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Held in San Diego, it was the perfect opportunity for Sean and Georgia to catch up with their network and enhance their understanding of the strategical and operational challenges their clients face.
So, over the next four days, they will be sharing their key takeaways from CTO’s Southern California’s conference…
Here's part 1.
1. THE IMPORTANCE OF FINDING RELEVANT PATIENT POPULATIONS
If you work within clinical operations or support the sector as we do, you know just how difficult developing a new therapy is; getting approval is an expensive, resource-intensive and lengthy operation. So, it's no surprise that efficacy was a key point of discussion at CTO Southern California!
The Tuft Center suggest that it costs $2.6 billion to get a drug approved, a figure that has increased by 145% in the last decade. Not to mention, on average, the process takes 10 years. Yet, despite this level of investment, 80% of drugs fail in the clinical trial stages.
What we learnt at CTO is that many of those drugs fail because they only work for specific subsets of patients. Large, poorly designed trials with broad inclusion criteria dilutes the number of favourable responses to targeted therapies, often causing the trial to bomb.
So, what's the solution? How can discrete patient populations be targeted?
On a basic level, predictive biomarkers can forecast how a patient will respond to a specific drug. Initially, the interaction of the biomarker and treatment are measured in nonclinical (in vitro) studies. This data allows the drug developer to screen patients for eligibility and include or exclude patients based on their likely response to the treatment.
This minimises the risk for patients, but also means that clinical trials can be shorter and involve fewer participants, reducing both the cost and the speed at which a drug can reach the market. Ultimately, delivering treatments to those patients most in need in the most efficient way.
Attending CTO, it became really evident that oncology is leading the way in the use of Biomarkers. In fact, in 2014, five out of eight new oncology molecules approved by the FDA were for biomarker-selected populations.
Thanks to extensive developments in the field of molecular diagnosis - our understanding of cancer and its genomic aetiology is much more advanced than other noninfectious diseases. This has led to the development of more targeted therapies, increasing the need for niche, relevant patient groups to ensure a trial's success.
The cost and demand for new oncology therapies is high, so from a commercial perspective oncology is an attractive therapy area for biomarkers to prove their value.
It was amazing to hear some real-life, tangible examples of the use of biomarkers at CTO. One team, who used biomarkers to redefined the subset of oncology patients involved in a trial, have recorded positive responses they had not previously found when testing a wider population; including the total eradication of cancer from one patient. Excitingly, the treatment is likely to be fast-tracked to Phase II thanks to this work.
From the buzz at CTO, it’s clear there is a commitment within the oncology space to discover, develop and implement meaningful biomarkers. We’ll definitely be watching this space closely over the next 12 months to see this space advances.
Missed Georgia or Sean at CTO Southern California 2020? Or want to share your thoughts on the conference?
Get in touch.
Georgia Cowderoy - email@example.com
Sean Farrell - firstname.lastname@example.org