SMi present the 5th annual Biosimilars & Biobetters

Transcription

1 Confirmed Attendees Include: AbbVie Ltd, AriVan Research LLC, BD Biosciences, Boehringer Ingelheim Pharma GmbH & Co. KG, Dr Reddy s Laboratories, Esteve SA, Ludger Ltd, Merck Switzerland Limited, Mundipharma GmbH, Oranyei BV, SAI MedPartners, Sanofi Aventis, Takeda UK Ltd, Teva Pharmaceuticals, Univercelles S.A., University of Basel, plus many more at this years event SMi present the 5th annual Biosimilars & Biobetters The biosimilars opportunity: creating and commercialising a quality product Holiday Inn Regents Park Hotel, London UPDATED BROCHURE: MORE SPEAKERS MORE PRESENTATIONS 29th - 30th SEPT 2014 Chairperson: Richard Dicicco, Chairman, Harvest Moon Pharmaceuticals New Speaker Confirmed: Samuel Woodley PhD, U.S. Senior Patent Attorney, Biosimlars Business, Boehringer Ingelheim Pharma GmbH & Co. KG Benefits of attending: The must attend event discussing strategies for accelerating biosimilar drug development to market Explore the latest thinking and techniques in this growing area Book now and join us for exciting interactive discussions about the current and potential offerings for biosimilar production Hear from knowledgeable presenters our expert panel of speakers are handpicked! The ideal platform for networking and learning from your industry peers Key Speakers Include: Dr Uwe Gudat, Head of Safety Biosimilars, Merck Catherine Akers, Regulatory Affairs Manager, Amgen Steiner Madsen, Medical Director, Department of Drug Information, Norwegian Medicines Agency Dr Alok Sharma, Principal Scientist & Head Analytical Development, Lupin Limited Alan Sheppard, Principal Global Head Generics, Thought Leadership, IMS Health, UK Victoria Fine, Founder, Psoriasense Look inside for further details! PLUS TWO INTERACTIVE HALF-DAY POST-CONFERENCE WORKSHOPS Wednesday 1st October 2014, Holiday Inn Regents Park Hotel, London A: Biosimilars - A Regulatory Update Workshop Leader: Dr Michel Mikhail, Chief Regulatory Officer, Executive Vice President, Global regulatory - Governmental Relations, Fresenius Kabi Headquarters 8.30am pm B: Biosimilars - The Holy Grail? Workshop Leader: Ineke Braat, Chief Executive Officer, PanGenrika 1.30pm 5.30pm Sponsored by: Register online or fax your registration to +44 (0) or call +44 (0) ACADEMIC & GROUPS DISCOUNTS

2 Biosimilars & Biobetters Conference Day One I Monday 29th September Registration & Coffee 9.00 Chairman s Opening Remarks Richard Dicicco, Chairman, Harvest Moon Pharmaceuticals MARKET OUTLOOK - PART I OPENING ADDRESS 9.10 What is on the horizon?... reviewing the opportunities and challenges for the biopharmaceutical industry Reviewing the sustainability of the biosimilars market, will it be saturated in the future? The big question who will be most successful, those who are: - the fastest to market - generates the most similar biosimilar Evaluating the barriers to market entry and uptake for biosimilars Where are we heading and what needs to happen? Alan Sheppard, Principal Global Head Generics, Thought Leadership, IMS Health, UK 9.50 The big guns are coming!...how will the entry of originator companies impact the biosimilars industry Understanding how this will shape the competitive, dynamic and commercially lucrative biosimilars market segment Reviewing why big pharma companies are considering entering the market with monoclonal antibody biosimilars Will their experience in marketing, manufacturing skills and industry knowledge give them a competitive advantage over those already in the market? What are their weaknesses? Richard Dicicco, Chairman, Harvest Moon Pharmaceuticals Morning Coffee Biosimilars, biobetters - the patients perspective A patients understanding of biologics, biobetters & biosimilars What biosimilars and biobetters actually mean to patients The true impact of biosimilars and biobetters Victoria Fine, Founder, Psoriasense REGULATORY UPDATES Biosimilars/ Biobetters in the USA US PTO regulations extending the impact of the Myriad decision Strategy and hurdles for patenting your biosimilar in the US Update on evolving FDA regulations for biosimilars: why are there no approvals in the US? Albin (Jim) Nelson, Partner, Schwegman, Lundberg, Woessner IP, P.A Robin Chadwick, Partner, Schwegman, Lundberg, Woessner IP, P.A Networking Lunch 1.10 Christening day but what shall we call you! Discussing the ongoing debate on naming biosimilars Taking an in-depth look at the discussion regarding the WHOs initiative for a unique identifier for biologics what will this mean? The use of identical INNs for biosimilars could lead to inadvertent switching at the pharmacy - true or false? What is the view at home and abroad? USA - GphA and originator citizen petitions to the FDA Peter Wittner, Senior Consultant, Interpharm Consultancy 1.50 You can t injunct me - I m a biosimilar! Review of the principles governing interim injunctions in patent litigation Application of those principles to pharma cases Why biosimilar cases may not necessarily be a good fit will the injunctions stick? Dominic Adair, Associate, Bristows 2.30 European update - the latest in regulatory thinking Understanding current regulatory approval standards for biosimilars in Europe, reviewing the regulatory pathways in other jurisdictions What are the regulatory requirements for non-clinical studies in developing biosimilars Other aspects of the regulatory framework to consider when preparing a marketing authorisation application Sarah Faircliffe, Legal Director, Bird & Bird Liz Fuller, Partner, Bird & Bird 3.10 Afternoon Tea 3.30 The case for biosimilars - a payer s perspective Why are payers interested in utilizing biosimilars? Switching or not switching in pharmacies? Switching or not switching for economical reasons after treatment initiation/during treatment? What will happen in Norway onwards? Erik A. Stene, Senior Advisor/MPhil Econ, Department for pharmacoeconomics/reimbursement/value assessment, Norwegian Medicines Agency 4.10 Same, similar, equivalent, this is a serious game! Proving that a biosimilar is similar to the originator is not trivial pursuit! Defining biosimilarity How similar is the biosimilar to the innovator measuring how much work this entails at the early stage Evaluating what metrics and analytical similarity assessments should be employed when designing a biosimilar development program ROUNDTABLE Determining type and volume of clinical data DISCUSSION required for establishing biosimilarity Establishing validated standardized assays that allow direct comparisons of the relative potency and immunogenicity of the biosimilar and the innovator product Considering the limitations of conventional biological assays that may be inadequate to detect differences resulting from a change in the manufacturing process Conducting a non-clinical or a clinical study Michael Tovey, INSERM Director of Research, Laboratory of Biotechnology and Applied Pharmacology, Ecole Normale Supérieure de Cachan 4.50 Pre-Launch supply readiness for biosimilars Understanding the safe harbor provisions against patent infringement in the United States The Board exemption to patent infringement, across the European Union and in individual countries Maximizing benefit of the exemptions to minimize risks of infringement before launch Samuel Woodley PhD, U.S. Senior Patent Attorney, Biosimlars Business, Boehringer Ingelheim Pharma GmbH & Co. KG 5.30 Chairman s Closing Remarks and Close of Day One Sponsored by Supplying the following bioproducts to research and industry: Albumins, Disease state serum, Human and animal sera for cell culture and diagnostic reagents. Human and animal Immunoglobulin s. Fluorescent conjugates for Flow Cytometry, HTS and Multiplexing. GLYKO and GlykoPrep products for glycan profiling. Raw materials for Diagnostic reagent manufacturers of Clinical chemistry and ELISA s. Schwegman Lundberg & Woessner was founded in 1993 with a commitment to innovation. Today, SLW has offices in Minneapolis, Silicon Valley, and Texas as well as attorneys in New York City, Washington DC, and San Diego. SLW has over 100 attorneys with advanced degrees in the areas of organic chemistry, molecular biology, genetics, biochemistry and other life sciences as well as chemical and mechanical engineering, electrical, computer/software. Register online at: Alternatively fa

3 Biosimilars & Biobetters Conference Day Two I Tuesday 30th September Registration & Coffee 9.00 Chairman s Opening Remarks Richard Dicicco, Chairman, Harvest Moon Pharmaceuticals MARKET OUTLOOK - PART II OPENING ADDRESS 9.10 Biosimilars - hurdles to patients access Development of biosimilars: A case study Patent protection INN issue Switching: interchangeability and substitution Dr Michel Mikhail, Chief Regulatory Officer, Executive Vice President, Global regulatory - Governmental Relations, Fresenius Kabi Headquarters 9.50 What do they really think...reviewing customer perceptions of biosimilars in Europe Discussing what doctors think of biosimilars and how willing are they to prescribe them Monitoring how patients react when their doctor prescribes a biosimilar Are payors pushing for more utilization of biosimilars in Europe? Ineke Braat, Chief Executive Officer, PanGenerika Morning Coffee Innovations in creating best in class biosuperior biologics: meeting the challenges of biosimilars Innovations in improving the existing biologics therapies to create best in class molecules for diseases with unmet medical needs Making biosuperiors successful and cost effective through advances in protein engineering and pioneering technologies - Case studies of biosuperior vs. biosimilars Identifying which class of biologics have the best potential for biosuperior development Challenges in development of biosuperior biologics Accelerated preclinical and clinical development of biosuperior biologics Rakesh Dixit, Vice President, R&D, Global Head, Biologics Safety Assessment, Medimmune (AstraZeneca Biologics) BIOSIMILAR DEVELOPMENTS Pharmacovigilance considerations for biologics and biosimilars Unique characteristics for biologics which influence their safety profile Importance for accurate traceability to allow effective pharmacovigilance How biologics have been recognised in the new EU pharmacovigilance legislation and what implementation looks like across Europe. Catherine Akers, Regulatory Affairs Manager, Amgen Networking Lunch 1.10 Tracking the introduction of biosimilar infliximab in Norway What are the attitudes of physicians? Switching study what is the status? Monitoring prices and sales Steinar Madsen, Medical Director, Norwegian Medicines Agency 1.50 Designing and executing comparability studies an important key in the development of products Conducting meaningful preclinical and clinical comparability studies, to establish analytical and bioanalytical equivalency between biosimilars and originators Ensuring a comparability exercise is followed with the innovator product at all levels of product development, including: - physicochemical attributes - biological activity - preclinical in vivo comparability - Phase I PK and safety - Phase III efficacy and safety Demonstrating equivalence to materials used in toxicology and early phase clinical trials to avoid bridging studies which increase timescales and costs Guidance on how to practically carry out comparability studies and prove comparability to regulators Dr Alok Sharma, Principal Scientist & Head Analytical Development, Lupin Limited 2.30 Afternoon Tea 2.50 A clinical perspective on biosimilars: development and beyond The challenge - creating strategies to overcome the obstacles we face The means - utilizing the tools at our disposal The scenarios - a collection of possible outcomes Dr Uwe Gudat, Head of Safety Biosimilars, Merck 3.30 A new dawn biosimilar monoclonal antibodies (mabs), a new milestone for the biosimilar market! Reviewing how approval of the first biosimilar monoclonal antibody therapy will impact the industry, what are the implications for 2014 and beyond Evaluating if this will spearhead the start of a new era of mabs in the pharma industry Discussing how to get regulatory approval for your mab Will this bring greater commercial rewards Will generic companies continue to dominate, or can Big Pharma gain control with its huge marketing muscle? Carsten Brockmeyer, Chief Executive Officer, Formycon AG 4.10 Market dynamics in biosimilars Assessment of the biosimilars market and identifying growth opportunities Key trends in biosimilars and biobetters Evaluating the competitive landscape of the biosimilars market Ranjith Gopinathan, Program Manager - Life Sciences, Healthcare Practice Europe, Frost & Sullivan 4.50 Chairman s Closing Remarks and Close of Day Two Supported by x your registration to +44 (0) or call +44 (0)

4 HALF-DAY POST-CONFERENCE WORKSHOP A Wednesday 1st October 2014 I 8.30am 12.30pm Holiday Inn Regents Park Hotel, London Biosimilars - A Regulatory Update Workshop Leader: Dr Michel Mikhail, Chief Regulatory Officer, Executive Vice President, Global regulatory - Governmental Relations, Fresenius Kabi Headquarters Overview of workshop: Europe is by far the most advanced region with a regulatory pathway for biosimilars for the last decade. This workshop will give a regulatory overview of the biosimilars rules & guidelines in the EU, US and India. This will address the differences between regulatory agencies approaches, helping participants build adequate regulatory strategies. Why you should attend: This Workshop will give a detailed overview of the current regulatory situation, current regulatory requirements and address the differences. It will help you to build adequate regulatory strategies to respond to the needs of early access to biosimilars. Programme: 8.30 Registration and coffee 9.00 Opening remarks 9.10 Session 1: Regulatory Overview EU and US: An update on the EU and US regulatory requirements for biosimilars 9.50 Session 2: EU and US Regulatory pathways: A refreshment of the current regulatory pathways for biosimilars in the EU and USA Coffee break Session 3: Biosimilars Regulatory Overview in India: A description of the regulatory requirement in India and the published biosimilars guidelines Session 4: Biosimilars Wrap-up. Questions and answers, allowing the workshop participants to interact and exchange experiences Closing remarks End of workshop About the workshop host: Dr. Michel Mikhail has more than 25 years pharmaceutical industry experience and a track record of achievement in R & D and International Regulatory Affairs in large multinational research-based pharmaceutical companies, as well as in the generic industry. Dr Mikhail is a chartered expert in pharmacology -toxicology, a chartered clinical expert as well as a chartered analytical expert. Dr Mikhail served on the Safety Working Group and Efficacy Working Group of the European Federation of Pharmaceutical Industry Associations (EFPIA) also as a topic leader. He served on the regulatory group of the European branch of the Pharmaceutical Research and Manufacturers of America (PhRMA Europe), on the Regulatory and Scientific Affairs Group of the European Generic Medicines Association (EGA), as well as Pharmacovigilance Working Group, Market Access Advisory Committee, among others and on different associations and organisations. Dr Mikhail is member of the EGA s European Biosmilars Group (EBG). Dr Mikhail is a Board Member of The European Generic Medicines Association (EGA) as well as member of the Executive Committee of the EGA. He is a member of the British Institute of Regulatory Affairs (BIRA), the European Society of Regulatory Affairs (ESRA), both now known as The Organisation for Professionals in Regulatory Affairs (TOPRA). Dr Mikhail is member of the Expert Committee for Toxicology of the United States Pharmacopea (USP). Dr. Mikhail has been recently nominated as a Member of the Expert Committee of the German Federal Institute of Risk Assessment (Bundesinstitut für Risikobewertung). Currently Dr. Mikhail is Chief Regulatory Officer & Executive Vice President Global Regulatory Governmental Relations at Fresenius Kabi, a multinational pharmaceutical company.

5 HALF-DAY POST-CONFERENCE WORKSHOP B Wednesday 1st October 2014 I 1.30pm 5.30pm Holiday Inn Regents Park Hotel, London, UK Biosimilars - The Holy Grail? Workshop Leader: Ineke Braat, Chief Executive Officer, PanGenrika Overview of workshop: Are biosimilars something that companies should want to introduce in their product portfolio or should we look at other opportunities and leave the bios to companies that have money to burn? That is the big question! Why you should attend: If you want to gain some insight into the costs and profitabiity of biosimilars and and biobetters. Also, if you want to know whether or not you are missing the boat if you don t get into these products then join this workshop to find out what is happening in this area. Programme: 1.30 Registration and coffee 2.00 Opening remarks 2.10 Session 1: Question you should ask within your organisation before starting to produce biosimilars 2.50 Session 2: Biosimilars what is the ROI for working with them? 3.30 Coffee break 4.00 Session 3: Why and more important; how do you introduce biosimilars 4.40 Session 4: Is there a yellow brick road? 5.20 Closing remarks 5.30 End of workshop About the workshop host: Ineke Braat, CEO of PanGenerika has been working in the pharmaceutical industry for over 30 years and is founder and owner of PanGenerika B.V., B-Medical B.V. and Sanare B.V, with all companies working within the pharmaceutical and or personal care industry. Ineke has worked in the innovating pharmaceutical industry (Abott; Yamanouchi e.a.) before starting her own companies. Ineke s main focus in all companies is the question: will it benefit the patient/consumer? About PanGenerika: PanGenerika began as an alliance of small/medium sized European pharmaceutical companies, but is expanding to all countries that accept e-ctd formatted dossiers. There is only one exclusive member per country. For information please visit SPONSORSHIP AND EXHIBITION OPPORTUNITIES SMi offer sponsorship, exhibition, advertising and branding packages, uniquely tailored to complement your company s marketing strategy. Should you wish to join the increasing number of companies benefiting from sponsoring our conferences please call: Alia Malick, Director on +44 (0) or amalick@smi-online.co.uk Want to know how you can get involved? Interested in promoting your services to this market? Contact Julia Rotar, SMi Marketing on , or jrotar@smi-online.co.uk

6 FAX your booking form to +44 (0) PHONE on +44 (0) BIOSIMILARS & BIOBETTERS CONFERENCE Conference: Monday 29th Tuesday 30th September 2014, Holiday Inn Regents Park Hotel, London I Workshops: Wednesday 1st October WAYS TO REGISTER ONLINE POST your booking form to: Events Team, SMi Group Ltd, 2nd Floor South, Harling House, Great Suffolk Street, London, SE1 0BS, UK Unique Reference Number Our Reference P-117 DELEGATE DETAILS Please complete fully and clearly in capital letters. Please photocopy for additional delegates. Title: Forename: Surname: Job Title: Department/Division: Company/Organisation: Company VAT Number: Address: Town/City: Post/Zip Code: Direct Tel: Mobile: Switchboard: Signature: Country: Direct Fax: I agree to be bound by SMi s Terms and Conditions of Booking. ACCOUNTS DEPT Title: Surname: Forename: Address (if different from above): Town/City: Post/Zip Code: Direct Tel: Country: Direct Fax: Date: VENUE Holiday Inn Regent s Park, Carburton St, London, W1W 5EE Please contact me to book my hotel Alternatively call us on +44 (0) , hotels@smi-online.co.uk or fax +44 (0) Terms and Conditions of Booking Payment: If payment is not made at the time of booking, then an invoice will be issued and must be paid immediately and prior to the start of the event. If payment has not been received then credit card details will be requested and payment taken before entry to the event. Bookings within 7 days of event require payment on booking. Access to the Document Portal will not be given until payment has been received. Substitutions/Name Changes: If you are unable to attend you may nominate, in writing, another delegate to take your place at any time prior to the start of the event. Two or more delegates may not share a place at an event. 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