Leaders in Pharmaceutical Business Intelligence (LPBI) Group

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 

 http://sm1.mailserv.in/omicsonlinebiz/lt.php?id=eR4DBVEEUA9UUksGBlMKAU4=UQMNDAgNSllRVQgECyUNWAodUg5C

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.

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

Day 1

Sep-10-2012

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

11:00-11:20

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

Ben Kaspar, MMS Holdings Inc., USA

11:20-11:40

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

11:40-12:00

Title: The role of patents in biosimilars and biobetters

Brian Dorn, Barnes & Thornburg LLP, USA

12:00-12:20

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

13:20-13:40

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

securing biosimilar approval

Michal Swit, Duane Morris LLP, USA

13:40-14:00

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

products in the European Union

Cecil Nick, PARAXEL Consulting, UK

14:00-14:20

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

Jennifer Brice, Frost & Sullivan, UK

14:20-14:40

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

Problem-Solution-Approach (PSA)

Joachim Stellmach, European Patent Office, Germany

14:40-15:00

Title: IP strategies for the biosimilar arena

Ulrich Storz, Michalski Huettermann Patent Attorneys, Germany

15:00-15:20

Title: Biosimilars in emerging countries: Argentina

Gustavo Helguera, University of Buenos Aires, Argentina

15:20-15:40

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

16:10-16:30

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

preclinical and clinical biosimilar programs

Kelly S. Colletti, Charles River Preclinical Services, USA

16:30-16:50

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

worldwide availability

William Velander, University of Nebraska, USA

16:50-17:10

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

hereditary colon cancer families

Inge Thomsen Bernstein, Hvidovre University Hospital, Denmark

17:10-17:30

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

17:30-17:50

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

Sep-11-2012

Breakout 1

Track 5: Biosimilars Therapeutics

Track 6: Commercialization or Globalization of Biosimilars

Session Introduction

09:30-09:50

Title: Development of antibody arrays for measuring biosimilar conformational

comparability at molecular level

Xing Wang, Array Bridge Inc., USA

09:50-10:20

Title: Biosimilar market overview, present and future

Leandro Mieravilla, Biosimilar-Biotech Global Expert, Canada

10:20-10:40

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

Pascal Bailon, Bailon Consultants, USA

Coffee Break 10:40-10:55

10:55-11:15

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

properties of biosimilars and biobetters

Hong Zhao, Enzon Pharmaceuticals, USA

11:15-11:35

Title: The clinical development of monoclonal biosimilars

Cecil Nick, PARAXEL Consulting, UK

11:35-11:55

Title: Ghrelin antagonist: Advantages and side-effects

Maria Vlasova, University of Eastern Finland, Finland

11:55-12:15

Title: Biosimilar market growth trends in emerging markets

Syamala Ariyanchira, Independent Consultant, Malaysia

12:15-12:35

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

13:15-13:35

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

Yang Chun, Chongqing Medical University, China

13:35-13:55

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

14:10-14:30

Title: Biosimilars: Lessons learned from development to commercial launch

Niranjan M. Kumar, ABS Inc. USA

14:30-14:50

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

Michael D. McLean, PlantForm Corporation, Canada

Coffee Break 14:50-15:05

15:05-15:25

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

16:20-19:20

Editorial Board Meeting

Poster Presentations

Scientific Partnering

Cocktails: Sponsored by Pharmaceutica Analytica Acta

Day 3

Sep-12-2012

Breakout 1

Track 9: Biowaivers

Track 10: BCS & IVIVC Based Biowaivers

Track 11: Bioequivalence Assessment

Track 12: Analytical Strategies

Session Introduction

09:30-09:50

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

biosimilars

Indu S. Javeri, CuriRx Inc., USA

09:50-10:20

Title: Current analytical techniques for analysis of carbohydrate containing biosimilars

Parastoo Azadi, University of Georgia, USA

10:20-10:40

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

10:55-11:15

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

drug

Su Chen, Chainon Neurotrophin Biotechnology Inc., USA

11:15-11:35

Title: Bioanalytical challenges in development of biosimilars

Carmine Lanni, Bioanalytical Development Services, USA

11:35-11:55

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

biologics

Laszlo Endrenyi, University of Toronto, Canada

11:55-12:15

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

David Goodall, Paraytec Limited, UK

12:15-12:35

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

behavior

Wendy Louise Hulse, University of Bradford, UK

Lunch Break 12:35-13:15

13:15-13:35

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

proteins

Amal Ali Elkordy, University of Sunderland, UK

13:35-13:55

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 

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Email: biosimilars2012@omicsgroup.com <mailto:biosimilars2012@omicsgroup.com>