Session 1: Possible Avenues to Speed Up Patient Access
Session Chairs: Irmela Radtke (Roche, CH) and Judith Taylor (Thyroid Cancer Alliance, NL)
Anne Willemsen (EUnetHTA, NL)
Anne Willemsen holds a double Masters Degrees in Health Sciences, specialising in both Health Technology Assessment (HTA) and Health Policy, leading her to roles in research and project management within the Dutch National Healthcare Institute over the past few years. Anne now spearheads the team responsible for coordinating EUnetHTA Pharmaceutical Joint Assessments, working to correlate stakeholder interest and maximise positive outcomes of European collaboration on HTA. She is also involved in developing methods for patient and healthcare professional engagement within the context of these EUnetHTA assessments.
Sabrina Hanna (the cancer collaborative, CA)
Sabrina Hanna is the founder and managing director of the cancer collaborative [colab], a Canadian, not-for-profit organisation designed to bridge science, policy and advocacy to contribute meaningfully to cancer care in Canada and positively impact patient outcomes. The organisation creates system-readiness and innovation in oncology through a multi-stakeholder platform that identifies challenges and creates opportunities to collaborate on solutions to reduce silos within healthcare and shape policy to benefit patients. Sabrina served as a member of the Innovative Medicines Canada (IMC) Quebec patient Advisory Committee (2017) , the All.Can group based in Europe (2017), the Melanoma International Patient Advocates Coalition (MI-PAC 2015-17), the Global Melanoma Coalition (2015-2017), the steering committee for the Colorectal Cancer Canada Patient Charter initiative in clinical trials (2018-), and is involved in the Innovative Partnership for Action Against Cancer (iPAAC 2019-). Sabrina graduated from Concordia University in Montreal with a Bachelor of Science in Exercise Science. After receiving her BSc, Sabrina earned a certificate in public relations. Since beginning her career in research at the Jewish General Hospital in Montreal, Sabrina has dedicated her professional life to the not-for-profit sector. She founded the cancer collaborative in 2018. The cancer collaborative is a member of ASCO, ESMO, AACR, SITC and is an affiliate member of ECPC.
Bert Boer (Erasmus University Rotterdam, NL)
Bert Boer is Professor emeritus in Policy and Research for Health Care Coverage, Erasmus University, Rotterdam. He investigates and teaches contents, procedures, criteria, and policy implications of HC coverage decisions. Until 2015, Dr Boer was an Executive Member of the Board of the National Health Care Institute in the Netherlands, advising the Minister of Health on all matters related to social medical insurance. Dr Boer began his career as a General Practitioner. In 2002, he finished his PhD thesis on the relationship between HTA and Health Policy. Dr Boer was active for many years, in a range of capacities, at the crossroads of research and policy. He is involved in the international field of HTA and Health Care sustainability and is currently engaged in establishing a European HTA Network.
Ansgar Hebborn (Roche, CH)
Ansgar Hebborn is Roche Pharma’s Head of European Access Policy Affairs. In this role, he focuses on the evolution of health systems, evidence development, HTA, pricing and reimbursement pathways and their impact on patient access, and biopharmaceutical innovation. Ansgar represents Roche in relevant industry associations, such as Chair EFPIA’s European HTA Working Group in Brussels. Having spent many years within health systems and the pharmaceutical industry, Ansgar has participated in a wide range of collaborative initiatives focusing on patient access (EU HTA Network and EUnetHTA, the HTAi Policy Forum Committee, the GetReal Initiative’s Think Tank). He has been instrumental in founding other projects in this field, (the Green Park Collaborative, the HTAi Asia Policy Forum, SwissHTA, and RWE4Decisions). Ansgar was previously on the ISPOR Board of Directors and co-led ISPOR’s Vision 2020 Research agenda. In earlier industry roles, he led global pricing and outcomes research functions in Europe and the US.
Session 2: CDDF Workshops in 2021
Session Chairs: Jaap Verweij (CDDF, NL) and Paul Stockman (AstraZeneca, UK)
Axel Glasmacher (CDDF, DE)
Prof Axel Glasmacher has been an adjunct professor of medicine since 2009 at the University of Bonn, Germany. He worked in Haematology and Oncology from 1989 to 2006, focusing on haematological malignancies (notably, acute leukaemias and multiple myeloma) and infections in neutropenic patients. Prof Glasmacher coordinated the clinical study group “Refractory Multiple Myeloma”, served as Vice-chair and Chair (2002-2006) of Antifungal Therapy at the Paul-Ehrlich-Society for Chemotherapy, and was Editor for the Cochrane Haematological Malignancies Group (2003-2006). He has coordinated and co-authored medical practice guidelines for several scientific societies, including the German Society of Haematology and Oncology and the British Society of Haematology. Prof Glasmacher worked from 2006-2018 as Medical Director, Germany, Vice-President Medical Affairs (Europe, Middle East, Africa), and Head of Global Clinical Research and Development Haematology-Oncology. In these roles, he developed risk management plans for thalidomide and lenalidomide, and clinical development and regulatory submissions for drugs such as lenalidomide, azacitidine, enasidenib and luspatercept. Prof Glasmacher established an independent consultancy in March 2018, focusing on drug development, medical communication, and leadership development for medical and scientific talents in the pharmaceutical industry. These experiences have facilitated Prof Glasmacher’s engagement in the drug development process from different viewpoints. His understanding of the scientific, economic and people-oriented perspectives in this arena allow him to make a valuable contribution to current research interest in drug development at the interface between industry, healthcare structures and society.
Dónal Landers (Digital Experimental Cancer Medicine Team, CRUK Manchester Institute, UK)
Dónal Landers is Strategic Director of the digital Experimental Cancer Medicine Team (ECMT) based at the Centre for Cancer Biomarker Sciences, Cancer Research UK (CRUK) Manchester Institute. The digital ECMT is a clinical decision science research group. Its mission is to provide next-generation cancer-patient care through comprehensive data-driven evidence to transform clinical decision-making, evolve the role of patients and improve patient outcomes. The digital ECMT has developed and implemented the Technology Clinical Trial model at The Christie to enable formal testing of AI methods, software and useability of devices in an oncology patient setting, which also encompasses ethical AI design. After obtaining his primary medical degree from Trinity College, Dublin, Dr Landers spent several years practising medicine as a clinical research registrar in HIV Medicine and Infectious Diseases. He undertook an MBA at University College, Dublin before transitioning to hospital senior management at St. James’s Hospital in Dublin. Here, he was responsible for Casemix strategy and clinical performance improvement, simultaneously collaborating with the Department of Health and Children on National Clinical and Health Informatics initiatives. He conducted computer science research with Dublin City University on clinical object database development. Dónal co-chaired the IT stream for the first NCI All Ireland Cancer Conference established as part of the Good Friday peace process. After several years of working within technology start-up companies, Dr Landers co-founded his own health informatics company developing patient-centric mobile technology solutions, which empowered patients to collect and monitor their personal health data. He subsequently joined PricewaterhouseCoopers as a senior specialist consultant, becoming sectoral lead for the healthcare and pharmaceutical industry. Dr Landers joined AstraZeneca (AZ) in 2010 as a Pharmaceutical Physician in Early Clinical Development (ECD). Later, as Senior Director Physician in ECD, Innovative Medicines and Clinical Discovery, he led AZ’s first extensive multi-drug oncology umbrella study in bladder cancer (BISCAY) before going on to lead the digital ECMT and set up his own specialist consultancy, DeLondra Oncology. Dr Landers is a specialist in Pharmaceutical Medicine and a Fellow of the Faculty of Pharmaceutical Medicine at the Royal College of Physicians and has completed his specialist training (CCT). He holds a Postgraduate Certificate in Translational Medicine from the University of Manchester and registered on the GMC specialist register. He is a member of both ASCO and ESMO.
Session 3: Cancer Drug Development in a Global Setting
Session Chairs: Herbert Kim Lyerly (AAADV, US) and Jaap Verweij (CDDF, NL)
Ron Mathijssen (Erasmus MC, NL)
Ron Mathijssen studied medicine at Erasmus University, Rotterdam where he received his MD degree in 2000. Two years later, he defended his thesis, ‘Irinotecan: from Clinical Pharmacokinetics to Pharmacogenetics’. Subsequently, he became Internist, Medical Oncologist and Clinical Pharmacologist. Since 2013, Dr Mathijssen is a professor in Individualised Oncological Pharmacotherapy at the Department of Medical Oncology, heading the Translational Pharmacology section. His research focuses on ‘tailored therapy’ of systemic anti-cancer agents such as chemotherapy, anti-hormonal therapy, tyrosine kinase inhibitors, and immunotherapy. One of Dr Mathijssen’s primary goals for the near future is to implement therapeutic drug monitoring (TDM) in daily oncological clinical practice. He has published over 300 peer-reviewed papers and book chapters. In addition, he is Chair of the Dutch Pharmacology Oncology Group; a nationwide collaboration to individualise anti-cancer drug oral dosing.
Richard L. Schilsky (ASCO, USA)
Dr Schilsky is the Executive Vice President and Chief Medical Officer (CMO) of ASCO. Formerly the Chief of Haematology /Oncology in the Department of Medicine and Deputy Director of the University of Chicago Comprehensive Cancer Center, he is a highly respected leader in clinical oncology. He specialises in new drug development and treatment of gastrointestinal cancers. Dr Schilsky is a past President of ASCO (2008-2009) and past Chair of one of the National Cancer Institute’s Cooperative Groups, Cancer and Leukemia Group B (CALGB). He has spent most of his career at the University of Chicago, joining faculty there in 1984, and subsequently rising to the rank of Professor of Medicine. He served in many roles there, including Associate Dean for Clinical Research in the Biological Sciences Division and Director of the University of Chicago Cancer Research Center. From 1995 to 2010, Dr Schilsky served as Chair of the Cancer and Leukemia Group B, a national cooperative clinical research group funded by the National Cancer Institute (NCI). Presently, he serves on the board of directors at Friends of Cancer Research and the Reagan-Udall Foundation for the FDA. Dr. Schilsky has served on the editorial boards of many cancer journals, including the Journal of Clinical Oncology. He presently serves on the editorial board of the New England Journal of Medicine. He is the author of more than 400 original research articles, reviews and commentaries. Dr Schilsky’s impressive experience and accomplishments in clinical medicine and research reflect his dedication to developing cancer medicine.
Irmela Radtke (Roche, CH)
Irmela Radtke has worked in regulatory program management for more than 15 years. She led regulatory programs with increasing responsibility at regional and global levels before taking on her current position as team leader in haematology. Irmela has an integrated view of drug development across various therapeutic areas and lifecycle stages of a medicinal product. She is passionate about exploring innovative regulatory pathways for individual development programs and collaborating via multi-stakeholder platforms to improve innovation. She currently co-chairs the industry partner group at the Cancer Drug Development Forum. Irmela Radtke graduated as a food engineer from the University of Hohenheim in Germany and worked at TüV Südwest e.V., Stuttgart, before joining F. Hoffmann-La Roche Ltd. in 1995.
Angelo de Claro (FDA, US)
Dr de Claro is currently the Acting Associate Director for Global Clinical Sciences with the US FDA Oncology Center of Excellence (OCE). In this role, he leads OCE efforts to advance cancer drug development and regulatory science globally, including directing Project Orbis, a global collaborative review program, which began in 2019. Dr de Claro is also Division Director for the Division of Haematologic Malignancies I with the Office of Oncologic Diseases. He provides leadership and scientific direction to staff engaged in reviewing and evaluating applications for investigational new drugs and drug approvals. Dr de Claro is board-certified in Internal Medicine, Haematology, and Medical Oncology. He completed his Haematology -Oncology fellowship at the University of Washington and undertook an Internal Medicine residency at Baylor College of Medicine, Texas. He has worked for the FDA since 2010.
Session 4: Advances in Imaging
Session Chairs: Marnix Bosch (Northwest Biotherapeutics, UK) and Catarina Edfjäll (CDDF, SE)
Marion Smits (Erasmus MC, NL)
Prof Dr Marion Smits is Full Professor of Applied Physiological Neuroimaging, Chief of Neuroradiology, and Co-Chair of the Neuroradiology Fellowship programme at Erasmus MC – University Medical Centre Rotterdam (NL). Prof Smits uses physiological imaging techniques to visualise the brain’s function and microarchitecture and to study pathophysiological and regenerative processes in various neurological diseases. Her current focus is on neuro-oncology, but she has also worked extensively in the field of dementia and brain trauma. Prof Smits works towards breaking down boundaries between the research arena and clinical practice, and vice versa, by disseminating the knowledge and insight gained from her research and clinical implementation of physiological MR neuroimaging within her teaching and leadership roles. Prof Smits is Past President of the European Society for Magnetic Resonance in Medicine and Biology (ESMRMB), Executive Council of the European Society of Radiology (ESR) member – as Chair of the Publications Committee, Chair of the Dutch Society of Neuroradiology, and Chair of the Imaging Group at the European Organisation for Research and Treatment of Cancer (EORTC). She uses this unique combination of affiliations to establish productive connections between relevant clinical research questions and implement scientific innovation in clinical practice.
Wim Oyen (Rijnstate Hospital Arnhem and Humanitas Univ Milan, NL)
Prof Wim Oyen is Nuclear Medicine Physician at the Department of Radiology and Nuclear Medicine of Rijnstate Hospital, Arnhem, The Netherlands, and full Professor of Diagnostic Imaging and Radiotherapy at Humanitas University in Milan, Italy. From 2015-2018, he was full Professor of Nuclear Medicine and Molecular Imaging at The Institute of Cancer Research and Head of the Department of Nuclear Medicine at The Royal Marsden Hospital, London, UK. Prior to this, Professor Oyen was a Nuclear Medicine Physician and full Professor of Nuclear Medicine at the Radboud University Medical Centre, Nijmegen, The Netherlands, serving as Head of the Department of Nuclear Medicine, Member of the Board of Medical Staff, and Director of the Research Institute for Oncology at the Radboud UMC. Prof Oyen’s main research interests are molecular imaging in oncology and infectious diseases and radionuclide cancer therapy. He is the (co-) author of more than 650 original science and review articles in international peer-reviewed journals. He is actively involved in the European Association of Nuclear Medicine (Board Member 2014-2020, past-Congress Chair 2015-2017 and EANM President 2019-2020), the International Cancer Imaging Society (Board and Trustees member 2016-present, President 2017-2018), the European Cancer Organisation (Board member 2012-2016 and 2020-present, Treasurer 2014-2015, 2020-2021) and the Biomed Alliance (Board member as of 2021). Prof Oyen is a member of several Editorial Boards, including the European Journal of Nuclear Medicine and Molecular Imaging and the Journal of Nuclear Medicine.
Session 5: Regulatory Hot Topics
Session Chairs: John Smyth (CDDF, UK) and Ralf Herold (EMA, NL)
Sinan B. Sarac (DKMA, DK)
Dr Sinan B. Sarac currently works as Chief Medical Officer at the Danish Medicines Agency. He holds a medical degree from the University of Copenhagen, Denmark, a PhD degree from the Technical University of Denmark and a Master of Science degree from Ulm University in Germany. Dr Sarac has been a member of the Committee for Medicinal Products for Human Use (CHMP) since 2015, Chair of CHMP’s Oncology Working Party since 2018, and a member of CHMP’s Scientific Advice Working Party (SAWP) and the Committee for Advanced Therapies (CAT). He is an experienced regulator, an expert in regulatory decision making, regulatory pathways and clinical trial design.