Perspectives on oncology personalised healthcare: Mya Thomae (transcript)
As we near publication of our round table video debate on the impact of personalised healthcare in oncology and beyond, Paul Tunnah speak with leading global in vitro diagnostics expert Mya Thomae to hear how pharma companies and diagnostics manufacturers can collaborate more closely.
This media accompanies the round table video debate ‘Oncology shaping the future of personalised healthcare‘, sponsored by AstraZeneca.
Ahead of the round table video debate ‘Oncology shaping the future of personalised medicine’, pharmaphorum will be releasing individual video interviews with the four expert participants. Below is the transcript from the video discussion between Paul Tunnah and Mya Thomae, an expert on in vitro diagnostics, where she explains the language around diagnostic tests, the regulatory environment, notable success stories and how the industry can more closely work with pharma.
(Interview conducted July 2013)
PT: What different classes of diagnostics are available?
MT: There are three key terms. The first is an IVD. Typically when we are talking about IVD, we are talking about FDA cleared or approved products, so your classic kits plus instruments, [and] often there is software involved. We get those approved through FDA and then distributed through laboratories. The other type of diagnostic that has really blossomed, particularly in the last ten years, is a laboratory-developed test. This is a test that is developed by a single laboratory; the result is delivered by a single laboratory.
Currently those tests are under FDA enforcement discretion, so they have to comply with clear requirements but they don’t have to comply with FDA requirements. The other key term is companion diagnostic, which has been defined very specifically by FDA as the test which is used to show that the drug is safe and efficacious. So, for instance, if a drug needs a BRAF test the companion diagnostic is the specific test [that] was used in the clinical trial and gets the FDA approval.
“The other key term is companion diagnostic, which has been defined very specifically by FDA…”
PT: What issues do laboratory-developed tests (LDTs) raise?
MT: The situation now with the laboratory-developed tests [is that] there are other tests often for the same thing, for example BRAF, that have not been reviewed by FDA. Those are not being seen as the companion diagnostics, so they are being allowed to stay on the market. So there’s a bit of a two tiered system going on, and a lot of the kit manufacturers are upset that they have to go through the FDA requirements but LDTs do not
PT: How much global variation is there around regulating diagnostics?
MT: The FDA has taken a very ‘hands on’ approach, looking for a lot of data; at least in the case of IVD products. For example, in Europe we’re regulated by the in vitro diagnostic directive, which is much looser. Most diagnostics that come into Europe don’t need review by a notified body; it’s more of a self-notification type of situation. So it’s fairly quick, fairly easy but sometimes the data is not always there to support use of that diagnostic.
From there we go into all different kinds of regulatory regimes. Some, for example, in Brazil where there is quite a bit of oversight, but then in other situations, like for most of Africa, there is almost no oversight. Australia is starting to regulate diagnostics but it’s really at the beginning of it. Around the world I think a lot of tests are still laboratory-developed. A lot of folks see tests as an extension of physician practice rather than medical devices.
PT: What have been the real success stories of diagnostics in personalised healthcare?
MT: HER2 is the longest term example, I think, that’s been fairly successful, but that came out quite a while ago. More recently we’ve had the Roche example with BRAF, the Abbott example with the ALT test, as well as some others that have just come out in the last couple of weeks. I think the real success is that FDA, particularly CDRH, has an impeccable record in ensuring that the test is ready to be approved at the same time as the drug. A lot of folks, when they started talking about this policy a few years ago, thought they wouldn’t be able to make it but so far, they have a spotless record. So I think that’s a huge success.
“We really have to understand the biological relevance of these markers…”
PT: What new technologies are driving the diagnostics space?
MT: I think that next-generation sequencing is there and with the larger panel tests similar to what foundation medicine is doing, where we can test for an awful lot of things all at once – that’s definitely very exciting, as well as the point-of-care type tests, [where] you wouldn’t have the breadth of menu but you get very rapid results. I think that could significantly change how companion diagnostics are delivered.
PT: What does successful collaboration between pharma and diagnostics companies look like?
MT: It varies in each program, but I really think working together early is the key thing. I think you have to actually partner before you understand what the revenues on either side are going to be. You really have to be partnering in terms of science, so it’s not ‘I’m going to hire a diagnostic partner and that’s going to go away so I don’t need to worry about it again’. And from the diagnostics perspective, it’s not ‘I’m just going to develop the tests that they gave me the specification for and I’m not going to care after that’. I think we really have to understand the biological relevance of these markers and really work together to make the right products.
About the interviewee:
Mya has over 20 years of experience with regulatory and quality, much of it as a consultant. Prior to becoming a consultant, Mya learned the ropes at Chiron and OraSure.
Mya has been involved in numerous successful applications before FDA for clients in the US, Canada and EU. She worked with FDA to develop the special controls document and regulation for microarray devices and helped establish the precedent for parallel 510(k) submissions. Mya received a Commissioner’s Special Citation at the 2009 FDA Honor Awards in recognition of her work to clear the ABI 7500 Fast Dx.
Mya founded Myraqa (formerly Mya Thomae Consulting) in 2008, building on several years as an independent contractor. Myraqa is the leading IVD regulatory consulting firm. Founded in 1998 as a solo practice, Myraqa has grown to include leading experts in Regulatory, Quality, Clinical, Biostatistics, and Development.
Myraqa serves a wide range of clients, including established players up & comers and even stealth startups. Myraqa has worked on a full range of IVD applications in the US and EU, including PMAs, pre-Subs, IDEs, 510(k)s, de novo 510(k)s, and EU technical files.
For more information about Myraqa please visit the following page:
Myraqa company website
How can pharma and diagnostics more closely align?