International Conference and Exhibition on Biowaivers & Biosimilars (Biosimilars-2012)

Venue: Hilton San Antonio Airport

Location: San Antonio, Texas, United States

Event Date/Time: Sep 10, 2012 End Date/Time: Sep 12, 2012
Registration Date: Jul 29, 2012
Early Registration Date: Apr 23, 2012
Abstract Submission Date: Jul 20, 2012
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Biosimilars-2012 is a remarkable event which brings together a unique and International mix of large and medium Pharmaceutical and Biotech companies; leading universities and Pharmacological research institutions making the conference a perfect platform to share experience, foster collaborations across industry and academia and evaluate emerging technologies across the globe.

Biosimilars-2012 is a specially designed cluster conference. The main theme of the conference is “A Synergistic Approach towards Biowaivers and Biosimilars” which covers a wide range of critically important sessions. Biosimilars-2012 is designed to discuss the development and progress of research in the areas of drug discovery, clinical trials, regulatory and economic considerations towards Biosimilars and waiver for Bioequivalence studies, BCS Biowaiver Studies, Dosage forms, Dissolution Testing and IVIVC.


Hilton San Antonio Airport, 611 NW Loop 410, San Antonio, Texas United States 78216
San Antonio
United States

Additional Information

Biosimilars-2012 comprises of 11 Tracks and 64 sessions: Track 1: Biosimilars: Innovator Pharmaceutical Products Track 1-1 Biosimilars: An Overview Track 1-2 Biotechnology Medicinal Products Different from Drugs Track 1-3 Future of Next Generation Biosimilars Track 1-4 Challenges Faced in Developing Biosimilars Track 2: Commercialization or Globalization of Biosimilars Track 2-1 Biosimilar Drugs Track 2-2 Economic Aspect towards Biosimilars Track 2-3 Biosimilars in Market Track 2-4 Investment and Returns on Biosimilars Track 3: Skill Set for Biosimilars Development Track 3-1 Immunogenicity Track 3-2 Clinical Development Track 3-3 Pharmacovigilance Track 3-4 Product Development Strategies Track 3-5 Generic Drug Development Track 3-6 Biomedical Informatics Track 4: Biosimilars: Regulatory Approach Track 4-1 Licensing of Biosimilars Track 4-2 EU Biosimilars Regulation Track 4-3 Patent Issues Track 4-4 FDA's view on Biosimilars Track 5: Clinical Studies Track 5-1 Clinical Trials Track 5-2 Risk Management and Quality Affairs Track 5-3 Transgenic animals Track 5-4 Targeted Cell line Development Track 5-5 Clinical PK/PD Studies Track 5-6 Toxicology Track 5-7 Aspects of Genotoxicity Tests Track 6: Biosimilars Therapeutics Track 6-1 Recombinant Blood Products Track 6-2 Recombinant Vaccines Track 6-3 Growth Hormones Track 6-4 Biosimilar Peptides Track 6-5 Recombinant Therapeutic Proteins Track 6-6 Biosimilars for Cancer Track 6-7 Biosimilars Monoclonal Antibodies Track 6-8 Biosimilar Interferon Track 7: Plant Produced Biosimilar Products Track 7-1 Transgenic Plants Track 7-2 Post Translational Genetics Track 7-3 Fermentation Culture Track 7-4 Product Safety & Efficacy Track 7-5 Molecular Farming Track 8: Biowaivers Track 8-1 FDA Approach to Bioequivalence Testing Track 8-2 Choice of Reference Product for Bioequivalence Testing Track 8-3 Safety and Quality Regulation for Drug Development Track 8-4 WHO Considerations for Bioequivalence and Dissolution Testing Track 8-5 Process Validation for Drugs and Biologics Track 9: BCS & IVIVC Based Biowaivers Track 9-1 BCS Biowaiver Studies Track 9-2 Waiver for In vivo Bioavailability or Bioequivalence Track 9-3 BCS: A Strategic Tool for Classifying Drug Substances Track 9-4 Consideration of Biowaiver Extensions for BCS Class III Drugs Track 9-5 IVIVC Based Biowaivers Track 9-6 Dissolution Testing in Drug Formulation Track 9-7 In vitro Preclinical ADME/BCS Testing Track 9-8 In vitro Drug Product Research Track 10: Bioequivalence Assessment Track 10-1 Bioequivalence Testing for Dosage Forms Track 10-2 Bioequivalence Testing for Topical Dosage Forms Track 10-3 Bioequivalence Testing for Respiratory Dosage Forms Track 10-4 Bioequivalence Testing for Transdermal Dosage Forms Track 10-5 Statistical Analysis for Bioequivalence Testing Track 11: Analytical Strategies Track 11-1 Bioanalytical Methods Track 11-2 Formulation Track 11-3 Bioassay for Comparability & Potency Testing Track 11-4 GMP Protein Analysis Track 11-5 LC/MS analysis for discovery, preclinical and clinical programs Track 11-6 Electrophoresis Track 11-7 Multimodal techniques