Challenges in oncology R&D – part 2
pharmafile | November 25, 2015 | Feature | Manufacturing and Production, Research and Development | R&D, Takeda, oncology
Pharmafile put questions on the challenges pharma companies face when working in oncology R&D to Dixie-Lee Esseltine, vice president of oncology clinical research at Takeda US.
What’s the background of Takeda in oncology?
We have been in the R&D area for a number of years. We’re quite familiar with the challenges of developing clinical trials to generate evidence to support the health authorities’ approval, and allowing drugs to get to market.
What would make oncology R&D easier?
That’s a great question, and I don’t have a good answer for that. I think about that every time we embark on a study; these are expensive, and time-consuming efforts, and if we fail it’s a big loss to patients, let alone other stakeholders. If we had a marker for the predicted outcomes, that would be very helpful. But I have tended to work in the area where we are looking at a signalling pathway, something without a specific marker, and that’s been a little bit harder.
I think we’re going to get to the point where at a disease level or a genomic level we’re understanding more about a particular cancer. For example in multiple myeloma, many studies have been done that tell us how a tumour will behave clinically. If I know going into Phase III that a certain chromosome abnormality or driver mutation is an aggressive behaviour, than that may be how I set up the trial – to look for an early marker such as response.
But I think we still have to have a few more prospective trials, I don’t feel personally I’m at the point right now where I could abbreviate very many trials. That’s why we’re looking at meta-analyses of many trials to understand what might be sufficient to submit to the regulators, and then you don’t have any surprises once you’ve registered it.
How can companies collaborate better with research partners?
In terms of monitoring, our CRO partners are using risk-based monitoring. So instead of full monitoring and checking every little piece of data, we have a system that varies according to the study and the key identified variables. Some of the evidence suggests that this reduces the time it takes for data review; it’s as efficient in terms of reducing errors as the old way of reviewing 100% of the data.
This is one of the things Takeda introduced about two years ago, along with an outsourced model that means we can increase our additional help to do the trial, by working with partner CROs. We can adjust how much support we get from them depending on how much work we have, so it makes it easier to have our internal staff overseeing that process and managing it.
The enlistment of expert CROs to help has been very useful, as well as central laboratories to look at the results and make sure they are consistent. I think we’re a company that values external input from experts to help us, we don’t have all the ideas or answers. You can devote a tremendous amount of time and energy in life to this field of drug development and you can lose your objectivity sometimes in your enthusiasm, so we have checks and balances built in.
What does Takeda see as the major future challenges in oncology R&D?
As we understand more about the biology of different tumours we’re realising that some of the cancers in different parts of the body may have similar histology but more importantly similar molecular make-up. That might point us to a similar treatment for a variety of cancers we would not previously have thought. So we’re realising that genomically there are some similarities.
The other thing that’s amazing me right now is that each cancer we used to think of as single entities. Now there are subsets of cancer, and we would use very different treatments for each, because of their characteristics. It’s harder and harder to find one drug that you might want to apply to every single cancer – we are dealing more with smaller, niche indications.
Even in multiple myeloma, Velcade has pretty good activity across the board, but we still appreciate that it is a disease with many different types that might need slightly different approaches and treatments. I think it’s getting more complex, but it’s getting complex in a way that’s pointing us to new treatments. And as we identify and understand the biology better, we’ll know there are certain targets that we think ‘is that target druggable?’ There have been so many advances in medicinal chemistry that mean we’re in a very different place than we were 15 years ago.
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