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Pharmaceutical And Biotechnology Middle East

Presents

Comparability, Immunogenicity and Biosimilars

Devise successful analytical, clinical and regulatory strategies throughout your drug production cycle

Conference: Monday 28 - Tuesday 29 April 2008 · Exhibition: Sunday 27 - Tuesday 29 April 2008 Venue: Dubai International Exhibition Centre, UAE This conference will address the following issues:

Determining which analytical method to use and when Latest developments in predicting and reducing immunogenicity Overcoming challenges faced when demonstrating comparability of biopharmaceutical glycosylation Successfully introducing biosimilar drugs into clinical practice Examining the design, validation and interpretation of screening and confirmatory assays Assessing the impact of different formulations on the immunogenicity of biological drugs

Media Partners:

www.pabme.com/cib

Register online at the website or Tel: +44 (0) 207 017 7481, Fax: +44 (0) 207 017 7823, Email: [email protected] Please quote CQ3352

Media Partners:

Comparability, Immunog

Conference Day 1 · Monday 28 April 2008

COMPARABILITY

08:30 09:30 Registration and Morning Coffee Opening Address from the Chairman 14:00

IMMUNOGENICITY

Session 3: Design and Validation of Immunogenicity Assays

Practical application of immunogenicity screening and confirmatory assays Comparison of technologies for immunogenicity assessment of biological products, predominately by ELISA and ECL. Aspects for discussion include assay design and validation, cut-points and assignment of positive controls, assessment of sensitivity (including LOD, LOQ), specificity and drug-antibody interference. Development of assays for screening of samples (for positive response), confirmatory assessment (immunodepletion of response by drug binding) and quantitative measurement of positive antibodies in different matrix. Protocols for validation of each method and comparison of data obtained will be presented. Ian Skitt, Head of Immunoassay, Covance Laboratories, UK

Session 1: Analytical Methodologies

09:40 Application of analytical methods for a successful comparability programme Which is the most appropriate method to use and when? This presentation will examine the analytical methods available to characterise biologics and how much/little data is required in order to demonstrate comparability. Two case studies will be presented ­ one in which comparability was successfully demonstrated and the other in which demonstrating comparability was more difficult due to product improvement. Dr Chris Gee, Senior Research Scientist, Product Characterisation, MedImmune, UK Using label-free interaction analysis for comparability and immunogenicity studies Over the past several years there has been a significant increase in the use of label-free interaction analysis for characterisation of biotherapeutic products and vaccines. Implementation of information-rich characterisation methods is critcial for bio-generics and new biologics. The objective of this presentation is to give an overview of how to use of SPR biosensors to improve product characterisation, immunogenicity testing and quality control. Dr Fredrik Sundberg, Strategic Market Development Director, GE Healthcare, Sweden Refreshment Break and Networking

10:20

Session 4: Pre-Clinical Studies, Predicting and Reducing Immunogenicity

14:40 Early prediction and evaluation of T cell immunogenicity Anti-drug antibodies (ADA) may cause infusion reactions or loss of efficacy in clinical testing of biotherapeutics. This presentation will give an overview on a new generation of human cell-based ex vivo and in silico approaches for pre-clinical risk minimisation. Tests utilising primary human CD4+ T cells have been qualified to identify T cell epitopes, deimmunize them and rank the response of naïve versus exposed individuals against a selection of lead candidates. First clinical evidence is now available that links the presence of predictable T cell epitopes to the occurrence of ADA in vivo underscoring the validity of the concept. Dr Harald Kropshofer, Global Coordinator Immunosafety, F. Hoffmann La Roche, Switzerland Panel discussion This is your opportunity to discuss all your pressing concerns with our international panel of experts. To make the most of this session please email any questions to the conference producer, [email protected] Close

11:00

Session 2: Glycosylation

11:50 Key issues in demonstrating comparability of biopharmaceutical glycosylation This talk gives an overview of the key issues in demonstrating comparability of biopharmaceutical glycosylation throughout the drug development cycle. Topics covered include: Current and emerging regulatory guidelines for characterisation of biopharmaceutical glycosylation; Alterations in glycosylation during process scale up and as a result of process change; Choosing appropriate glycosylation parameters to measure; Glycoprofiling using orthogonal analyses based on HPLC, CE and mass spectrometry; In-process measurement and control of glycosylation; Glycosylation comparability metrics; Ensuring comparability of glycoprofiling data for different labs; and how different glycosylation patterns are interpreted for comparability. The emphasis will be on practical issues relevant to regulatory submissions and biologics production. Dr Daryl Fernandes, Founder and CEO, Ludger Ltd, UK Spotlight Session Theses sessions are hosted by leading companies who operate in this field. They offer an opportunity to learn about the latest developments in the industry. For more information hosting theses sessions, please contact [email protected] Tel: +44 (0) 207 017 5011 Lunch and Networking

15:20

16:00

12:30

13:00

Join us at Antibody Production ­ Upstream and Downstream Processing and be part of PABME The Pharmaceutical and Biotechnology Middle-East (PABME) Exhibition. Designed to be an international destination where business cultures and ideas can meet, PABME is the region's only major exhibition with a multi-disciplinary conference running alongside to cater for global markets. The entire show will attract at least 1600 participants from all parts of the world including Europe, South Asia, Americas and the Middle East A Premier Networking Platform PABME offers an unprecedented opportunity to meet with the top decision-makers, market leaders and new investors from across the globe as well as the Middle East region. Ideal Blend of the Pharma & Biotech Industries Network with similar organisations in the industry and discover newer ways of developing more cost-effective and efficient methods & procedures. A Unique International Showcase PABME will showcase a wide spectrum of products and services to cater to all businesses associated with the pharmaceutical and biotechnology industries and offer them an opportunity to find new business contacts and gain further recognition worldwide. In addition to stand space, there are other ways to increase your awareness and raise your profile at PABME by exhibition and conference sponsorship. Visit www.pabme.com for more information

www.pabme.com/cib

Register online at the website or Tel: +44 (0) 207 017 7481, Fax: +44 (0) 207 017 7823, Email: [email protected] Please quote CQ3352

genicity and Biosimilars

Conference Day 2 · Tuesday 29 April 2008

IMMUNOGENICITY

09:30 Opening Address from the Chairman

Session 7: Regulatory and Scientific

14:00 Comparison of attempted copies from Asia and Latin America r-HuEPO with innovator product Epoetin alfa (Epogenâ) We compared the biochemical properties of attempted copies of rHuEPO manufactured from Asia and Latin America with the innovator product Epoetin alfa (Epogen®). We analysed glycoforms, conformational similarity, bioactivity, covalent aggregates and cleavage products using established methods. All rHuEPO products were different from Epoetin alfa (Epogen®). Concentrations varied and did not always match the information provided on the product's label. Dr SungAe Park, Senior Scientist, Amgen, USA

Session 5: Formulation

09:40 Impact of formulation and drug product features on immunogenicity of proteins This presentation will review the various reasons why a protein-based DP can induce immunogenicity. Excipient-induced and aggregate-induced immunogenicity will be reviewed and the main features of aggregates associated with immunogenicity will be discussed, based on the concepts of "aggregation-competent" species and "provocative" aggregates. The influence of formulation parameters on aggregate-induced immunogenicity will be presented, as well as the most efficient methods to detect and quantify aggregation in a protein formulation. The case of immunogenicity induced by impurities appearing in the DP during processing and storage will also be addressed. It is usually related to interactions with the fill-and-finish equipments (e..g. pumps and feed lines) interactions with containers and closures (leachables and extractables), as well as the influence of storage conditions, such as light or heat exposure. The influence of the route and frequency of administration, dosage and drug exposure will be discussed, showing that these are also key parameters to be taken into account in the early target product profile of the DP. As a conclusion, recommendations on how to face immunogenicity issues appearing for a protein DP will be given and related manufacturing challenges outlined. Dr Joel Richard, Director, Head of Pharmaceutical Development, Merck Serono, Italy Title and abstract to come. Dr Lincoln Tsang, Partner, Arnold & Porter, UK Refreshment Break and Networking

Session 8: Glycosylation

14:40 Strategies for dealing with the glycosylation of biosimilars This talk concerns strategies for dealing with the glycosylation of biosimilar therapeutics. The emphasis will be on issues related to the comparability of original and biosimilar drugs. Topics covered include: The technical challenges faced when comparing the glycosylation of an original drug and a biosimilar; Introduction to the FMM (FunctionMolecules-Measurements) model for specifying biopharmaceutical glycosylation and how it can be used in the demonstration of glycosylation comparability for biosimilars; Characterising glycosylation for regulatory applications and patents; Dealing with differences in glycosylation that could result in changes (including improvements) to the drug safety and efficacy profile. These topics will be viewed from the perspectives of both orginators and generics companies. Dr Daryl Fernandes, Founder and CEO, Ludger Ltd, UK Panel discussion: Business strategies for biosimilar drugs · Demonstrating structural comparability · Demonstrating functional comparability This is your opportunity to discuss all your pressing concerns with our international panel of experts. To make the most of this session please email any questions to the conference producer, [email protected] Close

10:20 11:00

15:20

BIOSIMILARS

16:00

Session 6: Clinical Considerations

11:50 Considerations for a safe and proper introduction into clinical practice Europe has developed an approval system for biosimilars. Other countries are following suit. However a number of issues still need to be clarified and borne in mind when considering introducing biosimilars into clinical practice due to specific nature of biotech medicines and the fact that biosimilars are not generics. This session will review these issues. Thomas Bols, Director Government Affairs, Europe, Amgen, Belguim Spotlight Session These sessions are hosted by leading companies who operate in this field. They offer an opportunity to learn about the latest developments in the industry. For more information hosting these sessions, please contact [email protected] Tel: +44 (0) 207 017 5011 Lunch and Networking

Conference Sponsorship Opportunities

Comparability, Immunogenicity and Biosimilars will be an ideal meeting platform for your company to demonstrate its products and services to a targeted audience and extend your marketing reach within the bioprocess industry. Apart from the exposure gained during the conference, you will have access to the PABME's Exhibition. To find out how you can increase your corporate identity, build brand awareness and showcase your leadership profile at this meeting please contact Lily Chong for a tailored sponsorship package. Tel: +44 (0) 207 017 5011 or email [email protected]

12:30

Present a Poster at the Conference

Posters must relate to the conference theme and should illustrate novel science, technologies and supporting data. How to submit your application: You must be booked on as a delegate to be able to present a poster. To apply please send your abstract of 200 words or less, written in English, listing the principle author and all contact details to [email protected] Last date for submission is 24th March 2008. · Posters submitted by Academic Institutions will not be charged a fee · Posters submitted by Biotech and Pharmaceutical organisations will be charged a fee of £198 (£99 per day) · Posters submitted by service providers / vendors are welcome and will be subject to evaluation by the scientific advisory board. Upon approval a fee of £399 will apply.

13:00

www.pabme.com/cib

Register online at the website or Tel: +44 (0) 207 017 7481, Fax: +44 (0) 207 017 7823, Email: [email protected] Please quote CQ3352

Comparability, Biosimilars and Immunogenicity

28 - 29 April 2008 · Dubai International Exhibition Centre, UAE

Conference Code: CQ3352

www.pabme.com/cib

GB/NG/LC/SF/TR

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