Sessions

    • Current concepts of drugs and Biologics
    • Approval Process
    • Reliance on Postmarketing Reporting
    • Cost and Reimbursement
    • Interchangeability and Substitution

    • U.S. Patent Strategies in the Biosimilars Space
    • Biosimilar Litigation Landscape
    • Decision Points and Strategies for the Patent Dance

    • Emerging trends and technologies
    • The current trends of the market
    • Trends for new products
    • Specialty medicines to treat chronic disease

    • Biotech vs Biopharma
    • The opportunity: Biopharma goes mainstream
    • The challenge: Cost, complexity, and regulatory scrutiny
    • Quality compliance and regulatory scrutiny
    • What’s next: Evolving in a booming industry

    • ELISA (single analyte)
    • Meso Scale Discovery (single and multiple analytes)
    • Singulex (Ultra-sensitive, single analytes)
    • Quanterix Simoa HD-1™

    • Organization setup
    • Operational effectiveness
    • Talent management
    • Pricing, Reimbursement & Market Access
    • Value-based Pricing

    • Biologic and Biosimilar Regulations
    • Switching, Substitution, and Interchangeability
    • Benefits of Biosimilars and Biologics
    • Clinical considerations

    • Biosimilar Multimodal Techniques
    • Biosimilar Electrophoresis and Formulation
    • Biosimilar GMP Protein Analysis
    • Supply Chain Challenges Before Biosimilars

    • Biosimilars Vs Generics: Similar but Not the Same
    • Differences Between Biosimilars and Generic Drugs
    • Inside biosimilar drug development
    • Critical quality attributes (CQAs)
    • Quality clone creation
    • Customizing the biosimilar development process

    • Implimentation of the BPCI Act
    • Patent protection and infringement issues
    • Patent negotiation and litigation phase
    • Market exclusivities

    • Drug Target Discovery
    • Molecular Biology - A New Route to Drug Discovery
    • Insilco Drug Discovery
    • Advanced Trends in Medicinal Chemistry in Drug Discovery and Designing
    • Innovative Drug and Nanotechnology

    • Variability in immunogenicity assays
    • Influence of dosing, sampling & patient populations
    • Limitations of comparative immunogenicity assessments
    • Postmarketing immunogenicity assessment

    • Strategies for the bioequivalence assessment of topical dosage forms
    • Bioequivalence approaches for transdermal dosage forms
    • Bioequivalence assessment of respiratory dosage forms
    • Evaluation of highly variable drugs and drug products

    • Patents
    • Trademarks
    • Copyright Law
    • Litigation

    • Trigger the immune system
    • Help the immune system to attack cancer
    • Other monoclonal antibodies

    • Licensing of biosimilars
    • Biosimilars regulation
    • BLA filing for biosimilars
    • Regulatory prospects of BRIC countries
    • A paradigm of traditional generics to biosimilars
    • Biowaiver approval for Biosimilars
    • Generic Biosimilars
    • BLA filing for biosimilars

    • Monoclonal antibody
    • Fusion protein
    • Biologic drug
    • Anti–tumor necrosis factor
    • Biotechnologic drug

    • Generics Drugs versus Follow-On Biologics
    • Therapeutic Biologics Applications
    • Biological Therapies for Cancer

    • BCS biowaivers
    • Preclinical and clinical testing for oral drug delivery
    • Waiver for In vivo Bioavailability or Bioequivalence
    • Consideration of Biowaiver extensions for BCS class III drugs
    • In vitro diffusion cells for dissolution testing in formulation development
    • Dissolution testing in drug formulation
    • In vitro preclinical ADME/BCS testing
    • In vitro drug product research

    • Safety and efficacy of biosimilars in oncology
    • Acceptance of Biosimilars in Oncology
    • Biosimilar Therapies for Cancer
    • Changing attitudes for biosimilars in gastroenterology
    • Development of biosimilars and potential cost savings
    • Clinical evidence supporting similarity of biosimilars to originator biologics
    • Biosimilars: patient’s view and HCPs’ knowledge

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