UMESH V. BANAKAR, PH.D.
`Professor
`10251 Tammer Drive
`Carmel, IN 46032 USA
`
`Tel./Fax: 317 334 0174 email: umeshbanakar@juno.com cell: 317 440 7784
`
`1989
`
` 1985
`
` 1978
`
`
`Universities attended
`
`Massachusetts Institute of Technology,
`Boston, MA
` Advances in Controlled Release Technology
`
`Duquesne University, Pittsburgh, PA U.S.A.
`Doctor of Philosophy (Ph.D.)
` Major - Pharmaceutical Technology
` Minor - Pharmaceutical chemistry
` Dissertation Title: Polyethylenes as Potential Prolonged Release Tablet Excipients
`
`Bombay University, Bombay, India
`Bachelor of Pharmacy (B. Pharm.)
`
`Professional Career
`
`University of Campinas
`Department of Medicine
`Campinas, SP- BRASIL
`Adjunct Professor
`
`Banakar Consulting Services
`Carmel, IN 46032
`President
`
`Creighton University
`School of Pharmacy & Allied Health
`Omaha, NE 68178
`Adjunct Professor
`
`Butler University
`College of Pharmacy and Health Sciences
`Indianapolis, IN 46208-3485
`Professor of Pharmaceutics
`Chairman, Pharmaceutical Sciences and Graduate Program
`
`St. Louis College of Pharmacy
`St. Louis, MO 63110
`Professor of Pharmaceutics
`Associate Professor (Pharmaceutics)
`Director of Research
`Section Head: Pharmaceutical Sciences
`
`Creighton University
`School of Pharmacy & Allied Health, Omaha, NE 68178
`Department of Pharmaceutical Sciences
`Associate Professor (Pharmaceutics)
`1988 - 1990
`Assistant Professor (Pharmaceutics) 1985 - 1987
`
`Duquesne University
`School of Pharmacy, Pittsburgh, PA U.S.A.
`Instructor-In-Charge (Pharmaceutics)
`
`J.N. Medical College
`School of Pharmacy, Belgaum, India
`Lecturer Pharmaceutics
`
`2004 – 2009
`
`2000 - Present
`
` 2001 – 2007
`
`1997 - 1999
`
`
`
`
`
`1990 -1997
`
`1994 - 1997
`1990 - 1993
`1990 - 1996
`1990 - 1996
`
`1985 - 1990
`
` 1981 - 1984
`
` 1980
`
`
`
`
`
`1
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`Lupin Exh. 1016
`
`

`
`1978 - 1979
`
`1977
`
`Roussel Pharmaceuticals (India) Ltd.
`Bombay, India; Product Chemist
`
`Pfizer (India) Ltd.
`Bombay, India; Trainee (App.) – Production
`
`Intl. Scientific Advisor (Drug/Product Design, Development and Evaluation: in vitro and clinical)
`
`Pharmaceutical corporations worldwide (partial listing)
`
`Merck S/A, Jacarepagua, Rio de Janeiro, BRAZIL (2011 – present)
`
`Althaia, Atibai, BRAZIL (2013 - present)
`
`Cipla, Mumbai, INDIA (2013 - present)
`
`Vista Pharmaceuticals Inc., West Orange, New Jersey, USA (2005 – present)
`
`Investigacion Farmaceutica y Biopharmaceutica (IFaB), Mexico City, MEXICO (2005 – present)
`
`Marjan Farma S.A., Sao Paulo, BRAZIL (2008 – 2013)
`
`Torrent Pharmaceuticals Limited, Ahmedabad, INIDA (1993 – 2008)
`
`EMS, S.A., Hortolandia, SP, BRAZIL (2001 – 2008)
`
`Wockhardt Limited, Mumbai, INDIA (1995 – 2005)
`
`Shasun Drugs & Pharmaceuticals Limited, Chennai, INDIA (2005 – 2008)
`
`PLIVA, d.d., Zagreb, CROATIA (1995 – 2000)
`
`
`Clinical/Contract Research Organizations (CRO) (partial listing)
`
`
`
`
`
`Expertise (not exclusive listing)
`
`Lotus Labs, Bangalore, INDIA (Founder, Director – Technical) – 2000 – 2005
`Quest Life Sciences Pvt. Ltd., Chennai, INDIA (Founder, Chairman) - 2003 - 2008
`
`
`
`Disciplines:
` Drug product development and evaluation, conventional and non-conventional
` Dissolution and bio-availability assessment
` Novel drug delivery systems
` Data characterization, evaluation, and model development
` Dosage form design for bio-availability /pharmacokinetic studies
` Clinical Research and Development - Phase I - IV clinical trials including BA/BE
`
`
`Testifying/Non-Testifying Expert [patent litigations] – as of March 2014
`
`
`
`
`Biovail vs Andrx
`
`
`
`Astra vs Andrx (2 cases)
`FTC vs Schering-Plough/Upsher-Smith/AHP
`Tishcon vs Douglas
`
`
`
`Eli Lilly vs Apotex (Canada)
`
`
`Shire vs Sandoz
`
`
`
`Shire vs Corepharma
`
`
`
`Shire vs Apotex
`
`
`
`Shire vs Teva
`
`
`
`Shire vs Zydus/Cadila (2 cases)
`
`
`Lupin vs Paddock
`
`
`
`Depomed/Valeant vs Sun
`
`
`Purdue vs Actavis
`
`
`
`UCB vs Teva
`
`
`
`Endo vs Impax/ThoRx
`
`
`
`Aptalis vs Mylan/Sandoz
`
`
`Pfizer vs Fresenius Kabi
`
`
`
`Forest vs Teva
`
`
`
`
`Organizations – Professional Associations
`
`Member of several professional organizations worldwide
`
`
`Glaxo vs Andrx
`Shire vs Impax
`Shire vs Barr
`Shire vs Nostrum
`Alza vs Andrx/Watson – 2 cases
`Shire vs Colony/Actavis
`Sanofi vs Sandoz
`Purdue vs Impax
`Endo vs Roxane/Ranbaxy/Impax/Teva
`Alza vs Kremers
`Malinckrodt vs Watson
`Warner-Chilcott vs Zydus
`Purdue vs Impax/Sandoz/Par
`Par vs Breckenridge
`MSD vs Warner-Chilcott/Actavis
`Takeda vs Sun
`Merck, Sharp & Dohme vs Fresenius Kabi
`Lab. HRA Pharma vs Teva
`
`PROFESSIONAL/ACADEMIC DISTINCTIONS (partial listing)
`
`
`Invited as member of the Distinguished Editorial Board of 6-Volume, 93 Chapters, Text Series: Nanobiomedicine, Studium
`Press, LLC, Houston, TX, USA (to be published _____ 2015).
`
`
`
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`2
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`

`
`Invited to develop and present Special Focus Professional Advancement Course Series, Cristalia Produtos Quimicos
`Farmaceuticos Ltda., Itapira, BRAZIL (2015 - 2016)
`• Principles of Time-Centered NEW Pharmaceutical Dosage Forms Development and Evaluation
`• Dissolution/Release Testing in Drug Development: Basics, Advances and Applications
`• Biorelevant Dissolution Method Development for Pharmaceutical Dosage Forms: Conventional and Specialized
`(Topicals, Dermals, Implants)
`• Bioefficacy Centered Dissolution Testing in Drug Development: Essentials of IVIVC
`• Comprehensive "First Time" Development of Controlled Release Drug Delivery Systems
`• Comprehensive Understanding of the In Vitro Dissolution/Release Performance: Characterization and
`Applications in Drug Development
`• Drug Development Program: Techno-Legal Considerations for Pharmaceutical Scientists
`IVIVC, Biowaivers and Clinical Applications of IVIVC
`•
`• Understanding Phase I Clinical Trial: New versus First Time Drug Development
`
`
`Invited as Course Director to develop and present Professional Development Certification Course Series entitled:
`Pharmaceutical Drug Development Process: Role of Dissolution Testing - 5-Course series, Society for Pharmaceutical
`Dissolution Science (SPDS), Mumbai, INDIA (March 2015)
`• Pharmaceutical Dissolution testing : Fundamentals and Advanced Applications.
`• BioEfficacy Centered Dissollution, Method Develoment : Applications and Analysis
`• Dissolution and Bioavailability : Fundamentals and Applications of IVIVC
`IVIVC , Biowaivers & Clinical Application of IVIVC
`•
`• QbD in Dissolution Method Development, QTTP, Critical Method Attributes, Discriminatory Method, DOE's,
`Method Finalization.
`
`
`Recipient of the Recognition Award for Outstanding Contributions to Pharmaceutical Dissolution Science awarded by
`Society for Pharmaceutical Dissolution Science (SPDS), Mumbai, INDIA (May 2014)
`
`Invited as Chief Guest and Guest of Honor, Goa College of Pharmacy, Golden Jubilee Conference and Celebration, Panjim,
`Goa, INDIA (March 2014)
`
`Invited to present a Special Focus 3-Day Intensive Program: Dissolution, Bioavailability and IVIVC: Fundamentals and
`Mechanics; CHEMO Research, Madrid, SPAIN (March 2014).
`
`Invited to present a Special Focus 1-Day Intensive Program: Understanding Patents for Pharmaceutical Formulation
`Scientists; Cipla - R&D, Vikhroli, Mumbai INDIA (March 2014).
`
`Invited to present a Special Lecture: In Vitro Dissolution Test: Surrogate to Predict Bioavailability; Vidya Prathishthan School
`of Biotechnology [VSBT], Baramati, INDIA (February 2014).
`
`Invited to present a Plenary Lecture at NANO-SCITECH 2014 International Conference, Chandigarh, INDIA (Feb. 2014)
`
`Invited to present a Special Focus 2-Day Intensive Program: IVIVC, Biowaivers and Clinical Applications of IVIVC; Althaia,
`Atibaia, SP; BRAZIL (October 2013 and January 2014).
`
`Invited to present a Special Focus 1-Day Intensive Program: Bioequivalence Testing: Understanding Challenges; Cipla,
`Mumbai INDIA (January 2014).
`
`Invited to present a Special Lecture: Bioavailability and Beyond; Mumbai Educational Trust [MET], Institute of Pharmacy,
`Mumbai, INDIA (October 2013).
`
`Invited to present a Special Lecture: Bioavailability and Beyond; Punjab Univ., Postgraduate Institute - Pharmaceutical
`Sciences, Chandigarh, INDIA (August 2013).
`
`Invited to present a Special Focus 3-Day Intensive Program: Bioefficacy Centered Pharmaceutical Product, Design,
`Development and Evaluation: Role of Dissolution Testing; Canitec, Guadlajara, MEXICO (July 2013).
`
`Invited to present a Special Focus 2-Day Intensive Program: IVIVC, Biowaivers and Clinical Applications of IVIVC; Canitec,
`Guadalajara, MEXICO (July 2013).
`
`Invited to present a Special Focus 1-Day Intensive Program: Understanding Patents for Pharmaceutical Formulation
`Scientists; Althaia, Atibaia, SP-BRAZIL (July 2013).
`
`Invited to present a Special Focus 1-Day Intensive Program: Biosimilars: Regulatory Perspectives and Challenges; Merck S.A.,
`Jacarapagua, RJ; BRAZIL (March 2013).
`
`Invited to present a Special Focus 3-Day Intensive Program: Bioefficacy Centered Pharmaceutical Product, Design,
`Development and Evaluation: Role of Dissolution Testing; Canitec, Mexico City, Mexico, D.F., MEXICO (April 2013).
`
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`3
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`Invited to present a Special Focus 2-Day Intensive Program: IVIVC, Biowaivers and Clinical Applications of IVIVC; Canitec,
`Mexico City, MEXICO (April 2013).
`
`Invited to present a Special Focus 2-Day Intensive Program: Pharmaceutical Drug Product Development: Role of Dissolution;
`Cipla Ltd. (India), Vikhroli, Mumbai, INDIA (March 2013).
`
`Invited to present a Special Focus 3-Day Intensive Program: Dissolution Test Method Development for Pharmaceutical
`Dosage Forms; Althaia, Atibaia, SP; BRAZIL (Mar. 11,12 and May 27, 2013).
`
`Invited to present a Special Focus 2-Day Intensive Program: Dissolution and Bioequivalence of Generic
`Pharmaceuticals; Agilent Technologies (India) Ltd., Hyderabad, INDIA (January 2013).
`
`Invited to present a Special Focus 2-Day Intensive Program: Correlating Dissolution and Bioavailability: Understanding
`IVIVC; Agilent Technologies (India) Ltd., Mumbai, INDIA (January 2013).
`
`Invited as a Founding Member and Principal International Scientific Advisor of Society for Pharmaceutical Dissolution
`Sciences [SPDS]; Mumbai, INDIA (Jan. 2013)
`
`Invited to present a Special Focus 2-Day Intensive Program: Dissolution and Bioequivalence of Generic
`Pharmaceuticals; Agilent Technologies (Brazil) Ltd., Sao Paulo, BRAZIL (November 2012).
`
`Invited to lead and moderate the Annual National Dissolution Discussion Group [DDG] meeting/conference, Agilent-
`Technologies - Brazil, Sao Paulo, BRAZIL (November 2012)
`
`Invited to present a Special Focus 3-Day Intensive Program: Principles in the Design, Development and Evaluation of Generic
`Pharmaceuticals; Novo-Lab Kft, Budapest, HUNGARY (November 2012).
`
`Invited as Chairperson and Moderate International Conference: IVIVC and Biowaivers; UBM-INDIA 2012, Mumbai, INDIA
`(October 2012).
`
`Invited to present Keynote Address at the International Conference: IVIVC and Biowaivers; UBM-INDIA 2012, Mumbai,
`INDIA (October 2012).
`
`Invited to present a Focus Session: Strategic Mapping of IVIVC in Drug Development Program, (Day 2) at the International
`Conference: IVIVC and Biowaivers; UBM-INDIA 2012, Mumbai, INDIA (October 2012).
`
`Invited to present a Keynote Address at 3rd Annual PharmaLytica INDIA 2012 Conference [Day 2], Mumbai, INDIA:
`Development of Discriminatory Media to achieve improved IVIVC in Drug Development; PharmaLytica INDIA 2012,
`Mumbai, INDIA (August 2012).
`
`Invited to present a Keynote Address at 3rd Annual PharmaLytica INDIA 2012 Conference [Day 3], Mumbai, INDIA:
`IVIVC Based Drug Release Quality Control Specifications - A Case Study; PharmaLytica INDIA 2012, Mumbai, INDIA
`(August 2012).
`
`Invited to present a Keynote/Lead Address to SINDUSFARMA [Brazilian Pharmaceutical Industry Assoc./Syndicate]: US
`FD&C Act Section 505(b)(2): Time to Revisit RDC 136; Sao Paulo, BRAZIL (July 2012)
`
`Invited to present a Special Focus 4-Day Intensive Program: Comprehensive Development of Controlled Release Drug
`Delivery Systems: Oral Solid Dosage Forms; Canitec, Guadalajara, MEXICO (March 2012).
`
`Invited to present a Special Focus 4-Day Intensive Program: Comprehensive Development of Controlled Release Drug
`Delivery Systems: Oral Solid Dosage Forms; Canitec, Mexico City, Mexico, D.F., MEXICO (February 2012).
`
`Invited to present a Keynote Address at International Analytical Conference – ANACON 2011, Mumbai, INDIA:
`Application of Quality by Design (QbD) to Dissolution Testing Across Various Phases of Drug Development;
`ANACON-2011, Mumbai, INDIA (Oct. 2011).
`
`Invited to present a Keynote Address at National Congress of Pharmaceutical Sciences, Ixtapa-Zihuatanejo, MEXICO:
`Bioavailability/Bioequivalence Issues and Challenges; Associacion Farmaceutica Mexicana, Mexico City, Mexico, D.F.,
`MEXICO (Oct. 2011).
`
`Invited to present a Keynote Address at National Congress of Pharmaceutical Sciences, Ixtapa-Zihuatanejo, MEXICO:
`Dissolution Testing: QBD (Quality by Design) Approach; Associacion Farmaceutica Mexicana, Mexico City, Mexico, D.F.,
`MEXICO (Oct. 2011).
`
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`4
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`
`Invited to present a Special Focus 3-Day Intensive Program: Dissolution Test Method Development for Pharmaceutical
`Dosage Forms; Canitec, Guadalajara, MEXICO (June 2011).
`
`Invited to present a Special Focus 3-Day Intensive Program: Dissolution Test Method Development for Pharmaceutical
`Dosage Forms; Canitec, Mexico City, Mexico, D.F., MEXICO (June 2011).
`
`Invited to present a Special Focus 4-Day Intensive Program: Dissolution and Bioequivalence of Generic Pharmaceuticals;
`Asociacion Farmaceutica Mexicana, Mexico City, D.F., MEXICO (Feb. 2011).
`
`Invited to present a Strategic Special Focus 1-Day Intensive Program: Enantiomeric Pharmaceuticals: Drug Development
`Considerations; Merck-Brazil, Rio de Janerio, BRAZIL (Feb. 2011).
`
`Invited to present a Special Focus 4-Day Intensive Program: Principles in the Design, Development and Evaluation of Generic
`Pharmaceuticals; Asociacion Farmaceutica Mexicana, Mexico City, D.F., MEXICO (June 2010).
`
`Invited to serve as International Scientific Advisor for Marjan Farma Industria, Sao Paulo, BRAZIL (Oct. 2008)
`
`Invited to present The Golden Jubilee Celebration Seminar: Dissolution Testing: Basic Concepts, Regulatory Considerations
`and In Vivo – In Vitro Correlation (IVIVC), Dr. B.A. Marathwada University, Aurangabad, INDIA (Aurangabad, India Feb.
`25. 2008)
`
`Invited to present a keynote address: In Vivo – In Vitro Correlation (IVIVC): Its Place and Significance in Drug
`Development; Intl. Conf. Drug Discovery and Nanotechnology, Dept. Of Chemistry, Yashwant Mahavidyalaya, Nanded, INDIA
`(Nanded, India Jan. 2008)
`
`Invited as one of the Keynote Speakers at the inauguration function, presided by His Excellency Dr. APJ Abdul Kalam, President
`of India, of TRIcell Stemcell Research Center, Chennai, INDIA (Chennai INDIA, Nov. 2007)
`
`Invited to present a Special 2-day Session: Dissolution Testing in Pharmaceutical Drug Development,Center for
`Pharmaceutical Technology, Chulalongkorn University, Bangkok, Thailand and MediTop Inc., Bangkok, THAILAND (Bangkok,
`Thailand, March 2007).
`
`Invited to present a keynote address: Clinical Drug Development in Humans; Intl. Sym. Drug Discovery, Faculdade de Ciências
`Farmacêuticas – UNESP – Araraquara – SP- Brazil (Araraquara, Brazil, July 2006)
`
`Invited to present Pre-conference Workshop: Biorelevant Dissolution Testing: Concept or Fallacy, at the Intl Conf.: Dissolution
`Testing: Beyond Quality Control; Institute for International Research, New York, NY (Philadelphia, Jan. 2006).
`
`Invited to deliver keynote presentation: Stem Cell Research in Clinical Therapeutics: Potential Regulatory Implications. 1st
`Intl. Sym.: Stem Cell Research, Lifecell (India) Ltd., Chennai (Jan 06, 2006); Mumbai (Jan. 07, 2006) and New Delhi (Jan. 08,
`2006)
`
`Invited to join the Management Board (Board of Directors) as International Scientific Advisor and Member – Board of Directors
`of Investigacio Farmacologia y Biopharmaceutica, S.A. de C.V., Tepepan, Mexico D.F., MEXICO (2005)
`
`Invited to serve as International Scientific Advisor to Shasun Chemicals & Pharmaceuticals Ltd., Chennai INDIA (2005).
`
`Invited to present a 2-Day intensive Professional Advancement Training Program: Dissolution and Bioequivalence of Generic
`Pharmaceutical Dosage Forms; INFARMED (Central Drug Regulatory Agency of Potrugal) and E.A. Campos, S.A., Lisbon,
`PORTUGAL (April 2005).
`
`Invited to present a special focus session: Biologically Relevant Dissolution Testing in Drug Development; Government
`Pharmaceutical Organization, Bangkok, THAILAND (Feb. 2005).
`
` Invited to present a special focus session: Discriminatory Dissolution Testing in Drug Development; Ministry of Public
`Health (MOPH), Bangkok, THAILAND (Feb. 2005).
`
`Invited to serve on the Editorial Advisory Board, Pharmacokinetic/Pharmacodynamic and Biopharmaceutics Section for the
`Brazilian Journal of Biological and Medical Sciences, Brazil (2004).
`
`Invited to develop and present a Graduate Course for Masters and Doctoral program at University of Campinas, Department of
`Medicine, Campinas, Brasil (Dec. 2003). Course Title: CLINICAL PHARMACY PRACTICE: Pharmacokinetics for the
`Practicing Healthcare Professional
`
`Invited to present a keynote address at the International Symposium on Pharmaceutical Issues in NDA and ANDA; 55th Indian
`Pharmaceutical Congress, Chennai, INDIA (Dec. 2003); Title of presentation: Techno-legal considerations in defending an
`Abbreviated New Drug Application (ANDA): A brief insight
`
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`5
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`
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`Invited to present a keynote address at the Focus Symposium on Small Scale Industries (SSI) in Indian Pharmaceutical Industry
`organized by Confederation of Pharmaceutical Industries at the 55th Indian Pharmaceutical Congress, Chennai, INDIA (Dec.
`2003); Title of presentation: Pharmaceutical Small Scale industries – The US Perspective
`
`Invited to present keynote address at the II Congreso Cientifico Internacional del Instituto Nacional de Salud organised by the
`Centro Nacional de Control de Calidad, Lima, Peru (July 2003); Title: In vitro- In vivo Correlation in Drug Development
`
`Invited to present a 2-day special focus intensive continuing education program: Diseno de estudios de bioequivalencia de
`medicamentos genericos; II Congreso Cientifico Internacional del Instituto Nacional de Salud organised by the Centro Nacional
`de Control de Calidad, Lima, Peru (July 2003)
`
`Invited to become the International Scientific Advisor to PIHCSA, Medica S.A., De C.V., Mexico City, Mexico (Mar. 2003).
`
`Invited to develop and deliver 2-day intensive program: Auditing and Qualifying Suppliers and Vendors, Pharmaceutical
`Training Institute, Institute of International Research, New York, NY (Jan. 2003)
`
`Invited to present a special 2-day session: Advanced Dissolution Testing and Characterization of Dissolution Data, Assoc.
`Espanola de Farm. de la Indust. (A.E.F.I.), Barcelona, Spain (Feb. 2002)
`
`Invited to become the International Scientific Advisor to EMS Sigma Pharma, Hortolandia, SP-Brasil (Nov. 2001).
`
`Invited to present a keynote address at the International Symposium on Laboratory Automation Research (ISLAR), Philadelphia,
`PA (Oct. 2001)
`
`Invited to present a special 2-day session: Modern Dissolution Testing: Principles and Applications, Cairo University, Cairo,
`Egypt (Oct. 2001)
`
`Invited to present a keynote workshop: Fundamentals of Biologically Relevant Dissolution Testing, Institute for International
`Research (IIR), New York, NY (Sept. 2001)
`
`Invited design and present a special 2-day focus presentation: How to Predict and Optimize Bioavailability of Drug Formulations,
`Institute for International Research (IIR-PTI), New York, NY (June 2001)
`
`Invited to present a 3-day Intensive Workshop: Dissolution Method Development for Pharmaceutical Dosage Forms,
`Chulalongkorn Univ., The Pharmaceutical Technology Service Center and Meditop Intl., Bangkok, Thailand (March 2001)
`
`Invited to present a keynote workshop: Biologically Relevant Dissolution Testing: Myth or Fallacy !, Institute for International
`Research (IIR), New York, NY (Feb. 2001)
`
`Invited to present a special 2-day program: Generic Drug Development Program – Techno-Legal Considerations, Torrent research
`Center, Ahmedabad, India (Nov. 2000)
`
`Invited to present a 3-day intensive discourse: Correlating Dissolution and Bioavailability, International Pharmaceutical
`Technology Conference and Expo, Bangkok, Thailand (Aug. 2000)
`
`Invited to lead and moderate Dissolution Discussion Group (DDG) Southeast Asia Meeting, Bangkok, Thailand (Aug. 2000)
`
`Invited to serve on NIH SBIR/STTR Multidisciplinary Study Section, Bethesda, MD (July 2000)
`
`Invited to serve on Special Emphasis review Panel by Center for Disease Control & Prevention, national Center for HIV, STD
`and TB Prevention, Atlanta, GA (March 2000)
`
`Invited to present a 4-day Focus Program: Principles of Generic Pharmaceutical Product Development and Biopharmaceutical
`Evaluation, Ministry of Health, Drug Regulatory Agency, Colombo, Sri Lanka (March 2000)
`
`Invited to present a Keynote Opening Address for the symposium on Innovations in Dissolution Testing, AAPS Ann. Mtg., New
`Orleans, LA (Nov. 1999)
`
`Invited to present keynote address at the Bases Cientificas y Technologicas de la Bio-equivalencia/ Normatividad Sarutaria,
`Seminario lnternacional FIFARMA, Association Mexicana de Industries de Investigation Farmaceutica, A.C., Mexico City,
`Mexico. Title of Presentation: Correlaciones In vivo-In vitro (Sept. 1999)
`
`Recipient of the distinguished P.C. Dandiya Award/Citation for Distinguished Service to the Profession of Pharmacy. Invited to
`present the oration at the Indian Pharmaceutical Association, National Annual Meeting, Indore, India (Dec. 1999)
`
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`Invited to present a 2-day intensive course: Correlating Dissolution and Bioavailability - Understanding IVIVC, Intl. Adv.
`Instruments Expo., Mexico D.F., Mexico (Nov. 1999)
`
`Invited to present a 3-h special technical WS session: ABCs of generic Drug Development: Case Study Approach, Interphex-
`USA'99, New York, NY (April 1999).
`
`Invited to chair the opening session: Dosage Forms and Drug Delivery, Intl. Conf. Pharm. Ingred. Excip., CphI’98, Amsterdam
`The Netherlands (Dec.1998).
`
`Invited to present a 2-day specialized Intensive Seminar: Generic Drug Product Development – Bio-availability, Bio-equivalence
`& In Vitro Equivalence, Intl. Advanced Instruments Expo, Mexico City, Mexico (Nov. 1998).
`
`Invited to chair NIH-SBIR/STTR, Special Multidisciplinary Study Section NIH, Bethesda, MD (Nov. 1997).
`
`Invited to chair session 2: Drug Delivery and Drug Delivery Technology, Intl. Conf. Pharm. Ingred. Excip., London, England
`(Nov. 1997).
`
`Invited to present a keynote address at the 41st International Seminar. Drug Delivery Systems, Pharmacokinetics and
`Pharmacodynamics, Warsaw, Poland (Nov. 1997).
`
`Invited to present a Special 2-day Session; The Modern Dissolution Laboratory, VanKel International, London, England (July
`1997).
`
`Invited to present a Special 2-day Session. The Modern Dissolution Laboratory, AGB International Ltd., Dublin, Ireland (July
`1997).
`
`Invited to present a Special 2-day Session: E1 Moderno Laboritorio de Dissolucion, Adyanced Instruments de Mexico, Mexico
`City, Mexico (Feb. 1997)
`
`Nominated for the Distinguished Fulbright Lecturing Award (Feb. 1997)
`
`Invited to chair NIH SBIR/STTR special Multidisciplinary Study Section, NIH, Bethesda, MD (March 1997)
`
`Invited to present Keynote Address at the 1st Int. Conf. on The Practice of Clinical Pharmacy, Univ. of Zagreb, Faculty of
`Pharmacy, Zagreb, Croatia (April 1997)
`
`Invited to present a key workshop: Challenging Opportunities in the Delivery of Proteins and Peptides, Interphex USA’97,
`Philadelphia, PA (April 1997)
`
`Invited to serve on the Organizing Committee (Scientific Conference Section), Reed Exhibition/Conference Companies, Inc.,
`Norwalk, CT (April 1997-Present)
`
`Invited to chair NIH-SBIR/STTR, Special Multidisciplinary Study Section, NIH, Bethesda, MD (June 1997).
`
`Invited to chair Session 4: Advances in Drug Delivery Technology, Intl. Conf. Pharm. Ingred. Excip., CPHI '96, Turin, Italy
`(Oct. 1996)
`
`Invited to chair NIH - SBIR/ STTR Special Multidisciplinary study section, NIH, Bethesda MD (Nov 1996).
`
`Invited to present a keynote address to the Pharmaceutical Technology Section, VIIth Congress of Argentine Association of
`Industrial Pharmacy and Biochemistry, Buenos Aires, Argentina (June 1996).
`
`Invited to present a plenary lecture at the VIIth Congress of Argentine Association of industrial Pharmacy and Biochemistry,
`Buenos Aires, Argentina (June 1996).
`
`Invited to present a keynote address at the AAPS Midwest Regional Meeting, Chicago, IL (May 1996).
`
`Invited to chair NIH-SBIR/STTR Study Section, NIH, Bethesda, MD (March 1996).
`
`Invited to present a keynote address at the Indo-Swiss Collaborative Program and International Conference on Bioprocess
`Technology, Center for Biotechnology, Anna University, Madras, India; "Advances and Opportunities
`in the Delivery of Theraputic Proteins and Peptides", (March 1996).
`
`Invited to lead a UN-IESC assignment to Extractum - Pharma, Ltd., Kunfeherto, Hungary (April – May 1996).
`
`Invited to serve on international Scientific Conference Committee, CphI’95, Miller Freeman BV, Maarssen, The Netherlands
`(1995-Present).
`
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`
`Invited to chair Session 2: Developments in Dosage Forms and Delivery Systems, Intl. Conf. Pharml. Ingred. Excip., Frankfurt,
`Germany (Nov. 1995).
`
`Invited to present a keynote lecture at the Symposium: Bio-availability l Bio-equivalence - Past, Present and Future, AI-Azhar
`Intl. Pharml. Conf., Cairo, Egypt (Dec.1995).
`
`Invited to present a 2-day session: Development and Evaluation of Import-Substituted (Generic) Products,University of
`Alexandria, Alexandria, Egypt (Dec. 1995).
`
`Invited to serve as a Coordinator and Chairman of the 1st International Conference an New Horizons in Drug Delivery and
`Targeting, Basel, Switzerland (1995).
`
`Invited to become International Scientific Advisor for Wockhardt international, Ltd., Bombay, India (1995).
`
`Invited to present keynote (opening) address at the National Congress on Rheumatology, "Percutaneous Transport of Drugs,"
`Paris, France (1995).
`
`Invited to serve on NIH, SBIR/STTR Special Study Section Z (March 1995).
`
`Invited to become the Founding Editor-in-Chief of International Journal of Pharmaceutical Advances, a scientific peer-reviewed
`journal, by Tochnomic Publishing Co., Inc., Ardsley, NY (1995).
`
`Invited to serve on NIH-NIAID, RFP Special Review Panel (1994).
`
`Invited to present a keynote address on "Specialized Drug Delivery" at the XXVIIth Ann. Ind.Pharmacol. Soc. Conf., Bombay,
`India (1994).
`
`Invited to present a 3-h special technical course. Pharmaceutical Bio-equivalence Testing - Critical and Contemporary Issues, by
`Expo Consult, The Netherlands; at the CPhI'94 Exposition and Convention, Paris, France; Sept. 19, 1994.
`
`Invited to present a plenary lecture at the First International Meeting on Pharmacy and Pharmaceutical Sciences, organized by
`Marmara University, Istanbul, Turkey (Sept. 4-7, 1994).
`
`Recipient of FoxMeyer Award for 'outstanding Scholarship and distinguished service to pharmacy education’ presented by Beta
`Kappa Chapter of Rho Chi National Pharmacy Honor Society (1994)
`
`Recruited as Volunteer Executive [VE] for a short-tem assignment by International Executive Service Corps [IESC), a UN-AID
`supported organization (1994).
`
`Invited to serve on NIH-SBIR/STTR Special Study Section (1994).
`Invited to serve as co-chairman of a NIH-NINDS technical review panel to review SBIR proposal (1994).
`
`Invited to serve as a NIH-NINDS review panel member for review of RFPs (1993).
`
`Invited to keynote IBSA Symposium: Flector EP Tissuegel-Transdermal Congress, June 04, 1994 in Lugano, Switzerland (1993).
`
`Invited to join the Scientific Advisory Board of ENAR Foundation Research Center, Bombay, India (1 993).
`
`Selected for inclusion in Who’s Who Among Asian Americans, Gale International Research, Inc., Detroit, MI (1993).
`
`"Specialized Drug Delivery System. Parts I-VII". Text translated from English version and published in Slovene language by
`Editor-in-Chief, Pharmaceutical Association, Press of Slovenia, Ljubljana, Republic of Slovenia (1993).
`
`Invited to join the International Editorial Advisory Board of Acta Pharmaceutical, Ljubljana, Republic of Slovenia (1993)
`
`Founder of St. Louis College of Pharmacy - Undergraduate Summer Research Institute [STLCOP-USRI] - a self supported
`institute to provide research opportunities for undergraduate students.
`
`Invited to join the International Editorial Advisory Board of Journal of Biomaterials Applications, Lancaster, PA (1992).
`
`Invited to chair and compose a Technical Session: Drug Delivery Systems at the 3rd International Conference on Pharmaceutical
`Ingredients and Excipients, CPhI'92, Wiesbaden, Germany (Nov. 1992).
`
`Invited to chair ‘Improving the Drug Development Process' Conference, 2nd Day, Princeton, NJ (Sept. 1992). Sponsored by 'The
`Institute for International Research, New York.
`
`
`
`8
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`

`
`
`Recipient of 'Service to Country' Award presented by International Executive Service Corps., Stamford, CT (1992).
`
`Invited to chair Technical Session relating to Pharmaceutical Technology at Interphex-USA '92, NY (March-April 1992).
`
`Recruited as a Volunteer Expert [VE] for a short-term international assignment by International Executive Service Corps,
`Stamford, CT(11991) Assignment: 'Technology Transfer through Education', with Ranbaxy Laboratories Ltd. New Delhi, INDIA;
`December 1991-February 1992.
`
`Invited to give a special short session. Dissolution Assessment of Novel Dosage Forms, at the European Symposium on 'Buccal
`and Nasal Administration as An Alternative to Parenteral Administration', Paris, France, December 10-11, 1991 (August 1991).
`
`Invited to address the 43rd Indian Pharmaceutical Congress, as a plenary speaker, at their annual convention, Goa, India,
`December 27-29, 1991 (August 1991).
`
`Nominated and selected for inclusion in 'American Men and Women of Science', (June, 1991).
`
`Recipient of 'Certificate of Achievement in the area of Research and Scholarly Activity' awarded by Creighton University School
`of Pharmacy & Allied Health Professions (June 1990).
`
`Recipient of NARD Foundation Smith Kline Beecham Grant Award (1990).
`Invited for membership to Phi Beta Alpha Honor Society for International Scholars (1990).
`
`Recipient of John C.Kenefick Faculty Development Award granted by Health Futures Foundation (1989).
`
`Invited to open a symposium on "Controlled Release Dosage Form Design' and present a paper on Design Considerations and
`Mechanistic Evaluation of Oral Controlled Release Systems', at the AAPS Western Regional Meeting, Reno, NV (Feb. 27,1990).
`
`Recipient of PMA (Pharmaceutical Manufacturers Association USA) Visiting Professor for 1989 Award. Sponsored by Searle
`Laboratories, Skokie, IL (Aug. 06-20, 1989).
`
`Recipient of the Distinguished Leadership Award and inclusion in the International Directory of Distinguished Leadership for
`outstanding service to the teaching profession (1989).
`
`Included in the list of experts with International Executive Service Corps (IESC) for Assignments (educational or otherwise)
`organized and administered through IESC worldwide (November 1988).
`
`Recipient of the distinguished Dr. Pete Ellerbeck Memorial Award for outstanding faculty service to students and School of
`Pharmacy (1988).
`
`Recipient of the Rho Chi National Pharmacy Honor Society award for "Excellence in Teaching" (1988).
`
`Recipient of Travel Grant for attendance and participation at 7th Pharm. Tech. Conf., London, UK (April 1988). Sponsored by
`Marion Laboratories. Kansas City, MO (1988).
`
`Nominated for Burlington Northern Foundation Scholar of the Year Award for the academic year 1986-87.
`
`Recipient of James M. Keck, Faculty Development Award granted by Health Future Found