Berlin, Germany | February 23 - 24, 2017
Scott Davis Senior DirectorTherapeutic Science & Strategy QuintilesIMS, UK
Caroline BouilliatCommercial Lead (Biosimilars)Amgen, Switzerland
Dr. Uwe GudatHead of SafetyBiosimilarsMerck, Switzerland
Dr. Steinar MadsenMedical DirectorNorwegian Medicines Agency
Dr. Christelle DagoneauDirector, Business Development - Biologics, EuropeCatalent Pharma SolutionsFrance
Matthew TurnerGlobal Medical Director BiosimilarsMerck, Switzerland
Dr. Beatrix MetznerDirector Global CMC Strategy & Tech RABoehringer Ingelheim Pharma GmbH & Co. KG, Germany
Hotel Riu Plaza Berlin | Martin-Luther-Strasse 1 | 10777 Berlin, Germany
Alan SheppardPrincipal, Global Generics & BiosimilarsThought LeadershipQuintilesIMS, UK
Riccardo TorosantucciLaboratory Head Formulation Development Sanofi, Germany
Jane HippenmeyerDirector Scientific AffairsAmgen, Switzerland
Ian ThompsonVice President BusinessDevelopment, Delivery SystemsYpsomed AG, Switzerland
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Fredrik SundbergGlobal DirectorGE Healthcare
Chairman of the Day1: Bernd LiedertSenior DirectorClinical Development BiosimilarsBoehringer Ingelheim Pharma GmbH & Co. KG, Germany
Chairman of the Day2:
The global regulatory landscape for biosimilars’ approvalThe latest achievements of biosimilars in therapeutic areasBioanalytics for biosimilars Extrapolation and InterchangeabilityImmunogenicityPharmacovigilance issuesDevelopments in the biosimilar guideline frameworkDrug safety factorsLegal considerations for biosimilars Successful implementation of biosimilars in the market
Speakers Board:
Key Practical Learning Points of the Summit:
Angeles Escarti-NebotRegulatory Affairs ManagerPAREXEL Consulting, UK
Dr. Louis BoonChief Scientific OfficerBioceros
Exhibit Sponsor:
This 3rd Annual Summit brings together industry experts to explore strategies and gain insight into designing new biosimilar development programmes and analysis methods, clinical advancement, and new solutions for successful im-plementation in the market.
It is a great environment for interactive networking, learning best practice, maintaining business relationships, and meet-ing new clients.
It is an honour and privilege to invite you to participate in this Summit.
We look forward to welcoming you at the Summit in Berlin this coming February!
e are pleased to invite you to the “3rd Annual Biosimilars Summit” sched-uled for the 23rd - 24th February 2017, in Berlin, Germany.W Who Should Attend:
Geographical Distribution:
Chief Executives, Directors, Vice Presidents, Department Heads, Leaders and Managers specialising in:
Biologics/Biotechnology/BiogenericsBiopharmaceuticalsLegal AffairsIntellectual propertyPricing & ReimbursementClinical ImmunologyRegulatory ComplianceR&DPreclinical & Clinical DevelopmentNew Product DevelopmentQuality Affairs/Quality ControlPharmacovigilance
Clinical Immunology Oncology Immunology Infection & Immunity Drug Safety Risk Management Preclinical Development Clinical Program Therapeutic Areas Personalized MedicineBusiness Development Portfolio Planning
Company Type:
PharmaceuticalBiotechnologCROCMONOPOther
Europe United StatesCanada APAC Other
BERLIN, GERMANYFEBRUARY 23 - 24
2017
Vaccines DevelopmentRegulatory AffairsScientific AffairsPharmacovigilanceValidationGlobal StrategyAnalytical CharacterizationAntibody EngineeringAntibody DiscoveryFormulation DevelopmentOutsourcing
From industries including:
Vonlanthen Group of Companies is made for inno-vative and senior business leaders focused on confronting challenges and seizing opportunities. We conduct extensive research and connect deal-makers and risk-takers across Eu-rope and emerging markets to help propel companies to the next level. Our conferences, events and training schemes are designed for senior decision-makers working at the top of their industries with cutting-edge strategies, products, pro-cesses and technologies. Vonlanthen Group of Companies is the natural home for companies always on the lookout for opportunities, always searching for the next deal, and always with an eye on the competition.
About Us
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DAY ONEFEBRUARY 23
2017
Registration and Welcome CoffeeOpening Address from the Chairman
SPEED NETWORKING
08:3009:00
09:10
09:40
CASE STUDY
What does the future hold for biosimilars?
10:20 CASE STUDY - Learning from the launches of the first biosimilar MAbs- Variation of uptake across markets- Perspective on the US marketSuccessful implementation
of Biosimilars in the market
MORNING COFFEE AND NETWORKING BREAK10:50
MARKET ACCESS STRATEGIES FOR BIOSIMILARS
Innovative approach to maximize networking capabilities through two minute periods, where delegates can meet their peers and exchange business cards before rotating to the next company representative.
1 2
- What is the perception after being on the market more than10 years?
- Cost savings associated with biosimilars- What is the response of originator companies?- Is there a future for biosimilars?
11:20 CASE STUDY - Update in analytical techniques- Formulation development strategy- Viscosity- Develop-ability- Device-ability and drug device combination
High throughput chemical denaturation and relative viscosity measurements via intrinsic and extrinsic fluorescence during formulation and biosimilar development
BIOANALYTICAL CHARACTERISATION OF BIOSIMILARS
BUSINESS LUNCH13:00
RICCARDO TOROSANTUCCILaboratory Head Formulation Development Sanofi, Germany
MATTHEW TURNERGlobal Medical Director BiosimilarsMerck, Switzerland
CAROLINE BOUILLIATCommercial Lead (Biosimilars)Amgen, Switzerland
12:20 CASE STUDY - Biosimilar development trends- An overview of current development models- Technology integration strategy to accelerate pipeline/ Catalent case study
The importance of integration of technologies to accelerate development of biosimilar molecules
DR. CHRISTELLE DAGONEAUDirector, Business Development - Biologics, EuropeCatalent Pharma Solutions, France
11:50 CASE STUDY - The global market and regulatory landscape update- Novel “Fingerprinting” approaches to establish bio-similarity- Industry case-studies on implementation of real-time detectionto accelerate time-to-market
Using innovative analytical and validation strategies to establish Bio-similarity
FREDRIK SUNDBERGGlobal DirectorGE Healthcare
BIOSIMILARS – CURRENT PROGRESS AND DEVELOPMENT CONSIDERATIONS
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DAY ONEFEBRUARY 23
2017
1 2
AFTERNOON COFFEE AND NETWORKING BREAK15:00
14:30 CASE STUDY - The unsustainable growth in the medicines budget aroundthe globe
- The pipeline of biologics driving future growth- Biologics entering new therapeutic areas- Life-cycle management of biologics- Affordability, access and improved outcomes arising frombiosimilars
The need for biosimilars
Innovative considerations for biosimilars development
With Speakers of the Day Moderated by the Chairman of Day1
16:00 PANEL DISCUSSION
CHAIRMAN’S CLOSING REMARKS AND END OF DAY ONE
BUSINESS DINNER
16:40
18:00
14:00 CASE STUDY - Immunogenicity and efficacy of extrapolation- Main issues about extrapolation and interchangeability- Challenges in new guidenessIn support of extrapolation of indications
and the current state of interchangeability
JANE HIPPENMEYERDirector Scientific AffairsAmgen, Switzerland
ALAN SHEPPARDPrincipal, Global Generics & BiosimilarsThought LeadershipQuintilesIMS, UK
Vonlanthen Group of Companies is the premier forum for deal-makers and business leaders. We help industry experts and investors find the next opportunity, strike the next deal and enter growing markets by:• Hosting summits, conferences and workshops for senior decision makers, with a focus on sharing practical advice and experience
to source opportunities and confront challenges• Putting top executives together to share insights on the outlook for their industry in our cutting edge leadership forums• Helping businesses - large and small - fund investment and growth by arranging capital-raising meetings• Conducting bespoke executive training courses to ensure management teams are operating at the highest possible levelEverybody who attends a Vonlanthen Group event has been pre-screened to ensure the highest quality of delegates and to kick-start thedeal-making process.
What We Do
DELIVERY DEVICES FOR BIOSIMILARS
15:30 CASE STUDY - Factors to consider when selecting an injection device- Delivery device strategies for biosimilar: me-too or differentiator?- Device development and customisation programmesDrug delivery injection devices for biosimilars
IAN THOMPSONVice President Business Development, Delivery SystemsYpsomed AG, Switzerland
© 2016 Vonlanthen Group All Rights Reserved
- Are biosimilars cost effective?- New opportunities for EU biosimilars in emerging economies interms of pricing
- Various factors that influence biosimilar adoption- Risk management plans for biosimilars- Global regulatory changes- Analytical challenges of establish biosimilarity
Registration and Welcome CoffeeOpening Address from the Chairman
- Impact of switching- Increasing competition to lower costs- Experiences in Nordic countries
08:3009:00
09:10 CASE STUDY - Putting immunogenicity of biologics in context- A risk-based approach to immunogenicity- Differential immunogenicity, not immunogenicity per se- Immunogenicity of IgG - what have we seen to date- Good Vigilance Practices (GVP) PII on biologics and immunogenicity
Biosimilars: taming the dragon of immunogenicity
09:40 CASE STUDY - Bioanalytical assay development considerations- Similarity assessment US vs EU- Building a scientific bridgeMonoclonal antibodies:
the effectiveness of targeted therapy
DR. BEATRIX METZNERDirector Global CMC Strategy & Tech RABoehringer Ingelheim Pharma GmbH & Co. KG, Germany
MORNING COFFEE AND NETWORKING BREAK10:10
10:40
BUSINESS LUNCH12:00
CASE STUDY
From biosimilars to biogenerics?
13:00
CLINICAL RESEARCH IN THERAPEUTIC AREAS
CASE STUDY
Clinical considerations for the development of biosimilars in oncology
REGULATORY CHALLENGES IN GLOBAL BIOSIMILAR DEVELOPMENT
- Overcoming the challenges to biosimilar development in oncology- Critical commercial, regulatory, and clinical considerations for oncology monoclonal antibodies in the development of biosimilars- Potential to increase investigator and patient awareness of biosimilars to expand patient access to important cancer treatments
DAY TWOFEBRUARY 24
2017
1 2
DR. UWE GUDATHead of Safety, BiosimilarsMerck, Switzerland
DR. STEINAR MADSENMedical DirectorNorwegian Medicines Agency
SCOTT DAVIS Senior Director, Therapeutic Science & Strategy QuintilesIMS, UK
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11:20 CASE STUDY
Upstream process modulation of biosimilar Mab CHOBC® cell lines to establish biosimilarity
- CQA process modulation- ADCC bio-assays- Fc gamma Receptor Binding- Galactosylation and fucosylation
DR. LOUIS BOONChief Scientific OfficerBioceros
- Extrapolation approach: change of the perception- US long-waited guideline for inchangeability- Do we need a Phase III?- Supplement of biosimilars program by innovative aspectsof clinical development
14:30 CASE STUDY
Statistical evaluation of quality and clinical similarity data
Future regulatory landscape
15:00 INTERACTIVE PANEL
CHAIRMAN’S CLOSING REMARKS AND END OF SUMMIT15:40
- Ranking impact of critical quality attributes- FDA approach to statistical comparison of biosimilar withreference product from a quality perspective
- Statistical considerations relevant to clinical data
DAY TWOFEBRUARY 24
2017
1 2
AFTERNOON COFFEE AND NETWORKING BREAK14:00
ANGELES ESCARTI-NEBOTRegulatory Affairs ManagerPAREXEL Consulting, UK
BERND LIEDERTSenior Director, Clinical Development BiosimilarsBoehringer Ingelheim Pharma GmbH & Co. KG, Germany
CASE STUDY
Clinical considerations: interchangeability and substitution in the EU and in the US
13:30 - Interchangeability and substitution: Position of EMA andEuropean Community Member States
- Just biosimilar or even interchangeable? The US perspective- Commercial and regulatory attractiveness of theinterchangeability status in the US
- US Federal State-level legislation on interchangeability- Design considerations on single transition and switchingstudies: population, endpoints, statistics
With Speakers of the Day Moderated by the Chairman of Day2
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Sponsorship
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SPEAKERSBIOGRAPHIES
1 2
Scott has more than 20 years of experience in clinical drug development with-in Pharma, Biotech’s and CRO’s. As Senior Director, Therapeutic Science and Strategy for Oncology Scott Davis applies his strategic therapeutic expertise to optimize the speed, quality, and cost of clinical development programs and drug development opportunities. Scott has provided therapeutic strategy input for multiple oncology indications across Phase I – IV over a number of years. Scott has more recently developed therapeutic strategies for immuno-oncology and adoptive cellular therapies. Scott also has a strong focus on Biosimilars and has Co-Authored Operational Challenges Associated with Bio-similar drug Development – Journal of Clinical Studies: Volume 7; Issue 2. Prior to Quintiles Scott had responsibility for a CNS marketed product within Eisai. He has held many global project management roles within the pharma-ceutical industry, biotech and CRO’s. Scott has also had additional experience in leading MAA/IND submission teams and has led CMC project teams in the development of novel products, reformulations and medical devices.
Uwe Gudat received his medical degree from the University of Marburg, Ger-many. He is licensed in internal medicine and diabetology as a sub-speciality, training under Michael Berger in Düsseldorf Germany. Uwe Gudat joined the pharmaceutical industry in 1995 with Eli Lilly and since then has held positions at Hesperion/Actelion, Novartis and Merck Serono. In this time he has led global clinical development teams, served as global medical brand director, led clinical teams for in-licensing due-diligence and managed clinical-trial review, first in man transitions and product safety assessments. Currently he is Head of Safety of the Merck Serono Biosimilars Unit. He has published a number of scientific papers in the field of diabetes and is currently on the editorial advisory board of Applied Clinical Trials.
SCOTT DAVIS Senior DirectorTherapeutic Science & Strategy Quintiles IMS, UK
DR. UWE GUDATHead of SafetyBiosimilarsMerck, Switzerland
Angeles Escarti-Nebot gained BSc in Pharmacy from the Complutense Uni-versity of Madrid, Spain and PhD in Molecular Biology from the Autonoma University of Madrid, Spain. Angeles has more than seven years of experience in biotechnology research and more than eight years of experience within the contract pharmaceutical and biotechnology industry particularly focused on the CMC, nonclinical development and early clinical stages of biological me-dicinal products including biosimilar products and ATMPs. As a consultant she provides scientific regulatory support to biotechnology, pharmaceutical and medical technology companies in the design and implementation of innova-tive and global regulatory strategies to expedite product development. Prior to joining PAREXEL, Angeles worked in the biotechnology sector developing biotechnological Orphan Drugs for retinal disorders (ProRetina) and before that she lead the GLP laboratory of a nonclinical CRO (Vivotecnia) with par-ticular focus on nonclinical studies for biotechnological products and ATMPs.
ANGELES ESCARTI-NEBOTRegulatory Affairs ManagerPAREXEL Consulting, UK
Caroline Boulliat, Pharm D, Senior executive leader in the biotechnology /pharmaceutical industry. She has been in the pharmaceutical industry for more than 15 years, working in a variety of commercial roles in in countries (France, UK) and internationally. Caroline has an expertise in biologics innova-tive markets, having worked on the launch of Cimzia and more recently on Remicade. At Hospira / Pfizer Caroline coordinated the launch of first Mono-clonal Antibody Biosimilar, Inflectra (Infliximab), across the world.
CAROLINE BOUILLIATCommercial Lead (Biosimilars)Amgen, Switzerland
Dr. Steinar Madsen is medical director at the Norwegian Medicines Agency. He has been working with generic substitution since it was introduced in Norway in 2001 and with biosimilars since 2006. He is member and previously chair-man of the committee for generic substitution at the Agency. Dr. Madsen is also engaged in the drug information service, with a special interest in the safe and cost effective use of drugs. He is a specialist in internal medicine and cardiology and works part time as a consultant in cardiology.
DR. STEINAR MADSENMedical DirectorNorwegian Medicines Agency
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FREDRIK SUNDBERGGlobal DirectorGE Healthcare
As Global Director of Strategic Market Development and Customer Relations, Fredrik is responsible for working with the global pharmaceutical industry and major academic power centers to improve current workflows with innovative protein analysis solutions and value-added services. He has over the past years been supporting the industry to expand the application of label-free in-teraction analysis throughout drug discovery, development and manufacturing processes. Additionally, he also advises on GE Healthcare R&D projects, Vac-cine Growth Initiatives and Business Development activities. Fredrik is author of several publications in the field of Drug Discovery Strategies, Biosimilars and Vaccines. A recognized industry leader, he is also member of an EMEA Pharmaceutical Industry Expert Panel. On a regular basis, Fredrik lectures and discusses regulatory issues with government authorities, such as US FDA.
BERND LIEDERTSenior DirectorClinical Development BiosimilarsBoehringer Ingelheim Pharma GmbH & Co. KG, Germany
Dr. Liedert, trained as a pharmacologist, is familiar with both sides of the ta-ble, the developers´ objectives and the regulators´ perspective on biosimilars development: Today he is Senior Director, Clinical Development Biosimilars at Boehringer Ingelheim, guiding biosimilar monoclonal antibodies and related molecules starting from Due Diligence, over bioequivalence and Phase III studies to BLA/MAA (immunology, oncology) Across programs he is Strate-gic Advisor for Extrapolation and Clinical Immunogenicity. For more than 6 years he served as Head of Immunopharmacology at Merck Serono (FIM, POC studies, companion diagnostics) and was in charge of the clinical design of Merck Serono´s initial biosimilars´ programs in 2012. Before, Dr. Liedert got insight experience of the Health Authorities´ perspective, when he served as regulator at the Paul-Ehrlich-Institute (PEI), the German Federal Agency for biologics. At the EMA, he represented the PEI and Germany in the Safety Working Party. He was co-author of several guidelines, which focus on risk mitigation for early clinical trials, immunogenicity and comparability/biosimi-larity exercises.
SPEAKERSBIOGRAPHIES
SPEAKERSBIOGRAPHIES
1 2
Alan has over 45 years extensive experience within the healthcare industry, including innovator R&D pharmaceuticals, OTC and generic companies and working with Government departments, law firms, venture capital companies and industry associations. Alan is responsible for developing services and in-sights for the industry and its associations on generic medicines and biosimi-lars through a combination of consulting, information and market analyses. Previous positions held include Executive Vice-President, Europe Generics, for Dr Reddy’s Laboratories Ltd; Vice-President of Global Corporate Strategy for PLIVA (now Teva); European Marketing Director for Medeva (now UCB); General Manager, Rhône-Poulenc Rorer UK (now Sanofi); General Manager, Institute Mérieux UK; and management roles with Servier Laboratories and SmithKline & French. Alan is also an expert witness on patent litigation issues and their commercial impact, working with leading international law firms. Other roles have included Chairman of the Technical Advisory Group for the Access to Medicines Foundation; guest lecturer at the University of Wales working in the medicines faculty specialising in pharmaceutical marketing; a long serving member of the Prescription Medicines Code of Practice Authority Appeals Board; a Fellow of the Chartered Institute of Management; Fellow of the International Doctors’ Association and Member of the Chartered Institute of Marketing.
ALAN SHEPPARDPrincipal, Global Generics & BiosimilarsThought LeadershipQuintilesIMS, UK
RICCARDO TOROSANTUCCILaboratory Head Formulation Development Sanofi, Germany
Riccardo received his Master degree in Chemistry and Pharmaceutical Tech-nologies from the University of Rome La Sapienza and his PhD from the Uni-versity of Leiden. During his PhD he studied the relationship between protein oxidation, aggregation and immunogenicity, working with insulin and insulin´s biosimilars, besides other therapeutic proteins. As a part of his PhD, he spent 5 months at the Department of Pharmaceutical Chemistry of Kansas Univer-sity, working on the mechanisms responsible for covalent protein aggregation during oxidation. From 2013 until November 2015, Riccardo worked as Proj-ect Manager analytic and formulation at Coriolis-Pharma, in Munich, dealing mainly with Biosimilars develop-ability. Starting from December 2015, he is Laboratory Head in the Bioanalytics and Formulation department of Sanofi, in Frankfurt, where he works on the Early and Late stage NBEs formulation development.
Ian Thompson has been with Ypsomed AG, formerly Disetronic AG, since 1995 in a number of roles in key account management and business development working with pharma companies to develop and bring to market innovative self-injection systems. He studied biochemistry and biotechnology in the UK from 1979-1983, working initially in commercial roles for fermentation tech-nology. He has worked in medical device companies since moving to Switzer-land in 1990. Since 2003 his main focus has been business development and new product innovation leading to the successful development and launch of a range of new pen and autoinjector Custom Products for Ypsomed Delivery Systems. Ypsomed Delivery Systems continues to focus on the development and manufacture of next generation pen, autoinjector and wearable injector technologies.
IAN THOMPSONVice President BusinessDevelopment, Delivery SystemsYpsomed AG, Switzerland
© 2016 Vonlanthen Group All Rights Reserved
DR. CHRISTELLE DAGONEAUDirector, Business Development - Biologics, EuropeCatalent Pharma Solutions, France
Dr. Christelle Dagoneau, PhD, is Director, Business Development for Catalent Pharma Solutions where she has been involved in the design of biologics and biosimilar development programs for the past 5 years. Prior to joining Catalent, Christelle served as Head of Marketing and Sales at PX’Therapeutics (France) for 6 years and has held additional commercial, marketing and re-search funding roles in France and in the United Kingdom between 2001 and 2005. Christelle holds a PhD in Organic Chemistry as well as a Master in Technology & Business Management obtained from Grenoble Business School.
MATTHEW TURNERGlobal Medical Director BiosimilarsMerck, Switzerland
Over 20 years in pharma industry with last 10 years working in the area of bio-similars. Formally Global Head of Medical Affairs at Sandoz biosimilars work-ing on this exciting and rapidly evolving area of biosimilars. During this time I have experience in strategic planning and execution for medical affairs to educate HCPs on the biosimilar concept, publish widely and generate further supporting datasets post-launch for the first wave of biosimilars worldwide.
Dr. Boon received his Ph.D. in Biochemistry at the University of Amsterdam. In 2003 he was one of the founders of Bioceros BV were he currently hold a position of CSO. In addition, he held position as CSO for MacroZyme BV, 4AZA Bioscience NV, FF Pharma and VP Preclinical for PanGenetics BV and Tanox. Dr. Boon is author of over 240 papers in international scientific journals in the field of medical biotechnology. Bioceros generates production cell lines for the industry and used its proprietary CHOBC® platform to generate a portfolio of cell lines producing biosimilar monoclonal antibodies. Since the acquisition of Bioceros by EPIRUS in 2015, he extended this expertise and developed a complete process toolbox to fit biosimilar CQAs. After the acquisition of Epirus NL by the Polpharma Biologics group in June 2016, he has continued to work on biosimilar development and innovative new molecular antibody entities, which now within the Polpharma Biologics group can be extended to GMP production and clinical testing
DR. LOUIS BOONChief Scientific OfficerBioceros
Dr. Beatrix Metzner studied chemistry at the University of Regensburg and the Albert-Ludwigs-University of Freiburg where she was specialized in biochem-istry. Furthermore she was PhD student at the Department of Experimental Dermatology at the University of Freiburg and Post Doctoral Research Fellow at the Memorial Sloan-Kettering Cancer Center in New York. From 2000 until 2005 she worked at MediGene AG as Senior CMC Project Manager and from 2006 until 2013 at Merck KGaA (Merck Serono) as Director Global Regulatory Oncology. In November 2013 she took over the position as Head of Global Regulatory CMC Strategy Biosimilars and since January 2015 as Director Glob-al CMC Strategy and Tech RA, both at Boehringer Ingelheim.
DR. BEATRIX METZNERDirector Global CMC Strategy & Tech RABoehringer Ingelheim Pharma GmbH & Co. KG, Germany
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