Plattform Life Sciences 2/2017

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Märkte & Technologien country. Detiffe envisions a future 5 to 10 years from now where patients are involved in the decision process. Sharing personal data, particularly regarding medical records, is still under strict regulations. But the landscape is starting to change. The recent FDA deci- sion to allow 23andMe to provide patients information about the probability risks for 10 diseases based on their genetic makeup has opened the path towards involving the patients more and more in the pro- cess. “The good news is that patient asso- ciations are getting more and more empowered, and are starting to have good infl uence on regulatory authorities”, says Jemila Houacine, Associate at the life- sciences investment fi rm Medicxi. “It is very important that regulatory authorities integrate this idea of having specifi c biomarkers, diagnostics and drugs addressed to a subpopulation. This will allow quicker approval for specifi c drugs and the adjustment of the design of clinical trials so that less patients need to be recruited to get a clear answer to the effect of a drug. That’s for me the next big thing. The FDA and the EMA have to fully integrate this idea of personalized medi- cine in their scope.” 1 The paradigm is already shifting It seems clear that for personalized medicine to gain the momentum everyone was initially expecting it to have, authori- ties will need to adapt the regulations in order to allow the new paradigm to con- solidate and expand worldwide. The existence of outdated laws and the disparity of regulation between different countries, especially in Europe, is one of the main drawbacks implement diagnostic tools that allow personalized medicine. to Regulatory agencies seem to be starting to pick up the cues and are starting to address one of the factors that suppose a big risk for personalized medi- cine investors: reimbursement. It takes a long time to achieve reimbursement status, and failing to do so can severely affect the commercial success of the product. But the paradigm is already shifting. “We currently see lots of European countries opening the door for reimburse- ment. This is really the next step for us,” says Marjolaine Barldo, Head EMEA at Agendia. Her company is known for MammaPrint, a diagnostic test for breast cancer that can help determine whether chemotherapy is the right treatment for the patient. After a Phase III trial last year the test can reduce the use of such a devastating therapy by 46%, which has paved the way for reimbursement in several countries. Strategies like condi- tional reimbursement, which Mamma- Print is trying out with the French National Health Services (HAS) for three years while evaluating the outcome, are an attractive option to overcome this big challenge. 1)Brian B. Spear, Margo Heath-Chiozzi, Jeffrey Huff, “Clinical Trends in Molecular Medicine,” Volume 7, Issue 5, 1 May 2001, pages 201-204 Sources: The Cost of Sequencing a Human Genome (July 2016), National Human Genome Research Institute www.genome.gov/sequencingcosts/ Illumina wants to sequence your whole genome for $100 (January 2017) https://techcrunch.com/2017/01/10/illumi- na-wants-to-sequence-your-whole-genome-for-100/ Discussing the Future of Personalized Medicine with Biotech Experts (November 2016) http://labiotech.eu/ personalized-medicine-future-biotech/ FDA allows marketing of first direct-to-consumer tests that provide genetic risk information for certain condi- tions (April 2017), U.S. Food and Drug Administration https://www.fda.gov/NewsEvents/Newsroom/ PressAnnouncements/ucm551185.htm Plattform für Crowd-Investoren und professionelle Anleger zur Finanzierung von Life Science Unternehmen Finanzierung von Seed bis Wachstum Crowd-Investments über Nachrangdarlehen Side Investments von professionellen Anlegern in Equity Mehr als eine Finanzierungsplattform: ein umfangreiches Netzwerk zu Life-Science-Professionals Investieren Sie jetzt in die Zukunftsbranche! 02-2017 „Personalisierte Medizin“ ls 19 www.medifundo.de

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