행사/교육
Biosimilar Drug Development World Europe
- 등록일2013-02-18
- 조회수37051
- 구분 국외
- 행사교육분류 행사
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주관기관
Health Network Communications Ltd
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행사장소
Jumeirah Carlton Tower Hotel - London
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행사기간
2015-04-23 ~ 2013-03-01
- 원문링크
- 첨부파일
brochure.pdf
Biosimilar Drug Development World Europe
conference programme
Pre-Conference Workshop - Tuesday 26 February 2013
08.30 Registration
Biosimilars and Biobetters are considered as a future growth engine of the pharmaceutical industry. The current global market for biologics is more than $ 130 billion. By 2020, more than $ 55 Billion sales of biologics will lose patent protection. The forecast of the global Biosimilars market for 2015 is $ 3.5 - 4.8 billion.
Starting in 2006, Europe has approved biosimilar somatropin, epoetin and filgrastim. Biosimilar versions of three more product classes are currently under review in the EU (MoAb infliximab, FSH and insulin). Based on the experience gained with the first Biosimilars in Europe, the US and the EU are working on both sides on the future scientific and regulatory standards for Biosimilars. FDA has recently laid down the scientific principles and issued its long awaited three draft Biosimilar guidelines. The EU is revising most of its Biosimilar guidelines, has issued the final biosimilar monoclonal antibody guideline, and has currently announced that it intends to accept batches of reference medicines sourced from outside the EU in the future.
This workshop will help to develop an expert understanding of the latest regulatory requirements and technical aspects for successful development of Global Quality Biosimilars including CMC, comparability studies, QbD, accelerating development, cell line technologies and manufacturing.
› Prof Carsten Brockmeyer, Founder and MD, Brockmeyer Biopharma GmbH
Registration
09.00 Welcome remarks from workshop leader
•Welcome remarks of the workshop leader and introduction•Update on biosimilars regulations in Europe, United States and emerging markets (EM)•Existing and upcoming revised versions of biosimilarguidelines in the EU / US / EM•Understand the EU guideline for biosimilar monoclonalantibodies
Welcome remarks from workshop leader
10.30 Morning Refreshments
11.00 Successful development plans and regulatory strategies
Development challenges, technical hurdles, and regulatory expectations associated with Quality by Design and CMC characterization /comparability studies
Quality Target Product profile and Critical Quality Attributes
Successful development plans and regulatory strategies
12.30 Lunch
13.30 How to accelerate development without compromising on quality
Innovative cell line technologies and manufacturing strategies
How to accelerate development without compromising on quality
14.30 Afternoon Refreshments
15.00 Accelerate clinical development and regulatory filing
Case studies of biosimilar products incl. biosimilar monoclonal antibodies
Accelerate clinical development and regulatory filing
16.00 Close of workshop
Day One - Wednesday 27th February 2013
08.00 Registration
08.50 Opening remarks from the chair
› Prof Carsten Brockmeyer, Founder and MD, Brockmeyer Biopharma GmbH Opening remarks from the chair BIOSIMILAR MARKET HEALTHCHECK
09.00 Harmonising global biosimilar development
•Review of the unique regulatory approaches in the highly regulated markets•Describe approaches to choosing which reference product is used (European vs US)•The focus for biosimilar development remains matching the product attributes and biological function of the reference product•Discussing the sometimes unrealistic expectations for biosimilar clinical trials•Reviewing Immunogenicity assessment of biosimilars › Mark McCamish, Head Global Biopharmaceutical Development, Sandoz International GmbH Harmonising global biosimilar development
09.30 Biosimilars are not generics: addressing the unique challenges facing biosimilar developers
Small differences in manufacturing may result in different products Concerns focus on biosimilar quality, efficacy and safety The most important safety issue is immunogenicity Clinical trial and pharmacovigilance data are essential to monitor potential immunogenicity Production and therapeutic use of insulin and insulin analogue biosimilars pose specific challenges not faced by other biologics All potential biosimilars should be required to provide relevant preclinical and clinical data for marketing authorization Regulatory authorities recognize the potential risks of biosimilars and are open to external input › Prof Heinz Haenel, Diabetes Division R&D Projects, Sanofi Aventis Biosimilars are not generics: addressing the unique challenges facing biosimilar developers
10.00 Opportunities for partnering in biosimilar development
A quick recap on the importance of biosimilars, in both RM and EMMy view of why partnerships are key for biosimilars (access specific capabilities and stay agile and flexible)A brief overview of the DRL-Merck Serono partnership and some of the lessons learned to make partnerships work › Raymond De Vre, Vice President Commercial Biologics, Dr. Reddy's Laboratories Opportunities for partnering in biosimilar development 10.30 Speed networking & refreshments PRODUCT & PROCESS DEVELOPMENT
11.30 CMC requirements for biosimilars
CMC considerations based on the ICH common Technical Document with additional reference product comparabilityUse of CMC in defining overall development programmeQuality and comparability considerations – structure, activity, purity, stabilityReference product selection and cell line developmentComparative structural analysis for demonstrating similarity between biosimilar and reference productProtein characterisation to define the quality Target Product Profile (Blueprint for the Biosimilar)Stress studies to evaluate the instability profileComparability to proof the similarityStability study strategies › Robert Zoubek, Director Scientific Affairs and Customer Relationship, Formycon GmbH CMC requirements for biosimilars
12.00 Process optimisation for biosimilar development
•Reverse engineering, upstream cell culture and downstream purification•Fermentation & Reproducibility•Scale up challenges when taking a biosimilar from cell bank to full capacity manufacture•GMP, manufacture process, production and purification•Quality control › Brian Hosung Min, Vice President, Samsung Process optimisation for biosimilar development
12.30 Product development consideration for monoclonal antibody biosimilars › Fei Jiang, Head R & D, 3SBio Inc Product development consideration for monoclonal antibody biosimilars
13.00 Lunch
USA BIOSIMILAR REGULATORY ENVIRONMENT
14.00 Congressional update and Q&A session on generic and biosimilar legislation
› The Honorable Henry Waxman, Member of Congress, United State of America Congressional update and Q&A session on generic and biosimilar legislation 14.30 Industry perspective on the USA current and future regulatory setting for biosimilarsFDA guidance for biosimilars What US regulations actually say – current status What clinical requirements are needed to meet the regulations? Opportunity to use comparability data from non-U.S.-licensed reference product Industry perspective on the USA current and future regulatory setting for biosimilars BIOSIMILAR PRE CLINICAL DEVELOPMENT
15.00 Bioanalytical and Early Stage Clinical Strategies for Biosimilars
Bioanalytical and early stage clinical strategies to support the registration of biosimilarsThorough and thoughtful understanding of non-clinical and clinical studies used to support the innovator productAvailability of reagents (antibodies and/or target) used for the bioanalytical and immunological testing of both the innovator product and the biosimilar productDue to variability in the manufacturing lots of both the innovator and the biosimilar product, bioanalytical variability needs to be minimizedAvailability of reagents and cell lines for developing cell based assays to test for functionality and to determine if the immunological response is neutralizingPresence of a sound immunological testing programComparability of clinical PD markers is more important than PK comparability › Raymond H. Farmen, PhD, Vice President, Global Bioanalytical Services, Celerion Bioanalytical and Early Stage Clinical Strategies for Biosimilars
15.30 Non clinical study design for biosimilars
What non clinical data is requiredConsiderations including dose response, immunogenicity and toxicitySelection of animal modelConsiderations for what in-vivo testing is neededWhat are the non clinical considerations including quality and clinicalNon clinical assessment of immunogenicity and its consequencesStatistical considerations for the pre clinical stage › Praveen Kumar Reddy, Associate Scientific Manager, Biocon Ltd Non clinical study design for biosimilars
16.00 Immunogenicity testing strategies for biosimilars
Immunogenicity in the development stageTechniques and effectiveness of early immunogenicity identification at the pre clinical stageImmunogenicity testing –strength/weaknesses of different analytical techniquesIdentifying severity of immune responseAssay design and validation for immunogenicity assessment › Meenu Wadhwa, Expert of the BMWP EMA, NIBSC Immunogenicity testing strategies for biosimilars BIOSIMILAR MANUFACTURING AND LOGISTICS
16.30 Afternoon refreshments
17.00 Sourcing of originator medication strategies at pre-clinical and clinical stages
How to find a variety of different lots from various markets for an analytical dossierWhat are the challenges of originator drug sourcing?How to supply your clinical trials at later phases and the difference between pre-clinical sourcing and clinical trial supplies during phase IIIHow partnering with a full-service provider can enable you to speed up your development: market research for originator biologics, trusted sourcing for analytical purposes, add-on services with strategic partners (regulatory and analytical), supply-chain expertise procurement and quality assurance › Dr Christian Schmitz, Business Development Int. Key Accounts, Multipharma› Lekishia White, VP MD, Multipharma SA Sourcing of originator medication strategies at pre-clinical and clinical stages
17.30 Recent trends in stability testing for biosimilars
Stability testing to provide evidence for how the quality of a drug substance or drug product varies with time under the influence of a variety of environmental factors such as temperature, humidity and light Types of stability studies and there trend analysis with case studies. Stability guidelines Temperature excursion studies and its significance. › Rajiv Dua, Analytical and Stability Coordinator, Lupin Biotech Recent trends in stability testing for biosimilars
18.00 Evening networking drinks reception
19.00 Gala Dinner
Day Two - Thursday 28th February 2013
08.50 Opening remarks from the chair
› Fred Pritchard, Vice President, Global Drug Development, Celerion Opening remarks from the chair BIOSIMILAR REGULATORY REVIEW
09.00 European regulatory setting for biosimilars
•Current regulatory requirements for biosimilar approval in Europe
•Regulatory documentation submission for biosimilars
•Regulatory and industry interaction – building a better regulatory setting for the biosimilar industry of tomorrow
•Acceptance of non EU reference products
•Pre clinical regulations for biosimilars European regulatory setting for biosimilars
09.30 mAb regulations update affecting biosimilars
Review and update on mAb regulations in Europe including pre clinical requirements, In vitro/vivo study design, documentation submission
› Andrea Laslop, Head of Scientific Office, Austrian Agency for Health and Food Safety
mAb regulations update affecting biosimilars
10.00 Panel discussion: Biosimilars global regulatory Q&A session - is harmonised international development in sight?
Moving towards a truly global biosimilar programme - the evolution of bridging studiesUpdate on emerging markets – focus on regulatory environment in IndiaChallenges and regulatory hurdles to a multi-country biosimilar entry strategyBridging studies – update on regulatory acceptance, challenges, benefitsIs harmonised international development in sight?WHO Consultation on International Nonproprietary Names
› Smita Singhania, Vice President Reg affairs, Mabpharm Pvt. Ltd. Biotech Joint Venture of Cipla Ltd› Andrea Laslop, Head of Scientific Office, Austrian Agency for Health and Food Safety› Dr Alex Kudrin, Medical Assessor in Licensing of Biological Products, MHRA Panel discussion: Biosimilars global regulatory Q&A session - is harmonised international development in sight?
10.30 Morning Refreshments
CLINICAL TRIAL ENVIRONMENT
11.00 Opening remarks from the chair
› Dr Nicole Filser PhD, Independent consultant, Formerly Senior Director Clinical Development Biologics, Mylan Opening remarks from the chair
11.10 Clinical trial requirements – is the extent and depth of trial requirements necessary?
What could the clinical environment of tomorrow look like - Less extensive trials, just proving similarity?
Do patient’s benefit from the current environment or is existing data being repeated?
Challenges associated with clinical trials for biosimilar
Abbreviated trials
What are the statistical considerations for clinical trials
Building a clinical trial programme with appropriate clinical endpoints that satisfies all regulators – is it possible?
Bioequivalence
US Interchangeability studies
Phase 1 clinical study design for biosimilars
Phase 3 clinical study design for biosimilars
Clinical trial requirements – is the extent and depth of trial requirements necessary?
11.40 Clarifying the term ‘biosimilar’ from a clinical perspective
Biosimilarity required by EMA is something very different from non EMA regulated markets
Clinically we cannot compare a phase 3 study designed to prove biosimilarity in accordance with EMA or FDA guidelines with non regulated markets Understanding the difference and the consequences
› Dr Irek Otulski, Director Clinical Development, Polpharma Biuro Handlowe Sp. z o.o.
Clarifying the term ‘biosimilar’ from a clinical perspective
12.10 Immunogenicity testing for biosimilars: How to translate regulatory expectations into clinical trial concepts
Feasibility of statistically sound evaluation of immunogenicty in the pre-authorization phase of biosimilar developmentDealing with potential immunogenicity-related safety issues in the pre-authorization phaseDefinition of the most eligible immunogenicity population in phase IIISpecification of acceptable equivalence margins for immunogenicityInterpretation of mmunogenicity data gained from non-comparative post-marketing surveillance of immunogenicityImmunogenicity and extrapolation
› Bernd Liedert, Director Head of Immunopharmacology & Scientific/Regulatory Business Partner Biosimilars, Merck Serono
Immunogenicity testing for biosimilars: How to translate regulatory expectations into clinical trial concepts
12.40 Lunch
13.30 Pharmacovigilance of biosimilars: pre- and post-approval activities
Utilising non clinical and clinical data to plan pharmacovigilance for biosimilarsBiosimilar Risk Management Plans & risk communicationExploring known risks from the originator to develops risk management strategySafety specification and pharmacovigilance plan documentation requirementsOperational challenges in undertaking late phase studies (including observational studies, registries and surveillance)Regulatory requirements for pharmacovigilance and risk management in biosimilars
› Dr Alex Kudrin, Medical Assessor in Licensing of Biological Products, MHRA Pharmacovigilance of biosimilars: pre- and post-approval activities INTERNATIONAL BIOSIMILAR DEVELOPMENT
14.00 The development environment for biosimilars in emerging markets
Incentives for biosimilar development on emerging marketsEvolution of regulatory requirements for biosimilars in BRIC countriesBio-better and next-in-class biologicals: affordable innovative products for emerging markets
The development environment for biosimilars in emerging markets
14.30 Biosimilar development – an emerging market perspective
Different aspects of biosimilar development, manufacturing, clinic
› Mr Cyrus Karkaria, President, Biotech, Lupin Pharmaceuticals Biosimilar development – an emerging market perspective
15.00 Afternoon Refreshments
ACHIEVING BIOSIMILAR PRODUCT APPROVAL
15.30 Transforming the good science and regulatory compliance into regulatory approval and better patient access
› Hideaki Nomura, President and CEO, Fujifilm Kyowa Kirin Biologics Co., Ltd.
Transforming the good science and regulatory compliance into regulatory approval and better patient access
16.00 How to encourage physician and patient uptake of biosimilars
What data do physicians require to improve trust and increase biosimilar use?
› Dr Steinar Madsen, Medical Director, Norwegian Medicines Agency, Norway How to encourage physician and patient uptake of biosimilars
16.30 Close of conference
Post-Conference Workshop - Friday 1st March
08.30 Registration
Regulatory development and commercialisation framework for biosimilars
Objective:
The aim of the workshop is to evaluate the breadth of clinical data requirements within complex biosimilar program, the extent of pharmacovigilance and immunogenicity studies, and what is required from developers to overcome regulatory, development and market access hurdles. Apart from training on how to prepare for successful scientific advice interactions with regulatory authorities, trainees will be familiarised with what is necessary to consider in delivering successful market access, reimbursement and commercialization of complex biosimilars. The emphasis of the workshop will be on regulatory learning from EU, US and, to a lesser extent from emerging market perspectives.
› Dr Alex Kudrin, Medical Assessor in Licensing of Biological Products, MHRA Registration
09.00 Implementing the EU Biosimilars guidelines Roadmap for complex biosimilar development: clinical, regulatory and commercial strategy
11.00 Morning Refreshments
11.30 How to design successful development plans for EU and US Biosimilars? What regulatory trends are expected from the upcoming EU Biosimilars guidelines and regulatory submissions?
12.30 Lunch
13.30 How to develop a scientific advice strategy and a submission plan for successful EU Biosimilars approvals?
14.30 Afternoon Refreshments
15.00 Plans for development and approvals of biosimilars in emerging markets. Reimbursement and post-approval pharmacovigilance issues
16.00 Close of workshop
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