Posts Tagged ‘bioequivalence’

Reporter: Aviva Lev-Ari, PhD, RN

“A Synergistic Approach towards Biowaivers & Biosimilars”. Biosimilars-2012 is scheduled on September 10-12, 2012 at Hilton San Antonio Airport, USA.

Biosimilars or Follow-on biologics
http://en.wikipedia.org/wiki/Biologic_medical_product are terms used to describe officially-approved subsequent versions of innovator biopharmaceutical http://en.wikipedia.org/wiki/Biopharmaceutical  products made by a different sponsor following patent and exclusivity expiry on the innovator product.[1] http://en.wikipedia.org/wiki/Biosimilar#cite_note-biosimilars2012-0 Biosimilars are also referred to as subsequent entry biologics (SEBs) in Canada.[2] http://en.wikipedia.org/wiki/Biosimilar#cite_note-1 Reference to the innovator product is an integral component of the approval.
A Biowaiver is a waiver (exemption) of clinical bioequivalence studies given to a drug product.

Biowaivers and Biosimilars.

The main theme of the conference is “A Synergistic Approach towards Biowaivers & Biosimilars”.

Biosimilars-2012 is scheduled on September 10-12, 2012 at Hilton San Antonio Airport, USA.

 Click here to view the downloadable Preliminary Program 


This three day conference will cover the latest trends and challenges in Biowaivers and Biosimilars.   Biosimilars-2012 highlights the following topics:   

  • Biosimilars Pathway  
  • Immunogenicity   
  • Skill Set for Biosimilars Development  
  • Biosimilar Therapeutics      
  • Biomedical informatics  
  • BCS and IVIVC based biowaivers  
  • Transgenic animals & plants  
  • In vitro & In vivo Correlations  
  • Bioequivalence Testing  
  • BCS and IVIVC based biowaivers    
  • Oral drug delivery     

Conference assets are William Velander (University of Nebraska, USA), Lisa J. Murray (Absorption Systems, PA, USA), Leandro Mieravilla (Biosimilar-Biotech Global Expert, Canada) and David Goodall (Paraytec Limited, UK) who will discuss their novel research on Biosimilars & Biowaivers.

This conference is perfect for researchers and experts, as well as those who require in-depth analysis of the latest trends, technologies, and techniques.

Confirmed Speakers Including

Tentative Scientific Program18:00-19:00Registrations Sep-09-2012

Day 1


07:00-08:00 Registrations

08:00-08:30 Breakfast

Breakout 1

08:30-09:00 Opening Ceremony

Keynote Forum

09:00-09:05 Introduction

09:05-09:30 Lisa J. Murray, Absorption Systems, USA

09:30-09:55 Yet to be Confirmed

09:55-10:20 Yet to be Confirmed

10:20-10:45 Yet to be Confirmed

Coffee Break 10:45-11:00

Track 1: Biosimilars : Innovator Pharmaceutical Products

Track 2: Biosimilars: Regulatory Approach

Session Introduction


Title: The role of scientific justification in the nascent us biosimilars approval pathway

Ben Kaspar, MMS Holdings Inc., USA


Title: The what million dollar question: Patent litigation and strategy under the biologics

price Competition and Innovation act

Bryan J. Vogel, Robins, Kaplan, Miller & Ciresi L.L.P., USA


Title: The role of patents in biosimilars and biobetters

Brian Dorn, Barnes & Thornburg LLP, USA


Title: New patent reform litigation options for biosimilars

Paul A. Calvo, Sterne, Kessler, Goldstein & Fox P.L.L.C., USA

12:20-12:40 Title: Regulatory consideration of the assessment of biosimilar products

Jun Wang, Duke University School of Medicine, USA

Lunch Break 12:40-13:20


Title: What hath FDA wrought: The February 2012 guidance and their implications for

securing biosimilar approval

Michal Swit, Duane Morris LLP, USA


Title: The role of clinical trials in demonstrating similarity of biological medicinal

products in the European Union

Cecil Nick, PARAXEL Consulting, UK


Title: Biosimilars panel: Opportunities and challenges to be overcome in the near term

Jennifer Brice, Frost & Sullivan, UK


Title: Graphical representation of the assessment of inventive step for patents using the

Problem-Solution-Approach (PSA)

Joachim Stellmach, European Patent Office, Germany


Title: IP strategies for the biosimilar arena

Ulrich Storz, Michalski Huettermann Patent Attorneys, Germany


Title: Biosimilars in emerging countries: Argentina

Gustavo Helguera, University of Buenos Aires, Argentina


Title: Developing biosimilars: Considerations, opportunities and challenges

Ming Wang, Gan & Lee Pharmaceuticals, China

Panel Discussion 15:40-15:55

Coffee Break 15:55-16:10

Track 3: Skill Set for Biosimilars Development

Track 4: Clinical Studies for Biosimilars

Session Introduction


Title: Strategies for development and validation of immunogenicity assays to support

preclinical and clinical biosimilar programs

Kelly S. Colletti, Charles River Preclinical Services, USA


Title: Transgenic blood proteins: An abundant source for next generation therapies with

worldwide availability

William Velander, University of Nebraska, USA


Title: The Danish HNPCC-system – Biomedical support to individual health care in

hereditary colon cancer families

Inge Thomsen Bernstein, Hvidovre University Hospital, Denmark


Title: Use of human protein transgenic animal models for immunogenicity testing and

their value for comparative studies of biosimilars

Melody Sauerborn, TNO Triskelion BV, The Netherlands


Title: Application of nanotechnology in drug delivery

Rawia Khalil, National Research Centre, Egypt

Panel Discussion 17:50-18:05

18:05-19:05 Cocktails: Sponsored by Journal of Bioequivalence & Bioavailability

Day 2


Breakout 1

Track 5: Biosimilars Therapeutics

Track 6: Commercialization or Globalization of Biosimilars

Session Introduction


Title: Development of antibody arrays for measuring biosimilar conformational

comparability at molecular level

Xing Wang, Array Bridge Inc., USA


Title: Biosimilar market overview, present and future

Leandro Mieravilla, Biosimilar-Biotech Global Expert, Canada


Title: Modified biosimilars: Potential role in the emerging global biosimilar market

Pascal Bailon, Bailon Consultants, USA

Coffee Break 10:40-10:55


Title: The application of releasable pegylation linkers to improve the pharmaceutical

properties of biosimilars and biobetters

Hong Zhao, Enzon Pharmaceuticals, USA


Title: The clinical development of monoclonal biosimilars

Cecil Nick, PARAXEL Consulting, UK


Title: Ghrelin antagonist: Advantages and side-effects

Maria Vlasova, University of Eastern Finland, Finland


Title: Biosimilar market growth trends in emerging markets

Syamala Ariyanchira, Independent Consultant, Malaysia


Title: Developing of long acting glycoprotein hormones using gene fusion and gene

transfer: From bench to clinics

Fuad Fares, University of Haifa, Israel

Lunch Break 12:35-13:15


Title: Th1 immune response induced by Ipr1-PPE68 DNA vaccine in BALB/C mice model

Yang Chun, Chongqing Medical University, China


Title: Anticancer noscapinoids: Synthesis to nanomedicine

Ramesh Chandra, University of Delhi, India

Panel Discussion 13:55-14:10

Track 7: Plant Produ ced Biosimilar Products

Track 8: Aggregation and Immunogenicity of Biosimilars

Session Introduction


Title: Biosimilars: Lessons learned from development to commercial launch

Niranjan M. Kumar, ABS Inc. USA


Title: Plant-based production and preclinical analysis of biosimilar Trastuzumab

Michael D. McLean, PlantForm Corporation, Canada

Coffee Break 14:50-15:05


Title: Immunological aspects of formation of anti-drug antibodies against aggregated

protein drugs

Melody Sauerborn, TNO Triskelion BV, The Netherlands

15:25-15:45 Speech Opportunity Available

15:45-16:05 Speech Opportunity Available

Panel Discussion 16:05-16:20

Breakout 2


Editorial Board Meeting

Poster Presentations

Scientific Partnering

Cocktails: Sponsored by Pharmaceutica Analytica Acta

Day 3


Breakout 1

Track 9: Biowaivers

Track 10: BCS & IVIVC Based Biowaivers

Track 11: Bioequivalence Assessment

Track 12: Analytical Strategies

Session Introduction


Title: Role of process controls in mitigating the risk associated with manufacturing of


Indu S. Javeri, CuriRx Inc., USA


Title: Current analytical techniques for analysis of carbohydrate containing biosimilars

Parastoo Azadi, University of Georgia, USA


Title: Improving outcomes: A decade of industry and regulatory experience with BCS

based biowaivers

Lisa J. Murray, Absorption Systems, USA

Coffee Break 10:40-10:55


Title: Approach for development of w-3 phospholipid dietary supplement to potential lipid


Su Chen, Chainon Neurotrophin Biotechnology Inc., USA


Title: Bioanalytical challenges in development of biosimilars

Carmine Lanni, Bioanalytical Development Services, USA


Title: Some statistical issues on the evaluation of the similarity and interchangeability of


Laszlo Endrenyi, University of Toronto, Canada


Title: Rapid characterization of formulations: Protein size, aggregate levels and viscosity

David Goodall, Paraytec Limited, UK


Title: Taylor dispersion analysis, a rapid, nanolitre method to monitor protein aggregation


Wendy Louise Hulse, University of Bradford, UK

Lunch Break 12:35-13:15


Title: Effects of drying technology and polymers on integrity and biological activity of


Amal Ali Elkordy, University of Sunderland, UK


Title: A global perspective on the challenges of GLP/GCLP-bioanalysis for biosimilars

Aparna Kasinath, Clinigene International Limited, India

13:55-14:15 Speech Opportunity Available

14:15-14:35 Speech Opportunity Available

14:35-14:55 Speech Opportunity Available

14:55-15:15 Speech Opportunity Available

Panel Discussion 15:15-15:30

Editorial Board Meeting

For Biosimilars-2012 Organizing Committee 

OMICS Group Conferences
5716 Corsa Ave., Suite110
Westlake, Los Angeles
CA91362-7354, USA
Phone:+1-650-268-9744 <tel:%2B1-650-268-9744>
Fax:+1-650-618-1414 <tel:%2B1-650-618-1414>
Email: biosimilars2012@omicsgroup.com <mailto:biosimilars2012@omicsgroup.com>

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