In pharma and life sciences, innovation drives growth. Building on the latest research, only an innovative product – something better than before – will get approved by regulators, approved by insurers, prescribed by HCPs, increase sales and revenue, increase market share and ultimately better the lives of patients. For pharmaceutical companies, “innovation” is more than a buzzword; a deep focus on innovation is integral to success. My predictions for 2017 are centered on focused and tangible innovation in pharma and life sciences:
- CRISPR – the biggest technology in drug development you haven’t heard of, CRISPR is a gene-editing tool which is starting to revolutionize drug development. Scientists are now able to edit gene sequences, which may allow for the elimination of genetic diseases such as sickle cell anemia, MS, CF or Huntington’s. With this powerful tool also comes the potential to cause harm, so profound ethical questions still exist, and the technology is still controversial. Nonetheless, you will start to hear more about its impact on innovation in drug development.
- Early convergence of personalized medicine with patient-centric efforts – As genomic data, clinical trial data, electronic health records (EHR) data and claims data are combined, powerful findings from meta-analysis will improve drug development, leading to more informed decisions and better treatment of patients. This rich blend of data will allow pharma to create a more innovative, focused, and personalized approach to patient care. From a commercial viewpoint, the company that personalizes that story on a local level will “win”.
- Increased presence of apps and wearables – As many pilots have proven their value, apps and wearables have led to vast amounts of valuable patient data, enabling remote monitoring and patient tracking. This category will continue to expand its presence as these data have contributed to smarter, more innovative drug development.
- Increasing investment in digital – Digital functionality supports drug discovery, drug development, testing, and outcomes – all of which provide rich information about patients’ responses to drugs. As these findings continue to lead to innovations, pharma will continue to invest. Digital used to be the exclusive domain of the CIO and is now spreading to all departments, including to CEO initiatives.
- Continued rise of the cloud in drug development – In order for pharma to access the latest innovations in drug discovery digital platform (EDC, CTMS, eTMF) development, the cloud provides more cost-effective, immediate access than replacing on- premise equipment and servers. CIOs are largely moving towards the cloud for this reason, as well as for bridging cross-platform linkages and reducing cost of ownership.
- Increased partnerships with externals – Following recent pharma partnerships with Google, IBM, and Apple, I expect these relationships to deepen and a broader group of externals to develop partnerships. These partnerships have produced great results and will continue to grow, enhancing pharma’s data and analytics capabilities, extending pharma’s digital presence and ultimately driving greater innovation.
- Biosimilars activity on the rise - As cheaper, near-replicas of biologics drugs lose patent protection, biosimilar action will increase this year. With 7 of top 10 drugs under biosimilar attack in 2017, there will be a big increase in the release of biosimilars, undercutting the price of their reference drug.1 As many pharmas are creating biosimilars of other companies’ drugs, and some are creating biosimilars of their own products, this dance will create a great deal of activity.
- Increase in industry partnerships – By blending strengths, pharma partners can drive innovation, enter new and emerging markets, increase capabilities, relieve pricing pressure and expand portfolio while they’re at it. Many pharma CEOs are planning to enter partnerships as they see more growth opportunities today than in the past few years, so I predict an increase in JVs and M&A activity.
- 21st Century Cures Act – Although there is controversy around easing the requirements for drug approval with less evidence of the drug’s safety and efficacy, the Act is a huge push to bring medicines to market more quickly. From a 19-year high of 45 new drugs approved in 20152 to a six-year low of 22 drugs approved in 2016,3 with a corresponding drop in approval rate, I predict the number of drugs approved will fall somewhere in between the extremes this year.
New pharmaceutical trends are continually emerging. In spite of the ongoing changes ahead, one key factor remains in play: focused and tangible innovation will sustain the success of leading players in pharma and life sciences into 2017.
1 Staton, T. (December 8, 2016). Top of 2017's pharma heap? Pfizer, Novartis, Roche—and 7 drugs headed for biosim attack. FiercePharma. Retrieved January 4, 2017 from http://www.fiercepharma.com/pharma/biosim-threats-coming-fast-for-world-s-top-2017-drugs
2 (January 2016). Novel Drug Approvals for 2015. U.S. Food and Drug Administration. Retrieved January 4, 2017 from http://www.fda.gov/Drugs/DevelopmentApprovalProcess/DrugInnovation/ucm430302.htm
3 (January 2017). Novel Drug Approvals for 2016. U.S. Food and Drug Administration. Retrieved January 4, 2017 from http://www.fda.gov/Drugs/DevelopmentApprovalProcess/DrugInnovation/ucm483775.htm