Nermeen Varawalla is Senior Vice President, Head of Clinical Development at BTG International - a pharmaceutical and medical device business focused on 'interventional medicine' largely across oncology, pulmonology and vascular. She explains that 'what makes our portfolio and therapy special is that these are image-directed therapies; often a combination of a pharmaceutical product and a device that's administered locally at the point of care.'
In this exclusive interview for PCT TV at Partnerships in Clinical Trials Europe (Nov 2017) Varawalla explains their innovative approaches to generating real world evidence as well as working with vendors in clinical trials. Read the key highlights or watch the full interview below.
Given that the portfolio you oversee includes devices and drugs, how do you select the best approaches for generating the clinical evidence that you need?
NV: 'Given that the regulations for device registration are different from those of pharmaceutical registration and then there's a difference in different markets in the world - in particular within the US under the FDA jurisdiction and in Europe - the approach is very much is tailored according to the regulations and the registration status of the product. Then the next very important piece is that just achieving registration is the first step, then the next big hurdle is reimbursement. And of course that will depend on the requirements of the reimbursement authorities in those regions.
Then we work very hard to find the data that will meet the needs neccessary to drive the adoption of our products, which includes the needs of our physicians and our patients. It's only after taking all those requirements into consideration that we craft the right design with respect to collecting that evidence.
So typically in pharmaceutical led clinical development, the randomized control trial, the Phase III study, is still very much the gold standard. Now that is a very expensive, resource intensive and prolonged way of conducting clinical trials and within BTG our framework allows us the opportunity to look for smarter designs outside this standard construct.'
Could you describe your approach then for collecting real world evidence?
NV: 'We are making initial forays into what we are calling 'e-digital', which is about collecting clinical evidence through patient reported outcomes. Then we are assessing whether there is a place for implantables or wearables to actually deliver real-time data that's linked to our therapies and products. Apart from those highly creative approaches, we then also rely on the conductor registries as well as retrospective analyses of the experience of our users. It's that entire spectrum that constitutes the body of evidence that is real world data for us.'
How do you engage with your vendors?
NV: 'Given the needs of our portfolio and our particular needs, our approach is to work selectively with CROs. The full service outsourcing doesn't suit us, but we work with a number of vendors in a far more niche, customized fashion, working with them for our requirements and to supplement in-house expertise.'