liposome formulation and
`physical characterization, lipid-antibody conjugation (immunoliposomes), design and
`formulation of phospholipid and other lipophilic prodrugs in liposomes, and stability,
`sterilization and scale-up of liposomal drugs.
`
`Developed a lipid admixture for the solubilization of lipophilic and other hydrophobic
`compounds that can be administered parenterally or orally.
`
`Liposome formulation and characterization, kinetic and thermodynamic studies of a
`homogeneous liposome-based immunoassay.
`
`As a principal investigator, prepared and submitted to NIH two Small Business
`Innovation Research (SBIR) Phase I grants, on a) Formulation and Antitumor Activity of
`Lipophilic Methotrexate and, b) Target-Specific Delivery of Lipophilic Anticancer
`Drugs. Both were highly rated but not approved for funding.
`
`Industrial Internship, Kyknos Canning Company, Nafplion, Greece.
`
`Work involved chemical analysis of canned fruits and vegetables such as acidity, solid
`content and other quality tests.
`
`
`Academic Research & Teaching
`
`2014 – 2016
`
`Affiliate Professor of Biopharmaceutical Sciences, Roosevelt University, College of
`Pharmacy, Schaumburg, Illinois.
`
`
`
`Member of the Biopharmaceutical Sciences Research Council.
`
`2012-2013
`
`Affiliate Associate Professor of Biopharmaceutical Sciences, Roosevelt University,
`College of Pharmacy, Schaumburg, Illinois.
`
`
`
`Member of the Biopharmaceutical Sciences Research Council.
`
`2007-2009
`
`
`
`
`
`1998 - 2000
`
`
`
`
`
`1987- 1989
`
`
`
`
`
`
`Professor in-charge, University of Wisconsin, School of Pharmacy, Extension
`Services in Pharmacy.
`
`Coordinator and co-instructor of the annual short course on “Nanoparticles: Applications
`in Formulation and Drug Delivery”.
`
`Associate Professor (Affiliate), Department of Pharmaceutics, University of
`Washington, Seattle, Washington.
`
`Co-instructor in a Pharmaceutical Biotechnology course and career mentor for graduate
`students. Research collaborations in drug transport and delivery.
`
`Assistant Professor (Adjunct), Biochemistry Department, University of Tenessee,
`Knoxville, Tennessee.
`
`Co-instructor in a physical chemistry course (graduate level). Topics covered: lipid and
`membrane dynamics, biological spectroscopy (NMR, EPR, IR and Raman) and liposome
`technology.
`
`8
`
`Purdue 2002
`Collegium v. Purdue, PGR2018-00048
`
`
`
`
`1985 - 1987
`
`
`
`
`
`1983 - 1985
`
`
`
`
`
`1978 - 1980
`
`
`
`
`1977 - 1983
`
`
`
`
`
`1976-1977
`
`
`
`
`1977
`
`
`
`Special Skills
`Technical
`
`
`
`
`
`
`
`
`
`Associate Research Scientist, (Equivalent to Assistant Research Professor),
`Department of Pharmacology and the Comprehensive Cancer Center, Yale
`University School of Medicine, New Haven, Connecticut.
`
`Research focused on the interaction of anthracyclines with lipid bilayers using
`Differential Scanning Calorimetry, as well as on size characterization of liposomes using
`Sedimentation Field Flow Fractionation, Electron Microscopy and Gel-Filtration.
`
`Postdoctoral Fellow, Department of Pharmacology, Yale University School of
`Medicine, New Haven, Connecticut.
`
`Reseach focused on: a) adriamycin-induced fusion of liposomes using EPR-spin-
`labelling, DSC, and Electron Microscopy; b) location of anthracyclines in lipid bilayers
`by paramagnetic quenching studies; and c) spin-trapping studies of hydroxyl and
`superoxide free radicals generated by the bioactivation of anticancer antibiotics.
`
`Research Assistant, Brown University, Providence, Rhode Island.
`
`Thesis reseach on the physical properties of long-chain fatty acyl-CoAs using Surface
`Tension, Conductivity, Fluorescence and Analytical Ultracentrifuge. Early work involved
`enzymatic studies with membrane-bound acyltransferace in a cell-free system to
`understand how the activity of the enzyme is controlled by the physical state of the lipid
`bilayer.
`
`Teaching Assistant, Chemistry Department and Division of Biology and Medicine,
`Brown University, Providence, Rhode Island.
`
`teaching of Physical, Organic Chemistry and Biochemistry.
`the
`in
`Assisted
`Responsibilities included lectures on concepts and techniques pertaining to laboratory
`experiments, and preparation and supervision of laboratory sections and evaluation of
`student progress by grade assignment.
`
`Teaching Assistant, Inorganic Chemistry Department, Athens University, Athens,
`Greece.
`
`Duties included preparation and supervision of laboratory sections.
`
`Part-time Teacher in Chemistry, Saint John Institute, Limassol, Cyprus.
`
`Preparation of high school students for university entrance examinations (G.C.E. level).
`
`In depth-knowledge of the formulation and drug delivery science. Core competency:
`physical chemistry and biopharmaceutics of drug delivery systems with research and
`development expertise in lipid-based systems.
`
`Product development experience (formulation, analytical and process development and
`manufacturing) of parenteral, oral and topical formulations.
`
`Working knowledge of colloid and surface chemistry techniques, spectroscopic and
`bioanalytical methods, lipid and membrane biochemical and biophysical methodologies.
`
`9
`
`Purdue 2002
`Collegium v. Purdue, PGR2018-00048
`
`
`
`
`
`
`
`Management
`
`
`Computer skills : MacIntosh and IBM/PC using several programs, such as, Sigma Plot,
`Prism, Microsoft Office (Word, Excel, Project and Power Point).
`
`Supervisory and Project Management skills. The background of people
`supervised
`include: chemists, chemical engineers, biochemists, biologists and
`pharmacists at a B.Sc, M.Sc and Ph.D levels, as well as, undergraduate and graduate
`students in the aforementioned disciplines. Experienced in both line and matrix
`management. Proactive and coaching management style. Results oriented with excellent
`organization and communication skills.
`
`
`
`
`Networking skills . Ability to interface with various levels of management and groups
`both
`internally and externally and achieve
`results working with multiple
`teams/disciplines.
`
`
`Honors and Awards
`
`9/73 - 6/77
`
`9/84 - 9/85
`
`6/85 - present
`
`Fellowship for Academic Excellence, National Fellowship Foundation of Greece.
`
`Brown-Coxe Postdoctoral Fellowship, Yale University School of Medicine.
`
`Invited reviewer of research papers and review articles published in various Biochemical,
`Pharmaceutical and Medical Journals.
`
`
`1994- present
`
`
`1997
`
`
`2002-2003
`
`
`2003
`
`
`2003
`
`
`2006 - 2008
`
`2006
`
`
`2007
`
`
`
`Member of the planning committee of the Annual Industrial Pharmaceutical Research
`and Development (June Land O' Lakes) Pharmaceutical Conference.
`
`Chair of the June ‘97 Land O’ Lakes Pharmaceutical Conference on “Challenges and
`Prospects in the Design and Development of Oral Controlled Release Products”,
`June 2-6, 1997, Devil’s Head Lodge-Merrimac, WI.
`
`Scientific Advisory Board member of the conference on Peptide and Protein
`Formulation Strategies for Drug Delivery and Development organized by the Institute
`of International Research.
`
`Chair, Pre-conference Symposium on “Identifying Opportunities and Overcoming
`Challenges in Oral Protein and Peptide Delivery” of the 2nd IIR Protein & Peptide
`Formulation Strategies for Drug Development and Delivery, March 31- April 2, 2003,
`Boston, MA.
`
`Invited Theme Issue Editor “Advances in Lipid-Based Drug Solubilization and
`Targeting” Adv. Drug Del. Rev. 56(9) 7 May, 2004.
`
`Chair, Lipid-Based Drug Delivery Systems Focus Group of AAPS.
`
`Co-Chair, 2006 BIO Entrepreneurial Boot Camp for Chief Scientific Officers and
`Academic Researchers, April 8-9, Chicago, Illinois.
`
`Co-Chair, AAPS Workshop “Effective Utilization of Lipid-Based Systems for
`Enhancing
`the Delivery
`of Poorly Soluble Drugs: Physicochemical,
`Biopharmaceutical and Product Development Considerations”, March 5-6, 2007,
`Bethesda, MD.
`
`10
`
`Purdue 2002
`Collegium v. Purdue, PGR2018-00048
`
`
`
`
`2007
`
`
`2007-2009
`
`
`2008 - 2009
`
`2009 - 2011
`
`2010
`
`2009-present
`
`
`2011
`
`
`2011
`
`
`2012
`
`
`11/2012-11/2013
`
`11/2013-11/2014
`
`2013
`
`
`2012-present
`
`
`2013
`
`
`2013
`
`
`2014
`
`
`11/2014-10/2015
`
`7/28/2015
`
`
`
`Co-chair, iiBIG Conference “New Directions for Drug Delivery”, October 29-30, 2007,
`Las Vegas, NV.
`
`Coordinator and Professor in-charge, short course “Nanoparticles: Applications in
`Drug Formulation and Delivery”, Univ.of Wisconsin, Extension Services in Pharmacy.
`
`Past Chair, AAPS Lipid-Based Drug Delivery Systems Focus Group
`
`Chair, AAPS Nanotechnology Focus Group.
`
`Elected Fellow of the American Association of Pharmaceutical Scientists (AAPS)
`
`Editorial Advisory Board Member, Recent Patents in Drug Delivery and Formulation,
`Bentham Science Publishers.
`
`Chair, AAPS Drug Delivery Workshop “Emerging Oral Delivery Strategies and
`Technologies to Enable Biopharmaceutical Performance of BCS II, III and IV
`Molecules”, April 14-15, 2011, Baltimore, MD.
`
`Co-Chair, 4th Annual Nanotechnology Symposium, Sullivan University, College of
`Pharmacy, September 23-24, 2011, Louisville, KY.
`
`Chair, 47th AAPS Arden House Conference “Nanoscience in Pharmaceuticals:
`Translating Fundamental Understanding to Practical Application in Drug and
`Device Development”, March 11-14, 2012, The Thayer Hotel, West Point, NY.
`
`Vice Chair, AAPS Formulation Design and Development (FDD) Section of AAPS.
`
`Chair-Elect, AAPS Formulation Design and Development (FDD) Section of AAPS.
`
`Chair, Program Committee, Drug Discovery and Development Track, BIO2013
`International Convention, April 22-25, 2013, Chicago, IL.
`
`Advisory Committee Member, Nanotechnology Employment, Education and Economic
`Development, Oakton Community College, Oakton, IL.
`
`Organizer and Co-Chair, Sort Course on “Quality Control Aspects of Nanoparticulate
`Dugs: Manufacturing, Characterization and Regulatory Considerations”, Nov. 10,
`2013, 2013 AAPS Annual Meeting, San Antonio, TX.
`
`Chair, 3rd International Conference and Exhibition on Pharmaceutics & Novel Drug
`(Pharmaceutica-2013), OMICS Group, April 8-10, 2013,
`Delivery Systems
`Northbrook, IL.
`
`Chair, 4th International Conference and Exhibition on Pharmaceutics & Novel Drug
`Delivery Systems (Pharmaceutica-2014), OMICS Group, March 24-26, 2014, San
`Antonio, TX.
`
`Chair, Formulation Design and Development (FDD) Section of AAPS.
`
`2016 AAPS Annual Meeting Jamboree Enterprise Award Recipient.
`
`11
`
`Purdue 2002
`Collegium v. Purdue, PGR2018-00048
`
`
`
`
`8/2015 – present
`
`10/26/2015
`
`Associate Editor, AAPS Open Journal.
`
`Formulation Design and Development (FDD) Section Chair and Leadership Award,
`American Association of Pharmaceutical Scientists (AAPS).
`
`
`
`Professional Organizations
`
`Past member of the American Biophysical Society, American Association for Cancer
`Research, American Association for the Advancement of Science and the New York
`Academy of Sciences, American Chemical Society and the Controlled Release Society.
`Active member of the American Association of Pharmaceutical Scientists and BIO/iBIO.
`
`Native is Greek, fluent in English, some knowledge of French.
`
`
`Languages
`
`
`Recreational Activities
`
`
`
`Strong interest in Byzantine art and music. Enjoys mount hiking, bicycling and sports
`both as spectator and participant.
`
`
`References
`
`Available upon request.
`
`
`
`12
`
`Purdue 2002
`Collegium v. Purdue, PGR2018-00048
`
`
`
`PUBLICATIONS, PRESENTATIONS AND PATENTS
`
`
`Original Research Papers
`
`
`
`1.
`
`Panayiotis P. Constantinides and Joseph M. Steim (1985) " Physical Properties of Fatty Acyl-
`CoAs: Critical Micelle Concentrations, Micellar Size and Shape " J. Biol. Chem. 260, 7573
`- 7580.
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`2.
`
`3.
`
`4.
`
`5.
`
`6.
`
`7.
`
`8.
`
`9.
`
`Panayiotis P. Constantinides and Joseph M. Steim (1986), " Solubility of Palmitoyl-CoA in
`Acyltransferase-Assay Buffers Containing Magnesium Ions"