The value-based healthcare model is pushing life science companies towards precision medicine, which requires extensive data analysis, technology integration and industry collaboration. Within the medical device industry, there are notable partnerships forming between diagnostics and Big Pharma, device companies and tech and biotech, and small and medium-sized organizations looking for scale and negotiating power. As the use of wearables, mobile medical applications and patient monitoring devices increases, leading companies will determine how to strategically address data management and security, and regulatory uncertainty, while driving innovation.
President Obama’s announcement of the Precision Medicine Initiative this year emphasizes the importance of employing patient data to developpersonalized medical solutions.Personalized Evidence Based Medicine
(EBM) uses diagnostic testing on patients to analyze genetic, cellular or molecular data to identify biomarkers, predict future illnesses and proactively treat them. A growing number of companies are leveraging personalized therapies, such as t-cell based personalized immunotherapies and oncogenomics, to treat conditions in a customized way. However, this shift may present challenges with intellectual property rights, reimbursement policies and patient privacy.
With FDA and global regulatory agencies emphasizing stringent proof of clinical efficacy and innovation, companies exploring regenerative medicine are experiencing complicated and, in many cases, unclear regulatory pathways. Organovo, however, recently valued at $500 million, has achieved FDA approval and reached market commercialization with their 3D-printed human liver tissue preclinical drug assay. Biotechs investing in regenerative medicine (whether cell modifying, allogeneic, or autologous treatments) should evaluate factors such as: patent risks, regulatory pathways and dialog, reproducible GMPs, necessary yields and manufacturing scale, handling and storage approaches, and marketing & payer strategies.
Patients use social media for treatment information, to seek usage advice, and to provide feedback on therapy experiences. This begs the attention of biotechs, investors and regulators. As such, the FDA has published industry guidelines for corporate social media engagement. How biotechs interact with patients on social platforms will demand both an offensive and defensive strategy. Roche and Regeneron have published social media policies to mitigate the likelihood of noncompliance, the effects of which Chimerix has already exemplified. In 2015, as social media continues to impact public perception, biotechs will need to develop concrete guidelines for how they
will engage in social media.
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