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Recorded Webinar
Vital Perspectives on Monoclonal Antibody (mAB) Biosimilars and the New Generation of mAB
timelapse 60 mins with 10-15 mins of Q and A
Note:
This webinar occured in the past
Along with recorded webinar, copy of presentation slides will be shared
Recorded Webinar can be played unlimited times
Speaker/Presenter
Short Abstract
Addressed will be the needs of American Pharma Companies: Leveraging European Experience of Regulatory Submissions, Guidance, Development and Registration of Biosimilars Medicines 2002-2011, for FDA approvals.
With the passage of the US Patient Protection and Affordable Health Care (PPAHC) Act passed by the US Senate in 2010, FDA was given authority to approve biosimilars by an abbreviated BLA pathway. But how can this be practically implemented?
This presentation will provide unique and fresh insights and perceptives into the practicalities and experiences of the pharmaceutical, nonclinical and clinical development of Biosimilars with application to monoclonal antibodies (mAbs).European and American pioneering experience of the presenter permits identifying success factors for Biosimilars development internationally. The presenter had a leading role in the submission and approval of one of the first of two biosimilar approvals in Europe and the Western world, a somatropin (rhGH) in April 2006. Since then he has been engaged in consulting for a number of companies in the full development of other biosimilars: interferons, GCSF, EPOs, insulin’s, FSHs, heparins and monoclonal antibodies etc. The lessons learned will be shared with delegates and practical tips will be provided. Therefore, the pitfalls that need to be anticipated and the proactive measures taken to avoid them will be addressed from both a European and International perspective. Safety Risk Management Plan considerations which are uppermost in the regulators and physicians mind when prescribing a Biosimilar to start a patient on therapy or switch a patient from a existing ‘biological reference medicine’ to a Biosimilar will be highlighted. That is, factors affecting interchangeability and substitution will be clarified. Predicting immunogenicity effects using a limited database requires skill and good scientific and empirical reasoning. This will be put in context. Modifying the structure of the biosimilar in a restricted way making a new generation mAb, sometimes called a “Biobetter”, may improve the stability, safety profile or efficacy of the product.
A variety of tips will be provided to increase the sponsors chances of marketing approval success and reduce overall risk to the program.
To conclude, the presentation and follow up discussion will identify success factors for Biosimilars development in an international setting, based on European experience.
Who should attend
This webinar will provide valuable assistance to :
- Patent Attorney / Patent Agents / Patent Consultants / IPR Professionals
- Pharmaceutical companies or financial or investment institutions, or service providers as CROs, CMOs concerned with Biologics/Biotechnology/ Biogenerics, Biopharmaceuticals/ Biotherapeutics
- Head/VP/Director, Senior Managers of Commercial Affairs, Business Development, Marketing & Sales, Commercial Affairs, Legal Affairs Pricing and Reimbursement, Health Economics, Intellectual Property, Pharmacovigilance, Clinical Immunology
- Head/VP/Director, Senior Managers of R&D Biotechnology Clinical/Nonclinical/Pharmaceutical
- VP / Director of Product Development, or QA
- VP / Director of Business Development
- Director Regulatory Affairs or Clinical Operations
- VP / Director of Pharmaceutical/Healthcare/Biotechnology
- QA Manager
- Clinical Quality Assurance
- Research and Development
- Clinical Serv
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