Expert Insights

Expert Insights

The Promise of Precision Medicine: Advances in Oncology Clinical Trials – Part II

The Promise of Precision Medicine: Advances in Oncology Clinical Trials – Part II
28 February 2019

With 25 years working in drug development in the pharmaceutical and CRO industries as well as investigational cooperative groups, Etienne Drouet, vice president Oncology Development at Synteract was recognized in 2017 for his strong work ethic and contributions to the field as a PharmaVoice 100 Clinical Expert. We sat down with him recently. Part I of this interview deals with the promise of precision medicine and what needs to happen to make it a reality. In Part II, Etienne addresses the promise of advanced diagnostics.

How are advanced diagnostics changing the playing field for the different stakeholders: researchers, physicians, patients, pharma companies in immunotherapy?
The industry has moved from a time where a very broad population of patients received the same treatment, to a scenario where treatments are customized and even individualized. In some instance for each patient. 

The need to connect the dots between all stakeholders has increased. Drug companies are looking for specific, small subgroups of individuals with biomarker or genetic characteristics that are actionable by their treatments. Physicians are looking for the diagnostic and technical support to identify the best treatments for their patients. Advocacy groups are helping patients to obtain greater awareness of treatment options to fight their diseases.

How is precision medicine changing the current pharmaceutical company operating model?
The drug development strategy has moved from companies developing agents directed to the entire patient population that are offering average to generally modest benefits, to an effort to develop drugs with strong and predictive effects on smaller subgroups of patients with specific gene mutations or biomarker patterns. 

The identification of biomarker and gene alteration actionable by a targeted treatment is now introduced at an early stage in development, immediately after, or at the same time as the initial safety and tolerability evaluation. This has been achieved through the introduction of new and more complex clinical study designs identifying, at an early development stage, the best population target and increasing the predictability of treatment outcome. The aim is to decrease development failure at the confirmatory stage. Due to this more targeted and predictive approach, the effect expected at the confirmatory stage is higher and consequently the size of trials has decrease on average, as has development and approval time.

What barriers do companies need to overcome to develop precision medicines?
Access to the right patient population is a barrier to development of precision medicines. The development of a drug generating a strong effect on a patient population harboring a rare mutation has to integrate the practical challenge of candidate treatment identification. Broader use of gene panel analysis and a globalization of data access are already starting to happen for indications where a number of mutations have actionable treatment (such as with ovarian and lung cancer). These are positive steps to begin to address this issue.

To learn more about emerging trends and advances in immunotherapy and oncology drug development, visit our oncology and resource pages or sign up for our upcoming webinars on this topic.

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