Journal of Bioanalysis & Biomedicine

3^rd International Conference and Exhibition on Biowaivers, Biologics & Biosimilars

October 27-29, 2014 Hyderabad International Convention Centre, Hyderabad, India

Scientific Tracks Abstracts

• A double blind, phase 1, randomized, parallel-group, single dose, 2 arm, biosimilar study, of a “New Biologic” and “Comparator”, intravenously administered to healthy subjects

  Krishna Menon

  PDF HTML

• Biosimilar regulations in the ASEAN

  Shivraj Dasari

  PDF HTML

• Challenges in demonstrating biosimilarity and interchangeability of biosimilar products

  Rodeina Challand

  PDF HTML

• Comparison of US/EU biosimilar guidelines

  Kamali Chance

  PDF HTML

• Challenges and its resolutions in the conduct of biosimilars clinical development

  Chirag Shah

  PDF HTML

• Being-similar: From benchside to bedside

  Manish Mahajan

  PDF HTML

• Quality attributes of biologic products and standard setting process – USP perspective

  Ranjan Chakrabarti

  PDF HTML

• Emerging trends in biosimilars and biologics

  Kaiser Jamil

  PDF HTML

• Potential value of biosimilars- will biosimilars be cost effective compared to the branded equivalents?

  Shabana Khan

  PDF HTML

• Can excluding pharmaceuticals from patenting will lead to cost effective and quality drugs/ biosimilars?

  Shilpa Bhilegaonkar

  PDF HTML

• Biological and functional characterization of anti-TNFα biosimilar durgs

  Daniel Galbraith

  PDF HTML

• Evaluation of immunogenicity in biotherapeutics

  Surendra J Chavan

  PDF HTML

• Commercial opportunities in biosimilars

  Steven Lehrer

  PDF HTML

• Plant derived cyclopolypeptides: Targets for drug discovery

  Rajiv Dahiya

  PDF HTML

• Risk assessment: A pragmatic approach to develop biosimilars

  Harish Shandilya

  PDF HTML

• Successful conduct of clinical trials to prove biosimilarity by defining a best fit outsourcing strategy

  Heike Schoen

  PDF HTML

• Intas-Merck Millipore: Partnership in biosimilars development strategy for emerging markets

  Jennifer Campbell and Harish Shandilya

  PDF HTML

• Enzyme engineering: An innovative way to manage the economics of biosimilars- Polyclone case study

  Naveen Kulkarni

  PDF HTML

• Roadmap of stability studies for biosimilar product development

  Rashbehari Tunga

  PDF HTML

• Future of next generation biosimilars

  Kamlesh Patel

  PDF HTML

• Clinical development of biosimilars: Overcoming challenges

  Charu Manaktala

  PDF HTML

• Challenges faced in the development of biosimilars

  Hima Bindu Gujjarlamudi

  PDF HTML

• Clinical trials of biosimilars in developing nations: Obstacles and opportunities

  N Srinivas

  PDF HTML

• Best practices for high concentration ultrafiltration applications

  Subhasis Banerjee

  PDF HTML

• Bioanalytical strategy for biosimilars: Recommended steps for establishment of comparability

  Aparna Kasinath

  PDF HTML

• Understanding osteomyelitis and its solution through cost effective biomaterial based strategies

  Samit Kumar Nandi

  PDF HTML

• Virus filtration for biosimilar manufacturing: From needs to solutions

  Tathagata Ray

  PDF HTML

• An alternate approach for sialic acid estimation in glycoproteins by HPAEC-PAD method

  Jayachandran R, Anjali Kumari, Disha Dadke and Ranjan Chakrabarti

  PDF HTML

• Analytical biosimilarity: Strategies and challenges

  Shalini Sharma

  PDF HTML

• Alternate approaches addressing variability in ADCC assay

  Prabhavathy Munagala, Shubrata Khedkar, Praveen Kumar T, Disha Dadke and Ranjan Chakrabarti

  PDF HTML

• Biosimilars in the United States - Update on FDA implementation and other current issues

  James C Shehan

  PDF HTML

• The positive role of intellectual property in the creation of cost effective and affordable biosimilars

  Mohan Dewan

  PDF HTML

• IP checklist for similar biologics

  Mita Sheikh

  PDF HTML

• Patent issues in biopharmaceutical industry

  Vijay Kumar

  PDF HTML

• The exclusions from patentability and especially the rationale for medical use patents

  Dieter Tzschoppe

  PDF HTML

• Patenting of biosimilars in India and related issues

  Vijay Kumar Makyam

  PDF HTML

• Biowaivers: A delicate balance between biosimilars and innovations

  Poongothai A R and Vijay Kumar M

  PDF HTML

• Challenges for biosimilar generics

  Vivek Kashyap

  PDF HTML

• Preparing for U.S. market entry–strategy considerations in view of BPCIA and AIA

  Renita S Rathinam

  PDF HTML

• Biosimilars: Globalization of biosimilars

  Ravi R Ghanghas

  PDF HTML

• Host cell protein and other impurity clearance assays for biosimilar development

  Arumugam Muruganandam

  PDF HTML

• Safety concerns related to global biosimilars drug development

  Nigel Rulewski

  PDF HTML

• Pharmacovigilance of biosimilars: Challenges & possible solutions

  J Vijay Venkatraman

  PDF HTML

• Role of pharma industries in the improvement of pharmacovigilance system

  Kamlesh Patel

  PDF HTML

• Synergism of ‘nutraceutical’ and ‘pharmaceutical’ for safety

  Ekta K Kalra

  PDF HTML

• The key roles & responsibilities of pharmacists in biosimilars development

  N Srinivas

  PDF HTML

• Dissolution testing of nicotinamide cocrystals of a model BCS-Class-II drug

  Kale Mohana Raghava Srivalli and Brahmeshwar Mishra

  PDF HTML

• Medication usage and nutritional status in hemodialysis

  S Chan Mubeena and A Jyothi

  PDF HTML

• Combined approach of biosimilar trastuzumab monoclonal antibody with nanoparticles targeted to prostate tumor cells

  Dubey Satendra Kumar, Thomas Abhilash and Samanta Malay Kumar

  PDF HTML

• Effect of lipid digestion media on the fate of drug in lipid based nanoemulsion

  R Suresh Kumar, Ashwati Prakash and K Gowthamarajan

  PDF HTML

• Design and synthesis of some novel antibacterial agents targeting Gyrase B and Par E

  Janarthanan T and Md.Afzal Azam

  PDF HTML