Dear Madam, Dear Sir,

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, pharma market forecasts predict that 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 a great range of business opportunities, biosimilar manufacturers face high economic risk and need to come up with an innovative business models. In addition, it is crucial for them to ensure 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 convincing physicians and handling pricing as well as reimbursement issues effectively with regulatory authorities.

The 1st annual Biosimilars conference provided insights on :

- Biosimilar market (rhu-GH, rhu-EPO, GCSF, Insuline et analogues, HBPM)
- The successfull strategy for the different actors through Epoetin alfa’s
biosimilar experience
- The EMEA guidelines and the French national scientific society position

The aims Biosimilars 2010 are to :

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

A series of interactive roundtable discussions will follow each lecture.

Please find hereafter the preliminary program.

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

Dr Marvin Edeas

Scientific Comittee of Takayama
www.takayama-conferences.com

SCIENTIFIC PROGRAM

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

9H45 – 11H40 Session : Exploring R&D challenges

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
M. 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
Mme E. Berthet, Cabinet Armengaud Guerlain, Paris, France

14H3O 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, Hôpital 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, 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. 01 55 04 77 55 - Fax : 01 55 04 77 57