Journal of Bioanalysis & Biomedicine

4^th International Conference and Exhibition on Biologics & Biosimilars

October 26-28, 2015 Baltimore, USA

Scientific Tracks Abstracts

• Exploring government pricing and reimbursement policy challenges associated with biosimilars

  William A Sarraille

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• The economic viability of a US biosimilars industry

  Alex Brill

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• Challenges and approaches in demonstrating biosimilarity at the physicochemical and biological level

  Jill A Myers

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• Clearing the path for market entry before the USPTO

  Jenny Chen

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• Similar biologics in India – Legal and regulatory perspective

  Milind Antani

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• US biosimilars taking flight: Discussion of the key events and cases shaping the US biosimilar landscape

  Timothy J Shea

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• Biosimilars market access and penetration in the Obama care era –Considerations for providers, payers, prescribers and patients

  Gary C Cupit

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• U.S. biosimilars – The courts interpret BCPIA steps

  Denise M Kettelberger

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• AVX-470, an orally-delivered GI-targeted anti-TNF bio-better

  Neil L Schauer

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• Challenges of the recombinant pharmaceutical biosimilar proteins expression and enhanced refolded recovery from E. coli

  Vivek Kumar Morya

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• Emerging biosimilar in therapeutics: Where we are and what is future?

  Dipti Gulati

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• Impact of the biosimilars pipeline and nomenclature on market development

  Ronald A Rader

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• Evolution of the global biosimilars market: Lessons learned

  Raymond A Huml

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• Biosimilars: Is the risk worth the reward?

  James Harris III

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• Biosimilar Companies and Market Development Worldwide

  Lisa Mueller

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• Patent eligibility challenges to biologics under America Invents Act (AIA) and Myriad

  Raj S Davé1, Neil Shivraj Davey2, Sonya R Davey3 and Sreenivas Gannavaram4

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• Cost-effective clinical trial design to detect immunogenicity and efficacy differences between biosimilar and innovator product

  Candida Fratazzi

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• Janssen Biotech vs. Celltrion: The balance between the BPCIA and litigation

  Kerisha A Bowen

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• Issues in the clinical development of the first wave of biosimilars

  Nigel J Rulewski

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• Supplementary protection certificates (SPCs) in Europe – What is the ‘basic patent’ and what is the ‘product’?

  Tom Carver

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• CMC consideration for biosimilar drug development and manufacturing process

  Marcus Mreyen

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• Overcome challenges in manufacture of biosimilars through media/feed screening and cell culture process optimization

  Min Zhang

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• Erbitux biosimilar

  Alan L Epstein

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• Production of biosimilar MAbs in transgenic animals: Opportunities and challenges

  Roman T Drews

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• A review of the how state regulators are dealing with biosimilars: A case study of the Maryland policy debate and legislation

  Gene M Ransom III1, 2

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• Safety and biosimilarity of ior®EPOCIM compared to Eprex® based on toxicologic, pharmacodynamic and pharmacokinetic studies in the Sprague-Dawley rat

  Gordon T Bolger1, Kresimir Pucaj1, Katherine Riddle1, Simon R Taylor1, Nuris Ledon2 and Albert Licollari1

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• Prevention potency of soaps and disinfectants on Vancomycin resistant Enterococcus faecalis infection

  Olawale A K, Raimi O R, Lawal R T, Abejoye O A and Oladipupo O A

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• Bioanalytical challenges of biosimilar development; making you wish you had a mirror to put in front of the innovator drug

  Afshin Safavi

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• Protein binding drug-drug interaction

  Mariana Babayeva

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• The characterisation of biosimilar mAbs using biologically relevant and sensitive ADCC methodologies

  Andy Upsall

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• Development of a biosimilar CMC strategy for the identification of critical quality attributes

  Samantha Little

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• Characterization of glatiramer acetate C-terminal heterogeneity

  Mario DiPaola

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