Perspectives on oncology personalised healthcare: Mya Thomae
As we near publication of our round table video debate on the impact of personalised healthcare in oncology and beyond, Paul Tunnah speaks 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 healthcare’, pharmaphorum will be releasing individual video interviews with the four expert participants. Here, Paul Tunnah speaks to 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)
0’25” – What different classes of diagnostics are available?
1’33” – What issues do laboratory-developed tests (LDTs) raise?
2’04” – How much global variation is there around regulating diagnostics?
3”09″ – What have been the real success stories of diagnostics in personalised healthcare?
3’50” – What new technologies are driving the diagnostics space?
4’15” – What does successful collaboration between pharma and diagnostics companies look like?
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