Stanford Medicine, Lucas Center에
Astrazeneca inc,의 James MacKay 박사 발표를 들으며 정리한 내용.
Title:
The role of radiological imaging in clinical drug development
Abstract:
In this talk, I will describe the broad role of radiological imaging in clinical drug development – the unmet needs in drug development that imaging can potentially address, the potential use cases of imaging across the drug development lifecycle, the practical considerations and some closing thoughts about what the future might hold.
Speaker Bio:
Jamie is a UK-based academic musculoskeletal radiologist. He currently works for AstraZeneca where he leads clinical imaging across immunology drug development programs. Alongside this, he maintains honorary academic affiliations at the University of Cambridge and University of East Anglia and continues to work clinically as a consultant radiologist. Among many honors and accolades, Jamie was the winner of the W.S. Moore Young Investigator award at the 2021 ISMRM annual meeting. He spent a few months at the Lucas Center in early 2019, a time he remembers very fondly!
Traditional R&D Model에서 주로 활용하는 figure
청자 질문) 어디가 가장 많은 어려움이 있나?
답변: Phase I -> Phase II -> Phase II transition 부분에서 가장 많은 어려움이 있음
Phase 1 / Healthy volunteers +- patients: 10~20
Major goal: Safety
Phase 2 / Patients ~50-300
Major goal: Dose-finding, Efficacy
Phase 3 / PAtients >= 100 (Can be several thousand)
Major goal: Efficacy
Problems with the traditional model:
median 8.3 years clinical development.
-> economically unsustainable?
-> Potential solutions
1. Late Phase Attrition
2. Earlier understanding of critical information (5 Rs)
3. Imaging can play a key role
Schwarz, Neurotheraputics 2021 figure
Imaging can contribute throughtout clinical drug development process
Imaging의 신약개발에 활용 장점
- Non-invasive
- Whole-organ whole-body imaging
- Ability to combine structural information
1. Imaging에서 약물에 효과적인 환자를 미리 찾고 약물을 처방할 경우
더 dramatic한 result를 얻을 수 있는 몇가지 케이스를 소개함
A randomized, double blined, placebo-controlled, sixteen-week study of subcutaneous golimumab in patints, 2015
2. NSCLC Lung cancer에서 Brain metastasis 관련해서 Brain PET 이미지를 보여줬는데, 여기서 imaging role이 뭔지 잘 이해 못했음.
3. Pharmacodynamics
-> Dose selection (Cediranib)
-> Dose interval selection (Brivalib)
O'connor, James PB, et al. "Imaging biomarker roadmap for cancer studies." Nature reviews Clinical oncology 14.3 (2017): 169-186.
Quantifying antivascular effect of monoclonal, clinical cancer research
O'Connor, James PB, et al. "Quantifying antivascular effects of monoclonal antibodies to vascular endothelial growth factor: insights from imaging." Clinical Cancer Research 15.21 (2009): 6674-6682.
4. Rheumatoid arthritis에서, qMRI를 활용, 이를 통해
Repeatable, Responsive를 증가
Observer dependent를 줄임
-> Tofacitinib 약물의 예
* Trends in drug development influencing role of imaging
1. Moving from symptom control -> Disease modification
2. PRecision medicine -> Requirement for precision endpoints with closerl ink to disease biology
3. Need to understand critical information content earlier in development process (5r)
Inclusion of patients form Ph1 beyond onclogy due to B/R of advaned therapies
- earlier oppportunity to assess efficacy
4. understanding of effect of drugs in tissue key for efficacy and differentiation
Recently, medical AI companies are trying to include their AI models in clinical trials as part of the patient's protocol. Is there any related work being done at AstraZeneca in this regard?
-> 이거 키드니나 다양한 사례들 얘기해주면서, 아스트라제네카에서도 바이오마커로서, imaging의 역할이 증가하고있다는 얘기를 많이 하고있고, 성장하는 분야라는 대답을 해줌
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