Session 1: Who is the gene and cell cancer-killer: deep dive on the gene and cell scientific approaches in oncology
Session Chairs: Simona Paratore (Novartis, IT); Alessandro Aiuti (San Raffaele Hospital, IT)
Emma Morris (University College London, UK)
Session 2: How to develop a gene and cell cancer-killer: the clinical trials
Challenges in timely initiation and conduct of clinical trials in gene and cell therapies in haematology. From planning to trial authorisation to patient treatment and follow up
Session Chairs: Martina Schuessler-Lenz (Paul-Ehrlich-Institut; EMA CAT chair, DE) & Ulrich Jaeger (Medical Universirt Vien, AT)
Martina Schuessler-Lenz (Paul-Ehrlich-Institut; EMA CAT chair, DE)
Adnan Jaigirdar (FDA, USA)
Adnan Jaigirdar is an oncologist in the Office of Tissues and Advanced Therapies (OTAT), Center for Biologics Evaluation and Research (CBER), U.S. Food and Drug Administration (FDA). More recently, he also served as the Acting Associate Director for Cell and Gene Therapy in the Oncology Center of Excellence (OCE), FDA. As an FDA regulator, he conducts key assessments of novel innovative therapies and clinical issues that surround the development and approval of new drugs and biologics in oncology.
He received his M.D. at the University of Cincinnati, during which time he trained in cancer immunology focusing on tumor vaccines, at the National Cancer Institute (NCI). He received his general surgery training at the University of California, San Francisco (UCSF), where he was also a post-doctoral research fellow at the UCSF Department of Surgery, Transplant Division, studying mechanisms of immune tolerance. During his surgical oncology clinical fellowship training, he also conducted cellular and immunotherapy research at the Surgery Branch, NCI.
Prior to joining the FDA, Dr. Jaigirdar was a practicing surgical oncologist in the U.S. Navy at the Walter Reed National Military Medical Center, Fort Belvoir, and a clinical assistant professor of surgery at Uniformed Services University of the Health Science (USUHS). He joined the FDA in 2016 and focuses on the review of investigational biologic and combination advanced therapies involving cell and gene therapy in solid tumors.
Laura Pearce (GSK, USA)
Laura Pearce is Clinical Development Lead, Cell and Gene Therapies at GSK. Laura has over 20 years of experience in global drug development—the majority focused in oncology and immuno-oncology. She has held senior positions in clinical development, clinical study operations, quality assurance and compliance, business development, alliance management, and global medical affairs—working across academic, non-profit, biotech, and pharmaceutical settings. Prior to joining GSK, Laura consulted with multiple leading groups in immuno-oncology including the Canadian Cancer Trials Group, as Director of Industry and Academic Research Partnerships and with the Cancer Research Institute in New York as Head of Clinical Alliances where she led strategic broad clinical trial collaborations between industry, academia, and non-profit groups. Laura has experience building oncology capabilities across multiple organizations and has expertise starting and leading multiple complex studies with innovative master/umbrella designs and in building collaborations for efficient study design and delivery, and in leading global teams integrating medical and clinical to optimize site engagement, relationship building, and trial execution.
Michael Hudecek – (University of Würzburg, DE)
Michael Hudecek performed medical training at the University of Leipzig, Germany, where he also commenced his specialist training in hematology and oncology. In 2007, Michael joined the Fred Hutchinson Cancer Research Center in Seattle as a post-doctoral research fellow, where he trained in the laboratory of Prof. Stanley R. Riddell and worked on identifying and validating novel tumor antigens in hematologic malignancies, the design and functional optimization of chimeric antigen receptor (CAR) constructs, as well as defining optimal cellular compositions of CAR T-cell products. In 2012, Michael was recruited to the Universitätsklinikum Würzburg, Germany, where he established a translational research program on CAR T-cell immunotherapy. At present, this program comprises physicians, scientists, doctoral students, master students and technicians in a multidisciplinary, international team that performs cutting-edge research with focus on novel transformative CAR technologies, and first-in-man clinical application of novel CAR-T products. Michael is an extraordinary member of the Bavarian Academy of Sciences, and recipient of the 2017 Artur Pappenheim Award of the German Society for Hematology and Medical Oncology.
Session 3: How to bring a gene and cell cancer killer to patients: how to improve patient access
Session Chairs: Catarina Edfjäll (CDDF, SE); Hans Scheurer (MPE, NL)
Bernd Eschgfaeller (Novartis, CH)
Dr. Bernd Eschgfäller is passionate about providing new treatment options to patients with life-threatening diseases.
Bernd is the Head of Cell & Gene Therapy Operations Europe at Novartis. In this role, he oversees the European patient operations and customer service deliveries along the entire cell journey, the onboarding and qualification of treatment centers and the center support in the order process. He has an extensive 20-year history of working in Lifesciences in pharma and biotech in Global, Regional and Local roles with strong experience in science, development and commercial. Bernd holds a Ph.D. in natural sciences from the ETH Zurich, Switzerland.
Kate Morgan (MPE, UK)
Kate Morgan is Head of Policy and Access at Myeloma Patients Europe (MPE). She holds a Bachelor’s degree in Government from the London School of Economics and Political Sciences and a Master’s degree in International and European Politics from the University of Edinburgh. She also holds a Diploma in Public Relations from the Chartered Institute for Public Relations. Her main area of interest is health policy, with a specific focus on policies affecting drug development and access in European countries.
Kate previously worked for eight years in the Policy Team at Myeloma UK, where she was involved in influencing a range of policy and reimbursement decisions affecting myeloma patient access to good quality care and effective new drugs. She was involved in a number of patient and public advisory panels in the UK healthcare system, including for the Scottish Medicines Consortium, the drug approval body in Scotland.
She been involved in a wide-range of patient organisation networks, both nationally and internationally – most recently chairing the Blood Cancers Alliance, an information-sharing network of haematological cancer charities in the UK.
Kate currently lives and works in Edinburgh, Scotland.
Session 4: Future perspective in the eco-system
Session Chairs: Darko Milijkovic (GSK, CH); Jaap Verweij (CDDF, NL)
Nicolaus Kroeger (Medical Center Hamburg-Eppendorf, DE)
Emily Bratton (IQVIA, US)
As part of the Real-World Solutions Epidemiology & Outcomes Research team at IQVIA, Dr. Bratton is responsible for the development, analysis, and interpretation of observational studies (both retrospective and prospective) and low interventional clinical trials. She advises on the appropriate design and methods to address Sponsor and stakeholder research needs. Her areas of specialization and interest include: natural history studies, disease and drug registries, drug safety, and comparative effectiveness research. At IQVIA, she has been involved in the design and execution of both prospective and retrospective studies (as well as enriched solutions), with emphasis on challenging designs and innovative solutions. She also is a scientific leader who manages a team of epidemiologists. Dr. Bratton received her MSPH in Epidemiology (2008) and PhD in Infectious Disease Epidemiology (2012) from the University of North Carolina at Chapel Hill where she now holds an adjunct assistant professor position. She is based in Durham, NC (USA).
Thomas Clozel (Okwin, FR)