Anna has extensively worked on a diverse set of assignments to acquire valuable experience in marketing, portfolio and project management from both big pharma, as well as generics perspective. She holds a Master of Sciences in Pharmaceutical and Healthcare Marketing from the University Paris VI, and is currently responsible for developing biosimilar commercial activities in her role as Head of Commercial Operations, Biotechnology at Gedeon Richter.
Dr. Beatrix Metzner studied chemistry at the University of Regensburg and Freiburg, Germany where she specialized in biochemistry. Furthermore she was a PhD student at the Department of Experimental Dermatology at the University of Freiburg, Germany and Post Doctoral research Fellow at the Memorial Sloan-Kettering Cancer Center in New York, USA. From 2000 she worked at MediGene AG, Germany as Senior Scientist and later as Senior CMC Project Manager.
Mr. Bryan Kim is currently Vice President of Business Development with Samsung Bioepis, where he oversees strategic partnerships and growth initiatives. He has 20 years of global experience in healthcare/pharmaceuticals, having lived and worked in US, Europe and Asia. Most recently, Mr. Kim managed emerging markets Asia business for Boehringer Ingelheim.
Cecil Nick, Vice President (Technical), at PAREXEL Consulting has been working in regulatory affairs and clinical development for over 30 years; for over 25 years he has focused on biological medicines. Cecil Nick has particular expertise in monoclonals and biosimilars, having worked on over 20 such programs, engaged in over 50 interactions and meetings with regulatory agencies in the EU, US, Canada, Australia, Mexico, Brazil and supported 6 submissions in the EU and US including the first monoclonal biosimilar to be approved in the EU and US
Dr. Dairine Dempsey is the CEO/CMO & a co-founder of Open Orphan DAC, a Dublin-based EU pharmaceutical company specialised in bringing orphan drugs to EU patients.
Dairine has over 15 years experience in the pharmaceutical industry including almost 10 years in the national regulatory authority for medicines (now the Health products Regulatory Authority).
Dr Fiona Greer was a founding Director of M-Scan (Mass Spectrometry Consultants and Analysts), contract analytical laboratories specializing in biopharmaceutical characterization. Following acquisition in 2010, she is now Global Director, Biopharma Services Development, SGS Life Sciences.
Senior Director, Clinical Pharmacology and Biosimilars Development – Scientific Affairs at PRA Health Sciences
Dr Hazel Gorham has 26 years of experience in both academia and the pharmaceutical research/industry across a wide range of roles. She also has 8 years of experience in all aspects of biosimilar development including formulating clinical development plans, study design (Phase I and Phase III) and regulatory agency discussions both at national and regional levels.
Helder Mota Filipe
Member of the Executive Board at INFARMED (National Authority of Medicines and Health Products)
Prof. Helder Mota Filipe has a degree in Pharmaceutical Sciences and a PhD in Pharmacology from the Faculty of Pharmacy of the University of Lisbon and is Associate Professor of Pharmacology and Therapeutics (Faculty of Pharmacy of the University of Lisbon).
Vice-President (2005-2015) and President of Infarmed, IP. (2015-2016) and Member of the Executive Board of INFARMED (since 2016).
Jakob is an Engineer and Materials Scientist by training with an MSc degree in Chemical Engineering from the Royal Institute of Technology in Stockholm, Sweden and a PhD in Polymer Science from the Swiss Federal Institute of Technology in Lausanne, Switzerland. He has written and published more than 30 peer-reviewed papers on medical devices, packaging materials and polymers and is a regular contributor to technical and scientific conferences.
Joanna is a patent attorney who focuses her practice on all aspects of services related to patents in the life sciences. Joanna has experience counseling clients on the Hatch-Waxman Act and is monitoring developments involving biosimilars under the Biologics Price Competition and Innovation Act. Joanna is also an Adjunct Lecturer at the Harvard T.H. Chan School of Public Health and the Editor-in-Chief of the Journal of Commercial Biotechnology.
Dr. Michael Muenzberg is currently working as an independent Consultant for Biosimilars and Biotech related topics.He was born in Austria and educated in Austria, Canada and Sweden. Dr. Muenzberg is licensed as Doctor of Nuclear Medicine and has 20 years’ experience in Pharmaceutical Industry, working as local as well as global Medical Manager/Director for Serono, Novartis, Amgen, Roche, Sandoz International Biopharmaceuticals and Merck Serono Biosimilars.
Visiting lecturer value based pricing & innovative contracting new medicines at University of Porstmouth & Former member of nice adoption & impact reference panel
Qualified with a hospital pharmacy background, Omar has been working as the Formulary Advisor for Surrey & Sussex Healthcare NHS Trust for over 15 years, sitting on the regional Joint Drugs & Therapeutics Committee as well as the CCG/Commissioning Prescribing Clinical Network.
Reenita Das is an industry expert with +25 years of healthcare marketing and consulting experience which include engaging with global clients and start ups to develop and implement growth strategies. She is a passionate visionary, futurist, innovator and thought leader working towards changing healthcare. Das currently serves as Transformational Health Partner and Senior Vice President and is the first woman Partner at Frost & Sullivan. In addition, she is the Founder of the Corporate GLOW (Growth and Innovation of Women) program.
Rodeina Challand B.Sc., Director, Challand Biosimilar Consulting Ltd., Graduate from London University with over 25 years of experience in healthcare, cancer research and pharmaceutical industry across a wide range of roles including developing and implementing clinical development strategies for biosimilars at Hospira Inc. as Director of Clinical Projects and Head of Clinical Operations in the EU.
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.
Tamal has a PhD from University of Calcutta and post-doctoral experience at University of California (San Diego, USA), IISc Bangalore and University of Massachusetts Medical Centre. Tamal has rich experience in biopharmaceutical development and regulatory strategy having undertaken extensive work in Biologics and Biosimilar product development, process development (CMC), non-clinical and clinical development strategy, comparability studies, technology transfer, global regulatory, CTD modules and analytical characterization.
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.