CEO, amcure ,
Session Details: Unleashing the full potential of combination treatments: Bringing a whole new flavour to oncology trials 28-11-2019, 12:15 pm View In Agenda
Project Director, Modra Pharmaceuticals,
Biography: Marianne Keessen is Project Director at Modra Pharmaceuticals, where she is responsible for the operational management of Modra clinical trials. She has a clinical background in oncology, mainly focused on early phase clinical trials. Prior to Modra, she worked for over 25 years at the Netherlands Cancer Institute - Antoni van Leeuwenhoek (NKI-AVL) as a nurse practitioner and project manager, and was project manager for a nationwide study in biogenetic research in oncology at the Center Personalized Cancer Treatment (CPCT). Marianne holds a master’s degree in nursing and in business (MBA).
Session Details: CASE STUDY: Outlining challenges and lessons learned during phase I oncology trials for a more timely and cost-effective process 28-11-2019, 3:15 pm View In Agenda
Regional Business Leader Health and Life Sciences EMEA, Microsoft,
Session Details: Harnessing benefits of AI applications to pharma and healthcare 27-11-2019, 3:45 pm View In Agenda
Head of Clinical Trials, Swedish Medicines Agency,
Biography: Gunilla Andrew-Nielsen has held her current position as Head of Clinical Trial and Special Permission at the MPA in Sweden during seven years. Since the early 1990s, she has held various positions within global R&D in the pharma industry including project and training management and later as Director of Quality Assurance.
Session Details: Swedish Medicines Agency Spotlight: Overcoming challenges with new clinical trial regulations 28-11-2019, 1:45 pm View In Agenda
European Lead, Patient Innovation, MSD,
Biography: Paul qualified in medicine and after 10 years in cardiology in the NHS, joined the pharmaceutical industry, with experience in clinical trial operations, medical affairs and patient engagement. He represents MSD in PARADIGM, a pan European project to make patient engagement in clinical development the norm. He continues to practice medicine and is a member of the NICE committee that decides whether new medicines should be paid for by the NHS in England.
Session Details: PANEL DISCUSSION: How can we place patients at the centre of our oncology trials to improve patient centricity through engagement and retention? 28-11-2019, 11:00 am View In Agenda
Global Director Clinical Operations, Novocure,
Biography: Leszek Bialecki is a Global Director Clinical Operations at Novocure. He’s been working in Clinical Development for the past 20 years holding various positions at top pharmaceutical companies and was involved in successful completion of major clinical programs resulting in marketing authorizations in North America, Europe and Asia. In his current position, as a senior member of the R&D team he’s responsible for shaping company’s clinical development strategy as well as leadership of the rapidly growing clinical organization.
Session Details: LIVE DEBATE: ‘Patient recruitment is most successful when taking the grass roots approach compared to spending millions on social media’ Do you agree or disagree? 27-11-2019, 10:00 am Challenging your vendor and understanding their mind-set to better that partnership 27-11-2019, 12:15 pm PANEL DISCUSSION: How can we place patients at the centre of our oncology trials to improve patient centricity through engagement and retention? 28-11-2019, 11:00 am View In Agenda
Chief Scientific Officer, Neovii Pharmaceuticals,
Biography: Dr. Sachse holds a degree in medicine and a board certification in Clinical Pharmacology. With more than 25 years experience as a physician and scientist, he has extensive expertise in a variety of different therapeutic areas. In addition to registration studies, he is especially experienced in the design and implementation of translational programs to bridge research programs to the clinic, as well as in the design and implementation of clinical pharmacology programs, enabling successful registration of products at the international level. He has broad general management experience with a focus on leading high performing organizations and change management.
Session Details: Speaker Hosted Roundtables 28-11-2019, 9:00 am View In Agenda
Associate Director, Lead Study Management,Takeda
Takeda Pharmaceuticals International 2016 – Present
Associate Director, Lead Study Management
Medical Affairs Europe and Canada
Novocure 2015 – 2016
Clinical Trial Manager
Novartis Pharma Schweiz 2012 –2015
Project Manager, Oncology Business Unit
Celgene International 2010 – 2012
Clinical Trial Associate, Oncology Clinical Operations
Inselspital, Children’s Hospital Bern – Switzerland 2010
Research Associate – Pediatric Oncology and Hematology
Children’s Hospital Zurich 2009 –2010
Research Associate – Pediatric Oncology and Hematology
University of Naples, Italy 2005 –2008
Research Associate – Endocrinology and Oncology Department & Diagnostics, Biotechnology Department
University of London - Epidemiology, 2010
Federico II University of Naples
Master of Science in Medical Biotechnology, 2007 – 2008
Federico II University of Naples
Bachelor of Science in Biotechnology, 2003 – 2006
Session Details: Evaluating recruitment and engagement strategies to develop a successful rare indication drug development model 28-11-2019, 11:45 am View In Agenda
Co-Founder and Managing Partner, admedicum Business for Patients ,
Biography: Andreas is a health-care professional and entrepreneur in the field of patient-centered health-care. He is a state-registered pharmacist and earned a PhD in Pharmacology from the Johann Wolfgang Goethe-University, Frankfurt, Germany and an MBA from the University of Bradford, UK. He has more than 27 years of experience in health care: 4 years of academic research in pharmacology, more than 7 years in the pharmaceutical industry (clinical research, international marketing, drug information), more than 12 years as President, CEO and Managing Director in patient organizations. He was serving as a patient-representative at the Federal Joint Committee (G-BA), the central steering body in the German health-care system for almost 11 years. He held multiple volunteer positions at national and European level in the board of patient-organisations. In 2015, Andreas established admedicum® that helps companies and health-care providers aligning their products and services with the needs of the patients along the life-cycle from early development over clinical development and market-access to commercialization.
Session Details: Speaker Hosted Roundtables 28-11-2019, 9:00 am Case study on large scale patient engagement programme: Patient Engagement supporting recruitment in an ATMP-clinical trial 28-11-2019, 2:15 pm Live Debate: ‘This House Believes that Brexit Will Stimulate Clinical Trial Innovation in the UK’ 28-11-2019, 3:45 pm View In Agenda
Head of Clinical Research, Global Clinical Operations, Janssen-Cilag ,
Biography: PHD in Chemistry in 2001 Started in the area of Clinical Research at Abbott in Wiesbaden in 2002 and moved to PAION in Aachen in 2005. Started at Janssen in Neuss in 2007, first as Local Trial Manager and then in 2012 as Clinical Research Manager (i.e. Unit Head for Hemato-Oncology).
Session Details: The ePRO hype: Discussing the use of ePROs for individual patient care in oncology trials to achieve better symptom control and more effective data management 27-11-2019, 4:15 pm View In Agenda
Head of Clinical Operations,Medigene
Biography: Jessica Cordes studied Molecular Life Science in Luebeck and started her business career for 2 years at the Central Lab MDS Pharma Services as project manager. She moved then to GlaxoSmithKline where she worked as country project leader for 4 years. In 2013, she moved to MorphoSys, working for four years in an international role as clinical trial leader. 2017 she moved to Medigene headquarter as clinical trial manager and is now leading the Clinical Operations group since 2018
Session Details: Chair Opening Remarks 27-11-2019, 8:15 am Chairman’s Closing Remarks & Drinks Reception Sponsored by CROWN CRO 27-11-2019, 4:45 pm Chair Opening Remarks 28-11-2019, 8:15 am Case study on large scale patient engagement programme: Patient Engagement supporting recruitment in an ATMP-clinical trial 28-11-2019, 2:15 pm View In Agenda
Global Feasibility Lead, Janssen: The Pharmaceutical Companies of Johnson & Johnson ,
Biography: Pinal Patel is a Global Feasibility Lead - Oncology within Global Clinical Development Operations at Janssen: The Pharmaceutical Companies of Johnson & Johnson. In her current role, Pinal is responsible for strategy and implementation for country selection encompassing protocol planning and patient insights. Prior to joining Janssen, she was an Engagement Strategy Lead at Bristol-Myers Squibb where she focused on building novel, fit for purpose patient and site centric strategies to drive enrollment for clinical trials in Oncology arena. Understanding the patient journey was at the center of it all in identifying risks and opportunities to achieve the end result. Pinal graduated from Connecticut College, USA with a B.A. in Psychology.
Session Details: LIVE DEBATE: ‘Patient recruitment is most successful when taking the grass roots approach compared to spending millions on social media’ Do you agree or disagree? 27-11-2019, 10:00 am Speaker Hosted Roundtables 28-11-2019, 9:00 am Live Debate: ‘This House Believes that Brexit Will Stimulate Clinical Trial Innovation in the UK’ 28-11-2019, 3:45 pm View In Agenda
Ex. Director Medical Affairs, Beigene Switzerland GmbH,
Biography: Dirk Weber is an MD, PhD with 20+ years of Pharma Industry experience in Drug, Business and Corporate Development from executive leadership positions at Merck Serono, Novartis and Takeda and entrepreneurial experience from co-founding 2 Biotech companies leading them as Chief Medical Officer to clinical stage. Dirk has worked in early and late-stage Clinical Development, conducted successful filings, led submissions teams, has developed a regional oncology Medical Affairs organization (MSL, Medical Director) and has extensive experience in conducting Medical Affairs activities to prepare for successful commercial product launches. He has longstanding oncology drug development expertise in haemato-oncology and worked on major oncology brands for Novartis (Afinitor – Breast), Merck Serono (Erbitux - CRC) and with Takeda on ADC Adcetris (Hodgkin and non-Hodgkin Lymphomas), proteasome inhibitor Ixazomib (Multiple Myeloma) and on IO drug Mepact (Osteosarcoma). He has excellent regulatory filing and launch experience throughout career.
Session Details: KEYNOTE: Implementing best practices for identifying and selecting a CRO with a global presence and the indication-specific knowledge you require 27-11-2019, 9:00 am View In Agenda
Patient Engagement and Advocacy Lead, Janssen, the Pharmaceutical Companies of Johnson & Johnson,
Biography: In this function, Daniel is part of a global multi-functional leadership team that helps the company to engage with patients in a systematic way, and helps to build partnerships in developing solutions that better meet the existing needs. He also leads a group of colleagues in the region who play a crucial role in working towards a more collaborative approach in innovation. Daniel De Schryver joined Johnson & Johnson in 2001 as Director Corporate Communications. In that function, he initially worked in the field of oncology. In 2006 he joined the Janssen teams working in Infectious Diseases where he helped to maintain and enhance the company’s relationships with the HIV Patient Community. Later, he built the external relationships in the field of Hepatitis C, before becoming the Global Therapeutic Area Communications Leader Infectious Diseases and Vaccines. In this function he developed world wide strategic communications and public affairs programs about infectious diseases and global public health. Daniel has a Master in Romance Philology (Literature) and he started his career as a teacher. After having worked in communications roles in the car industry for several years, he joined the non-profit sector and became country manager for Médecins Sans Frontières in Bosnia, Croatia and Angola. Back in Europe, he headed the Communications department for the organization. Before joining Johnson & Johnson, he worked at Burson-Marsteller as a consultant on corporate communications. His personal interests are contemporary art and architecture, politics and meeting people.
Session Details: Speaker Hosted Roundtables 28-11-2019, 9:00 am PANEL DISCUSSION: How can we place patients at the centre of our oncology trials to improve patient centricity through engagement and retention? 28-11-2019, 11:00 am View In Agenda
Head of Scientific & Medical Affairs, Philip Morris,
Biography: Dr. Alexander K. Nussbaum studied biochemistry in Tübingen, Germany, and the USA. He conducted 10 years of immunological research on vaccines against viral infections and tumors in Germany, the USA and France. At the time, he held lectures on cancer, in which he recommended his audience to stop smoking to avoid home-made risks of cancer. After spending 8+ years in Medical Affairs roles in the pharmaceutical industry in the fields of autoimmunity and cancer, Dr. Nussbaum joined Philip Morris Germany in December 2016. As Head of Scientific & Medical Affairs he engages with scientific and medical communities, media, authorities and the broader public on PMI´s scientific assessment program and tobacco harm reduction. He is convinced that novel, potentially risk-reduced products offer a historic opportunity for the prevention of smoking-related diseases and thus hold enormous potential for public health.
Session Details: 2019 Update: A non-pharma real-life case study for achieving FDA authorization 27-11-2019, 2:15 pm View In Agenda
Founder and Chairman of the Board, aPODD,
Biography: Cesare has more than 20 years of experience in the drug development field, in both scientific and commercial roles. He is co-founder and Chief Operating Officer of Oncoheroes Biosciences Inc., a Boston-based biotech company exclusively focused on paediatric oncology drug development. Prior to that he held senior positions at AMRI, Aptuit Laurus, ThalesNano and Auxiliis BV. Cesare started his career as research scientist in a pharmaceutical company (Eisai, London) and in academia (Institute of Enzymology, Budapest). Following the death of his first daughter Laura to cancer, Cesare set up aPODD Foundation, a London-based charity focused on accelerating paediatric oncology drug development. As aPODD’s chairman and trustee he is actively involved on a pro-bono basis in drug repurposing projects, advocacy efforts and research collaborations with other childhood cancer charities. Cesare holds an MSc in Applied Molecular Biology and a PhD in Neurosciences from UCL, University of London, as well as an MBA from the Central European University, Budapest.
Session Details: LIVE DEBATE: ‘Patient recruitment is most successful when taking the grass roots approach compared to spending millions on social media’ Do you agree or disagree? 27-11-2019, 10:00 am CASE STUDY: Designing oncology trials to include adolescents/paediatric patients and how to overcome common operational pitfalls 27-11-2019, 11:15 am View In Agenda
Senior Editor, Global Data,
Biography: Jennifer C. Smith is Senior Editor for GlobalData’s investigative, science journalism team based in New York and London. An award-winning healthcare journalist with a deep knowledge of the US and European pharmaceutical, regulatory and pricing/reimbursement sector, Jennifer works closely with other management on editorial strategy and output, mentors and trains junior reporters and is responsible for wide-ranging editorial projects. Her passion for healthcare and science-related news, with a particular focus on government and public and social policy, has led to diverse reporting experience across the US and internationally over the past decade.
Session Details: LIVE DEBATE: ‘Patient recruitment is most successful when taking the grass roots approach compared to spending millions on social media’ Do you agree or disagree? 27-11-2019, 10:00 am PANEL DISCUSSION: How can we place patients at the centre of our oncology trials to improve patient centricity through engagement and retention? 28-11-2019, 11:00 am Live Debate: ‘This House Believes that Brexit Will Stimulate Clinical Trial Innovation in the UK’ 28-11-2019, 3:45 pm View In Agenda
Board Chairman, A1M Pharma AB,
Session Details: Live Debate: ‘This House Believes that Brexit Will Stimulate Clinical Trial Innovation in the UK’ 28-11-2019, 3:45 pm View In Agenda
Senior VP Clinical Operations EU,Precision for Medicine, Oncology & Rare Disease
Biography: Veteran of global oncology clinical operations, with in-depth experience in phase 1–3 oncology and hematology research as well as early-phase studies. Builder of world-class oncology research teams and leader of strategic growth of resources and operations across Europe. Keenly focused on study delivery, mitigation of study risk, and client service.
Session Details: Innovations in biomarker driven oncology 27-11-2019, 11:45 am View In Agenda
Session Details: Key considerations for sourcing and managing data handling services, processes and systems in oncology trials 27-11-2019, 2:45 pm View In Agenda
Senior Director, Oncology Strategy, IQVIA Biotech,
Biography: With 25 years of experience across all phases clinical development spanning large pharma, CROs, consulting and software companies, as well as recently managing a leading oncology phase I clinical research unit in Central London, Matt is part of IQVIA Biotech’s Oncology Strategy team, using this experience to support operational teams and clients in developing robust clinical strategies for novel anti-cancer therapies.
Session Details: Operational Nuances in CAR-T Trials: Experience Sharing and Key Considerations 27-11-2019, 9:30 am View In Agenda