Amer Alghabban, GXP Quality Assurance, Karyopharm Therapeutics
Amer has over 26 years of experience in the pharmaceutical industry. Prior to joining Karyopharm, he was the Managing Director of GxP Compliance and Training Partners (GCTP) helping pharmaceutical companies and aca¬demic institutions to achieve compliance with GCP, GVP and GLP. Prior to that, he was Global Director, Head of Quality Assurance & Audit Management at Merck Serono. Mr. Alghabban has published 2 references books, Pharmaceutical Medicine Dictionary and Dictionary of Pharmacovigilance. He was Assistant Editor for 11 medical journals and an invited Course Director for Pharmacovigilance Auditing at the UK RQA.
Caroline Beaudoint, Clinical Trial Manager, Boston Scientific
Caroline Beaudoint has been involved in clinical trials in the medical device industry for 12 years. She has held various positions at Boston Scientific, including Lead Clinical Research Associate whose main responsibility was study wide compliance oversight. In her current role as Clinical Trial Manager, Caroline is leading clinical studies outsourced to a CRO, focusing on clinical studies and programs in Japan. She is responsible for the design, planning, execution and vendor oversight of the trials and for leading cross-functional clinical teams and clinical programs.
Eric Leire, President & CEO, DanDrit Biotech
Dr. Eric Leire is the CEO of DanDrit Biotech USA. The vision of DanDrit is to radically improve outcomes for patients with unmet needs in oncology and HIV/AIDS. DanDrit is focused on using genome editing, gene therapy, gene regulation and cell therapy science to harness the power of the immune system. The company develops a dendritic cell-based immunotherapy for the treatment of advanced colorectal cancer (Phase II/III clinical trial). Dr. Leire brings to the company:
• Pharma experience: Pfizer, Schering Plough, Pharmacia
• Biotech experience: CEO of 2 US venture-backed biotech companies, Partner
at BioStrategies (Boston)
• Academic experience: Research Associate at the Harvard AIDS Institute
• Private Equity experience: Partner at Biofund Venture Capital
He also currently serves as a member of the Board of Directors of Novicol Life (Canada) and Blake Insomnia (OTCQB: BKTI). Dr Leire has an MD from Grenoble University and an MBA from HEC and Kellogg School of Management, Northwestern University. Dr. Leire is also the inventor of several patents
Henrik Torp Nielsen, Head Medical Affairs Finance, Novartis
Finance professional with more than 20 years of international experience including different finance roles in Fast Moving Consumer Goods and Pharma (Novartis) while living and working in Denmark, UK, US, Italy and Switzerland.
Medical Affairs focus since 2012 working with scientists from across the world and engaging with scientific community in collaborations, clinical trials, medical activities and increased financial transparency.
Sabrina Wijnen, Managing Director, Clinitude
Sabrina Wijnen is the founder and Managing Director of Clinitude, a no-nonsense CRO known for its pragmatic clinical monitoring services and broad regulatory experience. Prior to devoting her work fulltime to build Clinitude, Sabrina was active in clinical research for several years with respected international CRO’s, resulting in more than 14 years of experience in managing European studies and a deep familiarity with all phases of clinical development. Early 2006 Sabrina founded Clinitude to service the Belgian market with high quality monitoring and project management services. Not much later the services were expanded to other European countries, additionally Clinitude has build an extensive understanding of European regulatory requirements.
In 2014 Sabrina Wijnen started Clinitude’s Asian Clinical Operations with a permanent offshore team in the Philippines and Singapore to service the surrounding countries. In 2016 Sabrina Wijnen introduces Clinitude’s latest product, the ‘CRA Liaison’, to redefine the traditional CRA role with a highly efficient new approach to increase the efficiency and quality of the traditional CRA on site.
Véronique Freund, Quality Head Europe & APAC, Sanofi
Currently Head of Europe & APAC Clinical External Parties Quality Management (CEPQM) and Deputy Global Head at Sanofi.
CEPQM department is in charge of development and deployment of the outsourcing strategy and model for Clinical Operations.
I am also Leader of a group of Subject Matter Experts ensuring the quality and integrity of Interactive Response Technology (IRT) for all R&D studies.
I have 20 years of experience in Clinical Quality Assurance with extensive expertise in the audit strategy and methodology in GxP domains and process optimization.
Expands expertise for 10 years in services providers governance and oversight.
Anne Dirix, Company Manager, DigiDyco
During my career, I have been working mainly within the pharmaceutical sector and more specifically in clinical research. First I developed a broad experience as CRA. Later I became clinical operation manager at Astellas, where I contributed to increasing performance in clinical operations. When I became aware of the growing complexity, I realized the pharmaceutical industry would benefit from simplified processes. This led me to a new professional challenge: designing practical and easy-to-use platforms for Life Sciences.
Catherine Hoet, Business Manager, DigiDyco
Since my start in the clinical research sector in 1996, I got the chance to work in different pharmaceutical companies and gained a practical, pragmatic and consequently clear view on the currently used processes. I am convinced that these clinical processes can be simplified to gain time and manpower. This idea was my driving force to start with the development of reliable applications that excel in simplicity and efficiency.
Isabelle Naeije, Associate Global Trial Director, Novartis Pharma
Isabelle Naëije has a Master in Sciences degree in bio-engineering (Free University of Brussels, Belgium). Her thesis was devoted to the study of the protein MxiC in the regulation of the type III secretion system of Shigella flexneri. She works for Novartis Pharma AG, Basel, Switzerland. She is an Assoc. Global Trial Director in charge of several trials (phase I to IV, oncology). Before taking this role, she worked during 5 years at Actelion Pharmaceuticals Ltd, Switzerland as Project Manager in the Clinical Pharmacology department. She moved to Switzerland in 2011 after 5 years spent as Global Study Manager at GlaxoSmithKline Biologicals, Belgium. Prior to moving to the pharmaceutical industry, she worked as on-site clinical Research Assistant at the Erasmus University Hospital, Belgium. In 2014, she became a certified Project Management Professional from the Project Management Institute (PMI).
Gaby Anthonijs, Early Development and Alliance Suppliers Strategy Lead I BRQC Janssen Quality Planning & Strategy, Janssen Pharmaceutical
Gaby Anthonijs brings over 30 years of pharmaceutical experience as she began her career at Solvay as a Scientific Associate (CRA) and subsequently held global management positions at Glaxo, Astra Pharmaceutica, Janssen Pharmaceutica, Yamanouchi Europe, Medtronic (medical devices), Farma Research, MSource, Astellas and Johnson & Johnson. She served as the VP/General Manager at a full-service CRO in the Netherlands with a 40-bed Phase I unit. Gaby received a Bachelor of Medicine and her M.Sc. from the Free University Amsterdam in Medical Sciences.
Gaby Anthonijs re-joined Janssen Pharmaceutical Companies of Johnson & Johnson in November 2011 whereby she was globally responsible to develop and establish an E2E Vendor Lifecycle Management strategy, process and oversight including Performance Management of the various vendors (or vendor types) through mutually agreed Key Performance Indicators (“metrics”) as well as issue capturing, tracking, resolution and escalation. Since Jan. 2014, Gaby Anthonijs is in the position of CRO Q&C Liaison, responsible for ensuring effective harmonization, central coordination, implementation and maintenance of activities associated with Quality & Compliance oversight associated with global CRO vendors to ensure Inspection Readiness. Since Nov. 2016, Gaby Anthonijs is in the position of Alliance Suppliers Strategy lead, Strategic Sourcing Network Quality Lead at BioResearch Quality & Compliance Janssen (BRQC) Janssen Quality Planning & Strategy. In May 2017 she was asked to also take the responsibilities of Early Development ESP Oversight as a Lead.
Michele Marzola, Chief Executive Officer & Founder, Interceptin
Founder & Investor in Life Science companies, with more than 20 active projects; previously General Manager, IBM Global Services EMEA and Principal, Booz Allen & Hamilton. MBA Columbia University, MS Università di Bologna.
Ian Lauf, Head, Clinical Business Operations, Shionogi
Ian Lauf has approximately 17 years of experience working in global outsourcing roles within the biopharmaceutical industry supporting drug discovery, pre-clinical, clinical development (Phases I-IV), sales, marketing and manufacturing activities. He has worked at numerous sponsors of all sizes and in various positions ranging from entry level analyst to head of department. Ian is currently Head, Clinical Business Operations at Shionogi Inc. where he is responsible for overseeing clinical outsourcing, site budgeting/contracting and R&D finance. Prior to Shionogi, Mr. Lauf was Founder & CEO of ClinSource Global, Inc., a management consultancy dedicated to providing strategic and operational outsourcing advisory services, M&A due diligence, market trend analyses and other services to life sciences companies (pharma, biotech, med device), financial institutions (private equity firms, hedge funds, venture capital firms), government agencies, law firms and management consultancies. Ian holds a BS in Public Health from Stockton University, an MBA in Pharmaceutical Business from University of the Sciences in Philadelphia and is planning to start a Doctorate in Business Administration at the University of Florida in Fall 2018.
Jan Mous, Senior consultant, MRM Consulting
Senior consultant / owner of MRM Consulting GmbH, in Giebenach (Switzerland). Nanomedicine consultant BaselArea.swiss (2015- )
Education: 1980: PhD in biochemistry at the University of Leuven (Belgium); 1981 –1984: post-doctoral stays at the Rega Institute in Leuven (1981) and at the Institute of Molecular Biology II of the University of Zürich (Switzerland, 1982-1984);1993: venia docendi of the University of Basel (Switzerland).
Professional career: 1985-2000: R&D manager at Hoffmann-La Roche’s Pharma division in Basel (Switzerland), former positions: Head of Molecular Virology (HIV, HSV, HCV); Department Head Molecular Biology, Deputy Head CNS research; last position: Senior VP, Global Head Genomics; 2000-2002: CSO of LION bioscience AG, a bio-IT company in Heidelberg (Germany) and non-executive director of LION bioscience Inc.(Boston, MA); 2003-2007: President & CEO of Molecular Diagnostics company IntegraGen SA in Evry (France); 2008: independent consultant, MRM Consulting GmbH, in Giebenach (Switzerland); 2009-2015: CEO of PharMida AG, Basel, a clinical nanomedicine company, affiliate of Midatech Ltd., Abingdon, UK
Marion Wolfs , Associate Director Risk Management Central Monitoring, Janssen Pharmaceutical
Marion holds a Master of Science degree in Biomedical Sciences. She started working career as a scientist at the National Institute for Public Health and Environment in the Netherlands. In 2007 she has joined the Pharmaceutical Industry in clinical operations. Since 2013 she is the associate director of the Risk Management and Central Monitoring group with in the GCDO organization of Janssen, JnJ. As such she is responsible for designing, planning and executing central monitoring aspect of clinical trials being conducted under analytical risk based monitoring (RBM) at Janssen, both for their in-house and outsourced trials, and taking lead on continuous improvement of ARBM processes. Marion is also the CRO forum engagement lead in the Transcelerate Risk Based Monitoring work stream.
Craig Elliott, Global Head Clinical Operations, Clintec
Global Head of the Clinical Operations at Clintec responsible for turning data into “meaningful management information”. Following a degree in Physiology and a PhD in Respiratory and Exercise Physiology at Newcastle University, he stated life in the pharmaceutical industry as a CRA at Wyeth. He has 25 years experience within the industry, working within numerous global clinical operation functions, performance management and process improvement groups in both large pharmaceutical and medium CROs companies. He has a special interest in risk based monitoring, quality improvement and performance management.