Dr. Steinar Madsen
Medical Director, Norwegian Medicines Agency
Dr. Steinar Madsen, is medical director at the Norwegian Medicines Agency.
He is a specialist in internal medicine and cardiology and works part time as a consultant in cardiology. He has been working with generic substitution since it was introduced in Norway in 2001. He is member of a working group at the Agency that is looking into several aspects on the regulation of generic substitution in Norway, including biosimilar drugs, with the aim of a better legal framework. Dr. Madsen is also engaged in the Agency’s drug information service, with a special interest in the safe use of drugs.
Vice President (Technical) PAREXEL
Gained BSc (Hons) in Biochemistry from University of Cape Town and has been working in regulatory affairs and clinical development for over 30 years; for the last 25 years focused on biological medicines. Particular expertise in monoclonals and biosimilars, having worked on over ten such programs and participated extensively in Industry and International meetings on the subject.
Joined PAREXEL in February 2001 and has been involved with issues relating to clinical development, regulatory submissions, biosimilars, orphan drugs and training. In the last five years alone has worked on scores of clinical development plans connecting the input from pharmacologists, statisticians, therapeutic experts, and feasibility analyses to craft development plans which are effective, highly efficient and achievable with extensive experience in the field of inflammatory disease.
Cecil has particular expertise in regulatory, biotechnology and clinical development and is a well-known expert on biosimilarity and comparability. Most recently Cecil has been extensively involved in the development of monoclonal biosimilars and has supported a number of global marketing applications. He has been a frequent international speaker and author on the topic of biosimilars and comparability.
Chief Executive, British Biosimilars Association
Mark Samuels is the Chief Executive of the British Biosimilars Association and its sister body, the British Generic Manufacturers Association, representing the companies that supply four out of five medicines used by the NHS.
Mark’s career has spanned diverse experiences across the life sciences sector. He is a former executive at Roche and co-founded the Medicines Discovery Catapult Ltd. He was the founding Managing Director of the government’s Office for Clinical Research Infrastructure – instrumental in managing the Department of Health’s £0.6 billion/year investment in research centres across the NHS. Mark served for seven years on the Chief Medical Officer for England’s strategy board for health research, and he has worked with Number 10 to contribute to the Prime Minister’s strategy for life sciences.
Mark is a graduate of QMUL and Oxford’s Saïd Business School. He has also held a Policy Fellowship at Cambridge University.
Board Member, Non-executive Director, The RSA Group
Jo Pisani is a Management Consultant and Chartered Engineer with three decades of senior commercial experience.
Jo graduated from Bristol University with a Physics degree and then – becoming a Chartered Engineer – began her career as an engineer at BP. That was followed by eight years as a project director at SmithKline Beecham (now GSK); she later progressed into a senior role at management strategy consultants Booz Allen Hamilton. Until 2019 Jo was a partner with PwC Strategy, leading the UK Pharma and Lifesciences practice; a 500-person business, focused on supporting clients with strategic planning, consulting, tax, audit, and deals.
More recently, as well as joining The RSA Group, Jo has taken Board positions at the Dementia Research Institute, a £290M initiative leading the UK’s dementia research efforts, the University of Strathclyde, and MedCity in London.
H. Fai Poon
President, Quacell Biotech Ltd
Dr. Poon is currently the President of Quacell Biotech Ltd. He previously worked for Hisun Biopharm, Merck (SAFC), Roskamp Institute in USA. He completed his Ph.D. in Biological Chemistry at University of Kentucky, and MBA from University of South Florida. He has years of experience in the field of biological therapeutics, analytical research, bioinformatics and proteomics. He has more than 10 years of cell culture experience with focus on biopharmaceutical products.
He published more than 30 peer-reviewed articles, and contributes to more than 5 book chapters. He is currently the managing editor for biomedical and pharmacology journal ; associate Editor for Journal of Chemistry, Biochemistry; and Molecular Biology, Band Journal of Bioinformatics and Biometrics.
Research Interest: Biotherapeutics; proteomics, metabolomics, cell line engineering, cell cultures, multivariate analysis, QbD, PAT.
Executive Chair, The RSA Group
Global Scientific Officer, Biogen Biosimilars Unit (BBU)
As Scientific Officer of the BBU Global Headquarter in Baar, Switzerland, Dr. Burkhard Pieper is responsible to advance the scientific understanding of biosimilars across stakeholders and to support early accessibility of biosimilars to patients eligible for the treatment with biologics. In his role he is collaborating with key medical experts, scientific societies and organizations, and patient advocacy groups across several therapeutic areas and geographies.
Since 2015 he was heading up the BBU Global Scientific Affairs team, leading the medical and scientific launch readiness for our anti-TNF and anti-VEGF portfolios.
CEO, The Danish Generic and Biosimilar Medicines Association
Peter Jørgensen has a Master in Political Science from the University of Copenhagen, 1977. 42 years of professional experience, including: Head of section in the Ministry of Social Affairs, Head of section in the Ministry of Labour, Labour Counsellor at the Danish UN-mission in Geneva, Health Counsellor at the Danish EU-representation in Brussels, Spokesman in the European Commission in Brussels for the Danish Commissioner for Environment and Climate Change, Advisor in the Cabinet of the Danish Minister for Health, Head of International Affairs in the Association of Danish Pharmacies (pharmacy owners)
Since 2013, Peter, is the CEO in The Danish Generic and Biosimilar Medicines Association. He is a Member of the Board of Medicines for Europe, a Member of the Board of DMVO (Danish Medicines Verification Organisation), a Member of the Board of ENLI (Danish Ethical Committee for the Pharmaceutical Industry).
Principal, F.-X. Frapaise Pharma Consulting, Former VP. Clin Dev. Merck
Dr. Francois-Xavier Frapaise, M.D has over thirty-five years of international drug development, strategic planning and marketing experience at major pharmaceutical companies including Sanofi, Bayer and Abbott ; he has hold multiple C-level positions (CSO,CMO,CEO) in different Pharmacos in the US and Europe. He is currently heading a Development Consulting Company (FX Frapaise Pharma Consulting); he has extensive experience of biosimilars development (Merck KGaA, Boehringer-Ingelheim, Pfenex);Dr. Frapaise held an academic position at the Thrombosis Research Center at the Loyola Medical Center in Maywood (IL).Dr. Frapaise holds an M.D. degree from Faculté de Médecine René Descartes Paris France, and is an INSEAD alumni. He is President of the French Association of Pharmaceutical Medicine, IFAPP Officer and member of the Leadership team of Boston-based Trestle Compliance.
Global Head of Biopharmaceuticals Strategy, Portfolio and BD&L, Sandoz
Hoori leads Strategy, Portfolio, New Product Planning, and Business Development & licensing for the Biopharma division at Sandoz. In her role she is responsible for driving strategy and portfolio decisions for Sandoz’ biosimilar group and development choices for its pipeline of assets which has doubled over the past two years to 15+ deep. She is also responsible for driving BD&L exploration and licensing to build the Biopharma pipeline, as well as the management of alliance programs. Prior to joining Sandoz, Hoori was with Pfizer for over 20 years, where she held a number of national roles in the UK and France, including GM roles leading a number of Pfizer’s businesses. During that time she drove a number of launches and integrated acquisitions into her business. Hoori also held a number of global commercial positions at Pfizer’s HQ in New York across a variety of disease areas including cardiovascular disease, diabetes, and oncology. She holds a BSc in Chemistry and Food Science and lives in Basel.
Member of the Board of Directors, Cube RM
Nico Bacharidis is an independent Healthcare expert working with multiple companies and startups helping them developing and growing. He has spent over 13 years in the pharmaceutical industry in local, regional and global positions and in areas of Tendering & Contracting, global and local KAM, Finance, Marketing as well as General Management. Nico has built and led the global team at Pfizer responsible for the management of the worldwide Tender & Contracting business and the continuous improvement of tender processes, capabilities and policies. During this time he was also part of Pfizer’s global x-functional leadership team for Biosimilars. From 2016-2018 he has lead the Pfizer PFE Switzerland GmbH, where he was responsible for launching Biosimilars into the local Swiss market.
Visiting Professor of Cancer Medicine and Oncology, Imperial College London
Professor Justin Stebbing at Imperial specialises in a range of malignancies, their treatment with biologics (breast, GI and lung and clinical trials), having originally trained in medicine at Trinity College Oxford, where he gained a first class degree. After completion of junior doctor posts in Oxford, he undertook training and a residency programme at The Johns Hopkins Hospital in the US, returning to London to continue his career in oncology at The Royal Marsden and then St Bartholomew’s Hospitals.Professor Stebbing’s original PhD research investigated the interplay between the immune system and cancer; he was appointed a senior lecturer in 2007, and a Professor in 2009. Professor Stebbing has published over 600 peer-reviewed papers. The National Institute for Health Research (NIHR) awarded Justin Stebbing its first translational research professorship in oncology, aiming to bridge the gap between the laboratory and the patient to ensure therapy is personalised. In 2016 Justin was internationally recognised with his appointment as Editor-in-Chief of Oncogene (Springer Nature’s foremost cancer journal) and election to the American Society for Clinical Investigation.
Chief Commercial Officer, RSA Group
Based in Frankfurt, Basel and London, Kristian ensures that all functions of the organisation are aligned to meet strategic commercial objectives and drive business growth. Prior to returning to RSA in 2019, he was a Partner in two global Executive Search firms and has over 18 years of consulting experience. Kristian returned to RSA the 2nd time in July 2012 as Managing Director after working for two years as Head of Tender Management for a mid-sized German Generics company. He was responsible for handling incoming tenders which included but was not limited to scouting API vendors and CMO globally, and managing the business of the SCM, Regulatory and Quality departments. Kristian is a qualified lawyer certified in pharmaceutical law and he holds an MBA. He is fluent in German and English.
Senior Consultant, RSA Group
Poppy leads the company’s work in Pharmaceutical Services, especially CRO, CDMO, Medical Communications, Digital Health, and Personalised Medicine, bringing connections to a vast network of industry leaders from established multinationals, pioneering SMEs and start-ups. Prior to joining RSA, Poppy served as an executive search Business Manager, where she built a team of consultants operating throughout Diagnostics and Contract Services to the Pharmaceutical, Life Sciences, Cosmetics, Chemicals, Packaging and Medical Devices industries. She has substantial experience assessing C-suite executives, supporting talent functions, and working with private equity partners internationally.
Head of Global Marketing, RSA Group
Sandy joined The RSA Group in May 2019 as part of the company’s Executive Leadership Team, directing the global marketing, internal communications, and events. Sandy has over 20 years’ experience in advertising, brand marketing, PR and communications across Life Sciences, Healthcare, Education, Consumer Brands, and Professional Sports. With such a wide range of skills and experience across the whole business spectrum, Sandy provides a fresh and visionary sounding board across the business.
Senior Medical Scientific Liaison, Fresenius-Kabi
CEO & Founder, Genchrome Limited (Former Biosimilar Country Manager- Amgen- & Global Team Lead Biosimilar -Pfizer)
President & Founder, Arven Pharmaceuticals
Arven Pharmaceuticals is the Turkish R&D-based company behind the first biosimilar drug developed and manufactured from cell to final product in the country, and the first patented and produced dry powder inhaler in Turkey. Its founder and president, Zafer Toksöz, explains the company’s pioneering journey and the circumstances that have led the company to transform into a CDMO, offering its unique biosimilars development and production expertise to the global industry. Zafer Toksöz graduated from the Chemistry Department of Boğaziçi University in 1996. After the MBA degree, he has also held various management positions on Sanovel Pharmaceutical , Mr. Toksöz still remains on the company’s board of directors.
Rodeina Challand B.Sc., LLB.,
VP Scientific Affairs, BioFactura, Inc.
The 14th Biosimilars Global Congress 2022 Europe, will provides a unique platform for the convergence of stakeholders in the biosimilars industry to discuss and network with top tier government, hospitals, pharmaceuticals, biopharmaceuticals, non-profit organizations, biosimilar developers as well as regional and local manufacturers. Our event delegates include Chief Executives, Executive Directors, Vice Presidents, Heads, Team Leaders & Managers from a range of organisations including..
AbbVie Canada – Abbvie – Abzena – AGES MEA – Alliance for Safe Biologics – Amgen Inc – Applied Photophysics Ltd – Arecor – Avalere Health – AstraZeneca – Barclays – Bates White – Baxalta Inc – Baxalta US Inc – Baxter Healthcare – Benchworks Inc – Biocad Brazil – Biocad Russia – Bioeq – BioFactura Inc – Biogen Idec – Biogen International GmbH – Biogen – Biologics Consulting Group Inc – BIOMEDICA – BioPharm Insight – Biopharmaspec Inc – BioVirtus – BioWorld Today – Bird and Bird – Boehringer Ingelheim – Bristol Myers Squibb – Caprion – Cardinal Health – Charles River Laboratories – Chatfield Pharmaceuticals Ltd – CIMA Industries SA – Cipla Ltd – Clearside Biomedical – Clinigen CTS – CMC Biologics A/S – COFEPRIS – Consumer Health Forum of Australia – Cook Pharmica LLC – Deutsche Bank – Dr. Reddy’s Laboratories – Drinker Biddle & Reath – Durbin Global – Dyadic International (USA) Inc – EMD Millipore – EMD Serono – ENCB-IPN – Epirus Biopharmaceuticals – Eurofins Lancaster Laboratories – FirstWord – Fresenius Kabi – Fujifilm Diosynth Biotech – Fujifilm Kyowa Kirin Biologics Co. Ltd – GE Healthcare Life Sciences – Genentech – Geolab Pharmaceutical Industry – Glyconex – Granzer Regulatory Consulting & Services – Grupo Farmaceutico Somar – GSK – Hanwha Biologics – Hanwha Chemicals – Harvest Moon Pharmaceuticals – Hospira Inc – IMS Health – Innovent Biologics Inc – Intra – Cellular Therapies Inc – inVentiv Health Clinical – Janssen Inc – JHL Biotech Inc Taiwan – KLJ Associates – Lake Partners – Libbs Farmaceutica – Lifescience Dynamics – Lonza Biologics PLC – Lupin Pharmaceuticals India – mAbXience – Medimmune – Merck & Co – Merck Biosimilars – Merck Millipore – Merck Serono – Merck Sharp & Dome Ltd – Merck – Merckle GmbH – Milliman – MITSUBISHI GAS CHEMICAL COMPANY INC – Momenta Pharmaceuticals Inc – Multipharma – Mylan – Myoderm – Napp Pharmaceuticals – Nippon Kayaku Co Ltd – NIPTE – Norwegian Medicines Agency – Novo Nordisk – Omnicare Pharma GmbH – Orygen Biotechnologica – PARAXEL International – Patheon – PCI Pharma Services – Pfizer Inc – Plexus Ventures Limited – PPD – PRA Health Sciences – PRA International – Probiomed S.A de C.V – Protagen Protein Services GmbH – Qually Corporacion S.A de C.V – Queens University – Ratiopharm – Roche Farmaceutica – Sanape LLC – S &Oz Inc. (a Novartis Company) – Sciex Separations – SciMentum – SGS Group Ltd (USA) – SGS Life Sciences Services – SGS M-Scan Ltd – Shanghai CP Guojian Pharmaceutical Co Ltd – Spectrum Paharmaceuticals – SPL – Stefantech Systems Inc – Sterne Kessler Goldstein & Fox P.L.L.C – Sughrue Mion PLLC USA – Sun Pharmaceuticals Industry Ltd – Taylor Wessing LLP – Teva Pharmaceuticals – Texcell – Therapeutic Proteins International LLC – Toxikon Europe – Transformity – University Alkharh EDU – Virdispharma – Voisin Consulting Life Sciences – West Pharmaceutical Services Inc – Woodley Bio Reg Ltd – Wyatt Health Management – YAKUMED – Ypsomed AG – ZOTEK King Lai Co. Ltd (KunShan)