Journal of Bioanalysis & Biomedicine

2^nd International Conference and Exhibition on Biowaivers & Biosimilars

September 23-25, 2013 Hilton Raleigh-Durham Airport at RTP, NC, USA

Scientific Tracks Abstracts

• Strategy for biosimilar development

  Jichao Jay Kang

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• The need for a reference product database for biosimilars

  Jeff Lyons

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• Freedom to operate issues and patent litigation considerations for biosimilars

  Sailesh K. Patel

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• Clearing the biosimilar patent thicket with IPRs

  Kevin W. McCabe

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• Integrated strategy for biosimilar development: A multidisciplinary approach for risk reduction

  Adriana E. Manzi

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• Rituximab and biosimilars: Equivalence and reciprocity

  Charles Bennett and Zaina Qureshi

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• Compliance and thoughtfulness from idea to commercial production

  Deborah Thibodeaux

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• Complexities of biosimilar product

  Alok Bandyopadhyay

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• Biosimilar in pharmerging markets

  Jun Wang

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• Analytical characterization of biosimilar products to establish biosimilarity

  Fiona Greer

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• Challenges in demonstrating biosimilarity and interchangeability of biosimilar products

  Rodeina Challand

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• Power without a patent: Twelve-year biologics data exclusivity period & a totlality of the evidence standard for biosimilarity

  Jonathan R.K. Stroud

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• The relevance of immunogenicity in preclinical development

  Ciriaco Maraschiello

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• The data of the head-to-head use of two biosimilars of beta-interferon-1b in MS therapy at the Moscow MS Center

  E. Popova, A. Boyko, M. Davidivskaya, T. Demina, T. Kukel, N. Lashch, N. Popova, N. Kchachanova, S. Shchur and E. Gusev

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• Post-approval safe harbor…or not?

  Brian R. Dorn

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• Development and manufacturing of a biobetter therapeutic: A case study

  Michiel E. Ultee and Kent E. Pryor

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• Use of apoptosis assays as tools to compare biosimilarities of anticancer drugs or agents

  Subhash Basu, Rui Ma and Manju Basu

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• Alpha ENaC-b as a gene therapy in salt-sensitive hypertension

  Marlene Shehata, Fady Youssef and Alan Pater

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• Reverting antibiotic tolerance of bacterial persisters by a brominated furanone, (Z)-4- bromo-5-(bromomethylene)-3-methylfuran-2(5H)-one

  Jiachuan Pan and Dacheng Ren

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• Comprehensive functional & biological characterization of biosimilar monoclonal antibodies

  Daniel Galbraith

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• Some possibilities in trial design to reduce sample size

  Russell Reeve

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• Current analytical techniques for characterization of carbohydrate biosimilars

  Parastoo Azadi

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• Accelerating biosimilars mAbs to market: A predefined process coupled with consultative services

  Jennifer Campbell

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• Publication planning for biosimilars

  Paul Lane

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• Commercialization considerations for biosimilars

  Steven Lehrer

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• Successful commercialization of biosimilars in Europe-1 market authorization, 27 markets

  Marguerite Mensonides-Harsema

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• Biosimilar market: Business development overview

  Leandro Mieravilla

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• Use of cardiac glycosides for inhibition of C-reactive protein and treatment of atherosclerosis- Road map to clinical applications

  Oliver Zimmermann, Kefei Li and Jan Torzewski

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• Comparability study to support upstream and downstream process development

  Rong-Rong Zhu

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• How long should adjuvant chemotherapy be given?

  Michael Retsky

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• Biosimilar characterization and comparability assessments-Experiences from a CRO GMP protein chemistry laboratory

  Leonard Bell

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• Robust, streamlined 2-D western blot workflow for evaluation of antibodies developed for detection of host cell proteins (HCP)

  Sricharan Bandhakavi, T. Berkelman, A. Harbers, Sara Heitkamp and Michael Early

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• The use of high-speed liquid chromatography/tandem mass spectrometry in the GLP assays for biosimilars

  Yunsheng Hsieh

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• Silicon photonic bio-sensing, a new technology for immunogenicity testing

  Martin Gleeson

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• The use of mass spectroscopy in the GMP analysis of biosimilars

  Mario DiPaola

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• Host cell protein characterization for bioprocess and product improvement

  Rong-Rong Zhu

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• Novel pharmacologic and phenotypic methods to characterize carrier-mediated and nanoparticle agents as part of preclinical and clinical development

  William C. Zamboni

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• Human photosynthesis: A turning point in the understanding and treatment of Alzheimer´s disease

  Arturo Solís Herrera*, Jerzy Leszek, María del Carmen Arias Esparza, Ruth I. Solís-Arias, Paola E. Solís-Arias and Martha P. Solís-Arias

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• Human skin as an in vitro surrogate model for bioequivalence comparison of topicals

  Ajay K. Banga

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• PNIPAM hydrogels and PLGA nanoparticles: Applications in drug delivery systems

  Hu Yan

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• Antioxidative and anticholinesterase compounds from two closely related Croton species

  Ashwell R. Ndhlala, Mutalib A. Aderogba, Bhekumthetho Ncube and Johannes Van Staden

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• B-PAPM- Biological potency of certain antifeedant plant extracts against some pathogens for the management of human disease

  S. Abideen

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