The 2019 pharmaceutical trends build off an exciting 2018 in pharma with new developments in artificial intelligence, R&D, personalized medicine, drug pricing, and more. As pharmaceutical industry leaders look to the coming months, there will be even greater opportunities for transformative growth as the landscape continues to evolve and take shape. Businesses addressing the critical 2019 pharmaceutical trends will:
- continue to embed transparency within strategy and operations, especially in the areas with a greater focus by regulators, legislators, and patients such as pricing and clinical trial reporting,
- further expand investment and development in personalized medicine with a critical eye to pricing and administration,
- rigorously access current R&D strategy to realize opportunities for innovation using artificial intelligence, big data, and analytics to strengthen returns and reverse the decline of R&D ROI across the industry, and
- fortify the organizational culture of quality to mitigate the increasing risks associated with data integrity failures.
1. Transparency in Clinical Data Reporting
Last year, the 2018 Edelman Trust Barometer showed consumer trust in the pharmaceutical industry hit a new low to a score of 38%, marking the industry as the least trusted of the 15 industries tracked by Edelman. Patients, payers, and politicians carry an even more critical view on the industry and are increasingly expecting and demanding transparency, so regulators are following suit with regulatory levers to drive greater visibility into many areas, including clinical trials. The FDA released a draft guidance in September 2018 introducing penalties for entities or responsible parties that fail to register clinical trials or report clinical trial data in a timely fashion. Moving forward, drug makers and clinical research and development organizations must embed transparency into each step of the clinical process. As the industry shifts towards greater visibility for all stakeholders, companies will be well-positioned by beginning this change management effort now.
2. What’s Next for Personalized Medicine?
2018 was a banner year in personalized medicine, representing a dynamic shift in the way drugs are developed and administered – particularly in oncology. Looking to 2019, it’s readily evident that we’re just scratching the surface of personalized medicine’s potential both therapeutically and commercially. With few approved treatments on the market, companies with developed or developing CAR-T treatments are realizing the difficulties in commercializing the products due to high costs to the patient and insurers. Furthermore, while innovation in the space has been tremendous, we’re only beginning to understand the hefty side effects the treatments can carry. Regardless, CAR-T treatments and other personalized and precision medicines remain a promising evolution for the industry. As we move into 2019, innovators in this space must keep a critical, laser focus to managing the end cost to the patient and collaborating with payers early.
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