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 interaction analysis throughout drug discovery, development and manufacturing processes. Addition­ally, he also advises on GE Healthcare R&D projects, Vaccine 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.

Dr. Liedert, trained as a pharmacologist, is familiar with both sides of the table, 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 Strategic 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/biosimilar­ity exercises.

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 innovative markets, hav­ing worked on the launch of Cimzia and more recently on Remicade. At Hospira / Pfizer Caroline coordinated the launch of first Monoclonal Antibody Biosimilar, Inflectra (Infliximab), across the world.

Uwe Gudat received his medical degree from the University of Marburg, Germany. 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 has more than 20 years of experience in clinical drug development within 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 Biosimilar 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 pharmaceutical 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.

Angeles Escarti-Nebot gained BSc in Pharmacy from the Complutense University 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 medicinal 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 innovative 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 particular focus on nonclinical studies for biotechnological products and ATMPs.

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 chair­man 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.

Over 20 years in pharma industry with last 10 years working in the area of bio­similars. Formally Global Head of Medical Affairs at Sandoz biosimilars working 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. 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 research 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.

Dr. Beatrix Metzner studied chemistry at the University of Regensburg and the Albert-Ludwigs-University of Freiburg where she was specialized in biochemistry. 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 Global CMC Strategy and Tech RA, both at Boehringer Ingelheim

Riccardo received his Master degree in Chemistry and Pharmaceutical Technolo­gies from the University of Rome La Sapienza and his PhD from the University 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 University, working on the mechanisms responsible for covalent protein aggregation during oxidation. From 2013 until November 2015, Riccardo worked as Project 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.

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 insights for the industry and its associations on generic medicines and biosimilars 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.

Jane Hippenmeyer was appointed Director of Scientific Affairs Amgen Biosimilars Europe in March 2016. In this role she is responsible for the creation of Scientific Affairs structures in European affiliate countries, to prepare for the launch of Am­gen Biosimilars in Oncology and Inflammation. Jane is additional responsible for the execution of Scientific Affairs educational initiatives, advisory boards, medical society engagement and internal and external education on Amgen Biosimilars. Jane has been with Amgen Europe since 2004, when she joined the Medical Com­munications team. She has worked on the launch of several of Amgen’s Oncology Biologics within Europe, most recently working on Blinatumomab (Blincyto). Prior to joining the Pharmaceutical Industry, Jane worked as Director of Drug Informa­tion Service at Memorial Sloan-Kettering Cancer Center, where she oversaw the hospital formulary decisions. Jane holds a Bachelor of Science in Pharmacy from the University of Illinois, Chicago and her Doctorate of Pharmacy from University of the Sciences in Philadelphia.

Ian Thompson has been with Ypsomed AG, formerly Disetronic AG, since 1995 in a number of roles, including 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 1979-83, working initially in commercial roles for fermentation technology. He has worked in medical device companies since moving to Switzerland 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 manufacturing of next-generation pen, autoinjector, and wearable injector technologies.

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.