This 1-hour webinar will review a published consensus statement from the British Journal of Cancer (BJC), looking at recommendations for effective delivery of Complex Innovative Design (CID) cancer trials.
The traditional cancer drug development pathway is being superseded by trials that address multiple clinical questions. CID trials not only assess the safety and toxicity of novel anticancer medicines but also their efficacy in biomarker-selected patients, specific cancer cohorts or in combination with other agents. They can be adapted to include new cohorts and test additional agents within a single protocol. Whilst CID trials can speed up the traditional route to drug licencing, they can be challenging to design, conduct and interpret.
Sarah Blagden, Associate Professor of Medical Oncology, University of Oxford and Alain Thibault, Chairman Simbec-Orion Oncology Advisory Board, will review the changing landscape and the need for a clinical trials revolution in early phase oncology drug development. They will also review the operational recommendations and practical considerations for delivering CID cancer trials.
This webinar will cover:
- The changing landscape of oncology drug development – safety, toxicity and efficacy in biomarker selected patient cohorts and other agents
- Trial planning & design – stakeholder engagement, engagement with regulators
- Protocol development & structure – identifying adaptations
- Data & databases – defining the end of the trial
- Risk assessment & monitoring – financial and operational, including source data verification
- Trial management – the importance of compliance and communication in managing multiple cohorts from multiple parties
- Statistical considerations – experience and flexibility
Sarah Blagden, Associate Professor of Medical Oncology, University of Oxford
Following medical training and subsequent specialist training in Medical Oncology at Addenbrooke’s Hospital in Cambridge and the Royal Marsden Hospital, Sarah was awarded a CRUK Junior Clinician Scientist PhD fellowship in 1999 at Cambridge University and held a Clinical Fellowship at the Institute of Cancer Research’s Drug Development Unit.
She was appointed as Senior Lecturer and Honorary Consultant at Imperial College in 2006 and became Director of Imperial’s Early Cancer Trials Unit and established her laboratory studying the dysregulation of mRNA translation in cancer. She has been chief or principal investigator for a number of national and international clinical studies.
Alain Thibault, Chairman, Simbec-Orion Oncology Advisory Board
Alain is a medical oncologist and a renowned expert in first-in-man trials and oncology drug development. He has broad pharma experience in overseeing clinical programs from the preclinical/translational stage to IPO at the director, VP, and CMO levels in the US and EU (Roche, Janssen, Regeneron, arGEN-X). His area of expertise also includes chemotherapy, small molecule targeted therapy and biologics (monoclonal antibodies). Most recently, he focused on immuno-oncology development targeting co-stimulatory receptors and modification of the tumor micro-environment. His regulatory experience ranges from IND/IMPD-CTA write-up to IND/BLA submission and approval. Alain also has senior corporate-level experience with board presentations/communications and fund-raising.Message Presenter
Who Should Attend?
For CMO, CEO, CSO and Directors of Clinical Operations of biotechs and drug development companies.
This webinar is ideal for those who have assets identified for clinical development and early phase clinical trials.
What You Will Learn
- The changing landscape of oncology drug development
- Trial planning & design
- Protocol development & structure
- The role of data & databases
- Risk assessment & monitoring
- Trial management
- Statistical considerations
Simbec-Orion Group is a full-service boutique international CRO focused on oncology, rare disease and healthy volunteer studies. We offer our clients a full spectrum of drug development services from first-in-human Phase I clinical studies through to pivotal Phase III studies and Phase IV post-marketing studies. We have expertise in all drug types, dosage forms and delivery mechanisms. Established in 1976, our experience and expertise enables us to become a true ally on your drug development journey