Congrès-Exposition International sur les Sols, les Sédiments et l'Eau Droits et Gestion

UDIAS, l’association professionnelle des distributeurs et constructeurs d’équipement et de produits pour le laboratoire, organise le salon professionnel du laboratoire Laborama au printemps 2010. La onzième édition de ce salon se tiendra à nouveau au Brussels Kart Expo de Grand-Bigard.

Le sol est-il un déchet ? De l'industrie du XIXème siècle à l'urbanisme du XXIème : Partage et transfert des responsabilités

Recent Advances in Anemia, Oncology, Thrombosis, Neurology and Virology

A Slow Rising Wave or a Storm?


Establish Solutions to Developmental and Strategic Issues for Pharma Biotech Manufacturers

Provide the Pharmacologic and Medical Knowledge to Physicians becoming fully aware about Mains Challenge and Outcomes for their daily activity

On behalf of the Scientific Committee, we are pleased to announce the organization of the 2nd Biosimilars Conference which will be held the 18th March 2010 in Paris.

Within the next two years, biopharmaceuticals will amount to more than 50% of newly approved medicines. In addition to a growing market share, a substantial number of major biotechnology based drugs (rhu-EPO, Darbepoetin alfa, monoclonal antibodies….) will come off patent and enable the development of new biosimilar products. US’governance aims to set up specific guidelines for Biosimilars (F.O.B : Follow On Biologic) :  this  new scenario provides opportunities for companies considering biosimilar as a priority for growing in pharmaceutical market. 


While this facilitates opportunities, biosimilar manufacturers face high economic risk and need to come up with an innovative business models. It is crucial that their R&D and production processes guarantee safety and efficacy of their products. As some regulatory issues like interchangeability have not been resolved, manufacturers are particularly forced to come up with a strong and innovative marketing strategy (pricing, reimbursement...). 


The 1st annual Biosimilars conference provided insights on :

 
-         Biosimilar market (r-GH, rhu-EPO, GCSF, Insuline et analogues, HBPM)

-         Successfull strategies of actors through Epoetin alfa’s and r-GH's biosimilar experience

-         EMEA guidelines and the French national scientific society position

The aims of Biosimilars 2010 are to :
 

-        Establish solutions to both developmental and strategic issues for pharma biotech manufacturers

_       Provide pharmacologic and medical knowledge to physicians becoming fully aware about mains challenges and outcomes for their daily activity through lecture and case study driven presentations from leading pharma biotech manufacturers and relevant point of view from expert in their area.

This event will provide best practice solutions to help the main actors to resolve their existing and upcoming challenges in this market.

We look forward to welcoming you in Paris for this particular event.
 

Dr Marvin Edeas

 

Scientific Comittee of Takayama

At your Diary :

CME-ERA-EDTA Course: Long-Term Post Transplantation Care:

What the Non Transplant-Nephrologists Should Know ?

April 1st 2010, Bordeaux-France
--------------------------------------------------------------------------------

PROGRAM :

2nd World Congress on BIOSIMILARS

Speakers :

Dr A. D’Andon, Chef du Service Evaluation des Médicaments, Haute Autorité de Santé, Paris, France

Dr I. Mac Dougall, Consultant Nephrologist, Department of Renal Medicine, King’s College Hospital, London, UK

Dr M. Froissart, Néphrologue, Hôpital Georges Pompidou, Paris, France (TBC)

Pr B. Polack, CHU de Grenoble, Grenoble, France

Dr M. Pavlovic , Responsable des avis scientifiques, DEMEB-AFSSAPS, Paris, France

Dr J-Y. Lecotonnec, Ceo, Triskel, Geneva, Switzerland

Mr J-N. Treilles, Ceo BioPartners GmbH, Baar, Switzerland (TBC)

Mr P-E Gérard, Principal, Management Consulting, IMS Health, Paris, France

Mr K. Powel, CEO POLYTHERICS, UK

Dr F. Lawny, Vice President Biotechnology, Triskel Integrated Services, Geneva, Switzerland

Mrs E. Berthet, Cabinet Armengaud Guerlain, Paris, France

8H30 : Registration

9H00    Opening remarks from the Chair
 

Dr D’Andon, Chef du Service Evaluation des Médicaments, Haute Autorité de Santé, Paris, France

9H15    Evaluating the Biosimilars Market/Developing a biosimilar product in a regulated market

Key-note session: 

Reason of generic companies (TEVA, Ratiopharm, Sandoz….) and new players (Novartis, GSK, Sanofi synthelabo, MSD….)

Pursuit of biosimilar market?

What are the key factors of success?

Who are the potential players?

Why physician are reluctant to adopt this new class of biotech?

Main challenges to face for the actors?

How do regulations impact portfolio development and market approval ?

Factors driving the biosimilars market?

Establishing product development strategies ?

Implementing successful business models for follow-on biological medicines ?

Highly innovative marketing strategies and implementation approaches?

Considering quality and cost when developing biosimilars.

Mr P-E Gérard, Principal, Management Consulting, IMS Health, Paris, France


Session : Exploring R&D challenges

9H45 – 11H40


9H50    Post translational modifications (PTMs)

            Importance in the context of therapeutic proteins, range of PTMs, their structure, function and

importance in the context of therapeutic proteins? potential of PTMs to affect product

functional equivalence and immunogénicity? Reviews of PTMs associated with actual/likely

biosimilar products? Demonstrating comparability and managing subtle differences?

Dr J-Y. Lecotonnec, Ceo, Triskel, Geneva, Switzerland

10H20 : COFFE BREAK

10H50   Strategies for immunogenicity assessment, An update on regulatory guidance

Identifying testing procedures to evaluate a potential immunogenetic response? Update on regulatory guidance? Preclinical and clinical strategies for immunogenicity risk assessment? overview of selected case-studies? 


11H30   Half-life modification and superior biosimilars

- Unmodified biosimilars and how the market moved on: e.g. Interferon alpha vs. PEGylated molecules

- Outlining the need for site-specific modification of the protein

- Assessing the potential for an improved molecule with improved properties

- Examples of generic proteins with half-life modification

Mr K. Powel, CEO POLYTHERICS, UK

 
12H00   Exploring the 2nd generation of biosimilars : mythe or reality?

- Assessing biosimilar antibodies as the 2nd generation of follow-on protein products : new opportunities as therapeutic antibodies come off patents ? Outlining the process of developing antibody biosimilars? Specific technical issues concerning monoclonal antibodies? Clarifying issues with clinical proof of similarity ? Discussing strategic issues and understanding feasibility? 

- Is the framework for biosimilars in Europe applicable to monoclonal antibodies? Current experience with biosimilars ? Challenges for biosimilar antibodies ? Future perspectives in the EU ?


Dr F. Lawny, Vice President Biotechnology, Triskel Integrated Services, Geneva, Switzerland

           
12h30 : LUNCH

14H00   Overcoming regulatory and Intellectual Proprieties hurdles. Patents, patent term

extensions and data exclusivity: opportunities for biosimilars?

- How to make optimal use of “composition of matter” patents and “life cycle” patents

- Clarifying the IP implications of launching a biosimilar

- Data exclusivity, patent term extensions and new EU legislation on biosimilars

- Impact of the stringent regulatory regime involved in bringing biosimilars to market on your patent strategy

Mrs E. Berthet, Cabinet Armengaud Guerlain, Paris, France


14H30   Regulatory requirements for monoclonal antibody biosimilars 


15H00   Roundtable session

Delegates will be able to attend three one-hour roundtable discussion groups from a selection of key topics.

Each session will be chaired by an industry expert who will facilitate an exchange of opinions, essential experiences and learning related to a current aspect of biosimilars.

Implementing successful business models for follow-on biological medicines of epoetin
 

30’ NEPHROLOGY

30’ CANCEROLOGY

 

Dr I. Mac Dougall, Consultant Nephrologist, Department of Renal Medicine, King’s College Hospital, London, UK

Dr M. Froissart, Néphrologue, Hôspital Georges Pompidou, Paris, France (TBC

15h30 : COFFE BREAK
           

16H00   G-CSF and epoetin alfa in oncology: experience from the recent launch


Pr B. Polack, CHU de Grenoble, A. Michalon Pôle Biologie BP 217, Grenoble, France

 
16H30   Heparine guidelines : from guideline to clinical practice

Dr M. Pavlovic , Responsable des avis scientifiques, DEMEB-AFSSAPS, Paris, France

17H30   Closing remarks from the Chair and close of day

Scientific Secretary

Agence TAKAYAMA

15 Rue de La Paix - 75002 Paris

Tél. +33 1 55 04 77 55

Fax : +33 1 55 04 77 57

takayama-conferences@orange.fr
2nd World Congress on BIOSIMILARS 




A Slow Rising Wave or a Storm?

 

 18 March 2010 - Paris, France

 

 Establish Solutions to Developmental and Strategic Issues for

Pharma Biotech Manufacturers


Provide the Pharmacologic and Medical Knowledge to Physicians becoming

fully aware about Mains Challenge and Outcomes for their daily activity





On behalf of the Scientific Committee, we are pleased to announce the organization of the 2nd Biosimilars Conference which will be held the 18th March 2010 in Paris.

Within the next two years, biopharmaceuticals will amount to more than 50% of newly approved medicines. In addition to a growing market share, a substantial number of major biotechnology based drugs (rhu-EPO, Darbepoetin alfa, monoclonal antibodies….) will come off patent and enable the development of new biosimilar products. US’governance aims to set up specific guidelines for Biosimilars (F.O.B : Follow On Biologic) :  this  new scenario provides opportunities for companies considering biosimilar as a priority for growing in pharmaceutical market. 


While this facilitates opportunities, biosimilar manufacturers face high economic risk and need to come up with an innovative business models. It is crucial that their R&D and production processes guarantee safety and efficacy of their products. As some regulatory issues like interchangeability have not been resolved, manufacturers are particularly forced to come up with a strong and innovative marketing strategy (pricing, reimbursement...). 

 

The 1st annual Biosimilars conference provided insights on :

 

-         Biosimilar market (r-GH, rhu-EPO, GCSF, Insuline et analogues, HBPM)

-         Successfull strategies of actors through Epoetin alfa’s and r-GH's biosimilar experience

-         EMEA guidelines and the French national scientific society position

 

The aims of Biosimilars 2010 are to :

 

-        Establish solutions to both developmental and strategic issues for pharma biotech manufacturers

_       Provide pharmacologic and medical knowledge to physicians becoming fully aware about mains challenges and outcomes for their daily activity through lecture and case study driven presentations from leading pharma biotech manufacturers and relevant point of view from expert in their area.

 

This event will provide best practice solutions to help the main actors to resolve their existing and upcoming challenges in this market.

 

We look forward to welcoming you in Paris for this particular event.

 

Dr Marvin Edeas

 

Scientific Comittee of Takayama

 

 

At your Diary :

 

CME-ERA-EDTA Course: Long-Term Post Transplantation Care:

What the Non Transplant-Nephrologists Should Know ?

April 1st 2010, Bordeaux-France

 



--------------------------------------------------------------------------------

PROGRAM

 

2nd World Congress on BIOSIMILARS

 

Recent Advances in Anemia, Oncology, Thrombosis,

Neurology and Virology

 

A Slow Rising Wave or a Storm?

 

18 March 2010 - Paris, France

 


Speakers :

Dr A. D’Andon, Chef du Service Evaluation des Médicaments, Haute Autorité de Santé, Paris, France

Dr I. Mac Dougall, Consultant Nephrologist, Department of Renal Medicine, King’s College Hospital, London, UK

Dr M. Froissart, Néphrologue, Hôpital Georges Pompidou, Paris, France (TBC)

Pr B. Polack, CHU de Grenoble, Grenoble, France

Dr M. Pavlovic , Responsable des avis scientifiques, DEMEB-AFSSAPS, Paris, France

Dr J-Y. Lecotonnec, Ceo, Triskel, Geneva, Switzerland

Mr J-N. Treilles, Ceo BioPartners GmbH, Baar, Switzerland (TBC)

Mr P-E Gérard, Principal, Management Consulting, IMS Health, Paris, France

Mr K. Powel, CEO POLYTHERICS, UK

Dr F. Lawny, Vice President Biotechnology, Triskel Integrated Services, Geneva, Switzerland

Mrs E. Berthet, Cabinet Armengaud Guerlain, Paris, France

 

 

8H30 : Registration

 

9H00    Opening remarks from the Chair

 

            Dr D’Andon, Chef du Service Evaluation des Médicaments, Haute Autorité de Santé, Paris,

France

 

9H15    Evaluating the Biosimilars Market/Developing a biosimilar product in a regulated

market

Key-note session: 

Reason of generic companies (TEVA, Ratiopharm, Sandoz….) and new players (Novartis, GSK, Sanofi synthelabo, MSD….)

Pursuit of biosimilar market?

What are the key factors of success?

Who are the potential players?

Why physician are reluctant to adopt this new class of biotech?

Main challenges to face for the actors?

How do regulations impact portfolio development and market approval ?

Factors driving the biosimilars market?

Establishing product development strategies ?

Implementing successful business models for follow-on biological medicines ?

Highly innovative marketing strategies and implementation approaches?

Considering quality and cost when developing biosimilars.

            Mr P-E Gérard, Principal, Management Consulting, IMS Health, Paris, France

 

Session : Exploring R&D challenges

9H45 – 11H40

 

9H50    Post translational modifications (PTMs)

            Importance in the context of therapeutic proteins, range of PTMs, their structure, function and

importance in the context of therapeutic proteins? potential of PTMs to affect product

functional equivalence and immunogénicity? Reviews of PTMs associated with actual/likely

biosimilar products? Demonstrating comparability and managing subtle differences?

 

            Dr J-Y. Lecotonnec, Ceo, Triskel, Geneva, Switzerland

 

10H20 : COFFE BREAK

 

10H50   Strategies for immunogenicity assessment, An update on regulatory guidance

Identifying testing procedures to evaluate a potential immunogenetic response? Update on regulatory guidance? Preclinical and clinical strategies for immunogenicity risk assessment? overview of selected case-studies? 

 

11H30   Half-life modification and superior biosimilars

- Unmodified biosimilars and how the market moved on: e.g. Interferon alpha vs. PEGylated molecules

- Outlining the need for site-specific modification of the protein

- Assessing the potential for an improved molecule with improved properties

- Examples of generic proteins with half-life modification

 

Mr K. Powel, CEO POLYTHERICS, UK

 

12H00   Exploring the 2nd generation of biosimilars : mythe or reality?

- Assessing biosimilar antibodies as the 2nd generation of follow-on protein products : new opportunities as therapeutic antibodies come off patents ? Outlining the process of developing antibody biosimilars? Specific technical issues concerning monoclonal antibodies? Clarifying issues with clinical proof of similarity ? Discussing strategic issues and understanding feasibility? 

- Is the framework for biosimilars in Europe applicable to monoclonal antibodies? Current experience with biosimilars ? Challenges for biosimilar antibodies ? Future perspectives in the EU ?

 

Dr F. Lawny, Vice President Biotechnology, Triskel Integrated Services, Geneva, Switzerland

           

12h30 : LUNCH

 

14H00   Overcoming regulatory and Intellectual Proprieties hurdles. Patents, patent term

extensions and data exclusivity: opportunities for biosimilars?

- How to make optimal use of “composition of matter” patents and “life cycle” patents

- Clarifying the IP implications of launching a biosimilar

- Data exclusivity, patent term extensions and new EU legislation on biosimilars

- Impact of the stringent regulatory regime involved in bringing biosimilars to market on your patent strategy

 

Mrs E. Berthet, Cabinet Armengaud Guerlain, Paris, France

 

14H30   Regulatory requirements for monoclonal antibody biosimilars 

 

15H00   Roundtable session

 

Delegates will be able to attend three one-hour roundtable discussion groups from a selection of key topics.

Each session will be chaired by an industry expert who will facilitate an exchange of opinions, essential experiences and learning related to a current aspect of biosimilars.

Implementing successful business models for follow-on biological medicines of epoetin.

 

30’ NEPHROLOGY

30’ CANCEROLOGY

 

Dr I. Mac Dougall, Consultant Nephrologist, Department of Renal Medicine, King’s College Hospital, London, UK

Dr M. Froissart, Néphrologue, Hôspital Georges Pompidou, Paris, France (TBC)

   

 

15h30 : COFFE BREAK

           

16H00   G-CSF and epoetin alfa in oncology: experience from the recent launch


Pr B. Polack, CHU de Grenoble, A. Michalon Pôle Biologie BP 217, Grenoble, France

 

16H30   Heparine guidelines : from guideline to clinical practice

Dr M. Pavlovic , Responsable des avis scientifiques, DEMEB-AFSSAPS, Paris, France

 

17H30   Closing remarks from the Chair and close of day

 

Scientific Secretary

 

Agence TAKAYAMA

15 Rue de La Paix - 75002 Paris

Tél. +33 1 55 04 77 55

Fax : +33 1 55 04 77 57

takayama-conferences@orange.fr