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Scientific Programme
Track Information
 
 
Opening Ceremony
8:00 - 8:10
Group Photo/Prayer
8:20 - 8:30
Chair's Opening Remark
8:30 - 9:00
VIP's Address
Keynote Forum
9:00 - 9:25
Title: Challenges in BE Requirements for Certain Class / Types of Drug Products
Dr. Vinod P. Shah, Consultant, Documentary Standards Division,
US Pharmacopeia, 12601 Twinbrook Parkway, Rockville, MD, USA.
9:25 -9:50
Title: Challenges of Bioavailability/Bioequivalence in the 21st Century: An
FDA Perspective

Dr. Mansoor A. Khan,
Director, Division of Product Quality Research, FDA/CDER/OPS/OTR,
White Oak, LS Building 64, Room 1070, 10903 New Hampshire Ave,
Silver Spring, MD, USA.
9:50 - 10:15
Speech Opportunity Available
10:15 - 10:25
Coffee Break
10: 25 - 10:50
Speech Opportunity Available
10:50 - 11:15
Title: Optimizing Systemic Exposure in Preclinical Species and Humans: Practical Strategies and Learnings for Discovery and Development
Dr. Tycho Heimbach,
Novartis Institutes for BioMedical Research,
DMPK - Translational Sciences (TS), USEH, 436/3253,
One Health Plaza, East Hanover, NJ 07936-1080, USA.
11:15 - 11:40
Speech Opportunity Available
11:40 - 12:05
Speech Opportunity Available

Sponsor/
Partial supporter/
Co-organizer

Track 1: Practical Solutions to Pharmaceutical Bioequivalence/Bioavailability Implementation
 
 Time  Track
March 1, 2010
 (Monday)
  13:00-18:00
Track 1-1: Bioequivalence Strategies in Development-an Industry Perspective
Session Chair: Dr. Sam H. Haidar, Lead Pharmacologist,
Office of Generic Drugs, Food and Drug Administration, Rockville, Maryland, USA.
Session Co-Chair: Call for Co-Host
13:00-13:05 Session Introduction
13:05-13:30 Title: Recent Advances in the Evaluation of Bioequivalence
Dr. Sam H. Haidar, Lead Pharmacologist,
Office of Generic Drugs, Food and Drug Administration,
Rockville, Maryland, USA.
13:30-13:55 Speech Opportunity Available
13:55-14:20 Title: TBD
Dr. Subhash C. Basu
, University of Notre Dame, Notre Dame, Indiana 46556, Department of Chemistry and Biochemistry, USA.
14:20-14:45 Speech Opportunity Available
14:45-16:20 Coffee Break & Poster Session 
16:20-16:45 Speech Opportunity Available
16:45-17:10 Title: The Situation of Bioequivalence Studies in Thailand: Past, Present, and Future
Dr.
 Supornchai Kongpatanakul, 
MD, Head,
Department of Pharmacology and Siriraj Bioequivalence Center,
Faculty of Medicine Siriraj Mahidol University, Bangkok, Thailand.
17:10-17:35 Speech Opportunity Available
17:35-18:00 Panel Discussion
 
March 1, 2010
 (Monday)
 13:00-18:00
Track 1-2: Comparative Bioavailability Studies for  New Drugs  (NDA)
Session Chair: Dr. Yellela Sri Rama Krishnaiah,
Associate Professor of Pharmaceutics,
Department of Pharmaceutical Sciences, College of Pharmacy,
Nova Southeastern University, 3200 South University Drive,
Fort Lauderdale, USA.
Session Co-Chair: Call for Co-Host
13:00-13:05 Session Introduction
13:05-13:30 Title: TBD
Dr. Yellela Sri Rama Krishnaiah,
Associate Professor of Pharmaceutics,
Department of Pharmaceutical Sciences, College of Pharmacy,
Nova Southeastern University, 3200 South University Drive,
Fort Lauderdale, , USA.
13:30-13:55 Speech Opportunity Available
13:55-14:20 Title: TBD
Dr. Rachel W. Li
,
Trauma and Orthopaedic Research Laboratory,
The Australian National University Medical School,
University of Canberra, Division of Immunology and Genetics, JCSMR, Australia.
14:20-14:45 Speech Opportunity Available
14:45-16:20 Coffee Break & Poster Session 
16:20-16:45 Speech Opportunity Available
16:45-17:10 Speech Opportunity Available
17:10-17:35 Speech Opportunity Available
17:35-18:00 Panel Discussion

University of Hyderabad,
India
March 1, 2010
 (Monday)
13:00-18:00
Track 1-3: Comparative Bioavailability Generic Drug Products (ANDA): Bioequivalence Studies
Session Chair: Dr. Barbara M DavitUS Food and Drug Administration,
Center for Drug Evaluation and Research,
Office of Generic Drugs, 7520 Standish Place, Rockville,
Maryland 20855, USA.
Session Co-Chair: Dr. Ashwini Nangia, School of Chemistry,
University of Hyderabad, Hyderabad 500 046, India.
13:00-13:05 Session Introduction
13:05-13:30 Title: TBD
Dr.
 Barbara M Davit
US Food and Drug Administration,
Center for Drug Evaluation and Research,
Office of Generic Drugs, 7520 Standish Place, Rockville,
Maryland 20855, USA.
13:30-13:55 Title: TBD
Dr. Monika Pawłowska,
Institute of Biotechnology and Antibiotics, Warsaw, Poland.
13:55-14:20 Title: TBD
Dr. Fakhrul Ahsan, Department of Pharmaceutical Sciences,
Texas Tech School of Pharmacy, Amarillo, Texas, USA.
14:20-14:45 Title: TBD
Dr. Ashwini Nangia, School of Chemistry,
University of Hyderabad, Hyderabad 500 046, India.
14:45-16:20 Coffee Break & Poster Session 
16:20-16:45 Speech Opportunity Available
16:45-17:10 Speech Opportunity Available
17:10-17:35 Speech Opportunity Available
17:35-18:00 Panel Discussion

University of Petra,
Jordan
March 1, 2010
 (Monday)
13:00-18:00
 Track 1-4: Implementing BA/BE Guidelines and CRO Qualification Criteria
Session Chair: Call for Host
Session Co-Chair: Dr. Nasir M. Idkaidek, College of Pharmacy & Medical Sceinces,
University of Petra, Amman, Jordan.
13:00-13:05 Session Introduction
13:05-13:30 Title: Effect of Truncated AUC Method on Drug Bioequivalence in Humans: an EMEA Draft Guideline Evaluation
Dr. Nasir M. Idkaidek, College of Pharmacy & Medical Sceinces,
University of Petra, Amman, Jordan.
13:30-13:55 Speech Opportunity Available
13:55-14:20 Speech Opportunity Available
14:20-14:45 Speech Opportunity Available
14:45-16:20 Coffee Break & Poster Session
16:20-16:45 Speech Opportunity Available
16:45-17:10 Title: TBD
Dr. Fotso Wabo Ghislain
17:10-17:35 Title: TBD
Dr. Tapan Pal, Bioequivalence Study Centre,
Jadavpur University, Kolkata, India.
17:35-18:00 Panel Discussion
 
Welcome Banquet  : March 01, 2010 Call for sponsor!

 Time  18:15-20:00
Track 2: Pharmacokinetic/Pharmacodynamic Models, Biowaivers and Biosimilars
 
 Time  Track
March  2, 2010
 (Tuesday)
 8:30-12:00
Track 2-1: Human/Animal Models in Oral Drug Absorption
Session Chair: Dr. Nasir M. Idkaidek, College of Pharmacy & Medical Sceinces,
University of Petra, Amman, Jordan.
Session Co-Chair: Dr. Antoine Malek, University Hospital Zurich,
Department of Obstetrics, Research Division,
Frauenklinikstr. 10, 8091 Zurich, Switzerland.
8:30-8:35 Session Introduction
8:35-9:00 Title: TBD
Dr. Xiaoyan Jiang
, MD, Medical Genetics,
University of British Columbia, Senior Scientist,
Terry Fox Laboratory, BC Cancer Research Centre,
675 West 10th Avenue, Vancouver, BC V5Z 1L3, Canada.
9:00-9:25 Title: Inter individual variability and science of drug development
Dr. Harih Padh, Director, B. V. Patel Perd Centre,
Thaltej-gandhinagar highway, Thaltej, Ahmedabad, India.
9:25-9:50 Title: TBD
Dr.Laszlo Endrenyi
, President-Elect,
Canadian Society for Pharmaceutical Sciences, Canada.
9:50-10:15 Title: The Importance of the Human Placenta Ex Vivo Perfusion Model in the Drug Development for Human Pregnancy
Dr. Antoine Malek, University Hospital Zurich,
Department of Obstetrics, Research Division,
Frauenklinikstr. 10, 8091 Zurich, Switzerland.
10:15-10:25 Coffee Break
10:25-10:50 Title: Drug Discovery from Natural Toxins and on Animal models
Dr. P.Gopalakrishnakone
,
President, International Society on Toxinology,
Department of Anatomy & Venom and Toxin Research Programme, Yong Loo Lin School of Medicine,
National University of Singapore,
Lower Kent Ridge Road, Singapore.
10:50-11:15 Speech Opportunity Available
11:15-11:40 Speech Opportunity Available
11:40-12:00 Panel Discussion

King Saud University,
Saudi Arabia
March 2, 2010
(Tuesday)
13:00-18:00
Track 2-2: Biosimilars and Biowaivers
Session Chair: Dr. David Goldsmith, Renal Unit, New Guy House, 
Guy's Hospital, London, UK.
Session Co-Chair: Dr. Khalid Alkharfy,College of Pharmacy,
King Saud University, Riyadh, Saudi Arabia.
13:00-13:05 Session Introduction
13:05-13:30 Title:  Biosimilar Products Selection: Challenges for Clinicians
Dr. Khalid Alkharfy,College of Pharmacy,
King Saud University, Riyadh, Saudi Arabia.
13:30-13:55 Title: Biosimilars and follow-on biologics
Dr. Fuhr Joseph P, Widener University, One University Place, Chester, PA 19013, USA.
13:55-14:20 Title: Biosimilar Epoetins in Europe - A success story?
Dr. David Goldsmith, Renal Unit, New Guy House,
Guy's Hospital, London, UK.
14:20-14:45 Title: Drug Delivery in Pregnancy: Transport of Nanoparticles Across the Human Placenta and Fetal Exposure
Dr. Antoine Malek
, University Hospital Zurich,
Department of Obstetrics, Research Division,
Frauenklinikstr. 10, 8091 Zurich, Switzerland.
14:45-16:20 Coffee Break & Poster Session
16:20-16:45 Title: European regulations in the context of biosimilars
Dr. Jean-Louis Prugnaud, Chef de Service,
Hôpital Saint-Antoine, 184 rue du Fbg Saint-Antoine,
Paris.
16:45-17:10 Title: Biosimilars and CHMP EU scientific advice
Dr. Efthymios Manolis
, Scientific Administrator,
Scientific Advice Human - Pre Authorisation Evaluation, EMEA,
7 Westferry Circus, Canary Wharf, London, UK.
17:10-17:35 Title: Biosimilar of epoetin alfa: issues on comparability and immumogenicity
Dr. Lucia Del Vecchio

Department of Nephrology and Dialysis,
A. Manzoni Hospital, Lecco, Italy.
17:35-18:00 Panel Discussion

GSB Life Sciences, USA
March 2, 2010
 (Tuesday)
 8:30-12:00
Track 2-3: Biosimulation in BE Studies-Prediction Tools
Session Chair: Dr. Srinubabu Gedela,
Stanford University School of Medicine, USA.
Session Co-Chair: Call for Co-Host
8:30-8:35 Session Introduction
8:35-9:00 Speech Opportunity Available
9:00-9:25 Title: Drug Delivery System for Proteins and Biosimilars
Dr. Sathy V. Balu-Iyer
, Associate Professor,
Department of Pharmaceutical Sciences, 521 Hochstetter Hall, University at Buffalo, State University of New York, Amherst, New York, USA
9:25-9:50 Title: TBD
Dr. Alexey Goltsov, Centre for Systems Biology of Edinburgh,
School of Biological Sciences, University of Edinburgh,
The Kings Buildings, Mayfield Road, Edinburgh, EH9 3JU, UK.
9:50-10:15 Title: TBD
Dr. Hsin-Yun HSU, Laboratory of Medical Genomics,
Department of Human Genome Research,
Kazusa DNA Research Institute, Kisarazu, Chiba, Japan.
10:15-10:25 Coffee Break
10:25-10:50 Speech Opportunity Available
10:50-11:15 Speech Opportunity Available
11:15-11:40 Speech Opportunity Available
11:40-12:00 Panel Discussion
 
March 2, 2010
 (Tuesday)
13:00-18:00
Track 2-4: Statistical Issues in BA/BE
Session Chair: Prof. Kwang-il Kwon, College of Pharmacy,
Chungnam National University, Daejeon, Korea.
Session Co-Chair: Call for Co-Host
13:00-13:05 Session Introduction
13:05-13:30 Title: Bioequivalence Methods for Assessment of Highly
Variable Drug – ABE, SABE, PBE and IBE
Prof. Kwang-il Kwon
, College of Pharmacy,
Chungnam National University, Daejeon, Korea.
13:30-13:55 Speech Opportunity Available
13:55-14:20 Speech Opportunity Available
14:20-14:45 Speech Opportunity Available
14:45-16:20 Coffee Break & Poster Session
16:20-16:45 Speech Opportunity Available
16:45-17:10 Speech Opportunity Available
17:10-17:35 Speech Opportunity Available
17:35-18:00 Panel Discussion
 
March 2, 2010
 (Tuesday)
 8:30-12:00
Track 2-5: In Vivo/In Vitro Methods to Determine Bioavailability
Session Chair: Call for Host
Session Co-Chair: Dr. Luis Pereira, Associate Professor,
Pharmacometrics MCPHS, Childrens' Hospital Boston,
Harvard Medical School, Boston, MA, USA.
8:30-8:35 Session Introduction
8:35-9:00 Title: Magnetic Resonance Imaging studies as a source of additional information on controlled release formulations behaviour during dissolusion. Towards the enhancement of reliability and rationalization of formulation selection for BE studies
Dr. Piotr Kulinowski
,
Department of Magnetic Resonance Imaging,
Institute of Nuclear Physics, Polish Academy of Sciences, Poland.
9:00-9:25 Speech Opportunity Available
9:25-9:50 Title: TBD
Dr. Luis Pereira, Associate Professor,
Pharmacometrics MCPHS, Childrens' Hospital Boston,
Harvard Medical School, Boston, MA, USA.
9:50-10:15 Speech Opportunity Available
10:15-10:25 Coffee Break
10:25-10:50 Title: Bioavailability of  Flavonoids: In Vitro Methods for Assessing Bilitranslocase-Mediated Membrane Transport
Dr. Sabina Passamonti
, University of Trieste,
Department of Life Sciences, via L. Giorgieri 1, 34127 Trieste,
Italy.
10:50-11:15 Speech Opportunity Available
11:15-11:40 Speech Opportunity Available
11:40-12:00 Panel Discussion

Pharmaceutics International, Inc, USA
March 2, 2010
 (Tuesday)
 13:00-18:00
Track 2-6: Role of Drug Delivery Systems in Bioequivalence and Bioavailability
Session Chair: Dr. Praveen S. Hiremath, Pharmaceutics Int., Inc., USA.
Session Co-Chair: Call for Co-Host
13:00-13:05 Session Introduction
13:05-13:30 Title: Role of drug delivery systems in enhancing the bioavailability of poorly soluble and/or poorly permeable drugs
Dr. Praveen Hiremath, Product Development,
Pharmaceutics International, Inc., 10189 Gilroy Road,
Hunt Valley, MD, USA.
13:30-13:55 Title: Effect of Preformulation/ Formulation Parameters on the
Bioequivalence & Bioavailability for Immediate Release and Modified Release Formulations

Dr. Sajeev Chandran, Sr. Manager, Innovation Cell,
Pharma Research, Lupin Ltd. (Research Park), Pune, India.
13:55-14:20 Title:Bioavailability and Bioequivalence of Novel drug delivery systems
Dr. N. Udupa, Professor and Principal,
College of Pharmaceutical Sciences, MAHE, Manipal, India.
14:20-14:45 Speech Opportunity Available
14:45-16:20 Coffee Break & Poster Session
16:20-16:45 Speech Opportunity Available
16:45-17:10 Speech Opportunity Available
17:10-17:35 Speech Opportunity Available
17:35-18:00 Panel Discussion
 
Track 3: Bioanalytical Methodology Development and Validation Using HPLC and LCMS

Agilent Technologies,
India
 Time  Track
March 2, 2010
 (Tuesday)
  8:30-12:00
Track 3-1: Advances in Mass Spectrometry Methodology Development
Session Chair: Dr. Tanay Waingankar, Life Science Industry Marketing Manager,
Agilent Technologies, Life Science & Chemical Analysis Division, G01, Prime Corporate Park, 230/231, Sahar Road, Andheri (E), Mumbai-99, India.
Session Co-Chair: Call for Co-Host
8:30-8:35 Session Introduction
8:35-9:00 Title: TBD
Dr. Tanay Waingankar, Life Science Industry Marketing Manager,
Agilent Technologies, Life Science & Chemical Analysis Division, G01, Prime Corporate Park, 230/231, Sahar Road, Andheri (E), Mumbai-99, India.
9:00-9:25 Speech Opportunity Available
9:25-9:50 Title: TBD
Dr. Sotiris Athanaselis, Associate Professor of Toxicology,
Department of Forensic Medicine and Toxicology,
Medical School, University of Athens, Greece.
9:50-10:15 Title: Ion Trap as a tool for in-vitro and in-vivo metabolite profiling
Dr. Girish kumar jain,
Head, Division of Pharmacokinetics & Metabolism,
Central Drug Research Institute, Lucknow-226001, India.
10:15-10:25 Coffee Break
10:25-10:50 Speech Opportunity Available
10:50-11:15 Title: Bioanalytical methodology Development and Validation using HPLC and LCMS-Advances in Mass Spectrometry Methodology Development
Dr. Constantinos Pistos, Lecturer of Toxicology,
Laboratory of Forensic Medicine and Toxicology,
Medical School, University of Athens, Greece.
11:15-11:40 Speech Opportunity Available
11:40-12:00 Panel Discussion
 
March 2, 2010
 (Tuesday)
13:00-18:00
Track 3-2: Antiviral, Anti Retroviral, Antibacterial and Anti Fungal Drugs  
Session Chair: Call for Host
Session Co-Chair: Call for Co-Host
13:00-13:05 Session Introduction
13:05-13:30 Title: TBD
Dr. Silvia Lima Costa
,
Laboratorio de Neuroquimica e Biologia Celular,
Universiade Federal da Bahia, Instituto de Ciências da Saude, Brazil.
13:30-13:55 Title: TBD
Dr. Sotiris Athanaselis, Associate Professor of Toxicology, Department of Forensic Medicine and Toxicology,
Medical School, University of Athens, Greece.
13:55-14:20 Speech Opportunity Available
14:20-14:45 Title: The necessity of new sinergistic fromulations to combat the drug resistance
Dr. Henrique Douglas Coutinho,
Laboratory of Microbiology and Molecular Biology,
Depart. of Biological Sciences,
University of Region of Cariri - URCA, AV. Cel Antonio Luiz,
Crato (CE), Brazil.
14:45-16:20 Coffee Break & Poster Session
16:20-16:45 Title: Standardization of Herbal Drug Preparations using LC-MS
Dr. Jawahar Lal, Scientist E-II,
Pharmacokinetics & Metabolism Division,
Central Drug Research Institute, CSIR, Lucknow, India.
16:45-17:10 Title: TBD
Dr. Mohammadreza Ghandforoush-Sattari,
Assistant Professor of Clinical Toxicology,
Dept.Pharmacology & Toxicology, Faculty of Pharmacy,
Tabriz University of Medical Sciences, Tabriz, Iran.
17:10-17:35 Speech Opportunity Available
17:35-18:00 Panel Discussion

EMF Consulting, France
March 2, 2010
 (Tuesday)
8:30-12:00
Track 3-3: Drugs Acting on Central Nervous Systems  
Session Chair: Dr. Marc Antoine FABRE, EMF Consulting, BP 2,
13545 Aix-en-Provence cedex 4, France.
Session Co-Chair: Dr. Raphael Serreau, MD, Responsable Appel d'Offre - PV,
URC Paris Necker-Cochin- EA 3620, Hopital Cochin, Paris.
8:30-8:35 Session Introduction
8:35-9:00 Title: Bioequivalence of generic antiepilepsy drugs
Dr. Gregory Krauss, MD, Professor of Neurology,
Johns Hopkins University, Baltimore, MD, USA.
9:00-9:25 Speech Opportunity Available
9:25-9:50 Title: Codeine transfer in breastmilk, what are the latest pk and pharmacovigilance data in 2009
Dr. Raphael Serreau
, MD, Responsable Appel d'Offre - PV,
URC Paris Necker-Cochin- EA 3620, Hopital Cochin, Paris.
9:50-10:15 Title: TBD
Dr. S. Chattopadhyay
10:15-10:25 Coffee Break
10:25-10:50 Speech Opportunity Available
10:50-11:15 Title: TBD
Dr. Darshak Karia
, MD, Director, Heart Failure Services,
Einstein Heart and Vascular Institute, Levy 3 East,
Albert Einstein Medical Center, Philadelphia, USA.
11:15-11:40 Speech Opportunity Available
11:40-12:00 Panel Discussion

Boys Town National Research Hospital, USA
March 2, 2010
 (Tuesday)
13:00-18:00
Track 3-4: Anticancer/Anti-Neovascular Drugs
Session Chair: Dr. Jasna Mihailovic, Center of Nuclear Medicine,
Oncology Institute of Vojvodina , Sremska Kamenica, Serbia.
Session Co-Chair: Dr. Sudhakar Akulapalli, Creighton University Medical Center and University of Nebraska Medical Center.
Director & Coordinator: Cell Signaling and Tumor Angiogenesis Laboratory, Boys Town National Research Hospital, Omaha, USA.
13:00-13:05 Session Introduction
13:05-13:30 Title: TBD
Dr. Ney Carter do Carmo Borges
, MD, PhD, FACC, FESC, FACP, FAHA, FASCPT, Post Graduate Professor FCM UNICAMP,
Principal Investigator Synchrophar Clinical Trials.
13:30-13:55 Title: Signaling Mechanisms of Endogenous Anti-cancer Molecules Derived From Extra Cellular Matrix Type IV Collagen
Dr. Sudhakar Akulapalli
, Creighton University Medical Center and University of Nebraska Medical Center.
Director & Coordinator: Cell Signaling and Tumor Angiogenesis Laboratory, Boys Town National Research Hospital, Omaha, USA.
13:55-14:20 Speech Opportunity Available
14:20-14:45 Title: TBD
Dr. Jasna Mihailovic,
Center of Nuclear Medicine,
Oncology Institute of Vojvodina , Sremska Kamenica, Serbia.
14:45-16:20 Coffee Break & Poster Session
16:20-16:45 Speech Opportunity Available
16:45-17:10 Speech Opportunity Available
17:10-17:35 Speech Opportunity Available
17:35-18:00 Panel Discussion
 
Track 4: IP, Regulatory Affairs and Outsourcing Alliance
 
 Time  Track
March 2, 2010
 (Tuesday)
8:30-12:00
Track 4-1: Clinical Data Harmonization Across Countries
Session Chair: Call for Host
Session Co-Chair: Call for Co-Host
8:30-8:35 Session Introduction
8:35-9:00 Speech Opportunity Available
9:00-9:25 Speech Opportunity Available
9:25-9:50 Speech Opportunity Available
9:50-10:15 Speech Opportunity Available
10:15-10:25 Coffee Break
10:25-10:50 Speech Opportunity Available
10:50-11:15 Speech Opportunity Available
11:15-11:40 Speech Opportunity Available
11:40-12:00 Panel Discussion

University of Pisa, Italy
March 2, 2010
 (Tuesday)
13:00-18:00
Track 4-2: ICH/FDA Guidelines and Regulatory Updates   
Session Chair: Prof. Mario Giorgi, Pharmacology & Toxicology Section,
University of Pisa, V.le delle Piagge 2, 56124 Pisa, Italy.
Session Co-Chair: Call for Co-Host
13:00-13:05 Session Introduction
13:05-13:30 Speech Opportunity Available
13:30-13:55 Title: PK-PD integration/modeling of NSAID in veterinary pharmacology
Prof. Mario Giorgi
, Pharmacology & Toxicology Section,
University of Pisa, V.le delle Piagge 2, 56124 Pisa, Italy.
13:55-14:20 Speech Opportunity Available
14:20-14:45 Speech Opportunity Available
14:45-16:20 Coffee Break & Poster Session
16:20-16:45 Speech Opportunity Available
16:45-17:10 Speech Opportunity Available
17:10-17:35 Speech Opportunity Available
17:35-18:00 Panel Discussion
 
March 2, 2010
 (Tuesday)
 8:30-12:00
Track 4-3: Partnerships with Animal Research Centres, Universities and Non-Profits    
Session Chair: Call for Host
Session Co-Chair: Call for Co-Host
8:30-8:35 Session Introduction
8:35-9:00 Speech Opportunity Available
9:00-9:25 Speech Opportunity Available
9:25-9:50 Speech Opportunity Available
9:50-10:15 Speech Opportunity Available
10:15-10:25 Coffee Break
10:25-10:50 Speech Opportunity Available
10:50-11:15 Speech Opportunity Available
11:15-11:40 Speech Opportunity Available
11:40-12:00 Panel Discussion

Abbott Laboratories, USA


Aurobindo Pharma Ltd., India
March 2, 2010
 (Tuesday)
13:00-18:00
Track 4-4: Perspectives of Regulatory Agencies, Worldwide, on Bioequivalence Testing
Session Chair: Dr. A.T. Bapuji,
Vice president, Clinical Pharmacology Department,
APL Research Centre, Aurobindo Pharma Ltd.,
Hyderabad, India.
Session Co-Chair: Dr. Rajendra S Pradhan,
Director, Clinical Pharmacokinetics and Pharmacodynamics,
Clinical Pharmacology and Pharmacometrics, Abbott labs,
Abbott Park, IL, USA.
13:00-13:05 Session Introduction
13:05-13:30 Title: TBD
Dr. Rajendra S Pradhan
,
Director, Clinical Pharmacokinetics and Pharmacodynamics,
Clinical Pharmacology and Pharmacometrics, Abbott labs,
Abbott Park, IL, USA.
13:30-13:55 Speech Opportunity Available
13:55-14:20 Speech Opportunity Available
14:20-14:45 Speech Opportunity Available
14:45-16:20 Coffee Break & Poster Session
16:20-16:45 Title: Bioequivalence Testing - Industry Prespective
Dr. A.T. Bapuji
,
Vice president, Clinical Pharmacology Department,
APL Research Centre, Aurobindo Pharma Ltd.,
Hyderabad, India.
16:45-17:10 Title: In-Vitro Release and Pharmacokinetics of Anti-tubercle
Drug Ethionamide in Healthy Male Subjects
Dr. Mahmaood Ahmad
, Lecturer, Department of Pharmacy,
The Islamia University of Bahawalpur, Punjab, Pakistan.
17:10-17:35 Speech Opportunity Available
17:35-18:00 Panel Discussion
 
Track 5: Toxicology
 
 Time  Track
March 3, 2010
 (Wednesday)
8:30-12:00
Track 5-1: Biomarkers in Toxicology
Session Chair: Dr. Rita Mattos, Senior Researcher,
National School of Public Health, Fundacao Oswaldo Cruz,
Ministry of Health, Brazil.
Session Co-Chair: Dr. Dominic Williams, MRC Centre for Drug Safety Science,
Dept. Pharmacology & Therapeutics, Sherrington Building,
The University of Liverpool, Liverpool, UK.
8:30-8:35 Session Introduction
8:35-9:00 Title: TBD
Dr. Kar Chowdhuri, Scientist F and Deputy Director, Embryotoxicology Lab, Indian Institute of Toxicology Research,
P.O. Box No. 80, Mahatma Gandhi Marg, Lucknow 226 001,
Uttar Pradesh, India.
8:35-9:00 Title: Advances and strategies in using biomarkers in children lead exposure
Dr. Rita Mattos, Senior Researcher,
National School of Public Health, Fundacao Oswaldo Cruz,
Ministry of Health, Brazil.
9:25-9:50 Title: TBD
Dr. Maibach  Howard, Dermatology, 
University of California, Sanfransisco, CA, USA.
9:50-10:15 Speech Opportunity Available
10:15-10:25 Coffee Break
10:25-10:50 Title: Biomarkers of Drug-Induced Liver Injury
Dr. Dominic Williams
, MRC Centre for Drug Safety Science,
Dept. Pharmacology & Therapeutics, Sherrington Building,
The University of Liverpool, Liverpool, UK.
10:50-11:15 Speech Opportunity Available
11:15-11:40 Speech Opportunity Available
11:40-12:00 Panel Discussion
 
March 3, 2010
 (Wednesday)
13:00-18:00
Track 5-2: Toxicogenomics & Metabolomics
Session Chair: Call for Host
Session Co-Chair: Dr. Utkan Demirci,
Bio-Acoustic-MEMS in Medicine (BAMM)Laboratory,
Center for Bioengineering, Department of Medicine,
Brigham and Women’s Hospital, Harvard Medical School, Boston, MA, USA.
13:00-13:05 Session Introduction
13:05-13:30 Title: TBD
Dr. Utkan Demirci,
Bio-Acoustic-MEMS in Medicine (BAMM)Laboratory,
Center for Bioengineering, Department of Medicine,
Brigham and Women’s Hospital, Harvard Medical School, Boston, MA, USA.
13:30-13:55 Title: TBD
Dr. Brown, Eric M
13:55-14:20 Title: TBD
Dr. Sandra van Os, Project Leader Clinical R&D, Synthon BV,
Microweg 22, 6503 GN Nijmegen, The Netherlands.
14:20-14:45 Speech Opportunity Available
14:45-16:20 Coffee Break & Poster Session
16:20-16:45 Title: Nonviral Cationic Gene Delivery Nanosystems: Geno compatibility and Toxicogenomics Dilemma
Dr. Y. Omidi, Associate Professor, Faculty of Pharmacy,
Director, Research Center for Pharmaceutical Nanotechnology,
Dean, School of Advanced Biomedical Sciences,
Tabriz University of Medical Sciences, Tabriz, Iran.
16:45-17:10 Speech Opportunity Available
17:10-17:35 Speech Opportunity Available
17:35-18:00 Panel Discussion
 
March 3, 2010
 (Wednesday)
 8:30-12:00
Track 5-3: Environmental Toxicology  
Session Chair: Call for Host
Session Co-Chair: Dr. Sivakumar Gowder, Associate Professor,
Dept. Pharmacology & Biochemistry, Al-Qassim University,
College of Pharmacy Buraidah, Saudi Arabia.
8:30-8:35 Session Introduction
8:35-9:00 Speech Opportunity Available
9:00-9:25 Title: Effect of antioxidants on PCB induced changes in male reproduction
Dr. Arunakaran J
, Department of Endocrinology,
Dr. ALM PGIBMS, University of Madras, Chennai, India.
9:25-9:50 Title: Composite ion exchange materials and their applications to remove toxic metal ions
Dr. MU. Naushad
, SRM University NCR Campus,
Modinagar, India.
9:50-10:15 Title: TBD
Dr. Sivakumar Gowder
, Associate Professor,
Dept. Pharmacology & Biochemistry, Al-Qassim University,
College of Pharmacy Buraidah, Saudi Arabia.
10:15-10:25 Coffee Break
10:25-10:50 Speech Opportunity Available
10:50-11:15 Title: Attitude and Knowledge of Nonsmokers about Secondhand Smoke and their Opinion towards Cessation of Smoking in Malaysia – Findings from International Tobacco Control (ITC) Survey Malaysia
Dr. Mohamed Shukry Zawahir,
South Asian Clinical Toxicology Research Collaboration,
Faculty of Medicine, University of Peradeniya, Peradeniya,
Sri Lanka.
11:15-11:40 Title: Exposure to Bisphenol A, an Environmental Estrogen on Reproductive Health
Dr. Geeta Vanage
,
National Center for Preclinical Reproductive and Genetic Toxicology, National Institute for Research in Reproductive Health (ICMR), JM Street, Parel, Mumbai 400 012, Maharashtra, India.
11:40-12:00 Panel Discussion
 
March 3, 2010
 (Wednesday)
 13:00-18:00
Track 5-4: Molecular Epidemiology  
Session Chair: Call for Host
Session Co-Chair: Call for Co-Host
13:00-13:05 Session Introduction
13:05-13:30 Speech Opportunity Available
13:30-13:55 Title: TBD
Dr. Yoshihiro Ishikawa
, Dean, Graduate School of Medicine, Professor and President, Cardiovascular Research Institute, Yokohama City University, Graduate School of Medicine, Japan.
13:55-14:20 Title: TBD
Prof. Michael V. Miles,
Clinical Pediatrics and Neurology,
Div. of Pathology & Laboratory Medicine,
Children's Hospital Medical Center, 3333 Burnet Ave.,
Cincinnati, OH 45229, USA.
14:20-14:45 Speech Opportunity Available
14:45-16:20 Coffee Break & Poster Session
16:20-16:45 Title: TBD
Prof. Thamar Stollman,
Department of Surgery,
Radboud University Nijmegen Medical Center, Nijmegen,
The Netherlands.
16:45-17:10 Speech Opportunity Available
17:10-17:35 Speech Opportunity Available
17:35-18:00 Panel Discussion
 
Track 6: PK/PD and Drug Discovery
 
 Time  Track
March 3, 2010
 (Wednesday)
8:30-12:00
Track 6-1: Anticancer, Antiviral Drug Development
Session Chair: Call for Host
Session Co-Chair: Dr. Guo Rui Chen, Institute of Clinical Pharmacology,
Qilu Hospital of Shandong University, Jinan, Shandong, China.
8:30-8:35 Session Introduction
8:35-9:00 Title: TBD
Dr. Mitchell Ho
, Head, Antibody Therapy Unit,
Laboratory of Molecular Biology, National Cancer Institute, NIH, Bethesda, MD, USA.
9:00-9:25 Title: Pharmacokinetics, Metabolism and Tissue Distribution of norcantharidin in human body, studied by HPLC-MS/MS and Isotope-labeled methods
Dr. Guo Rui Chen
, Institute of Clinical Pharmacology,
Qilu Hospital of Shandong University, Jinan, Shandong, China.
9:25-9:50 Title: Recent Advances in Anticancer Drug Discovery: Multiple Target Approach to Tackle Tough Tumors
Dr. Sanjay Kumar,
Group Leader,
Department of Medicinal Chemistry, Piramal Life Sciences,
Nirlon Complex, Off Western Express Highway, Goregaon (E),
Mumbai 400 063, India.
9:50-10:15 Title: Quantitative Structure-Activity Relationship Studies on Anti-Hepatitis Viral Agents
Dr. S.P.Gupta
, Departemt of Pharmaceutical Technology,
Meerut Institute of Engineering and Technology, Meerut, India.
10:15-10:25 Coffee Break
10:25-10:50 Title: Targeted therapy for Treatment of Lung Cancer
Dr. Mandip Singh Sachdeva, Professor and section Leader, Pharmaceutics, Florida A & M University, College of Pharmacy,
Editor in Chief, CRC Critical Reviews in Therapeutic Drug Carrier Systems, Tallahassee, Florida, USA.
10:50-11:15 Title: Natural products and chemo informatics-The modern drug designing principles
Dr. A.jayashree, Scientist, Jntu, Hyderabad, India.
11:15-11:40 Speech Opportunity Available
11:40-12:00 Panel Discussion
 
March 3, 2010
 (Wednesday)
13:00-18:00
Track 6-2: Molecular Drug Targets and Fragment based Drug Design
Session Chair: Call for Host
Session Co-Chair: Dr. Nazaré Soeiro
13:00-13:05 Session Introduction
13:05-13:30 Title: Assessment of exposure to carcinogens: correlation of surrogate biomarkers with adducts in target tissues
Dr. Franky Richter
, Walther Straub Institute,
Department of Toxicology, Ludwig-Maximilians University, Germany.
13:30-13:55 Title: Design of New Drug Molecules to be Used in Reversing Multidrug Resistance in Cancer Cells
Prof. Mayur Yergeri, Department of Medicinal Chemistry,
V.L. College of Pharmacy, Raichur, India.
13:55-14:20 Speech Opportunity Available
14:20-14:45 Title: TBD
Dr. Fakhreddin Jamali,
Faculty of Pharmacy & Pharmaceutical Sciences,
University of Alberta, Edmonton, Alberta, Canada.
14:45-16:20 Coffee Break & Poster Session
16:20-16:45 Title: TBD
Dr. Nazaré Soeiro
16:45-17:10 Title: Biophotonics: Application towards Modern Drug Discovery
Dr. Srinivas kantevari, Sr. Scientist,
Organic Chemistry Division-II,
Indian Institute of Chemical Technology,
Hyderabad, India.
17:10-17:35 Speech Opportunity Available
17:35-18:00 Panel Discussion
 
March 3, 2010
 (Wednesday)
8:30-12:00
Track 6-3: Improving ADME/DMPK Profile
Session Chair: Call for Host
Session Co-Chair: Prof. Bhupinder Singh Bhoop,
Pharmaceutics & Pharmacokinetics,
Univ Inst Pharm Sci (UGC Center of Adv Studies),
Dean (Alumni Relations), Panjab University, Chandigarh, India.
8:30-8:35 Session Introduction
8:35-9:00 Title: TBD
Dr. Jian Li

Facility for Anti-infective Drug Development and Innovation,
Drug Delivery, Disposition and Dynamics,
Monash Institute of Pharmaceutical Sciences,
Monash University, Australia.
9:00-9:25 Title: TBD
Dr. Hong Wan
,
Lead Generation DMPK and Physical Chemistry,
AstraZeneca R&D Mölndal, Sweden.
9:25-9:50 Speech Opportunity Available
9:50-10:15 Title: TBD
Dr. William Jia
, Department of Surgery, Faculty of Medicine, University of British Columbia, Brain Research Centre, Canada.
10:15-10:25 Coffee Break
10:25-10:50 Title: Enhancing Oral Bioavailability of Drugs using Self-Emulsifying Drug Delivery Systems
Prof. Bhupinder Singh Bhoop
,
Pharmaceutics & Pharmacokinetics,
Univ Inst Pharm Sci (UGC Center of Adv Studies),
Dean (Alumni Relations), Panjab University, Chandigarh, India.
10:50-11:15 Speech Opportunity Available
11:15-11:40 Speech Opportunity Available
11:40-12:00 Panel Discussion
 
March 3, 2010
 (Wednesday)
 13:00-18:00
Track 6-4: PK/PD and Bioanalysis Outsourcing Alliance
Session Chair: Call for Host
Session Co-Chair: Call for Co-Host
13:00-13:05 Session Introduction
13:05-13:30 Speech Opportunity Available
13:30-13:55 Speech Opportunity Available
13:55-14:20 Title: TBD
Dr. Sofiane Bezzine,
Institut Supérieur de Biotechnologies de Sfax,
Route de Soukra km 4, Sfax 3038, Tunisie.
14:20-14:45 Title: TBD
Dr. S. Tamilvanan
14:45-16:20 Coffee Break & Poster Session
16:20-16:45 Speech Opportunity Available
16:45-17:10 Speech Opportunity Available
17:10-17:35 Speech Opportunity Available
17:35-18:00 Panel Discussion

Sun Pharma, India



Central Drug Research Institute, India
March 3, 2010
 (Wednesday)
 13:00-18:00
Track 6-5: Road Map to Drug Discovery and Develoment
Session Chair: Dr. Girish kumar jain,
Head, Division of Pharmacokinetics & Metabolism,
Central Drug Research Institute, Lucknow-226001, India.
Session Co-Chair: Dr. Sanjay Mandhane, Pharmacology Division,
Sun Pharma Advanced Research Company Limited,
Atladara, Tandalja Road, Vadodara, Gujarat 390 020, India.
13:00-13:05 Session Introduction
13:05-13:30 Speech Opportunity Available
13:30-13:55 Speech Opportunity Available
13:55-14:20 Title: Materials and Methods for Innovation-Are We Ready for Drug Discovery?
Dr. Sanjay Mandhane
, Pharmacology Division,
Sun Pharma Advanced Research Company Limited,
Atladara, Tandalja Road, Vadodara, Gujarat 390 020, India.
14:20-14:45 Speech Opportunity Available
14:45-16:20 Coffee Break & Poster Session
16:20-16:45 Speech Opportunity Available
16:45-17:10 Speech Opportunity Available
17:10-17:35 Speech Opportunity Available
17:35-18:00 Panel Discussion
 
Track 7: Bioavailability
 
 Time  Track
March 3, 2010
 (Wednesday)
 8:30-12:00
Track 7-1: Influence of Disease on Bioavailability
Session Chair: Call for Host
Session Co-Chair: Dr. Thirumurthy velpandian,
Associate Professor & In-Charge,
Department of Ocular Pharmacology & Pharmacy,
Dr.Rajendra Prasad Centre for Ophthalmic Sciences,
All India Institute of Medical Sciences, New Delhi, India.
8:30-8:35 Session Introduction
8:35-9:00 Title: TBD
Dr. Jyoti Paliwal
, Director, Metabolism & Pharmacokinetics,
Ranbaxy Research Laboratories, Gurgaon, India.
9:00-9:25 Speech Opportunity Available
9:25-9:50 Title: Pros and cons of ocular bio-availability of drugs
Dr. Thirumurthy velpandian
,
Associate Professor & In-Charge,
Department of Ocular Pharmacology & Pharmacy,
Dr.Rajendra Prasad Centre for Ophthalmic Sciences,
All India Institute of Medical Sciences, New Delhi, India.
9:50-10:15 Speech Opportunity Available
10:15-10:25 Coffee Break
10:25-10:50 Speech Opportunity Available
10:50-11:15 Speech Opportunity Available
11:15-11:40 Speech Opportunity Available
11:40-12:00 Panel Discussion

Novartis, USA
March 3, 2010
 (Wednesday)
13:00-18:00
Track 7-2: Factors Influencing Bioavailability and Bioequivalence
Session Chair: Dr. Isadore Kanfer, Emeritus Professor, Faculty of Pharmacy,
Rhodes University, Grahamstown, South Africa.
Session Co-Chair: Call for Co-Host
13:00-13:05 Session Introduction
13:05-13:30 Title: Immunomodulation by biologic Intravenous Immunoglobulins IVIG: Immune Thrombocytopenia ITP as a Model for the last 30 Years
Dr. Paul Imbach
, University Children's Hospital Basel UKBB, Basel, Switzerland.
13:30-13:55 Title: Current Strategies for the Bioequivalence Assessment of Topical Dermatological Dosage Forms
Dr. Isadore Kanfer
, Emeritus Professor, Faculty of Pharmacy,
Rhodes University, Grahamstown, South Africa.
13:55-14:20 Title: TBD
Dr. Peinan Sun
, The Department of Clinical Pharmacology, Huashan hospital of Fudan University, Shanghai, China.
14:20-14:45 Title: TBD
Dr. Motte Laurence
, Université Paris, Nanomaterials group,
CSPBAT Laboratory, France.
14:45-16:20 Coffee Break & Poster Session
16:20-16:45 Title: Roles of Oral Drug Absorption, Bioavailability and Exposure Prediction in Drug Development
Dr. Tycho Heimbach,
Novartis Institutes for BioMedical Research,
DMPK - Translational Sciences (TS), USEH, 436/3253,
One Health Plaza, East Hanover, NJ 07936-1080, USA.
16:45-17:10 Speech Opportunity Available
17:10-17:35 Speech Opportunity Available
17:35-18:00 Panel Discussion
 
March 3, 2010
 (Wednesday)
 8:30-12:00
Track 7-3: The Role of Intestinal Metabolism on Bioavailability
Session Chair: Call for Host
Session Co-Chair:  
8:30-8:35 Session Introduction
8:35-9:00 Title: Challenges in Establishing Bioequivalence of Complex Modified Release Dosage Forms
Dr. Salomon Stavchansky
, Division of Pharmaceutics,
College of Pharmacy, University of Texas at Austin, Austin, Texas, USA.
9:00-9:25 Title: TBD
Dr. Jonathan P. Wong, Defence Scientist,
Defence Research and Development Canada Suffield,
CP 4000, Succ. Main, Medicine Hat, Alberta, Canada.
9:25-9:50 Title: TBD
Dr. Abdullah Al-Mohizea
,
Director of Product Evaluation and Standard Setting Department, Drug Sector, Saudi Food and Drug Authority, Riyadh, Saudi Arabia.
9:50-10:15 Title: The Importance of Intestinal Wall Metabolism – the case of Raloxifene
Dr. Trontelj Jurij
, Dept. Biopharmacy and Pharmacokinetics,
Faculty of Pharmacy, University of Ljubljana Askerceva 7, Ljubljana, Slovenia.
10:15-10:25 Coffee Break
10:25-10:50 Title: Bioequivalence methods for assessment of highly variable drug – ABE, SABE, PBE and IBE
Prof. Kwang-il Kwon
, College of Pharmacy,
Chungnam National University, Daejeon, Korea.
10:50-11:15 Speech Opportunity Available
11:15-11:40 Speech Opportunity Available
11:40-12:00 Panel Discussion

Cetero Research, USA
March 3, 2010
 (Wednesday)
  13:00-18:00
Track 7-4: In Vitro Methods to Determine Bioavailability & In Vitro-In Vivo Correlations
Session Chair: Dr. Sam Raney, Director, Pre-Clinical Dermatology,
Cetero Research, USA.
Session Co-Chair: Dr. Shivanand Puthli, Drug Delivery Division,
Panacea Biotec Ltd., Navi-Mumbai, Maharashtra, India.
13:00-13:05 Session Introduction
13:05-13:30 Title: Assessing BA/BE of Topical Formulations In Vitro:
In Vitro – In Vivo Correlation Provides a Practical Surrogate to Clinical BE Studies
Dr. Sam Raney
, Director, Pre-Clinical Dermatology,
Cetero Research, USA.
13:30-13:55 Title: TBD
Dr. Shivanand Puthli
, Drug Delivery Division,
Panacea Biotec Ltd., Navi-Mumbai, Maharashtra, India.
13:55-14:20 Speech Opportunity Available
14:20-14:45 Speech Opportunity Available
14:45-16:20 Coffee Break & Poster Session
16:20-16:45 Title: TBD
Dr. Avijeet Jain,
Research Scholar, Natural Product Research Laboratory,
Dept of Pharmaceutical Sciences, Dr H S Gour University,
Sagar, MP, India.
16:45-17:10 Speech Opportunity Available
17:10-17:35 Speech Opportunity Available
17:35-18:00 Panel Discussion