NorthWest Biotherapeutics Inc (NWBO)

[Lykiri]

Evaluate,

Summary of Discussion Cancer Drug Development Forum (CDDF) 12th Spring Conference 2021.
Current and Future Challenges of Innovative Oncology Drugs Development.
8-10 February 2021.
Virtual Conference.
Prepared by CDDF.

Regulatory Perspective on Cancer Drug Development in a Global Setting.
R. Angelo de Claro (FDA, USA)

Even during the COVID-19 pandemic, FDA Oncology Center of Excellence (OCE) has remained highly active on several initiatives consistent with its mission to advance patient-centred regulatory decision-making through innovation and collaboration. Project Orbis, a global collaborative program launched in 2019, reported 38 approvals in its first year. Current Project Orbis partners include the regulatory health authorities of Australia, Brazil, Canada, Singapore, Switzerland, and the United Kingdom. FDA OCE reported the initial experience with the Real Time Oncology Review (RTOR) program which facilitates earlier submission of datasets to support an earlier start to the FDA application review. The median approval time was 3.3 months (range 0.4-5.9 months) for the initial set of 20 marketing applications that used RTOR (February 2018 to April 2020).
Other regulatory achievements include the issuance of 17 guidance in 2020 on many aspects of oncology drug development, including the broadening of eligibility criteria for cancer clinical trials. Patient-centred efforts include Project Community which introduces the work of the FDA to underserved communities and Project Facilitate which is a single point of contact call centre to health care providers through the expanded access request process. To facilitate interactions across multiple programs, OCE switched to virtual platforms to continue the attention on cancer drug development and to assure patients with cancer that they have not been forgotten.

P.17-18

RWE: technical perspective
Sinan Bardakci Sarac (DKMA, DK)

Q&A and Discussion

• Ultimately, drugs are developed for use in the real world. Does the lecture suggest that yet RWD will be excluded from regulatory process?
And what are the thought on using historical data from previously, or even contemporaneous, performed trials?
? What is relevant is that the data are of good and reliable quality. Pre-planned collection of RWD registries, following a specific protocol and pre-discussed with the regulators, could be acceptable.
? Indirect comparisons between trials remain difficult, and one tries to avoid this. And historical data would be hampered by the recent changes in cancer biology understanding

https://cddf.org/wp-content/uploads/2021/03/2021-CDDF-Spring-Conference-Report_Final.pdf