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Difficulties Predicting Safety and Dose in FIH Setting: Options When There are No Options, an Industry and Regulator Perspective
Session Chair(s)
Jeroen Bos, PharmD
Global TA lead Regulatory Affairs
Novartis Pharma AG, Switzerland
Jan Willem van der Laan, PhD
Senior Assessor Pharmacology and Toxicology
Medicines Evaluation Board, Netherlands
Following a successful session in DIA2020, this years' FIH session focuses on difficulties in predicting safety and dose for FIH studies, when the standard tools (eg animal models) are not an option- for example, many Severely Debilitating and Life-Threatening Diseases (SDLT) have human targets only. First introducing real-life cases and different challenges in gene therapies and immunogenicity, a dynamic regulators vs industry dialogue will follow, discussing advanced technologies and approaches, such as platform technologies and microphysiology systems.
Speaker(s)
Introduction of Topic and Speakers
David Jones, MS
ApconiX, United Kingdom
Consultant, Regulatory Pharmaco-Toxicologist
Panelist
Andreas Hartmann, PhD
Novartis Pharma, Switzerland
Executive Director
Introduction of Topic and Speakers
Jan Willem van der Laan, PhD
Medicines Evaluation Board, Netherlands
Senior Assessor Pharmacology and Toxicology
Roy Forster, PhD, MA
Experimental Pharmacology and Oncology Berlin-Buch GmbH, Germany
Expert, Nonclinical Development
Panelist
Beatriz Silva Lima, PharmD, PhD
University of Lisbon, Portugal
Director of FFUL, Faculty of Pharmacy
Introduction of Topic and Speakers
Jeroen Bos, PharmD
Novartis Pharma AG, Switzerland
Global TA lead Regulatory Affairs
Panelist
Robert Vries
Hubrecht Organoid Technology (HUB), Netherlands
CEO
Response
David Jones, MS
ApconiX, United Kingdom
Consultant, Regulatory Pharmaco-Toxicologist
Panelist
Charles Benson, MD, PhD
Eli Lilly and Company, United States
Senior Director Clinical Phamacology
Panelist
Elke Stahl, PhD
Federal Institute For Drugs and Medical Devices (BfArM), Germany
Senior Expert, Clinical Trials Department
Panelist
Peter Pertel, MD, MPH, FACP
Novartis Institutes for BioMedical Research, United States
Global Head of Translational Medicine for Respiratory and Infectious Diseases
Panelist
Ulla Wändel Liminga, DrMed, MS, RPh
Medical Products Agency (MPA), Sweden
Scientific Director Pharmacology/Toxicology
Panelist
Joseph Brady, PhD
Pfizer, United States
Senior Director
Panelist
Salah-Dine Chibout
Novartis Pharma AG, Switzerland
Global Head Discovery & Investigative Safety/Preclinical Safety Therapeutic Area
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