The Cancer Drug Development Forum (CDDF) will hold a live webinar on “Long-term outcomes of in-utero exposure to cytotoxic therapy: is involving pregnant patients an absolute no-go in cancer drug development?” on 4 December at 16:00 CET. This webinar will include a lecture by Frédéric Amant (UZ Leuven) that will be followed by a 25-minute panel discussion moderated by Jaap Verweij (CDDF) and Agnes Saint-Raymond (Former EMA Head of International Affairs Division).
WEBINAR OUTLINE
A one-hour webinar to challenge our fear-based approach: cancer and pregnancy happen together. Pregnant patients data cannot be obtained in other populations. Do we have the necessary data to treat our patients ? What is the outcome of children born to cancer patients having received cytotoxic drugs ? This webinar will review the ethical and scientific need to develop cancer drugs for pregnant patients to protect them and their children through cautious, prospective enrollment into clinical trials.
LEARNING EXPECTATIONS
- Short reminder of ethical need for data in pregnant patients
- Understand the differences in PK and PD between pregnant and non-pregnant patients
- Identify the priority indications for pregnant patients
- Understand the data that are required before inclusion of pregnant participants in trials for cancer drugs
- Plan for regular reviews of data until inclusion of pregnant participants in trials for cancer drugs
- Plan for pharmacovigilance and follow-up of pregnant patients and their offspring after birth
Agenda: (CET time zone)
16:00 – 16:05 Introduction – Jaap Verweij (CDDF) and Agnes Saint-Raymond (former EMA Head of International Affairs Division)
16:05 – 16:30 Lecture by Frédéric Amant (UZ Leuven)
16:30 – 17:00 Panel discussion – moderated by Jaap Verweij (CDDF) and Agnes Saint-Raymond (former EMA Head of International Affairs Division)
Frédéric Amant
Frédéric Amant (MD, PhD) received his medical degree from the University of Leuven (KU Leuven), Belgium in 1992, completed his specialty training as an obstetrician/gynecologist in 1998 and his subspecialty training in gynecologic oncology in 2000. He is professor at the KU Leuven in Belgium and at the University of Amsterdam (UvA) in the Netherlands, and honorary professor at the university of Pretoria, South Africa. He is specialist at the Netherlands Cancer Institute in Amsterdam and the UZ Leuven in Belgium.