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Shift towards precision medicines forcing innovation in oncology drug development

26 Oct 2020

Webinar addresses key challenges in oncology drug development as a result of the shift towards precision medicines and the increasing use of biomarkers

The launch of several diverse, targeted medicines with various mechanisms of action is fueling growth in oncology and encouraging innovation at all phases of development.

This was the message from a recent roundtable at the CPhI Festival of Pharma, Innovation in Oncology Development, sponsored by West Pharmaceutical Services.

Setting the scene, Yasemin Bettina Karanis, Consultant - Thought Leadership at IQVIA described oncology as the largest therapy area globally, growing at a 12% compound annual growth rate (CAGR) in the past decade and currently valued at approximately USD 150 billion. She also pointed to 17 new active substances launched in oncology in the past five years, showing the “strong productivity” of its pipeline.

“Innovation has fueled this phenomenal growth with the sustained launch of diverse medicines most of which are targeted with various mechanisms of action,” she said. “When we talk about innovation in oncology, we’re not just talking about molecular innovation or new active substances.

“We’ve had the dawn of biosimilars, which can be seen as enablers of spending elsewhere, not just old blockbuster products.

“We’ve seen reformulations of harder to administer infusions into subcutaneous formulations that aim to take the pressure off hospitals and healthcare systems. This has become infinitely more important as a result of the pandemic and its effects.”

She added that a clear shift in the treatment paradigm has emerged as the industry has developed a deeper understanding of the underlying biology and natural history of oncology: “Many new sophisticated therapies have emerged with a clear shift towards precision medicine. These include new treatment modalities such as cell and gene therapies, antibody drug conjugates and bio-specific antibodies. We’ve also seen many new biomarkers becoming clinically relevant.”

Sian Estdale, Head of Scientific Affairs, CTTS at drug development company, Covance, told the audience that in the development stage, there was an increasing number of trials looking at developing biomarkers, so the industry was being encouraged to stratify and understand whether they would be predictive biomarkers in order to have a patient group predicted to be responsive to a particular treatment.

“That’s pushing us towards more and more adaptive trials -- going through different stages rather than the classical phase I, II and III, and looking at ways to understand and work on the basis of the data that we’re seeing coming through,” she said. “So, these new therapies are forcing us to be a bit more innovative and creative in the way that we are setting up our clinical trials.”

Victoria Morgan, Director, Segment Marketing, Global Biologics at West Pharmaceutical Services said that from the drug delivery perspective, there had been a huge amount of innovation within the oncology sector.

She gave the example of white blood cell stimulant, Neulasta (pegfilgrastim) which is now available in an on-body wearable auto-injector format.

“For somebody who’s been in a rigorous chemotherapy session, to have to come back into the hospital and all the pressures that can put onto them in terms of energy levels, cost and time, having a device that you can apply on body that’s automatically going to give you the drugs that you need at the right time without a repeat visit, really shows how that innovation is making a difference to the patient,” she said.


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