Personalised Medicine
The good news for companies with a global strategy is that there is the possibility of joint FDA- EMA Voluntary Genomic Data Submissions. Although this process is relatively untested at this stage, it should be possible to make a single sub- mission to both the European and US regulatory agencies and receive, hopefully, a unified response. The importance and benefit of biomarkers to opti- mise both current and new treatments from the patients’ perspective is of increasing interest. The opportunity to use biomarkers to select which patients who will be considered to respond best to a treatment should contribute to an increased num- ber of biomarkers that will be verified by the regu- lators for clinical use.
It should also be possible with the increasing opportunities for interaction on this topic among the regulatory authorities in Europe and the US to expand the use and implementation of new biomark- ers in the personalised medicine space. In addition, with the introduction of new Consortia both in European and the US with experts from academia, industry and the regulatory authorities, a more har- monised approach to biomarker development for use in the clinical setting may advance over coming years.
Conclusion
The cancer therapeutics space is driving the devel- opment of the personalised medicine field. As more disease-associated biomarkers are identified and validated, this will expand the reach of person- alised medicine into many therapeutic areas beyond oncology. Beyond gene expression and pro- tein expression profiles, novel biomarkers are being validated with association with disease, espe- cially microRNAs in various types of cancer. The growth of the number of biomarkers and their util- isation to stratify patient populations is developing in parallel with the new guidance on their valida- tion and usage by the European and US regulatory authorities. A regulatory framework is important,
and the newly introduced procedures provide a clear playing field and platform for various com- panies seeking to provide content and tools for per- sonalised medicine and we believe will contribute to the growth and development of the personalised medicine field.
Details of this report can be found at:
www.selectbiosciences.com/marketreports/Micro RNA_and_Cancer_PM2009.aspx.
DDW
Dr Enal Razvi is currently a biotechnology analyst based in the San Francisco Bay Area. In this capaci- ty, he analyzes a number of different market spaces in biotechnology and works with companies in mar- ket analysis, business development and commerciali- sation operations. Previously, Dr Razvi served as Vice-President of Business Development at a number of biotechnology tools and technology companies. Before this, at LJL BioSystems (Sunnyvale, CA), he was Senior Director of Business Development and played a major role in developing LJL BioSystems’ SNP genotyping business. Subsequent to the acquisi- tion of LJL BioSystems by Molecular Devices Corporation, Dr Razvi ran Molecular Devices’ Genomics business. Prior to LJL, while at Frost & Sullivan, Dr Razvi served as Director of its Drug Discovery Consulting business. Dr Razvi holds a doctorate in biomedical sciences and completed post- doctoral work at The Rockefeller University in New York and at Harvard Medical School.
Dr Patricia Hurley is Head of Project Management and Biomarkers Division at ERA Consulting (UK) Ltd with overall responsibility for project manage- ment and the Biomarker division. She has significant experience on the regulatory and product develop- ment issues with biomarkers and biological medicinal products in Europe/USA. Patricia was formerly Principal Scientist at Epistem Ltd and played a key role in developing its biomarker platform technology.
BD Biosciences
Biocius Life Sciences BioTek Instruments, Inc BMG Labtech Gmbh
Cambridge Healthtech Institute CISBIO International SA ELRIG
EYEFORPHARMA Febit Holding Gmbh
90
45 19 30 14 83 56 84 60 17
ADVERTISEMENT INDEX 23
ForteBio, Inc
Greiner Bio-One International AG Hamamatsu Photonics KK Hamilton Company HTStec Ltd
ID Business Solutions Ltd
Life Technologies Corporation Molecular Devices, Inc
PerkinElmer Life & Analytical Sciences
50 53 24 10 29 13 6 8
Promega Corporation Roche Applied Science Select Biosciences Ltd
Sigma-Aldrich Corporation
Society of Biomolecular Sciences Symyx Technologies, Inc Tecan Schweiz AG
Thermo Fisher Scientific TTP LabTech Ltd
49 21
IBC
IFC-3 59 42 77
70,OBC 4
Drug Discovery World Summer 2010
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