NorthWest Biotherapeutics Inc (NWBO)

[Lykiri]

Who's mouth did these pearls recently drop from?

“The patient is the client at the FDA.”

“The sciences is changing and should guide our decisions.”

“Are we acting in the best interests of the patient, or are we adhering to regulatory orthodoxy?”

“And when we act in the best interests of patients, we are always right.”

“There are circumstances when a randomized trial does not provide the relevant answers, or may not be the best approach.”

They are from Richard Pazdur, who heads the FDA Oncology Center of Excellence, when he spoke at the recent Cancer Drug Development Forum (CDDF) Spring Conference in the Netherlands, on February 12, 2020, was about “FDA Guidelines” as it pertains to “Regulatory Guidance on Oncology Drug Development”.

Sentiment,

View the speakers’ presentations here: https://cddf.org/events/past-events/cddf-11th-spring-conference-2020/presentations/

CDDF 11th Spring Conference 2020
Current and Future Challenges of Innovative Oncology Drugs Development
Noordwijk aan Zee, Netherlands – 10-12 February 2020

DAY 3
TOPIC 5: REGULATORY GUIDANCE ON ONCOLOGY DRUG DEVELOPMENT
Update on the Revision of EMA Anti-Cancer Guideline & Regulatory Science Strategy 2025:

Sigrid Klaar (Swedish Medical Products Agency, SE) & Ralf Herold (EMA, NL)
https://cddf.org/wp-content/uploads/2020/02/0900_Sigrid-Klaar-1.pdf
https://cddf.org/wp-content/uploads/2020/02/0920_Ralf-Herold.pdf

FDA Guidelines – Richard Pazdur (FDA, US)
https://cddf.org/wp-content/uploads/2020/02/0945_Richard-Pazdur.pdf

Industry Aspect – Eric Rubin (Merck, US)
https://cddf.org/wp-content/uploads/2020/02/1100_Eric-Rubin_Updated-on-10-Feb.pdf