12 Life Sciences Trends to Look Forward to in 2018

Jan 11, 2018

In 2017, life sciences companies took important steps to advance their business processes and drive greater efficiencies in drug development and commercial operations. The industry will embrace transformation initiatives at a faster pace in 2018, across multiple functional areas, including commercial, clinical, regulatory, and quality. In product development, companies are focused on streamlining end-to-end processes to speed time to market and maintain compliance. For commercial teams, driving smarter engagement with customers remains a core focus as they launch more specialized products.

Here is what to expect for life sciences companies in the coming year.

1. Immunotherapies (i.e., CAR T-cell) will shape new and inspiring business models.

In August 2017, the FDA approved its first CAR-T immunotherapy, and in October approved a second for certain difficult-to-treat cancers. Food and Drug Administration (FDA) Commissioner Scott Gottlieb hailed it as “a milestone in the development of a whole new scientific paradigm for the treatment of serious diseases.” The unique development approach and pricing models introduced with CAR-T will transform the pharmaceutical business model. As a genetically modified therapy, the unique process of collecting patients’ cells, altering them in a lab, and infusing them back into patients impacts clinical trials, supply chains, and commercialization. And, due to the very high success rate, innovative pricing models like Novartis’ money-back guarantee on Kymriah, mark a true paradigm shift. In 2018, these groundbreaking therapies will continue to inspire drug manufacturers to rethink their business models.

2. Oncology will propel life sciences companies to engage stakeholders differently.

Product launches for specialized medicine are top of mind for every life sciences company, with oncology drawing the most attention. Globally, the oncology market is expected to hit $120 billion by 2020. Treatment complexity is growing exponentially, impacting everything from clinical trials to the commercial model. To help doctors, patients, and payers navigate these intricacies and drive optimal patient outcomes, companies are rethinking how to improve engagement with all key stakeholders. Technology will play a key role in delivering better data to form insights about oncologists and medical key opinion leaders for more valuable, personalized experiences with drug companies.  

3. Companies will expand the use of artificial intelligence across the enterprise.

There are a higher volume and increasing diversity of data sources available for life sciences companies to generate unique insights. However, due to reliance on small groups of experts and data scientists, companies are limited in their ability to analyze and embed this information into commercial processes. In 2018, companies will significantly scale their use of artificial intelligence for a wider range of commercial applications. With greater scale, applications such as predictive customer engagement will become more ubiquitous.

4. Augmented reality will change HCP engagement.

Augmented Reality (AR) will soon become a powerful part of the physician education process as more companies master the technology. In 2018, life sciences companies will begin experimenting with this new format to create HCP presentations that improve learning with 3-D demonstrations. With AR, physicians can visualize how a drug works, clinical researchers can better monitor their studies, and nurse practitioners can be trained more precisely how to administer drugs with unique delivery mechanisms. More use cases will evolve as this promising digital technology becomes mainstream.

5. Companies will adopt new industry Technology standards.

In 2017, the life sciences industry came together to define technology standards to make it easier for their shared customers to get drug information and services. This coming year, companies will begin to put these standards into action by adopting technologies that make customer engagement easier. HCPs will then be able to access product and services information easier and more quickly across life sciences companies’ various digital channels, leading to better outcomes for patients.

6. Risk-Based Everything (RBX) will take center stage.

The shift to personalized medicine, along with the evolution of adaptive methodologies, is pushing the boundaries of traditional clinical data collection. According to new research from the Tufts Center for the Study of Drug Development, the number of data sources utilized is projected to increase from four to six in three years. To leverage this additional data, risk-based monitoring (RBM) will be replaced this year by risk-based everything (RBX), a new approach where each data point can be analyzed for better decision-making. Modern data management systems will enable the transition to RBX and make it possible to manage the increasing volume and diversity of data sources.

7. The outsourcing industry will modernize clinical.

The top eight contract resource organizations (CROs) have consolidated into just six and represent more than two-thirds of the market. As such, competition is very high, driving CROs to re-examine their operations and expand their offering to become turnkey partners to sponsors. This shift from transactional to more collaborative, strategic partnerships with sponsors has already started. In 2018, expect to see CROs focus on modernizing their technical and data environments to build differentiation.  

8. Regulatory and quality teams will come closer together.

As companies expand globally, change control and variation management becomes more difficult. For example, according to industry consultancy, Kinapse, a top 20 pharmaceutical company may evaluate more than 40,000 change requests in a single year, yet approve only approximately 15,000 changes to implement across their global organization. In 2018, regulatory will begin automating the variation management process and start exchanging information with quality teams to eliminate information gaps. This will make it easier to identify impacted product licenses, determine the required variation filings, and develop global submission strategies.

9. Companies will advance global regulatory processes.

Life sciences companies are under continued pressure to globalize, and will focus on transforming global operating capabilities by unifying regulatory information management (RIM) technologies. Moving to a common RIM model with shared global systems will streamline processes with local affiliates and countries to work more effectively in a global regulatory environment. Regional offices and individual affiliates will be able to work in the same system as headquarters, improving data quality and end-to-end business processes. 

10. Companies will prepare for submissions that require content and data.

Global health authorities have previously relied heavily on document content to conduct their reviews. Gradually, this approach has started to shift to a request for a combination of content and data to provide a more holistic picture of product safety and efficacy. SPL and CDISC were early examples of this combined approach. More recently, upcoming regulations such as IDMP are driving sponsor organizations to carefully examine their approach to product-related information moving forward. As a result, more organizations will begin the transformation of their processes and systems to incorporate both content and data-related elements. While this transformation will support emerging health authority requirements, it will also provide significant benefit to life sciences organizations around the globe through a more complete and more accessible view of their products.

11. Enterprises will adopt a cloud-first strategy in quality.

The continued outsourcing of critical manufacturing functions and high costs of quality issues are prompting companies to improve quality management. Enterprises are recognizing the value of streamlining processes across global sites, suppliers, contract manufacturers, and other partners and are beginning their move to the cloud. While there is still uncertainty about the FDA’s new quality metrics initiative, the potential 2018 implementation could introduce challenges for manufacturers, increasing pressure to modernize quality systems and processes. As a result, organizations will leverage cloud technology to drive greater efficiency and visibility across quality processes.

12. Life sciences industry will unify product development.

Organizations want to invest resources in product innovation but are hindered by the costs of integrating a growing number of disparate applications. Next year, momentum will continue as the industry brings together their applications to support their drug development processes. Companies will focus on streamlining their systems and processes in clinical, regulatory, and quality to eliminate functional siloes and improve efficiency and compliance across the product development lifecycle.

2018: Driving innovation with speed

There will be a sustained focus on transformational change this year, as companies seek to reduce costs while continuing to drive innovation at a faster pace. Embracing digital will be viewed as the key enabler to keep up with external pressures that are rapidly changing, adapt business models to capture new opportunities, and streamline processes to drive new efficiencies. The ‘golden age of life sciences’ will continue as more companies advance groundbreaking therapies and improve patient outcomes. 

 

Veeva Systems Inc. is a cloud-based software for the global life sciences industry. 

native1_300x100
lorem ipsum