Precision Oncology: An Era that Calls for a New Model for Conducting Clinical Trials?

Genomic sequencing techniques and bioinformatics have led us to a better understanding of cancer biology, resulting in a shift from empirical strategies to molecular (precision oncology) and immunological therapeutic approaches in clinical oncology. Consequently, clinical trials have evolved from drug- to target-oriented trials, and this shift has raised several challenges.

During the discussion, we will talk about :

The importance of a new era of precision oncology, and what this means in practice for conducting clinical trials
The lessons learnt from the development of targeted therapies and immunotherapeutic agents in the past years
In what sense we say that the current methodology of oncology trials is based on molecular oncology
Why there a need for a new “patient-centred” and target-oriented model of clinical trials
Does the new era of precision oncology call for a new model for conducting clinical trials, and what does this mean for sponsors, CROs and sites?

Speakers:

Alain Thibault, MD, Chairman, Simbec-Orion Oncology Advisory Board

Alain is a medical oncologist and a renowned expert in first-in-human 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 tumour 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.

Ahmad Awada, MD, PhD, Institut Jules Bordet – Brussels, Founder of Oncodistinct Network

Ahmad Awada is Head of the Oncology Medicine Department at Jules Bordet Cancer Institute in Brussels, Belgium and is Professor of Oncology Medicine at the Université Libre de Bruxelles. He has important clinical activity in the treatment of solid tumours and in particular breast cancer. Dr. Awada took an active part in the development of new drugs (cytotoxics, molecular-targeted therapies, immunotherapy), some of them already widely used. He has published 32 book chapters and 335 peer-reviewed articles in international publications.

Nuria Kotecki, MD, Institut Jules Bordet – Brussels, Executive Officer of Oncodistinct Network

Nuria Kotecki is a medical oncologist at Jules Bordet Institute, in Brussels. Her main fields of activity and research interests are breast cancer and development of innovative medical therapeutics for solid tumor patients. She has authored and co-authored articles in national and international papers as well as many abstracts in congresses.

Philippe Cassier, MD, PhD, Medical Oncologist, Centre Léon Bérard

Philippe Cassier is a medical oncologist, head of the phase 1 unit at Centre Léon Bérard, in Lyon, France. His main interest is in experimental therapy and drug development, with a particular focus on precision oncology and gastrointestinal cancers, in particular pancreatic cancer. He has published over 100 articles in peer-reviewed journals.

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