Pre-Conference Workshop Day
Tuesday, January 24
Track 1
Track 2
Workshop A
9:00 - 12:00
Workshop B
9:00 - 12:00
Delving into Regulations:
Setting Yourself Up for Approval
Under the global development mindset, preparing interactions with regulatory authorities to advance development candidates into first-in-human or late-stage (pivotal) clinical study is a complex process. A seamless clinical development plan is supported by multiple disciplines with a clear regulatory pathway. This workshop will be dedicated to highlighting the evolving regulatory trend at FDA and EMA in the past 12 months.
This workshop will cover:
- Discuss selected new projects and initiatives at Oncology Center of Excellence (OCE) FDA
- Introduce selected items under the Prescription Drug User Fee program (PDUFA) VII in US
- Highlight selective new initiatives and procedures at EMA.
Workshop Leaders:
- Chun-Pyn Shen, Vice President & Head of Regulatory Affairs, IMPACT Therapeutics
- Ritesh Jain, Director, Global Regulatory and Scientific Policy, EMD Serano
- Sonia Rodrigues, MSc Ph.D., Executive Director Oncology Regulatory Science and Strategy, Hematology Head, AstraZeneca
Panelists:
- Jian Wang, Global Head of Translational Oncology
Regulatory Science, AstraZeneca - Christopher Price, Manager, Global Regulatory
Oncology, Merck Healthcare KGaA - Sonia Rodrigues, MSc PhD, Executive Director Oncology RegulatoryScience and Strategy, Hematology Head, AstraZeneca
Mapping the DDR Pathway:
What We Know So Far
Synthetic lethal based monotherapies for treating DNA repair deficient cancers are challenged by acquired drug resistance, causing a huge risk for novel DDRi agents of failing clinical trials. A combination of DDRi agents has shown encouraging results for efficacy in pre-clinical model systems. However, combining DDRi agents comes with the challenge of extreme toxicity for patients. In this workshop leading experts will discuss possible ways forward including novel biomarkers and optimized dosing schedules to overcome the toxicity challenge from DDRi combination treatments
This workshop will cover:
- Identifying tumors that are most likely to respond
- Panel biomarkers to help select suitable patients for treatment
- Optimizing the dosing schedule to maximize the efficacy and minimize toxicity
Workshop Leaders:
- Arne Nedegaard Kausholt, Postdoc, Netherlands Cancer Institute
- Shridar Ganesan, Professor, Rutgers Cancer Institute of New Jersey
Panelists:
- Michal Zimmerman, Associate Director of Cancer Biology, Repare Therapeutics
- Norman E. Sharpless, Nominating and Governance Committee, G1 Therapeutics
Lunch & Networking
12:00 - 1:00
Workshop C
1.00 - 4.00
Workshop D
1.00 - 4.00
Mapping the DDR Pathway:
What We Know So Far
Kicking things off with a comprehensive overview of what we know about the complex DDR pathway. In order to successfully select targets and design DDRi drugs
accordingly, the biology behind how the DNA damage response pathway is vital to understand. While this is still not completely understood, Nimrat Chatterjee, an expert academic will paint a picture of what pathways make up DDR, what the key proteins involved are, and how this impacts the immune system.
This workshop will cover:
- Structural biology: utilizing new crystallized forms
- Common biomarkers
- Genomic Scarring
Workshop Leader:
- Nimrat Chatterjee, Assistant Professor, Massachusetts Institute of Technology
Panelist:
- Hiroki Umehara, Director Cancer Research Unit, Sumitomo Pharma
- Joshua Victor, Graduate Research Assistant, University of VermontCancer Center
- Kanayo Ikeh, Graduate Research Assistant, University of VermontCancer Center
- Erica Lamkin, Graduate Research Assistant, University of VermontCancer Center
Key Considerations for Clinical Trials
Testing: CNS-penetrant DDR Inhibitors
A challenge that exists across all of the pharmacology is passing the BBB. A host of leading glioblastoma experts will discuss the promise of DDRi’s in being able to overcome this issue, opening the possibility of new approaches to CNStumor treatment.
This workshop will cover:
- Key considerations in the assessment of CNS penetration in DDRi clinical trials
- Phase 0 considerations in trials with CNS-penetrant DDRis
- Combining treatments like radiotherapy with DDRis to maximize efficacy in CNS-tumor treatment
Workshop Leaders:
- Kirk Tanner, Chief Scientific Officer, National Brain Tumor Society
- Ranjit Bindra, Harvey and Kate Cushing Professor, Yale University School of Medicine
Panelists:
- Jing Li, Professor of Oncology and Director of Pharmacology & Metabolomics Core, Wayne State University School of Medicine
- Jann Sarkaria, Professor - RadiationOncology, Mayo Clinic
- Nathalie Agar, Associate Professor of Radiology, Harvard Medical School