Amber Donahue speaks about Business Fit-for-Purpose: From Sample Management to Validation to Final Sample Analysis Data at the 5th Annual MarketsandMarkets Biomarker and Companion Diagnostics Conference

Amber Donahue, Ph.D. is a Senior Manager, Biomarker Clinical Assay Lead in the Oncology Clinical Assay Group in Global Product Development at Pfizer. She is responsible for scientific technical oversight and operational management of external and internal partners performing clinical trial biomarker sample analyses aligned with translational oncology strategies. Prior to joining Pfizer in early 2015, she developed and validated esoteric testing assays for the Hematology/Oncology R&D group at Quest Diagnostics-San Juan Capistrano. Amber holds a Ph.D. in Molecular Biology & Biochemistry, with a focus in Immunology, from the University of California, Irvine.

We interviewed Mrs. Donahue about her thoughts on the current scenario of the Biomarker industry, new researches in the field, his presentation at the Conference and his take on the conference program.

Question: What are the recent advances in Biomarker research/commercialization and current challenges that need immediate attention? 

Amber Donahue: The decreasing price and increasing prevalence of next-generation sequencing-enabled platforms is allowing us to ask more and bigger questions. However, the resulting data are huge and intricate, and have created multiple challenges including file transfer mechanisms, short- and long-term file storage, data transfer specifications, and the size of transferred files in the specified data format. Workarounds have been and are being created, but processes and infrastructure require thoughtful overhaul to accommodate this new normal.

Question: What are the new opportunities emerging in your field of work? 

Amber Donahue: Working in support of translational oncology biomarker research provides an opportunity to be at the center of the generation of huge amounts of valuable data which can help to transform our understanding of different cancer indications, treatment mechanisms of action, resistance mechanisms, etc. Due to the increasing complexity of the data, the folks supporting this research have a unique opportunity to shape the analyses and the outputs, and be a part of the analysis of the resulting data.

Question: What are the key take away points from your presentation topic which will help in building the knowledge base of attendees?

Amber Donahue: Hopefully my presentation will help the audience to understand the nature of fit-for-purpose biomarker analysis, and the considerations that need to be addressed in determining the requirements for vendor selection, validation, data formatting and reconciliation, and documentation, depending on the intended use of the data.

Question: Hope you had a chance to go through the agenda, what are your views on it and how helpful it is to the targeted audience?

Amber Donahue: The agenda looks great, and I’m looking forward to being a part of the meeting! It’s a varied agenda, which should provide attendees with a lot of food for thought, and folks with varied expertise to chat with.

Mrs. Amber Donahue is one of the speakers of the 5th Annual MarketsandMarkets Biomarker and Companion Diagnostics Conference being held on February 6th -7th, 2020 at the  Sheraton San Diego Hotel & Marina, 1380 Harbor Island Dr, United States. She will be presenting on Day 1 of the conference on the topic – ‘Business Fit-for-Purpose: From Sample Management to Validation to Final Sample Analysis Data’

Know more about his presentation visit our website –

If you wish to learn a great deal from her about the Biomarker Industry, then register online or email [email protected] to book your slot at the conference.

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